JP2010520771A - Ultraviolet purification in the dispensing environment - Google Patents

Abstract

Systems and methods for reducing bioburden at at least a portion of a fluid transfer port include providing a dose of radiation to a portion in optical communication with at least one radiation source. In an illustrative example, a medical container, such as a vial or IV bag, receives a dose of ultraviolet (UV) energy substantially at a predetermined region of the fluid transfer site. In some examples, such a purification process may precede a fluid transfer operation in which fluid is transferred into or out of the medical container by passing through the cleaned region. Such fluid transfer may be used in automated or semi-automated dispensing processes, such as drug reconstitution. Various embodiments may further include one or more seal assemblies, each seal assembly having an opening through which a dose of radiation is delivered from the source to a controlled area on the fluid transfer port. Is done.

Description

CROSS REFERENCE TO RELATED APPLICATIONS ) Claim priority. This application also relates to US Provisional Patent Application No. 60 / 988,600 entitled “Method and Apparatus for Automated Fluid Transfer Operations” filed November 16, 2007 by Eliuk et al. Insist on priority. This application also claims priority under US Patent Act §119 (e) on US Provisional Application No. 60 / 971,815 entitled "Gripper Device" filed September 12, 2007 by Eliuk et al. To do. The entire disclosure of each of the documents is hereby incorporated by reference.

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

Background Many medical drugs are delivered to a patient from an intravenous (IV) bag into which an amount of medical drug has been introduced. Sometimes the medical drug may be a mixture with a diluent. In some cases, IV bags contain only medical drugs and diluents. In other cases, the IV bag may also contain a carrier or other material to be poured into the patient at the same time as the medical drug. The medical drug can also be delivered to the patient using a syringe.

  Medical drugs are often supplied in powder form, for example, in medical drug containers or vials. Diluent liquids may be supplied to form a mixture with a medical drug separately or in a diluent container or vial. The pharmacist may mix a certain amount of a medical drug (eg, in a dry form such as a powder) with a certain amount of diluent according to the prescription. The mixture may then 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 appropriate amount of diluent and medical drug according to the prescription for the patient. Some prescriptions (eg insulin) may be prepared to accommodate a number of certain types of patients (eg diabetes). In such cases, many similar IV bags containing similar medical drugs can be prepared in one batch, but for example, the volume of each dose can vary. Other prescriptions, including those containing chemotherapeutic drugs, may require very accurate and careful control of diluents and medical drugs to follow prescriptions tailored to the needs of each patient .

  Preparation of a formulation in a syringe or IV bag can include, for example, transferring a fluid such as a medical drug or diluent 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 a range of sizes, shapes, and designs.

A system and method for reducing bioburden in at least a portion of a fluid transfer port includes providing a dose of radiation to a fluid transfer port in optical communication with at least one radiation source. . In an illustrative example, a medical container, such as a vial or IV bag, receives a dose of ultraviolet (UV) energy substantially at a predetermined region of the fluid transfer site. In some examples, such a purification process may precede a fluid transfer operation in which fluid is transferred into or out of the medical container by passing through the cleaned region. Such fluid transfer may be used in automated or semi-automated formulation processes such as drug reconstitution. Various embodiments may further include one or more seal assemblies, each seal assembly having an opening through which a dose of radiation is directed from the source to a controlled area on the fluid transfer port. Supplied.

  In one aspect, an automated dispensing and mixing system (APAS) is an automated system for transporting medical containers such as bags, vials, or syringes within a blending chamber that may be adjusted to a pressure above or below atmospheric pressure. May be included. In one implementation, an automated transport system grips and transports syringes, IV bags, and vials of various shapes and sizes from a storage system in an adjacent chamber that may be adjusted to a pressure above or below atmospheric pressure. Configured to do. Various aspects may include a controller adapted to activate an automated transport system that moves the injection port of the IV bag, vial, or syringe to match the filling port at the fluid transfer station in the chamber. . One implementation includes a purification system that can substantially clean the stopper on the injection port of the vial or IV bag in preparation for transport to the fluid transfer station. A Port Purification System (PSS) may be used for vial and bag port purification in IV blending applications. The PSS system may be a stand-alone or table-top system, or may be adapted for incorporation into an APAS cell. PSS is a source of one or more radiation (eg, UV); one or more mechanisms for holding medical containers (eg, drug vials, IV bags, and syringes); for radiation sealing or containment It may include one or more mechanisms; one or more cooling, purging, and / or venting systems; a control and monitoring system; and an interlock and / or safety mechanism.

  PSS may utilize a single centralized UV source or multiple distributed UV sources. The UV source can be made to reach the UV radiation in pulses and / or a constant waveform and by continuous radiation, intermittent radiation, or pulsed radiation. The UV source can reach a predetermined dose with a fixed or variable profile based on the target biological contaminant. To reduce transmission loss, at least one optical conduit (eg, light pipe, optical fiber, and optical waveguide) may be used to transmit UV radiation from the UV source to the object to be cleaned.

  The PSS may include one or more other aperture assemblies to seal or contain UV radiation. The seal assembly can be designed so that it does not contact the area to be cleaned during operation. In some embodiments, the seal opening assembly includes at least one baffle configured to form one or more openings. In some aspects, the seal opening assembly includes a gasket formed around the opening. A pressure chamber may be used to engage the medical container and the seal assembly by forming a substantially light seal between them. In some aspects, the seal opening assembly includes a concave receptacle having an opening. In some aspects, multiple seal opening assemblies are used to cover medical containers having different shapes and sizes.

  The PSS may incorporate a controller that can determine which radiation seal assembly to use based on the size and / or shape of the medical container to be cleaned.

  The PSS may also include actuators that move various components (e.g., medical containers, devices for holding medical containers, radiation seal assemblies, and UV sources) individually or together. The portion of the fluid transfer port to be cleaned can be in optical communication with the UV source through an opening in the radiation seal assembly.

  Various aspects may provide one or more of the following advantages. APAS eliminates toxic and / or volatile substances, such as those used for chemotherapy, from ambient pressure in order to substantially avoid accidental leakage of those substances out of the chamber. It may be formulated in a low pressure, substantially aseptic chamber. APAS is also programmed to select medical containers, such as IV bags, syringes, and / or vials, according to protocols for specific locations (e.g., hospitals) for containers for special drug orders. May be. In addition, medical items including IV bags and vial stopper ports may be positioned to receive a purified dose of ultraviolet radiation that can effectively reduce bioburden (eg, viruses, bacteria, mold, etc.). Additional advantages may include the reduction or elimination of cleaning consumables and a significant reduction (in encapsulated cell situations) of explosive gas risks associated with some consumable disinfectants.

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

An exemplary automated dispensing and mixing system (APAS) cell is shown. FIG. 2 is a top cutaway view of the APAS cell of FIG. 3A-3C show cross-sectional views of an example port purification system (PSS). 4A-4C show cross-sectional views of an exemplary PSS that accepts various sized objects to be cleaned in an APAS cell. Example encapsulated PSS is shown. 2 shows an exemplary PSS without a surrounding wall. An example PSS with a gripper mechanism is shown. FIGS. 8A and 8B show exemplary IV bag and drug vial clarification, respectively. 9A and 9B are a top view and an isoparametric view, respectively, of an exemplary cleaner carousel. 3 is a block diagram of an exemplary control module for the PSS of FIGS. 11A-11F are cross-sectional views of an example PSS in an APAS cell. 2 illustrates an exemplary apparatus for performing a fluid transfer operation.

Detailed Description of Exemplary Embodiments An automated dispensing and mixing system (APAS) may include a manipulator that transports medical containers such as bags, vials, or syringes around a substantially sterile mixing chamber. In some examples, the chamber includes a plurality of processing stations that can process medical containers to perform reconstitution for prescription medical drug doses. In a particular example, such a processing station may include an apparatus for substantially cleaning, disinfecting, and / or sterilizing portions of the medical container prior to performing a fluid transfer operation.

  In a practical example, the gripper assembly is configured to substantially universally grasp and retain syringes, IV bags, and vials of various shapes and sizes. In an exemplary embodiment, the grasping device may include a claw configured to grasp a plurality of different types of IV bags, each type having a different infusion port configuration. An aspect may include a controller adapted to actuate the transport assembly and position the injection port of the bag, vial, or syringe to coincide with a filling port, such as a cannula installed at the filling station. Or, it may be equipped with a carousel delivery system adapted to carry bags, vials, and syringes to the mixing system and deliver a medical drug configured in the bag, vial, or syringe to the release area.

  FIG. 1 illustrates an exemplary automated dispensing and mixing system (APAS) cell device 100 for use within a hospital dispensing 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 perform one or more operations that would otherwise be performed by a dispensing staff within a laminar airflow hood. The APAS cell 100 includes a robotic cell that automates the formulation and dispensing of drug doses in IV bags and / or syringes, such as those that can be prepared in a hospital dispensing department. The robotic cell may use a syringe-based fluid transfer process and a robotic manipulator (e.g., multi-freedom) to move drug vials, syringes, and IV bags through the cell as the medical drug is processed. Degree arm).

  FIG. 2 shows an exemplary top cutaway view of the APAS cell of FIG. APAS cell 100 includes two chambers. The inventory chamber 202 is used as an inventory loading area and can be accessed by an operator to load the APAS cell 100 through a loading door (not shown). In some embodiments, inventory chamber 202 provides a substantially sterile environment, which may be an ISO class 5 environment that complies with clean room standards. The processing chamber 204 includes a blending area where mixing and / or blending processes can occur. In some embodiments, the processing chamber 204 provides a substantially sterile environment, which may be an ISO class 5 environment that complies with clean room standards. Mounted outside the APAS cell 100 are two monitors 102, which may serve as input / output devices.

  The inventory chamber 202 includes two inventory rack carousels 210 and 212 and a temporary inventory rack 214. A temporary inventory rack 214 may be used to place in-process drug vials containing enough material to provide multiple doses. Each inventory rack carousel 210 or 212 may support a plurality of inventory racks (not shown). In some applications, the operator may remove one or more racks from the carousel 210, 212 and replace them with racks that are loaded with inventory. The rack may be loaded on the carousel 210, 212 according to the loading map, which map may be generated by an operator for submission to the APAS cell 100, or generated by the APAS cell 100 and communicated to the operator. May be. The chambers 202, 204 are substantially separated by a partition 216.

  The processing chamber 204 includes a multi-degree-of-freedom robot arm 218, which further includes a gripper, which can be used, for example, to extract items from a pocket on a rack or within the APAS cell 100 for manipulation. Items can be gripped. Robotic arm 218 responds to command signals from a controller (not shown) to retrieve, manipulate, or reposition inventory items in processing chamber 204 and in and around carousels 210, 212. Also good. Robot arm 218, for example, removes a vial, IV bag, or syringe from the rack of carousels 210, 212 in inventory chamber 202 and moves the item to a station in processing chamber 204 for use in formulation preparation. Thus, the inventory item may be operated. In some examples, the robotic arm 218 may manipulate inventory items on the carousels 210, 212 through an access port (not shown) in the septum 216. The septum 216 may be substantially sealed so that a substantially sterile environment can be maintained for the compounding process within the processing chamber 204.

  According to an example, a drug order coming from a remote user station (not shown) should be filled with individual doses of drug reconstituted from the drug provided in one or more vials Includes batch production orders for syringes. For example, the operator initiates, monitors, and / or controls the loading process by loading the carousel 210 with an inventory rack of drug vials and aligning with the APAS cell 100 using the input / output device 102 Accordingly, the APAS cell 100 may be preloaded with the drug in the loading process. As APAS cell 100 processes the previous order, the operator can add syringes, drug vials, and IV bags to carousel 212 while APAS cell 100 is operating carousel 210 for the next batch production order. Stock racks may be loaded. Once the loading process is complete, the operator may submit the batch production process. This may begin immediately or after another process is complete.

  To perform batch production, in this example, the robot arm 218 may withdraw a syringe from a pocket in the rack in the carousel 210. 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 218 may carry the syringe to the decapper / deneedler station 220 where the needle cap is removed from the syringe / needle assembly and the needle is exposed. The robot arm 218 moves the syringe to the scale station 226 where the syringe is weighed and the empty weight is determined. The robot arm 218 may transfer the syringe to the needle-up syringe manipulator 222, where the robot after one or more inspection operations (e.g., metering, barcode scanning, and / or machine vision recognition technology) A dose of drug is withdrawn from a vial previously placed there by arm 218. The robot arm 218 moves the syringe to the decapper / needle removal station 220 where the needle is removed from the syringe and discarded into a sharps container (not shown). The robot arm 218 then moves the syringe to the syringe capper station 224 where the needleless syringe is capped. The robot arm 218 moves the syringe to the stale station 226 where the syringe is weighed and the predetermined dose programmed into the APAS cell is confirmed. The robot arm 218 then moves the syringe to the printer and labeling station 228 and receives 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 the syringe, dose amount, and date for entry And / or lot code information. The robot arm 218 then moves the syringe to the output scanner station 230 where the information on the ID label is read by the scanner to check that the label is readable. APAS cell 100 may use the local communication network to report back to the remote user station for use in the operational plan. The syringe is then transported by the robot arm 218 and loaded into the syringe discharge chute 232 where the dispensing engineer can obtain the syringe for placement, for example, in inventory in a hospital dispensing department. As the process continues, the robot arm 218 may remove an empty vial from the needle-up syringe manipulator 222 and place it in the waste chute 233 during the drug ordering process.

  In another exemplary example, the syringe is as an input that includes the fluid (e.g., diluent or known drug compound) to be mixed in the compounding process, and as an output that includes a prepared dose suitable for delivery to the patient. May be used in both. Such a syringe may need to implement a special reconfiguration order programmed into the APAS cell 100 via, for example, the input / output capabilities of the monitor 102. In another example, the order may be an emergency order, which may be accepted from the hospital interface. In this example, the operator performs in-situ loading by placing the syringe used for both reconstitution and dosing in a pocket on the rack already installed on the carousel 210. The operator places the reconfiguration order into the APAS cell 100. The robotic arm 218 pulls the selected syringe from the pocket in the rack within the carousel 210 and moves it to the decapper / needle removal station 220 where the needle cap is removed from the syringe / needle combination, thereby removing the needle. Expose. Thereafter, the syringe is transferred to the needle down syringe manipulator 234 by the robot arm 218. At station 234, diluent is drawn into the syringe from diluent supply IV bag 236 previously placed thereon by robot arm 218. Diluent supply 236 may be contained in an IV bag suspended on a needle down syringe manipulator 234 by a clip (not shown). If necessary, an air extraction process may be performed to prepare an IV bag. The syringe then punctures the membrane of diluent port 238 with the needle down. The syringe is actuated, for example, to remove a predetermined amount of diluent from the IV bag. The needle down syringe manipulator 234 then moves the reconstituted vial 250 previously placed thereon by the robot arm 218 under the syringe. The diluent in the syringe is transferred to the vial for reconstitution with the vial contents. Robot arm 218 then moves the vial to mixer 248 and shakes it according to the mixing profile. The robotic arm 218 then moves the vial to the needle-up syringe manipulator 222 where the appropriate amount of reconstituted drug is withdrawn from the vial and placed in the “output” syringe previously delivered there by the robotic arm 218. .

  In another aspect, the APAS cell 100 may accept a manufacturing order that prepares a compound that may include an IV bag as an input inventory item or as an output. In some examples, the IV bag may be selected as a diluent source for reconstitution in a drug order that is output in a separate medical container. In another example, the selected IV bag may be used as output after the drug order preparation is complete. Some IV bags may be placed on the carousel 210, 212 and used as an input that may be at least partially infused with a diluent that may be used to reconstitute the drug. Good. 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 210 for use in a production order. During the manufacturing order, the robot arm 218 pulls the IV bag from the rack on the carousel 210 and moves it to the scale and bag ID station 226. At this station, the IV bag is identified by bar code or pattern matching and its weight is recorded. This may be done, for example, as an error check and / or to positively identify the type and / or volume of diluent used for reconstitution. Thereafter, if an IV bag is selected as the diluent source, it may be weighed before using the bag to confirm the presence of diluent in the IV bag. If an IV bag is selected for output, it may be weighed multiple times, eg, before, during, and / or after each fluid transfer step. As a post-transfer inspection process, after the fluid transfer operation has occurred, the weight may be rechecked to determine whether the weight change is within an expected range. Such a check may, for example, detect leaks, spills, overfills, or material input errors. In this example, the robotic arm 218 moves the IV bag to the port cleaner station 240, where ultraviolet (UV) light or other purification processes are used to substantially sterilize at least a portion of the IV bag port, It may be disinfected or purified. The robot arm 218 moves the IV bag to a needle-up syringe manipulator 222 that is loaded with a pre-injected syringe. The IV bag may be inverted so that the injection port is directed downward for the injection process. The contents of the syringe may then be poured into an IV bag. The robot arm 218 then transports the IV bag to the scale station 226 where the IV bag is weighed and the predetermined dose programmed into the APAS cell 100 is confirmed. The robot arm 218 then moves the IV bag to the bag labeler tray station 242 where the label printed by the printer and labeling station 228 is applied to the IV bag. The robot arm 218 may move the IV bag to the output scanner station 230 where the information on the ID label is read by the scanner to check that the label is readable. One or more additional inspection checks may be performed. The IV bag is then transported to the robot arm 218 and loaded into the IV bag discharge chute 244, where a pharmacist can obtain the IV bag for placement, for example, in inventory in a hospital dispensing department.

  In another aspect, a vial (or another medical item or container) may be prepared for reconstitution. While this process is performed by the APAS cell 100, the vials may be identified at the vial ID station, where, for example, a scanner and / or image hardware in combination with image processing software can The code label may be read. The acquired information may be processed to identify the vial contents and correlate with what is expected. In some implementations, as an alternative to or in conjunction with barcode reading, the APAS cell 100 may use pattern matching on a vial using optical scanning techniques. Also, during the reconstitution process, the vial contents may be mixed with diluent using a vial mixer 248 prior to use 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 imaging and the image 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). In some aspects, the image information may be transmitted wirelessly (eg, using infrared or RF (radio frequency) transmission) to a receiver coupled to the APAS. Such a receiver may be installed inside or outside the chamber with the robot manipulator. Using such a reader, read machine-readable indicia at various locations in and around the compounding chamber, including on the portion of the storage carousel that passes through the window and is exposed to the compounding chamber. Also good.

  In the embodiments described herein, a UV port purification system (PSS) is used for the purification of vial and bag ports in IV blending applications. Variations on the system described herein may also include cleaning the syringe body. The system may be part of the APAS cell or may be used as a stand-alone device. Examples of APAS systems include, for example, U.S. Patent Application No. 11 / 316,795 entitled "Automated Pharmacy Admixture System" filed December 22, 2005, and "Automated Pharmacy Admixture" filed March 27, 2006. US patent application Ser. No. 11 / 389,995 entitled “System” is described in further detail, the contents of each of which are incorporated herein by reference.

  In general, the action of cleaning an object may refer to the action of reducing bioburden on the object to be cleaned. In some applications, the cleansing action may be intended to reduce bioburden that is active (eg, alive) to some extent. In some aspects, the disclosed object cleaning may substantially disinfect at least a portion of the object. In some other aspects, the disclosed cleaning of the object may substantially sterilize at least a portion of the object. Exemplary desired bioburden inactivation is greater than or equal to a 6 log reduction, but may vary slightly from this depending on the target organism. In some embodiments, at least 99.9999%, 99.99%, 99%, 95%, 90%, 80%, 75%, 70%, 60%, or at least about 50% of a particular biological contaminant is killed Or it may be disabled. In some embodiments, between about 1-100% of special biological contaminants can be inactivated.

  In an exemplary embodiment, the mechanism for cleaning the target object may be via exposure to ultraviolet radiation. This exposure may be reached in pulses and / or a constant waveform in several ways. In some embodiments, the dose of ultraviolet radiation may include one or more pulses. In another aspect, the dose may include a timed exposure at a controlled intensity. For example, the intensity may be controlled by modulating the current and / or voltage applied to the radiation source to substantially achieve a controlled radiation level, the radiation level being It may increase, decrease, and / or remain substantially constant. In some aspects, the controller may select which of many optical paths to use by modulating the optical path transmission characteristics and combining radiation from the source to the target area on the injection port, for example. And / or by modulating optical coupling (eg, filtering) characteristics and effectively coupling radiation from the source to the target, a time-varying or constant radiation level may be achieved. The radiation received by the target is known as the ultimate dose. Dose includes accumulated exposure values. In the example, the desired dose is, for example, a desired energy density selected to be sufficient to inactivate one or more types of biological contaminants to a selected degree. It is determined in advance based on the accumulated exposure value. In general, purification may include, for example, reducing the number of viable microorganisms present in the sample.

  Biocontaminants known as bioburden can include, but are not limited to, for example, viruses, bacteria, molds, protozoa, and yeast. In one range of examples, ultraviolet light is used to inject, for example, in, or within, a portion of an IV bag, syringe, and / or vial, such as an IV bag, syringe, and / or vial. One or more types of biological contaminants around the port may be killed. For example, in some cases, such bioburdens are packaged, prepared, stored, transported, or otherwise handled in a clinic, hospital, hospital dispensing department, laboratory, or drug It can be found in the environment, such as other possible facilities. Some embodiments include vials, syringes, packaging (e.g., IV bags), tubes, access ports, and / or related equipment (e.g., handling equipment, including robotic manipulators), fluids (e.g., water), or purification May be advantageously applied to provide or enhance purification of other materials that may be in close proximity and / or contact with objects that may be of concern. 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.

  In various embodiments, a UV port purification system (PSS) may include one or more of the following components: one or more UV sources; one or more vials, syringes, and / or bag port Retention system or method; one or more systems or methods for proper sealing or containment of UV for both drug / fluid and / or user protection; one or more cooling, purging, and / or Or ventilation systems; control and monitoring systems; and interlocks and / or safety mechanisms.

  In various examples, some embodiments of the PSS may include a single centralized UV source with selectable masks or openings for various vials and bags. Some aspects also include multiple distributed lines that can be conveniently installed (e.g., for replacement, maintenance) or combined with another subsystem or function in an APAS cell situation. Sources may be used. In the example described herein, the amount of UV time exposure required for purification is a function of the energy level received by the target in the required frequency spectrum. However, the predetermined exposure time for a dose may be based on another criterion. Both fixed and variable profiles may be performed at various levels of intensity, number, space, and timing. The output of the UV source can decay over time. Calibration and / or closed loop control is performed by the processor, e.g., on a programmable logic controller or embedded controller, to maintain the desired profile (e.g., a predetermined accumulated dose of radiation). May be compensated for.

  In some embodiments with multiple UV sources, the PSS concentrates or directs radiation supplied from each of the UV sources onto one or more selected areas or spots, or uses offsets And a device that combines the output patterns to provide a desired illumination pattern at the target injection port. The UV source may have an uneven output pattern. By changing the pattern center line, a total output energy pattern that satisfies the desired requirements can be generated. An example is having three UV sources combined in a manner that provides a nearly equal energy output over a much wider range than can be achieved by concentrating the three UV sources in a single spot. .

UV sources, for example, including during 100Nm～280nm, the UV-C band, but not limited to, 1 J / cm ² or 10J / cm ² or on the order of 30 J / cm ^2,, a very high peak energy level, It may also contain a flash bulb that produces In some examples, these are provided with very short swarms ranging from 1 ns to less than 100 ms at a frequency of about 0.01 Hz to about 1 kHz. Some pulsed bulbs can produce a broadband spectrum. In some embodiments, the UV light output may include a broader radiation spectrum. For example, pulsed UV light may include an energy content in the UV-A, UV-B, and UV-C range, including some energy content at wavelengths shorter and / or longer than the UV wavelength, such as IR or visible light. But you can.

Mercury evaporation lamp, UV sources such as a metal halide lamp, and certain other wave source generally provides energy of about 1mJ / cm ² ~400mJ / cm ² or more in the range of UV-C band. When packaged alone or with multiple source packages to increase the total dose, such UV sources provide energy levels suitable for purification at a particular time be able to. Depending on purification time constraints, lower or higher energy levels may be used.

UV sources such as LEDs can be tuned to provide very narrow band energy including, for example, UV-C. The output spectrum can be adjusted to provide a total spectrum within ± 500 nm, ± 100 nm, ± 10 nm, or ± 1 nm, or less, for example, of a central band frequency of about 250-290 nm or 265-275 nm. . This advantageously affects wider spectrum light bulb heating, ozone production, and / or operator safety. Alone or packaged, or to increase the total dose packaged with the plurality of sources package, LED and / or in the range of 1mJ / cm ² ~400mJ / cm ² or more dose, LED arrays provide energy levels suitable for purification with high throughput for automated applications. For example, lower or higher energy levels may be used due to purification time constraints. In various embodiments, one or more UV LED sources may be placed at various locations that are dispersed and directed to illuminate at least one surface to be cleaned. UV LEDs may be distributed in a rectangular, straight, curved, circular, spherical, or other pattern to expose UV radiation to one or more regions and / or surfaces. In various applications, a pre-defined LED may be selected and operated at a selected time to provide a dose of UV irradiation. The choice of dose and which LED to activate and the timing of its activation may be determined according to the type and / or size of the object to be exposed (e.g. vial, IV bag, or the like) Good. LEDs can be activated sequentially, in parallel, overlapping, or similarly, and the timing of activation is often the purpose to be achieved, for example, high dose, low dose, long duration, source lifetime Depends on, etc. Examples of UV LEDs that may be used in some embodiments are described, for example, in US Published Patent Application No. 2004/0099869, filed Oct. 22, 2003, the contents of which are incorporated by reference.

  In some embodiments, the UV lamps in the port purification system may be cooled and / or cleaned with a stream of clean air. Such air flow may cool the particulates or organic solvent and / or substantially reduce particulates or organic solvent from depositing on the lamp surface. Connecting the air flow to the low pressure perimeter duct forces air to be drawn into the UV lamp housing from just below the fan filter unit outlet (which is the cleanest) and flow over the UV lamp to provide cooling. In some embodiments, such cooling may be performed without additional air moving elements that may create an air flow that may disrupt the layered air flow pattern controlled in the blending zone. Good.

  Examples of methods of delivering the required dose of ultraviolet radiation to the target may include continuous radiation, intermittent radiation, and pulsed radiation. With continuous radiation, a suitable source may require warm-up time and is typically not adapted to repeated and / or frequent on / off cycles. Examples of such sources include, but are not limited to, mercury vapor lamps, fluorescent backlights, and metal halide lamps, and combinations of these and other sources. With intermittent radiation, a suitable source can operate continuously and can also have the capability of repeated and / or frequent on-off cycles (eg, LEDs and lasers). For pulsed radiation, suitable sources include sources designed to illuminate at a particular frequency with a particular pulse width, such as a flash bulb using xenon or other suitable gas.

  In one example of UV purification, an optical conduit (eg, light pipe, optical fiber, optical waveguide) can be used, for example, to reduce transmission loss between at least one UV source and the purification target. In some implementations, the optical conduit allows transmission of a special wavelength range (eg, the UV wavelength range used for purification). The conduit can be placed in close proximity to the UV source so that substantially most or all of the UV light emitted by the UV source (eg, a diffusion source) strikes the entrance surface of the conduit. In some implementations, when UV light enters the conduit, the loss in the conduit can be a function of the conduit material and structure. For example, the optical conduit may include one or more optical fibers or one or more forming structures (eg, glass or plastic structures). Light exiting the optical conduit may pass through one or more optical lenses. One or more convex and / or concave lenses may be selectively applied (eg, on a rotating mechanism) to provide selective control of the beam width incident on the surface to be cleaned.

  In some implementations, one or more optical conduits are arranged to collect and / or combine UV light from one or more UV sources and parallel the UV light to one or more purification targets. Or simultaneously. For example, multiple UV sources can be combined using an optical conduit to focus the UV light on a single purification target. In another example, a single UV source can be split using multiple optical conduits to direct UV light to multiple purification targets. In another example, UV light incident on a target surface from a first optical conduit can substantially overlap or combine with UV light emitted from a second optical conduit. In some implementations, the one or more UV sources can include a light emitting diode (LED) or a xenon flash UV source. An example of a flash UV source is described with reference to FIGS. 26A-29C of US patent application Ser. No. 11 / 389,995, filed by Eliuk et al. On March 27, 2006, entitled “Automated Pharmacy Admixture System”. The entire disclosure of which is incorporated herein by reference.

  In some implementations, the optical conduit may include an exit surface arranged in close proximity to the target so that diffusion losses between the conduit exit surface and the purification target are substantially minimized. In some implementations, the conduit allows the UV source to be placed substantially far away from the purification target (eg, due to packaging or mounting constraints and / or to simplify UV source maintenance). In some implementations, a remotely located UV source allows maintenance to be performed on the UV source (e.g., bulb replacement) without contaminating the surfaces to be cleaned (e.g., fluid ports and needles). It becomes possible. In some implementations, a remotely located UV source protects the user from flashes from, for example, LED or xenon flash UV sources. In some implementations, the amount of benefit gained from the conduit can vary depending on factors such as optical conduit loss (e.g., coupling loss or transmission loss), purification target size, number of UV sources, conduit geometry, etc. is there. In some implementations, the conduit radiates energy that impinges on the target to the same purification target at the same distance from the same UV source without the light conduit, for the UV source that illuminates the vial stopper or IV bag fluid port through the light conduit. Compared to about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 300%, 500%, 1000% or more increase.

  The described PSS is one or more systems for holding medical containers (e.g., drug vials, syringes, or IV bags) whose ports are to be cleaned (i.e., receiving a cleaning dose) Or incorporate a method. Examples of drug vials include, but are not limited to, 1 ml to 100 ml with the full range of vial seal / stopper sizes and types involved. Examples of bags and / or IV containers include IV fluid bags of all sizes of solutions (e.g., saline, dextrose, sterile water, and combinations thereof) including but not limited to sizes up to 3 liters. But not limited to. In one APAS cell application, the item to be cleaned may be held by the cell robot or passed to another holding mechanism. One holder embodiment achieves retention by using a gripper or clip. The gripper or clip in this case may contact the vial at the top, neck, or body of the vial. Another holder embodiment can use a platen on which a vial is placed. Yet another holder embodiment can use a cradle in which a vial is placed. Yet another holder embodiment involves the use of a vacuum in combination with a sealing / containment function to hold the vial in place by suction at the top surface (area to be cleaned). Another embodiment may incorporate a movable platen that is used to firmly engage the vial with the exposure orifice when properly attached by a user, manipulator, and / or robot. The movable platen can be driven by a spring, motor, aerodynamics or hydraulics. The robot holder / holding mechanism used may be stationary or may include moving continuously or stepwise between various positions. Further, the retention mechanism or method may be combined with another subsystem function to improve cell efficiency. If the object to be manipulated is a vial, the PSS holder may be combined with a vial ID operation function. For IV bags, the PSS holder may be coupled with a bag scale / ID station.

  In various aspects, the retention mechanism / method may also be generally applicable to syringes. Several options may also apply to stand-alone PSS. In a stand-alone PSS system, the operator may manually hold the item to be cleaned in the required position. The above holding options include embodiments with a stationary holder or a movable holder that includes one or two additional movement axes for positioning items for cleaning. In other embodiments, an automatic transfer mechanism may be used to remove the object from the chamber after exposure to ultraviolet radiation. The automatic transfer mechanism may include a robot manipulator and / or a rotating platen and may manipulate or move the object in response to a series of commands automatically generated by a processor executing a command program. Location features may be included to help the operator (eg, dispensing staff) locate the object at the correct location within the PSS chamber.

  3A-3C show cross-sectional views of an example PSS300. In an exemplary embodiment, the PSS 300 may be used to clean items in an automated drug compounding device, such as the APAS cell 100, an example of which is described with reference to FIGS. In this example, the PSS 300 can be used to clean items including but not limited to drug vial ports, IV bag ports, and syringes. The cleaning process performed by the PSS 300 may be used alone or in combination with one or more other cleaning processes, such as wiping with alcohol.

  The PSS 300 may be used to perform an operation to purify an object placed in the PSS chamber. In this example, PSS 300 includes an ultraviolet (UV) lamp 305, a lamp housing 310, a baffle 315, and a chamber wall 320. Chamber wall 320 may substantially reflect and / or absorb radiation such that UV radiation 325 from UV lamp 305 is substantially contained within the PSS chamber. UV radiation 325 from the UV lamp 305 may illuminate an object 330 located in the PSS chamber. In this example, object 330 is a drug vial positioned to be exposed to UV radiation 325 by manipulator 335. The manipulator 335 may be a robot gripper.

  3A-3C show a single chamber embodiment in which the lamp housing 310 and UV lamp 305 are mounted above the object 330 and the UV radiation 325 is directed downward. In another embodiment, the one or more UV radiation sources may be guided upward and / or from the side, alone or in combination with a UV lamp 305 guided downward. An exemplary UV radiation source for lamp 305 is a xenon lamp. The light aperture size in the baffle 315 may be suitable for the object to be purified. The object 330 may be presented to the UV irradiation source mechanically or by a robotic mechanism.

  The PSS 300 of FIG. 3A includes baffles 315 arranged to form a gap that allows light to pass over the object 330. The PSS 300 of FIG. 3B includes a baffle 315 arranged to provide a substantially cylindrical or tubular vertically oriented tubular structure through which the object 330 is illuminated. The baffle 315 may have a reflective surface. The PSS 300 of FIG. 3C includes a baffle 315 arranged to form a partial conical surface with an aperture that directs substantially all light to an object 330 placed near the aperture. Other similar arrangements of baffle configurations can be used to direct a significant percentage of the light entering the PSS chamber to an object located near one or more apertures, such as the apertures of FIGS. Good. 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 rotatable carousel that can be repositioned (eg, by an actuator motor) and the most effective baffle is positioned to illuminate the size, type, and / or shape of the object .

  The PSS 300 may be adapted for incorporation into the APAS cell 100 for use in a hospital dispensing department or similar environment, or may be configured for stand-alone (eg, table top, self-supporting) operation. Information for identifying a medical container (eg, content, shape, and / or size) may be received by a controller from a drug prescription database. In an environment such as hospital dispensing, dispensing staff prepares a prescription by using an expansion tool (e.g., tongs) to grasp the object to be cleaned and place it in a PSS chamber for cleaning. May be. Location features (not shown) may be included to assist the dispensing staff in positioning the object at the correct location within the PSS chamber.

  4A-4C show cross-sectional views of an example PSS 400 that receives objects of various sizes to be cleaned. In FIG. 4A, object 405 is a large vial, in FIG. 4B object 405 is a small vial, and in FIG. 4C, object 405 is an IV bag. In each example, the manipulator 410 may move along a trajectory suitable for positioning the object at a location suitable for being cleaned within the PSS chamber 400. In FIG. 4C, the IV bag 405 may be bent to position, for example, within the PSS chamber 400 (e.g., when empty), so that the IV bag port 415 is (e.g., manually or automatically fluid transfer operation). Can be cleaned prior to physical contact with the syringe.

  Thus, the object to be cleaned need not provide a primary light seal. Chamber wall 420, in combination with manipulator 410, may provide effective light containment. Chamber wall 420 may further include features such as baffles 425, reflective surfaces, and / or absorbing surfaces to minimize UV radiation leaking from SS chamber 400.

  In one example of PSS, the wall may substantially enclose the chamber, with at least one wall having a gap for receiving a medical container and a portion of the transfer mechanism. FIG. 5 shows one exemplary embodiment of an encapsulated PSS500. In the case of a stand-alone system, the vial 560 to be cleaned can be placed on the spring loaded platen 570 by either a robotic or manual method. Seal assembly 540 is pushed up by spring platen 570 through vial 560 to form a seal with pressure chamber 530. The pressure chamber 530 can substantially form a pressurized seal between the vial port and the seal assembly by reducing the pressure in the chamber and providing a substantially vacuum. In some examples, the pressure chamber 530 is evacuated to promote a tight light seal. In various aspects, the pressure chamber meets a predetermined criteria (e.g., at least maintained at a minimum threshold vacuum or a positive applied pressure level) by a measurement signal from a pressure sensor in the chamber. Therefore, if the vial port is not properly installed in the seal assembly 540 and if it is not It may be operated as an invalid interlock. The illustrated example shows a hinge seal assembly. Another variation may include a rotating carousel of seal assemblies or simply a single fixed seal assembly. The pressure chamber 530 may be at least partially encapsulated by the UV transmissive glass 520 or equivalent. The pressure / vacuum may be monitored in the chamber 530 to determine when to activate the UV source 510. Another criterion may be used to enable the UV source, such as a signal indicating that the door 550 is closed and radiation is substantially contained within the PSS 500.

  FIG. 6 shows an exemplary PSS 600 whose walls do not surround the item 660 to be cleaned. The seal assembly 640 is shown as a hinge seal assembly; another embodiment may include a rotating carousel of different seal assemblies or a single fixed seal assembly. A spring platen 670 can be used to push the vial 660 and seal assembly 640 upward and place them in the pressure chamber 630. On the other hand, the spring loaded platen 670 can be omitted and the manipulator or operator can hold the vial 660 in a position to place the seal assembly 640. In some other embodiments, the at least one seal assembly is an adjustable aperture (e.g., iris) to control the size, shape, and / or location of the predetermined area that is exposed to the radiation dose. ) Or providing a masking profile. When using a vacuum in the pressure chamber 630, the manipulator or operator may release the grip from the vial 660 while the cleaning process is being performed and utilize the vacuum to hold the vial 660 in place. If a vacuum is generated that indicates a proper seal, the UV source 610 is enabled and the dose is delivered through the UV transparent glass 620 to the port of the vial 660.

  FIG. 7 shows an exemplary PSS 700 that includes a gripper and a motion axis. In this example, the operator (if manual) or robot places the vial 760 on the platen 770. The gripper 790 is pushed down by the electric slide 780 and the vial 760 is taken by the grip finger 795. The vial 760 is then lifted to a seal assembly 740 that is installed relative to the pressure chamber 730. A secondary light barrier such as baffle 750 may be used. If a pressure / vacuum is generated that indicates a proper seal, the UV source 710 is activated and the dose is delivered through the UV transparent glass 720 to the port of the vial 760.

  Depending on the safety environment, UV energy containment may not be required. For example, some products (eg, sterile water bags) may not be affected by UV light exposure. For example, if personnel safety is provided in terms of sufficient UV containment by cell walls and doors, cleaning in an encapsulated setting may not be necessary. If the operating environment allows a reduction in light containment specifications, a simplified operating trajectory may reduce processing and / or transport time, thereby increasing throughput for manual or automated cleaning processes. The In some embodiments, one or more optical sensors are installed in and around the PSS, from around the light seal, through a medical container, or otherwise a predetermined source as a radiation source. The presence and / or intensity of “leaked” radiation that may leak from the main optical path between the regions may be detected. The control device may monitor such sensors and take some corrective action if the detected leak exceeds a predetermined level. Examples of corrective actions include generating notification signals (eg, electronic messages to operators, warning lights, or the like), disabling sources, or, for example, sealing with medical containers being processed Examples include, but are not limited to, attempts to reconfigure the light seal assembly by selecting different light seals that may provide improved engagement. In this way, the best available light seal for any (possibly unrecognized) medical container is determined and recorded in the data store for use in future operations based on leak sensor feedback. May be.

  Figures 8A and 8B show an exemplary IV bag and drug vial clarification, respectively. In FIG. 8A, a robot (not shown) grabs an IV bag 810 using a robot finger 805 from a previous station (eg, an IV bag scale or rack) and transports the bag 810 to the PSS. The robot then places the bag port 815 in close proximity to the UV source 820. Light or laser emitter 830 and detector 832 are used to detect the presence or absence of a bag port. Emitter 830 emits a light or laser beam that can be detected by detector 832. When the bag port is placed between the emitter 830 and the detector 832, the beam is interrupted, which then sends a signal to a controller (not shown) to enable the UV source 820. When the robot places the bag port 815 in the correct position, the beam emitted by the port 815 is interrupted, allowing the UV source 820 to illuminate the portion of the port that is to be cleaned. After the required dose is provided, the robot moves the bag 810 to the next station, which can be any scale, temporary holding station, or syringe manipulator.

  A shield / mask may be used to prevent UV from reaching the contents of the bag or leaking into the cell. In the case of a bag, UV exposure may not be a problem if there is no drug in the bag. UV leakage to the surrounding chamber or environment may be controlled by the shape of the robot finger 805 that can cover a small gap and / or a majority of the gap. The surface of a robot or actuator that may be exposed to UV radiation may be treated to facilitate controlled reflection, absorption, diffusion, or other combinations thereof.

  In one implementation, a flexible mask with slits is used. The robot pushes the bag port through the slit so that the mask is located between the upper and lower protrusions of the robot finger 805. This effectively seals the entire lower portion of the optical path, while the path between the robot finger and the assembly surface directly above (emitter 830 is seated) remains open.

  In FIG. 8B, a suitable movable aperture seal assembly 840 is moved and aligned based on the identification information about the drug vial 812 to be cleaned. The movable seal assembly 840 has some vertical compliance and stops just below the two mating surfaces 850 when aligned. The two mating surfaces 850 may be two machined surfaces. Robot (not shown) grabs vial 812 from previous station (e.g. vial weighing station or rack, container cover / seal removal station, or the like) using robot finger 805 and seals vial 812 directly Convey under assembly 840. The robot then moves the vial 812 upward, deforms the flexible mask 860, and brings the movable seal assembly 840 into contact with the mating surface 850. A vacuum port (not shown) is used to draw air from the chamber created as a result of the seal assembly 840 contacting the mating surface 850. A pressure sensor (not shown) is used to measure the pressure inside the chamber. When the pressure is reduced to a defined level, the vial 812 is in the correct position, resulting in a substantial light seal. An o-ring or other gasket-type material may be used with the mating surface to improve the light seal. The UV source 820 is then enabled so that the portion of the vial port 817 to be cleaned is illuminated. After the required dose is provided, the robot moves the vial 812 to the next station, which can be a scale, temporary holding station, or syringe manipulator. In one implementation, a light seal may be provided by placing a cover over the drug vial to be cleaned.

  Some aspects of the PSS chamber may be customized for a particular area to be cleaned of an object, taking into account requirements such as: object access requirements for the light source, object size, light containment, and from the light source The distance of the object.

  In various aspects, the sealing system or method may be designed so that it does not contact the area to be cleaned of the stopper or fluid transfer port. This can help protect the area to be cleaned from both microbial and drug cross contamination. Referring to FIGS. 9A and 9B, the aperture seal assemblies 910a-f are designed to incorporate chamfer guides 920a-f to aid engagement. In order to engage an item (eg, a vial) to be cleaned, an operator (if manually) or a robot places the item in the center of the opening 930. If the position of the item at the time of insertion is too far, it is considered not to engage. The size of the opening 930 is configured to be larger than the size of the area to be cleaned, so that when engaged, the area to be cleaned is not touched and complete exposure of the area to be cleaned is achieved. It is thought that it will be secured. Proper engagement provides a seal between the pressure chamber (not shown) and the seal assembly 910. The seal assemblies 910a-f can be removed and / or replaced from the rotating or stationary carousel 900.

  In some embodiments, a rigid, semi-rigid, or flexible gasket 940 (e.g., rubber, foam, plastic, or flexible UV blocking or reflecting material) may be formed around the aperture 930. Good. When purifying the fluid port of a vial or IV bag, the dispensing operator or the robot arm in the APAS cell may locate the fluid port to be cleaned close to the opening 930, so that the gasket 940 is a vial. Or form a substantial light seal interface with the body of the IV bag. The opening 930 may provide a substantially UV transmissive window through which one or more surfaces on the fluid port may be exposed to ultraviolet radiation.

  Open gaskets 940a-f generally include, but are not limited to, materials that are compliant with forming a seal (eg, silicone rubber). Such materials may also be selected and screened to provide suitable resistance to heat and UV exposure in applicable embodiments of PSS. One embodiment includes several gasket openings 930a-f (see FIGS. 9A and 9B) that combine to cover a wide range of vial seal / stopper diameters. Each opening 930 may address a sub-range of vial top size. Sealing is accomplished on the outer edge of the metal portion on the top of the vial, removed from the central stopper or port puncture area. These openings 930a-f may be at fixed locations or may be indexed by various means at fixed interface locations. Guide features may also be incorporated to guide the progression of the item to be cleaned into the exposure opening. Seal quality is checked before and during exposure by monitoring pressure / vacuum in a pressure chamber (not shown).

  Instead of, or in combination with, a flexible boot, some embodiments may provide a receptacle 910f for receiving a fluid port proximate to a UV exposure port. The receptacle 910f may be sized to receive one or more size and style fluid ports for the IV bag and one or more size and style fluid ports for the vial. The concavely open receptacle 910f 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 exchanged to accommodate a wide range of items to be cleaned. Different receptacles may have mounting pins, rotation and / or sliding features to hold the receptacle used. An interlock feature may be incorporated into each receptacle. For example, proximity or pressure sensors are used to determine when the receptacle is properly installed and an appropriately sized vial or IV bag fluid port is inserted or pushed into the receptacle to be exposed to ultraviolet radiation. May be.

  In some aspects, the automatic transfer mechanism may provide at least a partial light seal around at least a portion of the gap on the PSS chamber wall. For example, the manipulator may provide a thin (e.g., pencil-like) expansion device that extends the reach of the manipulator through a reduced (e.g., narrower) slot in a narrow portion of the gap within the PSS chamber housing. May be adapted. A buffing ring may be provided on the expansion portion of such an expansion device or manipulator itself, and either an internal or external light seal may be provided around some or all of the gap in the PSS chamber housing. For example, a flexible rectangular buffing (e.g., plastic, rubber, or foam with a reflective or absorbing coating) may be used, and the object in the PSS chamber housing when the object is positioned to receive UV radiation. A substantial UV light seal is provided over some or all of the narrow and / or wide gaps.

  In some aspects, the object to be cleaned may provide an effective light seal. The baffle design shown in FIGS. 3B-3C may be such that it effectively seals the gap in the baffle when an object is substantially in contact with the baffle. The baffle design may also be adapted to provide some tolerance in the positioning of the object relative to the baffle (eg, a flexible baffle material, a baffle assembly with a spring mounted, or a bellows). The gap in the baffle may be sized to maximize the amount of UV irradiation on the target area to be cleaned.

  In some embodiments, for example, the UV source may be cooled, the sealing material and their mounting structure may be cooled, the object to be cleaned may be cooled, and / or generated by some UV source. A cooling and venting system may be included to remove certain ozone gases.

  A typical implementation for cooling and venting may be applied using pipe suction from the APAS exhaust fan plenum, and cooling air may be drawn from the PSS as needed, at the same time. If a new APAS cell has vented exhaust, ozone can be vented. Another aspect may utilize a local fan to provide cooling air, drawing air from the clean cell and providing cooling. This air can flow back into the cell or be sent to a local exhaust air duct. In yet another aspect, both exhaust suction and local fans may be combined to provide increased air flow and / or ozone capture. In yet another embodiment, cooling air can be obtained directly from the HEPA filter fan filter unit. In one implementation, a combination of conduction and convective heat transfer mechanisms are used to manage the heat load of the UV source. For any of these runs, an ozone catalyst may be placed in the air stream to reduce the amount of ozone that is generated and recirculated. In one example, the catalyst may be localized in the PSS housing to reduce its size and immediately reduce the ozone level. A catalyst may be placed along the exhaust filter to clean the ozone repeatedly and / or when the cell operates in recirculation mode. In some embodiments, incoming air may be filtered to prevent particles from reaching the object to be purified. The filtered air may also prevent particles from coming into contact with the UV lamp, which increases bulb life and efficiency. In some cases, the PSS may be designed to be applied within an APAS cell ISO class 5 clean air environment.

  FIG. 10 is a block diagram of the control module 1000 of the exemplary PSS 300 of FIGS. In an exemplary embodiment, the PSS 300 described herein may include a PSS chamber, a UV lamp assembly, and a control module 1000. The control module 1000 also includes a processing unit 1005, a COM port 1010, one or more sensors 1015, a device 1020 for operating an air handling system, an input / output (I / O) port 1025, and a power supply 1030. Good. The processing unit 1005 can be used to supervise, monitor and control operations according to program instructions and / or hardware configurations (eg, analog, digital, PAL, and / or ASIC circuits). Sensors 1015 include, but are not limited to, temperature, smoke, contaminants, vibration, position, and light intensity sensors. The I / O port 1025 can be used to receive and send signals to sensors 1015 and / or actuators (eg, motors, UV lamps) within the PSS 300. In some aspects, the control module 1000 may send and / or receive status information and control information to or from the host computer or control device via the COM port 1010. COM port 1010 may be serial or parallel and uses packet or non-packet based communication protocols (e.g., RS-232, USB, firewire) to receive and / or send signals to the main controller May be. An example of a device for operating the air handling system 1020 is described with respect to FIG. 22 of US patent application Ser. No. 11 / 389,995 entitled “Automated Pharmacy Admixture System” filed by Eliuk et al. The entire disclosure of which is incorporated herein by reference. The elements in the control module 1000 can be combined to operate the PSS 300 to clean objects in pharmaceutical applications. In some aspects, a user interface 1035 may be included. A stand-alone device is an example in which a user interface 1035 is included.

  The PSS may use system information available to the APAS controller, for example, to optimize the UV purification process. For example, the APAS cell 100 may include a control module 1000, as shown with reference to FIG. 10, whereby control information (e.g., indicating the next object to be purified) is communicated via the COM port 1010. The operations that can be transferred to the PSS 300 are controlled. Such control information may include optimal waveform, amplitude, pulse repetition rate and rate, object size, type, and / or shape related information. The controller in the PSS 300 may generate a purification profile that is tuned to purify the next object in response by configuring the power supply 1030 and trigger control. Such optimization does not produce unnecessary heat, consumes unnecessary energy, does not prematurely degrade flash elements, or introduces unnecessary delays into the purification process. Cleanup is promoted. In some embodiments, the robotic arm may not be able to perform other tasks during the UV cleaning process. In another aspect, the robotic arm may release the object, perform one or more other actions, and return to grasp and carry the object after cleaning is complete.

  In response to the initiation signal, a dose of ultraviolet radiation may be delivered. The dose may be a specific intensity, duty cycle, repetition rate (eg, fixed or variable), and number of pulses, or total energy, according to a preprogrammed instruction set. The start signal may be generated by a switch that is pressed when the body of the object is pushed into the boot, or a proximity sensor (e.g., a light sensor, a Hall effect sensor to detect a robot arm, or the like) A fluid port or other relevant feature in the appropriate position, a signal generated by a controller or another switch (which may be manually pressed), or a combination of such or other such detection techniques To detect.

  In some implementations, a UV light sensor may be provided to measure the intensity of the UV light and monitor the sufficiency of the light pulse. Sensors may be used to monitor the condition of the bulb and the intensity of the emission and / or flash. This monitoring may be performed during normal use and / or as part of a regular maintenance schedule. The sensor may be monitored as well to confirm that the appropriate amount of light has been delivered. For example, if the processing unit determines that the UV waveform does not meet the average minimum threshold across multiple pulses, the processing unit may generate a defect signal for the COM port 1010. In some aspects, the sensor may measure the approximate total energy delivered and send feedback information to the controller. The controller may enable the UV output until a predetermined energy threshold is delivered. In addition, the sensor can be used as part of a regular (e.g. daily) self-diagnostic routine that alerts the operator that radiation from the UV source has decreased, which causes this source to fail. Can be replaced before. In some embodiments, a small amount of UV energy is collected using a mirror or other reflective or partially reflective medium. This allows the use of sensors with lower energy handling capabilities to monitor the total output from the UV source.

  In some embodiments, sensors (eg, light, proximity, contact, or vacuum / pressure) may be included in the PSS chamber to monitor the position or proximity of objects exposed to UV radiation. The sensor may also be used to monitor the position or proximity of items that are displaced due to the presence of an object (eg, a switch) with respect to the bulb. The sensor may provide an interlock so that if the object is not in the correct position, the bulb output cannot be enabled. The sensor may also be used to monitor airflow and terminate the system if insufficient airflow is detected. The bulb or bulb / lamp / LED may have temperature and air flow monitoring.

  In various examples, interlocks advantageously provide enhanced operator safety in APAS cell and PSS independent aspects, proper and reliable operation of PSS, and / or protection from damage and misuse of PSS equipment. May be. For example, an interlock may be provided to disable the light source until a part of the object is in the PSS chamber so that a substantially complete light seal is formed and substantially no light leaks Good. Suitable interlocks include light source temperature monitoring, doors on PSS and / or APAS cells, light leak detection, vacuum seals, air flow, position sensors, ozone level monitoring, and lasers. It is not limited.

  In manual operation, some aspects may include a feedback signal to indicate to the operator that the UV profile has been completed or that the item to be cleaned has been exposed to a selected dose of UV. In some embodiments, the display may indicate the exposure level based on, for example, time, number of pulses delivered, or total energy delivered. In some aspects, the operator may control the exposure level based on how long the item is pushed into the boot.

  In the exemplary embodiment, the PSS operates as follows. Automatic transfer mechanisms, such as robotic arms, take medical containers (eg, drug vials or IV bags) out of stock. From multiple radiation seal assemblies that cover medical containers having different sizes and shapes, the controller of the PSS system can determine which radiation seal assembly has been removed based on the size and / or shape of the medical container or the like. Decide whether it corresponds to the container. The robot arm can then present the medical container to the PSS ultraviolet light source by engaging the medical container with a corresponding radiation seal assembly. Alternatively, the robotic arm can place the medical container on the holding device, which can then be actuated to connect the medical container and the corresponding radiation assembly in proximity to the UV source. The controller then commands the UV light source to emit UV light at the required intensity for the required duration and either in a pulsed or continuous waveform, exposed fluid transfer port (e.g., drug vial The desired effect of cleaning the seal / stopper or port, or IV bag injection port) is achieved. If the item to be cleaned cannot be exposed to the emission spectrum (e.g., UV light may affect the drug contained in the vial), the sealing / containment system or method will allow the drug or IV fluid container and / or Or the contents may be exposed to substantially reduced UV light, or not exposed to UV light, as required. If the item to be cleaned is not affected by exposure to UV light, the sealing / containment system or method may be designed to limit exposure to the operator only, or the possibility of exposure If a product is allowed, it may not be included at all. A cooling, purging, and / or venting system keeps the PSS and items to be cleaned cool, and controls the accumulation of ozone gas, if any, if any. The control system controls all aspects of PSS operation. Monitoring on the system confirms that the correct UV exposure was produced and that the target was in the correct place to receive the dose. Interlocks and safety mechanisms ensure that the UV source will not work unless appropriate safety protections or conditions are in place. Even if the PSS cleans selected surfaces (e.g., drug vial ports and IV bag ports) using ultraviolet (UV) light, fluid transfer operations may be performed through the cleaned fluid transfer port. Good.

  Some embodiments may provide one or more other features. For example, in conjunction with features such as interlocks, sensors, etc., the purification process may be initiated by user input (eg, by touching a button or other trigger device). There may be audible and / or visual indications to signal the operator or to inform progress. The operator may have settings that can be used for things such as exposure time, port size, and vial height, for example.

  11A-11F show cross-sectional views of an example PSS 1100 in the APAS cell 100 of FIG. The PSS 1100 can use a rotating platen 1105 with upright vertical walls 1110 to position the object 1115 to be cleaned. Except as noted or otherwise not applicable, the above description regarding aspects of PSS 300 is generally applicable to aspects of PSS 1100. For example, the PSS 300 may operate using a control module, an example of which is described above with reference to FIG.

  An object 1115 to be cleaned is loaded onto a platen 1105 outside the PSS chamber. Using a suitable drive mechanism (e.g., a stepper motor, servo motor, mechanical linkage coupled to a solenoid), the platen 1105 is rotated to position the object 1115 inside the PSS chamber, where the object is UV Exposure to irradiation 1120 can be made. The vertical wall 1110 serves as a baffle and substantially provides a light seal to the chamber where most of the UV radiation 1120 may not leak. In some aspects, using a sensor (e.g., an encoder on a platen axis, an indicator mark using a Hall effect sensor, an optical interrupter, etc.), when the platen 1105 is in place for loading or pulsing, Alternatively, it may be detected when the wall 1110 is in the sealing position. While positioned within the chamber, the object 1115 may receive a dose of UV irradiation, as described. The platen 1105 then rotates to position the object 1115 (a portion of which may be substantially cleaned) outside the PSS chamber, where the object may be recovered for further processing.

  The PSS 1100 may be adapted to be incorporated into the APAS cell 100, or may be configured for stand-alone (eg, table top) operation for use in a hospital dispensing department or similar environment. In an environment such as a hospital dispensing department, the dispensing staff prepares a prescription by loading one or more objects to be cleaned onto the platen 1105, performs the cleaning, and the platen 1105 rotates the objects to rotate the chamber. After leaving, the purified object may be recovered for further processing. Information (e.g., size, shape, type) indicating the form of the medical container may be requested and / or obtained from a dispensing computer system, e.g., directly or via a network data channel, which may be wired and / or wireless. There may be. As is known in the art, various data transfers may include a packet of data and / or error detection and correction to ensure data integration.

  In some embodiments, the wall 1110 may further include a plurality of compartments (eg, 3, 4, 5, 6, 7, 8, or more) on the platen 1105. The walls may be evenly distributed, so that if any compartment is exposed to UV radiation 1120, a portion of wall 1110 is positioned to form a light seal.

  In another aspect, the platen 1105 may be a circular or non-circular track. It may be advanced substantially continuously or partially in accordance with the chamber. In some aspects, the platen 1105 may be advanced in response to a user command, such as from a keypad or a “start” button. In another aspect, the platen 1105 may advance upon detecting the weight of the object or objects being processed.

  Similar to that described with reference to FIGS. 3A-3C, the PSS 1100 may be configured to include another arrangement of baffles 1125, examples of which may be shown in FIGS. 11C, 11D, 11E, and 11F.

  Other modifications may be made to the PSS1000. For example, an exemplary embodiment of a PSS 1100 that includes a larger (or distributed) lamp system 1150 in combination with an exemplary embodiment of a baffle 1125 is shown in FIG. 12F. In this example, the UV radiation 1120 can be distributed over a larger area. The baffling 1125 and the reflective surface on the platen 1105 can provide a widely dispersed UV illumination pattern across the top and side surfaces of the object 1115b. Further, the platen 1105 carries two objects 1115a and 1115b. Object 1115b can be inside the PSS chamber and object 1115a can be outside the PSS chamber. The ability of this PSS system 1100 to carry multiple objects can facilitate efficient handling, for example, in hospital dispensing environments where UV purification processing time can affect productivity and throughput.

  In another aspect, the platen 1105 may be adapted to receive a tray of objects to be cleaned. For example, a tray of two or more vials to be cleaned may be placed on a portion of the platen 1105 that is outside the PSS chamber. The tray may include a transport handle for convenient placement and / or stacking of vials. Such trays may be prepared in advance and can then be batched efficiently, which saves time and effort to process the drug mixture.

  To assist in aseptic processing, the entire PSS 1100 may be designed for use in an ISO Class 5 clean air environment. Such an environment may exist, for example, in a containment cabinet in an APAS cell, or in a laminar airflow hood of a hospital dispensing department. If necessary, an air cooling system may be used to dissipate heat in the lamp housing 1170 or chamber 1175.

  In addition to the above examples, the UV purification system may be implemented using systems, methods, or computer program products other than those described above.

  In various aspects, the PSS system may communicate using suitable communication methods, equipment, and techniques. For example, the PSS control module may communicate with the APAS control unit and / or the hospital dispensing department network using point-to-point communication, where a dedicated physical link (e.g., fiber optic link, The message is transmitted directly from the source to the receiver via a point-to-point wiring (daisy chain). Other aspects may transport messages, for example, by delivering to all or substantially all devices coupled together to a communication network.

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

  In one aspect, an automated purification system for a dispensing environment for killing or disabling biological contaminants may provide one or more objects to be purified. The system can include a chamber with a pulsed or constant waveform UV source. The system can further include an automatic transport mechanism and can be placed in a chamber for exposing the object to be cleaned to ultraviolet radiation from a UV source.

  In various aspects, the automated transport mechanism may further remove the object from the chamber after exposure to 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 enclose the chamber, with at least one wall having a gap for receiving a part of the object and the transport mechanism. In some aspects, the automated transport mechanism may provide at least a partial light seal around at least a portion of the gap.

  The UV source may provide UV irradiation in response to the trigger signal. The controller may generate one or more pulses or timed constant waves 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 or constant waves according to the selected cleaning routine. The selected cleaning routine may correspond to characteristics such as the type, size, or manufacturer of the object to be cleaned. The controller may receive the message over a communication link, and the message may include information about the characteristics of the object to be cleaned.

  The object to be cleaned may include a vial, IV bag, or part of a syringe. Biological contaminants to be killed or incapacitated include one or more viruses, bacteria, and / or fungi. Ultraviolet radiation may include UV-A, UV-B, and / or UV-C wavelengths. Some embodiments may expose the fluid transfer port to be cleaned to a combined dose of both continuous and pulsed radiation for a predetermined period of time.

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

  In another aspect, a method for cleaning at least one object surface may include generating an operational trajectory command for a transport mechanism to place an object in a chamber. The method may also include exposing at least a portion of the object to a dose of ultraviolet radiation.

  In some embodiments, the dose of ultraviolet radiation may include one or more pulses or timed constant waves. The method may further comprise identifying a number of pulses or constant waves of ultraviolet radiation sufficient to kill or disable the one or more types of biological contaminants to a selected degree. The selected degree is substantially all biological contaminants, e.g., at least 99.9999%, 99.99%, 99%, 95%, 90%, 80%, 75%, 70%, 60%, or at least about 50% It is good. In some embodiments, between 1-100% of certain biological contaminants can be killed or substantially disabled by the dose of ultraviolet radiation.

  A fluid transfer operation may be performed after the PSS uses ultraviolet (UV) light to clean selected surfaces (eg, drug vial port, IV bag port, and syringe). FIG. 12 shows an example of an apparatus 1200 for performing a fluid transfer operation. An exemplary aspect of a similar syringe manipulator device is shown, for example, in FIG. 7 in US Patent Application No. 11 / 937,846 entitled “Control of Fluid Transfer Operations” filed by Doherty et al. On November 9, 2007. The entire contents of which are incorporated herein by reference. In some implementations, the protective cover 1202 in an uncontrolled position does not contaminate selected surfaces (e.g., the needle 1204) or the needle 1204 is inserted into the desired fluid port during fluid transfer operations. Care should be taken not to disturb it. The protective cover 1202 covers the first fluid transfer port 1206 of the container 1208. Container 1208 similarly includes a second fluid transfer port 1210. In one example, the fluid transfer operation is performed using the second fluid transfer port 1210 of the container 1208.

  Container 1208 is held by container manipulator 1212. The container manipulator 1212 can move horizontally and vertically, and special containers and fluid transfer ports can be aligned with the needle 1204.

  In an illustrative example, withdrawal from a vial may be performed as described below. Initially, the syringe plunger may be positioned such that a predetermined amount of air is drawn into the syringe barrel. This amount may be determined based on the required fluid volume of the formulation (first pull). With a predetermined amount of air, that volume of fluid that is withdrawn is exchanged for approximately equal volumes of air. Therefore, when drawing out 10 ml of fluid, 10 ml of air can be pushed in and replaced. During this process, the system may estimate or monitor the “headspace” in the vial. In preferred embodiments, the method may maintain a slightly 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, a negative pressure can occur. This can be limited so as not to pull beyond 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 volume of fluid removed. Fourth, the syringe plunger can again be retracted to an amount approximately equal to the amount of air poured 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 cycling, the volume in the syringe can be substantially comparable to the amount of withdrawal required, and there may be a slight negative pressure in the vial.

  In a case example, the withdrawal from the IV bag may be performed as follows. The IV bag may be suspended by its inlet on the indexer of the needle down syringe manipulator station. The indexer then moves the IV bag to a position below the needle of the syringe. The IV bag port then engages the syringe needle. The syringe plunger may be withdrawn so that air exits the IV bag and is drawn into the syringe. For example, a syringe plunger may be pulled for some additional time to provide a margin for withdrawal until a change in torque is detected, so that a small amount of fluid is drawn, and The IV bag is negatively pressurized relative to ambient pressure. The indexer then lowers the IV bag.

  Similar to the withdrawal from the vial or IV bag described above, one skilled in the art will readily recognize that dispensing into a vial or IV bag can also be performed.

  A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope. For example, the steps of the disclosed technology are performed in a different order, the components in the disclosed system are combined in a different manner, or the component is replaced with another component, or the component has a different configuration Favorable results may be achieved when replenishing elements. 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. . Accordingly, other implementations are within the scope of the following disclosure.

Claims (57)

A chamber;
An automated system for transporting medical containers within the chamber;
A compounding system placed in a chamber for transferring a medicinal agent between medical containers;
A purification system for substantially reducing biological activity at at least a portion of a fluid transfer port of a medical container,
At least one radiation source for supplying a dose of radiation;
A plurality of radiation seal assemblies, each radiation seal assembly having an opening and configured to engage a fluid transfer port of a medical container having a special shape;
A controller for determining which radiation seal assembly corresponds to the fluid transfer port to be cleaned;
A system for automating drug formulation comprising: a purification system comprising: an actuator for optically communicating a portion of a fluid transfer port to be cleaned with a radiation source through an opening in a determined radiation seal assembly.   The system of claim 1, further comprising a control system for adjusting the pressure in the chamber.   The system of claim 1, wherein the radiation source comprises an ultraviolet (UV) source.   4. The system of claim 3, wherein the UV source is configured to provide a dose of UV radiation that substantially includes a pulse waveform.   4. The system of claim 3, wherein the UV source is configured to provide a dose of UV radiation that includes a substantially constant waveform.   4. The system of claim 3, wherein the UV source is configured to maintain a predetermined profile of UV output through calibration.   4. The system of claim 3, wherein the UV source is configured to maintain a predetermined profile of UV output with closed loop control.   The system of claim 1, wherein the purification system further comprises at least one optical conduit configured to transmit radiation from the radiation source to a portion of the fluid transfer port to be purified.   The system of claim 1, wherein each radiation seal assembly is configured not to contact a portion of the fluid transfer port to be cleaned.   The system of claim 1, wherein the at least one radiation seal assembly includes a gasket formed around the opening.   11. The system of claim 10, wherein the radiation seal assembly further comprises a chamfer guide that facilitates engagement between the fluid port to be cleaned and the gasket.   The system of claim 10, wherein the gasket comprises a flexible UV blocking material.   11. The system of claim 10, wherein the purification system further comprises a pressure chamber configured to substantially form a light seal between the fluid transfer port to be cleaned and the gasket.   The system of claim 1, wherein the purification system further comprises an interlock for determining whether the radiation source can be activated to provide a dose of radiation.   The system of claim 1, further comprising a fluid transfer system capable of transferring fluid through the purified portion of the fluid transfer port.   The system of claim 1, wherein the medical container to be cleaned comprises a drug vial.   The system of claim 1, wherein the medical container to be cleaned comprises an IV bag.   The system of claim 1, wherein the medical container to be cleaned comprises a syringe.   The system of claim 1, wherein the interior of the chamber is substantially sterile.   21. The system of claim 19, wherein the interior of the chamber meets ISO Class 5 clean room standards.   The system of claim 1, wherein the purification system substantially disinfects the portion of the fluid transfer port to be purified.   24. The system of claim 21, wherein the purification system substantially sterilizes the portion of the fluid transfer port to be purified. At least one radiation source for supplying a dose of radiation;
A plurality of radiation seal assemblies, each radiation seal assembly having an opening and configured to engage a fluid transfer port of a medical container having a special shape;
A fluid transfer port of a medical container including an actuator that optically communicates a portion of the fluid transfer port with a radiation source through an opening in the radiation seal assembly determined to correspond to the fluid transport to be cleaned. A purification system for substantially reducing biological activity, at least in part.   24. A purification system according to claim 23, further comprising a controller for determining which radiation seal assembly corresponds to a fluid transfer port to be purified.   24. A purification system according to claim 23, wherein the radiation source comprises an ultraviolet (UV) source.   26. A purification system according to claim 25, wherein the UV source is configured to provide a dose of UV radiation substantially comprising a pulse waveform.   26. A purification system according to claim 25, wherein the UV source is configured to provide a dose of UV radiation comprising a substantially constant waveform.   26. A purification system according to claim 25, wherein the UV source is configured to maintain a predetermined profile of UV output by calibration.   26. A purification system according to claim 25, wherein the UV source is configured to maintain a predetermined profile of UV output with closed loop control.   24. A purification system according to claim 23, further comprising at least one optical conduit configured to transmit radiation from a radiation source to a portion of the fluid transfer port to be purified.   24. A purification system according to claim 23, wherein each radiation seal assembly is configured not to contact a portion of the fluid transfer port to be purified.   24. A purification system according to claim 23, wherein the at least one radiation seal assembly includes a gasket formed around the opening.   33. A purification system according to claim 32, wherein the radiation seal assembly further comprises a chamfer guide that facilitates engagement between the fluid port to be cleaned and the gasket.   33. A purification system according to claim 32, wherein the gasket comprises a flexible UV blocking material.   33. A purification system according to claim 32, further comprising a pressure chamber configured to substantially form a light seal between the fluid transfer port to be purified and the gasket.   24. A purification system according to claim 23, further comprising an interlock for determining whether the radiation source can be activated to provide a dose of radiation.   24. A purification system according to claim 23, wherein the medical container to be purified comprises a drug vial.   24. A purification system according to claim 23, wherein the medical container to be purified comprises an IV bag.   24. A purification system according to claim 23, wherein the medical container to be purified comprises a syringe.   24. The purification system of claim 23, further comprising a pressure control chamber that substantially includes a radiation source, a plurality of radiation seal assemblies, and an actuator.   41. A purification system according to claim 40, wherein the interior of the pressure control chamber is substantially sterile.   41. The purification system of claim 40, wherein the interior of the pressure control chamber meets ISO Class 5 clean room standards.   24. A purification system according to claim 23, wherein the control device is coupled to receive identification information about the medical container from the drug prescription database.   24. A purification system according to claim 23, which substantially disinfects the portion of the fluid transfer port to be purified.   45. The system of claim 44, wherein the portion of the fluid transfer port that is to be purified is substantially sterilized. Providing a purification system having at least one radiation source and a plurality of radiation seal assemblies, each radiation seal assembly having an opening and having a special shape in a fluid transfer port of a medical container A step configured to engage;
Removing the medical container to be purified;
Determining which radiation seal assembly corresponds to the medical container;
Engaging the medical container with the determined radiation seal assembly; and providing a predetermined dose of radiation from the radiation source to the portion of the fluid transfer port to be purified to substantially enhance the biological activity thereon. A method of substantially purifying at least a portion of a fluid transfer port of a medical container, comprising the step of reducing.   48. The method of claim 46, wherein the radiation source comprises an ultraviolet (UV) source.   48. The method of claim 46, wherein the step of removing the medical container includes activating an automatic transfer mechanism to substantially match the fluid transfer port to be cleaned with the determined radiation seal assembly.   48. The method of claim 46, wherein providing the predetermined dose comprises transmitting the dose through an optical conduit.   Engaging the medical container with the determined radiation seal assembly substantially forms a light seal using the pressure chamber between the medical container to be cleaned and the determined radiation seal assembly. 49. The method of claim 46, comprising:   48. The method of claim 46, wherein the medical container that is removed comprises a drug vial.   48. The method of claim 46, wherein the medical container that is removed comprises an IV bag.   48. The method of claim 46, wherein the medical container that is removed comprises a syringe.   48. The method of claim 46, further comprising transferring fluid through the purified portion of the fluid transfer port.   48. The method of claim 46, wherein each radiation seal assembly is configured not to contact a portion of the fluid transfer port to be cleaned.   48. The method of claim 46, wherein the step of purifying the portion of the fluid transfer port includes substantially disinfecting the portion of the fluid transfer port to be cleaned.   48. The method of claim 46, wherein the step of purifying the portion of the fluid transfer port comprises substantially sterilizing the portion of the fluid transfer port to be purified.

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