EP2885528A1 - Appareils et procédés de collecte de liquides afin de détecter la désactivation de virus - Google Patents

Appareils et procédés de collecte de liquides afin de détecter la désactivation de virus

Info

Publication number
EP2885528A1
EP2885528A1 EP13816904.0A EP13816904A EP2885528A1 EP 2885528 A1 EP2885528 A1 EP 2885528A1 EP 13816904 A EP13816904 A EP 13816904A EP 2885528 A1 EP2885528 A1 EP 2885528A1
Authority
EP
European Patent Office
Prior art keywords
liquid
collection
valves
workstation
valve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP13816904.0A
Other languages
German (de)
English (en)
Other versions
EP2885528A4 (fr
Inventor
Jan Hofman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alfa Wassermann Inc
Original Assignee
Alfa Wassermann Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/543,951 external-priority patent/US9664597B2/en
Application filed by Alfa Wassermann Inc filed Critical Alfa Wassermann Inc
Publication of EP2885528A1 publication Critical patent/EP2885528A1/fr
Publication of EP2885528A4 publication Critical patent/EP2885528A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G01N1/20—Devices for withdrawing samples in the liquid or fluent state for flowing or falling materials
    • G01N1/2035—Devices for withdrawing samples in the liquid or fluent state for flowing or falling materials by deviating part of a fluid stream, e.g. by drawing-off or tapping
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G01N1/18—Devices for withdrawing samples in the liquid or fluent state with provision for splitting samples into portions
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G01N1/20—Devices for withdrawing samples in the liquid or fluent state for flowing or falling materials
    • G01N1/2035—Devices for withdrawing samples in the liquid or fluent state for flowing or falling materials by deviating part of a fluid stream, e.g. by drawing-off or tapping
    • G01N2001/2071—Removable sample bottle

Definitions

  • the present disclosure relates to automated aseptic liquid collection methods and apparatuses. More particularly, the present disclosure relates to automated aseptic liquid collection methods and apparatuses for detecting virus deactivation.
  • liquid products must be performed in a sterile environment and/or an aseptic environment to protect the product.
  • liquid products can include, but are not limited to, pharmaceutical products (e.g., medicines and vaccines), food products, biological products, biochemical products, chemical products, and any combinations thereof.
  • a liquid collection device includes an input conduit, an output conduit, a plurality of product collection containers, and a valve block.
  • the input and output conduits are connectable to a liquid processing line.
  • the valve block has a valve block input in fluid communication with the input conduit, a valve block output in fluid communication with the output conduit, and a plurality of valves.
  • the valves correspond in number to product collection containers and each valve places the input conduit in liquid communication with a different one of the product collection containers.
  • An automated liquid collection workstation includes a processor, a peristaltic pump, a valve actuator, and an algorithm resident on the processor.
  • the valve actuator moves a plurality of valves, when the valves are operatively associated with the valve actuator, between a recirculate position and a collection position.
  • the algorithm is configured to: move all of the plurality of valves to the recirculate position and place the pump in an on state when recirculation is required and move a respective one of the plurality of valves to the collection position for a predetermined collection time period while leaving the pump in the on state when a collection is required.
  • a method of automatically collecting liquid from a processing line or vessel includes placing an input conduit of a liquid collection device in liquid communication with the processing line or vessel; placing an output conduit of the liquid collection device in liquid communication with the processing line or vessel, the input and output conduits being in fluid communication with a valve block having a plurality of valves; operatively coupling the input conduit to a peristaltic pump;
  • valve block operatively coupling the valve block to a valve actuator so that each of the plurality of valves is movable by a different portion of the valve actuator between a recirculation position and a collection position; controlling the valve actuator to ensure all of the plurality of valves are in the recirculation position and turning on the peristaltic pump so that liquid from the processing line or vessel is pumped through the input conduit, the valve block, and the output conduit back into the processing line; and controlling the valve actuator to move a particular valve of the plurality of valves to the collection position while the peristaltic pump remains on and while at least the valves upstream of the particular valve remain in the recirculate position.
  • the particular valve is associated with a particular collection container so that liquid from the processing line is pumped through the valve block to the particular collection container.
  • FIG. 1 is a front, top perspective view of an exemplary embodiment of a workstation according to the present disclosure
  • FIG. 2 is a front pla n view of the workstation of FIG. 1;
  • FIG. 3 is a top view of the workstation of FIG. 1;
  • FIG. 4 is a front, top perspective view of an exemplary embodiment of a collection portion of the workstation of FIG. 1;
  • FIG. 5 is a perspective view of an exemplary embodiment of a liquid collection set according to the present disclosure for use with the workstation of FIG. 1;
  • FIG. 6 is a perspective view of an exemplary embodiment of a valve block according to the present disclosure for use in the liquid collection set of FIG. 5;
  • FIG. 7 is a schematic view of a liquid collection set in use with a vaccine production vessel.
  • FIG. 8 is a flowcha rt illustrating an exempla ry embodiment of a liquid collection method for detecting virus deactivation according to the present disclosure.
  • Workstation 10 is configured to automatically aseptically collect, label, and store, in liquid collection device 12 (shown in FIG. 5), a plurality of liquid collections from a processing line or vessel (A).
  • Workstation 10 is configured to automatically collect liquids such as, but not limited to, pharmaceutical products (e.g., medicines and vaccines) and any combination thereof
  • Workstation 10 includes a base or cabinet 14 supported, in some embodiments, by a plurality of wheels or casters 16 such that the workstation is mobile and can be positioned, as desired, in various locations within a processing facility.
  • Workstation 10 is includes collection portion 18 for pumping liquid into collection device 12.
  • Collection portion 18 includes a pump 20, a valve actuator 22, in some embodiments, a liquid edge detector 24, and a plurality of liquid holding areas 26.
  • Pump 20 can be any desired pumping device but is, preferably, a non-contact pump that selectively draws liquid without directly contacting the liquid itself.
  • pump 20 is a peristaltic pump.
  • Liquid edge detector 24 can be any desired detector such as, but not limited to a sonic, a capacitance, or any other non-contacting or contacting sensor for determining the presence and absence of liquid in one or more areas of liquid collection device 12. Detector 24 can be in electrical communication with workstation 10 so that the workstation can detect when liquid is present in a predetermined location in liquid collection device 12.
  • liquid collection device 12 includes a plurality of product collection containers 28 (six shown) and a valve block 32.
  • Product containers 28 can be configured to have any desired volume so that the volumes of the product containers are identical to one another and/or different from one another.
  • Product collection containers 28 can be any desired collection container such as, but not limited, collection bags as shown in FIG. 5.
  • containers 28 can be collection bags such as the AllegroTM 2D Biocontainer, which is commercially available from Pall Corporation.
  • each container 28 includes an input line 29 releasably sealed with a clamp 33, an output line 31 releasably sealed with a clamp 33, and a port 35.
  • containers 28 be any sterile collection container including, but not limited to, collection bottles, collection boxes, collection syringes, and others.
  • Device 12 further includes an output conduit 30 and an input conduit 34 configured to place the processing line A in liquid communication with valve block 32.
  • Input and output conduits 34, 30 each include at least one flexible portion 36, which allow workstation 10 to be easily placed near processing line or vessel (A).
  • Portion 36 of the input conduit can be configured to operably mate with pump 20 so that the pump can force the liquid into containers 28 of liquid collection device 12.
  • flexible portion 36 is made of a material having sufficient resiliency (e.g., silicone tubing) to operate in cooperation with the peristaltic pump.
  • Liquid collection device 12 finds use with two-part, aseptic connectors 38.
  • input conduit 34 has only one part 38-1 of a two-part connector 38 connected thereto.
  • output conduit 30 has only one part 38-1 of a two-part connector 38 connected thereto.
  • the mating parts 38-2 for two-part connector 38 of input and output conduits 36, 30 are in liquid communication with processing line or vessel (A).
  • Liquid collection device 12 can be liquidly connected to the processing line or vessel (A) by joining both halves 38-1, 38-2 of two part-connector 38 at input conduit 34 and the processing line or vessel A to one another and by joining both halves 38-1, 38-2 of two part-connector 38 at output conduit 30 and the processing line or vessel A to one another. In this manner, liquid collection device 12 forms a continuous closed loop with the processing vessel (A) as seen in FIG. 7.
  • the use of device 12, which forms a continuous loop with vessel (A) has been found to allow the necessary samples to be taken and to mitigate dead legs from the system. Moreover, the use of device 12 allows vessel (A) to be a closed vessel so that the risk of exposure to live virus is reduced and the risk of sterility failure is reduced.
  • Two-part connectors 38 can be any disposable, two-part aseptic connector such as, but not limited to the KleenpakTM connector, which is commercially available from Pall Corporation, the Opta * SFT-I connector, which is commercially available from Sartorius Stedim Biotech, the Lynx ® ST connector, which is commercially available from Millipore Corporation, and the AseptiQuikTM connector, which is commercially available from Colder Products Corporation.
  • liquid collection device 12 product collection containers 28 and valve block 32 are removably connected to one another.
  • liquid collection device 12 can include a plurality of connectors 39 such as, but not limited to Luer lock connectors.
  • All product contact surfaces within collection device 12 are made of any material sufficient to hold or contact the liquid without interacting or contaminating the liquid.
  • collection device 12 can be packaged within one or more outer wrappings (not show) then can be sterilized using known sterilization methods such as, but not limited to, gamma irradiation. In this manner, collection device 12 can remain in a sterile condition until ready for use.
  • Valve block 32 as shown in FIG. 6, includes an input 40, an output 44, and a plurality of valves 46 (six shown).
  • the input 40 is in liquid communication with input conduit 34 and output 42 is in liquid communication with output conduit 30.
  • Valves 44 correspond in number to the plurality of collection containers 28, with an output 46 from each of the valves being in liquid communication with a different collection container 28.
  • Valves 44 are each movable by rotation of a valve handle 48 among at least two positions: a "recirculate” position and a “collection” position. [0042] In the recirculate position, each valve 44 allows liquid from input 40 to flow through the valve towards waste output 42, but prevents flow toward its respective output 46. In the collection position, each valve 44 allows liquid from input 40 to flow through the valve towards the respective output 46, but prevents flow toward the waste output 42.
  • Handle 48 of each valve 44 operably mates with a different portion of valve actuator 22 so that the valve actuator can selectively rotate each handle independently of one another among the three positions.
  • workstation 10 via valve actuator 22, is configured to actuate valve block 32 to selectively divert liquid from the processing line or vessel (A) into any one of collection containers 28 or return the liquid back into the processing line or vessel.
  • valves 44 are provided during various sampling activities contemplated by the present disclosure.
  • valves 44 are sequentially numbered, in the direction of liquid flow, as valves 44-1 through 44-6 and the collection containers 28 are sequentially numbered, in the direction of liquid flow, as containers 28-1 through 28-6.
  • liquid collection device 12 is positioned in workstation 10 so that flexible portion 36 of input conduit 34 is operatively positioned in pump 20 and valve block 32 is operatively positioned in valve actuator 22.
  • the half of two-part connector 38 at input conduit 34 is operatively connected to its mating half arranged on the line or vessel (A) and the half of two-part connector 38 at output conduit 30 is operatively connected to its mating half arranged on the line or vessel (A).
  • valve actuator 22 can be automatically controlled by workstation 10 as described in more detail herein below to collect samples according to a desired protocol.
  • workstation 10 is discussed above by way of example as including pump 20.
  • processing line or vessel (A) it is contemplated by the present disclosure for processing line or vessel (A) to be pressurized or have its own liquid circulation device such that no additional pump is required.
  • Workstation 10 can, in some embodiments, include a sample container holding area 50, which can maintain containers 28 in a desired position and/or in a desired condition suitable for the liquid contained therein.
  • workstation 10 can include environmental controls sufficient to maintain containers 28, and thus, liquid contained therein, at a desired temperature.
  • workstation 10 can include agitation and/or vibration devices sufficient to maintain the liquid within containers 28 in a mixed or agitated state.
  • Workstation 10 can include one or more sensors 52 to monitor and record the conditions (e.g., temperature, humidity) within base 14, the conditions within containers 28 (e.g., temperature, turbidity, volume, etc), and other conditions of the workstation. Additionally, workstation 10 can include sensors or can connect to sensors outside 54 the workstation to monitor and records the conditions outside the base 12 including but not limited to temperature, pressure, humidity, particulates, and detection, typing and monitoring of viral and/or microbial organisms.
  • conditions e.g., temperature, humidity
  • containers 28 e.g., temperature, turbidity, volume, etc
  • workstation 10 it is contemplated by the present disclosure for workstation 10 to coordinate the control of pump 20, valve actuator 22, liquid edge detector 24, and sensors 50 within workstation 10 as well as collection of signals and data from any other (wireless or hardwire connected) human-machine input devices 56 such as, but not limited to, keyboards, and touch screens or any other data communication devices, USB or other data communication ports, CD or other data reading devices, computers, PLC's, analyzing equipments, testing devices and sensors outside the workstation.
  • human-machine input devices 56 such as, but not limited to, keyboards, and touch screens or any other data communication devices, USB or other data communication ports, CD or other data reading devices, computers, PLC's, analyzing equipments, testing devices and sensors outside the workstation.
  • liquid collection device 12 can include a disposable flow meter 58 in electrical communication with workstation 10.
  • workstation 10 can include a processor 60 having human-machine- interface (HMI) 56 with one or more input devices 62 and one or more output devices 64.
  • HMI human-machine- interface
  • Processor 60 can include devices such as, but not limited to, a computer, a programmable logic controller (PLC), or any other processor suitable to control the various components of workstation 10.
  • HMI 56 can includes, for example, a keyboard, a mouse, a bar-code reader, a touch screen, a USB or other data communication port, CD or other data reading device, a remote control, or any other data communication device suitable for inputting commands to processor 60 in a wired and/or a wireless manner, and any combinations thereof.
  • Output device 64 can include a computer monitor, an audible alarm device, a visual alarm device, a printer, a USB or other data communication port, a CD or other data writing device, a (wireless or hard-wired) data communication device or any other device suitable for receipt of a wired and/or a wireless output from processor 60.
  • HMI 56 includes at least one bar code reader 62 and liquid collection device 12 can include at least one machine readable label 66, which includes details regarding the liquid collection device such as, but not limited to, the lot number, the expiration date, the number of product containers 28, the volume of product containers 28, the volume of conduits within the collection device, and other details.
  • the operator can scan machine readable label 66 of liquid collection device 12 using bar code reader 62 so that processor 60 can determine and record the various details regarding the liquid collection device 12.
  • output devices 64 include at least one printer.
  • Processor 60 controls printer 64 to print labels, which can be applied by the operator directly on each container 28 and includes information that is relevant to the liquid contained within the container.
  • processor 60 can control printer 64 to print information such as, but not limited to, date of collection, time of collection, operator, batch ID, program sequence, room number, station number, collection location, and other process or environmental variables.
  • printer 64 is configured to print information on the label in a machine readable language, such as a bar code, so that a laboratory technician can scan the machine readable code to input all relevant data related to the liquid within the container, which can mitigate instances of data entry errors.
  • Processor 60 is in electrical communication via any wireless or wired manner such as, but not limited to, electrical, optical, audible, infrared, radiofrequency, magnetic and other means of communication with any one or more of pump 20, valve actuator 22, level sensor 24, manual controls 48, sensors 52 and 54, HMI 56, flow meter 58, output devices 60, as well as bar code reader 62 and printer 64.
  • wireless or wired manner such as, but not limited to, electrical, optical, audible, infrared, radiofrequency, magnetic and other means of communication with any one or more of pump 20, valve actuator 22, level sensor 24, manual controls 48, sensors 52 and 54, HMI 56, flow meter 58, output devices 60, as well as bar code reader 62 and printer 64.
  • processor 60 is configured to coordinate the control of workstation 10 and the collection of liquid in collection device 12, as well as to provide information on labels for placement onto containers 28.
  • processor 60 can communicate in wired and/or wireless manner with one or more computers (not shown) external to workstation 10, where such external computers can include data collection, data archiving, data analysis and data management software.
  • the aseptic liquid collection ability of workstation 10 and collection device 12 mitigate or eliminate the risk of contaminating the collected liquid or the processing line.
  • Workstation 10 via processor 60, can be programmed to aseptically obtain one or a series of liquid collections taken randomly, at manual selected times or at pre-set times and with manually selected volumes or pre-set volumes. [0065] Referring now to FIG. 8, a method 70 of operating workstation 10 having liquid collection device 12 during virus deactivation is shown.
  • a first or selection step 72 the appropriate liquid collection device 12 for desired collection is selected by the operator.
  • a second or assembly step 74 the operator assembles the selected liquid collection device 12 in workstation 10. Specifically, containers 28 are placed in area 50 and valve block 32 is operatively positioned in valve actuator 22. When pump 20 is present, flexible portion 36 of input conduit 34 can be operatively positioned in the pump. Additionally, when level liquid edge detector 24 is present, a portion of input conduit 34 can be operatively positioned in the detector.
  • a third or verification step 76 the operator inputs information related to the liquid collection device 12 into processor 60 and inputs information related to the desired processing line or vessel (A) from which workstation 10 will be collection the liquid.
  • the verification step 76 includes requiring the operator to use scanner 62 to scan bar code 66 on liquid collection device 12.
  • processor 60 verifies liquid collection device 12, the processor sends an output to the operator in a fourth or connection step 78 to instruct the operator to place the liquid collection device in liquid communication with the processing line or vessel (A) via HMI 56.
  • liquid collection device 12 is placed in liquid communication with the processing line or vessel (A) by interconnecting two- part connectors 38 of both input and output conduits 34, 30 to the vessel.
  • Step 80 may initiate a manual collection process 82 using manual controls 48. Alternately, step 80 may initiate an automated collection process using an algorithm 84 resident on processor 60.
  • algorithm 84 is configured to activate pump 20 to force liquid from the processing line or vessel (A) through input conduit 34, valve block 32, and through output conduit 30 back into the vessel.
  • algorithm 84 controls valve actuator 22 to ensures that all valves 44 are in the recirculate position.
  • algorithm 84 controls, at a collection step 88, workstation 10 to activate valve actuator 22 to move the desired valve 44 to the collection position for a period of time sufficient, based on the flow rate of liquid through collection device 12, to collect a sample of desired volume in container 28.
  • algorithm 84 controls, at collection step 88, workstation 10 to activate valve actuator 22 to return valve 44 to the recirculation position in the manner discussed above with respect to Table No. 1.
  • Algorithm 84 repeats the recirculate and collection steps 86, 88 until all of the desired liquid collections have been obtained.
  • algorithm 84 can use inputs from the flow meter to ensure proper sample volumes.
  • algorithm 84 can use inputs from the sensor to ensure proper sample volumes.
  • algorithm 84 is further configured to activate printer 64 to print data onto a label when a respective collection of liquid is obtained during a print step 90. The operator can then apply the label on the appropriate container 28, respectively. [0076] Once all of the collections of liquid have been obtained, the operator can, during a disconnection step 92, disconnect liquid collection device 12 from the processing line or vessel by separating two-part connectors 38 at both the input and output conduits 34, 30. Similarly, the operator can remove each product container 28 from liquid collection device 12 by separating two-part connectors 38.

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  • Life Sciences & Earth Sciences (AREA)
  • Hydrology & Water Resources (AREA)
  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

L'invention concerne un dispositif de collecte de liquide. Le dispositif comprend un conduit d'entrée, un conduit de sortie, une pluralité de récipients de collecte de produit et un bloc soupape. Les conduits d'entrée et de sortie peuvent être raccordés à une ligne de traitement de liquide. Le bloc soupape présente une entrée de bloc soupape en communication fluidique avec le conduit d'entrée, une sortie de bloc soupape en communication fluidique avec le conduit de sortie et une pluralité de soupapes. Le nombre des soupapes correspond aux récipients de collecte de produit et chaque soupape place le conduit d'entrée en communication fluidique avec un récipient différent parmi les récipients de collecte de produit. L'invention concerne également un poste de travail de collecte de liquide automatisé, à utiliser avec le dispositif de collecte de liquide, et un procédé de collecte automatique de liquide depuis un conteneur ou une ligne de traitement.
EP13816904.0A 2012-07-09 2013-06-27 Appareils et procédés de collecte de liquides afin de détecter la désactivation de virus Withdrawn EP2885528A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/543,951 US9664597B2 (en) 2010-12-03 2012-07-09 Liquid collection methods and apparatuses for detecting virus deactivation
PCT/US2013/048221 WO2014011406A1 (fr) 2012-07-09 2013-06-27 Appareils et procédés de collecte de liquides afin de détecter la désactivation de virus

Publications (2)

Publication Number Publication Date
EP2885528A1 true EP2885528A1 (fr) 2015-06-24
EP2885528A4 EP2885528A4 (fr) 2016-12-07

Family

ID=49877515

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13816904.0A Withdrawn EP2885528A4 (fr) 2012-07-09 2013-06-27 Appareils et procédés de collecte de liquides afin de détecter la désactivation de virus

Country Status (2)

Country Link
EP (1) EP2885528A4 (fr)
WO (1) WO2014011406A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3045154A1 (fr) * 2015-12-10 2017-06-16 Axens Dispositif d'echantillon de solides granulaires

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA819408A (en) 1969-08-05 Texsteam Corporation Pipeline sampler
US4307620A (en) * 1978-03-04 1981-12-29 Jiskoot Joost J Liquid sampling system
JP2004018112A (ja) * 2002-06-19 2004-01-22 Yasuzumi Tanaka 複数の密封弁なし単独袋を有する梱包シート
GB2445745B (en) 2007-01-17 2009-12-09 Schlumberger Holdings System and method for analysis of well fluid samples
US20100300563A1 (en) * 2009-05-27 2010-12-02 John Ramunas Modular device and method for moving fluids to and from a sample delivery element
US8815179B2 (en) * 2010-12-03 2014-08-26 Alfa Wassermann, Inc. Automated aseptic liquid collection workstations and collection devices therefore

Also Published As

Publication number Publication date
WO2014011406A1 (fr) 2014-01-16
EP2885528A4 (fr) 2016-12-07

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