JP5139976B2 - Automatic pharmacy mixing system (APAS) - Google Patents

Abstract

In a preferred embodiment, an automated Pharmacy Admixture System (APAS) may include a manipulator (322) system to transport medical containers such as bags, vials, or syringes in a compounding chamber regulated to a pressure below atmospheric pressure. In a preferred implementation, the manipulator system is configured to grasp and convey syringes (1106), IV bags (1102), and vials (1104) of varying shapes and sizes from a storage system in an adjacent chamber regulated at a pressure above atmospheric pressure. Various embodiments may include a controller adapted to actuate the manipulator system to bring a fill port of an IV bag (1102), vial (1104), or syringe (1106) into register with a filling port at a fluid transfer station in the chamber. A preferred implementation includes a sanitization system that can substantially sanitize a bung on a fill port of a vial (1104) or IV bag in preparation for transport to the fluid transfer station.

Description

TECHNICAL FIELD Various embodiments relate to the handling of medicinal containers such as syringes, vials and IV bags.

Cross-reference to related applications This application was filed on December 22, 2005, filed on December 22, 2005, with the names of the inventors Rob, Eliuk, and Mlodzinski as inventors under §120 of the US Patent Act. Claims priority to US patent application Ser. No. 11 / 316,795 entitled “Automated Pharmacy Admixture System”, claiming priority to US Provisional Patent Application No. 60 / 638.776. This application is also a U.S. Patent Provisional, entitled `` Device and Method for Cleaning and Needle / Cap Removal in Automated Pharmacy Admixture System '' filed May 16, 2005 under U.S. Patent Act §119 (e). Claim priority to Application No. 60 / 681.405.

BACKGROUND Many medical agents are delivered to a patient from an intravenous (IV) bag into which a certain amount of medical agent has been introduced. Occasionally, the pharmaceutical agent may be a mixture with a diluent. In some cases, the IV bag contains only the medical agent and diluent. In other cases, the IV bag may also include a carrier or other material that is injected into the patient at the same time as the medical agent. The medical agent can also be delivered to the patient using a syringe.

  The medical agent is often supplied in powder form, for example, in a medical agent container or vial. Diluent liquid may be supplied to make a mixture with the medical agent in a separate or diluent container or vial. Depending on the prescription, the pharmacist may mix a certain amount of the medical agent (eg, in a dry form such as a powder) with a special amount of diluent. Thereafter, the mixture may be delivered to the patient.

  One role of the pharmacist is to prepare a dispensing container, such as an IV bag or syringe, containing the correct amount of diluent and medical drug according to the prescription for the patient. Some prescription drugs (eg, insulin) may be prepared to suit many types of patients (eg, diabetes). In such cases, many similar IV bags containing similar pharmaceutical agents can be prepared in one batch, but for example, the volume of each dose may vary. Other prescriptions, such as those involving chemotherapeutic drugs, may require very accurate and careful control of diluents and pharmaceuticals to satisfy prescriptions tailored to each patient's needs.

  Preparation of a prescription drug within a syringe or IV bag includes, for example, the transfer of fluids such as medical drugs or diluents between vials, syringes, and / or IV bags. IV bags are typically flexible and can easily change shape as the volume of fluid contained changes. IV bags, vials, and syringes are commercially available in various sizes, shapes and designs.

Overview In a preferred embodiment, an automated pharmacy mixing system (APAS) may include a manipulator system for transporting medical containers such as bags, vials, or syringes in a compounding chamber that is regulated to a pressure below atmospheric pressure. In a preferred implementation, the manipulator system is configured to grasp and transport variously shaped and sized syringes, IV bags, and vials from a storage system in an adjacent chamber regulated at a pressure above atmospheric pressure. Various embodiments may include a controller adapted to operate the manipulator system to align the injection port of the IV bag, vial, or syringe with the injection port of the fluid transition station in the chamber. A preferred implementation includes a disinfection system that can substantially disinfect the stopper on the injection port of the vial or IV bag in preparation for transport to the fluid transfer station.

  Various aspects may provide one or more of the following advantages. First, APAS formulates toxic and / or volatile substances, such as those used for chemotherapy, in a substantially sterile chamber at a pressure below atmospheric pressure, where the substance is outside the chamber. May be substantially prevented from leaking unintentionally. Second, the APAS is programmed to select medical containers such as IV bags, syringes, and / or vials according to the protocol for the specific location (e.g., hospital) for the container for special drug orders. May be. Third, medical items including IV bags and vial stopper ports may be arranged to receive a disinfecting dose of pulsed ultraviolet radiation.

  The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description, drawings, and claims.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS Various exemplary embodiments relate to the processing of medical items contained in containers such as bags, vials, and syringes. Some embodiments include automating the process of transferring and / or packaging fluids, compounding drugs, and preparing medical items.

  An automated pharmacy mixing system (APAS) may include a manipulator that transports medical containers such as bags, vials, or syringes for a substantially sterile mixing chamber. In a preferred implementation, the gripper assembly is configured to grasp and hold a substantially wide variety of syringes, IV bags and vials of various shapes and sizes. In an exemplary embodiment, the gripping device may include a claw configured to grasp a plurality of different types of IV bags, each type having a different injection port structure. Aspects may include a control device adapted to actuate the transport assembly to align the injection port of the bag, vial or syringe with the injection port, such as a cannula located at the injection station. And a carousel delivery system adapted to carry the syringe to the mixing system and deliver the constituent medical agents in the bag, vial or syringe to the release area.

  FIG. 1 shows an exemplary automated pharmacy mixing system (APAS) cell 100 device for use in a hospital pharmacy environment. The APAS cell 100 may automatically mix the contents of the syringe and IV bag using automated techniques. For example, aspects of the APAS cell 100 may otherwise perform one or more operations performed by pharmacy personnel in a laminar flow hood. The APAS cell 100 includes a robotic cell that automates compounding and dispensing of drug doses into IV bags and / or syringes, such as those that may be prepared at hospital pharmacies. A robotic cell may use a syringe-based fluid transfer process, and a robotic manipulator (e.g., a multi-degree-of-freedom arm) for moving drug vials, syringes, and IV bags through the cell as the pharmaceutical agent is processed. ) May be used.

  FIG. 2 shows an exemplary device 200 that allows an operator to load inventory, enter control information, and / or remove a syringe and / or IV bag from the APAS cell 100 of FIG. it can. The APAS cell 100 includes a flat panel monitor 202, which an operator, eg, a pharmacist, may use as a user interface to the APAS cell 100. The APAS cell 100 may include one or more flat panel monitors 202, which may be used, for example, to input control information and / or output status information. In this example, the flat panel monitor 202 may also act as a controller, and the operator can start, stop, and suspend the APAS cell 100, for example, by touching an indicator on a touch screen. As an output device, the flat panel monitor 202 can be used in the monitoring of APAS status and warning status, for example, by displaying a message to the operator when a preset status occurs. As another example, the operator may use the flat panel monitor 202 to control the process of loading the drug required to perform the compounding process into the APAS cell 100. An operator may use the flat panel monitor 202 as an input device, for example, to control the cleaning of the APAS cell 100 in a step-wise manner. While training the system for new drugs prepared in the APAS cell 100, the flat panel monitor 202 may be used as an input and output device, for example, by a pharmacist.

  In conjunction with the APAS cell 100, a remote user station (RUS) 206 may provide inventory control, planning, and / or management and management functions. The RUS 206 may include a workstation 208, an inventory rack 210, and an inventory (eg, drug container) 212. Workstation 208 is interfaced to APAS cell 100 either directly or via a computer network (e.g., LAN, WAN, MAN, wLAN) that may be part of a hospital interface network in some implementations. Also good. For example, the operator may use the workstation 208 to review, add, prioritize, or modify drug orders and planned manufacturing for the APAS cell 100. The operator may also use the workstation 208 to plan and manage drug dose formulation and / or distribution by the APAS 100 and / or report actions related to such processes. In another example, workstation 208 may be used in APAS cell management to control the release of a drug order queue to a cell for the compounding process or to monitor the APAS cell status during the compounding process. Workstation 208 and / or APAS cell 100 may identify and may include, for example, hardware and / or software for scanning barcodes, RFID tags, etc., identifying inventory, and / or on inventory racks. Easy to place in.

  In this example, the operator may use RUS 206 to adjust the loading of inventory rack 210. The inventory rack 210 may be loaded with an inventory 212 that may include various size 214, 216 vials, syringes 218 and / or IV bags (not shown). In this aspect, each of the racks 210 may store only one type or size of inventory items, but different racks may be arranged to hold inventory items of various sizes. In some aspects, one or more racks 210 may be configured to store inventory items of multiple sizes and / or types. In this embodiment, the rack 210 is arranged to store large vials 220, syringes 222, or small vials 224. Another embodiment of a rack 210 for storing inventory may include a rack for IV bags, examples of such racks are described with reference to FIGS. 5 and 14, for example. Each inventory item may be manually placed in a suitable support, such as a retaining clip, hook, shelf, bin, slot, or pocket on rack 210. Can be mentioned.

  Stock 212 may be used as an input to APAS cell 100, supplying vials, syringes, and / or IV bags that may contain drugs and / or diluents required by the system for the compounding process Also good. APAS cell 100 is a syringe and a syringe prepared for use, for example, in dispensing drug doses to patients in hospitals, healthcare facilities, clinics, or for distribution to outpatients (e.g., home care visits). An IV bag may be output.

  In some implementations, the inventory rack 210 may be pre-loaded with inventory 212 required for input to the APAS cell 100 (eg, offline beforehand). For example, a pre-loaded rack of commonly used inputs (eg, saline IV bags) may be prepared to meet the predicted, anticipated, or planned formulation manufacturing order. For example, racks, drug inventory, and container inventory may be preloaded at off-site warehouses where they may be stored. Some or all operations associated with a remote workstation may be performed in a work area having a controlled environment that may be a substantially sterile environment. The computing device 208 may communicate with the APAS cell 100, each processing and / or exchanging information about previous, current and predicted inventory, providing a schedule, and requesting information It may be programmed as follows. Information may be used to prioritize, plan, and order inventory, for example, respond to and satisfy manufacturing input requests for one or more APAS cell 100 systems . In some cases, the APAS cell 100 cooperates with a hospital inventory control system, for example, automatically placing orders and certain inputs or outputs of the APAS cell 100 based on previous and expected request information You may maintain a minimum level of inventory.

  In some examples, the APAS cell 100 may be operated in batch mode, producing a number of substantially similar outputs, e.g., producing a special dose of cefazolin in a special type of syringe. Also good. In another example, APAS cell 100 may be operated such that inventory is loaded 226 in situ. In situ loading can occur at virtually any time to generate a typically limited number of outputs, which may include, for example, a single dose. In situ loading includes, for example, loading inventory onto a rack in the APAS cell 100 without interfering with the ongoing blending process or when the APAS cell 100 is in idle mode.

  Some embodiments may include two independently operable carousels. In one mode of operation, one of the carousels can be operated to deliver inventory to the processing chamber and the other carousel is unloaded or loaded. In another aspect, APAS cell 100 may include three or more inventory delivery systems, which may perform the same function as a carousel, examples of which are described elsewhere herein. In such an embodiment, one or more carousels may be operated to deliver inventory while one or more other carousels are enabled or inventory is loaded / unloaded.

  For example, a pharmacist responds to an order (sometimes called a stat order or an on-demand order) received from a physician in writing about a necessary medical drug immediately or by email (sometimes called a stat order or an on-demand order). Loading may be used. The APAS cell 100 may inform the technician what input needs to be loaded to satisfy the order. Knowing the items needed for a stat order, the technician loads any stock (eg, drug vials, syringes, and / or IV bags) and performs the compounding and / or dispensing process on the appropriate rack 210 Alternatively, the rack 210 is arranged on a carousel (not shown here) in the APAS cell 100. In another aspect, the technician may load the inventory into an unused location in one or more racks that already exist on the carousel in APAS cell 100. An engineer may enter order information or instructions to configure the APAS cell 100 to satisfy a stat order.

  In some examples, the APAS cell 100 may store a recipe for formulation in a memory or database. In such cases, the operator may identify the prescription to be recalled from memory. In another example, a pharmacist or operator may teach an APAS cell how to process inventory, for example, using a user interface driven by software. The APAS cell 100 may learn a new prescription through the training mode, which may include the user entering command information via a graphic user interface displayed on the monitor 202. The operator may indicate, for example, the location of inventory items on a graphical map of the inventory system.

  In some embodiments, the storage rack may be scanned by a scanner (eg, barcode, FRID, etc.) when refilling inventory. Reports that may be printed by APAS or by a printer associated with a network computer (e.g., a hospital pharmacy data entry terminal) are cross-referenced, e.g., when allocating (e.g., to a patient, hospital cart, etc.) Barcode information that can be included. Data stored in memory that can be accessed by the computer system may include data associated with medical items, authorized system users and associated access rights, storage areas, and supplemental information. Authorized user information may relate user identification information, eg, biometric data, passwords, challenge response authentication, as well as other mechanisms known to those skilled in the art. In some implementations, in at least some modes, access to the storage chamber requires an authorized user to have access to a door, which is unlocked in response to an authorization request for access. May be.

  The stored data may include machine-readable indicia (e.g. 1 or 2D barcodes, RFID tag codes, etc.), text that may be read using optical character recognition (OCR), and / or speech recognition information. Good. The stored data for the medical item may include trademark and / or generic name information. Medical containers including IV bags, vials, and / or syringes may be labeled with such data, along with individual or kitted outputs of storage carousels or storage racks, eg, medical items.

  FIG. 3 is an exemplary top cutaway view of the APAS cell of FIG. APAS cell 100 includes two chambers. The inventory chamber 302 is used as an inventory loading area, which can be accessed by an operator and loaded into the APAS cell 100 via a loading door (not shown). The processing chamber 304 includes a blending region where mixing and / or blending processes can occur. In some embodiments, the processing chamber 304 provides a substantially sterile environment, which may be an ISO class 5 environment that complies with clean room standards. Two monitors 202 are mounted outside the APAS cell 100, which may function as an input / output device as described with reference to FIG.

  The inventory chamber 302 includes two inventory rack carousels 310 and 312 and a temporary inventory rack 314. A temporary inventory rack 314 may be used to place in-process drug vials containing enough material to provide multiple doses. Each inventory rack carousel 310 may support a plurality of inventory racks 210. In some applications, the operator may remove one or more racks from the carousel 310, 312 and replace them with racks loaded with inventory. The rack may be loaded on the carousel 310, 312 according to the road map, and the road map may be created by an operator for submission to the APAS cell 100, or may be created by the APAS cell 100 and contacted by the operator. Chambers 302 and 304 are separated by a dividing wall 316, an example of which is described with reference to FIG.

  The processing chamber 304 includes a multi-degree-of-freedom robot arm 318, which can further be used, for example, to pick items from a pocket on a rack or to grasp items in the APAS cell 100 for manipulation. Includes gripper that can. Exemplary grippers are described in further detail with reference to FIGS. The robotic arm 318 may select, manipulate, or reposition inventory items in the processing chamber 304 and in or around the carousels 310, 312 in response to command signals from a controller (not shown). . The robotic arm 318, for example, selects a vial, IV bag, or syringe from a rack of carousels 310, 312 in the inventory chamber 302 and moves the item to a station in the processing chamber 304 for use in formulation preparation. Inventory items may be manipulated. In some examples, the robot arm 318 may manipulate inventory items on the carousel 310, 312 via the access port 410 in the septum 316. Septum 316 may be substantially sealed so that a substantially sterile environment is maintained for the compounding process within process chamber 304.

  According to an illustrative example, drug orders arriving from RUS 206 include batch manufacturing orders in which syringes contain individual doses of drug reconstituted from the drug provided in one or more vials. The operator can, for example, load an inventory rack of drug vials into the carousel 310 and interface with the APAS cell 100 using the input / output device 202 to initiate, monitor, and / or control the loading process. Drugs may be preloaded into the APAS cell 100 during the loading process. When APAS cell 100 is processing the previous order, the operator can add a syringe, drug vial, and IV to carousel 312 while APAS cell 100 is operating carousel 310 for the next batch production order. An inventory rack of bags may be loaded. As soon as the loading process is complete, the operator may submit a batch manufacturing process, which may be started immediately or after another process is completed.

  In order to perform batch manufacturing, in this example, the robot arm 318 may remove the syringe from one pocket of the rack in the carousel 310. The syringe in the carousel may have a needle and a needle cap. The needle cap is removed for processing in the APAS cell 100. The robotic arm 318 may carry the syringe to the decapper / deneedler station 320 where the needle cap is removed from the syringe / needle assembly and the needle is exposed. The robotic arm 318 may move the syringe to a needle-up syringe manipulator 322, where a dose of drug is transferred to one or more confirmation operations (e.g., gravimetric measurement, barcode scanning, and / or After machine vision recognition technology), the robot arm 318 pulls it out of the vial previously placed there. The robot arm 318 moves the syringe to the decapper / denierler station 320 where the needle is removed from the syringe and discarded into a needle container (not shown here). The robot arm 318 then moves the syringe to the syringe capper station 324 where the needleless syringe is capped. The robot arm 318 moves the syringe to the weighing station 326 where the syringe is weighed and the predetermined dose programmed into the APAS cell is confirmed. The robot arm 318 then moves the syringe to the printer and labeling station 328 and accepts a computer readable identification (ID) label that is printed and affixed to the syringe. This label may have a barcode or other computer readable code printed thereon, such as patient information, drug name in syringe, dosage, and date and / or Alternatively, lot code information for input may be included. The robot arm 318 then moves the syringe to the output scanner station 330 where the information on the ID label is read by the scanner to confirm that the label is readable. The APAS cell 100 may return a report to the RUS 206 for use in the operations plan using the hospital interface network. The syringe is then picked up by the robot arm 318 and thrown into the syringe discharge chute 332 where it can be utilized by a pharmacist, for example, in stock in a hospital pharmacy. If the process continues, it may take time for the robot arm 318 to remove the empty vial from the needle raising syringe manipulator 322 and place it in the waste chute 333 during the drug ordering process.

  In another illustrative example, the syringe is both as an input containing a fluid (e.g., a diluent or a known drug compound) that is mixed during the compounding process and as an output containing a prepared dose suitable for delivery to a patient. May be used. Such a syringe may be required, for example, to execute a special reconfiguration order programmed into the APAS cell 100 via the input / output function of the monitor 202. In another example, the order may be a stat order that may be received from a hospital interface. In this example, the operator performs in situ loading 226 by placing a syringe that is used for both reconstitution and dosing in a pocket on the rack already placed on the carousel 310. The operator enters a reconfiguration order into the APAS cell 100. Robotic arm 318 picks the selected syringe from the pocket in the rack in carousel 310 and moves it to decapper / denier station 320, where the needle cap is removed from the syringe / needle combination, thereby exposing the needle. To do. Thereafter, the syringe is moved to the needle lowering syringe manipulator 334 by the robot arm 318. At station 334, the diluent is drawn into the syringe from the diluent supply IV bag 336 previously placed therein by the robot arm 318. Diluent supply 336 may be included in an IV bag, which is suspended by a clip onto needle lowering syringe manipulator 334 as shown in FIGS. If necessary, an IV extraction bag may be prepared by performing an air extraction process, details of which will be described with reference to FIGS. The syringe then punctures the membrane of the diluent port 338 (another example of this is shown in FIG. 7) in the needle down direction. The syringe is activated, for example, to remove a predetermined amount of diluent from the IV bag. The needle lowering syringe manipulator 334 then moves the reconstitution vial 340 previously placed there by the robot arm 318 under the syringe. The diluent in the syringe is transferred to the vial for reconstitution with the vial contents. The robot arm 318 then moves the vial to a mixer for shaking according to the mixing profile. The robotic arm 318 then moves the vial to the needle raising syringe manipulator 322, where an appropriate amount of reconstituted drug is withdrawn from the vial into the “output” syringe previously transported by the robotic arm 318.

  In another aspect, the APAS cell 100 may accept a manufacturing order that prepares a formulation that may include IV bags as input inventory items or as output. In some examples, an IV bag may be selected as a diluent source for reconstitution in a drug order that is output in another medical container. In another example, the selected IV bag may be used for output after drug order preparation is complete. Several IV bags may be placed on the carousel 310, 312 and used as an input that may be at least partially filled with a diluent that may be used to reconstitute the drug. The reconstituted drug may be output in the form of a filled syringe or IV bag. The operator loads the syringe and IV bag rack into the carousel 310 for use in the production order. During the manufacturing order, the robot arm 318 picks an IV bag from the rack on the carousel 310 and moves it to the scale and bag ID station 326. At this station, the IV bag is identified by bar code or pattern matching and its weight is recorded. This may be performed, for example, as an error check and / or proactively to identify the type and / or volume of diluent used for reconstitution. If an IV bag is selected as the diluent source, the bag may be weighed prior to use to confirm the presence of diluent in the IV bag. When selecting an IV bag for output, it may be weighed multiple times, eg, before, during, and / or after each fluid transfer step. As a post-transition confirmation step, the weight may be rechecked after performing the fluid transfer operation to determine if the change in weight is within the expected range. Such a check may detect, for example, a leak, spill, overfill, or material input error. In this example, robotic arm 318 moves the IV bag to port cleaner station 340, where pulsed ultraviolet (UV) light or other disinfection processes are used to substantially sterilize at least a portion of the IV bag port, It may be sterilized and / or disinfected. The robot arm 318 moves the IV bag to the needle raising syringe manipulator 322 where the prefilled syringe is loaded. As in the example described with reference to FIGS. 17A-17C, the IV bag may be inverted so that the injection port is oriented downward for the injection process. The contents of the syringe may then be injected into the IV bag. The robot arm 318 then moves the IV bag to the weighing station 326, where the IV bag is weighed and the predetermined dose programmed into the APAS cell is confirmed. The robot arm 318 then moves the IV bag to the bag labeler tray station 342 where the label printed by the printer and labeling station 328 is applied to the IV bag. The robot arm 318 may move the IV bag to the output scanner station 330 where the information on the ID label is read by the scanner to confirm that the label is readable. One or more other verification checks may be performed and such examples are described elsewhere in this specification. The IV bag is then captured by the robot arm 318 and thrown into the IV bag discharge chute 344 where the pharmacist can be placed, for example, in inventory in a hospital pharmacy.

  In another aspect, vials (eg, other medical items or containers) may be prepared for reconstitution. While performing this process with the APAS cell 100, the vials may be identified at the vial ID station, where the barcode label on the vial is, for example, by image hardware combined with a scanner and / or image processing software. , May be read. The acquired information may be processed to identify the contents of the vial and correlate with what is expected. In some implementations, as an alternative or in combination with barcode scanning, APAS cell 100 may use pattern matching on vials using optical scanning techniques. Also, during the reconstitution process, the vial mixer 346 may be used to mix the vial contents with the diluent and then use it for administration.

  In some aspects, the robotic manipulator may include a device for reading machine-readable indicia in the APAS, including a blending chamber and / or a storage chamber. For example, the manipulator may include a fiber optic camera for taking images that can be processed for comparison with stored image information (eg, a bitmap). In another example, the reader may include optical scanning (eg, barcode) or RFID (radio frequency identification). Some aspects may transmit image information wirelessly (eg, using infrared or radio frequency (RF) transmission) to a receiver coupled to the APAS. Such a receiver may be placed inside or outside the chamber with the robot manipulator. Such readers can be used to read machine-readable indicia at various locations in and around the compounding chamber, including from windows and on portions of the storage carousel exposed to the compounding chamber. Good.

  FIG. 4 is a perspective cutaway view 400 of an exemplary APAS, one example of which is an APAS cell 100, showing details of an apparatus for handling syringes and IV bags in the APAS cell. The handling device delivers inventory, including syringes, vials, or IV bags of various sizes and types that are grasped by the robot arm 318 within the processing chamber 304. The operator or technician may load / unload an inventory rack that stores inventory until delivered to the robot arm 318. In this example, the carousels 310, 312 may store, for example, syringes, vials, and / or IV bags for use in the process performed in the APAS cell 100. A partial view 400 of the APAS cell 100 is shown showing the robotic arm 318 and how the robotic arm can access the inventory chamber 302 with most of the processing chamber 304 removed.

  In this embodiment, an inventory chamber 302 with a loading door 404 is shown, which may be opened to load or remove a rack from any of the carousels 310, 312. The operator places the APAS cell 100 in loading mode and controls the carousel by indexing it away from the robot access position, where the carousel rack position is presented to the robot access port 410 by the curved wall 408. This is present in a part of the partition wall 316. The carousels 310, 312 rotate to align the rack station on the carousel with the loading door 404 and allow rack-loading access 412. The carousel is commanded by the operator and can be placed with any one of the rack positions aligned with the loading access port 412. A rack aligned with the access port 412 can be removed and replaced with a rack containing full inventory, or the rack may have the inventory replaced in situ, and inventory is referred to as a single pocket at a time. Load into a small one. The racks can be reloaded with any combination of individual racks, including replacing all racks at once. As a result of rack loading, the operator may indicate via the touch screen that the APAS cell loading process is complete. This initiates a cycle where the carousel rotates with a 360 degree rotation and the bar code reader adjacent to the carousel reads the bar code on each of the racks (e.g., bar code 1408 in FIG. 14). Can do. This allows the system to update inventory data and correlate racks and inventory with carousel location information.

  In this example, the septum 316 includes a curved wall 408, but separates the inventory chamber 302 from the processing chamber 304 so that, for example, the carousel 310 can process even while the operator is loading the carousel 312. The compounding process can be performed in a substantially sterile environment within chamber 304. In the in situ process, for example, as described with reference to FIG. 2, the loading of the carousel 312 by the stat order may be performed while the APAS cell 100 is operating outside the carousel 310. Septum 316 may be designed to substantially minimize airflow between inventory chamber 302 and processing chamber 304. Similarly, airflow restrictions may be set at the loading door 404 in the inventory chamber 302, for example, the rack is in the rack loading position (e.g. aligned with the access port 412) and the door 404 is open. Air exchange with the atmosphere is limited.

  In one embodiment, the loading door 404 may be coupled to an interlock that requires the loading door 404 to close during each advancement of the carousel 312 for operator safety. Such an embodiment may also help reduce uncontrolled air exchange within or outside the inventory chamber 302 while the carousel 312 is rotating.

  FIG. 5 illustrates inventory that can be accessed by a robot to select inventory (e.g., drug vials, syringes, and / or IV bags) that may be processed by an automated system cell, e.g., APAS cell 100, etc. An exemplary inventory system 500 with expanded area is shown. The inventory system 500 includes one or more carousels 502 for placing inventory. The carousel 502 may be located within the robot travel range so that the robot can access the entire height of the rack on the carousel 502. The inventory is placed in a finite number of vertical racks 504 of the type shown in FIG. 2 placed around the carousel. In this example, carousel 502 includes 12 racks, but the design can accommodate any number of racks, including, for example, a partial length (eg, half length) rack. The rack size and configuration depends on the user's requirements for inventory item size or inventory quality. All the racks can be moved within the reach of the robot arm 506 by rotating the carousel 360 degrees while individually stopping with respect to each rack. Inventory position positioning may include repeatedly positioning the rack on the carousel and repeatedly rotating the carousel at each rack position and preprogramming it to stop.

  For example, as described with reference to FIGS. 12-13, the rack may be easily replaced from the carousel for replenishment. The racks are generally interchangeable with respect to their location on the carousel so that the racks can be removed, refilled and reinstalled in any order. Although FIG. 5 shows that the racks are all the same size and type, inventory may be stored separately on the rack for each size IV bag. Similarly, a rack can be configured for each size syringe, or a combination of syringe and size quality.

  The rack for drug vials may also be configured to handle a full range of vial sizes. Some vial racks may be dedicated to large vial sizes, and some may be partitioned to handle two or more vial volume sizes. Rack versatility and rack compatibility allow cells to be loaded and used for batch processing of one type of drug in multiple doses, or for various drug ranges that can be processed on demand The mode can be switched between inventory loads. Also, for example, the batch process may withdraw inventory from one carousel, and the on-demand order may withdraw inventory from a second carousel.

  Extra racks can expand the possible range of inventory in a cell, and in-situ (e.g. online) replenishment of inventory in a cell can be achieved using multiple carousels (2 or more) Can do. Cell downtime can be substantially minimized by reloading one carousel once another carousel is empty and the cell is obtained from another.

  In this example, the carousel is substantially circular and rotates about the vertical axis. In another aspect, the carousel may be configured to rotate about a horizontal axis and the racks may be arranged vertically or horizontally. In some aspects, the carousel may have a cross-section that is substantially oval, rectangular, square, triangular, or other polygon suitable for providing a rack of inventory to a robotic arm. In some aspects, the central portion of the carousel may rotate about an axis. In another aspect, the rack is secured to a continuous or segmented belt (e.g., a chain) and supported by two or more vertical or horizontal axes that rotate when the rack is indexed into place. Or may be supported by one or more support members, which are supported by and / or extend from a rotating hoop or shaft.

  The control electronics may accept a unique electronic rack identification (eg, hall sensor, encoder, barcode reader, pattern recognition, etc.) and identify the rack at each location on the carousel. This position information may be used to adjust carousel rotation, facilitate inventory loading / unloading, and supply inventory to the robot arm for processing.

  In some aspects, the APAS cell controller may associate the stopping position of the carousel being loaded with the position of each rack. Thus, the controller may automatically determine and monitor the inventory quantity at each inventory location in the carousel. In some examples, the controller may monitor inventory location information with substantially no operator input.

  In an exemplary embodiment, an APAS cell has an IV bag of all sizes accurately defined or aligned in the inventory system, so it is picked up by a robot, moved, and placed at other stations in the cell. Infusion port retention and grasping features that can be kept. These infusion port holders may be provided to repeatedly control the position of the port so that the robot gripper grasps the bag with the infusion port and moves the IV bag between the stations in the cell to accurately Can be placed on the needle and the dose is injected. With minor improvements, these features can be adapted to fit IV bags from all major manufacturers, each potentially offering a unique shape.

  An exemplary device for holding the infusion port of an IV bag commercially available from Baxter 600 and Abbot 602 is shown in FIGS. An exemplary retention device, or retention clip, includes substantially rigid holders 604 and 606, respectively. In these holders 604, 606, due to the compliance of the injection port, the injection port can be slightly deformed while being inserted into the holder.

  In various aspects, interference between the engagement surface of the holder and the injection port may provide sufficient frictional force to hold the injection port in the holder after insertion. The embodiment of the holder may be designed to take out the bag infusion port and has a unique alignment on the bag's geometric features that match between bags as well as the full range of bag sizes from each IV bag manufacturer. Provided.

  Another exemplary embodiment of a compliant holder 700 is shown in FIG. The design or variations thereof may be used on a bag that includes an injection port 702 constructed of a rigid material or for a high volume use station in a cell. Examples of such stations may include a meter hook or tray near the station. The robot may place a bag to be weighed on the scale one or more times during processing.

  An example of an IV bag holder attached to the inventory rack 224 of FIG. 2 is shown in FIG. 8, which includes a front view 800 and a side view 802. FIG. Front view 800 and side view 802 show how an IV bag 804, e.g., Baxter bag 600, slides into pocket 806 in inventory rack 224 and by inserting injection port 810 into injection port holder 812. It shows whether the injection port 810 is fixed to the inventory rack 808.

  The robot may be programmed to remove the IV bag from the holder position via the injection port 810, as shown in the perspective view 900 and side view 902 of FIG.

  In this example, the robot gripper 904 grasps the injection port 810 with the two jaw gripper fingers 906 both on the top and bottom of the bag holder 812, securely grips and provides alignment of the port to the gripper axis. The robot gripper finger moves in the lateral direction 908 and grasps the injection port 810. Removal of the bag is accomplished by moving the gripper linearly away from the holder (substantially parallel to the plane on which the holder body is present) and moving the injection port away from the holder 812. When the injection port is moved away from the holder 812, the robot manipulator may then withdraw the bag from the slot with an appropriate action.

  The robot manipulator may grasp the IV bag injection port using the gripper fingers. FIG. 10 is an exemplary set of gripper fingers 1000. The gripper finger 1000 includes handling of IV bags, but can perform multiple operations including handling of other items such as vials and syringes of various sizes and types.

  The gripper finger 1000 provides a multi-purpose design where the finger jaw tip has a substantially semi-circular cutout 1002 for holding or grasping the injection port on the IV bag and / or syringe. The semicircular chin design may substantially follow the general shape of the IV bag injection port. In various aspects, the gripper fingers may be sized and shaped to grasp and handle the various IV bag infusion ports, reducing the weight of a fairly heavy fluid-filled IV bag without damaging or deforming the ports to unacceptable levels. It may be designed to support.

  As can be seen with reference back to FIG. 9, the gripper fingers may include upper and lower sets of opposing jaws. The space between the upper and lower sets may be sufficient to grasp the upper and lower injection ports of the holder 812, respectively.

  In some embodiments, one or more support members (not shown) may extend above and / or below the top surface and / or bottom surface of the inner diameter of the notch 1002. Such a support member may provide an additional surface area for engaging the injection port so that when the gripper fingers are inserted into or removed from the holder 812, the injection port The force applied to the injection port may be distributed over a larger area of the port. Such support members may also provide additional friction to support heavier IV bags, if necessary.

  Interchangeable gripper fingers may be provided to accommodate injection ports from various manufacturers. A gripper finger exchange station may be provided in the processing chamber 304 of the APAS cell 100, for example. In order to replace one gripper finger 1000 with a different type of gripper finger based on the type of IV bag being handled, the robot arm has a second notch 1002, for example, having different sizes for handling different types of IV bags. Instead of this set, one set of gripper fingers 1000 may be released. The releasable coupling between the gripper fingers and the robot arm may include an electromagnet, one or more screws or bolts, and / or a spring mechanism operated by the fingers.

  Or, a common interface to a robot manipulator has a uniform coupling interface to the robot arm, but is adapted to accommodate various types of IV bag infusion ports or for such infusion ports It may be provided using a specially sized retaining clip. Such a clip may be attached to the injection port outside the APAS cell and may be recycled for reuse after the IV bag has been processed by the APAS cell 100.

  The second jaw region 1004 provides a universal V-shaped portion of the jaw that may be used to grasp a wide range of rigid syringes and vials as shown in FIG. A two-finger design 1100 may move the opposing jaws in a coordinated (e.g. mirror image) movement to grasp an item, e.g., IV bag 1102, vial 1104 or syringe 1106, so that the item is substantially aligned with the gripper axis. May be self-aligned.

  In some aspects, force feedback may be used in conjunction with position sensing (e.g., using potentiometers, encoders, etc.) to coordinate and control gripper finger grasping with robot arm movement, thereby May grasp, hold and release items in a coordinated manner. Force feedback and gripper finger position sensing may be monitored to determine if the item to be grasped is in the expected location and has the appropriate dimensions. For example, if the force feedback indicates that the outer diameter of the syringe cylinder is 10% larger than expected, the APAS cell 100 may inform the operator of the error. As another example, if the syringe is too small for a pocket on the carousel rack and therefore tilts at an unexpected angle, force feedback and gripper finger position sensing can detect such a condition and The operator may be informed.

  The engagement surface of the notch 1002 and / or the V-shaped portion 1004 may be smooth or textured. The gripper fingers may be composed of metal, plastic, or a combination thereof. Some embodiments may include, for example, a non-smooth, textured surface on at least a portion of the engagement surface, which may include rubber or other gripping material. For example, the jaw region 1004 may have a rough surface, and the gripper finger 1000 can more securely grasp, for example, a plastic syringe cylinder.

  In this example, gripper finger 1000 further includes a notch disposed at the tip of V-shaped portion 1004. They may be used for various purposes, such as needle support and / or correction.

  FIG. 11 illustrates the flexibility of gripper fingers 1100 for exemplary handling of various inventory items. A set of gripper fingers 1100 can handle an IV bag 1102, a vial 1104, and a syringe 1106. As such, the gripper finger 1100 may be used to perform various operations within the APAS cell 100, for example. For example, gripper fingers can accommodate vials and syringes having various sizes, shapes (eg, not necessarily circular), weights, materials (eg, plastic, glass, metal). The gripper fingers 1100 can also handle, for example, vials and syringes regardless of the spatial orientation of the item.

  12A-12D illustrate an exemplary carousel and rack system for rack loading of racks within the carousel of APAS cell 100. FIG. An inventory rack carousel, one example of which is the carousel 310 of FIG. 3, has features at its top and bottom that engage the inventory rack and allow for quick replacement of racks on the carousel.

  FIG. 12A shows the shape for the carousel top plate 1206 on the carousel 1200 for engaging the rack. The carousel top plate 1206 includes rack alignment ridges 1202 and rack retention slots 1204. FIG. 12B shows the shape for the upper end of the rack 1212 that engages and engages the carousel 1200. The upper end of the rack 1212 engages the rack upper end plate 1214 on the rack housing 1216, which provides features such as the retention ridge 1218, and the rack alignment ridge 1202 in the rack retention slot 1204, and the side of the rack in the carousel 1200. It has a lateral alignment groove 1220 that helps provide both alignment and retention. This engagement is accomplished by engaging a lateral alignment groove 1220 on the rack top end plate 1214 with a rack alignment ridge 1202 on the carousel top plate 1206. The upper end of the rack 1212 is held in the carousel by engaging the holding convex edge 1218 on the rack 1212 with the rack holding slot 1204 in the rack aligning convex edge 1202 on the carousel 1200.

  In this example, the lower end of rack 1212 uses the same convex edge and groove alignment features as the upper end of rack 1212. FIG. 12D shows the shape for the carousel lower plate 1238 on the carousel 1200 with which the rack engages. The carousel lower plate 1238 includes a rack alignment convex edge 1234 and a rack holding roller 1236. FIG. 12C shows the shape for the lower end of the rack 1212 for engaging the carousel 1200. The lower end of the rack 1212 has a rack lower end plate 1224 on the rack housing 1226 that provides features such as a lateral alignment groove 1230 that assists in engaging the retaining surface 1228 and the rack alignment ridge 1234. A rack holding roller 1236 on the carousel lower plate 1238 is used to help guide the lower end of the rack 1212 into the carousel 1200. The lower end of the rack 1212 is engaged in the carousel 1200 by engaging the lateral alignment groove 1230 on the rack lower end 1224 with the rack alignment convex edge 1234 on the carousel lower plate 1238. This provides the rack with lateral alignment and alignment.

  13A-13C show the assembly sequence for loading the rack 1212 into the carousel 1200. FIG. FIG. 13A shows a first step 1300 of the assembly sequence in which the rack 1212 is first engaged on top of the carousel top plate 1206. The rack 1212 can then slide into the carousel 1200 by moving over the rack holding roller 1236 on the carousel lower plate 1238. FIG. 13B shows a second step 1302 of the assembly sequence in which the rack 1212 is fully inserted into the carousel 1200. The rack 1212 moves on the rack holding roller 1236 on the carousel lower plate 1238 and engages the rack alignment convex edge 1234 in the lateral alignment groove 1230 shown in FIG. Since the rack has been fully inserted, FIG. The final step 1304 of the assembly sequence to be engaged is shown. The rack 1212 can be placed in the carousel 1200, so that the holding surface 1228 on the rack bottom plate 1224 falls behind the rack holding roller 1236 on the carousel lower plate 1238, as shown in FIG. Restraint retention is formed within.

  Removing the rack from the carousel is essentially the reverse of insertion. The rack 1212 is first lifted toward the carousel top plate 1206 and then the lower end of the rack 1212 is rotated outward. This disengages the holding ridge 1218 from the alignment ridge 1202 in the carousel top plate 1206, after which the rack is free from the carousel.

  In some embodiments, the carousel upper plate 1206 and the carousel lower plate 1238 may be replicated one or more times in the rack channel, providing multiple partial length racks instead of a single full length rack. Partial length racks may be provided at one or more locations on the carousel. Single part length racks may be replaced independently of other racks, thus eliminating the need to replace the entire rack to replace a small portion of the inventory stored on the rack. Partial length racks may be advantageous, for example, for racks that contain physically heavy inventory for an operator to lift and load into a carousel. Partial length racks may also be advantageous, for example, for certain inventory that is not used very often. In some settings, mixing of part length and full length racks may be advantageous to optimize inventory management.

  In another embodiment, the rack 1212 may be modified as a shell arranged to support two or more insertable mini racks. The minirack may be inserted into and removed from the shell in a manner substantially similar to that described above with reference to FIGS. 12A-12D and 13A-13C. Shell racks are easily replaceable, allowing full length racks to be used as needed, providing flexible inventory management.

  FIG. 14 illustrates an exemplary set of inventory rack designs 1400 that may be used to hold an inventory (e.g., drug container) 212 as shown in FIG. 2 that is used by the APAS cell 100 during the compounding process. Indicates. Rack design set 1400 includes, but is not limited to, three types: rack 1402 designed to load IV bags, rack 1404 designed to load vials, or to load syringes Designed rack 1406. In this example, only one type of drug container is supported in each rack. However, in another example, a single rack may include syringes, vials, and / or IV bags of various sizes and types.

  Each inventory rack mold may include multiple designs, corresponding to a different size of each of the drug container molds loaded into the rack. The inventory rack design may correspond to one size of a particular drug container, or may correspond to a selected number of sizes of a particular drug container. Examples of IV bag rack designs include racks that can load up to four 1000 milliliter (ml) Baxter IV bags, and load up to eight 500 ml or 250 ml Baxter IV bags in any combination. Racks that can be loaded in any combination of up to 12 100 ml and 50 ml Baxter IV bags, including but not limited to. Examples of vial rack designs include, but are not limited to, racks that can load up to 8 100 ml vials, up to 18 50 ml vials, and up to 22 20 ml vials. Another rack design example for vials can load 58 5 ml to 2 ml vials with a combination of up to 30 5 ml to 4 ml vials and up to 28 2 ml vials. Examples of syringe rack designs include up to 8 140 cubic centimeter (cc) Monoject syringes, up to 12 60cc BD or Monoject syringes, up to 14 30cc BD or 35cc Monoject syringes, up to 18 20cc BD or Monoject syringes, up to 33 Including, but not limited to, a 12cc to 1cc BD or Monoject syringe, or a rack that can be loaded with any combination thereof. Monoject syringes are commercially available from Tyco medical, Massachusetts. BD syringes are commercially available from Becton Dickson, New Jersey.

  Each inventory rack has an electronically readable label 1408 attached for identification purposes. By way of example, the electronically readable label 1408 may include a barcode that can be scanned using, for example, a barcode scanner disposed adjacent to the carousels 310, 312 in the inventory chamber 302. The barcode may include or be associated with information stored in the information storage location, such as information about the contents of the rack that can be used by the APAS cell, inventory data is updated, Racks and inventory correlate with carousel location.

  In another aspect, the drug container may be attached with an electronically readable label, such as a bar code label, which contains information about the amount and type of drug in the container. The drug container may be a syringe, IV bag, or vial and contains the drug or diluent needed for the reconstitution process by the APAS cell. Each inventory rack may also have, for example, a bar code label in each pocket within the rack, as well as a label on the rack itself, as described above. The operator may use a portable bar code scanner to scan each drug container before placing it in the rack pocket and then scan the pocket label. In conjunction with rack loading, the operator may scan a bar code on the rack. Data obtained from this scan may be moved to the APAS cell 100 for use in the reconstruction process. The data may indicate the exact location of the drug or diluent in the rack on the carousel.

  15A-15C show an apparatus and method for extracting air and diluent from an IV bag. Depending on the method of extracting gas from the IV bag, the IV bag can be used for automated fluid transfer operations and operations with a special embodiment needle down-oriented syringe.

  In this example, the IV bag is positioned such that the injection port 1502 is punctured by the needle lowering syringe manipulator 1504, an example of which is the manipulator 334 described with reference to FIG. In each of FIGS. 15A-15C, two IV bags are described as being held by corresponding holding clips holding IV bag injection ports. The retaining clip may be similar to that described with reference to FIGS.

  IV bags placed in hospital inventory may be filled with a diluent, such as 0.9% saline, sterile water or a glucose mixture. To the extent that the IV bag processed in the APAS cell contains some gas and this appears as headspace in the IV bag, it is capable of accepting drugs injected into the IV bag. For example, a pharmacist using a drug-filled syringe may inject the inner volume into the IV bag by puncturing the membrane on the IV bag port with a syringe needle. The IV bag then contains the required dose. However, APAS cells may also use IV bags as a diluent source in the drug reconstitution process, where the drug is contained in a vial (eg, in liquid or dry form, eg, as a powder). For example, the APAS cell 100 may reconstitute the drug in the vial by extracting a predetermined amount of diluent from the IV bag and injecting it into the vial.

  FIG. 15A shows exemplary steps of a reconfiguration process that may occur at the needle lowering syringe manipulator station 1504. Needle lowering syringe manipulator station includes holding clip 1506, IV bag 1508 with infusion port 1502 aligned by clip 1506, fluid transfer syringe oriented so that needle 1514 is in the lowered position to puncture infusion port 1502 Includes 1510. The retaining clip 1506 is mounted on an indexer 1512 that can position the injection port 1502 laterally and / or perpendicular to the needle 1514.

  At the station 1504, the injection port 1502 is aligned by the retaining clip 1506 so that a puncturing operation with respect to the needle 1514 is possible. In some embodiments, a quick puncture operation may be used to reduce the amount of air that can be trapped in the IV bag 1508 by the needle. The weight of the IV bag 1508 may be supported by the retaining clip 1506, but some or substantially the majority of the weight of the IV bag may be supported by a horizontal shelf on which the IV bag can be placed.

  When the IV bag is oriented so that the injection port 1502 is on top, air (or other gas) can rise toward the injection port 1502. During fluid transfer operations, a process for extracting substantially all of the air from the IV bag may be performed to keep substantially no gas from being drawn from the IV bag 1508 into the syringe 1510. Once all the air has been drawn from the IV bag 1508 and the syringe 1510 has drawn fluid, the process may be stopped. The syringe 1510 of the needle lowering syringe manipulator station 1504 can reliably extract air by monitoring a syringe plunger manipulator (not shown).

  Based on the relative movement of the syringe plunger and / or the force required to move the plunger, the controller is configured to determine when substantially all of the gas has been withdrawn from the IV bag 1508. May be. The controller may accept input from a sensor, which may be interpreted, for example, to indicate different forces or velocities that are obtained when comparing the air transition to the fluid transition. For example, if the plunger is withdrawn at a constant speed, the tensile force on the syringe plunger (not shown) can be measured when substantially all of the air is extracted and fluid begins to be withdrawn from the IV bag 1508 into the syringe 1510. May increase to a certain extent. As another example, if the plunger is withdrawn with a constant tensile force or a substantially constant excitation (e.g., terminal voltage for a DC motor), the speed of the syringe plunger is such that the last air is extracted and the fluid is in an IV bag When it begins to be drawn from 1508 into syringe 1510, it can be measurable. The force on the syringe plunger may be monitored, for example, by a strain sensor, a torque sensor coupled to the motor shaft, and / or a motor current. For example, a sudden increase in current to the motor may indicate a transition from air extraction to fluid extraction. Speed using various speed sensing techniques such as encoders, resolvers, multi-turn potentiometers, linear potentiometers, Hall sensors, commentator noise, end stop limit detection, limit switches, etc., or combinations of such elements It may be measured or determined. Velocity changes may be determined from position measurements obtained over time intervals.

  In another embodiment, a change in force as air moves from the syringe to the IV bag 1508 may be detected. For example, a selected volume of air and / or fluid may be transferred from the IV bag 1508 into a syringe. The volume transferred from the IV bag 1508 may then be transferred back to the IV bag 1508. Changes in force on the syringe plunger can be detected and recorded. The detected change in force may correspond to a change between air / fluid transitions. The syringe plunger may then be pulled back to the air and fluid change point, resulting in a ready IV bag.

  In another aspect, fluid withdrawal may be detected optically, eg, by an optical sensor that monitors light passing through the injection port 1502 and / or the syringe 1510. The intensity of light passing through the syringe can change as the material extracted into the syringe changes from gas to liquid. Optical detection may be used alone or in combination with syringe plunger force and / or speed monitoring.

  In some embodiments, a known volume of air may be transferred from the IV bag into the syringe. This volume of air may be greater than the expected volume of air. The syringe can then be weighed to confirm that some fluid is present in the cylinder, indicating that the IV bag is ready. Thereafter, the syringe may be discarded.

  According to one implementation, the reconfiguration process may be performed, for example, by the robot arm 318 that places the IV bag 1508 in the clip 1506 of the station 1504 in the APAS cell 100. The IV bag 1508 may hang from the injection port 1502 on the indexer 1512 of the needle lowering syringe manipulator station 1504. The indexer 1512 may move the IV bag 1508 to a position below the syringe needle 1514. The IV bag port 1502 may then engage the syringe needle 1514. The syringe plunger may be withdrawn so that air is drawn into the syringe 1510 from the IV bag. The syringe plunger, for example, may be withdrawn for some additional time until a change in torque is detected, allowing room for withdrawal and being negatively pressurized relative to atmospheric pressure. A small amount of fluid is drawn into the IV bag. The indexer 1512 then lowers the IV bag 1508.

  FIG. 15B illustrates another exemplary stage of a reconfiguration process that may occur at the needle lowering syringe manipulator station 1504. The indexer 1512 moves the IV bag 1508 from which air has been removed to a position where the waste vial 1516 is placed under the syringe needle 1514. The waste vial 1516 is then raised by the indexer 1512 to a position where the syringe needle tip is just inside the vial neck. The syringe plunger is then driven and air and any fluid are pushed out of the syringe 1510 into the waste vial 1516.

  In FIG. 15C, the indexer 1512 is lowered and repositioned so that the IV bag 1508 is under the syringe needle 1514 and the diluent can be withdrawn immediately. While the needle is lowered and the diluent is withdrawn, some small amount of air may be drawn into the syringe along with the liquid or fluid (eg, microbubbles).

  The needle lowering syringe manipulator station 1504 may be operated, for example, by a programmed controller in the APAS cell 100, and an exemplary method 1600 for extracting gas from an IV bag follows the flowcharts of FIGS. To be implemented. This method 1600 may be applied, for example, to withdraw a diluent from an IV bag and prepare it to reconstitute the drug.

  When performing the example method 1600, the indexer 1512 moves the IV bag 1508 to a position below the syringe needle 1514 at step 1602, and the IV bag injection port 1502 is placed on the syringe needle 1514 in preparation for diluent withdrawal. Is engaged. In step 1604, the APAS cell 100 controller determines whether the IV bag is considered new.

  If the controller determines that the IV bag is new, then at step 1606, the controller activates the syringe plunger to draw air from the IV bag 1508 as described with reference to FIGS. The syringe plunger manipulator 1504 may, for example, pull the syringe plunger while monitoring the torque at step 1608, and in some embodiments, the process change is that all of the air is drawn into the syringe and now fluid is drawn. It shows that. At step 1610, the syringe plunger may be monitored and it is confirmed that the syringe plunger has not reached its moving end before all the air is withdrawn from the IV bag. If the plunger has not reached its moving end, step 1608 is repeated.

  If the plunger reaches its moving end at step 1610, the waste vial is moved to near the syringe at step 1620 and air is expelled from the syringe at step 1622. In this example, the controller then determines at step 1624 whether the IV bag repeats the gas extraction process, including steps 1620-1622, beyond limits. The limits may be based on information about the IV bag, such as volume, usage history (eg, in the APAS cell 100), or gravity measurements. If the limit is exceeded, the controller then creates a message and notifies the operator at step 1626 and the process may be aborted.

  If the torque change detected in step 1608 occurs before reaching the syringe plunger travel end, this indicates that substantially all of the air has been removed from the IV bag. In step 1612, the indexer 1512 then moves the waste vial 1516 to a position below the syringe needle 1514 in step 1612, raising it to a position where the tip of the syringe needle 1514 is inside the neck of the vial 1516. The syringe plunger manipulator 1504 operates the syringe plunger until it stops, and in step 1614, all air and all liquid are expelled from the syringe into the waste vial 1516. The indexer 1512 then moves the IV bag 1508, from which all air has been removed, to a position below the syringe needle 1514 and engages the IV bag port 1508 on the syringe needle 1514 at step 1616.

  In step 1604, if the controller determines that the IV bag is not new, or after completion of step 1616, in step 1650, the controller activates the syringe plunger and begins to draw a predetermined amount of diluent from the IV bag. You may do it. While the diluent is being drawn, the controller may monitor the exact torque on the motor at step 1655 in some embodiments. If the torque is not accurate or unexpected, a problem may have been indicated and the APAS cell 100 may notify the operator at step 1660. However, if the torque is deemed correct, the controller may check whether a predetermined amount of diluent has been drawn in step 1665. This may include the control device receiving a signal from a sensor, such as a slide potentiometer. When the withdrawal is complete, method 1600 then ends. Otherwise, the controller checks at step 1670 whether the syringe plunger travel end has been reached. This may be detected based on motor current, speed, plunger position, or a combination of these or similar measurements. If the plunger moving end has not been reached, step 1655 is repeated. If the plunger end has been reached, the controller may send a status notification to the operator at step 1675 and the method 1600 ends.

  The APAS cell determines how long the syringe plunger manipulator should be pulled over the syringe plunger in order to extract the required fluid volume by knowing the size of the syringe and the amount of diluent that needs to be withdrawn. During withdrawal, the syringe plunger manipulator monitors the amount of torque required to control the syringe plunger. The torque phase change 1620 before withdrawal 1622 may indicate a problem and should be reported 1624 to the operator, and the process is aborted. If the syringe plunger end 1628 is reached before withdrawal is complete, an error is also indicated. This should also be reported 1624 to the operator and the process is aborted. As soon as the withdrawal is successful, the process ends.

  In some embodiments, the controller may measure, monitor, record, and / or store information indicative of the volume remaining in a particular IV bag. This information may be used, for example, for quality control purposes and to determine when to withdraw diluent from the bag (eg, when the effective volume falls below a practicable level).

  17A-17C show an exemplary apparatus 1700 for operating an IV bag 1700 that is used to supply diluent for the reconstitution process.

  In FIG. 17A, an exemplary diluent bag manipulator station 1702 is provided, for example, in the APAS cell 100 for the purpose of operating an IV bag containing diluent required in the reconstitution process. As described in FIG. 3, the robot arm 318 may carry or transport the IV bag to the station 1702. The arm may be actuated by a controller in the APAS cell 100, and the infusion port 1704 of the transported IV bag is aligned with the clip 1706 on the platen 1708 as described with reference to FIGS. The The bottom of the IV bag 1712 is placed in the gripper 1714 with the gripper jaws 1716 in the open position. Next, in FIG. 17B, the gripper jaws 1716 are closed to grasp the bottom of the bag. The IV bag 1712 is thus constrained by the closed gripper jaws at the bottom of the bag and the top of the IV bag is secured with an IV bag clip 1706. FIG. 17C shows how the platen 1708 rotates, for example, 180 degrees along the axis of rotation 1710, flipping the IV bag and orienting the IV bag injection port 1704 downward, thereby allowing the IV bag The air in 1712 can rise to the top. In this embodiment, the diluent may be supplied (eg, by gravity feed or peristaltic pump) without the preliminary step of extracting air from the IV bag 1712 before the syringe is withdrawn.

  In this embodiment, the diluent bag manipulator station 1702 may orient the IV bag for fluid transfer on the needle lift syringe manipulator station 322, an example of which is described with reference to FIG. .

  In some aspects, the APAS cell 100 may store information about the approximate fluid volume available in the IV bag (eg, derived from visual inspection, weight measurements, historical information, user input, etc.). When the effective volume in the IV bag falls below that level, the controller in the APAS cell will be discarded when the IV bag is discarded or used up for another purpose. May be determined.

  In some embodiments, removing the IV bag from the diluent bag manipulator station 1702 may include rotating the platen again 180 degrees to reorient the IV bag, as shown in FIG. 17B. Thereafter, the gripper jaws may be opened to open the bottom of the IV bag. The robot arm 318 may then grasp the IV bag at the port, as described, and may pull to remove the bag from the clip. The robot arm 318 may then place, for example, an empty bag in the waste chute 333 as shown in FIG.

  In another aspect, gripper 1714 may move in one direction to increase or decrease the spatial distance between jaw 1716 and clip 1706 to allow for different sized bags.

  FIG. 18 is a flowchart of exemplary batch mode operation that may be used to fill an order provided to an APAS cell. Batch mode 1800 includes loading a batch of input drug and diluent and an output volume syringe and IV bag into the APAS cell to generate a predefined drug order. For example, the operator creates a master daily preparation list 1802, which is a list of all drug orders that need to be filled by the APAS cell for that day. This may include, for example, many prescriptions of one type or a variety of different prescriptions. The list is then loaded into the APAS cell, in whole or in part (eg, depending on the size of the list), as a “run” list 1804 that is used by the APAS cell to prepare drug orders. The software in the APAS cell scans drug orders and ensures that the APAS cell is trained to fill them. The APAS cell then identifies the inventory needed to fill the drug order and the rack configuration from valid ones. Prepare a load list 1806 to guide loading of inventory into the rack. The required inventory includes the drugs and diluents necessary to prepare the order, which may be contained, for example, in vials, syringes, or IV bags. It may include a syringe (attached to the needle) needed to process the order and an output container for the drug dose, for example a syringe or IV bag. From this load list, the operator, for example, obtains stock from the clean room inventory 1806 and loads 1810 off-line into the inventory rack at a position on the rack as indicated by the load list.

  The operator then delivers the rack to the APAS cell. The operator then follows the inventory loading process as described in FIG. 4 and first unloads empty inventory 1812 and unused inventory that may be included on the carousel from the previous run. The operator then unloads the waste container 1814 and empties it in preparation for the run. The waste container is under the waste chute 333, as described in Figure 3, even if an empty container used in the APAS cell (e.g. used or empty syringe, bag, vial) is retained. Good. Next, in the inventory loading process described in FIG. 4, the operator loads 1816 an inventory rack onto the carousel. The operator initiates the batch process by setting the APAS cell to run 1818, for example, by selecting a run button on a touch screen flat panel monitor, one example of which is monitor 202. Thereafter, the APAS cell operates autonomously 1820 and an output order is generated, which may be dropped by the drug container into the syringe discharge chute 332 or IV bag discharge chute 344, examples of which are shown in FIG. Is described with reference to. A receptacle located directly under each chute may collect the containers. The pharmacy personnel member can retrieve 1822 the output to be placed in stock, for example in the ward.

  The APAS cell will run until 1822 when the run is complete and continue to prepare drug orders. The system may generate a signal that provides information to the operator. For example, the system may provide information to the operator by displaying a message on a flat panel monitor that functions as an input / output device 306, an example of which is described with reference to FIG. If all open orders are completed, or if the input required to complete all open orders is not available in the rack inventory, the blending operation may end. In some implementations, an APAS cell may operate autonomously in a “fully automatic” mode, substantially without operator intervention, and process orders using available inventory.

  FIG. 19 is a flowchart of operation in on-demand mode that may be used to fill an order provided to an APAS cell. On-demand mode 1900 loads APAS cells with input drug and diluent supplements and syringes and IV bags for output doses and may constitute the most common drugs used on a given day Including generating an order. The APAS cell prepares 1902 a load list that guides the loading of inventory into the rack. The entire set of drug orders to be filled can be obtained from the order entry system or manually entered by the operator. By analyzing the entire set of drug orders to be filled, the APAS cell can determine the total number of drugs, syringes, vials, and IV bags needed to fill the entire set of drug orders. A total list can then be provided to the operator. The operator can select the required drugs, syringes, vials and IV bags from the current inventory to meet the APAS cell load requirements for the entire set of drug orders. The required inventory may include replenishment of required drugs and diluents, which may be contained, for example, in vials, syringes, or IV bags. The inventory also includes output containers for drug doses, which can be, for example, syringes or IV bags. The operator enters 1904 a load list into the APAS cell using, for example, a flat panel monitor 202 as described in FIG. From this load list, the operator obtains stock from, for example, a clean room inventory 1906 and loads 1908 off-the-shelf stock at a fixed location on the rack as indicated by the load list.

  The operator then delivers the rack to the APAS cell. The operator then follows the inventory loading process as described in FIG. 4 and first unloads empty and unused inventory that may be contained on the carousel from the previous day's operation 1910. The operator then unloads the waste container 1912 and empties it in preparation for the day's order. The waste container is under the waste chute 333 as described in FIG. 3 and holds the empty container used in the APAS cell. Next, in the inventory loading process described in FIG. 4, the operator loads 1914 the inventory rack onto the carousel.

  The APAS cell then waits 1916 until a drug order is received from the hospital pharmacy, eg, by the hospital network, as described in FIG. When the order is received by the hospital pharmacy, it is entered into the APAS cell. The APAS cell checks 1918 to ensure that supplies are in place to meet the order. If so, the order is entered into the queue for the APAS cell 1920, where the APAS cell may then run and complete the order 1922. The output order may be dropped by the drug container into the syringe discharge chute 332 or IV bag discharge chute 344, as described with reference to FIG. 3, where it is placed directly under each chute. The receptacle may hold a container. The pharmacy personnel member may retrieve 1924 the output to be used that day, for example, in the ward.

  When the order is received, if the APAS cell determines that the supply needed to fill the order is not in place 1918, the operator is notified 1926, and the operator is responsible for reloading the inventory to the machine 1906.

  The APAS cell may be operated in either batch mode or on-demand mode, depending on user requirements. For example, it can be used in an on-demand mode during a day shift in response to demand from the hospital. During evening and night shifts, drug batches can be manufactured that are transported in bulk at the hospital pharmacy to maintain inventory.

  An exemplary system 2000 that can align the injection port with a fixed IV bag is shown in FIGS. Embodiments may implement fluid transfer in the direction of needle down or needle up. The alignment may involve, for example, a portable fluid transfer port and / or a fixed bag.

  The embodiment may be operated by a control device, in which the IV bag is transported by the robot manipulator 2015 from the carrier to the installation fixture 2010 in the cell where the process of installation is performed. In the example of FIG. 20A, the system 2000 includes an exemplary installation fixture 2010, which in some aspects may be the IV bag manipulator 1708 of FIG. 17A. In another aspect, the installation fixture 2010 may also be a rack that holds one or more IV bags that may be manually loaded by an operator.

  The robot manipulator 2015 may release the IV bag 2005 and then grasp the fluid transfer port 2020 and align the port with the needle port on the IV bag. The fluid transfer port 2020 is connected to a fluid transfer device 2025, which can transfer fluid into or out of the IV bag (eg, using gravity feeds, pumps, or other transfer mechanisms). While orienting the bag so that the port is at the apex of the bag, the air at the apex of the bag (e.g. in the headspace) is first extracted as described elsewhere in this specification. Also good. The bag may be held on an IV bag manipulator and inverted to transfer fluid from the bag.

  As an exemplary embodiment, FIG. 20A shows a robot manipulator 2015 that knows the installed bag and fluid transfer port and aligns it with the needle port on the bag. FIG. 20B shows a robot manipulator 2015 that places an IV bag in an IV bag manipulator. FIG. 20C shows the robot manipulator 2015 grasping the fluid transfer port. FIG. 20D shows a robot manipulator 2015 that aligns the fluid transfer port with the IV bag needle port.

  In another embodiment, one or more IV bags may be mounted, for example, on a retaining clip, such as, for example, mounted on a rotating storage carousel or flat carrier. The robot manipulator may align the fluid transfer port with any of the fixed bags. In yet another aspect, 2, 3, 4 or more IV bags may be retained by an injection port retaining clip coupled to an indexer, such as indexer 1512 described with reference to FIG.

  In addition to the above examples, IV bags and syringes may be handled using systems, devices, methods or computer program products other than the above examples.

  For example, the APAS cell 100 may include a main controller and one or more additional controllers in a distributed network architecture. The main controller may provide supervision and management of cell operations and may adjust the performance of sub-operations by other controllers. Each controller may include one or more processors that perform operations according to software that may be developed and compiled using one or more languages. The controller may be in the form of an embedded system, a dedicated controller, PLC (programmable logic controller), PC-based controller with appropriate networking and I / O hardware and software, ASIC, or other implementation Have

  For some applications, one controller may be configured to control the robot manipulator, including determining the position and motion path for the manipulator within the processing chamber. The operational plan may include solving static and / or dynamic kinematic equations to optimize transport time and reduce energy consumption, and such calculations are local to the APAS cell. Or may be achieved in real time by a masco processor and / or a digital signal processor, which may be available, for example, on a remotely located workstation coupled to an APAS cell by a network connection. In another aspect, the predicted motion (eg, from carousel to scale) of the robot manipulator may be learned or taught.

  Providing a database to handle the predicted locations and orientations for various stock items on various stations on various types and sizes of IV bags, syringes, and vials, and storage carousels, racks, and entire processing chambers Also good. Comparing motion, position, force, diameter, and similar parameters against the upper and lower limits in some cases, the manipulator may, for example, give an error signal, warning to the responsible pharmacist, operator, or system maintainer It may be determined whether an e-mail notification, instant message, paging signal, or other signal is being encountered.

  In order to accommodate IV bags of various sizes, molds, and manufacture, an appropriately sized holder may be placed in a fixed position in the cell, and the IV bag may be installed by a manipulator at that position. Based on information determined from either user input or automatic detection (e.g. by bar code) sufficient to couple the IV bag to a suitable holder, the manipulator is the most suitable for the IV bag being handled and transported. An IV bag may be selectively installed in a suitable holder. For example, referring to FIG. 15A, multiple types and designs of IV bag retaining clips 1506 may be mounted on the indexer 1512 so that the manipulator is placed on a selected holder that is most suitable for the IV bag. A bag may be installed. This approach may also be applied to storage racks and various stations located within the processing chamber.

  In some embodiments, the indexer 1512 moves the waste vial 1516, the IV bag 1508, and the vial containing the reconstituted drug (see FIGS.15A-15C) laterally and / or vertically, as appropriate. The item may be aligned with the needle 1514 of the syringe 1510. In another aspect, the needle lowering syringe manipulator may move the syringe and needle vertically and / or horizontally relative to the waste vial 1516, IV bag 1508, and vial containing the reconstituted drug.

  In some aspects, the robotic manipulator may directly align an item that is grasped and held, such as an IV bag injection port or syringe, to perform a fluid transfer operation. The fluid transfer or gas extraction process may be performed using a robotic arm that grasps and supports at least one container associated with the fluid transfer operation.

  In some aspects, each APAS cell may be programmed with information and may be initialized with substantially the same information stored in non-volatile memory. In another aspect, one or more APAS devices may be ordered to perform a particular function. For example, one APAS cell performs both ordering and batch processing functions by responding to information about the formulations required to fulfill various prescriptions and information about various other stock solutions It may be configured as follows.

  In various aspects, the APAS cell 100 may handle and operate inventory items, such as IV bags, vials, and syringes from various manufacturers. In some implementations, IV bag injection port retention clips located at various adjacent stations in the processing chamber, and / or gripper fingers on the robot arm, are required to accommodate inventory items of various designs and types It may be changed or exchanged depending on the situation. Conveniently, for example, some aspects of the gripper fingers can accommodate a wide range of commercially available items of size and design, as described above.

  In one embodiment, the compounding operation may be performed using a commercially available container adapted for parenteral use. APAS cells can also accommodate parenteral fluid containers, such as those used for the preparation of complete parenteral nutrition. In one example, such containers may be treated as input and / or output from APAS cell 100. In another aspect, the compounding operation may be performed using a commercially available flexible fluid container for some other medical or pharmaceutical application. By way of example, such containers may be treated as input and / or output from the APAS cell 100.

  For some applications, the compounding operation may be performed in a clean environment according to aspects of the embodiments described herein. For example, aspects may be implemented in a clean room environment, such as an ISO class 5 environment. In another aspect, the compounding operation may be performed in a ventilation (eg, flow hood) work area. In another aspect, the blending operation may be performed in a chamber, one example of which is the blending chamber 304. In various implementations, a series of compounding processes may be performed in a partial chamber, flow hood, and / or clean room. In various aspects, compounding operations, inventory storage, and / or item activation and transportation may be performed in a substantially sterile environment. In various aspects, the compounding chamber 304 may be negative with respect to ambient atmospheric pressure, and the inventory chamber 302 may be positive with respect to ambient atmospheric pressure.

  In some embodiments, the pressure in the chamber of the APAS cell may be different from the surroundings, for example, at least about 10 inches of water above or below ambient atmospheric pressure, or between about 0.1 and 1.0 inches. It may be water. Negative pressure can reduce the likelihood that a chemical will be released, for example, outside the chamber.

  In conjunction with the compounding area, the inventory item may be tailored to handle inventory items with a carrier that may provide one or more items within the vicinity of the manipulator, for example. In one aspect, one or more inventory items may be provided or delivered to a manipulator, an example being a robot arm 318.

  The manipulator system may include one or more coordinated axes of movement to grasp, transport, and / or orient inventory items. Inventory items may be aligned on retaining clips on a storage rack, or aligned with a fluid transfer port, or otherwise associated with formulation, including operations involving fluid transfer at a fluid transfer station, etc. There is a possibility of being operated in support of the operation. In an aspect, the manipulator system may carry the item in part by a gravity feed system or an action imparted by one or more motors (eg, electric motors) operating alone or in combination.

  In some aspects, for example, the inventory delivered to the robot arm 318 in the APAS cell 100 may be a syringe that includes a syringe cylinder with a needle operably coupled to the cylinder. In some embodiments, the needle is capped and the needle cap is removed as a preliminary step for operating the syringe in various compounding steps.

  Next, systems, methods, and computers suitable for using pulsed ultraviolet (PUV) light to substantially reduce active contaminating microorganisms and sterilize, sterilize, and / or disinfect objects in an environment such as a pharmacy Describes the program product. In one aspect, PUV light is applied within the APAS cell. APAS cells include robotic cells that automate compounding and dispensing drug doses into IV bags and syringes, such as those routinely manufactured in hospital pharmacies. The APAS cell uses a syringe-based fluid transfer process and uses a robot to move the drug vial, syringe, and IV bag through the cell as the medical drug is processed. Another aspect of applying PUV light to sterilize and / or disinfect objects external to the APAS cell is also described. In an exemplary embodiment, the PUV light may be implemented as a desktop system that allows pharmacy personnel to disinfect drug packaging and / or other equipment.

  The systems, methods, and related devices include “critical areas” on drug vials and automatic cleaning / disinfection of IV bag ports during an automated, semi-automated, or manual mixing compounding process.

  FIG. 21 shows an exemplary cleaning process 2100 in the APAS cell 100 of FIG. In one aspect, process 2100 may be controlled, for example, controlled (e.g., regular and / or metered volume), pressurized, and guided by a controller that controls the operation of APAS cell 100. A cleaning agent spray 2105 is provided. The cleaning agent is, for example, mainly about 70% isopropyl alcohol, but is not limited thereto. The pressurized spray 2105 may act to remove particles and sterilize the surface 2110. The amount of cleaning fluid dispensed may be metered using a controllable valve (eg, a solenoid valve). The cleaning fluid is pumped from the reservoir to the spray nozzle 2115 using a suitable method. Suitable methods include, but are not limited to, direct pumping of the cleaning fluid and / or pumping the cleaning fluid into a pressurized air (or other gas) stream. In some aspects, the cleaning fluid reservoir may provide a sensor for detecting fluid level. There may also be a system for detecting pressure, fluid flow and confirming fluid spray. The waste liquid 2120 may be collected in a suitable container and then evaporated, discharged, recovered, and / or discarded.

  FIG. 22 shows an exemplary cleaning chamber 2200. When applied in the APAS cell 100, the forced air flow 2220 may be used to substantially control the mist and overspray from the spray nozzle 2225 from leaking from the cleaning chamber 2200. Chamber 2200 may include one or more fans or pressurized fluid sources to maintain airflow. The exhaust air stream 2230 exiting the cleaning chamber 2200 is filtered from the APAS cell 100 and / or discarded to prevent accumulation of fumes. Sensors can be used to monitor the air flow and if the detected air flow is insufficient, drug processing in the APAS cell is interrupted. In this case, for example, the operator may be warned by an audible beep or a message on a display terminal connected to the APAS. An air stream can also be used to dry the cleaning fluid from the cleaned area. In some embodiments, the stream may include additives or alternatives to air, such as an inert gas.

  A surface and / or object 2205 to be cleaned may be provided in the chamber by robot arm 2210. The object 2205 to be cleaned may be removed during the cleaning process, and a larger area is cleaned. For example, the gripper 2215 on the robot arm 2210 may provide multi-degree of freedom motion by rotating and / or translating along one or more axes. Primary cleaning surfaces to be cleaned include, but are not limited to, for example, vial ports, diluent ports, and IV bag ports.

  The cleaning chamber 2200 can also be packaged as a stand-alone device, manually or automatically in a self-contained unit to facilitate cleaning during manual drug formulation.

  For example, the device may be used in the APAS cell 100 to remove the needle cap and needle from the syringe and to remove the cap from the drug container / vial. Syringes and vials can be provided to the device in one of several ways. In APAS cell 100, a robotic manipulator, an example of which is described above, may provide syringes and vials to the device.

  An exemplary method of actuating the jaws of the device includes using a servo electric manipulator. In a pharmaceutical environment, a servo electric manipulator is an example of an actuator type that may be suitable for the clean environment required for a drug. Various other actuation mechanisms are possible.

  One or more sensors (eg, optics, force, current, etc.) may be used to monitor cap and / or needle removal. In one aspect, the sensor may operate to detect caps and needles present in the robot gripper. In some aspects, the sensor can be positioned or oriented on the jaw and sense items from just outside the device. A sensor may be used to sense the presence or absence of a portion when the device is opened and a portion is discarded into the lower chute by gravity and / or a push pin.

  FIG. 23 shows an exemplary process 2300 for removing the needle cap. In the APAS cell 100, the robot gripper 2305 may provide a needle / syringe combination 2310 to the device for removing the needle cap. The device may include an actuator 2315 and a jaw 2320.

  Prior to using the needle / syringe combination 2310, the needle cap 2325 may be removed from the needle 2330. The needle cap can be removed by opening the jaw 2320 of the actuator 2315 and placing the needle cap 2325 into the V-shaped feature in the jaw 2320 and closing it to grasp the cap 2325. Needle / syringe combination 2310 can then be withdrawn from cap 2325. The jaws 2320 can then be opened and discarded in a disposal receptacle 2335 with the cap 2325 positioned below the jaws 2320.

  Feedback from jaw 2320 may be used to detect whether needle cap 2325 was present on needle / syringe combination 2310. Feedback from the jaws 2320 may be in the form of diameter feedback information. If a needle cap 2325 is predicted but not detected by the jaw 2320, it may be considered that the needle 2330 may be contaminated. As such, the APAS cell can dispose of the needle / syringe combination 2310, or items may be sent and sterilized as described elsewhere herein.

  FIG. 24 shows an exemplary process 2400 for needle removal. In the APAS cell 100, the robot gripper 2405 may provide a luer lock syringe 2410 to the device for needle removal. The device may include an actuator 2415 and a jaw 2420. The device may be the same device used for needle cap removal as described with reference to FIG.

  The needle 2425 from the luer lock syringe 2410 may be removed by unscrewing. The same jaw 2420 V feature used for needle cap removal may be used to grasp the needle 2425 with a luer hub for removal. When using a clever robot to hold the syringe 2410, the device is placed so that it does not move, while the robot can rotate the syringe 2410 around the needle axis and unscrew the needle 2425.

  In another aspect, the device may be mounted on a device having a rotating base so that the rotating device can be unscrewed from the syringe as the robotic manipulator slowly pulls the syringe.

  In various aspects, the syringe may be received in the compounding chamber with or without a needle attached. In one example, a syringe with an attached needle may be transported to a station where the tip cap on the needle is removed and an amount of the medical agent is dispensed from or drawn into the syringe and removed. The tip cap thus made is returned to the original position on the syringe by the operation using the robot arm. In some implementations, one or more syringes, tip caps, needles, capped needles, or syringe caps may be sterilized at the PUV station. In some systems, a needle dispenser may be provided to provide a needle for grasping by a robotic manipulator or otherwise coupled to a syringe. In some cases, the needle dispenser provides a needle for packaging in a kit having at least one syringe (these may be coated).

  25A-25E show an exemplary apparatus 2500 for vial cap removal. In the APAS cell 100, a robot gripper (not shown) may provide the vial 2500 to the device 2500 for vial cap removal. The device 2500 may include an actuator 2510 and a jaw 2515. The jaw 2515 may include a jaw edge 2545 that grasps the vial cap. The jaw 2515 may also include a V-jaw 2550 for grasping the needle and needle cap. The jaw 2515 may also include a cap retention feature 2555. The device may include features for needle cap removal as described with reference to FIG.

  The vial 2505 can be inserted into the jaws 2515 of the device by a vial cap 2520. The vial cap 2520 can be grasped by the jaw edge 2520 using a grasping jaw mechanism. When the jaw 2515 is then closed over the vial cap 2520, the rim of the jaw 2515 engages the vial 2505 just below the vial cap 2520. Thereafter, when the vial 2505 is withdrawn from the jaw 2515, the jaw edge holds the vial cap 2520.

  In some embodiments, the jaw edge pairs may have different lengths and offsets 2525 relative to each other, for example, as shown in FIG. 25D. Because of the offset and length differences, only one jaw edge can engage the vial cap at a time, and leverage similar to manual removal facilitates vial cap removal. Offset 2525 allows the second jaw to engage the vial cap if the first jaw fails to remove the vial cap in the first attempt. This can occur when the first jaw passes through the vial cap and the actuator 2510 is further closed to allow the second edge to contact the vial. The difference in edge length can be designed to work with the actuator when the jaws move in unison. In one embodiment, the vial may be provided on the central axis of the gripper, which is consistent with syringe presentation and facilitates robot setup. The jaw design may include the removed item, so that the vial cap does not exit the jaw in an uncontrolled manner until the jaw opens and is dropped into the waste chute, as shown in Figure 25E. You may stop.

  Multiple sets of vial decapping edges may be provided, corresponding to various sized vial caps that can be used with the device, and to accommodate actuator stroke ranges. For example, jaws 2535 and 2540 shown in FIG. 25E have two sets of decapping edges.

  In various aspects, the vial or syringe may be capped or removed as necessary to assist in operations, such as compounding or fluid transfer between containers. Such operations may be performed in advance, e.g., during an interruption time to build a reservoir, or as needed for a particular operation planned or ongoing (e.g., at the last minute). ) May be implemented. In some examples, the operation may include providing a feature indicating that the drug container has been modified by capping and / or sealing. 26A-26C are cross-sectional views of an exemplary pulsed ultraviolet (PUV) disinfection system 2600. In an exemplary embodiment, a pulsed ultraviolet (PUV) system 2600 may be used to disinfect items in an automatic pharmacy compounding device, eg, the APAS cell 100 described by way of example with reference to FIG. In this example, the PUV system 2600 can be used to disinfect items including, but not limited to, drug vial ports, IV bag ports, and syringes. The disinfection process performed by the PUV system 2600 may be used alone, for example, in combination with one or more other cleaning processes described elsewhere herein.

  The PUV system 2600 may be used to perform an operation to disinfect objects placed in the PUV chamber. In this example, system 2600 includes an ultraviolet (UV) lamp 2605, a lamp housing 2610, a baffle 2615, and a chamber wall 2620. Chamber wall 2620 substantially reflects and / or absorbs radiation, and UV radiation 2625 from UV lamp 2605 is substantially contained within the PUV chamber. UV radiation 2625 from the UV lamp 2605 may irradiate an object 2630 located in the PUV chamber. In this example, object 2630 is a drug vial arranged to be exposed to UV radiation 2625 by manipulator 2635. The manipulator 2635 may be, for example, a robot gripper such as those described above.

  FIGS. 26A-26C show a single chamber embodiment in which the lamp housing 2610 and UV lamp 2605 are mounted above the object 2630 and the UV radiation 2625 is directed downward. In another embodiment, one or more UV radiation sources may be guided upward and / or from the side, alone or in combination with a UV lamp 2605 guided downward. An exemplary UV radiation source for lamp 2605 is a xenon lamp. The light aperture size in the baffle 2615 may be suitable for the object to be sterilized. The object 2630 may be presented to the UV irradiation source by mechanical or robotic mechanisms.

  The operation of disinfecting an object may generally indicate an operation that reduces the number of contaminating microorganisms on the object to be disinfected. In some applications, the disinfection operation may be aimed at reducing the number of active (eg, viable) contaminating microorganisms to some extent. For example, a 6 log reduction of bacillus subtillis on an object may be achieved by disinfection operations. In another example, the disinfection operation may kill all or substantially all spores and / or fungi on the treated surface.

  The contaminating microbial count may include (but is not limited to) viruses, bacteria, spores, and / or fungi. In one range of examples, pulsed UV radiation is used to kill one or more types of contaminating organisms on, around, or in a syringe or vial part, such as a syringe or vial port. Also good. In some cases, the number of such contaminating microorganisms is the number of clinics, hospitals including hospital pharmacies, or laboratories, or other that may package, prepare, store, transport, or otherwise handle drugs. It may be found in environments such as facilities. Some embodiments can be conveniently applied to vials, syringes, packaging (e.g., IV bags), tubes, access ports, and / or related devices (handling devices including robotic manipulators), fluids (e.g., water) or Disinfection of other materials that come near and / or in contact with objects that may be involved in sterilization and / or disinfection may be provided or enhanced. Some applications may relate to the preparation of drugs and / or medical devices, such as delivery systems for providing parenteral nutrition or insulin to patients. The disinfection method may be regular and / or metered pulses of UV irradiation 2625, directly and / or reflected, primarily UV-C wavelengths, but not limited thereto. In one example, the object 2630 to be sterilized may have a flash intensity and duration presented to the object, and a reduction in the number of contaminating microorganisms associated with the number of flashes. Some systems may achieve at least about 6 log reduction of Bacillus subtilis, for example, within 2 seconds.

  In various aspects, UV exposure may include exposure across various wavelengths. In various implementations, the exposure is between about 200-3000 nm, such as between about 160-380 nm, or between about 230-300 nm, or between about 250-about 270 nm, etc. -A, UV-B, and / or UV-C may be included.

  In some embodiments, exposure to pulsed ultraviolet light may occur for various lengths of time. For example, the exposure may be completed, for example, in less than 10 msec, up to about 1, 5, 20, 30, 40 seconds, or up to at least about 60 seconds. When pulsed, the pulses may be delivered at a fixed or variable frequency between about 0.01 Hz and about 1 kHz, such as between about 0.1 Hz and 100 Hz, or between about 2 Hz and about 10 Hz. Individual pulse widths are less than 1 second, e.g., between about 1 ns and 100 ms, or between about 10 ns and 10 ms, or between about 100 ns and 1 ms, or between about 1000 ns and about 0.1 ms, e.g., about 300-400 ms It may be between. Multiple power supplies and / or flash lamps may be used in combination to interleave and / or increase the peak intensity of radiation exposure from one or more locations around the target surface. Different storage profiles may be performed with different levels of pulse intensity, number, interval, and timing. Control may be implemented by a processor, such as a programmable logic controller (PLC) or an embedded controller.

  Ventilation and / or cooling may incorporate an air treatment device alone or in combination with a purging system (eg, nitrogen). The energy delivered to the object to be sterilized may be a function of the number of pulses and the energy associated with each pulse. In some examples, the total energy delivered is less than 1 joule, between about 1 joule and about 20 joules, up to about 30, 40, 70, 100, 250, 500, 600, 750 joules, or at least about 1000 joules. It may be Jules. Over a longer period of time, any feasible amount of energy may be delivered to achieve an effective and / or desired reduction in the number of active contaminating microorganisms, such as spores, bacteria, and / or viruses.

  In some embodiments, the PUV system includes an interlock that prevents the light source from functioning until a portion of the object enters the PUV chamber, thereby forming a substantially complete light seal and substantially Light is blocked from leaking.

  Other embodiments of the PUV system 2600 are possible. For example, the PUV system 2600 of FIG. 26B includes a baffle 2640 that is substantially cylindrical or annular, vertically oriented, and arranged to provide a lumen through which an object 2645 is illuminated. The baffle 2640 may have a reflective surface. In another example shown in FIG. 26C, the baffle 2650 is arranged to form a partial conical surface having an aperture that directs substantially all of the light to an object 2655 located near the aperture. Similar arrangements of other baffle structures can be used to direct a substantial portion of the light entering the PUV chamber to an object located near one or more apertures, such as those of FIGS. Good.

  The PUV system 2600 may be adapted to be integrated into the APAS cell 100, or configured for stand-alone (e.g., tabletop, self-supporting) operation for use in a hospital pharmacy or similar environment. Good. In a hospital pharmacy-type environment, pharmacy personnel can prepare prescription drugs by using an expansion tool (e.g., tongs) to grasp the object to be sterilized and place it in the PUV chamber for sterilization. Good. Positioning features (not shown) may be included to assist pharmacy personnel in placing the object in the correct location within the PUV chamber.

  In embodiments, a rigid, semi-rigid, or flexible boot (eg, rubber, foam, plastic, or flexible UV blocking or reflective material) may be formed around the aperture. When disinfecting the fluid port of a vial or IV bag, the pharmacy operator or the robot arm in the APAS cell may place the fluid port to be sterilized near the aperture so that the boot is substantially along with the vial or IV bag body. A light-shielding interface is formed. The aperture may provide a substantially UV transmissive window through which one or more surfaces on the fluid port may be exposed to ultraviolet light that has passed through the window. In response to the initiation signal, a dose of pulsed ultraviolet radiation may be delivered. The dose may follow a preprogrammed set of pulses of a specific intensity, duty cycle, number of repetitions (eg, fixed or variable), and number of pulses, or total energy. The start signal is generated by a switch that is pressed when the body of the object is pushed into the boot, or when a proximity sensor (e.g., an optical sensor, a Hall effect sensor for detecting a robot arm) detects a fluid port in place. Alternatively, the signal may be generated by a controller or another switch (which may be manually pressed), or a combination of such or other detection techniques.

  For manual operations, some embodiments may include a feedback signal that indicates to the operator that the UV pulse profile is complete, or that the item has been exposed to a selected dose of pulsed UV. In some aspects, the display may indicate an exposure level based on, for example, time, number of pulses delivered, or total energy delivered. In some modes, the operator may control the exposure level based on the time that the item is pushed into the boot.

  Instead of or in conjunction with a flexible boot, some embodiments may provide a receptacle that receives a fluid port proximate to a UV exposure port. The receptacle may be sized to receive one or more sizes and types of IV bag fluid ports and one or more sizes and types of vial fluid ports. The concave opening receptacle may be adapted to accept a range of sizes. One or more different sized and / or shaped receptacles may be provided. In some aspects, the receptacle may be replaced to accommodate a wide range of items to be sterilized. Different receptacles may have locating pins, rotating and / or sliding features to hold the receptacle used.

  An interlock feature may be integrated into each receptacle. For example, proximity or pressure sensors may be used to determine when the receptacle has been correctly installed, and the correct size vial or IV bag fluid port is inserted or pushed into the receptacle exposed to ultraviolet light.

  In some aspects, the sensor may measure the approximate total energy delivered and send feedback information to the controller. The controller may deliver pulses until a predetermined energy threshold is delivered.

  FIG. 27 is a block diagram of a control module 2700 for the exemplary PUV system 2600 of FIGS. In an exemplary embodiment, the PUV system 2600 discussed herein may include a PUV chamber, a PUV lamp assembly, and a control module 2700. The control module 2700 may include a processing unit 2705, a COM port 2710, one or more sensors 2715, a device for operating the air processing system 2720, an input / output (I / O) port 2725, and a power source 2730. The processing unit 2705 can be used to supervise, monitor and control operations according to program instructions and / or hardware configuration (eg, analog, digital, PAL, and / or ASIC circuitry). Sensor 2715 may include, but is not limited to, temperature, smoke, contaminants, vibration, position, and light intensity sensors. The I / O port 2725 can be used to receive signals from and send signals to sensors 2715 and / or actuators (eg, motors, PUV lamps, etc.) in the PUV system 2600. In some aspects, the control module 2700 may send and / or accept status and control information to and from the host computer or controller via the COM port 2710. COM port 2710 may be serial or parallel, may use packet or non-packet based communication protocols (e.g., RS-232, USB, firewire) to accept signals from the main controller, and And / or sent to the main controller. An example of an apparatus for operating the air treatment system 2720 has been described with reference to FIG. Elements within the control module 2700 can cooperate to operate the PUV system 2600 and disinfect objects for pharmaceutical use.

  For the air treatment system 2720 in the control module 2700, airflow may be used to cool the UV lamp 2605 and / or the PUV chamber. For some applications, the air treatment system may also exhaust ozone that may be generated in the PUV chamber. The input air may be filtered to prevent particles from reaching the object 2630. The filtered air may also prevent particles from coming into contact with the UV lamp 2605 itself, which increases bulb life and efficiency. A sensor may be used to monitor airflow and shut down if insufficient airflow is detected. In some aspects, the PUV system 2600 may be designed for application in an APAS cell 100 ISO class 5 clean air environment.

  The system may further include an air treatment system for venting the PUV chamber. Ventilation can be used to cool the air on the UV lamp 2605 so that the bulb does not overheat.

  The power supply 2730 may provide a voltage and / or current that drives the UV lamp 2605 during the pulse. For example, the power supply 2730 may store energy in, for example, a capacitor, inductor (including a booster and flyback transformer), or a resonant (L-C) circuit. The energy stored in response to the trigger signal may be released to a flash lamp, such as a xenon flash lamp. In some embodiments, the pulsed light output includes energy at ultraviolet wavelengths. A radiation spectrum may be included. For example, the pulsed UV light may include an amount of energy in the range of UV-A, UV-B, and UV-C, and may include some amount of energy that is shorter and / or longer than the UV wavelength.

  Pulsed UV light emitted during a particular pulse may be characterized, at least in part, by UV light exposure or dose, or by one or more waveforms that an object may accept . Each waveform may have a range of intensities, widths, rise and fall times, and repetition intervals between pulses. Therefore, the control electronics that drive the flash element have characteristic waveforms based on inductive (trigger) pulse characteristics, flash element conversion efficiency and dynamic impedance, applied voltage / current, and power supply impedance, and parasitic stray capacitance, resistance, and inductance May be determined. In some examples, the PUV waveform may be controllable, for example, by adjusting the amplitude of the voltage applied during the pulse. Amplitude (eg, intensity) and / or pulse repetition rate and number of repetitions may be programmed to defaults or may be user-configurable via a user interface (not shown) for APAS.

  In some implementations, a UV light sensor may be provided to measure PUV light intensity for monitoring the sufficiency of light pulses. Sensors may be used to monitor light bulb status and flash intensity. The sensor may be monitored to confirm that the proper amount of light is being delivered. For example, if the processing unit determines that the PUV waveform cannot meet the average minimum threshold across multiple pulses, the processing unit may generate a fault signal on the COM port 2710.

  A sensor (eg, a light beam, proximity, or contact) may be included in the PUV chamber to monitor the position or proximity of the object. The sensor may be used to monitor the position or proximity of items that are replaced by the presence of an object (eg, a switch) relative to the bulb. This sensor may provide an interlock so that the bulb cannot be flashed unless the object is in the correct position.

  FIG. 28 is a perspective view of an exemplary embodiment for a PUV chamber housing 2800 for the systems of FIGS. 26A-26C and FIG. Side 2805 of housing 2800 includes an air treatment assembly, which may include a filter and / or a fan. The front surface 2810 of the housing 2800 has stepped wide and narrow openings 2815. The wide opening allows the robot manipulator to insert a wide object, such as an IV bag, near its base. The narrow opening above the wide opening may correspond to the width of the manipulator used to place the object in the PUV chamber. For example, referring to FIGS. 26A-26C, manipulator 2635 may insert object 2635 (eg, a vial, syringe, or IV bag) through a wide opening near the base of housing 2800. The manipulator 2635 can then move vertically up towards the aperture and / or UV lamp 2505 in the baffle 2615. When the object 2630 is placed in a PUV chamber and undergoes sterilization exposure, some aspects of the manipulator are further partially or substantially around at least a portion of the narrow and / or wide opening in the housing 2800. A complete light seal may be provided.

  In various aspects, the manipulator provides a thin (e.g., pencil-like) expansion device (not shown) via a reduced (e.g., narrower) slot in the narrow portion of the opening in the PUV chamber housing. It may be adapted to extend the reach of the manipulator. Such an expansion device, or an external portion of the manipulator itself, may be provided with baffling, providing either internal or external light shielding around some or all of the openings in the PUV chamber housing. . For example, when an object is placed to receive pulsed UV irradiation using a flexible rectangular buffing (e.g., plastic, rubber, or foam with a reflective or absorbing coating), the narrow and / or within the PUV chamber housing Alternatively, UV shielding may be provided over some or all of the wide apertures.

  In some aspects, the object to be sterilized may provide effective light shielding. The design of the baffle shown in FIGS. 26B-26C may be such that the object effectively seals the opening in the baffle when the object is in substantial contact with the baffle. The baffle design may be elastic (eg, a flexible baffle material, a spring mounted baffle assembly, or a bellows) so that some tolerance is allowed when placing an object relative to the baffle. The opening in the baffle may be sized to maximize the amount of PUV irradiation to the target area to be sterilized.

  FIGS. 29A-29C are cross-sectional views of an exemplary PUV disinfection system 2900 that accepts various sized objects to be sterilized. In FIG. 29A, object 2905 is a large vial, in FIG. 29B, object 2910 is a small vial, and in FIG. 29C, object 2915 is an IV bag. In each example, the manipulator 2920 may move along a trajectory that is suitable for placing the object in a position suitable for disinfection within the PUV chamber. In FIG. 29C, for example, the IV bag 2915 of FIG. Can be sterilized.

  Thus, the object to be sterilized need not provide primary shading. Chamber wall 2930, along with manipulator 2920, may provide an effective light confinement. The chamber wall 2930 may include features such as baffles, reflective surfaces, and / or absorbing surfaces to further minimize UV radiation leakage from the PUV chamber.

  Embodiments of the PUV chamber may be customized for a particular range of objects to be sterilized taking into account the object's access requirements to the light source, object size, light confinement, and the distance of the object from the light source.

  In some aspects, the buffing may be reconfigurable automatically or manually, providing suitable illumination of the object. For example, the baffle may be on a rotating carousel that can be repositioned (eg, by a motor), and the baffle that is most effective at illuminating the size, shape, and / or shape of the object is placed.

  The PUV system may use system information available to the APAS controller, for example, to optimize the PUV disinfection process. For example, referring to FIG. 27, APAS cell 100 controls operations that may move control information (e.g., indicating the next object to be disinfected) to PUV system 2600 via COM port 2710. A control module 2700 as shown may also be included. Such control information may include optimal waveform, amplitude, pulse repetition rate and rate, object size, type, and / or shape related information. A controller in the PUV system 2600 may respond by configuring the power supply 2730 to trigger a control that generates a disinfection profile that is tuned to disinfect the next object. Such optimization generates effective heat, consumes unnecessary energy, prematurely flashes the flash element, or unnecessarily delays the PUV disinfection process. Facilitate. In some aspects, the robot arm 318 may not be able to perform another task during the PUV disinfection process. In another aspect, the robot arm 318 may eject the object, perform one or more other actions, and return to grasp and transport the object after disinfection is complete.

  30A-30F are cross-sectional views of an exemplary PUV disinfection system 3000 in the APAS cell 100 of FIG. The system 3000 can place an object 3015 to be disinfected using a rotating platen 3005 having a vertical wall 3010, as shown in FIG. 30A. Except for the differences described or not applicable, the above discussion regarding aspects of the PUV system 2600 can generally be applied to aspects of the PUV system 3000. For example, the PUV system 2600 may operate using a control module, an example of which is described above with reference to FIG.

  In FIG. 30A, an object 3015 to be sterilized is loaded onto a platen 3005 outside the PUV chamber. The platen 3005 is rotated using a suitable drive mechanism (e.g., a mechanical connection coupled to a stepper motor, servo motor, solenoid) to place the object 3015 inside the PUV chamber, where the object is placed in the UV Can be exposed to irradiation 3020. The vertical wall 3010 functions as a baffle and provides substantially light shielding for the chamber and is maintained so that most of the UV radiation 3020 does not leak. In some aspects, the platen 3005 is placed in place for loading or pulsing using sensors (e.g., encoders on platen shafts, index marks using Hall effect sensors, light interrupters, etc.) Or when the wall 3010 is in the closed position. While placed in the chamber, the object 3015 may receive a dose of PUV radiation, as described. The platen 3005 is then rotated and an object 3015 (a portion of which may be substantially sterilized) is placed outside the PUV chamber where it may be retrieved for further processing.

  The PUV system 3000 may be adapted to be integrated into the APAS cell 100 or configured for stand-alone (eg, tabletop) operation for use in a hospital pharmacy or similar environment. In a hospital pharmacy-type environment, pharmacy personnel prepare a prescription by loading one or more objects to be disinfected on the platen 3005, perform disinfection, and the platen 3005 rotates to remove the objects from the chamber. After that, the disinfected object may be collected for further processing.

  In some embodiments, the wall 3010 may further include a plurality of compartments (eg, 3, 4, 5, 6, 7, 8, or more) on the platen 3005. The walls may be evenly distributed, so that if any of the compartments are exposed to UV radiation 3020, a portion of the wall 3010 is positioned to form a light shield.

  In another aspect, the platen 3005 may be a circular or non-circular track. Depending on the chamber, it may be advanced substantially continuously or in segments. In some embodiments, the platen 3005 may advance in response to a user command, eg, from a keypad or “start” button. In another aspect, the platen 3005 may advance upon detecting the weight of one or more objects to be processed.

  Similar to that discussed with reference to FIGS. 26A-26C, the PUV system 3000 may be configured to include other arrangements of baffles 3025. This example can be illustrated by baffle 3030 in FIG. 30C, baffle 3035 in FIG. 30D, and baffle 3040 in FIG. 30E.

  Other improvements may be made to the PUV system 3000. For example, an exemplary embodiment of a PUV system 3000 that includes a larger (or distributed) lamp system 3050 in combination with another exemplary embodiment of a baffle 3045 is shown in FIG. 30F. In this example, the UV radiation 3055 can be distributed over a wider area. The baffle 3045 and the reflective surface on the platen 3005 can provide a UV illumination pattern that is widely distributed on the top and side surfaces of the object 3060. Furthermore, the platen 3005 carries two objects 3060 and 3065. Object 3060 can enter the PUV chamber and object 3065 can be located outside the PUV chamber. The ability to carry multiple objects of this PUV system 3000 can facilitate efficient handling, for example, in a hospital pharmacy environment where PUV disinfection time can affect productivity and throughput.

  In another aspect, the platen 3005 may be adapted to receive a tray of objects to be sterilized. For example, a tray of two or more vials to be sterilized may be placed on a portion of the platen 3005 that is outside the PUV chamber. The tray may include a transport handle for conveniently placing and / or stacking vials. Such trays may be prepared in advance and later can be efficiently batch processed, thereby saving time and effort for processing the drug mixture.

  To assist in aseptic processing, the entire PUV system 3000 may be designed for use in an ISO Class 5 clean air environment. Such an environment may exist, for example, in a storage cabinet in an APAS cell, or in a hospital pharmacy laminar flow hood. If necessary, an air cooling system may be used to dissipate heat in the lamp housing 3070 or chamber 3075.

  In addition to the above examples, the disinfection system may be implemented using a system, method, or computer program product other than the above examples.

  In various aspects, the PUV system may communicate using suitable communication methods, apparatus, and techniques. For example, the PUV control module may communicate with the APAS control unit and / or the in-hospital pharmacy network using point-to-point communication, in which case the message is a dedicated physical link (e.g., fiber optic link, point-to-point). (Direct wiring, daisy chain) sent directly from source to receiver. Other aspects may send the message, for example, by sending to all or substantially all devices coupled together by the communication network.

  In some aspects, each PUV system may be programmed with the same information and started with substantially the same information stored in non-volatile memory. In another aspect, one or more PUV systems may be ordered to perform a particular function. For example, one PUV system may be configured to perform both custom and batch processing functions by responding to information about the object to be sterilized.

  In one aspect, an automated disinfection system for a pharmacy environment for killing or disabling contaminating organisms may provide one or more objects to be disinfected. The system can include a chamber having a pulsed ultraviolet source. The system can further include an automated transport mechanism for placing an object to be sterilized into the chamber for exposure to pulsed UV radiation from a pulsed UV source.

  In various aspects, the automated transport mechanism may further cause the object to be removed from the chamber after exposure to pulsed ultraviolet radiation. The automated transport mechanism may include a robot manipulator and / or a rotating platen. The automated transport mechanism may manipulate or move the object in response to a series of commands automatically generated by a processor executing a command program.

  The wall may substantially surround the chamber, with at least one wall having an opening for receiving the object and a portion of the transport mechanism. In some aspects, the automated transport mechanism may provide at least a portion of light shielding around at least a portion of the opening.

  The pulsed ultraviolet source may provide an ultraviolet pulse in response to the trigger signal. The controller may generate one or more pulses of the controlled waveform. The waveform may be controlled to provide a desired amplitude, shape, and / or intensity. The controller may generate a plurality of controlled pulses according to a selected disinfection routine. The selected disinfection routine may correspond to characteristics such as the type, size, or manufacturer of the object to be disinfected. The controller receives a message over the communication link, and the message may include information about the characteristics of the object to be sterilized.

  The object to be sterilized may include a vial, IV bag, or part of a syringe. Contaminated organisms to be killed or rendered inactive may include one or more viruses, bacteria and / or fungi. The ultraviolet light may include UV-A, UV-B, and / or UV-C wavelengths.

  Some systems may be stand-alone or table-top systems; other systems may be adapted to be integrated into APAS.

  In another aspect, a method of disinfecting at least one object surface may include causing the transport mechanism to generate an operational trajectory command that causes the object to enter the chamber. The method may also include exposing at least a portion of the object to a dose of pulsed ultraviolet radiation.

  In some embodiments, the dose of pulsed ultraviolet radiation may include one or more pulses. The method may further comprise identifying a number of pulses of ultraviolet radiation sufficient to kill or render inactive one or more types of contaminating organisms to a selected degree. The selected degree may be substantially all biological contaminants, for example, at least 99.99%, 99%, 95%, 90%, 80%, 75%, 70%, 60%, or at least about 50%. In some embodiments, between 1-100% of certain contaminating organisms may be killed or rendered substantially inactive by pulsed UV radiation doses.

  An air treatment system for the drug formulation area may provide a sterile environment for drug treatment. The air treatment system for the drug formulation area may also provide exposure protection for the system operator. The air supplied to the drug formulation area can be filtered using a high performance filter (HEPA) or ultra low permeation air (ULPA) filter to ensure that the particle level is consistent with federal and national regulations. Exhaust air drawn from the drug formulation area may be filtered to reduce contaminant levels. The exhaust air drawn from the drug compounding area may be discarded from the building, or may be partially or fully recycled to the drug compounding area. Drugs that have a benign exposure effect, such as antibiotics, can be treated in the positive pressure region within the APAS cell, where the positive pressure is relative to atmospheric pressure outside the APAS cell. The positive pressure region can remix some or all of the air from the drug compounding region and return it to the general pharmacy region where the drug compounding region is located. The cytotoxic agent may be formulated in a sterile area that operates in a negative pressure zone within the APAS cell, where the negative pressure is relative to atmospheric pressure outside the APAS cell. The negative pressure zone allows all external ventilation of the exhaust air.

  31A-31B are perspective cut-away views showing exemplary details of a portion of an air treatment system in an APAS cell. The APAS cell 3100 can be designed to formulate both antibiotic (eg, positive pressure) and cytotoxic (eg, negative pressure) drugs with little change in its setting or operation. The APAS cell 3100 can be divided into blending area sections including a blending area section 3105 and an inventory supply area 3110. The APAS cell 3100 can also include an exhaust area section 3115. The inventory supply area 3110 can include a carousel area having a carousel loading door 3120. The chambers in the inventory supply area 3110 may be maintained at a positive pressure relative to the atmospheric environment. The chamber in region 3110 is also at a negative pressure relative to atmospheric pressure, but may be maintained at the same or more positive pressure than the pressure in the chamber in the compounding region.

  In various modes, one or more controllers adjust the pressure in the compounding area chamber and / or storage area chamber either independently or with respect to each other and / or to ambient atmospheric pressure. May be. Such adjustment may conveniently be hindered so that the ambient environment is not substantially exposed to the air in the formulation area during loading of the inventory supply area 3110. The positive pressure in the inventory supply area 3110 can also help maintain cell cleanliness. The inventory carousel in the inventory supply area 3110 described with reference to FIGS. 3 and 4 can operate as a type of revolving door opening, with uncontrolled air between the inventory supply area 3110 and the surrounding environment. To prevent the transition. This may occur during APAS cell 3100 loading. The inventory carousel in the inventory supply area 3110 can also prevent uncontrolled air migration between the inventory supply area 3110 and the blending area 3105 during inventory access.

  In some embodiments, the air treatment system may monitor, record, and / or adjust temperature, humidity, and / or composition. Temperature control may be implemented in one or more zones within either or both of the compounding chamber and the storage chamber. For example, temperature control may be implemented by forced air heating or cooling, radiant heat (eg, electric heat), a heat exchanger filled with liquid, and the like. In some embodiments, the gas composition in the chamber is selective to, for example, catalyze the reaction, neutralize toxic byproducts, and / or clean or otherwise disinfect the environment in the chamber. May be controlled by introducing one or more gases (eg, nitrogen). In some embodiments, a visible (eg, colored) gas may be introduced to assess laminar flow within individual chambers, detect sealing integrity, and so forth. In some embodiments, desiccants and / or adsorbents may be used to control the environment within the chamber.

  The blending region 3105 can be negative with respect to the surrounding environment. Harmful aerosolized drugs or fumes may be included in the formulation region 3105. These can be drained from the blending region 3105, as in the examples described elsewhere herein. The compounding area 3105 may be sealed to the surrounding environment during compounding. The cleanliness level of the APAS cell can be continuously monitored during compounding. The completed product from the APAS cell can be output to the surrounding environment through the opening output door. An opening output door can be used to minimize the transfer of air to the surrounding environment. The compounding area 3105 is opened to the surrounding environment by compounding area doors 3125, 3130, and 3135. This can be done as needed or based on a predetermined schedule for replenishment, maintenance, and routine cleaning. This may include routine wiping and cleaning inside the compounding area 3105, drip mat removal and replacement, syringe cap refilling, and sharp needle container removal and replacement.

  The APAS cell 3100 can include a HEPA filter housed in a HEPA filter unit 3140 that filters exhaust air from the APAS cell 3100. HEPA filters retain the contaminant particles contained in the exhaust air and prevent them from being released into the surrounding environment. The APAS cell discharge system can include multiple modes of operation. One mode of operation can include complete external ventilation of the APAS cell exhaust air. This mode of operation may be used for some processes, such as certain cytotoxic drug processes, and may be optional for some other medical drug treatments. The second mode of operation can include partial or complete recirculation of the filtered exhaust air to the surrounding environment. This mode of operation can be used in medical drug processing where no cytotoxic drugs are involved, eg antibiotic treatment.

  Formulation region 3105 is a sealed enclosure (e.g., chamber) that is supplied with clean ULPA-filtered air from a fan filter unit (FFU) 3145 mounted on the top surface of the APAS cell 3100 at a position above the formulation region 3105. Can be included. The air flow through the volume of the blending region 3105 can be a substantially vertical laminar flow from the top surface of the blending region 3105 of the APAS cell 3100 to the bottom surface of the blending region 3105 of the APAS cell 3100. The exhaust air may be drawn into a duct 3150 that surrounds the lower periphery of the blending region 3105. The second independent FFU 3155 can supply clean air for the inventory supply area 3110, which also has an exhaust intake at the bottom. A single fan unit 3160 can draw exhaust air from both the blending area 3105 and the inventory supply area 3110. The layout of the duct and airflow into the fan unit 3160 is shown in FIGS. 31A and 31B. Air flow to ducts 3150 and 3165 can be controlled and restricted (e.g., using adjustable anemometers, flappers, slats, or other flow restriction elements) and the ducts are blended area 3105 or inventory supply area The pressure can be lower than any of 3110. The restriction is implemented by making the size of the inlet slot 3175 of the surrounding duct 3150 in the compounding area 3105 small enough to limit the total amount of air that can be pushed into the duct due to the pressure differential created by the ventilation fan 3160. May be. Pressure management in the inventory supply area 3110 may be managed in a similar manner using the inlet slot 3180.

  One or more techniques may be used to treat the exhaust air when leaving the APAS cell 3100. In embodiments used to treat some drugs, such as cytotoxic drugs, a ventilation fan discharge pipe 3185 is routed to a duct (not shown) that leads out of the building if desired by the user for the antibiotic cell. By doing so, substantially all of the air may be released from the building, and the air recirculation grille 3190 and associated piping may not be necessary.

  For example, in some aspects, such as for some antibiotic treatments, substantially all of the air discarded from the cell can be reintroduced into the surrounding local area around the cell. Air may be discarded from the recirculation grille 3190 on either side of the APAS cell 3100 near the ventilation fan 3160, and an external discharge pipe 3185 connection may not be required.

  For example, in an antibiotic treatment cell, some exhaust air may be exhausted out of the building, but the remainder of the air may be recycled to the surrounding local area. In this example, an air recirculation grill 3190 and an external discharge pipe 3185 may be used. Some of the flow can enter the recirculation duct and go to the grill 3190, and the rest can be discarded to the outside by the external discharge pipe 3185. An air flow control element (not shown) can be placed in the external discharge pipe 3185 to adjust the flow balance as the downstream duct conditions vary due to external factors.

  Some embodiments may include a number of regions in or coupled to the formulation region 3105, where additional air entrainment may be included to assist in managing the cell environment. As described elsewhere herein, such areas include, but are not limited to, the waste storage area below the compounding area 3105 where consumable waste is deposited by the robot. Not. Some embodiments may also provide airflow from a printer housing that can house one or more printers. Some other embodiments include an air flow that is local to one or more multiple syringe manipulators. Some alternative embodiments provide an air extraction system in the blending region 3105 that serves to cool an ultraviolet (UV) lamp in a port disinfection system, an example of which is described with reference to FIGS. .

  The air flow in each of the above regions may be provided, for example, through ducts that are in fluid communication with the surrounding duct 3150. As such, a low pressure zone may be provided in the blending basin 3105 and in one or more of the above regions around it.

  In some embodiments, the waste storage area may be connected to a low pressure ambient duct 3150 in the compounding area 3105, generating a local air flow from the compounding area 3105 to the waste storage area. Any airborne drug residue from waste material (e.g., empty vials, used syringes, and / or empty bags) can be withdrawn directly from the waste storage area and is substantially transferred to the compounding area. It is prevented from coming back.

  The printer housing and syringe manipulator housing can be a particle source because of the concentration of the mechanism and the type of activity that occurs in all of these areas. Air drawn directly from these areas can draw particles into the surrounding duct 3150 where it is discarded, rather than moving the particles to the compounding area 3105.

  In some embodiments, the UV lamps in the port disinfection system may be cooled and / or cleaned with a clean air stream. Such air flow may cool and / or substantially reduce the deposition of particles or organic solvent on the lamp surface. When connected to the low pressure ambient duct 3150, air can be drawn into the UV lamp housing from directly below the FFU output (which is cleanest here) and flow over the UV lamp for cooling. In some aspects, such cooling may be performed without additional air moving elements that may generate airflow that may disrupt laminar flow within the blending region.

  FIG. 32 is an exemplary block diagram of an APAS cell air treatment control system 3200 within an APAS cell. The APAS cell air treatment control system 3200 includes a compounding area 3205, carousel area 3210, fan filter unit (FFU) # 1 3215, FFU # 2 3220, HEPA filter housing 3225, combined variable speed drive (VSD) ventilation fan 3230 and air valve 3235. Including. A cell controller (not shown) can manage the control of the air pressure level of the blending area 3205 and the carousel area 3110, previously referred to as the inventory supply area, relative to ambient pressure. The air pressure level can be controlled by the APAS cell air treatment control system 3200, and a preset pressure level is maintained.

  The air pressure level in the blending region 3205 can be controlled based on the input from the differential pressure sensor 3245. The air pressure in the blending region 3205 may also be controlled by varying the speed of FFU # 2 3220 based on the input from the differential pressure sensor 3260.

  The air pressure level in the carousel region 3210 can be controlled based on the input from the differential pressure sensor 3240. The air pressure in the carousel region 3210 may also be controlled by changing the speed of FFU # 1 3215 based on the input from the differential pressure sensor 3265.

  The air pressure levels in the compounding area 3205 and carousel area 3210 can also be varied by varying the speed of the ventilation fan / VSD 3230 based on the input from the differential pressure sensor 3255, which monitors the differential pressure 3250 and the air pressure level in the HEPA filter housing 3225. Can be controlled.

  Although control based on the pressure of the air pressure level in the carousel region 3210 and the blending region 3205 has been discussed, other methods may be used. The method may include, but is not limited to, air flow, velocity measurement, or air particle counter measurement. The method may be used alone or in various combinations to control the pressure.

  The differential pressure measurement may be used as a diagnostic to ensure that fans FFU # 1 3215 and FFU # 2 3220 operate properly. The differential pressure can also be measured on the HEPA filter in the HEPA filter housing 3225 by a differential pressure sensor 3255. A differential pressure measurement on the HEPA filter may be performed to monitor HEPA filter loading. In some embodiments, various filters, including one or more biological filters, are combined with an air treatment system for a blending chamber, a storage chamber, and / or a clean tent, an example of which is described with reference to FIG. It may be included.

  Whenever an operator opens the blending area doors 3125, 3130 and 3135, some or all blending operations may be suspended. In some cases, any item with an exposed critical surface being processed may be discarded or re-sterilized (eg, by pulsed ultraviolet light). After the APAS cell has measured the ISO Class 5 air cleanliness level, processing in the compounding area 3105 may resume. For example, operation may be resumed after it is determined that the pressure level is within control limits and / or that the number of particles is below a predetermined threshold. Formulation regions 3125, 3130 and 3135 may generally remain closed before and after each batch process except for service / cleaning. In some aspects, the APAS cell access door may have a magnetically controlled lock (or other interlock or access control device), and in some modes, access to other than authorized users is blocked. Is done.

  In some embodiments, a particle counter may be used to monitor the level of contaminant particles in the blending cell. The particle counter may include a sensor (eg, a laser beam) that senses when particles pass. As the particles pass, the number of particles can be increased. For example, the particle counter may be a model CI-3000, commercially available from Crimet Instruments Company, California. In some embodiments, particles may be counted when they meet or exceed a particle size threshold. In one example, the particle counter may include two channels, one that measures particles up to about 0.5 microns (μm) and the other between about 0.5 μm and about 5 μm. It measures the size. To meet Class 100 clean room standards, the particle count may be maintained at 100 or less 0.5 μm (or more) particles in 1 cubic foot of air. Other channels, counters, or detectors may be monitored for other types or sizes of contaminants (eg, smoke). The number of particles may be stored for each drug order, for example, in the APAS database.

  FIG. 33 is an exemplary cutaway view showing details of a carousel area in an APAS cell. The carousel 3300 is shown with the top plate 3305 removed. The APAS cell inventory access may include an open door with a robot arm 3302 and an accessible robot access port 3310 from the inventory supply area 3110 into the compounding area 3105. The carousel 3300 can be placed in the robot access position, where a portion of the carousel rack 3320 is presented to the robot access port 3310 by the curved wall panel 3315. This can be managed with minimal air exchange since the door panel is always substantially blocking the door aperture. This may be implemented in the APAS cell 100 by creating compartments around the outside of the carousel. One compartment for each of the 12 inventory racks per carousel, eg carousel racks 3325 and 3320, can be generated. Other embodiments can include different numbers of racks, such as 2, 3, 4, 5, 6, 8, 10, 14, 16 or more.

  FIG. 34 is an explanatory view showing details of the carousel trim panel in the APAS cell. The compartment may be formed from a three-sided sheet metal trim panel 3405 that spans the distance from the lower disc to the upper disc attached to the carousel shaft. The trim panel 3405 can separate the volume occupied by each rack from the inside of the carousel and from adjacent racks. The two vertical edges of the trim panel can be fitted with a flexible edge lip using an adjustable seal 3410. The flexible rim substantially avoids a hard pinch point between the trim panel 3405 and the adjacent wall panel for operator safety, while the adjustment provides an adjustable seal 3410 for the carousel disc. It can arrange | position so that it may correspond with an outer diameter.

  The APAS cell inventory supply area 3110 may be maintained at a positive pressure with respect to either or both of the external environment and the compounding area 3105. This can be pressurized with ULPA or HEPA-filtered air, which can be fed from FFU 3155 in inventory supply area 3110 with outlet vents at the floor level and the incoming product by air descending through the volume Laminar flow scrubbing is possible.

  A curved wall panel 3315 that separates the carousel 3300 from the blending region 3105 may include a curved segment for each carousel that fits the carousel outer diameter from the top plate to the bottom plate 3330. In a preferred embodiment, the curved wall panel 3315 may not interfere with the carousel outer features because frictional contact may generate some material and undesirable particles. Therefore, a gap on the order of about 1 mm can be maintained between the curved wall panel 3315 and the carousel stroke volume, and frictional contact can be substantially avoided. The robot access port 3310 may be located in the curved wall panel 3315 and there is always at least one vertical trim panel edge seal 3410 that engages the curved wall panel 3315 on both sides of the door aperture as the carousel rotates. be able to. The top and bottom carousel plates may function to restrict all air paths to the top or bottom surface of the door aperture. These measures can substantially prevent unrestricted airflow from entering the compounding area 3105 from the carousel volume during carousel rotation or while positioned for robot access. However, from the inventory supply area 3110 to the compounding area 3105, the amount of air exiting through the carousel around the door opening can be minimized. Because the inventory supply area 3110 can be pressurized with clean HEPA filtered air, there may be virtually no opportunity for contaminants to be introduced into the compounding area 3105. Making the formulation area 3105 a pressure lower than the inventory supply area 3110 volume can substantially limit potentially harmful materials from moving from the formulation area 3105 to the inventory supply area 3110 and / or the surrounding external environment. .

  The carousel loading door access 3330 may be covered with a wall panel 3335 through which the rack is installed and removed, but may expose the rack compartment 3340 to be filled at any time the loading door is open. Good. This can be done by rack loading access 3345. The rack loading access 3345 may have the same minimum gap between the outer diameter of the wall panel 3335 and the carousel upper and lower plates and the trim panel edge. This structure allows a restricted flow of clean air from the pressurized stock supply area 3310 volume to exit past the carousel while the loading door is open, but with pressurization, virtually all Contaminants from the outside are prevented from entering the inventory supply area 3110 from the outside environment. For example, a controller for a servo motor driven carousel can prevent rotation of the carousel as an operator safety measure while the external loading door is open. The carousel and wall panel may be substantially sealed while the carousel is in the loading position.

  FIGS. 35A-35C show a product output chute 3500 in an APAS cell. Product exiting the APAS cell 100 can enter the product output chute 3500. Product output chute 3500 includes two product paths, also referred to as chutes 3505 and 3510, an inner door 3515, an outer door 3520, an inner surface 3525, an outer surface 3530, and a product divider 3535. Product output chutes 3505 and 3510 and product divider 3535 allow separation of the product exiting the cell (eg, syringe, IV bag). Chute 3505 and 3510 may include a vertical product path that is sealed at the end with an electromagnetically actuated door. There can be an inner door 3515 that covers both product paths, and an outer door 3520 that blocks both product paths.

  36A-36B are diagrams showing a product output chute 3500 in the course of product release from the APAS cell 100 of FIG. The inner door 3515 on the product output chute is normally closed 3605 while the outer door 3520 is normally open 3610. When the product is ready to be pumped out of the APAS cell, the outer door can be closed 3615, then the inner door can be opened 3620, the product through the opening of the inner door, through the vertical product path or chute Can be put in one. The product can then be released by the robot. From there the product can descend. As soon as it descends, the product can be on a closed exterior door 3615. Then, the inner door can be closed 3605, after a few seconds, the outer door can be opened 3610, gravity can help the product exit the aisle. The exterior door can remain 3610 open until the next product is ready to be delivered. The opening and closing of the inner door can be controlled by a solenoid 3625. The opening / closing of the external door can be controlled by a solenoid 3630. In another aspect, each vertical product path may have a separately controllable inner door, outer door, or both.

  FIGS. 37A-37C illustrate an exemplary printer system 3700 for an APAS cell. Printer system 3700 includes printers 3705 and 3710, which are mounted within housing 3715, which includes an automatic label shuttle 3735, which can provide a route to compounding region 3105. The printer system 3700 includes a printer mounting plate 3775, which includes an easily removable pin 3770, which facilitates removal of the printer mounting plate 3775 assembly. Housing 3715 includes an external door 3730 for an operator to access printers 3705 and 3710 for media loading and service, for example. The printer housing 3715 is disposed inside the external door 3730 and can be sealed with respect to the panel 3765 placed on the door frame. For example, when the operator opens the outer door 3730 for printer maintenance, the panel 3765 can be used to seal the inside of the APAS cell from the surrounding environment. As previously described, the printer housing 3715 is a duct and / or activity that provides fluid communication from the inside of the printer housing to the low pressure point in the air treatment system described with reference to FIGS. 31A-31B. The fan may be operated at a negative pressure rather than the blending region 3105. This negative relative pressure may substantially reduce the movement of particles produced by the printer operation from the printer housing 3715 to the blending region 3105.

  System 3700 includes a pair of spring-loaded housing doors 3720 and 3725 that lead to housing 3715 to receive a label tray on automatic label shuttle 3735 from compounding area 3105. The shuttle 3735 includes a slide motor 3740, a slide cover 3745, a slide motor housing 3760, a bag label tray 3750, and a syringe label tray 3755. Shuttle 3735 can push open doors 3720 and 3725 to enter and obtain a printed label for presentation to the syringe or IV bag to which the label is applied.

  FIG. 38 shows an exemplary tray 3800 for the printer system 3700 of FIGS. The tray 3800 may be a bag label tray 3750 or a syringe label tray 3755. The tray 3800 includes a fan 3805 (eg, having a DC or stepper motor) and wheels 3825 for contacting the printer housing. A fan 3805 is placed inside the tray 3800, and the label can be adsorbed onto the tray 3800 when it is separated from the printer. A proximity sensor can be placed in the top plate 3810 to detect the presence and exact location of the label. When labels are adsorbed on tray 3800 with the aid of inflow air 3820, the labels can overcome all natural label curl and static effects. This ensures that the label is accurately placed on the tray 3800, removed, and then presented to the bag or syringe. The fan 3805 sends air from the tray 3815 toward the inside of the printer housing 3715. This ensures that the particles are blown into the printer housing 3715 and not into the blending cell 3105, at which time the label is removed from the back.

  Some embodiments may include one or more printers and associated application devices, where labels are printed and the labels are affixed to vials, syringes, and / or IV bags. Some implementations may accept a label for a vial as the label is dispensed while rotating the vial. Various other aspects may use a barcode reader to print a label in response to identification of the barcode verification. Some labels may be printed in one or more languages, in whole or in part, as required by the health care provider or patient. Some labels may include a description of the exact content attributes or image information of the medical container. Some embodiments may print information such as 1 or 2D barcodes, text, or other indicia on the exposed surface of the IV bag. In some examples, the surface may be specially coated or may include a previously applied label that is substantially prevented from entering the marking material into the interior of the IV bag. In some embodiments, machine readable indicia (eg, barcodes, patterns) may be imprinted on at least one surface of a pill, tablet, or other solid medical agent. Some medical items may accept RFID tags instead of or in addition to any other label.

  39A-39B are diagrams illustrating an exemplary waste storage area 3900 of an APAS cell. The waste storage area includes waste storage areas 3905 and 3910, an inner door 3915, an outer door 3920, and a waste storage area housing liner 3925. The waste storage area 3900 can be coupled to the compounding area 3105 via a passage, so that the waste storage areas 3905 and 3910 can be emptied without interrupting cell processing. The waste storage area 3900 can be a stainless steel enclosure, enclosure liner 3925, which can be sealed from the surrounding environment. When closed, an inner door 3915 can be installed that can separate the waste storage area 3900 from the compounding area 3105. An outer door 3920 may be attached to access the waste storage area 3900 from the outside for removal of the waste storage areas 3905 and 3910. The inner door 3915 and the outer door 3920 can be interlocked so that when the outer door 3920 is opened several times, the inner door 3915 is completely closed. As described with reference to FIGS. 31A and 31B, when connected to the surrounding duct 3150 around the base of the APAS cell, air is drawn from the APAS cell and the outer door 3920 opens as long as the inner door 3915 is open. Air is drawn in from the outside. This may substantially prevent aerosolized drug from returning from the waste storage area 3900 to the APAS cell area or leaking out of the APAS cell. Interlocking can be implemented by mechanical coupling, but it may also be implemented by electro-mechanical actuators on the inner door 3915, sensing on the outer door 3920 or operator switches.

  In some cases, the inside of the syringe cylinder behind the syringe plunger may be considered a critical surface. An example of the inside of the syringe cylinder behind the syringe plunger is described in more detail with reference to FIG. APAS cell 100 may be configured such that critical surfaces avoid exposure to non-sterile environments (eg, less than ISO class 5).

  The operating procedure for obtaining a syringe from a class 5 assembly area through a non-class 5 environment and returning it to a class 5 cell, e.g. APAS cell, can be handled in many ways, e.g., maintaining syringe sterility . Two exemplary implementations are described below.

  A first exemplary implementation may be to load a syringe into a clean rack in a class 5 environment, and as soon as it is loaded, a clean cover is placed over the rack and syringe. The rack can then be transported from the assembly environment to the APAS cell 3100 with minimal risk of contamination. The cover can remain in place until the rack is installed in the carousel area 3110. As soon as the cover is removed, the chance of contamination is minimized by the class 5 airflow pattern at the front of the exposed rack loaded into the carousel area 3110. As described in the discussion of air treatment in APAS cells, the carousel region 3110 can be maintained at a positive pressure relative to the external environment. There can be a gap of about 1-2mm between the outer wall closure panel and the carousel top and bottom plate and the vertical trim panel seal, so that as soon as it is put into the carousel area 3110, clean air Can flow into the front area of the rack. As long as the external door is open, clean air can be blown onto the surface of the rack from the top, bottom and sides, minimizing the chance of external environmental contaminants actually reaching the syringe.

  FIG. 40 shows soft wall downdraft cleanrooms 4000 and 4005 attached to the sides of the APAS cell 100 of FIG. The second exemplary implementation essentially adds a soft wall downdraft clean room to the side of the cell structure that can be entered by the operator for APAS cell loading, as shown in FIG. Thus, a local class 5 clean environment may be created outside each carousel loading door. This type of clean room can add flexibility to the APAS cell loading paradigm. This can be large enough to cause the carousel door 3120 to open. This provides access to the operator interface panel inside the clean area and may optionally include a small work surface that facilitates any routine operator task. The work surface may be placed on the APAS cell or may be independent. The work surface may also be a suitably equipped mobile cart, which may also provide a mechanism for transporting supplies and / or transporting packaging material to the APAS cell. Load syringes, vials, and / or IV bags into a rack in a Class 5 clean bench, then place them in a covered rack and transport them to the clean area attached to the APAS cell; It can be loaded inside and the cover can be removed, resulting in an aseptic process. In some embodiments, syringes and other supplies are loaded directly into a rack already installed in the carousel, or loaded into a clean area with the rack attached, and then placed into the carousel. Can be brought directly to the clean area outside the carousel door 3120.

  The clean rooms 4000, 4005 may form a stand-alone clean tent, which may be formed in any shape and any suitable dimensions may be used. Clean rooms 4000 and 4005 contain FFU 4105 and 4020, respectively, and blow off from the ceiling of the APAS cell. In another aspect, the clean room may include piping configurable to couple to one of the existing FFUs 3145, 3155 on the APAS cell. The wall 4025 may be, for example, a combination of overlapping plastic strips and / or flexible plastic sheet curtains. Such a configuration can be swung or retracted from the side of the APAS cell, for example, and the APAS cell door can be opened for cleaning and maintenance as needed. Air quality can be quickly restored after all doors are closed again.

  FIG. 41 shows an exemplary APAS 4100 for an exemplary hospital environment. APAS 4100 includes one APAS cell 4130 and two optional APAS cells 4135 and 4140 connected to one or more remote user stations 4105 and 4145 by an APAS local network 4110. In other aspects, four or more APAS cells may be included in the APAS 4100. Using network communications (e.g., packet-based communications), any actual number of APAS4100 cells can be used in various geographic locations (e.g., different locations within a building, between multiple facilities, or one or It may operate in a coordinated manner from multiple geographically separated locations). Examples of communication networks include, for example, LANs, WANs, wireless and / or optical networks, and computers and networks that form the Internet.

  The APAS 4100 may accept the drug processing request through the hospital communication network 4115. The APAS 4100 may accept a drug processing request from the current hospital drug order / prescription order entry system 4120.

  In some implementations, the APAS 4100 may be integrated into the current process flow model where drug orders are prepared, verified, and passed to the pharmacy for manual processing. The process flow model may be managed by the hospital IT system 4150. Some current order entry systems 4120 may generate a label printed by the hospital printer 4125 that includes drug order information (eg, drug name, dose level, concentration, patient data). Such a label can create a processing demand for operations performed manually at the pharmacy. APAS 4100 can use such information on the label as a drug order source for automated processing.

  One exemplary manner in which the APAS process begins can occur when a drug order is obtained on the hospital interface, as described with reference to FIG. A drug order can be a trigger event. Drug orders can start on a time basis, start when a file exists, start when printer port data is acquired, or start when some other type of hospital order entry system message occurs There is sex.

  Another exemplary manner in which the APAS process begins includes an operator manually entering a request that is not patient specific for drug processing. APAS 4100 may be incorporated into the current pharmacy process flow, where a request is made by medical staff to administer a medical agent to a patient. The request is then examined by pharmacy personnel, typically in combination with order entry software. The pharmacist may review the order entry by reviewing the dose level, other medical drugs the patient is using, and other related factors. The APAS 4100 can accept drug orders that have already been authenticated and / or examined. These safety checks can be avoided if patient specific orders are entered directly into the APAS4100. In some aspects, the APAS can only accept patient specific requests via the hospital interface. This mode of operation can support batch operation in a pharmacy. A batch operation can be an operation in which a certain amount of product is prepared in anticipation of demand. The batch product can then be refrigerated or frozen. For example, a pharmacy operator may wish to prepare 100 1 g Cefazolin syringes, or 200 saline syringes for line flushing.

  Since the data already exists in some electronic formats, the installation site (eg, hospital) may move an electronic file that contains the information requested by the APAS 4100. Some implementations may use well-known electronic data exchange techniques. The drug order may be predefined, for example, outside the APAS 4100. Any review of drug orders, any contraindications, contraindications, or validity of prescription dose accuracy can be performed by current hospital systems outside the APAS 4100. The resulting drug order may be input to the APAS cell for processing.

  In some aspects, the APAS may include an interface to a hospital system to obtain some important information about the drug request, which is then processed by the APAS and a series of processing instructions to the APAS cell and The APAS cell can control the preparation of drug orders in an automated fashion.

  In addition to different interface methods, the actual content of drug orders can vary between hospitals. The APAS 4100 may have a flexible drug order interface that can accommodate various devices for order entry while maintaining a fixed and authenticated back-end automation system.

  Drug orders can be received from APAS4100 in various ways. FIG. 42 is a flowchart of an exemplary method 4200 for an APAS process for APAS 4100. Method 4200 may create an ASCII delimited file that the hospital system retrieves via FTP by APAS 4100.

  Method 4200 begins with drug order capture at step 4205. Various ways to obtain drug orders for APAS4100. These options include, for example, acquisition of print stream data, connection to the HL-7 interface where APAS creates a connection to the hospital message server and records the drug order request message packet, data storage (e.g., memory stick , Disk, CD, or other removable storage device), direct information entry (eg, manual rekeying), optical character recognition reading, and / or scanning barcode information. Some implementations may include electronic data exchange methods, examples of which may encode XML, HTML, or otherwise be associated with, for example, data fields, as specified by style sheets A bar code having a tag bar code that encodes certain tag information.

  Two exemplary approaches for performing the order capture process 4205 are shown in FIGS. FIG. 43A is a flowchart of an exemplary order capture method 4300 involving the creation of an ASCII delimited file. FIG. 43B is a flowchart of an exemplary order capture method 4310 involving the acquisition of print stream data. Another method of performing the order capture process 4205 includes an HL-7 interface, where the APAS 4100 creates a connection to the hospital message server and records the drug order request message packet.

  Hospital IT system 4345 may execute drug order entry software in method 4300. The hospital IT system 4345 can create a drug order label by generating an SQL query for the database in the hospital IT system 4345. The drug order label can then be printed by printer 4350.

  The hospital IT system 4345 can also create an ASCII delimited drug order label data file 4355, which can be referred to as a label data file, which can be retrieved by APAS via File Transfer Protocol (FTP) 4360. it can. The label data file 4355 can be placed in a folder included on the hospital IT system that can be accessed by APAS. As soon as accessed by the APAS, the label data parser 4315 can parse the label data file to determine if the APAS can process the drug order. The analyzed label data file is then reviewed by the drug order review system 4320 within APAS. If the drug order cannot be processed by the APAS, the APAS can send the drug order label to the current network printer 4350.

  For drug orders that can be processed by APAS, a drug order record that can be stored in the APAS database 4340 by the drug order review system 4320 can be created. The APAS can execute the planning software 4325, which can create production queue and inventory load data that can be stored in the APAS database 4340. The database 4340 may again be updated with the information determined in the inventory storage process 4330, where an inventory mapping can be created for the APAS. Thereafter, in the production process 4335, APAS creates processing information, which is also stored in the APAS database 4340.

  Hospital IT system 4345 may execute drug order entry software in method 4310. The hospital IT system 4345 can create a drug order label by selecting the current printer driver in the hospital IT system 4345. The drug order label can then be printed by printer 4350. The method may include, for example, an HL-7 interface, in which case the APAS may connect to a hospital message server and record a drug order request message packet.

  The hospital IT system 4345 can also be selected to print on the APAS. An APAS printer driver 4365 can be provided for the hospital IT system 4345 to print to a port on the APAS cell. The port may be in various ways, for example, a network command, USB, Firewire, wLAN, or other serial or parallel implementation. The APAS printer driver 4365 can create a print file on APAS. The print file may be in the form of a label data file 4370. In some embodiments, the label data file 4370 may trigger label data analysis software. The label data analysis software can parse the label data file and determine whether APAS can process the drug order. The label data printer 4375 can take the analyzed label data file information and create a drug order label. The analyzed label data file is then reviewed by the drug order review system 4320 within APAS. If the drug order cannot be processed by the APAS, then the APAS can send the drug order label to the current network printer 4350.

  For drug orders that can be processed by APAS, drug order review system 4320 can create a drug order record that can be stored in APAS database 4340. The APAS can run the planning software 4325, which may create production queue and inventory load data, which can also be stored in the APAS database 4340. The database 4340 may again be updated with the information determined in the inventory storage process 4330, where an inventory mapping can be created for the APAS. Thereafter, in the production process 4335, APAS creates processing information, which is also stored in the APAS database 4340.

  Different hospitals may have different label formats. In order to accommodate various interfaces, FIGS. 43A and 43B show that the input method 4300 and the input method 4310 in the order capture process may vary, but the process steps 4320, 4325, 4330, And 4335 indicate that they remain the same. This allows a flexible interface to the hospital system while maintaining a consistent automation method. When APAS 4100 is first installed at a hospital location, configuration information can be pre-loaded into APAS cell 100, which defines how to interpret received drug order data. This can include defining which sections of drug label data are associated with important fields for processing. The label may contain information that is not necessary to automate the process, such as the patient's bed position. Such information can be stored in free-form fields that can appear on prepared syringe and bag labels.

  In an exemplary embodiment, a drug order record for each drug order processed by the APAS may be stored in the APAS database 4340. Each drug order record may be associated with parameter information related to the state of the APAS cell during the processing of the drug order. This information may include, but is not limited to, a unique dose ID. In one or more data tables in database 4340, the parameter information may be associated with a unique dose ID. For example, an operator, loader, responsible pharmacist, prescribing doctor or health care provider, inventory loader, and patient related information may be associated with each unique dose ID. Date and timestamp information (eg, start time, end time) may be associated with one or more data items associated with each unique dose ID. The information may also include information about the type (eg, manufacturer, model) and size of the medical container that was used to process the drug order, including the intermediate and output medical containers that were used. The medical container information includes, for example, measured values of inner diameter and / or outer diameter at a certain position, length, image information (eg, prototype bitmap), and / or container weight. Each dose ID is a process measure, e.g., a weight measure at a different processing stage, a captured image (e.g., bitmap, .gif, .jpeg or .mpeg video clip), predicted and actual image data, image It may be associated with comparative confidence and threshold levels, barcode data, number and intensity of pulsed UV exposure (eg, or selected profile) and the identity of the exposed item. Each dose ID is an environmental parameter measurement, e.g., particle counter reading, mass flow rate in an air treatment system, internal (e.g., in a blending chamber, inventory chamber, clean tent) and external (ambient atmosphere) humidity, temperature, And pressure (eg, gauge, difference between chambers and / or inside and outside).

  The drug order record in the APAS database 4340 may be associated with an image of the drug and / or diluent used to process the drug order, and an image of the final order in the container to be delivered. Information about the status of APAS may also be stored in a drug order record in APAS database 4340. For example, control settings for the air treatment system (fan speed, flow control elements), various motor operations, robot parameters (e.g. motion profile, lockout area), maintenance levels, software and hardware versions, training Profiles, error or confirmation messages, abnormally terminated drug processes, associated communications with the hospital interface, user input information, and similar information may be associated with each dose ID. Other data that may be stored in the drug order record in the APAS database 4340 includes various other parameters for the drug order, e.g., expiration date, and at the same time as or for each drug dose preparation. Various other APAS settings and / or variables that are relevant.

  Collecting and associating some or all of such information in a relational database may provide various advantages. For example, drug dose records may be recalled for individual doses or recalled for a class of drug treatment (eg, all 10 mL syringe doses prepared last month). The recalled records may be reviewed for process control improvement, statistical analysis, auditing, repetition, profile editing, training, maintenance, and / or other purposes.

  After completing the order capture step 4205, the APAS analyzes and confirms the drug order received in step 4210. In various aspects, the APAS 4100 may support a wide range of input drug order formats. An input masking scheme may be implemented, where, for example, a configuration table stored in the APAS database 4340 includes analysis information about the labels. In one implementation, one or more SQL statements may be embedded in the label, using a configuration table to extract data from the input file and the appropriate fields in the drug order record in the APAS database 4340 Can be created. The parsing information may include information about field delimiters and format information, which may be present in the case of captured print stream data. The parsing information may also include a truncation or string subset for the requested character. An operation may be performed to remove printer control characters, such as on captured printer data. In various aspects, packet headers, ECC, XML tags, and / or other types of metadata are removed, interpreted, or decoded from packet-based or other serial or parallel communications to process drug orders Information may be interpreted.

By implementing an input masking scheme, APAS 4100 can accommodate various formats and orders of data in accepted drug labels with little or no change in software. The mapping information can be included in a table that can be easily improved. In a typical application of the method 4200, the hospital can predefine the contents of the input data and preload the configuration data. In some cases, this advantage may be that changes to the field are possible without requiring software improvements. This allows for a variety of formats and reduces the adaptation work required by current hospital information systems integrated with APAS4100. In some aspects, the system
1. Review drug orders accepted on the care provider order entry (CPOE) interface;
2. Tagging orders with APAS (eg, in a picklist) may identify which of the accepted drug orders should be handled; and
3. Confirmation that the amount of drug requested in the drug order is within the training range, tolerance if manual override / limit override is not accepted.

  In one example, a non-standard amount of drug may be required for a large patient. APAS may warn this case for reviews by authorized users. The user can accept the event without adjusting the predefined limits. If the event has been determined to be included within the range considered normal, it is possible to change the limit trained.

  The drug order can be accepted in a predetermined format, such as a delimited ASCII file. In some embodiments, the APAS 4100 can analyze the drug order and confirm that it is in the correct format. A drug order is created in the APAS database 4340 for each valid order received on the interface. The APAS cell 100 may identify orders that do not pass confirmation. For example, the drug order may be analyzed by extracting a key field from the drug order (eg, drug name, drug amount, unit, concentration, concentration unit). Confirmation may also include confirming that the drug order is an order that can be produced within the constraints of IV bag and syringe training inventory. Verification can be performed at step 4215.

  As individual drug orders are confirmed, they may be added to the production queue at step 4220. The addition may be automatic or manual. The operator can control which queues are assigned drug requests and move orders between queues. A cue represents a collection of orders that are released into a cell for production. The queue may be pre-processed to determine the total collection of drugs and consumables required to fill the queue, which may later be a list of inventory items to be loaded.

  Whether the item is released into the production cell is determined at step 4225. If the item is released, production process 4230 is performed. If the item is not released, the system transitions to the idle state 4235 and then step 4205 is repeated.

  The purpose of pre-processing may be to analyze a set of drug orders that are collected in a queue and released for production. Each order may be processed according to an algorithm that determines the processing steps required to complete the order. Processing steps can be read into the database table. The process can define details such as the amount of drug to be withdrawn, the syringe or bag size required, and / or any additional dilution requirements. The completed collection of these steps can be compiled to determine the total set of drugs, diluents, and bag and syringe requirements for the dispensed dose. The APAS software can then process each set, as needed to provide a drug that fills the production queue, for example, through iteration by the operator providing inventory details such as what vial size to use. The mix of vial size and reconstruction process input to be performed (eg, syringe, diluent) is determined. This information may be used to create an inventory storage list that can be sent to a display for the operator.

  The automatic compounding device may have preloaded information for a specific drug order. For example, a single automated device may have a preset table of data for handling a 1 g cefazolin filled syringe, or a 2 g cefazolin syringe. Handling an intermediate dose, eg, a 1.5 g dose, may include retraining of the system. In the APAS embodiment, the drug order and filling amount may be determined by algorithmic methods. In this approach, the software can calculate processing steps for any effective range of doses that can be produced within the limits of available medical containers (e.g., syringes and bags loaded into inventory). . As an example, APAS can correctly handle 1 g cefazolin 100 mg / ml, or 2 g, or 1.5 g orders without the need for further training. The system may also incorporate a range limit check to alert abnormal doses for confirmation.

  In an exemplary embodiment, software may be used to determine fluid volume requirements, syringe or bag size to dispense, and additional dilution steps. An exemplary process may use a series of key tables in APAS that define the drug, reconstitution profile, drug concentration, and distribution information described below.

  FIG. 44 illustrates an exemplary method 4400 by which APAS software analyzes a drug order and determines a fluid transfer process request. In some embodiments, the APAS may initially accept the requested drug name and its concentration at step 4405. For example, a drug order may include a drug name, drug amount, quantity unit, concentration, and concentration unit.

  Next, in step 4410, the APAS obtains a transform coefficient. To determine the conversion factor, the method 4400 can access the trained drug information using the order drug name to find the base unit, and then use the order unit to find the conversion factor. Can do. In the first pass of method 4400, the drug order quantity can be adjusted to a common unit in the trained drug table. For example, if a trained table drug uses milligrams as a base unit and the drug order is expressed in grams, the drug order can be converted to milligrams. The trained data can be accessed using the drug name on the order to determine which unit conversion is used to convert the drug order to the ordered basic unit. A trained drug in the trained drug database can be associated with a field that indicates a base unit. Typical units can be milligrams or units. The drug order amount can be analyzed and then used as an indicator to determine the conversion. For example, cefazolin 1G 100 mg / ml vial concentration may be expressed in units / ml.

  APAS determines distribution information from the distribution table. The distribution information may include which medium the drug dose and volume are distributed at the pharmacy. For example, the syringe, bag, and bag size may be determined based on threshold values in the distribution table. In step 4415, the system determines whether the media is available in the amount required by the APAS cell. If the required amount is not available, a drug request error is indicated at step 4420 and the method 4400 ends. An error may indicate that the drug order has an unknown unit.

  However, if the required amount is available, the drug order is adjusted to the same units as the medical container (eg, vial) at step 4425. The APAS may compare the request to the drug concentration present in the drug vial. For example, the vial may be reconstituted with an APAS cell and the fluid may already be available. Thereafter, in step 4430, fluid withdrawal is calculated. The system can determine the amount of fluid that can be transferred from the vial by dividing the amount of the drug order by the concentration of the vial.

  In step 4435, APAS checks whether the concentration is acceptable. Whether further processing steps to adjust the dose concentration are required depends on whether the vial concentration is equal to the dose concentration.

  However, if the concentration is not acceptable, then in step 4445 the system calculates the dilution ratio, for example, by dividing the vial concentration by the dose concentration. This may include withdrawing an amount, diluting the solution by withdrawing additional fluid, or decanting the withdrawn amount into the bag. In step 4450, additional diluent withdrawal is calculated, for example by multiplying the dilution ratio calculated in step 4445 by the fluid withdrawal. The fluid withdrawal is then subtracted from this product.

  After step 4445 or if the concentration is acceptable at step 4435, then the syringe size is determined at step 4440. The determined syringe size is based on fluid withdrawal and additional diluent. Thereafter, in step 4455, APAS determines whether the drug order should be dispensed into the IV bag. If distributed to an IV bag, APAS then appends bag information, including information about the IV bag used for distribution, to the processing data.

  After step 4460 or if not distributed to the IV bag at step 4455, then the process data is appended to the process data table and method 4400 ends.

  In various embodiments, one or more drug tables can be used to determine drug concentration. Such drug concentrations can be used, for example, to determine whether further dilution is required to complete the order.

  An exemplary APAS may implement a method that includes a defined series of process excerpts with parameters. In some cases, the type of drug preparation performed by an automated compounding system such as APAS can be broken down into one or more of these separate steps. Using this approach, APAS can accommodate a wide range of processing requirements and can support multiple types of output products (eg, syringes, bags).

  In the exemplary method of FIG. 44, the method steps may include draw, dilute, decant, dispense operations. Various combinations of such operations may be used to prepare drug orders using algorithms such as those described herein. Drug preparations under this algorithmic method fall into a combination of these four basic operations.

  In some aspects, the algorithm method may be a default approach for implementing a drug order for APAS. This method addresses several typical applications and provides the flexibility to handle a good amount of solution for a wide range of doses. Two additional exemplary methods supported by APAS are described below. These methods can be activated via drug orders from current hospital order entry systems or by operator action.

  Three exemplary methods for drug order processing are as follows. The first exemplary method includes the algorithmic method aspect described with reference to FIG. Preferred embodiments may include default methods of device operation and generally cover standard preparations of drugs. The second exemplary method may be referred to as a lookup method. The lookup method may define a specific dose level and another commonly repeated preparation instruction trained by the APAS. A third exemplary method may be referred to as a recipe method. Recipe methods enclose preparation instructions directly in a drug order or request. This method is typically used when there is variability in how drug orders should be prepared and dispensed, and / or when there are few commonly repeated instructions (drug treatments such as patient weight, surface area, etc. (Pediatric, chemotherapy, or other applications that can be adjusted based on factors). Look-up and / or recipe methods can be advantageous, for example, in situations where a pharmacist identifies drug order processing information (e.g., withdrawal, dilution, distribution information) that is outside the normal processing range for algorithmic methods. There is sex. These and / or other methods may be implemented alone or in combination.

  In some applications, the system may need to be trained to do something different for a particular drug at a particular dose level, recurringly different. For example, the system may be trained to use predetermined data rather than algorithmic methods for specific doses. The APAS may use one or more pre-defined preparation tables to implement a method for defining specific preparation requirements for specific dose size drugs. In this case, once the APAS accepts the drug order, the dose in the order can be checked against a pre-defined table. If present, then the predefined data can be used instead. Sometimes a hospital wants to use an algorithmic method, and sometimes a hospital wants to use a pre-defined method. For example, a hospital may have a protocol that requires 1 g of cefazolin dispensed into a syringe as a default in the algorithm, but sometimes a hospital may require 1 g of cefazolin dispensed as a 50 ml IV bag . To assist in this, some aspects of APAS provide a way to identify hope for a drug order, or an operator can use this for either a batch or one or more orders in a batch. It can be specified that another preparation method is applied. The default method requires information about drug name, amount, and concentration, but this method may accept information about other parameters that indicate whether another preparation method (e.g., a lookup table) should be used. Good.

  The recipe method may be particularly advantageous when doses and distribution media (eg, syringes, vials, IV bags, etc.) and concentrations vary considerably. For applications such as pediatric and chemotherapeutic preparations, the dose size can vary with the patient (eg, weight, surface area, weight, etc.). There may be times when a drug order or operator wishes to include specific ad hoc preparation information for a drug order. In this case, additional parameters in the label can define specific preparation requirements for that one drug order. APAS can support script recipes for preparation. By way of example, an order can specify details such as 10 ml cefazolin 100 mg / ml withdrawal, 20 ml sterile water withdrawal and dispensing into a syringe. Another example may be drawing 10 ml of cefazolin and dispensing it into a 50 ml sterile water bag. As described, the method can include specific processing instructions in the drug order itself. As such, APAS may not need to use either an algorithm or a lookup method. It can be specified that specific coded commands within a drug order should follow the recipe method.

  In order to control the drug process, the APAS software, when executed by the processor, can cause pre-processing to be performed on the drug order, as shown with reference to FIG. The amount of fluid transfer can be calculated from the required dose in the drug order using known drug vial concentrations listed in the table of drug products trained to be handled by the device. This information can then be combined with pharmacy distribution information that defines which doses can be provided to the syringe and which doses can be provided to the bag. This information may also be combined with the physical dimensional characteristics of the syringe used. In some aspects, there may be an interaction layer with the APAS operator that can identify drug inventory items that are used for a particular production process. They can be identified using defaults, or the operator may specifically enter information about which items to use. In this interaction, processing can identify inventory items, which allows APAS to calculate the sum of drug products, vials, syringes, bags, and diluents, and to process order collection. This aggregate information can be communicated to the operator as a load instruction or message, which can retrieve the item list and place it in the equipment inventory.

  During the pretreatment process, APAS can select the treatment order for each drug order. In the illustrative example, implementation of method 4400 includes only syringe withdrawal. An example may be for the cefazolin order, eg 1G 100 mg / ml, where the vial unit is mg. The vial concentration is 100 mg / ml. This can be the result of steps 4405, 4410 and 4415. The method continues to step 4425, where the drug order quantity is adjusted to the same units as the vial. This results in a 1000 mg drug request. In step 4430, the fluid withdrawal is determined to be 10 ml. This is determined by dividing the 1000 mg drug request by the vial concentration of 100 mg / ml. In step 4435, the vial concentration is determined to be equal to the dose concentration. The APAS determines at step 4440 that a 10 ml syringe is required based on the fluid withdrawal and additional diluent. In step 4455, it is determined that an IV bag is not required for dispensing. As such, the data includes a command to acquire a 10 ml syringe and withdraw 10 ml from the vial. Data for the drug order is added to the process chart at step 4465 and method 4400 ends.

  Another example of method 4400 further includes dilution and dispensing into IV bags. In this example, the drug order requires a penicillin order that is 1G sodium 6mu, 500,000 u / ml. The vial concentration is 500,000 mg / ml. This can be the result of steps 4405, 4410 and 4415. The method continues to step 4425, where the drug order quantity is adjusted to the same units as the vial. This results in a drug request of 6,000,000u. In step 4435, the fluid withdrawal is determined to be 12 ml. This is determined by dividing the 6,000,000 u drug request by the vial concentration of 500,000 mg / ml. In step 4435, the vial concentration is determined to be equal to the dose concentration. The method 4400 determines at step 4440 that a 20 ml syringe is required based on the fluid withdrawal and additional diluent, resulting in a total volume required of 12 ml. The method 4400 proceeds to step 4455 where it is determined that an IV bag is required for dispensing. Step 4460 adds bag information to the process data. In this example, a 50 ml bag of saline is required. In step 4465, data for the drug order is added to the process table. The data includes commands to acquire a 20 ml syringe, draw 12 ml from the vial, and add a 50 ml saline bag. Thereafter, the method 4400 ends.

  Another example of method 4400 further includes dilution. An example of method 4400 may be for the clindamycin order, eg, 600 mg, 15 mg / ml, using a 150 mg / ml concentration. This can be the result of steps 4405, 4410 and 4415. The method continues to step 4425, where the drug order quantity is adjusted to the same units as the vial. This results in a 600 mg drug request. In step 4435, it is determined that the fluid withdrawal is 4 ml. This is determined by dividing the drug request of 600 mg by the concentration of 500 mg / ml. In step 4435, the vial concentration is determined not to be equal to the dose concentration. The method 4400 then proceeds to step 4455 where the diluent ratio is calculated. In this example, the diluent ratio is determined to be 10: 1. This is based on the ratio of 150 mg / ml concentration to 15 mg / ml drug order. In step 4450, it is determined that an additional 36 ml of diluent is required for the drug order. This is determined by multiplying a 4 ml fluid draw by a dilution ratio of 10. The 4 ml fluid draw is then subtracted from the result 40 to determine 36 ml additional diluent draw. In step 4440, it is determined that a 60 ml syringe may be used for a total volume of 40 ml. In step 4455, it is determined that no IV bag is needed. In step 4465, data for the drug order is added to the process table. The data includes commands to acquire a 60 ml syringe, withdraw 4 ml from the vial and withdraw 36 ml of sterile water.

  The system independently calculates the amount of fluid drawn in milliliters, and the required size of the target syringe in milliliters, and the type and size of the dispensed bag, if any. Also good. The end result of this process may be a command order that indicates the process of meeting the drug order and fluid transfer parameters and syringe size. These processing commands may be stored temporarily and / or in a database and may be associated with a single drug order record for subsequent processing during a production operation.

  In the production planning phase, an example of which is described with reference to FIG. 42, the sum of drugs and consumables for a drug order is determined so that inventory items can be selected. In various applications, the operator may provide inventory items that are selected via stored rules and / or user input, or via a default definition as to which inventory item to use.

  For example, the total cefazolin for the production queue may be 100 g over 90 doses. Therefore, a minimum of 100 g of cefazolin may be provided in stock. As noted above, multiple size vials may exist. The operator can indicate which sizes and supplier contents can be used for the run. In some aspects, this can be automated using a default assumption on size, or optionally via an interface to the hospital inventory system. Pre-inventory identification allows the system to perform appropriate verification checks during production operations. As an example, pre-identification may identify information that may later be used during a production confirmation check. Production confirmation checks, for example, check vial label information using machine vision pattern matching, optical character recognition (OCR), barcode scanning, or any combination of these or other techniques described herein. May include.

  In some aspects, the process may include identifying which drug inventory to use and may include the drug size to use. This process may be at least partially automated. Automated identification may be overridden by the operator in several ways. If there are more than one APAS cells, the production queue can be assigned to a special APAS cell. The requested APAS carousel rack may also be identified.

  After identifying the inventory, the APAS cell can analyze the reconfiguration processing request and create a series of commands stored in a table (eg, a database) to control the reconfiguration process. Reconfiguration control can include high-level process commands with parameters that define drug and target concentrations. A pre-loaded table with trained drug and reconstitution data can be used to determine the required diluent and diluent volume.

  In some aspects, this stage may create a list of all inventory items required for the production process, along with a complete set of processing commands for both reconfiguration and drug processing. The APAS cell can also determine the rack and location for each inventory item. This information may be sent to the display or printed for review by the operator, who can retrieve the item and load it into the APAS cell.

  During this phase, the APAS cell may check inventory load requests for available rack compartments and can alert either issue if there is insufficient available rack space to accommodate the inventory load. . At this time, further iterations may be performed on the stock stock. For example, the operator may instruct the cell to use 100 small cefazolin vials, which may exceed the capacity of an effective inventory rack. In such a case, the production plan may be reduced to a level that can accommodate an effective rack space.

  When the production queue is preprocessed, the system may present an item roadmap to the operator. The roadmap may indicate to the operator which drugs, vial sizes, syringes, or bags should be in stock and which racks may be required.

  The operator may communicate with the APAS software either at the remote user station 206 or directly, for example, at a terminal located near the APAS cell (eg, flat panel monitor 202), and manually rack inventory items. You may load it. In some embodiments, each rack may be barcoded as shown in FIG. A bar code reader may be used to identify items (eg, medical items, medical containers) that have been bar coded when loaded. The operator may indicate the contents of some or all locations to build a database of information about where each inventory item is placed in the cell. This database may be used at a later stage, including during production.

  Confirmation of a drug vial via a barcode may be performed, for example, when the vial is loaded into an inventory rack. This may be done, for example, using a handheld scanner at either the remote user station 206 or in situ loading 226 at the APAS cell 100. During rack loading outside the APAS cell (eg, at an inventory station), the barcode scanner may identify the rack type and unique identifier using a barcode label secured to the rack.

  In some aspects, when a rack is loaded into an APAS cell, the door can be closed, the carousel can be rotated, using a rack barcode and a fixed barcode reader located within the APAS cell. Each installed rack can be confirmed by type, serial number and position. This process can be used to determine which racks are loaded at each carousel location, which allows the APAS cell to automatically determine the coordinates and motion profile to reach each item. Can do.

  Various aspects may exchange used data and provide demand predictions for medical items. Information collected from operations may be applied to inventory purchase decisions using appropriate software. Similarly, the collected data may be used for invoice and billing functions.

  In various aspects, APAS automatically uses software to improve algorithms and rules according to information about vials, trained products, and targeted output items (e.g., bags, syringes, vials, kits). A drug order process may be performed that determines fluid withdrawal, syringe, and product distribution.

  In one example, the drug order can be accepted at the hospital interface and forwarded to the APAS for processing. The drug order can define the drug name, dose size and / or required drug concentration fields, which can be used by the software to determine processing requirements. The drug order may also include other information (eg, patient name, bed location, patient ID, notes) that may appear on a label on the prepared drug product. This information may appear on the drug order but is not used by APAS. For example, the nurse may check the patient ID at the ward or for billing purposes and separate it from the APAS. To automatically fill an order, APAS software analyzes the order and translates the request into a series of processing steps, which process the requested drug, fluid transfer, and syringe and / or bag product. Identify. APAS cells are compatible with off-the-shelf IV products and standard syringes and can perform fluid transfer within the cell. A syringe with a pre-installed needle can be placed in stock and then moved to one of the two syringe manipulators 322, 334 as needed. Syringe manipulators 322, 334 include grippers and motor control sliders that can hold the syringe, articulate the syringe plunger, and perform the required fluid transfer under software control. Syringe manipulators 322 and 334 hold the syringe cylinder, push the vial or bag over the syringe needle, grasp and hold the plunger stem of the syringe, and move the plunger stem up and down, fluid through the needle A transition is triggered.

  During a production run, the APAS cell may retrieve this set of processing steps for a certain drug order. In some embodiments, the system can indicate that a drug is required, what fluid volume is required (e.g., in ml), and what type or size of syringe is required (e.g., in ml). The data shown can be read out. The software can check the inventory available for the device, find the appropriate syringe size, and extract the syringe physical properties from the appropriate table. Physical data can be used to determine dimensions for the syringe gripper (eg, plunger button diameter, cylinder outer diameter, total length, needle extension, maximum fill, and inner diameter). The APAS software now has information on top level fluid transfer demands and syringe dimensions used. The algorithm can then be used to convert the requested milliliters of fluid withdrawal into millimeters of plunger stem travel for the particular type of syringe selected. In some aspects, this calculation may be accomplished by using the inner diameter of the syringe to determine the length of the inner column of fluid, which is equivalent to the required plunger stem stretching. The software may, for example, use manufacturer average inner diameter information to minimize the effect of manufacturing tolerances on the inner diameter. In some embodiments, the software may add a default offset equal to one half of the inner diameter tolerance to compensate for the syringe below the average. In some aspects, a dynamically adjustable offset may be used to fine tune the compensation used for the syringe. The dynamically adjustable offset may be based on statistical analysis of recorded syringe measurements. For example, the weight of the syringe may be measured before and after fluid filling. Using this data over time allows adjustment of the compensation amount based on the history of the prepared dose. The APAS software may control the movement of the syringe manipulator slider to achieve the desired linear stretching, which is equal to the desired fluid volume. The filling syringe can then be weighed to confirm that the actual weight matches the expected weight. This can be done using tolerances that reflect the range of inner diameter variation. If the weight is within the expected range, the system caps the syringe, labels it, and then places it in the output bin for removal and dispensing by the operator. In various aspects, the above steps may be performed in a different order, may include additional steps, or may be modified to achieve a similar purpose.

  In illustrative examples, prescriptions may be assigned in various orders, eg first-in, first-out, or prioritized according to a delivery schedule. The system may determine the required size for one or more vials, syringes, and / or IV bags to process the formulation at various points, including before processing. Some formulations may be designated to be processed in separate filling, fluid transfer, and / or compounding processes and / or may be assigned a collection receptacle, for example, upon completion. The output may be provided in a pill, tablet, capsule, or other vial containing the drug order in solid, semi-solid, or liquid form (eg, may be capped again), IV bag, or syringe. In some embodiments, the APAS may include a pill counter and / or dispenser. The output may be distributed in combination with other items as a kit of medical items. For example, the syringe may be packaged with another syringe, which is administered simultaneously to the same patient. As another example, one or more IV bag preparations may be packaged as a kit with a syringe for special surgical procedures that may be performed in the future. In yet another example, the syringe may be provided in a kit with a needle encased in a protective sheath. In yet another example, auxiliary materials (eg, swabbing materials, disinfectants, etc.) may be included in the kit, for example as appropriate for a particular patient or procedure. The kit may be packaged, for example, in sterile plastic bags, shrink wrapped, disinfected by pulsed ultraviolet light, or otherwise prepared for storage or future use. Appropriate packaging and labeling equipment may be provided in the compounding chamber, in the storage chamber, in the clean tent, or external to the APAS. A computer coupled to APAS may accept and process requests for kits in combination with the preparation of drug compounds.

  Some systems may include one or more web servers and may support a web browser interface that includes information entry, control and reporting functions for the APAS. A web server may provide a gateway to the Internet or other wide area network, for example. In one embodiment, a blending operation may be granted remotely using a web server. The remote node may transmit an authorization signal to the APAS using various protocols (eg, HTTP, FTP). In response, the APAS cell may perform the requested blending operation upon validating the grant signal. Some web browser aspects include, for example, modules developed using HTML, XML, JAVA, applets, servlets, or combinations. Applications such as web portals may be used in combination with various programming languages to support the functions described herein.

  APAS features include the flexibility to handle different drugs of different sizes, the ability to prepare doses in the IV bag and syringe size range, and prepare these items in any order, or mix dose preparations Ability to do.

Achieving this flexibility may include a robust open system and may incorporate features and methods that make the system open. Various aspects may provide one or more advantages such as the following capabilities:
Handle drugs in different sized vials;
Perform drug reconstitution with different fluids and different levels;
Support various mixed profiles for reconstruction;
Support various mixed periods;
Use drugs from multiple vendors, for example cefazolin from two or three vendors;
-Handle a range of sizes for IV bags;
Handle a series of size syringes and support multiple manufacturers.

  To assist in drug order processing, an exemplary aspect of APAS implements a number of data tables in an associated database. An exemplary data table is given below. The data model shows the unique features of the APAS design, which allows APAS software to show high flexibility, thus allowing APAS to handle vials of different sizes from multiple manufacturers, Each of these sizes has multiple possible concentrations and reconstitution profiles. Site-specific customization of the final form of the product to be dispensed is also possible. For example, the output container for a drug order may vary depending on whether the patient is a child or an adult. Thus, a pediatric hospital may set a default container for a specific drug order as an IV bag, and a non-pediatric hospital may set a default container for the same drug order as a syringe.

  An overview of the data table is given below to illustrate the overall flow of the syringe process. In the exemplary database of the system, each drug may have a 1..N relationship with the drug manufacturer. For example, cefazolin may be associated with two manufacturers (eg, Parmaceutical Partners of Canada Inc. and Novopharm Ltd.). Each manufacturer has a one-to-many relationship with the vial. For example, Pharmaceutical Partners of Canada Inc. may correlate with vial information such as DIN 2237140 and 10G vials; and DIN 2236926 and 50 mg vials. Novopharm Ltd. may correlate with vial information such as DIN 2108135 and 10G vials; and DIN 2108127 and 1G vials. Each vial record may store information about physical properties such as, for example, medical container dimensions, tolerances, and weight. In another example, each vial record may be associated with information about one to many relationships to the reconstruction profile. For example, DIN 2237140 and 10G vials may be associated with reconstitution profile information such as 100 MG / ML, 96 ml sterile water added; and 200 MG / ML, 45 ml sterile water added.

  Drugs used in APAS may be trained in APAS cells. For example, physical properties and dimensions can be used by APAS in vial handling. Physical properties and dimensions may be used by the robot arm to calculate the offset. Physical properties and dimensions may also be used by grippers on robotic manipulators and syringe manipulators to determine the expected diameter for the various vials and syringes trained in APAS. Also, the predicted weight expressed in milliliters may be used for vials, syringes and IV bags before filling. A tolerance level may be included with each physical property and dimension, and the expected weight. In some embodiments, the dimensions may be obtained from gripper feedback in the APAS cell for vials and syringes.

  The operator is free to select any of the trained items in the APAS and load it into the APAS cell inventory. Selection may be determined using information stored for the trained inventory item. For example, APAS is trained on 1 g and 10 g cefazolin. Thus, the operator can choose between 1g and 10g cefazolin vials.

  In some cases, the system may perform a compounding operation by drawing from multiple sizes of drug in stock. For example, the storage rack may store cefazolin 10 g bulk vials (Novopharm DIN 02108135) and cefazolin 1G (Novopharm DIN 02108127) simultaneously. In some embodiments, the selection may be determined or confirmed by an operator during preparation and / or loading. In an illustrative example, if 50 1-gram vials are approaching the expiration date, the pharmacy personnel will raise the priority level based on the expiration date, and the system will load, for example, 50 1 g vials, for example, to the operator. You may respond by incorporating it into the map.

  In some cases, the system may perform the compounding operation with a single drug that may be supplied by any one of a number of manufacturers. For example, inventory may include cefazolin 10 g bulk vials supplied by Novopharm (DIN 02108135) or by Pharmaceutical Partners of Canada Inc. (DIN 02237140). In the system database, the formulation profile may be adapted for each source to identify the correct drug and use any source to complete the formulation operation. In some cases, drugs from both manufacturers may be stocked in stock at the same time.

  In some examples, one drug may be associated with multiple reconstitution profiles. The special profile may be selected from multiple profiles based on the required drug order dose. For example, a cefazolin 10 g bulk vial (eg, Pharmaceutical Partners of Canada Inc., DIN 02237140) may be associated with two drug profiles for injection. The first profile for producing a 200 MG / ML dose may include dilution with 45 ml of sterile water. A second profile for producing a 100 MG / ML dose may include dilution with 96 ml of sterile water.

  An exemplary training drug table lists drugs trained with APAS. The drug table lists generic drug names and may have a one-to-many relationship to the drug manufacturer's table. For example, the drug cefazolin can have multiple vendors. This table shows to APAS software which drugs are trained for handling by the device. This table can be consulted to confirm that APAS is trained to handle drugs.

  The drug table may contain a list of all drugs that APAS has trained to handle. The table can list generic drug names, which are available in multiple sizes and / or can be supplied by multiple manufacturers.

  An exemplary drug manufacturer table may store information related to a particular drug manufacturer. This can include the drug name and drug identification number. The drug identification number indicates the size. In some embodiments, the table can store multiple drugs and / or multiple sized drug vials from multiple manufacturers. For example, a manufacturer (eg, Novopharm Inc.) can provide 10 g and 1 g cefazolin vials.

  FIG. 45 shows an exemplary vial characteristic 4500 for a vial used in an APAS cell. The drug reconstitution table stores information about how to reconstitute a special vial. For example, the reconstituted fluid volume for Novopharm 10g cefazolin can be different from Sebex Inc. 10g cefazolin. Certain drug vials that require reconstitution may have at least one reconstitution table entry, and multiple reconstitution inputs are possible for each vial based on concentration. For example, a Novopharm 10g cefazolin vial can be reconstituted with 45 ml sterile water to achieve a 50 mg / ml concentration, or the vial can be reconstituted with 96 ml sterile water and 100 mg / ml concentration is achieved.

  An exemplary drug vial table 4505 stores dimensional information for a particular vial. The dimensional information for a particular vial may include vial diameters 4510, 4515, 4520, and 4525, and vial diameter tolerance 4530. A vial cap diameter 4535 may also be included. The dimensional information for the vial may also include heights such as a vial cap height 4540 and a vial height 4545. The vial can include a vial stopper 4550, which can include a stopper crimp cap 4555. The vial stopper 4550 can include a cap opening 4560, which is located on the top surface of the vial stopper. The plug recess depth 4565 can be defined as the distance from the plug crimp cap 4555 to the top surface of the plug 4550. The stopper depth 4570 can be defined as the distance from the top surface to the bottom surface of the vial stopper 4550. The vial 4575 can be held by the gripper 4580, where the gripper finger height 4585 can be defined as the distance from the bottom of the vial to the bottom of the gripper finger 4580. The vial 4575 can include a vial label 4590, a vial neck 4593, and a vial cap 4595.

  The Drug Vial Table 4505 can be used to analyze diameter, height, dry weight, reconstituted weight, stopper hole limits, trained vial label images and masks for pattern matching and barcodes. Can be fetched. This may be implemented, for example, as a one-to-one table with a drug manufacturer table entry.

  The vial label may be trained using a software interface and camera that takes an image of the vial label, and the unique (eg, informational) attributes of the vial label are identified. These unique attributes may form a search area for pattern matching. The search area can include any feature (eg, drug name, symbol, number, or barcode). These search areas can also include a conserved pattern against which subsequent vials may be compared. When evaluating vials against a trained pattern, the algorithm assigns a score to each region and indicates how well a given vial matches a pre-defined, trained pattern. A threshold may be used to define what is an acceptable match. To be verified, the vials can have a very high match to a predefined pattern. The threshold allows some amount of tolerance to be built into the system for things like small scratches on vial labels that can occur in daily pharmacy operations.

  Multiple search areas per vial label may be used to increase the robustness of the method and reduce the probability of false positives. For example, two drugs from the same manufacturer may have labels with similar appearance (eg, font, layout, size), vial size, and drug names that include some common characters. For example, both the drugs cefazolin and cefoxitin are provided in the form of 10 g vials with similar physical dimensions, and they may come from the same manufacturer and therefore have similar labels. In this example, the pattern matching software predicted cefazolin vials, but if cefoxitin vials were provided, pattern matching could report about 40% match between two different vials. is there. This can be rejected from the method as not meeting the threshold score value. Combining additional regions, such as drug codes, and some other keywords unique to vials, may improve the reliability of pattern matching without resorting to any single region.

  During the process of training the cell to handle the drug, once the vial label area is defined, the cell software can pass through all other trained vial patterns to ensure that there are no obscure vials. If ambiguities exist, additional regions can be added to the trained pattern set for that vial until all ambiguities are removed.

  The drug distribution table can determine the processing requirements. This implementation allows the software to be customized to how each hospital wants to dispense a medical drug. For example, some hospitals may select syringes for certain medical items, and other hospitals may select IV bags for similar applications. Selection criteria for some product types and formats can vary according to a set protocol that may be site specific. Protocol differences may be related to the patient receiving the drug product. For example, a child in a pediatric hospital may receive the drug product in an IV bag, while an adult patient in a non-pediatric hospital may receive the same drug product in a syringe.

  In another example, one hospital may have a protocol that requires 200 milligrams of gentamicin dispensed by syringe, while 250 milligrams or more are dispensed in a 100 milliliter bag.

  An exemplary distribution table identifies the drug, its distribution information (e.g., syringe, bag, vial), and any appropriate dose threshold or other criteria for choosing between containers, and container type or size To do. Such selection criteria may be applied to inputs, outputs, and / or intermediate products. Some embodiments may specify a cap format type (eg, syringe cap) to apply to the output. Certain caps may be color coded and tagged (e.g., RFID) and / or provide certain usage features (e.g., tamper-evident features, hooks, simple removal) These may be specified by operator or system default parameters.

  FIG. 46 shows an exemplary syringe characteristic 4600 for a syringe that may be used in the APAS cell 100. The syringe 4610 includes a plunger flange 4615, which may also be referred to as a plunger stem button. The plunger flange includes a plunger flange diameter 4680. The syringe 4610 also includes a plunger stem 4620 and a plunger 4625. The syringe also includes a cylindrical flange 4630, a cylindrical portion 4635, a luer lock 4640, and a syringe cap 4645. The syringe also includes a needle 4650 and a needle cap 4648. The syringe 4610 can be assembled with a needle cap 4648, a needle 4650, a cylindrical portion 4635 and a plunger 4620 as shown.

  In general, APAS may use consumables or inputs that are in stock and readily available. APAS cells may accommodate different sized syringes from different manufacturers. The APAS cell may contain predefined information related to the characteristics of the syringe being handled. Information about the physical properties of the syringe can be related to correctly perform fluid transfer for reconstitution, syringe filling, and decanting. Physical properties include dimensions such as inner diameter 4655 and outer diameter 4660. The inner diameter 4655 can be used to calculate the movement to complete the fluid transfer. Other characteristics include a maximum fill that limits the maximum stretch 4685 at the syringe plunger 4610. The syringe information can also be used for syringe operation within the APAS cell. This may include different syringe lengths and outer diameters for handling with different grippers in the APAS cell. The syringe length may include a closed syringe length 4665, an overall syringe length 4670, and a plunger length 4675.

  FIG. 46 shows a gripper 4690 having fingers 4695 that can be used to grasp shilling. The grip distance 4697 can be considered as the distance from the upper surface of the gripper finger 4695 to the upper surface of the luer lock 4640.

  Manufacturing tolerances can give uncertain ranges for some syringe dimensions. This may be taken into account by the APAS cell. The inner diameter used for fluid movement can be averaged using manufacturer's data minimum and maximum values.

  The example syringe table 4605 can store syringe information including dimensional data for each syringe trained to be handled by the APAS cell. Syringes can be identified by manufacturer, part number, and syringe size. The characteristics of each syringe trained to be handled by an APAS cell can be defined in the syringe table 4605. Dimensional characteristics can be collected by measurement or from an external input, so that the APAS cell can accurately calculate the fluid withdrawal and consequently the moving millimeter to achieve the required fluid transfer it can. The amount of plunger stem travel that achieves a given fluid transfer can be a function of the inner diameter of the syringe barrel.

  The syringe table 4605 may include pre-loaded manufacturer data for the syringe. The configuration file can identify which syringe is used in the hospital. When the hospital changes the syringe supply source, the maintenance staff may change the configuration file. In some aspects, the APAS may be hard-coded, otherwise it cannot accept user input syringe information. For example, the syringe may be uniquely identified by measuring the outer diameter of the syringe barrel and syringe plunger using feedback from the gripper on the robot manipulator. In some aspects, the APAS operator may not provide syringe information to the system because the syringe size used is determined algorithmically by software. In some embodiments, the selected syringe is a cylinder diameter, plunger diameter, machine vision with pattern matching, barcode, weight, OCR, or any combination thereof, and / or other described herein. It may be confirmed by one or more automatic measurements, such as a description.

  In order to support various labeling requests from different hospitals, some aspects may provide flexible methods that easily support changes in label content. APAS may implement a method for output label definition, which allows any site to fully customize the label and easily change the content and layout of the label. The data content in the label can include content from any field in any table in the APAS database included in the output label. This may include defining the output label as a series of accessible lines. Each accessible line can have an X and Y offset definition from the lower left of the label. This allows customization of the position of the line in the printable space of the label, and allows for a variable number of lines up to the maximum allowed by the physical footprint of the label. Each report line may present or reference a report text area that defines the format and content of the line. The report text area can specify various parameters, which may include: various parameters represented on the line; database table field names for these parameters; SQL selection statements (table Name); and format information (eg font, font size, height, etc.).

  By embedding SQL statements and building query strings from parameters, you can access any field in any table if you are interested in putting it on the output product label. This allows for a quick improvement of the output label to meet the facility requirements and may be used for testing and / or troubleshooting.

  As can be seen from the section on trained items, each dimension of the trained inventory can include dimensional tolerances. In addition, there is tolerance on the APAS cell for manufactured items that are in stock and readily available. These tolerances can cause cumulative uncertainties in, for example, information about the position of the container relative to the robot manipulator and / or the position within the system. Due to dimensional variability, one or more independent checks are incorporated into loading, removal, dose confirmation, and / or other operations involving input, output, and / or intermediate products to perform confirmation May be.

  Tolerances in medical containers can be reflected in various measurements of size, weight, and volume. In one example, the tolerance for measuring 10 vials of drug from one manufacturer with vials from 5 different lot numbers shows about 2.5% variation in measured diameter and about 1 mm variation in vial diameter There is a case. In another embodiment, the weight of 10 vials may exhibit a variation of about 1 g. In yet another example, the weight of six empty 60 ml syringes from the same lot number can show a variation of 1.2 g. In yet another example, the weight of the six syringes after filling to the 10 ml gradient line can show a variation of about 0.24 g, which is a variation of about 2.4% of the internal volume.

  FIG. 47 shows three different vials of various sized drugs. If many different vials have similar diameters, vial size ambiguities may exist. As such, some form of vial height verification (eg, vision system or edge detection) may be included if there is a vial manufacturer change.

  In one implementation, a set of drug orders or requests may be communicated to the APAS cell for analysis and a list of requested drugs is prepared. The operator can receive the list and retrieve the correct inventory. The operator's check can be an initial confirmation that the vial is stored in place on a serially numbered rack. Thereafter, as shown with reference to FIG. 5, the rack can be placed on the carousel at a known location that the APAS cell selects via the robot arm 506. In another aspect, inventory removal, rack loading, and / or checking may be partially or fully automated, as in an automated storage facility.

  FIG. 48 shows how the gripper information can be used in vial confirmation of APAS cells. A gripper 1000 having movable fingers 4810 and 4815 is attached to the robot arm 506 as shown with reference to FIG. The APAS cell control software has access to pre-defined and stored vial dimensions (eg, outer diameter and tolerances), coordinate information for the carousel, and numbered racks. Through one or more motion controllers, the APAS cell can command a series of robot and gripper moves to cause vials to be extracted from the inventory system. The pre-defined vial data can include, for example, the average outside diameter of the vial, with tolerances based on minimum and maximum diameters derived from measurements of the vial sample set. A gripper with fingers 4810, 4815 can be opened to a gripper distance 4805, which is larger than the maximum vial diameter and accommodates the required vial size. A maximum movement 4830 can be defined for each of the gripper fingers 4810, 4815. The gripper is then commanded, for example using current mode motor control, so that the gripper fingers close to the vial body with a constant amount of torque, and the fingers 4810, 4815 are controlled with a controlled (e.g. constant) torque. You can have them close together. The gripper may have a sensor (e.g., encoder, resolver, linear potentiometer, linear encoder, pulse counter, etc.) coupled to communicate position information over a serial interface in some aspects, The serial interface can return gripper position information to a controller (not shown). Software in the controller may monitor the gripper to determine when both fingers stop moving. This can be determined when the gripper stops or when the current limit is exceeded or when the position information stops progressing. The software can then read the location information provided by the serial interface.

  The attributes of gripper finger 4815 include gripper finger offset 4820, gripper finger V-notch depth 4825, and V-notch angle. The angle of the V-notch can be characterized as the angle 4830 of the V-notch from one side of the notch to the other as well as the angle 4845 of the V-notch relative to the center line 4840. In the illustrative example, the dimensions for gripper finger 4815 may include a gripper finger V-notch depth equal to 2.93 mm. The V notch angle can be 72 ° for the V notch angle 4845 relative to the center line 4840 and 144 ° for the V notch angle 4830 from one side of the notch to the other. Another attribute of gripper finger 4815 may include a vial edge 4845 for the apex. For example, this magnitude can be 18 °.

  A fully closed gripper is shown at 4850. For example, the minimum movement for the gripper can be -1/2 mm (eg, due to an offset) and the maximum movement for the gripper can be 68 mm.

  FIG. 49 shows an exemplary diameter verification of a vial using gripper finger position feedback. In an exemplary system, an algorithm in software can relate the gripper finger distance to the vial diameter. Each finger can have a v-notch that engages the vial, where the smaller the vial, the deeper the notch, so the gripper finger position feedback must be converted to the vial diameter. The position information from the gripper 1000 and the calculated diameter of the vial in the gripper can then be compared to an expected diameter with a predefined tolerance. This combination may provide confirmation as to whether the vial diameter matches the expected diameter within tolerance.

  If the gripper fingers are closed more than expected or not closed sufficiently, the wrong vial may be in the inventory position or there may be no vial at all. This step can be used to confirm that the vial matches the expected content and size so that the cell can proceed to the next step in the process. If the vial diameter does not match the expected diameter, the system may identify an error condition.

  In an exemplary embodiment, the vial fits symmetrically in the gripper fingers. The fingers can engage the vial with four contacts that may limit the travel depth. The vial may enter the V-notch, forming a gap 4920 from the edge of the vial to the apex of the V-notch. The length of the gap is relative to the vial radius. The angle forming the V notch is preset based on the finger shape. There may be different finger types with different angles. The fingers can be placed to have an offset with respect to gripper movement. FIG. 48 shows a vial profile 4925, a gripper finger profile 4930, and a V-notch depth 4935.

In an exemplary embodiment, the gripper movement may be roughly characterized by the following equation, with a related aspect shown as gripper movement distance 4940 in FIG.
Gripper movement = 2r- (2 (dV-x) -Fo)
In the formula:
Fo = predefined finger shape (4905)
φ = V notch angle (4910)
r = vial radius (4915)
c = r / cos (φ)
x = rc (4920)
dV = V notch depth (4935)

  In some cases, the gripper fingers can contact the circumference of the vial or syringe barrel. The gripper feedback distance can be related to the actual vial or syringe diameter by the algorithm so that the APAS cell can confirm that the diameter of the held object is within the expected range. Figures 49 and 48 illustrate the use of fingers in diameter confirmation as described above.

  Vials and syringe diameters can vary due to manufacturing variations. The gripper fingers can have manufacturing tolerances, as well as gripper placement and alignment tolerances, all of which can affect the measured gripper distance in diameter. To accommodate such tolerances, acceptable dispersion threshold settings may be defined in the syringe data.

  All gripper finger dimensions that affect the transformation (eg, V-notch angle, depth to vertex as shown with reference to FIG. 48) can be parameters stored in the data table. If the finger is changed in the APAS cell, these parameters may need to be updated and the calibrated cylinder can be used to adjust the parameters to accommodate manufacturing variations.

  When the system confirms that the vial diameter matches the expected diameter for the vial based on the gripper finger measurements, the APAS cell control software informs the robot about the vial as shown in FIG. It may be ordered to transport to the vial ID station 5000.

  The vial ID station 5000 includes a rotating platform 5005, a camera system 5010, light (not shown), and a processor (not shown) that executes pattern matching software. In an exemplary method, the robot can place the vial 5015 in the center of the platform 5005 and the APAS cell software can instruct the motion control hardware 5020 to begin rotation of the platform 5005. As the vial 5015 rotates, the camera 5010 can take an image of the vial label 5025. The image is passed to the pattern matching software, which compares the area of the vial label with a predefined and trained set of images for that drug. The region can include any unique features of the vial label, but may typically include the drug name, drug manufacturer, and / or drug code (eg, NDC or DIN). The vial 5015 may be rotated at one or more revolutions, and the pattern matching software checks each image for key label field matching accordingly. One or more threshold settings in the software can rate a match between the vial image and one or more trained, predefined images. The rating can correspond to a threshold based pass or fail score. In order to pass pattern recognition, there can be a good enough match for one or more defined fields. In preferred embodiments, at least two unique patterns per label may be used to identify medical containers (eg, vials, syringes, IV bags). The APAS cell may store vial images, which ensures that important fields are captured along with the vial lot number and expiration date. The software can then create logical links and associate drug orders using images and vials. This provides the ability to store information for auditing the records of the vials used to process any drug order.

  An additional feature of the pattern matching software may be to provide barcode recognition in the image. An exemplary method may include performing pattern matching on one or more features of one or more images of the vial. Pattern matching may be combined with reading a barcode from one or more of the vial images if one is available. The combination can provide additional robustness measurements for vial verification. .

  If the vial 5015 does not pass the pattern match, the vial 5015 may be rejected and the operator may be notified. The APAS cell may then attempt to remove another vial from the inventory system. The system can limit the number of retries. If verification fails several times in succession, for example, a rack load error may be indicated.

  As soon as the vial label 5025 is confirmed, the robot can transport the vial to the scale where it is weighed and the weight of the vial is based on pre-defined vial information including vial volume and contents. It can be compared to the expected weight for that vial.

  When the vial passes the weight check, it is picked up by a syringe manipulator gripper. The syringe manipulator can be fitted with a gripper similar to a robot, so the syringe manipulator gripper can be used to check the vial outer diameter.

  The syringe manipulator includes a vial stopper height sensor that can determine the stopper height relative to the syringe manipulator. Exemplary aspects of the vial stopper height sensor include, but are not limited to, a laser, an acoustic measurement system, and / or a vision system with associated image processing capabilities. The distance can be used to confirm the depth of travel of the syringe needle entering the vial septum.

  Taking a vial of unknown height, this may be due to improper placement in the storage rack, and the gripper 1000 will gradually open as the vial ID station 5000 slides the vial into the finger. Also good. Vial validation can then be performed using the vial pick-up height, calibrated to height.

  To account for variations in vial height due to manufacturing tolerances or potential changes in vials, a vial stopper height sensor can be incorporated. The vial stopper height sensor can be integrated into the syringe manipulator and can be used to determine the stopper height. This can also handle variations in the concave depth of the stopper relative to the crimp cap of the vial.

  A typical vial may be a non-control. Variations in the manufacture of the glass surface of the vial can result in variations in vial diameter. In one example, 10 vial samples of the same size and same drug from the same manufacturer are subject to a 2% variation in the diameter of a single vial measured with a caliper at various locations around the vial, between vials. There can be a 2.5% variation in diameter and a 2.7% variation in the weight of the empty vial. In some embodiments, each vial may be weighed prior to reconstitution and use.

  In some embodiments, automatic compounding may include the ability to reconstitute the drug by adding an appropriate amount of fluid to the drug in powder form and stirring until thoroughly mixed. In manual implementation, pharmacy personnel may add fluid, shake the vial, allow it to settle, and shake until there are no more visible particles in the vial. A concern for this approach may be that there is no quantifiable mixing time defined either during pharmacy practice or within the drug monograph. The instruction may indicate, for example, mixing until transparent. It can be difficult to detect small particles in all vial sizes and it can be difficult to safely conclude that no particles are present. Vial size and type can vary widely. Some vials may have labels that wrap around the entire vial cylinder. Some vials may have an embossed finish at the bottom of the vial. Some vials may have a plastic hanger loop that covers the bottom of the vial. In some aspects, APAS implements an exemplary method that is performed during drug training. In that method, enter the time it takes for manual mixing, apply a multiplier (e.g., 1.01, 1.05, 1.10, 1.15, 1.25, 1.50, 1.75, 2.0, 3.0, 4.0, up to at least about 10.0) and mix time The minimum amount of can be extended. For example, a drug determined to require 2 minutes of mixing by the pharmacist may be assigned a multiplier of 2.0, which results in an automatic mixing time of 4 minutes.

  The mixer in the APAS cell may include a servo motor drive assembly under software control. The assembly can implement various mixing operations at various speeds and profiles. In some examples, each mixer can be fitted with multiple surfaces, and each surface can be configured to hold one or more vials and / or syringes using clips and shelves. . The mixing of the faces and the clips on the faces can be customized for each installation. For example, a pharmacy may have a custom configuration of mixer surfaces. In another example, the maintenance staff can change the mixer surface and provide the mixer with different clip capabilities for mixing. The data table can define the configuration of each mixer in the cell. Multiple mixers can be installed. A typical installation may include two independently controllable mixing stations. Implement a mixing profile that stirs more vigorously in the direction toward the bottom of the vial to ensure that the vial is shaken vigorously, for example, every 2 or 3 cycles, moving the vial toward the bottom of the shelf and By preventing movement or elevation, it can be prevented from “moving” within the clip.

  Two or three mixing profiles can meet the requirements for all drugs handled by the device. These may consist of an active profile, a normal profile, and a weak shaking profile. The weak shaking profile may be for drugs that tend to foam and the monograph recommends gentle mixing. In the manual process, mixing can be achieved by a combination of waiting time and agitation time while powder soaking occurs. In an APAS cell, the mixer may temporarily cease once a drug vial is added to the station and removed from the station.

  51A-51B show an exemplary vial mixer 5100 for an APAS cell. FIG. 51A shows the vial mixer with the cover removed. FIG. 51B shows a vial mixer with a cover attached. The vial mixer 5100 includes a rotating drum 5105, a vial clip 5110, a vial maintaining device 5115, a vial mounting panel 5120, a frame assembly 5125, a servo motor drive 5130, and a gear reduction unit 5135.

  The vial mixer 5100 may simulate a mixing profile that a pharmacy technician uses to manually mix the drugs during the reconstitution process. The vial mixer 5100 can impart a rotational motion to the vial at a speed and strength similar to the person holding the vial and shaking it.

  The vial mixer 5100 includes a rotating drum 5105 having four sides on which a vial clip 5110 and a vial maintenance device 5115 are mounted to facilitate insertion of a vial by a robot. The maintenance device 5115 can certainly not shift under the vigorous shaking of the clip 5110 in the clip 5110 and can be discharged from the mixer. Each vial mounting panel 5120 on the face of the drum 5105 can be configured for a narrow range of vial sizes, but for all four face combinations, the vial mixer 5100 takes a commonly used vial size be able to. The panel 5120 on the mixer drum 5105 allows the vial refill to be adjusted with minimal reconstitution efforts if the special APAS cell uses either a more limited or a wider range of vial sizes.

  In one embodiment, the drum 5105 can be mounted in a frame assembly 5125 on a bearing and can be driven by a servo motor drive 5130 having an inline gear reduction unit 5135. In another aspect, a motor (e.g., stepper, brushless DC, induction, synchronization, reluctance, etc.) driven by a torque and position control system (e.g., using current and position estimation and / or feedback) is drum to motor shaft It may have a direct coupling to 5105 or optionally via a shaft coupler. The position control motor may provide, for example, a repeatable stop position for the drum 5105 on each of the four sides to facilitate removal and placement of the vial on the drum 5105 by the robot. Position feedback may include an index (eg, home), resolver, encoder, Hall effect sensor, pulse counter, or other well known position feedback technique. The flexibility of the mixing motion profile can provide a gentle mixing operation for the same unit and drugs that require vigorous shaking to minimize the time for drug reconstitution. Servo motor technology can provide any type of profile from slow continuous rotational motion to aggressive back and forth motion with a frequency of at least about 4 Hz and an amplitude of at least 30 °.

  Since there can be many vials on the mixer at a time, drugs that require the most gentle profile can command the shaking profile at a given time, ensuring complete reconstitution Thus, the exposure time for any drug that requires more intense agitation can be compensated by a longer time. Since some aspects of the APAS cell can have two mixers, one mixer can be set to a gentle agitation profile and the other mixer can be set to a more intense agitation, and the drug accordingly Can also be targeted. The operating profile can be a parameter specific to each drug type, and the profile can be automatically reset by the cell controller upon request to suit the drug being mixed.

  The motor and gear head 5135 is usually covered with a cover 5140 and is protected to facilitate easy cleaning and wiping. A local vent structure coupled to the air treatment system provides a local low pressure and may remove any emissions or contaminants that may occur locally to the mixing system.

  52A-52B illustrate an example of syringe decapping at an exemplary syringe manipulator station 5200. The syringe manipulator station 5200 includes a syringe plunger gripper 5210, a syringe barrel gripper 5210, a vial and bag indexer 5220, and a motor and associated motion control hardware 5225. The syringe plunger gripper can slide in the vertical range 5230 and can push and pull the syringe plunger within the syringe cylinder. The syringe cylinder gripper 5215 can be stationary. The grip distance 5235 may be a distance from the bottom of the syringe cylindrical part gripper 5215 to the upper surface of the syringe luer lock 4640 as described with reference to FIG. The vial and bag indexer 5220 may move vertically and horizontally in a sliding motion 5245.

  The syringe in the APAS cell may be loaded in stock with a needle and needle cap attached. During normal operation, the device can perform an operation to remove the needle cap, after which the syringe can be used with a manipulator. To do this, the syringe may be presented at a manipulator station 5200 that includes a needle gripper 5205 that holds the needle cap, and the robot performs a pulling action to remove the needle cap. The needle gripper 5205 can be opened to release the cap, and the sensor can detect a descending object. Thereby, it can confirm that the cap was removed. To confirm that the needle has not been removed in the process or that the needle has not been attached to the syringe, the APAS cell can detect the presence or absence of the needle by gripper feedback on the needle gripper 5205. The fingers on the needle gripper 5205 can engage the needle in the notch, which holds the needle firmly, straightens the needle to engage in the port of the IV bag or vial, and / or Or matched. Needle gripper 5205 may also provide position feedback regarding the distance between gripper fingers. Based on this position information, it is possible to detect whether an object (for example, a needle) exists between the gripper fingers. The position information can also be used to determine the gauge of an existing needle, depending on the finger shape. The location information can also be used to determine whether a syringe cap is present.

  A syringe verification procedure may be used to determine the syringe type based on one or more measured diameters. In some cases, a single measurement may uniquely identify the syringe type from all possible types of syringes that may be loaded. In some other cases, two or more measurements may be required to uniquely identify the syringe characteristics.

  In any given hospital, there may be syringe types from multiple manufacturers. Syringe sizes may overlap, in which case a size may exist from more than one manufacturer. For example, a hospital may use 20 ml syringes from two or more manufacturers. Supply contracts can also be negotiated and renegotiated within the hospital, and common or default syringe manufacturers can be changed. The APAS may be trained to function with one or more syringes from one or more manufacturers.

  In various aspects, the APAS may use pre-loaded and pre-defined syringe data obtained from published manufacturer information that is pre-installed on each delivered APAS. During processing, the APAS can determine what syringe size is needed to fill the cue or order and what is needed to reconstitute the vial to fill the drug order. In this case, the operator can accept information about which type and size of syringe is required to satisfy a special order based on the drug order request and pre-defined syringe data.

  APAS cells can perform fluid transfer using a syringe. Data about the physical properties of a particular syringe can be used to control the plunger operation for fluid transfer. To meet drug requests safely and accurately, the syringe data can be a verified, calibrated, pre-defined data set that is part of the delivered APAS. In some aspects, the APAS may prevent the user from changing the syringe data. Therefore, changing syringe data in APAS can be a maintenance operation performed by a maintenance technician trained according to an appropriate change control procedure, but not performed by a device user.

  53A-53D show various stages in which the syringe plunger is operated. FIG. 53A shows a syringe manipulator 5330 including an adjustable syringe plunger gripper 5330, an adjustable syringe barrel gripper 5315, a needle gripper 5335 and a movable carrier 5325. FIG. The syringe includes a plunger stem 5305, a plunger stem button 5310, and a cylindrical portion 5320.

  In various aspects, the APAS cell includes a syringe plunger gripper 5300 having an adjustable width to engage the plunger stem 5305. The syringe plunger gripper 5300 includes fingers that engage the syringe plunger. Actuation system (e.g. one or motor and associated connection, transmission device) is operated to control the separation of fingers on the syringe plunger gripper 5300, corresponding to different sizes of plunger size and plunger flange 5310 diameter Also good. The adjustable syringe barrel gripper 5315 can accommodate a variety of different syringe barrel 5320 diameters. The syringe plunger flange 5310 (or stem button) can be engaged to push and pull directly through this adjustable syringe plunger gripper 5300. The gripper 5300 is coupled to or mounted on the movable carrier 5325. The carrier 5325 is coupled to a vertical slide positioning system, which may be operated electrically, pneumatically, or hydraulically. The movement of the carrier 5325 is converted into a controllable push-pull of the plunger by the operation of the gripper 5300.

  Information about the position of the plunger stem 5305 and the position of the syringe within the syringe barrel gripper 5315 of the syringe manipulator 5330 can be used for accurate fluid transfer operations. The syringe 5320, needle and plunger 5305 can be precisely controlled, for example, to be operated by a needle lowering syringe manipulator, in which case the syringe can be used to draw diluent from the IV bag, and / Or fluid can be added to the vial for reconstitution.

  FIG. 53B shows that the syringe plunger gripper 5300 is closed and engaged with the syringe plunger flange 5310. The resistance force of the plunger can be detected, for example, as a step increase in force, and the position of the plunger flange may be monitored based on the position of the gripper 5300.

  FIG. 53C shows the movable carrier 5325 moving downward and pushing the syringe plunger stem 5305 into the syringe cylinder 5320, with the plunger completely within the cylinder. FIG. 53D shows the syringe plunger flange 5310 captured by the gripper 5300 after the gripper 5300 has opened, progressed down, closed, and engaged with the syringe flange 5310. From this position, the syringe plunger may be controllably pulled out of the cylindrical portion by upward movement of the carrier 5325.

  APAS cells may handle unknown grip heights due to, for example, the potential diversity of how syringes are in stock. This uncertainty can affect the position relative to the bag or vial septum (stopper) and puncture too deep (cannot pull the expected fluid volume from the vial) or does not puncture sufficiently deep (does not penetrate the septum) Or partially penetrated to form an air path, for example, leakage, aerosolization, or incorrect fluid transfer may occur). In one embodiment, a syringe manipulator can be used to correctly position the syringe with respect to height as described below. The plunger gripper can be closed and lowered toward the syringe. As the gripper moves vertically downward, the closed finger can push the plunger stem into the cylinder. The system can monitor torque feedback from the slider, and if a step change in torque is detected, the plunger is completely in the cylinder. The system can then open the plunger stem gripper and engage the plunger stem button. At this point, the system can loosen the syringe cylinder over the syringe cylinder and needle. By sliding the plunger gripper, the system can adjust the height of the syringe to a suitable vertical height.

  In another aspect, the syringe cylinder gripper opens slightly and the cylinder slides somewhat within the grip. When the plunger gripper is in the closed position, the plunger slider can be lowered to the expected height for that size syringe. This strategy may substantially place the plunger so that if the plunger stem is not fully deployed, the plunger moves into the syringe barrel. When the plunger is fully positioned, the cylinder moves within the gripper.

  FIG. 54A shows an IV bag on a syringe manipulator. FIG. 54B shows an IV bag with voids. In an exemplary method, fluid may be drawn from the IV bag with ports 5405 and 5420 facing up. The robot can take the IV bag 5400 from the inventory rack and place the injection port 5405 in the clip 5410 on the needle lowering syringe manipulator station 1504, an example of which is described with reference to FIG. 15A. When the IV bag 5400 oriented in this direction is used, the gap 5415 can be pulled out from the IV bag 5400. The needle can be placed in the fill port 5405 by puncturing the port in an amount equal to the plug penetration depth 5420. The method can take advantage of the feature that the IV bag can be a closed container with soft sides, so that the bag collapses when air and fluid are drawn from the IV bag. The syringe manipulator 1504 can draw air from the IV bag 5400, and the motion control system can monitor torque / force feedback on the syringe plunger stem as described elsewhere herein. As the fluid transition transitions between the air transition and the fluid transition, the force and / or torque can change substantially (eg, stepwise). In an illustrative example, a non-pointed filling needle may minimize air flow back into the bag when the needle is removed and then reengaged into the injection port plug.

  In some embodiments, a torque step change when the syringe plunger is pulled can also be detected by fluid transfer into the IV bag. Moving the syringe plunger stem with the syringe plunger gripper installed and pulling a vacuum in the syringe cylinder can include a detectable change in torque when pulling fluid compared to air. In another aspect, the syringe plunger stem can be pulled to a known level that is greater than the expected average gap in the IV bag. The syringe plunger stem can be held in the withdrawn position and can be stopped until the fluid reaches equilibrium in the syringe barrel. When the fluid fills the vacuum formed in the syringe cylinder, the torque value can decrease. The next step may be to push the syringe plunger stem and the fluid will move back into the IV bag while the torque value is monitored. A torque step change can be detected when all of the fluid is transferred back into the IV bag, so that substantially only air is transferred back into the bag. By monitoring the syringe plunger stem position data, it is possible to determine at which syringe plunger position the torque step change occurs. The plunger can then be pulled back to that position, resulting in an IV bag with the air volume removed.

  Identifying the syringe that needs to be loaded into the APAS cell may include identifying some information. The first information can be a drug order that may include drug name, drug amount / volume, and drug concentration not related to any syringe data. The second information can be a site-specific drug distribution table, which defines which size and type of container is used for that drug and size.

  For example, at one pharmacy, a 2 g dose of drug “X” may be delivered to the patient in a syringe. In different pharmacies, the same drug and dose may be delivered in an IV bag. Distribution tables can define site-specific preferences for sending orders to patients. Site-specific preferences can be independent of any syringe data. The third information is drug vial reconstruction data, which defines fluid transfer volume requirements and is part of the required syringe size determination.

  The APAS cell can use these items and algorithms to calculate fluid volume transfer requirements that are independent of special medical containers (eg, syringes). The APAS cell can then retrieve the preloaded syringe data and find a pre-defined syringe of an appropriate size to handle that fluid transfer. If a match is found, the APAS cell can then select the physical dimensions of the syringe from the preloaded data. When loading is required, the APAS cell can output syringe data to the operator and identify the syringe type and size selected for loading.

  The APAS controller can use preloaded syringe data in two exemplary processes: reconfiguration and drug order processing.

  In the reconstitution process, the APAS cell can use published data from the drug manufacturer that defines the type and volume of diluent needed to reconstitute the powdered drug in the vial. APAS can use this information to determine the fluid transfer volume for the vial, and then automatically use the requested volume and search the database to define more than the requested transfer volume. A reconstituted syringe can be selected by finding the smallest syringe with a defined volume. The APAS can then calculate the syringe plunger movement by using information about the required volume and syringe inner diameter.

  In the drug order fulfillment process, fluid is withdrawn from the vial into the syringe barrel and the entire syringe can be dispensed for use by the patient. In this case, the APAS can use the entered drug order data including drug name, amount, concentration, and / or optionally patient information. The APAS cell can use the drug volume and distribution table data to determine which type of container the drug and volume should be dispensed. For example, in one pharmacy, a 2g drug order may be dispensed into one bag, and another pharmacy may be dispensed into one syringe, which should be different between pharmacies be able to. The APAS cell can then automatically select the smallest size syringe that exceeds fluid transfer requirements. The APAS cell then uses the syringe parameters (e.g. inner diameter) to calculate the total plunger displacement, and then determines the appropriate operating cycling (e.g. plunger push-pull) Appropriate pressure can be maintained to prevent aerosolization of the contents in the vial.

  In some aspects, the APAS cell may not accept user input syringe information and, by design, rejects all user input of syringe data for safety and fluid transfer accuracy. In APAS cells, syringe data may be pre-defined and pre-loaded from published manufacturer data.

  Some aspects limit the types of inventory that can be loaded into an APAS cell. For example, in some APAS cells, the operator can choose between different pre-defined syringe types and confirm that only the type of syringe selected by the operator is loaded. In some aspects, the APAS cell may detect which syringes are in stock when used.

  The APAS cell may implement a method for checking which syringe type is loaded into the cell. Even if the preferred implementation strategy is to limit device operation to, for example, type A syringes, the operator may make mistakes and load the wrong syringe type during routine operation. For example, even if the system predicts a type A syringe, a type B syringe with a different inner diameter and / or length is loaded. Using a B-type syringe without detection can result in inaccurate fluid transfer and drug order errors. A device for verification may be implemented to reduce the risk associated with syringe loading errors by such operators.

  The APAS cell uses a combination of scale feedback (e.g., syringe weight when empty) with diameter feedback from grippers in the system and another technology to determine which syringes are presented to the system. Uncertainty may be reduced. A combination of independent detection methods may be used to identify medical containers, such as syringes, vials, or IV bags. For example, a combination of one or more gripper feedback and length feedback (e.g. using an optical light breaker detection system) and / or torque feedback from a syringe manipulator (e.g. as a function of position) for container verification May be used for A combination of these and other methods may be used, such as identifying the container by comparing stored (trained) image information with images acquired from the vision system.

  In some aspects, a separate drug order processing step may obtain drug order data and preloaded syringe data and calculate the linear movement that the plunger needs to move. The command can be placed in a buffer, for example, for a controller in an APAS cell. In one implementation, this may be a database table.

  In one aspect, a user (eg, pharmacy personnel) cannot invalidate syringe data preloaded into the APAS cell by manually entering the syringe data. In this aspect, the controller does not have to accept any input syringe information, and the controller does not have to calculate the plunger travel distance using the input syringe data. The controller that moves the plunger may not accept any input syringe data, but rather may accept preprocessed data that defines the plunger travel distance. The motion control hardware converts this to, for example, a motor pulse count for a stepper type motor. The controller may also implement an algorithm to manage (e.g., by maintaining below the storage threshold) the pressure in the fluid receptacle (e.g., vial or bag) and extend and retract the syringe plunger (e.g. For example, pressing and pulling) occur alternately.

  The APAS cell may calculate the distance traveled relative to the syringe plunger using, for example, information about the inner diameter of the syringe cylinder.

  Within an exemplary cell, an APAS cell can incorporate a series of linear grippers to hold a syringe, vial and / or needle. An example of a gripper is described with reference to FIG. 10 and FIG. Various fingers can be attached to the gripper, which incorporates unique features to improve gripper retention on syringe and vial cylinders. In particular, the fingers can incorporate a V-notch, increasing the contact area on the syringe barrel and vial body. The gripper fingers can provide feedback to the controller in the APAS cell via the serial interface. The feedback can include positional information of the space between the gripper fingers. The APAS cell can use this gripper feedback as part of the multi-step verification of vials and syringes.

  In the APAS cell, the IV bag may be used as a source for the diluent that reconstitutes the drug, as a source for diluting the drug in the syringe, and as a receptacle where the drug can be injected. Some aspects may provide a mechanism for verifying input and output content associated with automatic processing of IV bags.

  55A-55B show exemplary images of IV bags that may be used in an APAS cell. Using pattern matching with a visual subsystem, in some aspects, bags can be identified.

  Each IV bag may have various folds and distortions that can be resolved to identify the bag. APAS cells can incorporate a method of taking the distortion of the bag image. The drained flat bag can be used to capture a baseline image, after which APAS can map the sampled bag image to determine if it can be matched to the trained image. The software can attempt to determine the deformation grid and, when applied to the acquired image, will give a good match with the trained image. The APAS cell can return a score of how the distorted image matches the trained pattern. Another method may include the use of a filling bag as a source for the trained image. In many cases, the area of interest may be curved around the edge of the bag, and the use of a flat image may return a lower match score.

  In an exemplary embodiment, APAS may incorporate multiple independent methods to verify the contents of medical items such as IV bags, vials, and / or syringes. A bar code may be incorporated into the labeling of the IV bag. APAS can use the barcode to provide another independent check on the contents of the bag if the barcode is present on the IV bag. Visual software may be used to process and decode the captured barcode image. Optical character recognition software may process images with text to identify the content. Some embodiments may use an external barcode reader, and bag ID verification does not rely only on a single optical system (eg, vision system and vision software).

  In some aspects, the barcode can include a drug identification number, but can also include multiple barcodes or additional information encoded within the barcode (eg, lot number and expiration date). The APAS can include a processor (eg, digital circuit, ASIC, and / or microprocessor) that parses the barcode and / or identifies unique sub-elements of the barcode that identify drug content. The bar code may be one-dimensional or two-dimensional.

  In some cases, the barcode may be on the same side as the bag label information or on the opposite side of the bug. The APAS cell may include a method for obtaining location and position information on a barcode so that the robot can accurately present the barcode to a barcode reader outside the blending chamber. For example, if a barcode is present on the bag surface, a robotic rotary maneuver may be performed to present the barcode to an external reader.

  In some embodiments, APAS may incorporate multiple methods to check vial contents. A bar code may be incorporated into the labeling of the vial. APAS can use the barcode, if present on the vial, to provide another independent check on the contents of the vial. The captured bar code image may be processed and decoded using visual software. Some embodiments may use a separate external barcode reader so that vial identification and / or confirmation does not rely on only one visual system for verification.

  The bag fluid contents can vary between bags and batches due to, for example, manufacturing tolerances. An exemplary APAS cell can incorporate a method for identifying bags by weight and weight difference. The bag used for dispensing can be weighed before and after the drug is injected. The weight difference may be used to confirm that the appropriate fluid volume has been added or removed. Bags used for fluid withdrawal can also be weighed prior to use, and this weight can be used to ascertain bag size and expected fluid content. For example, the average empty bag weight and 1 ml fluid weight can be preloaded into the database table. Weigh the bag before use, subtract the weight of the bag material and divide the weight by the weight of 1 ml of fluid to get an approximate volume of fluid in the bag. This number can be used in the number of drawers that can be pulled from the bag. Although the data table can include the expected weight with tolerances for bags of that size, this method can ascertain the amount of fluid in the bag prior to use.

  56A-56B show an exemplary system for IV bag identification and confirmation in an APAS cell. System 5600 is shown in side view, FIG. 56A, and top view, FIG. 56B. Using the system, the IV bag 5605 can be identified using visual software for recognition as described above. A camera 5610 can be used to capture an image of the IV bag 5605 in the holder 5615. The captured image of the IV bag can then be identified using image recognition software. Dose confirmation can be performed by weighing the IV bag on the scale 5620 before, during and / or after the reconstitution process, as previously described. For dose confirmation purposes, APAS software can use weight.

  In some aspects, an APAS cell can implement a method that uses multiple regions of interest to improve the accuracy of machine vision pattern matching. The region of interest may include a fluid name and a fluid concentration. For some applications, the bag may contain saline, glucose, or sterile water. In the case of saline and glucose, the concentration can be a field that may be distinguished, for example, with standard concentrations of 0.9%, 0.45%, and 0.225%. In various embodiments, the vision system may resolve drug names and / or concentrations.

  In some embodiments, various procedures may be used to confirm system quality and / or performance. For example, patient and / or package information may be sent for display on a display device when the robotic arm removes a medical item from the storage system. In some examples, more than one code may be read, for example, a barcode on a medical item and an associated label that may be printed. A plurality of codes may be compared to confirm that the codes match. For example, some hospital systems may include data entry terminals where patient data may be entered and transmitted to the APAS. In some aspects, the total processing time may be calculated in advance and then compared to the actual processing time. Such information may be used to monitor system performance, and such information may be used to complete certain operations (eg, batch operations) and / or additional inventory. Objectives may be planned and planned by evaluating when they are loaded. Such forecast information may be transmitted to the inventory control device, which may prioritize and prepare racks to be loaded into the storage system to minimize downtime.

  The prepared syringe may have a syringe cap attached to the luer lock tip, substantially preventing leakage or outflow of fluid contents and protecting the contents from contamination. The syringe cap may be stored in a sterile packaging tray in a controlled environment.

  FIG. 57 shows an exemplary syringe cap tray 5700 used in an APAS cell. FIG. 58 shows a syringe cap storage housing 5800 that may be used in an APAS cell. FIG. 59 shows an exemplary syringe cap station 5900 that may be used in an APAS cell. The syringe capper station can include a camera 5905, light sources 5910 and 5915, and fiducial marks 5920.

  The APAS cell may incorporate a robot manipulator to remove the syringe cap tray 5700 from the syringe cap tray storage housing 5800 in the APAS cell and place the tray 5700 in the syringe capper station 5900.

  60A-60B illustrate exemplary aspects of syringe capping in an APAS cell. A top view of syringe cap 6015 in syringe storage tray 6025 and a side view of syringe cap 6020 in syringe storage tray 6025 are included in FIG. 60A. In some embodiments, capping the syringe may include engaging the cap to the syringe luer lock hub 6005. In some other aspects, the cap may be applied using other mechanisms, such as snaps. Plunger depth 6035 is shown as the depth that the syringe cap needs to cover so that it can be securely attached to the syringe. The position tolerance may be, for example, about +/− 0.5 mm 6010. The cap may include a bevel 6030 that is approximately 1 mm larger than the luer lock hub 6005 and narrows to approximately the same width as the luer lock hub 6005. This design provides a clamp spring at the syringe end, but may impose accuracy requirements on determining the center of the cap and relaying the determined information to the robot to obtain the correct placement. The robot can use the offset to place the syringe 6045 on the syringe cap in the syringe cap tray. The trained position of the robot can be defined using one or more markers, eg, ID station reference point marker 6040.

  61A-61B show an exemplary configuration of a syringe cap in a syringe cap tray 5700. FIG. In some embodiments, the APAS may incorporate a method that uses shallow illumination on each side of the cap tray to provide good illumination at the edge of the syringe cap. The camera 5905 can take a high resolution image of the cap tray, and the pattern matching software may process the image to place the center of each hole in the cap. 61A-61B show the results of pattern matching and detection of the center of the vial. As shown in FIG. 61B, it is possible that the cap may be out of position (eg, due to a cap tray collision). The image processing software can check the distance between the cap centers and detect all overlapping states. For example, reference point 16100 in FIG. 61B shows an example where the center of the cap has been found, but one cap deviates from the expected distance for another cap position. In this case, the system may identify that at least two caps are in error (e.g., out of position), but the software will also look at nearby caps and separate them as expected from each other Think about whether you are in the distance. The system may also identify an error if the distance away is less than expected.

  FIG. 62 shows an exemplary configuration of a syringe cap in the syringe cap tray of FIG. 57, where one cap 6200 is misplaced. In this example, the cap 6200 with one position off may not have a clear line for the syringe to access any of the seven caps, so the six surrounding caps are invalid. Make me think. This test may be used to indicate that the syringe has a well-defined path to the cap in one or more axes (eg, x, y, and z directions). At the end of the process, the software may identify a correctly placed set of caps and may identify all caps that cannot be used (e.g., lost, overlapping other caps). Shorter than the predicted separation distance).

  In some aspects, a fixed reference point mark may be incorporated at a capping station at a fixed position reference point for the robot. Image processing software can provide an X and Y offset 6000 for this fixed reference point mark, as shown with reference to FIG. 60B. The fixed reference point mark may be the position of the trained robot, so that, for example, the center of the mark is known by the robot's x, y, z, rotation, and joint angles. The height of caps in the tray can be stored in a database table and is consistent for all caps in the tray. In some aspects, only x, y offsets may be provided to the robot.

  Since the syringe can contain fluid, small drops can occur at the end of the luer lock hub to clamp the gripper on the cylindrical portion of the syringe. The system may be programmed to identify and / or follow an operating trajectory when transporting a capped syringe to minimize the chance of cross contamination. The robot path from the deneedler to the capping station may be arranged so that any other device is not overlooked, and virtually all droplets are on other surfaces (e.g., unused caps, etc. The chance of falling on the medical container (the surface in contact with the medical container) is minimized. Such a protocol may provide that a drop from a syringe is dropped onto a cleanable drip pan. For example, if an uncapped syringe is brought to the capping station, APAS software may make sure that the uncapped syringe does not pass through all caps to prevent cross contamination opportunities. . Thereafter, in some embodiments, the APAS cell is a syringe that is available from the outer edge of the tray or via some path that substantially avoids the approach to the syringe cap passing through any other cap in the middle. A cap may be selected.

  As soon as the capping operation for the syringe is complete, the APAS cell may verify that the syringe cap is correctly attached to the syringe. The APAS cell can incorporate a method using a camera and pattern matching software to verify that the syringe cap is at the end of the syringe. The robot can be instructed to perform an operation to position the syringe so that the edge of the side view of the cap and syringe is within the field of view of the camera. An image can be taken and pattern matching software can be used to detect the presence of the cap pattern on the syringe.

  Some embodiments may include a station where one or more syringe caps may be stored. In various embodiments, a supply of syringe caps may be provided for one or more types of syringes.

  In some embodiments, the APAS cell may expect the vial cap to be removed before being placed in the inventory rack. Some embodiments may further include a device that confirms that the vial cap is not present prior to an attempt to use the vial (eg, by an attempt to puncture the septum of the vial with a needle). In an exemplary aspect, the method for confirming vial decapping may include a camera and pattern matching software. The robot can be commanded to deliver the vial profile or top view into the camera's field of view. The camera may then take a picture of the vial and save the image. The image can be compared to the trained image. The trained image may consist of a circular area of the septum on the top surface of the vial or a hard edge of the profile of the vial cap. The trained image may be compared with the vial image to confirm that the vial cap is not present. The confirmation may be by demonstration that the camera looks at the circular septum and confirms that it is safe to puncture the vial.

  In addition to the above aspects, some APAS implementations may include a decapping device for removing caps from medical containers, such as bottles and / or vials. In one embodiment, the robot gripper securely grasps the vial and transports it to the decapping station. The decapping station includes one or more features that rotate and / or leverage the cap to remove the cap from the container. Software in the controller may optionally determine which feature is used to remove the cap, the selection being based on the design or characteristics of the medical container. The system may be trained with an operation and operation profile to remove the cap from a particular container. In some cases, such a decapping operation may be performed immediately prior to using the medical container, for example, in a mixing operation. In other cases, decapping may be performed on the capped medical container, for example, as needed, after the capped medical container is loaded into the storage system. The system loader may be instructed to remove the cap before loading, and the decapping station may be used to identify containers that have not been cap removed before loading.

  Various mechanisms may be used to remove the cap, including the safety cap. In one embodiment, the rotatable member includes a plurality of retaining sections, each section having a decapping element that can be opened and closed and grasp the cap in response to a control device. When the cap is rotated to loosen the cap, the robot may advance and remove the container along the axis of rotation. In another aspect, fingers biased relative to each other may engage the cap while the container is pulled and the cap is removed. In yet another aspect, the pivotable member may be biased and engage the cap delivered by the robot, and the container is moved and the cap is removed.

  Dose confirmation is performed by confirming that the drug and fluid are accurate using a combination of one or more techniques including, for example, machine vision, barcode, plunger movement monitoring, and / or metering be able to. In one example involving withdrawal and further dilution, each process change can be measured. For example, withdrawing 1 ml of drug and diluting it by withdrawing 4 ml of sterile water to achieve the target concentration is the first weight after the 1 ml transition and the second weight after the 4 ml transition. Become. In another example involving dispensing the drug into IV bags, the bag can be weighed before and after fluid transfer and the weight can be recorded, for example, for comparison of differences.

  Some aspects of the software may operate to verify the suitability of the medical agent before and after identifying the agent used to process the drug order.

  For vials, clips of various sizes can be present to hold inventory in an inventory rack. Vials can have a wide range of diameters. The APAS cell can relate the vial diameter to the clip to determine the separation distance from the back for the inventory rack and translate it into robot position information for retrieval. When a vial is placed in an inventory clip, the clip fingers expand and can expand to accommodate the vial in an amount that is expanded relative to the vial diameter. This allows the center of the vial to be placed at a different position relative to the surface of the inventory rack. For example, the center of one vial may be located farther from the back of the rack than the center of another vial. This may indicate that a vial placed far away from the back of the rack is larger than the other vials. The robotic manipulator may need to adjust the distance traveled to remove the vial and center the gripper on the vial. Therefore, there may be at least one approach position for each position on the rack. APAS can use the vial diameter to fine tune the distance that the robotic manipulator engages the vial. The robot can align the gripper fingers (eg, V-notches) with the center of the grasping vial. In another aspect, some storage rack locations may be pockets.

  For fluid transfer using a syringe, the speed of the plunger stem can be related to the needle hole. The needle inner diameter and fluid viscosity can limit how fast the fluid flows, thereby determining the articulation rate of the syringe plunger. If the syringe plunger is pulled too fast, the pressure balance will have to wait for the fluid to catch up. If pushed too fast, the air column in the syringe barrel may be compressed and a delay may occur as fluid continues to flow after the plunger articulation stops. APAS can limit the plunger speed or calculate the latency. In each case, when fluid is transferred to or from the vial, APAS may generate a slight negative pressure in the vial and maintain it to prevent it from aerosolizing when the needle is withdrawn. . This can be achieved in the needle lowering configuration by plunger cycling that alternates air transfer from the vial and fluid transfer into the vial. This can also be achieved in a needle-raised configuration by plunger cycling that alternates fluid transfer from the vial and air to the vial. The algorithm can convert the total fluid to be transferred into a series of push-pull cycles so that negative pressure is maintained in the vial. The headspace and internal pressure within the vial may not be known. For example, in reconstruction, the headspace may be equal to the amount of fluid being transferred and the pressure in the vial can be estimated to be atmospheric. The algorithm can ensure that the pressure is initially negative and then maintained around that value. For example, the transfer of 30 ml of water to a vial for reconstitution can initially be the first step of pulling a predefined percentage of the total volume of fluid. For example, 10% of the volume, or 3 ml, can generate a -3 ml vacuum in the vial. The fluid transfer can then be a series of repeated pull-pull volume, percent step values, until the fluid is completely transferred. In this example, the syringe plunger can cycle between push 3 ml and pull 3 ml, resulting in an increase in the air column in the syringe and a corresponding decrease in fluid volume in the syringe. Within the vial, an increase in fluid volume can occur, during which the pressure alternates between atmospheric pressure and -3 ml. As a final step, the plunger is pulled one step value, ensuring that negative pressure remains in the vial.

  In an illustrative example, withdrawal from the vial may be performed as follows. First, the syringe plunger may be arranged so that a predetermined amount of air is drawn into the syringe cylinder. This amount may be determined based on the required fluid volume of the prescription (first pull). A predetermined amount of air can replace the withdrawn fluid volume with an approximately equal volume of air. Therefore, when pulling out 10ml of fluid, push in 10ml of air and replace it. During this process, the system may evaluate or monitor the “headspace” in the vial. In a preferred embodiment, the method may maintain a slight negative pressure in the vial.

  Second, the syringe plunger can be actuated to draw a predetermined amount of fluid from the vial. In this case, negative pressure can be generated. This can be limited so that the pull does not exceed the force limit (eg, by limiting the motor current to a threshold level). Third, the syringe plunger can be actuated to force a volume of air into the vial and replace the removed fluid volume. Fourth, the syringe plunger can be retracted again to an amount approximately equal to the amount of air pumped into the vial. Fifth, the cycle can continue until the required amount of fluid is drawn from the vial into the syringe. Sixth, at the end of the cycle, the volume in the syringe can substantially match the required withdrawal amount, and there can be a slight negative pressure in the vial.

In an exemplary aspect, the parameters passed may include:
Vials Maximum pressure-Maximum pressure allowed in a vial expressed in (Pmax) atmosphere Vial Minimum Pressure-Minimum pressure allowed in a vial expressed in (Pmin) atmosphere (e.g. vacuum)
Vial, head volume-volume of air in the vial in (Vh) milliliters (headspace)
Vial. Fluid volume-the total volume of fluid (e.g., drug) in the vial in (Vfv) milliliters Drug. Draw volume-(Vdrug) Volume of drug requested to be drawn Maximum volume allowed in a syringe; milliliters per MM-VQsyr
Local and global processes; cycle control-used for process and logic control (cycle)
Process.completion control-used for logical control (completion)
Volume-Total-(Vtot) Total volume of air in the syringe and the entire vial Syringe. Volume of air (Vas)
Drug. Replacement volume (Vdl)
Syringe Current level-(SL) Plunger current syringe level Initialization Syringe upper limit = 30 (milliliters) // SLMax
Substituted volume per MM = value calculated using syringe characteristics // VQsyr
Completion control = 0 // Completion Cycle control = 0 // Completion Air volume in syringe = 0.0 // Estimate initial volume Total volume = Volume

  The APAS cell syringe manipulator 322 or 334 can operate to extend and / or retract the plunger. Syringes can be used to transfer fluid, so each syringe is fitted with a needle, where the needle engages the bag or vial septum, so that the plunger articulation does not cause fluid transfer. Achieve. The method uses an algorithm that calculates the varying length and direction of movement of the plunger, alternately extending and retracting the plunger to transfer fluid into the syringe while maintaining the appropriate pressure in the target receptacle, The contents may be prevented from being aerosolized. In some aspects of APAS, the syringe manipulator may perform extraction and deflation operations using a syringe as the fluid transfer mechanism. In some aspects, such operations may be conveniently performed without additional fluid transfer stations.

  In various aspects, the adaptation may include other features and capabilities. For example, some systems may be implemented as a computer system that can be used with an implementation of the present invention. For example, the various implementations may be implemented in digital electronic circuitry, or computer hardware, firmware, software, or combinations thereof. The apparatus can be implemented in an information medium, such as a machine-readable storage device or a computer program product that is explicitly embedded in a propagated signal, for execution by a programmable processor, and the method manipulates input data. By generating an output, it can be implemented by a programmable processor that executes an instruction program to implement the functions of the present invention. The software can incorporate multithreading or parallel operations to improve APAS cell throughput. The invention relates to a programmable system comprising at least one programmable processor coupled to receive data and instructions from a data storage system, at least one input device, and at least one output device, and to transmit data and instructions thereto. It can be conveniently implemented in one or more executable computer programs. A computer program is a set of instructions that can be used, directly or indirectly, in a computer to perform an activity or produce a result. A computer program is written in any form of programming language, including a compiled or interpreted language, and as an independent program or as a module, component, subroutine, or other unit suitable for use in a computer environment It can be deployed in any form including.

  Suitable processors for executing the instruction program include, by way of example, both general and special purpose microprocessors, and a single processor or one of a plurality of processors of any type of computer. Generally, a processor will receive instructions and data from a read-only memory or a random access memory or both. The essential elements of a computer are a processor for executing instructions and one or more memories for storing instructions and data. Generally, a computer also includes or is functionally coupled to communicate with one or more mass storage devices for storing data files; such devices include magnetic disks, such as internal hard disks and Includes removable disks; magneto-optical disks; and optical disks. Clearly suitable storage devices for embedding computer program instructions and data include, by way of example, semiconductor storage devices such as EPROM, EEPROM, and flash memory devices; magnetic disks such as internal hard disks and removable disks; magneto-optical disks and All forms of non-volatile memory are included, including CD-ROM and DVD-ROM discs. The processor and memory can be supplemented by or incorporated into an application-specific integrated circuit (ASIC).

  In order to provide user interaction, the present invention provides a display device for displaying information to the user, such as a CRT (cathode ray tube) or LCD (liquid crystal display) monitor, and the user provides input to the computer Can be implemented on a computer having a keyboard and a pointing device such as a mouse or trackball.

  The computer system may be implemented as a distributed computer system and may include clients and servers. A client and server are generally remote from each other and typically interact through a network. The client-server relationship occurs thanks to computer programs that run on individual computers and have a client-server relationship with each other.

  Some aspects include a back-end component, such as a data server, or include a middleware component, such as an application server or an Internet server, or a front-end component, such as a client computer having a graphical user interface or Internet browser, or It can be implemented in a computer system including any combination of these. System components can be connected over any communication network by any form or medium of analog or digital data communication, including packet-based messages. Examples of communication networks include, for example, LANs, WANs, wireless and / or optical networks, and computers and networks that form the Internet.

  In various aspects, systems such as those described herein for handling IV bags and / or syringes among other items communicate information using suitable communication methods, devices, and techniques. Also good. For example, an APAS controller may communicate using a hospital pharmacy network that uses hospital LANs and / or point-to-point communication, where messages are sent to dedicated physical links (e.g., fiber optic links, point-to-point wiring). , Daisy chain) directly from source to receiver. Another aspect is to transport messages by means of a communication network, for example by using omnidirectional radio frequency (RF) signals, by sending to all or substantially all devices coupled together. On the other hand, yet another aspect is optionally used with messages characterized by high directivity, e.g. RF signals transmitted using directional (e.g. narrow beam) antennas or focusing optics Possible infrared signals may be transported. Yet another embodiment can use appropriate interfaces and protocols, e.g., RS-232, RS-422, RS-485, 802.11 a / b / g, WiFi, Ethernet, IrDA, FDDI ( Fiber distributed data interfaces), token ring networks, or multiplexing techniques based on frequency, time, or code division, but are not limited thereto. Some implementations may optionally incorporate features such as error checking and correction (ECC) for data integrity, or security measures such as encryption (eg, WEP) and password protection.

  A number of implementations of the invention have been described. Nevertheless, it will be understood that various modifications can be made without departing from the spirit and scope of the invention. For example, advantageous results are achieved when the steps of the disclosed technology are performed in a different order, components in the disclosed system are combined in different ways, or components are replaced with other components or supplemented with other components. There is a possibility that. Functions and processes (including algorithms) may be implemented in hardware, software, or a combination thereof, and some implementations may be implemented in modules or hardware that are not identical to those described. Other implementations are therefore within the scope of what may be claimed.

Like reference symbols in the various drawings indicate like elements.
1 illustrates an exemplary automated pharmacy mixing system (APAS) cell. FIG. FIG. 2 illustrates an example inventory system for an APAS cell. FIG. 2 is a top cutaway view of the APAS cell of FIG. FIG. 3 is a perspective cut-away view illustrating exemplary details of an apparatus for handling syringes, IV bags, and drug vials in an APAS cell. FIG. 2 illustrates an exemplary inventory system using a carousel structure with an inventory rack accessible by a robotic arm in an APAS cell. FIG. 6 is a perspective view of an exemplary rigid holder embodiment for aligning an IV bag injection port. FIG. 4 is a perspective view of an exemplary flexible holder embodiment for aligning an IV bag injection port. FIG. 6 illustrates an exemplary IV bag holder embodiment on the inventory rack of FIG. FIG. 9 is a view showing a robot arm gripper that grasps an IV bag port from the holder of FIG. 8. FIG. 6 shows an exemplary set of replaceable gripper fingers for the robot arm of FIG. FIG. 11 illustrates an example of the use of the exemplary robot gripper finger of FIG. FIG. 5 illustrates an exemplary example of a lock that loads a rack into a carousel. It is a figure which shows the assembly order which puts a rack in a carousel. FIG. 3 illustrates an exemplary inventory rack. FIG. 6 illustrates an exemplary air extraction process for an IV bag. 3 is a flowchart of an exemplary method for air extraction from an IV bag. FIG. 3 illustrates an exemplary diluent bag manipulator. 3 is a flowchart of an exemplary batch mode method. 2 is a flowchart of an example of an on-demand mode method that may be used by the apparatus of FIG. FIG. 6 illustrates an exemplary operation for a robotic manipulator that aligns the injection port with the IV bag in the up-down direction of the needle. FIG. 6 illustrates an exemplary cleaning process in an APAS cell. FIG. 22 shows an exemplary airflow system for the process of FIG. FIG. 10 illustrates an exemplary process for removing a needle cap. FIG. 6 illustrates an exemplary process for removing a needle. FIG. 6 illustrates an exemplary process for removing a vial cap. 1 is a cross-sectional view of an exemplary pulsed ultraviolet (PUV) disinfection system in an APAS cell. FIG. 27 is a block diagram of a control module for the PUV disinfection system of FIGS. 1 is a perspective view of an exemplary embodiment for a PUV housing. FIG. FIG. 2 is a cross-sectional view for an exemplary PUV disinfection system that accepts various sized objects to be disinfected in an APAS cell. 1 is a cross-sectional view of an exemplary PUV disinfection system in an APAS cell. It is a cutaway perspective view which shows the detail of a part of air processing system in an APAS cell. 1 is an exemplary block diagram of an APAS cell air treatment control system in an APAS cell. FIG. FIG. 6 is an exemplary cutaway view showing details of a carousel area in an APAS cell. FIG. 6 is an exemplary diagram illustrating details of a carousel trim panel in an APAS cell. It is a figure which shows the product output chute in an APAS cell. It is a figure which shows product output chute AF00 in the process of releasing a product from an APAS cell. FIG. 2 illustrates an exemplary printer system for an APAS cell. FIG. 38 illustrates an exemplary tray for the printer system of FIGS. 37A-37B. FIG. 4 illustrates an exemplary waste storage area for an APAS cell. It is a figure which shows the soft wall downdraft clean room attached to the side surface of the APAS cell. FIG. 6 illustrates an exemplary APAS within a hospital environment. FIG. 42 is a flowchart of an exemplary method for an APAS process for the APAS of FIG. 41. Fig. 6 is a flow chart of an exemplary order taking method including creation of an ASCII delimited file. 3 is a flowchart of an exemplary order capture that includes capturing print stream data. FIG. 6 illustrates an exemplary method by which APAS software analyzes drug orders and determines fluid transfer processing requirements. FIG. 4 illustrates exemplary vial characteristics for a vial. FIG. 6 illustrates exemplary syringe characteristics for a syringe. FIG. 3 shows three different sized drug vials. FIG. 6 illustrates the use of gripper information to confirm a vial. FIG. 6 shows vial diameter confirmation using gripper finger position feedback. FIG. 3 illustrates an exemplary vial identification station. FIG. 3 illustrates an exemplary vial mixer. FIG. 6 illustrates an exemplary syringe operation at a syringe decapping station. FIG. 6 illustrates exemplary stages of syringe plunger steering. FIG. 54A is a diagram showing an example of an IV bag on a syringe manipulator. FIG. 54B is a diagram showing an example of an IV bag having a gap. It is a figure which shows the example image of IV bag. FIG. 2 illustrates an exemplary system for IV bag identification and confirmation in an APAS cell. FIG. 4 illustrates an exemplary syringe cap tray. FIG. 6 illustrates an exemplary syringe cap tray storage housing. FIG. 4 illustrates an exemplary syringe capper station. It is a figure which shows the aspect of the syringe capping in an APAS cell. FIG. 58 is a diagram showing an exemplary arrangement of syringe caps in the syringe cap tray of FIG. 57. FIG. 58 illustrates an exemplary arrangement of syringe caps in the syringe cap tray of FIG. 57 with one cap misplaced.

Claims (13)

A processor-based interface configured to accept a preparation request for one or more drug prescriptions; and
Coupled to the interface, in response to the accepted request, including controller configured to operate the automatic prescription preparation apparatus, an automatic drug treatment system by robots,
The automatic prescription drug preparation device is :
An inventory chamber for storing a plurality of inventory items used to adjust one or more drug prescriptions;
An operator is operable between a closed position and an open position to provide access for loading and unloading inventory items in the inventory chamber, the first sidewall of the inventory chamber housing An external access port formed in
A compounding chamber access port on the second side wall of the inventory chamber;
A rotating inventory carousel disposed within the inventory chamber to receive a plurality of inventory items,
The carousel is rotatable about a vertical axis, each having a first plurality of locations adapted to receive an IV bag, a second plurality of locations each adapted to receive a vial containing a drug, and A third adapted to receive a syringe configured with a plunger slidably disposed between a needle coupled to a first end of the cylindrical portion and a second opposite end of the cylindrical portion, respectively. Including a plurality of locations, and the carousel is adapted to cause the selected chamber item to be provided with the selected inventory item stored at the selected location at the selected location near the compound chamber access port. It is configured,
Rotating inventory carousel;
A blending chamber adjacent to the inventory chamber and in communication with the inventory chamber via a blending chamber access port on a second sidewall disposed between the blending chamber and the inventory chamber;
The inventory item placed in the compounding chamber and grasped from the carousel in the inventory chamber to the compounding chamber access port is grasped, the grasped inventory item is transported to the first processing location, and the processing at the first processing location is performed. A multi-axis multi-coupled robot configured to release inventory items for subsequent delivery of the processed inventory items to a second processing location in the compounding chamber;
A syringe manipulator station configured to hold a syringe having a needle oriented in a generally upward direction and to draw liquid from the vial through the needle into the held syringe;
A shaking station configured to impart a motion to the vial to mix its contents prior to withdrawal of the liquid from the vial;
An air treatment system arranged to provide an air flow through the compounding chamber;
A waste container area disposed adjacent to the compounding chamber to receive inventory items processed in the compounding chamber; and
Aperture that couples the compounding chamber to the waste container area
Including
Here, the air treatment system is arranged to flow at least a portion of the provided air flow from the inner region of the blending chamber through the aperture towards a waste container located generally in the waste container region. ,
An automatic medicine processing system using the robot .   The system of claim 1, wherein the air treatment system is further arranged to generate a substantially uniform air flow from the ceiling of the blending chamber toward the floor of the blending chamber.   The system of claim 1, wherein the air treatment system is further arranged to reduce the air pressure within the compounding chamber substantially below ambient atmospheric pressure and outside the compounding chamber.   The system of claim 1, wherein the syringe manipulator station is further configured to hold a syringe having a needle oriented in a downward direction to inject liquid from the syringe into the vial.   The system of claim 1, wherein the syringe manipulator station is further configured to hold a syringe having a needle oriented in a downward direction to inject liquid from the syringe into the IV bag.   The system of claim 1, further configured to draw a volume of liquid from the vial and create a negative pressure in the vial relative to ambient atmospheric pressure outside the vial when the fluid transfer operation is complete. Allowed air flow to flow from the interior region of the compounding chamber through the aperture to a waste container located generally in the waste container region when in the open position and substantially when in the closed position The system of claim 1, further comprising a door proximate to the aperture that inhibits.   2. A prescription database operatively coupled to the controller to provide recipe information for controlling the automatic prescription drug preparation system to prepare any of a plurality of prescriptions. The system described.   The system of claim 1, wherein the automatic prescription adjuster is configured to adjust a prescription drug for output to an IV bag.   The system of claim 1, wherein the automatic prescription adjuster is configured to adjust a prescription drug for output to a syringe.   The system of claim 1, wherein the blending chamber access port is formed in a second sidewall including a partition between the blending chamber and the inventory chamber.   The system of claim 1, wherein the needles of the third plurality of locations are covered with a needle cap.   The system of claim 1, wherein the drug prescription comprises a chemotherapeutic dose.

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