KR20120061763A - Automated aseptic liquid collection workstations and collection devices therefore - Google Patents

Abstract

PURPOSE: An automated aseptic liquid collecting workstation and a collecting device thereof are provided to automatically collect liquid products, to guarantee integrity, and to reduce errors by manually inputting data about the collected liquid. CONSTITUTION: An automated aseptic liquid collecting workstation(12) comprises a supply conduit, multiple production collecting containers(28), a water collecting container(30), and a valve block(32). The supply conduit is connected to a liquid production line. The production collecting containers respectively contain products. The waste collecting container contains waste. The valve block comprises multiple three-way valves and discharge ports. The number of three-way valves corresponds to the number of production collecting containers. The three-way valves are arranged in the supply conduit to circulate liquid in the production collecting containers with the others. The discharge ports circulate the liquid with the waste collecting container. The volume ratio of waste to production is less than 15:1.

Description

Automatic sterilization liquid recovery workstation and its recovery device {AUTOMATED ASEPTIC LIQUID COLLECTION WORKSTATIONS AND COLLECTION DEVICES THEREFORE}

This application is part of ongoing application of US application 12 / 959,647, filed Dec. 03, 2010, the entire contents of which are incorporated herein by reference.

The present invention relates to an automated sterilization liquid recovery workstation. More specifically, the present invention relates to a workstation used for the automatic recovery of liquids in the production process, as well as a recovery device for use with such automatic workstations.

The production of many liquid products can be performed in a sterile environment and / or a sterile environment to protect the product and / or production staff from contamination. Such liquid products may include, but are not necessarily limited to, pharmaceutical products (eg, drugs and vaccines), food products, biological products, biochemical products, chemical products, and combinations thereof.

It is known to recover the liquid during the production process. The recovered liquid can be used to sample or test the liquid product to ensure that the final product meets various acceptance criteria before, during and after a particular production process. The recovered liquid may also be a finished product, such as, but not necessarily limited to, a part recovered by centrifugation, or may be a pre-cursor of the finished product. The recovered liquid can also be recovered in any desired volume.

In some examples, recovery of the liquid may be performed during or after a particular production process and / or at certain time intervals. In another example, the recovery of the liquid may be performed after the product is made, but before one end of the produced product is released to the consumer.

It is important that the recovery of liquid from the production line is an important task and a potential risk of contamination of the product and / or sample. Unfortunately, the risk of contamination often limits producers to reduce liquid recovery time and / or limit the number of such liquid recovery sites.

In addition, withdrawal of the product testing the samples may result in false results that may undesirably delay the production process of the product until contamination of the sample establishes the cause of the breakdown and / or contamination of the undesirable product. can do. In addition, it is generally required to hard piped the sampling device to a specific location in the production line, requiring the cleaning or sterilization of the sample path before and / or after each batch, which is timely and Efficient ways can limit the flexibility of the production line to produce other products.

In addition, the container of recovered liquid must be appropriately identified by the operator and this identification information must be continuously entered by the department responsible for testing the sample or releasing the finished product. Manual identification of the recovered liquid container and manual entry of such identification have proven to be error prone, which can complicate proper testing and release of the product.

Accordingly, it is clear from this disclosure that there is a need for a workstation that can overcome, solve and / or mitigate one or more of the aforementioned and / or other detrimental effects in the prior art. For example, it is clear from this specification that a workstation is needed that can automate the recovery of liquid products, at the same time ensure integrity, reduce the risk of contamination, and reduce errors due to manual entry of data on recovered liquids. .

A liquid recovery device is provided. The liquid recovery device includes a supply conduit, a plurality of automatic product recovery containers, a waste recovery container, and a valve block. The feed conduit may be connected to a liquid production line. The plurality of product recovery containers each have a product and the waste recovery container waste. The valve block includes a plurality of three-way valves and outlets, the number of the plurality of three-way valves corresponding to the number of the plurality of product recovery containers, wherein each of the plurality of three-way valves has a supply conduit having a plurality of product recovery containers. Place it to distribute liquid to the other one. The discharge section distributes the liquid with the waste recovery container. In the liquid recovery device the waste to product has a volume ratio of 15: 1 or less.

An automatic liquid recovery workstation is provided. The workstation includes a processor, a peristaltic pump, a valve actuator, and an algorithm. The peristaltic pump and valve actuator are electrically connected to the processor. When disposed, the valve actuator can move the plurality of valves between the off position, the drain position, and the retract position. The algorithm is inherent in the processor and moves the plurality of valve modes to the off position when no return or drain is required, and places the pump in an off state, and when the drain is needed all of the plurality of valves. Move the pump to a drain position and position the pump for a predetermined drain time in the on state, and if a plurality of valves are needed, move the plurality of valves to the recovery position one by one and the one of the plurality of valves Each valve in the up direction of the valve is moved to a drain position, and the pump is positioned in the on state for a preset recovery time.

A method of automatically recovering a plurality of liquids from a production line is provided. The method comprises: cleaning a production line having a first half part of a two-part connector connected thereto; Liquid Recovery Device A supply conduit having a plurality of recovery vessels, a valve block, and a second half part of a two-part connector, a valve block having a supply, a plurality of three-way valves, and a discharge portion, wherein the plurality of three-way valves Corresponding to the number of the plurality of recovery vessels, each three-way valve disposed in the supply portion is in liquid circulation with the other of the plurality of recovery vessels, the outlet portion is in liquid circulation with the waste recovery vessel, the supply portion is 2 Connecting the second half part to the first part in a liquid recovery device of the part connector; Inserting a valve block into the valve actuator such that each handle of the plurality of valves can be moved by the valve actuator.

The method of automatically recovering a plurality of liquids from a production line also includes arranging the supply conduits of the liquid recovery device in fluid communication with the production line; Operatively connecting said supply conduit to a supply of a valve block having a peristaltic pump and a plurality of three-way valves; Operatively connecting the valve block to a valve actuator such that each of the plurality of three-way valves can be moved between an off position, a drain position, and a return position by different portions of the valve actuator; The peristaltic pump is configured to control the valve actuator to move all of the plurality of three-way valves to the drainage position and to pump liquid from a production line through the valve block to a waste container in fluid communication with the outlet of the valve block. Turning on; The valve actuator moves the specific valve of the plurality of three-way valves to the recovery position while the peristaltic pump is held, and moves all the valves upstream of the specific valve of the plurality of three-way valves to the drainage position. Control to move, and connecting the particular valve to a specific recovery vessel such that liquid from the production line is pumped to the specific recovery vessel via the valve block.

Other features and advantages of the present invention as mentioned above may be recognized and understood by those skilled in the art by the disclosure in the following detailed description and drawings.

1 is a front, top perspective view of a workstation according to an embodiment of the present invention;
2 is a front plan view of the workstation of FIG. 1;
3 is a top view of the workstation of FIG. 1 of FIG. 3;
4 is a front top perspective view of a recovery unit according to one embodiment of the workstation of FIG. 1;
5 is a perspective view of a liquid recovery set according to one embodiment of the present invention that may be used in the workstation of FIG. 1;
6 is a perspective view of a valve block according to one embodiment of the present invention for use in the liquid recovery set of FIG. 5;
7 is a flowchart showing a liquid recovery method according to an embodiment of the present invention;
8 is a flowchart showing a method for identifying a recovery apparatus according to an embodiment of the present invention; And
9A-9C illustrate a liquid recovery container and / or a waste recovery container in accordance with an alternative embodiment of the present invention for use with the liquid recovery set of FIG. 5.

Referring to the drawings, in particular in FIGS. 1 to 4, an automatic sterilizing liquid recovery workstation according to one embodiment of the present invention is shown and generally indicated by the numeral '10'. The workstation 10 is automatically configured for sterilization recovery processing, labeling, and storage, and in the liquid recovery apparatus 12 (see FIG. 5), is configured to perform a plurality of liquid recovery processing from the production line or the container A. do.

Workstation 10 is configured to automatically recover liquids such as, but not limited to, pharmaceutical products (eg, drugs and vaccines), food products, biological products, biochemical products, chemical products, and combinations thereof. The recovered liquid can be used as a sample, intermediate product, or finished product.

Preferably, workstation 10 is configured to be flexible, ie the workstation is configured to move from point to point and / or from one processing step to another in the production process. In addition, the workstation 10 is preferably suitable for use in a sterile or clean room environment, resulting in material selection (eg, stainless steel or other materials) and surface selection (eg, surface). Having material properties (such as surface finish) is sufficient for use in these conditions.

The workstation 10 comprises a cabinet 14 supported by a base or in some embodiments by a plurality of wheels or casters 16 so that the workstation is movable, if desired It can be located at various locations in the production facility.

The workstation 10 includes a recovery section 18 for pumping the pumped liquid to the recovery device 12. The retrieval section 18 includes a pump 20, a valve actuator 22, in some embodiments a liquid edge detector 24, and a plurality of liquid holding regions 26.

The pump 20 can be any desired pumping device. However, it is preferably a non-contact pump which can optionally draw the liquid without directly contacting the liquid itself. In a preferred embodiment, the pump 20 is a peristaltic pump.

The liquid edge detector 24 includes but is not limited to sonic, capacitance, or any other non-contact or contact sensor for detecting the presence and absence of liquid in one or more regions of the liquid recovery device 12. It may be any desired detector. The detector 24 may be electrically connected to the workstation 10 so as to detect whether the workstation is at a preset position in the liquid recovery device 12.

As shown in FIG. 5, the liquid recovery apparatus 12 includes a plurality of product recovery vessels 28 (six are shown), one or more waste containers 30 (only one is shown), and a valve block 32. ). The product containers 28 may be configured such that the volume of the product container is the same as the other and / or has a desired volume that is different from the other.

The product recovery container 28 and the waste container 30 may be, but are not limited to, a recovery container such as a recovery bag, as shown in FIG. 5. For example, the container 28,30 may be one hundred days recovery, such as commercially available Allegro ^TM 2 di bio container (Allegro ^TM Biocontainer 2D) from the arm Corporation (Pall Corporation). In this embodiment, each container 28, 30 is a supply line 29 sealed with a clamp 33, a discharge line 31 releasably sealed with a clamp 33, and a port 35. ).

Of course, it will be appreciated by the present invention that the containers 28, 30 may be, but are not limited to, a recovery bottle, a recovery box, a recovery syringe, and any other sterile recovery container.

In the illustrated embodiment, the liquid recovery device 12 includes, for example, five automatic product recovery containers 28 of the same volume on the order of approximately 50 milliliters (mL) and one of the larger volume on the order of about 500 ml. A manual recovery container 28. In addition, in the illustrated embodiment, the liquid recovery device 12 includes one waste container 30 of approximately 1,000 mL. Of course, it can be appreciated that the volume and number of containers 28 and 30 can be modified to any desired size.

The apparatus 12 further includes a supply conduit 34 configured to be disposed in the production line for liquid flow with the valve block 32.

Feed conduit 34 includes one or more flexible portions 36. The portion 36 can be configured to operate in conjunction with the pump 20 such that the pump can force the liquid into the containers 28, 30 of the liquid recovery device 12. In an embodiment the pump 20 is a peristaltic pump and the flexible portion 36 may be made of a material (eg, a silicone tube) with sufficient elasticity to be connected to and operate with the peristaltic pump.

It will be appreciated that the liquid recovery device 12 may be used with one or more two-part, sterile connectors 38. In the illustrated embodiment, the supply conduit 34 has only one part 38-1 of the two-part connector 38 connected thereto. The fastening part 38-2 for the two-part connector 38 of the supply conduit 36 is in liquid communication with the production line or vessel A.

In this way, the liquid recovery device 12 provides fluid to the production line or vessel by connecting half parts 38-1, 38-2 of the two-part connectors 38 to the other in the supply conduit and production line or vessel. Can be connected. In order to maintain sterility, the part 38-2 of the two-part connector coupled to the production line or vessel A may be sterilized or sanitized with the production line or vessel before production of the liquid.

Two-part connector 38 is not limited to eight but are Corporation (Pall Corporation) commercially available from Park Clean ^TM (Kleenpak ^TM) connector, Sato vitreous Ste dim Biotech Inc. (Sartorius Stedim Biotech), commercially available from opta ^® (Opta ^®) SFT-I connector, Millipore Corporation Springs commercially available from ^{(Millipore Corporation) ® (Lynx ®} ) ST connector, Calder Pro deokdeu Co. possible eosep tikwik using commercially from (Colder Products Corporation) ^TM (AseptiQuik Any disposable, two-part sterile connector can be used, such as a ^TM ) connector.

In some embodiments of liquid recovery apparatus 12, product recovery vessel 28, waste recovery vessel 30, and valve block 32 may be removably connected to the other. For example, the liquid recovery device 12 may include a plurality of connectors 39, such as but not limited to a Luer lock connector.

All product contact surfaces in the recovery device 12 may be made of any material that can hold or contact the liquid without interacting with or contaminating the liquid. In addition, recovery device 12 may be packaged through one or more external wrappings (not shown) and then sterilized using known sterilization methods such as, but not limited to, gamma irradiation. In this way, the recovery device 12 may remain sterile until ready for use.

The valve block 32, as shown in FIG. 6, includes a supply portion 40, a waste discharge portion 42, and a plurality of three-way valves 44 (shown in six). The supply portion 40 is in liquid circulation with the supply conduit 34 and the waste outlet 42 is in liquid circulation with the waste recovery container 30.

The plurality of three-way valves 44 corresponds to the number of the plurality of recovery vessels 28, and the discharge portion 46 is in fluid communication with the other recovery vessels 28 from each valve.

The three-way valve 44 rotates the valve handle 48 to each have three states: an "off" position; "Drainage" position; And a "recovery" position.

In the off position, each valve 44 prevents liquid from overflowing from the supply portion 40 to the waste discharge portion 42 or the discharge portion 46 through the valve. In the drainage position, each valve 44 may allow liquid to flow from the supply 40 through the valve to the waste outlet 42, but prevents it from flowing to its respective outlet 46. In the retracted position, each valve may allow liquid to flow from the supply portion 40 through the valve to the respective discharge portion 46 but prevent it from flowing to the waste discharge portion 42.

The handle 48 of each valve 44 is operatively coupled to another portion of the valve actuator 22 such that the valve actuator can optionally rotate each handle independently of the other one of the three positions. . In this way, the workstation 10, via the valve actuator 22, selectively bypasses the liquid from the production line or vessel to either the recovery vessel 28 or the waste vessel 30. Is formed to drive.

Referring to Table 1 below, the valves 44 may be provided in relative positions during various sampling operations that can be understood by the present invention.

Here, the plurality of valves 44 are continuously counted from the valves 44-1 to the valves 44-6 in the direction of the liquid flow and the recovery vessels 28 are the vessels (in the direction of the liquid flow). 28-1) to the container 28-6.

Valve status valve
(44-1) valve
(44-2) valve
(44-3) valve
(44-4) valve
(44-5) valve
(44-6) unused
off off off off off off Drain to waste container (30) Drainage Drainage Drainage Drainage Drainage Drainage Into the container (28-1)
bypass bypass off off off off off With container (28-2)
bypass Drainage bypass off off off off With container (28-3)
bypass Drainage Drainage bypass off off off Into the container (28-4)
bypass Drainage Drainage Drainage bypass off off With container (28-5)
bypass Drainage Drainage Drainage Drainage bypass off With container (28-6)
bypass Drainage Drainage Drainage Drainage Drainage bypass

Referring to Table 1 above, when the liquid recovery device 12 is not used, all the valves 44 rotate to the " off " position to prevent liquid from flowing through the valve block 32.

Each valve 44 is rotated to the “drain” position so that the supply portion 40 is discharged to the outlet 42 prior to recovery and / or whenever it is desired to drain or pour into the liquid flow path in the liquid recovery device 12. And liquid can be distributed. In this way, liquid from feed conduit 34 is diverted to waste container 30.

If it is desired to divert the liquid to a specific recovery vessel 28, the particular valve 44 connected to the specific vessel 28 moves to the "recovery" position. In addition, any valve in the upstream direction to the liquid flow through the valve block 32 moves to the drainage position. Preferably any valve 44 in the downstream direction to the liquid flow through the valve block 32 moves to the off position. However, these downstream valves 44 may have any desired state.

When the bypass to the particular recovery vessel 28 is completed, the valves 44 are returned to the "off" position.

In use, the liquid recovery device 12 has a pump 20 operable and a valve block 32 operatively positioned at the valve actuator 22 in the flexible portion 36 of the supply conduit 34. To the workstation 10 so as to. When liquid is produced through a liquid production line or vessel, the half part of the two-part connector 38 in the supply conduit 34 is operably connected to its fastened half part disposed in the production line or vessel. .

The valve actuator 22 may be used to manually operate the valve 44 by an operator. For manual operation, workstation 10 includes one or more valve operation buttons or control 48.

Alternatively, and in the preferred embodiment, the valve actuator 22 may be automatically controlled by the workstation 12 as described in more detail below. Of course, it can be understood that the valve actuator 22 can be controlled by any combination of manual control and automatic control by this specification.

According to the present invention, since the workstation 10 partially uses two-parts, the sterile connector 38 combined with the liquid recovery device 12 is optionally pointed at the production process to carry out the desired desired sampling process. We can predict that we can move from point to point. In addition, the workstation 10 may be installed at a specific position of the production line when the production line is set up to produce the first product, but the production line is set up to produce the second product. In that case it can then be relocated to another location on the production line. In other words, the workstation 10 reduces the cost of equipment to control the production process by using it at various locations on the production line during production run or by reconfiguring to another static location when the production line is reconfigured to accommodate production of other products. Can be.

The workstation 10 may include a waste container holding area 50 and a product that, in some embodiments, may maintain the containers 28, 30 in a desired state and / or in a desired state suitable for the liquid contained therein. have. For example, workstation 10 may include sufficient environmental controls to hold vessels 28 and 30, so that liquid is contained therein at a desired temperature. In another embodiment, workstation 10 may include agitating and / or vibrating devices capable of maintaining mixed or agitated liquids in vessels 28 and 30.

Workstation 10 may be in a state (eg, such as temperature, humidity) in base 14, a state (eg, temperature, turbidity, volume, etc.) in vessels 28, 30, and work One or more sensors 52 may monitor or record other states of the station. Additionally, workstation 10 monitors and records the detection, classification, and detection of temperature, pressure, humidity, particulates, and viral and / or microbial organisms, including but not limited to conditions outside of base 12. Sensors may be included or connected to sensors external to the workstation 54.

Workstation 10 controls the pump 20, the valve actuator 22, the liquid edge detector 24 and the sensor 52 in the workstation 10 by the present invention, but is not limited to keyboards, And analysis equipment, test equipment and work on touch screens or any other data exchange device, universal serial bus (USB) or other data exchange port, CD or other data readout device, computer, programmable logic controller (PLC). It will be appreciated that the collection of data and signals from any other (wireless or hardwired) human-machine supply 56, such as a sensor outside the station, can be controlled.

In some embodiments, the liquid recovery device 12 may include a detachable flow meter 58 electrically connected with the workstation 10.

Thus, workstation 10 includes a processor 60 having a Human-Machine-Interface (HMI) 56 having more than one supply device 62 and one or more discharge devices 64. It may include. Processor 60 may include, but is not limited to, a device such as a computer, a programmable logic controller (PLC), or any other processor suitable for controlling the components of workstation 10.

Human-machine interface (HMI) 56 may include, for example, a keyboard, mouse, bar-code reader, touch screen, universal serial bus or other data exchange port, CD or other data reading device, remote control, Or any other data exchange device suitable for inputting instructions to the processor 60 in a wired and / or wireless manner, and any combination thereof.

Ejection 64 is a computer monitor, audible alarm, visual alarm, printer, universal serial bus (USB) or other data exchange port, CD or other data recording device, (wired or hard-wired) Data exchange device or any other device suitable for receiving wired and / or wireless output from processor 60.

In a preferred embodiment, the human-machine interface (HMI) 56 includes one or more bar code readers 62 and the liquid recovery device 12 is not limited thereto, but includes lot numbers, shelf life, products and One or more machine-readable details including details about the liquid recovery device such as the number of waste containers 28, 30, the volume of product and waste containers 28, 30, the volume of conduits in the recovery device, and other details. Label 66 may be included. In use, the operator uses the barcode reader 62 to print the machine readable label 66 of the liquid recovery device 12 so that the processor 60 records and measures various details regarding the liquid recovery device 12. You can scan.

It will also be appreciated that the ejection device 64 according to the present invention may include one or more printers. The processor 60 controls the printer to print a label that can be applied by the operator directly to each of the containers 28 and 30 and contains information about the liquid contained in the container. For example, the processor 60 may include, but is not limited to, printer 64, recovery date, recovery time, operator, batch ID, program sequence, room number, station number, It can be controlled to print information such as recovery location, and other production or environmental variables.

Preferably, the printer 64 is configured to print the information on a label in a machine readable language such as a barcode so that the lab technician can scan the machine readable code to output all data related to the liquid in the container, and This can alleviate inattention, such as data entry errors.

The processor 60 is not necessarily limited thereto, but the pump 20, the valve actuator 22, the level in any wireless or wired manner, such as, but not limited to, electrical, optical, sound wave, infrared, radio frequency, magnetic force and one or more other means of communication. Sensor 24, manual control 48, sensors 52, 54, human-machine interface 56, flow meter 58, discharge device 60, as well as barcode reader 62 and printer 64 Can be electrically connected.

In this way, the processor 60 is configured to provide control of the workstation 10 and control the recovery of the liquid in the recovery device 12 as well as to provide label information about the location in the containers 28, 30.

In some embodiments, processor 60 may be connected to one or more computers (not shown) external to workstation 10 in a wired and / or wireless manner, where such external computers may retrieve data, record data, analyze data, and Data processing software.

The sterile liquid recovery capability of the workstation 10 and recovery device 12 reduces or reduces the risk of contamination of the recovered liquid or production line.

The workstation 10 may be programmed, via the processor 60, to optionally aseptically recover one or a series of liquids at a manually selected time or at a predetermined time and at a manually selected volume or a preset volume. have.

Referring to FIG. 7, a method 70 of operating a workstation 10 with a liquid recovery device 12 is shown.

In a first step or selection step 72, the liquid recovery device 12 for the desired recovery is selected by the operator.

In the second or assembly step 74, the operator assembles the selected liquid recovery device 12 to the workstation 10. In particular, the vessels 28, 30 are placed in the region 50, the valve block 32 is operatively arranged in the valve actuator 22, and the flexible portion 36 of the feed conduit 34 is pumped ( 20) is operatively arranged. If a level liquid edge detector 24 is present, a portion of the supply conduit 34 is operably disposed in the detector.

In a third step or verification step 76, the operator enters information relating to the liquid recovery device 12 into the processor 60 and inputs information relating to the desired production line or vessel from which the workstation 10 recovers the liquid. do. In some embodiments, the verifying step 76 includes an operator scanning the barcode 66 of the liquid recovery device 12 using the scanner 62.

Once the processor 60 has identified the liquid recovery device 12, the processor outputs to the operator and sends it to the fourth step or connection step 78 where the operator returns the liquid recovery device to the production line or vessel and the human-machine interface 56. To distribute the liquid through. As described in detail above, the liquid recovery device 12 may be arranged to liquid flow with the production line or vessel through the two-part connector 38.

If liquid is present in the production line or vessel, the operator starts the desired recovery sequence of workstation 10 during step 80. Step 80 may begin the manual retrieval process 82 using the manual control 48. Optionally, step 80 may begin using an algorithm 84 inherent in processor 60.

During automatic retrieval, the algorithm 84 forces liquid through the supply conduit 34 and the valve block 32 in the production line or vessel and to either the vessel 28 or the waste container 30 as preset. To drive the pump 20.

Before each retrieval, the algorithm 84 is configured to control the workstation 10 to a drainage step 86. During the drainage step 86, the algorithm 84 drains or drains the liquid for a predetermined period of time through the recovery device 12 to the waste container 30 by moving all valves 44 to the "drainage" position. .

Then, after the preset discharging or draining step 86, the algorithm 84 allows the processor 60 to return the plurality of valves 44 to the desired volume of liquid in the manner mentioned above with respect to Table 1. The retrieval step 88 is started to move to bypass.

After the predetermined volume of liquid is diverted to the selected recovery vessel 28, the algorithm 84 deactivates the pump 20 and returns the valve 44 to the "off" position to end the recovery phase 88.

The algorithm 84 activates the pump 20 to drain the liquid from the liquid recovery device 12 to the waste container 30, bypasses the liquid to the desired product container 28, deactivates the pump and recovers all desired liquid. The drainage and recovery steps 86 and 88 of closing the valve are repeated until is obtained.

In the embodiment where the liquid recovery device 12 includes a flow meter 58, the algorithm 84 may input and use information from the flow meter to ensure proper liquid and discharge volume. Similarly, in an embodiment where workstation 10 includes a liquid edge sensor 24, algorithm 84 may input and use information from the sensor to ensure accurate liquid and discharge volume.

Preferably, algorithm 84 may also be configured to enable printer 64 to print data on the label when each liquid recovery is obtained during print step 90. The operator can then apply the label to each appropriate container 38. Similarly, algorithm 84 may be configured to activate printer 64 to print data relating to a label on waste when each waste is recovered or after all waste has been recovered.

During the manual recovery process 94, the operator can cause the liquid recovery device 12 to drain to the waste container 30 manually and / or via the controller 60 during the manual drainage step 96 and if manual recovery If there is a step 98, the desired volume of liquid can be diverted to the manual vessel 28.

Once recovery of all liquid is achieved, the operator can release the liquid recovery device 12 from the production line or vessel by disconnecting the two-part connectors 38 during the release step 92. Similarly, the operator can remove each product container 28 and waste container 30 from the liquid recovery device 12 by separating the two-part connectors 38.

Preferably, the algorithm 84 recovers each liquid from the liquid recovery device 12 with a predetermined amount of liquid to ensure that the liquid recovered to the product container 28 is the liquid of the production line or container at the recovery time. Discharge before.

In order to carry out the desired discharge, the waste container 30 has a volume sufficient to hold the discharged liquid. In the illustrated embodiment, the ratio of the volume of the waste container 30 to the volume of the product container 28 is no greater than 15: 1, more preferably no greater than 10: 1, most preferably between 5: l and 2: l. to be. In this way, the waste container 30 recovers the liquid prior to each recovery to ensure that the liquid recovered in the product container 28 represents the liquid in the production line rather than from the bypass of the liquid remaining in the liquid recovery apparatus. The device 12 is provided to have a volume sufficient for drainage.

Referring now to FIG. 8, an embodiment of the verification step 76 from method 70 is shown in more detail. During the verification step 76, the user at processor 60 requests that the barcode 66 of the liquid recovery device 12 be scanned in the scanning step 100 through the scanner 62.

In some embodiments, prior to scanning step 94, the method 70 further includes a process verification step 102 of inputting the process and / or parameters and / or detailed information of the liquid to be recovered to the processor 60. It may include. The parameters and / or detailed information may be manually entered into the processor 60 by an operator and may be identifiers and / or process equipment located in the scanner 62 and batch records, or any manual and scanning data input. Can be scanned into the processor 60 using a combination of.

The verification step 76 determines whether the liquid recovery device 12 is new or previously used in step 104, based on the data in the processor 60 and the information from the barcode 66. If the liquid recovery device 12 has been previously used, the verification step 76 returns the user to the assembly step 74 so that a new recovery device can be used.

If the liquid recovery device 12 is new, the verification step 76 includes details of the recovery protocol stored in the processor 60 and the details of the liquid recovery device (eg, size and container) for the process monitored in step 106. Number (28, 30)). If the liquid recovery device 12 does not match the desired recovery profile, the verification step 76 returns the user to the assembly step 74 so that the correct recovery device can be used.

If the liquid recovery device 12 is correct, the verification step 76 records the liquid recovery device 12 as previously used in step 108 within the processor 60 and connects the liquid to the operator in step 78. It is instructed to place the recovery device in liquid distribution via the production line or vessel and the human-machine interface 56. As detailed above, the liquid recovery device 12 is arranged to be in fluid communication with the production line or vessel by connecting the two-part connector 38 to each other.

As mentioned above, containers 28 and 30 are described as bags. However, it will be appreciated that according to the present invention, the containers 28 and 30 can be any desired sterile container. Referring now to FIGS. 9A-9C, alternative embodiments of the vessels 28, 30 are shown and shown using numerals of multiples of 100.

In FIG. 9A, containers 228 and 230 are shown as fluid holding transport boxes. The vessels 228, 230 may be permanently or removably connected to the liquid recovery device 12. When removably connected, the containers 228, 230 include a connector 239, such as but not limited to a Luer lock connector, for connection to the liquid recovery device 12.

If the vessels 28 and 30 are white, the vessel is a generally ventless bag that can expand to allow fluid to be diverted to the bag by the workstation 10. However, vessels 228 and 230 have sufficient rigidity such that the vessel further comprises sterile vents 240. Vent 240 causes gas in vessels 228 and 230 to exit the vessel when liquid is diverted to the vessel. The vent 240 also preferably prevents gas outside the vessels 228 and 230 from entering the vessel and prevents liquid in the vessel from exiting the vessel. Vent 240 is not limited to any of these, such as vent, which is PHARMAVENT, and vent, which is fine spike, both of which are commercially available through CliniMed Holdings Limited. It may be a sterile vent.

Of course, it will be appreciated that according to the present invention it may be possible to include sterile vents therein if a folding bag is required.

In FIG. 9B, the containers 328, 330 are shown as fluid holding bottles. In addition, the containers 328, 330 may include a connector 339 for permanently or removably connecting to the liquid recovery device 12 and thus optionally for connecting to the liquid recovery device. In addition, the containers 328, 330 may have sufficient rigidity to include sterile vents 340 as described above.

In FIG. 9C, the containers 428, 430 are shown as fluid holding syringes. In addition, the containers 428, 430 include a connector 439 for permanently or removably connecting to the liquid recovery device 12 and thus optionally for connecting to the liquid recovery device.

The vessels 428 and 430 include a chamber 442 with a piston slidably received therein. Prior to use, the piston 444 is pressed into the chamber 442 to reduce the volume of gas in the vessels 428 and 430. When workstation 10 bypasses liquid to vessels 428 and 430, piston 440 is pushed or slides in chamber 442 such that the fluid holding syringe does not require a separate vent.

As described herein above, the liquid recovery vessel for both product and waste may be adapted to allow the gas in the vessel to expand or move to receive the feed liquid, either the vent or the vessel itself, at the same time to divert the liquid to the vessel. It may be a rigid container, a bottle or a carpule.

It should also be understood that the terms "first", "second", "third", "upper", "lower", and the like may be used in a variety of configurations. Such changes do not include the spatial, sequential, or structural order of the altered configurations not specifically mentioned.

The invention has been described with reference to one or more exemplary embodiments, and it will be understood by those skilled in the art that various changes may be made and equivalent components may be substituted without departing from the spirit of the invention. In addition, many modifications may be made to particular circumstances or materials without departing from the spirit of the invention. Thus, the present invention is not limited to the specific embodiments described as being the best embodiment, but this specification is intended to include all embodiments within the spirit of the invention.

Claims (17)

As a liquid recovery device,
A supply conduit that can be connected to the liquid production line;
A plurality of product recovery containers each containing a product;
A waste recovery container comprising waste;
A valve block comprising a plurality of three-way valves and outlets,
Said plurality of three-way valves corresponding to the number of said plurality of product recovery vessels, each of said three-way valves being disposed in said supply conduit to circulate liquid with another in said plurality of product recovery vessels,
The discharge portion is in liquid communication with the waste recovery container, and
And wherein said volume ratio of said waste to said product is no greater than 15: l. The method of claim 1,
And the ratio is 10: 1. The method of claim 1,
The ratio of the liquid recovery device, characterized in that 5: 1 to 2: l. The method of claim 1,
Wherein said valve block further comprises a machine readable label, said machine readable label comprising information relating to physical properties of said liquid recovery device. The method of claim 4, wherein
Wherein said physical property is selected from the group consisting of lot number, expiration date, number of product recovery containers, each volume of said product recovery container, volume of said waste recovery container, and combinations thereof.  2. The liquid recovery apparatus of claim 1, further comprising a first part of a two-part sterile connector in the supply conduit. 2. The liquid recovery apparatus of claim 1, further comprising a flowmeter that is detachable from the supply conduit. The method of claim 1,
And the product recovery container and the waste recovery container are containers selected from the group consisting of bags, bottles with vents, boxes with vents, syringes, and combinations thereof. A processor;
A peristaltic pump electrically connected to the processor;
A valve actuator electrically connected to the processor; And
An algorithm applied to the processor,
The valve actuator is disposed in a plurality of valves and is configured to move the plurality of valves among an off position, a drain position, and a drain position;
The algorithm is
Move the plurality of valve modes to the off position if no recovery or drainage is required to position the pump in the off state,
If drainage is required, move all of the plurality of valves to the drainage position, and place the pump in the on state for a preset drainage time,
If a plurality of valves are needed, each of the plurality of valves is moved to the recovery position one by one, and each of the plurality of valves is moved to the drainage position for all the valves in the upstream direction, and the pump is moved to the on state for a predetermined recovery time. Automatic liquid recovery workstation, characterized in that located. The method of claim 9,
And a barcode scanner in electrical communication with the processor. The method of claim 9,
And a label printer in electrical connection with the processor. The method of claim 9,
And a liquid edge director in electrical connection with the processor. The method of claim 9,
Further comprising a sensor electrically connected to the processor,
And the sensor is configured to sense an environmental condition. The method of claim 9,
Further comprising a base supported by a plurality of wheels,
And said processor, peristaltic pump and valve actuator disposed on said base. 15. The method of claim 14,
And the base further comprises a product and waste container holding area capable of causing the product and waste container to remain in a desired and / or desired condition suitable for the liquid contained therein. As a method of automatically recovering liquid from the production line,
Arranging the supply conduit of the liquid recovery device in fluid communication with the production line;
Operatively connecting said supply conduit to a supply of a valve block having a peristaltic pump and a plurality of three-way valves;
Operatively connecting the valve block to a valve actuator such that each of the plurality of three-way valves can be moved between an off position, a drain position, and a return position by another portion of the valve actuator;
The valve actuator controls to move all of the plurality of three-way valves to the drainage position, and the peristaltic pump such that liquid from the production line is in fluid communication with the outlet of the valve block through the valve block to pump to the waste container. Turning on; And,
The valve actuator moves a particular one of the plurality of three-way valves to the recovery position and maintains the peristaltic pump such that liquid from the production line is pumped through the valve block to the specific recovery vessel. Connecting all of the directional valves in the upstream direction of the particular valve to a drainage position, thereby connecting the particular valve to a particular recovery vessel. 17. The method of claim 16,
Controlling the valve actuator such that all of the plurality of three-way valves downstream of the particular valve move to the off position.

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