US20140060215A1 - Automated Aseptic Sampling Workstations and Sample Collection Devices Therefore - Google Patents
Automated Aseptic Sampling Workstations and Sample Collection Devices Therefore Download PDFInfo
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- US20140060215A1 US20140060215A1 US14/076,238 US201314076238A US2014060215A1 US 20140060215 A1 US20140060215 A1 US 20140060215A1 US 201314076238 A US201314076238 A US 201314076238A US 2014060215 A1 US2014060215 A1 US 2014060215A1
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- sample collection
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- 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
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M33/00—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus
- C12M33/04—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus by injection or suction, e.g. using pipettes, syringes, needles
- C12M33/06—Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus by injection or suction, e.g. using pipettes, syringes, needles for multiple inoculation or multiple collection of samples
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M37/00—Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
- F16K11/00—Multiple-way valves, e.g. mixing valves; Pipe fittings incorporating such valves
- F16K11/10—Multiple-way valves, e.g. mixing valves; Pipe fittings incorporating such valves with two or more closure members not moving as a unit
- F16K11/20—Multiple-way valves, e.g. mixing valves; Pipe fittings incorporating such valves with two or more closure members not moving as a unit operated by separate actuating members
- F16K11/22—Multiple-way valves, e.g. mixing valves; Pipe fittings incorporating such valves with two or more closure members not moving as a unit operated by separate actuating members with an actuating member for each valve, e.g. interconnected to form multiple-way valves
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- 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
- G01N1/14—Suction devices, e.g. pumps; Ejector devices
-
- 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
-
- 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
- G01N2001/205—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 using a valve
Definitions
- the present disclosure relates to automated aseptic sampling workstations. More particularly, the present disclosure relates to workstations for use in the automated taking of product samples during the processing of various fluids, as well as to sample collection devices used with such automated workstations.
- fluid products can be performed in a sterile environment and/or an aseptic environment to protect the product and/or the manufacturing personnel from contamination.
- fluid 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.
- pharmaceutical products e.g., medicines and vaccines
- food products e.g., food products, biological products, biochemical products, chemical products, and any combinations thereof.
- the sampling can be performed during or after certain process steps and/or at certain time intervals. In other instances, the sampling can be performed after the product has been made, but before the production batch is released for use by consumers.
- the taking of a sample from the processing line is a critical activity and creates a potential risk of contaminating the product and/or the sample.
- the risk of contamination often leads manufacturers to limit the number of samples that are obtained and/or to limit the number of locations where such samples are obtained.
- contamination of the sample may cause a false result, which can lead to the unneeded destruction of a product batch and/or unneeded delay in the continuation of the production process until the cause of the contamination is determined.
- the need to clean and sterilize the sample path before and/or after each batch typically requires the sampling devices to be hard piped into a specific location in the production line, which can limit the flexibility of the processing line to process other products in a timely and efficient manner.
- samples that are taken must be properly identified by the operator responsible for taking the sample and this identifying information must then subsequently be input by the department responsible department responsible for testing the sample.
- the manual identification of samples by the sample taker and the manual input of this identity by the sample tester have proven to be error prone, which can further complicate the proper testing and release of product.
- a sample collection device includes an input conduit, a plurality of automated sample collection bags, a waste collection bag, and a valve block.
- the input conduit is connectable to a fluid processing line.
- the automated sample collection bags each have a sample volume and the waste collection bag has a waste volume.
- the valve block a plurality of three-way valves and an output, where the plurality of three-way valves correspond in number to the plurality of automated sample collection bags, each of the three-way valves placing the input conduit in fluid communication with a different one of the plurality of sample collection bags.
- the output is in fluid communication with the waste collection bag.
- the collection device has a ratio of the waste volume to the sample volume of not more than 15:1.
- the workstation includes a processor, a peristaltic pump, a valve actuator, and an algorithm.
- the peristaltic pump and the valve actuator are in electrical communication with the processor.
- the valve actuator can move a plurality of valves, when disposed therein, among an off position, a flush position, and a sample position.
- the algorithm is resident on the processor and is configured to: move all of the valves to the off position and place the pump in an off state when no sampling or flushing is required, move all of the valves to the flush position and place the pump in an on state for a predetermined flush time period when flushing is required, and move a respective one of the valves to the sample position, move any of the valves upstream of the respective valve to the flush position, and place the pump to the on state for a predetermined sample time period when a sample is required.
- a method of automatically taking a plurality of fluid samples from a processing line includes: cleaning a processing line having a first half of a two-part connector connected thereto; connecting a second half of the two-part connector to the first part, the second half part of a sample collection device, the sample connection device having a plurality of collection bags, a valve block, and an input conduit with the second half of the two-part connector, the valve block having an input, a plurality of three-way valves, and an output, the plurality of three-way valves corresponding in number to the plurality of collection bags, each of the three-way valves placing the input in fluid communication with a different one of the plurality of collection bags, the output being in fluid communication with a waste collection bag, the input being in fluid communication with the input conduit; and inserting the valve block into a valve actuator so that a handle of each of the plurality of valves is movable by the valve actuator.
- a method of automatically taking a plurality of fluid samples from a processing line includes: placing an input conduit of a sample collection device in fluid communication with the processing line; operatively coupling the input conduit to a peristaltic pump and to an input of a valve block having a plurality of three-way valves; operatively coupling the valve block to a valve actuator so that each of the plurality of three-way valves is movable by a different portion of the valve actuator among an off position, a flush position, and a sample position; controlling the valve actuator to move all of the plurality of three-way valves to the flush position and turning on the peristaltic pump so that fluid from the processing line is pumped through the valve block to a waste bag in fluid communication with an output of the valve block; and controlling the valve actuator to move a particular valve of the plurality of three-way valves to the sample position and to move any of the plurality of three-way valves upstream of the particular valve to the flush position while the peristaltic pump remains on, the particular valve
- 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 plan 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 sampling portion of the workstation of FIG. 1 ;
- FIG. 5 is a perspective view of an exemplary embodiment of a sample 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 sample set of FIG. 5 ;
- FIG. 7 is a flowchart illustrating an exemplary embodiment of a sampling method according to the present disclosure.
- FIG. 8 is a flowchart illustrating an exemplary embodiment of a sample collection device verification method according to the present disclosure.
- Workstation 10 is configured to automatically aseptically sample, label, and store, in sample collection device 12 (shown in FIG. 5 ), a plurality series of fluid samples from a processing line or vessel (A).
- Workstation 10 is configured to automatically sample fluid samples including samples such as, but not limited to, pharmaceutical products (e.g., medicines and vaccines), food products, biological products, biochemical products, chemical products and any combinations thereof.
- pharmaceutical products e.g., medicines and vaccines
- food products e.g., medicines and vaccines
- biological products e.g., biochemical products, chemical products and any combinations thereof.
- workstation 10 is flexibly configured, namely is configured so that the workstation can be moved from point-to-point and/or from one process step to another process step in a manufacturing process. Further, workstation 10 is preferably suitable for use in an aseptic or clean room environment such that the material selection (e.g., stainless steel or other material) and material specifications (e.g., surface finish) are sufficient for use in such environments.
- material selection e.g., stainless steel or other material
- material specifications e.g., surface finish
- 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 sampling portion 18 for pumping a fluid sample into sample collection device 12 .
- Sampling portion 18 includes a pump 20 , a valve actuator 22 , in some embodiments, a liquid edge detector 24 , and a plurality of sample holding areas 26 .
- Pump 20 can be any desired pumping device but is, preferably, a non-contact pump that selectively draws fluid samples without directly contacting the fluid 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 sample collection device 12 .
- Detector 24 can be in electrical communication with workstation 10 so that the workstation can detect when fluid is present in a predetermined location in sample collection device 12 .
- sample collection device 12 includes a plurality of sample collection bags 28 (six shown), at least one waste bag 30 (only one shown), and a valve block 32 .
- Sample bags 28 can be configured to have any desired volume so that the volumes of the sample bags are identical to one another and/or different from one another.
- Sample bags 28 and waste bags 30 can be any desired collection receptacle such as, but not limited to the AllegroTM 2D Biocontainer, which is commercially available from Pall Corporation.
- each bag 28 , 30 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 .
- sample collection device 12 include five automated sample bags 28 of identical volume, e.g., about 50 milliliters (mL), and one manual sample bag 28 of a larger volume, about 500 ml. Also, in the illustrated embodiment, the sample collection device 12 includes one waste sample bag 30 of about 1,000 mL. Of course, it should be recognized that the number and volumes of bags 28 , 30 can be modified to any desired size.
- Device 12 further includes an input conduit 34 configured to place the processing line in fluid communication with valve block 32 .
- Input conduit 34 includes at least one flexible portion 36 .
- Portion 36 is configured to operably mate with pump 20 so that the pump can force the fluid sample into bags 28 , 30 of sample 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.
- Sample collection device 12 finds use with one or more two-part, aseptic connectors 38 .
- input conduit 34 has only one part 38 - 1 of a two-part connector 38 connected thereto.
- the mating part 38 - 2 for two-part connector 38 of input conduit 36 is in fluid communication with processing line or vessel A.
- sample collection device 12 can be fluidly connected to the processing line or vessel by joining both halves 38 - 1 , 38 - 2 of two part-connector 38 at the input conduit and the processing line or vessel to one another.
- the portion of the two-part connector 38 - 2 mated with the production line or vessel A can be sterilized or sanitized along with the production line or vessel before processing of the fluid.
- Two-part connector 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.
- KleenpakTM connector which is commercially available from Pall Corporation
- the Opta® SFT-I connector which is commercially available from Sartorius Stedim Biotech
- Lynx® ST connector which is commercially available from Millipore Corporation
- AseptiQuikTM connector which is commercially available from Colder Products Corporation.
- sample collection device 12 In some embodiments of sample collection device 12 , sample bags 28 , waste bag 30 , and valve block 32 are removably connected to one another.
- sample collection device 12 can include a plurality of connectors 39 such as, but not limited to Luer lock connectors.
- collection device 12 All product contact surfaces within collection device 12 are made of any material sufficient to hold or contact the sample fluid without interacting or contaminating the sample. Moreover, 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 , a waste output 44 , and a plurality of three-way valves 46 (six shown).
- the input 40 is in fluid communication with input conduit 34 and waste output 42 is in fluid communication with waste collection bag 30 .
- the plurality of three-way valves 44 correspond in number to the plurality of collection bags 28 , with a sample output 46 from each of the valves being in fluid communication with a different collection bag 28 .
- Three-way valves 44 are each movable by rotation of a valve handle 48 among three positions: an “off” position; a “flush” position; and a “sample” position.
- each valve 44 prevents fluid from input 40 from flowing through the valve to either waste output 42 or sample output 46 .
- each valve 44 allows fluid from input 40 to flow through the valve towards waste output 42 , but prevents flow toward its respective sample output 46 .
- each valve 44 allows fluid from input 40 to flow through the valve towards the respective sample 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 sampled fluid from the processing line or vessel into any one of sample bags 28 or waste bag 30 .
- valves 44 are provided during various sampling activities contemplated by the present disclosure.
- valves 44 are sequentially numbered, in the direction of fluid flow, as valves 44 - 1 through 44 - 6 and the sample bags 28 are sequentially numbered, in the direction of fluid flow, as bags 28 - 1 through 28 - 6 .
- valves 44 are rotated to the “off” position, preventing fluid communication through valve block 32 .
- each of the valves 44 can be rotated to the “flush” position, placing input 40 in fluid communication with output 42 . In this manner, fluid from input conduit 34 is diverted to waste bag 30 .
- the particular valve 44 associated with that particular bag 28 is moved to the “sample” position. Further, any valve upstream, with respect to fluid flow through valve block 32 , is moved to the flush position. Preferably, any valve 44 downstream, with respect to fluid flow through valve block 32 , is moved to the off position. However, these downstream valves 44 can have any desired state.
- valves 44 are returned to the “off” position.
- sample collection device 12 is positioned in workstation 10 so that flexible portion 36 of input conduit 34 is operatively positioned in pump 20 and so that 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.
- Valve actuator 22 can be used by the operator to manually operate valves 44 .
- workstation 10 includes one or more valve operating buttons or controls 48 .
- valve actuator 22 can be automatically controlled by workstation 12 as described in more detail herein below.
- valve actuator 22 it is contemplated by the present disclosure for valve actuator 22 to be controlled by any combination of manual and automated control.
- workstation 10 due to in part the use of two-part, aseptic connectors 38 in combination with sample collection device 12 , can be selectively moved from point-to-point within the manufacturing process to perform the desired sampling as needed. Also, workstation 10 can be installed in a particular location within the manufacturing line when that line is set up to make a first product, but can then be relocated to a different location within the manufacturing line when that line is set up to make a second product. In other words, workstation 10 can reduce the equipment cost to monitor a manufacturing process by being used in multiple locations within the manufacturing line during a production run or by being repositioned to a different stationary position when the manufacturing line is reconfigured to accommodate the manufacture of different products.
- Workstation 10 can, in some embodiments, include a sample and waste bag holding area 50 , which can maintain bags 28 , 30 in a desired position and/or in a desired conditions suitable for the samples contained therein.
- workstation 10 can include environmental controls sufficient to maintain bags 28 , 30 , and thus, samples contained therein, at a desired temperature.
- workstation 10 can include agitation and/or vibration devices sufficient to maintain the sample within bags 28 , 30 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 bags 28 , 30 (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.
- the conditions e.g., temperature, humidity
- the conditions within bags 28 , 30 e.g., temperature, turbidity, volume, etc
- 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.
- sample 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 .
- 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 .
- PLC programmable logic controller
- 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 sample collection device 12 can include at least one machine readable label 66 , which includes details regarding the sample collection device such as, but not limited to, the lot number, the expiration date, the number of sample and waste bags 28 , 30 , the volume of sample and waste bags 28 , 30 , the volume of conduits within the collection device, and other details.
- the operator can scan machine readable label 66 of sample collection device 12 using bar code reader 62 so that processor 60 can determine and record the various details regarding the sample 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 bag 28 , 30 and includes information that is relevant to the sample contained within the bag.
- processor 60 can control printer 64 to print information such as, but not limited to, date of sample, time of sample, operator, batch ID, program sequence, room number, station number, sample 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 sample within the bag, which can mitigate instances of data entry errors.
- a machine readable language such as a bar code
- 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 .
- 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 .
- processor 60 is configured to coordinate the control of workstation 10 and the collection of samples in collection device 12 , as well as to provide information on labels for placement onto bags 28 , 30 .
- 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 sampling ability of workstation 10 and sample collection device 12 mitigate or eliminate the risk of contaminating the sample obtained or the processing line.
- Workstation 10 via processor 60 , can be programmed to aseptically obtain one or a series of samples taken randomly, at manual selected times or at pre-set times and with manually selected volumes or pre-set volumes.
- FIG. 7 a method 70 of operating workstation 10 having sample collection device 12 is shown.
- a first or selection step 72 the appropriate sample collection device 12 for desired sampling is selected by the operator.
- a second or assembly step 74 the operator assembles the selected sample collection device 12 in workstation 10 . Specifically, bags 28 , 30 are placed in area 50 , valve block 32 is operatively positioned in valve actuator 22 , and flexible portion 36 of input conduit 34 is operatively positioned in pump 20 . When level liquid edge detector 24 is present, a portion of input conduit 34 is operatively positioned in the detector.
- a third or verification step 76 the operator inputs information related to the sample collection device 12 into processor 60 and inputs information related to the desired processing line or vessel from which workstation 10 will be taking samples.
- the verification step 76 includes requiring the operator to use scanner 62 to scan bar code 66 on sample collection device 12 .
- processor 60 verifies sample 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 sample collection device in fluid communication with the processing line or vessel via HMI 56 .
- sample collection device 12 is placed in fluid communication with the processing line or vessel by interconnecting two-part connector 38 .
- Step 80 may initiate a manual sampling process 82 using manual controls 48 . Alternately, step 80 may initiate an automated sampling process using an algorithm 84 resident on processor 60 .
- algorithm 84 is configured to activate pump 20 to force fluid from the processing line or vessel through input conduit 34 and valve block 32 and into, as desired, any one of sample bags 28 and waste bag 30 .
- algorithm 84 is configured to control workstation 10 to a flush step 86 .
- algorithm 84 flushes or purges fluid through sample collection device 12 into waste bag 30 for a predetermined period of time by moving all of the valves 44 to the “flush” position.
- algorithm 84 initiates a sample step 88 in which the processor 60 moves the plurality of valves 44 in the manner discussed above with respect to Table No. 1 to divert a sample into the desired collection bag 28 .
- algorithm 84 completes the sample step 88 by deactivating pump 20 and returning the valves 44 to the “off” position.
- Algorithm 84 repeats the flush and sample steps 86 , 88 to activating pump 20 to flush fluid within sample collection device 12 to waste bag 30 , divert the sample to the desired sample bag 28 , deactivates the pump, and closes the valves until all of the desired samples have been obtained.
- algorithm 84 can use inputs from the flow meter to ensure proper sample and purge volumes.
- algorithm 84 can use inputs from the sensor to ensure proper sample and purge volumes.
- algorithm 84 is further configured to activate printer 64 to print data onto a label when a respective sample is obtained during a print step 90 . The operator can then apply the label on the appropriate sample bag 28 , respectively.
- algorithm 84 can be configured to activate printer 64 to print waste related data onto a label when the respective waste is collected or after all of the waste has been collected.
- the operator can manually and/or via controller 60 flush sample collection device 12 to waste bag 30 during a manual flush step 96 and divert a sample to the manual sample bag 28 , when present, during a manual sample step 98 .
- the operator can, during a disconnection step 92 , disconnect sample collection device 12 from the processing line or vessel by separating two-part connector 38 . Similarly, the operator can remove each sample bag 28 and waste bag 30 from sample collection device 12 by separating two-part connectors 38 .
- algorithm 84 purges a predetermined amount fluid from with sample collection device 12 before taking each sample to ensure that the fluid collected in sample bag 28 is representative of fluid in the processing line or vessel at the time of the sample.
- waste bag 30 has a volume that is sufficient to hold the purged fluid.
- a ratio of the volume of the waste bag 30 to the volume of the sample bag 28 is not more than 15:1, more preferably 10:1, with between 5:1 to 2:1 being most preferred.
- waste bag 30 provides a volume sufficient to allow sample collection device 12 to be flushed before taking each of the samples to ensure that the fluid collected in the sample bag 28 is representative of the liquid in the processing line and, not, fluid remaining within the sample collection from the prior sample.
- verification step 76 from method 70 is shown in more detail.
- processor 60 requires the user to scan bar code 66 on sample collection device 12 using scanner 62 in a scanning step 100 .
- method 70 can further include a process identification step 102 , where parameters and/or details of the process and/or liquid to be sampled are entered into processor 60 .
- the parameters and/or details can be entered manually into processor 60 by the operator, can be scanned into processor 60 using scanner 62 and an identifier located on the batch record and/or the process equipment, or any combination of manual and scanning data entry.
- Verification step 76 determines, based on data within processor 60 and information from bar code 66 , whether sample collection device 12 is new or has been previously used at a step 104 . If the sample collection device 12 has been previously used, verification step 76 returns the user to assembly step 74 so that a new collection device can be used.
- verification step 76 compares the details of the sample collection device (e.g., size and number of bags 28 , 30 ) to the sample protocol stored within processor 60 for the process being monitored at step 106 . If the sample collection device 12 is not correct for the samples that are required, verification step 76 returns the user to assembly step 74 so that a correct collection device can be used.
- the details of the sample collection device e.g., size and number of bags 28 , 30
- verification step 76 logs sample collection device 12 as being previously used within processor 60 at step 108 and instructs the operator at connection step 78 to place the sample collection device in fluid communication with the processing line or vessel via HMI 56 .
- sample collection device 12 is placed in fluid communication with the processing line or vessel by interconnecting two-part connector 38 .
Abstract
A sample collection device is provided. The collection device includes an input conduit, a plurality of automated sample collection bags, a waste collection bag, and a valve block. The input conduit is connectable to a fluid processing line. The automated sample collection bags each have a sample volume and the waste collection bag has a waste volume. The valve block a plurality of three-way valves and an output, where the plurality of three-way valves correspond in number to the plurality of automated sample collection bags, each of the three-way valves placing the input conduit in fluid communication with a different one of the plurality of sample collection bags. The output is in fluid communication with the waste collection bag. The collection device has a ratio of the waste volume to the sample volume of not more than 15:1.
Description
- This application is a divisional of U.S. application Ser. No. 12/959,647 filed Dec. 3, 2010, now pending, which claims the benefit of U.S. Provisional Application Ser. No. 61/266,545, filed Dec. 4, 2009, the entire contents of which are incorporated herein in their entirety by reference thereto.
- 1. Field of the Invention
- The present disclosure relates to automated aseptic sampling workstations. More particularly, the present disclosure relates to workstations for use in the automated taking of product samples during the processing of various fluids, as well as to sample collection devices used with such automated workstations.
- 2. Description of Related Art
- The processing of many fluid products can be performed in a sterile environment and/or an aseptic environment to protect the product and/or the manufacturing personnel from contamination. Such fluid 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. During such processing, it is known to sample or test the fluid product before, during, and after certain processing steps to ensure that the resultant product meets various acceptance criteria.
- In some instances, the sampling can be performed during or after certain process steps and/or at certain time intervals. In other instances, the sampling can be performed after the product has been made, but before the production batch is released for use by consumers.
- Importantly, the taking of a sample from the processing line is a critical activity and creates a potential risk of contaminating the product and/or the sample. Unfortunately, the risk of contamination often leads manufacturers to limit the number of samples that are obtained and/or to limit the number of locations where such samples are obtained.
- In addition, contamination of the sample may cause a false result, which can lead to the unneeded destruction of a product batch and/or unneeded delay in the continuation of the production process until the cause of the contamination is determined. Further, the need to clean and sterilize the sample path before and/or after each batch typically requires the sampling devices to be hard piped into a specific location in the production line, which can limit the flexibility of the processing line to process other products in a timely and efficient manner.
- Further, the samples that are taken must be properly identified by the operator responsible for taking the sample and this identifying information must then subsequently be input by the department responsible department responsible for testing the sample. The manual identification of samples by the sample taker and the manual input of this identity by the sample tester have proven to be error prone, which can further complicate the proper testing and release of product.
- Accordingly, it has been determined by the present disclosure that there is a need for workstations that can overcome, alleviate, and/or mitigate one or more of the aforementioned and/or other deleterious effects of the prior art. For example, it has been determined by the present disclosure that there is a need for workstations that automate sampling of fluid products, while ensuring sample integrity and eliminating the risk of sample and product contamination, and minimizing errors related to manual input of data related to the samples.
- A sample collection device is provided. The collection device includes an input conduit, a plurality of automated sample collection bags, a waste collection bag, and a valve block. The input conduit is connectable to a fluid processing line. The automated sample collection bags each have a sample volume and the waste collection bag has a waste volume. The valve block a plurality of three-way valves and an output, where the plurality of three-way valves correspond in number to the plurality of automated sample collection bags, each of the three-way valves placing the input conduit in fluid communication with a different one of the plurality of sample collection bags. The output is in fluid communication with the waste collection bag. The collection device has a ratio of the waste volume to the sample volume of not more than 15:1.
- An automated sample collection workstation is provided. The workstation includes a processor, a peristaltic pump, a valve actuator, and an algorithm. The peristaltic pump and the valve actuator are in electrical communication with the processor. The valve actuator can move a plurality of valves, when disposed therein, among an off position, a flush position, and a sample position. The algorithm is resident on the processor and is configured to: move all of the valves to the off position and place the pump in an off state when no sampling or flushing is required, move all of the valves to the flush position and place the pump in an on state for a predetermined flush time period when flushing is required, and move a respective one of the valves to the sample position, move any of the valves upstream of the respective valve to the flush position, and place the pump to the on state for a predetermined sample time period when a sample is required.
- A method of automatically taking a plurality of fluid samples from a processing line is provided. The method includes: cleaning a processing line having a first half of a two-part connector connected thereto; connecting a second half of the two-part connector to the first part, the second half part of a sample collection device, the sample connection device having a plurality of collection bags, a valve block, and an input conduit with the second half of the two-part connector, the valve block having an input, a plurality of three-way valves, and an output, the plurality of three-way valves corresponding in number to the plurality of collection bags, each of the three-way valves placing the input in fluid communication with a different one of the plurality of collection bags, the output being in fluid communication with a waste collection bag, the input being in fluid communication with the input conduit; and inserting the valve block into a valve actuator so that a handle of each of the plurality of valves is movable by the valve actuator.
- A method of automatically taking a plurality of fluid samples from a processing line is also provided that includes: placing an input conduit of a sample collection device in fluid communication with the processing line; operatively coupling the input conduit to a peristaltic pump and to an input of a valve block having a plurality of three-way valves; operatively coupling the valve block to a valve actuator so that each of the plurality of three-way valves is movable by a different portion of the valve actuator among an off position, a flush position, and a sample position; controlling the valve actuator to move all of the plurality of three-way valves to the flush position and turning on the peristaltic pump so that fluid from the processing line is pumped through the valve block to a waste bag in fluid communication with an output of the valve block; and controlling the valve actuator to move a particular valve of the plurality of three-way valves to the sample position and to move any of the plurality of three-way valves upstream of the particular valve to the flush position while the peristaltic pump remains on, the particular valve being associated with a particular sample bag so that fluid from the processing line is pumped through the valve block to the particular sample bag.
- The above-described and other features and advantages of the present disclosure will be appreciated and understood by those skilled in the art from the following detailed description and drawing.
-
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 plan view of the workstation ofFIG. 1 ; -
FIG. 3 is a top view of the workstation ofFIG. 1 ; -
FIG. 4 is a front, top perspective view of an exemplary embodiment of a sampling portion of the workstation ofFIG. 1 ; -
FIG. 5 is a perspective view of an exemplary embodiment of a sample set according to the present disclosure for use with the workstation ofFIG. 1 ; -
FIG. 6 is a perspective view of an exemplary embodiment of a valve block according to the present disclosure for use in the sample set ofFIG. 5 ; -
FIG. 7 is a flowchart illustrating an exemplary embodiment of a sampling method according to the present disclosure; and -
FIG. 8 is a flowchart illustrating an exemplary embodiment of a sample collection device verification method according to the present disclosure. - Referring to the figures, and in particular to
FIGS. 1 through 4 , an exemplary embodiment of an automated aseptic sampling workstation according to the present disclosure is shown and is generally referred to usingreference numeral 10.Workstation 10 is configured to automatically aseptically sample, label, and store, in sample collection device 12 (shown inFIG. 5 ), a plurality series of fluid samples from a processing line or vessel (A). - Workstation 10 is configured to automatically sample fluid samples including samples such as, but not limited to, pharmaceutical products (e.g., medicines and vaccines), food products, biological products, biochemical products, chemical products and any combinations thereof.
- Advantageously,
workstation 10 is flexibly configured, namely is configured so that the workstation can be moved from point-to-point and/or from one process step to another process step in a manufacturing process. Further,workstation 10 is preferably suitable for use in an aseptic or clean room environment such that the material selection (e.g., stainless steel or other material) and material specifications (e.g., surface finish) are sufficient for use in such environments. -
Workstation 10 includes a base orcabinet 14 supported, in some embodiments, by a plurality of wheels orcasters 16 such that the workstation is mobile and can be positioned, as desired, in various locations within a processing facility. -
Workstation 10 is includessampling portion 18 for pumping a fluid sample intosample collection device 12.Sampling portion 18 includes apump 20, avalve actuator 22, in some embodiments, aliquid edge detector 24, and a plurality ofsample holding areas 26. -
Pump 20 can be any desired pumping device but is, preferably, a non-contact pump that selectively draws fluid samples without directly contacting the fluid itself. In a preferred embodiment,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 ofsample collection device 12.Detector 24 can be in electrical communication withworkstation 10 so that the workstation can detect when fluid is present in a predetermined location insample collection device 12. - As seen in
FIG. 5 ,sample collection device 12 includes a plurality of sample collection bags 28 (six shown), at least one waste bag 30 (only one shown), and avalve block 32.Sample bags 28 can be configured to have any desired volume so that the volumes of the sample bags are identical to one another and/or different from one another. -
Sample bags 28 andwaste bags 30 can be any desired collection receptacle such as, but not limited to the Allegro™ 2D Biocontainer, which is commercially available from Pall Corporation. In this embodiment, eachbag input line 29 releasably sealed with a clamp 33, anoutput line 31 releasably sealed with a clamp 33, and aport 35. - In the illustrated embodiment,
sample collection device 12 include fiveautomated sample bags 28 of identical volume, e.g., about 50 milliliters (mL), and onemanual sample bag 28 of a larger volume, about 500 ml. Also, in the illustrated embodiment, thesample collection device 12 includes onewaste sample bag 30 of about 1,000 mL. Of course, it should be recognized that the number and volumes ofbags -
Device 12 further includes aninput conduit 34 configured to place the processing line in fluid communication withvalve block 32. -
Input conduit 34 includes at least oneflexible portion 36.Portion 36 is configured to operably mate withpump 20 so that the pump can force the fluid sample intobags sample collection device 12. In the example wherepump 20 is a peristaltic pump,flexible portion 36 is made of a material having sufficient resiliency (e.g., silicone tubing) to operate in cooperation with the peristaltic pump. -
Sample collection device 12 finds use with one or more two-part,aseptic connectors 38. In the illustrated embodiment,input conduit 34 has only one part 38-1 of a two-part connector 38 connected thereto. The mating part 38-2 for two-part connector 38 ofinput conduit 36 is in fluid communication with processing line or vessel A. - In this manner,
sample collection device 12 can be fluidly connected to the processing line or vessel by joining both halves 38-1, 38-2 of two part-connector 38 at the input conduit and the processing line or vessel to one another. In order to maintain sterility, the portion of the two-part connector 38-2 mated with the production line or vessel A can be sterilized or sanitized along with the production line or vessel before processing of the fluid. - Two-
part connector 38 can be any disposable, two-part aseptic connector such as, but not limited to the Kleenpak™ 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 AseptiQuik™ connector, which is commercially available from Colder Products Corporation. - In some embodiments of
sample collection device 12,sample bags 28,waste bag 30, andvalve block 32 are removably connected to one another. For example,sample collection device 12 can include a plurality ofconnectors 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 sample fluid without interacting or contaminating the sample. Moreover,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 inFIG. 6 , includes aninput 40, a waste output 44, and a plurality of three-way valves 46 (six shown). Theinput 40 is in fluid communication withinput conduit 34 andwaste output 42 is in fluid communication withwaste collection bag 30. - The plurality of three-way valves 44 correspond in number to the plurality of
collection bags 28, with asample output 46 from each of the valves being in fluid communication with adifferent collection bag 28. - Three-way valves 44 are each movable by rotation of a
valve handle 48 among three positions: an “off” position; a “flush” position; and a “sample” position. - In the off position, each valve 44 prevents fluid from
input 40 from flowing through the valve to eitherwaste output 42 orsample output 46. In the flush position, each valve 44 allows fluid frominput 40 to flow through the valve towardswaste output 42, but prevents flow toward itsrespective sample output 46. In the sample position, each valve 44 allows fluid frominput 40 to flow through the valve towards therespective sample output 46, but prevents flow toward thewaste 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. In this manner,workstation 10, viavalve actuator 22, is configured to actuatevalve block 32 to selectively divert sampled fluid from the processing line or vessel into any one ofsample bags 28 orwaste bag 30. - Referring now to Table No. 1 below, the relative positions of valves 44 are provided during various sampling activities contemplated by the present disclosure.
- Here, the plurality of valves 44 are sequentially numbered, in the direction of fluid flow, as valves 44-1 through 44-6 and the
sample bags 28 are sequentially numbered, in the direction of fluid flow, as bags 28-1 through 28-6. -
TABLE NO. 1 VALVE POSITION Valve 44-1 Valve 44-2 Valve 44-3 Valve 44-4 Valve 44-5 Valve 44-6 Not in use Off Off Off Off Off Off Flush to waste bag 30Flush Flush Flush Flush Flush Flush Sample to bag 28-1 Sample Off Off Off Off Off Sample to bag 28-2 Flush Sample Off Off Off Off Sample to bag 28-3 Flush Flush Sample Off Off Off Sample to bag 28-4 Flush Flush Flush Sample Off Off Sample to bag 28-5 Flush Flush Flush Flush Sample Off Sample to bag 28-6 Flush Flush Flush Flush Flush Sample - As seen in Table No. 1 above, when
sample collection device 12 is not in use, all of the valves 44 are rotated to the “off” position, preventing fluid communication throughvalve block 32. - Before sampling and/or whenever it is desired to flush or prime the fluid flow path within
sample collection device 12, each of the valves 44 can be rotated to the “flush” position, placinginput 40 in fluid communication withoutput 42. In this manner, fluid frominput conduit 34 is diverted to wastebag 30. - When sampling to a
particular sample bag 28 is desired, the particular valve 44 associated with thatparticular bag 28 is moved to the “sample” position. Further, any valve upstream, with respect to fluid flow throughvalve block 32, is moved to the flush position. Preferably, any valve 44 downstream, with respect to fluid flow throughvalve block 32, is moved to the off position. However, these downstream valves 44 can have any desired state. - When the sampling to a
particular sample bag 28 is completed, valves 44 are returned to the “off” position. - In use,
sample collection device 12 is positioned inworkstation 10 so thatflexible portion 36 ofinput conduit 34 is operatively positioned inpump 20 and so thatvalve block 32 is operatively positioned invalve actuator 22. When fluid is being process through the production line or vessel, the half of two-part connector 38 atinput conduit 34 is operatively connected to its mating half arranged on the line or vessel. -
Valve actuator 22 can be used by the operator to manually operate valves 44. For manual operation,workstation 10 includes one or more valve operating buttons or controls 48. - Alternately, and in a preferred embodiment,
valve actuator 22 can be automatically controlled byworkstation 12 as described in more detail herein below. Of course, it is contemplated by the present disclosure forvalve actuator 22 to be controlled by any combination of manual and automated control. - It has been determined by the present disclosure that
workstation 10, due to in part the use of two-part,aseptic connectors 38 in combination withsample collection device 12, can be selectively moved from point-to-point within the manufacturing process to perform the desired sampling as needed. Also,workstation 10 can be installed in a particular location within the manufacturing line when that line is set up to make a first product, but can then be relocated to a different location within the manufacturing line when that line is set up to make a second product. In other words,workstation 10 can reduce the equipment cost to monitor a manufacturing process by being used in multiple locations within the manufacturing line during a production run or by being repositioned to a different stationary position when the manufacturing line is reconfigured to accommodate the manufacture of different products. -
Workstation 10 can, in some embodiments, include a sample and wastebag holding area 50, which can maintainbags workstation 10 can include environmental controls sufficient to maintainbags workstation 10 can include agitation and/or vibration devices sufficient to maintain the sample withinbags -
Workstation 10 can include one ormore sensors 52 to monitor and record the conditions (e.g., temperature, humidity) withinbase 14, the conditions withinbags 28, 30 (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. - It is contemplated by the present disclosure for
workstation 10 to coordinate the control ofpump 20,valve actuator 22,liquid edge detector 24 andsensors 50 withinworkstation 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. - In some embodiments,
sample collection device 12 can include adisposable flow meter 58 in electrical communication withworkstation 10. - Thus,
workstation 10 can include aprocessor 60 having human-machine-interface (HMI) 56 with one ormore input devices 62 and one ormore output devices 64.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 ofworkstation 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 toprocessor 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 fromprocessor 60. - In a preferred embodiment,
HMI 56 includes at least onebar code reader 62 andsample collection device 12 can include at least one machinereadable label 66, which includes details regarding the sample collection device such as, but not limited to, the lot number, the expiration date, the number of sample andwaste bags waste bags readable label 66 ofsample collection device 12 usingbar code reader 62 so thatprocessor 60 can determine and record the various details regarding thesample collection device 12. - Further, it is contemplated by the present disclosure for
output devices 64 to include at least one printer.Processor 60controls printer 64 to print labels, which can be applied by the operator directly on eachbag processor 60 can controlprinter 64 to print information such as, but not limited to, date of sample, time of sample, operator, batch ID, program sequence, room number, station number, sample location, and other process or environmental variables. - Preferably,
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 sample within the bag, 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 ofpump 20,valve actuator 22,level sensor 24, manual controls 48,sensors HMI 56,flow meter 58,output devices 60, as well asbar code reader 62 andprinter 64. - In this manner,
processor 60 is configured to coordinate the control ofworkstation 10 and the collection of samples incollection device 12, as well as to provide information on labels for placement ontobags - In some examples,
processor 60 can communicate in wired and/or wireless manner with one or more computers (not shown) external toworkstation 10, where such external computers can include data collection, data archiving, data analysis and data management software. - The aseptic sampling ability of
workstation 10 andsample collection device 12 mitigate or eliminate the risk of contaminating the sample obtained or the processing line. -
Workstation 10, viaprocessor 60, can be programmed to aseptically obtain one or a series of samples taken randomly, at manual selected times or at pre-set times and with manually selected volumes or pre-set volumes. - Referring now to
FIG. 7 , amethod 70 of operatingworkstation 10 havingsample collection device 12 is shown. - In a first or
selection step 72, the appropriatesample collection device 12 for desired sampling is selected by the operator. - In a second or
assembly step 74, the operator assembles the selectedsample collection device 12 inworkstation 10. Specifically,bags area 50,valve block 32 is operatively positioned invalve actuator 22, andflexible portion 36 ofinput conduit 34 is operatively positioned inpump 20. When levelliquid edge detector 24 is present, a portion ofinput conduit 34 is operatively positioned in the detector. - In a third or
verification step 76, the operator inputs information related to thesample collection device 12 intoprocessor 60 and inputs information related to the desired processing line or vessel from whichworkstation 10 will be taking samples. In some embodiments, theverification step 76 includes requiring the operator to usescanner 62 to scanbar code 66 onsample collection device 12. - Once
processor 60 verifiessample collection device 12, the processor sends an output to the operator in a fourth orconnection step 78 to instruct the operator to place the sample collection device in fluid communication with the processing line or vessel viaHMI 56. As discussed in detail above,sample collection device 12 is placed in fluid communication with the processing line or vessel by interconnecting two-part connector 38. - When the fluid is present in the processing line or vessel, the operator initiates a desired sampling sequence of
workstation 10 duringstep 80.Step 80 may initiate amanual sampling process 82 using manual controls 48. Alternately, step 80 may initiate an automated sampling process using analgorithm 84 resident onprocessor 60. - During automated sampling process,
algorithm 84 is configured to activatepump 20 to force fluid from the processing line or vessel throughinput conduit 34 andvalve block 32 and into, as desired, any one ofsample bags 28 andwaste bag 30. - Before taking each sample,
algorithm 84 is configured to controlworkstation 10 to aflush step 86. Duringflush step 86,algorithm 84 flushes or purges fluid throughsample collection device 12 intowaste bag 30 for a predetermined period of time by moving all of the valves 44 to the “flush” position. - Then, after the predetermined purge or flush of
step 86,algorithm 84 initiates asample step 88 in which theprocessor 60 moves the plurality of valves 44 in the manner discussed above with respect to Table No. 1 to divert a sample into the desiredcollection bag 28. - After a predetermined volume of sample fluid has been diverted into the selected
collection bag 28,algorithm 84 completes thesample step 88 by deactivatingpump 20 and returning the valves 44 to the “off” position. -
Algorithm 84 repeats the flush and sample steps 86, 88 to activatingpump 20 to flush fluid withinsample collection device 12 to wastebag 30, divert the sample to the desiredsample bag 28, deactivates the pump, and closes the valves until all of the desired samples have been obtained. - In embodiments where
sample collection device 12 includesflow meter 58,algorithm 84 can use inputs from the flow meter to ensure proper sample and purge volumes. Similarly, in embodiments whereworkstation 10 includesfluid edge sensor 24,algorithm 84 can use inputs from the sensor to ensure proper sample and purge volumes. - Preferably,
algorithm 84 is further configured to activateprinter 64 to print data onto a label when a respective sample is obtained during aprint step 90. The operator can then apply the label on theappropriate sample bag 28, respectively. Similarly,algorithm 84 can be configured to activateprinter 64 to print waste related data onto a label when the respective waste is collected or after all of the waste has been collected. - During
manual sampling process 94, the operator can manually and/or viacontroller 60 flushsample collection device 12 to wastebag 30 during a manualflush step 96 and divert a sample to themanual sample bag 28, when present, during amanual sample step 98. - Once all of the samples have been obtained, the operator can, during a
disconnection step 92, disconnectsample collection device 12 from the processing line or vessel by separating two-part connector 38. Similarly, the operator can remove eachsample bag 28 andwaste bag 30 fromsample collection device 12 by separating two-part connectors 38. - Advantageously,
algorithm 84 purges a predetermined amount fluid from withsample collection device 12 before taking each sample to ensure that the fluid collected insample bag 28 is representative of fluid in the processing line or vessel at the time of the sample. - In order to perform the desired purging,
waste bag 30 has a volume that is sufficient to hold the purged fluid. In the illustrated embodiment, a ratio of the volume of thewaste bag 30 to the volume of thesample bag 28 is not more than 15:1, more preferably 10:1, with between 5:1 to 2:1 being most preferred. In this manner,waste bag 30 provides a volume sufficient to allowsample collection device 12 to be flushed before taking each of the samples to ensure that the fluid collected in thesample bag 28 is representative of the liquid in the processing line and, not, fluid remaining within the sample collection from the prior sample. - Referring now to
FIG. 8 , an exemplary embodiment ofverification step 76 frommethod 70 is shown in more detail. Duringverification step 76,processor 60 requires the user to scanbar code 66 onsample collection device 12 usingscanner 62 in ascanning step 100. - In some embodiments, prior to scanning
step 94,method 70 can further include aprocess identification step 102, where parameters and/or details of the process and/or liquid to be sampled are entered intoprocessor 60. The parameters and/or details can be entered manually intoprocessor 60 by the operator, can be scanned intoprocessor 60 usingscanner 62 and an identifier located on the batch record and/or the process equipment, or any combination of manual and scanning data entry. -
Verification step 76 determines, based on data withinprocessor 60 and information frombar code 66, whethersample collection device 12 is new or has been previously used at astep 104. If thesample collection device 12 has been previously used,verification step 76 returns the user toassembly step 74 so that a new collection device can be used. - If the
sample collection device 12 is new,verification step 76 compares the details of the sample collection device (e.g., size and number ofbags 28, 30) to the sample protocol stored withinprocessor 60 for the process being monitored atstep 106. If thesample collection device 12 is not correct for the samples that are required,verification step 76 returns the user toassembly step 74 so that a correct collection device can be used. - If the
sample collection device 12 is correct,verification step 76 logssample collection device 12 as being previously used withinprocessor 60 atstep 108 and instructs the operator atconnection step 78 to place the sample collection device in fluid communication with the processing line or vessel viaHMI 56. As discussed in detail above,sample collection device 12 is placed in fluid communication with the processing line or vessel by interconnecting two-part connector 38. - It should also be noted that the terms “first”, “second”, “third”, “upper”, “lower”, and the like may be used herein to modify various elements. These modifiers do not imply a spatial, sequential, or hierarchical order to the modified elements unless specifically stated.
- While the present disclosure has been described with reference to one or more exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the present disclosure. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the disclosure without departing from the scope thereof. Therefore, it is intended that the present disclosure not be limited to the particular embodiment(s) disclosed as the best mode contemplated, but that the disclosure will include all embodiments falling within the scope of the present disclosure.
Claims (16)
1. A sample collection device, comprising:
an input conduit being connectable to a fluid processing line;
a plurality of automated sample collection bags each having a sample volume;
a waste collection bag having a waste volume;
a valve block having a plurality of three-way valves and an output, the plurality of three-way valves corresponding in number to the plurality of sample collection bags, each of the three-way valves placing the input conduit in fluid communication with a different one of the plurality of sample collection bags, the output being in fluid communication with the waste collection bag, and
a ratio of the waste volume to the sample volume is not more than 15:1.
2. The sample collection device of claim 1 , wherein the ratio is 10:1.
3. The sample collection device of claim 1 , wherein the ratio is between 5:1 to 2:1.
4. The sample collection device of claim 1 , further comprising a machine readable label on the valve block, the machine readable label including information regarding physical characteristics of the sample collection device.
5. The sample collection device of claim 4 , wherein the physical characteristics are selected from the group consisting of a lot number, an expiration date, a number of the sample bags, a number of the waste bag, a volume of each sample bag, a volume of the waste bag, and any combinations thereof.
6. The sample collection device of claim 1 , further comprising a first part of a two-part aseptic connector on the input conduit.
7. The sample collection device of claim 1 , further comprising a disposable flow meter in the input conduit.
8. A sample collection device, comprising:
an input conduit being connectable to a fluid processing line;
a plurality of automated sample collection bags each having a sample volume;
a valve block having a plurality of three-way valves, the plurality of three-way valves corresponding in number to the plurality of sample collection bags, each of the three-way valves placing the input conduit in fluid communication with a different one of the plurality of sample collection bags; and
a first part of a two-part aseptic connector on the input conduit.
9. The sample collection device of claim 8 , further comprising a machine readable label on the valve block, the machine readable label including information regarding physical characteristics of the sample collection device.
10. The sample collection device of claim 8 , further comprising a disposable flow meter in the input conduit.
11. The sample collection device of claim 8 , wherein the valve block further comprises an output.
12. The sample collection device of claim 11 , wherein the output is in fluid communication with a waste collection bag having a waste volume sufficient to allow flushing to the waste collection bag prior to collecting a sample in each of the sample collection bags.
13. The sample collection device of claim 12 , further comprising a ratio of the waste volume to the sample volume is not more than 15:1.
14. The sample collection device of claim 13 , wherein the ratio is 10:1.
15. The sample collection device of claim 13 , wherein the ratio is between 5:1 to 2:1.
16. The sample collection device of claim 11 , wherein each of the plurality of three-way valves is movable by rotation of a valve handle among an off position, a flush position, and a sample position,
wherein, when in the off position, each valve prevents fluid from the input conduit from flowing to either the output or any of the plurality of automated sample collection bags,
wherein, when in the flush position, each valve allows fluid from the input conduit to flow through the output, but prevents flow toward any of the plurality of automated sample collection bags, and
wherein, when in the sample position, each valve allows fluid from the input conduit to flow to a respective one of the plurality of automated sample collection bags and prevents flow to the output.
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US14/076,238 US20140060215A1 (en) | 2009-12-04 | 2013-11-10 | Automated Aseptic Sampling Workstations and Sample Collection Devices Therefore |
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US26654509P | 2009-12-04 | 2009-12-04 | |
US12/959,647 US8640556B2 (en) | 2010-12-03 | 2010-12-03 | Automated aseptic sampling workstation and sample collection devices therefore |
US14/076,238 US20140060215A1 (en) | 2009-12-04 | 2013-11-10 | Automated Aseptic Sampling Workstations and Sample Collection Devices Therefore |
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US12/959,647 Division US8640556B2 (en) | 2009-12-04 | 2010-12-03 | Automated aseptic sampling workstation and sample collection devices therefore |
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US20140060215A1 true US20140060215A1 (en) | 2014-03-06 |
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US12/959,647 Expired - Fee Related US8640556B2 (en) | 2009-12-04 | 2010-12-03 | Automated aseptic sampling workstation and sample collection devices therefore |
US14/076,240 Abandoned US20140060214A1 (en) | 2009-12-04 | 2013-11-10 | Automated Aseptic Sampling Workstations and Sample Collection Devices Therefore |
US14/076,238 Abandoned US20140060215A1 (en) | 2009-12-04 | 2013-11-10 | Automated Aseptic Sampling Workstations and Sample Collection Devices Therefore |
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US12/959,647 Expired - Fee Related US8640556B2 (en) | 2009-12-04 | 2010-12-03 | Automated aseptic sampling workstation and sample collection devices therefore |
US14/076,240 Abandoned US20140060214A1 (en) | 2009-12-04 | 2013-11-10 | Automated Aseptic Sampling Workstations and Sample Collection Devices Therefore |
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US20140060214A1 (en) | 2014-03-06 |
US8640556B2 (en) | 2014-02-04 |
US20120137793A1 (en) | 2012-06-07 |
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