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WO2003039961A2 - Collecteur d'echantillonnage - Google Patents

Collecteur d'echantillonnage Download PDF

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Publication number
WO2003039961A2
WO2003039961A2 PCT/US2002/035974 US0235974W WO03039961A2 WO 2003039961 A2 WO2003039961 A2 WO 2003039961A2 US 0235974 W US0235974 W US 0235974W WO 03039961 A2 WO03039961 A2 WO 03039961A2
Authority
WO
WIPO (PCT)
Prior art keywords
manifold
assembly
fluid
valve
sampling
Prior art date
Application number
PCT/US2002/035974
Other languages
English (en)
Other versions
WO2003039961A3 (fr
Inventor
Ronald E. Thomas, Jr.
Original Assignee
Entegris, 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
Application filed by Entegris, Inc. filed Critical Entegris, Inc.
Publication of WO2003039961A2 publication Critical patent/WO2003039961A2/fr
Publication of WO2003039961A3 publication Critical patent/WO2003039961A3/fr

Links

Classifications

    • 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
    • F16K27/00—Construction of housing; Use of materials therefor
    • F16K27/003—Housing formed from a plurality of the same valve elements
    • 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

Definitions

  • the present invention relates generally to obtaining samples of fluids and, more particularly, to a method and apparatus for obtaining a sample from a process without introducing contaminants.
  • Fluid sampling systems are often used to obtain one or more samples from an aseptic process.
  • Such aseptic processes are often employed in bioreactors and fermentors to manufacture chemicals and other substances for the biotechnology, pharmaceutical and food product industries.
  • These chemicals and substances may be enzymes, pharmaceuticals, food products, pigments or cultured microorganisms.
  • Bioreactors and fermentors are particularly sensitive to the introduction of contaminants such as undesirable microorganisms. This sensitivity stems, in part, from the reactor's favorable environment for the growth of such organisms. Additionally, the process occurring within the system may be impaired or spoiled by the introduction of impurities.
  • a septum port is a portion of the reactor vessel provided with a piercable elastomeric material through which a sample may be drawn. This material comprises a barrier between the aseptic environment of the reactor or vessel and the external environment.
  • a sterile cannula or hollow needle is used to pierce the elastomeric material and draw a sample from the vessel.
  • the sterilization is not usually complete.
  • the inside surfaces of the needle and the external portion of the elastomeric material may be sources of contamination.
  • airflow around the puncture site created by negative pressure from withdrawing a sample may introduce contamination to the system.
  • Another known method of aseptic sampling is through the use of a custom designed manifold in fluidic communication with the contents of the vessel or reactor.
  • custom manifolds are constructed of metal alloys.
  • One or more sterile sampling tubes can be attached to the manifold to withdraw samples.
  • the alloy components of the manifold cannot be effectively sterilized by radiation. Sterilization with steam or solvents does not produce sufficient cleanliness for many contaminant sensitive applications. Moreover, water vapor and/or solvent may be retained within the system, thereby contaminating the fluid samples.
  • Custom manifolds also do not permit sterilization of the manifold attachment points when assembled. Such attachment points may be sources of contamination.
  • the manifold is also often assembled in a non-sterile environment and, therefore, may contain contamination. The manifold must be removed for re-sterilization and subsequently reattached to the vessel assembly, thereby compromising sterility.
  • a further known method of aseptic sampling is through the use of metal valves and glass containers. These items can be sterilized in an autoclave and provided to the system in a manner similar to the manifold described above. This method requires the assembly of the valve, sampling container and a vent filter after each of the respective parts has been sterilized. Contaminants introduced during assembly cannot be removed due to the inability to re-sterilize the components and all contact points when at the service location.
  • U.S. Patent No. 5,409,841 discloses another method of obtaining an aseptic sample. This patent discloses a sampling tube with a pierceable septum wherein the piercing takes place within a sealable container including an ultraviolet (UV) light source for sterilization.
  • UV ultraviolet
  • This sampling method and apparatus requires separate sterilization of the sampling tube.
  • the tube can be potentially contaminated before introduction into a box or housing. Once contaminants enter the housing, they have the potential to contaminate the process or sample even if a UV light source is used to sterilize a portion of the sample tube.
  • the UV light source cannot sterilize the inside of the needle, which may allow contaminants to pass into the system.
  • the apparatus and method disclosed in U.S. Patent No. 5,409,841 is not easily portable, has many components and requires a power supply to operate the UV light source. The complexity is increased significantly when configured to obtain multiple simultaneous samples.
  • U.S. Patent No. 6,032,543 discloses a pierceable septum type-sampling device.
  • a transfer member is provided to a fastening device fastened to the tank containing the fluid to be sampled.
  • the transfer member contains a hypodermic needle that pierces a seal to withdraw a sample from within the tank. The sample is then collected in a vessel connected to the needle.
  • the sampling device according to U.S. Patent No. 6,032,543 must be assembled in the field prior to the tank being used and then sterilized along with the tank. There is no means disclosed to reseal the sampling system once the desired sample has been provided.
  • the sampling device according to U.S. Patent No. 6,032,543 is further subject to certain of the drawbacks associated with the pierceable septum methods described above.
  • the apparatus in one embodiment may include a manifold assembly comprising a manifold body defining a fluid flow path and a primary valve disposed within the body for controlling fluid flow.
  • a secondary valve is contained within a secondary housing that communicates with the manifold assembly for controlling fluid flow into individual sampling vessels.
  • the sampling apparatus may be comprised of fluoroplastics, which permits the complete assembly to be sterilized by irradiation.
  • the method may include sterilizing a sampling manifold with radiation, coupling the manifold process fluid conduit, opening a primary flow valve and then opening a secondary valve to allow flow into a sampling vessel.
  • a venting assembly may also be provided to the secondary housing to prevent contaminated air from entering the apparatus.
  • the invention also includes the method of manufacturing and method of providing the apparatus as well as systems incorporating the apparatus.
  • SIP steam-in-place
  • FIG. 1 is a front view of a sampling manifold according to an embodiment of the present invention.
  • FIG. 2 is a top view of a sampling manifold according to an embodiment of the present invention.
  • FIG. 3 is a side view with partial section detail along line A-A of FIG. 1.
  • FIG. 4 is a partial sectional view showing detailed aspects of FIG. 3.
  • FIG. 5 is a partial sectional view showing detailed aspects of FIG. 3 according to an alternative embodiment of the present invention.
  • FIG. 6 is a partial sectional view showing detailed aspects of FIG. 3.
  • FIG. 7 is a side view of a system of a biopharm sampling manifold according to an embodiment of the present invention coupled to a steam-in-place apparatus and in fluidic communication with a reactor.
  • FIG. 8 is a top view of a sampling manifold according to an embodiment of the present invention.
  • FIG. 9 is a front view of a sampling manifold according to an embodiment of the present invention.
  • FIG. 10 is a side sectional view of a sampling manifold according to an embodiment of the present invention.
  • FIG. 11 is a top diagrammatic view of the primary flow control valve utilized in the embodiment of the present invention shown in FIG. 8.
  • FIG. 12 is a top diagrammatic view of the secondary flow control valve utilized in the embodiment of the present invention shown in FIG. 8.
  • Bioreactors and fermentors normally operate in an aseptic state.
  • An aseptic state is understood to mean that the particular process contains only the desired organism(s).
  • Sterility is defined to be the absence of all organisms. Devices used for sampling aseptic processes can also be used to sample sterile processes. Therefore, it is understood that the use of the term "aseptic" when applied to sampling may include sterile sampling as well.
  • bioreactor, reactor, and fermentor are meant to refer to a reaction vessel for containing a chemical or biological process.
  • the sampling manifold disclosed herein may also be used in non-sterile and non-aseptic applications as well as food industries for the processing of items such as dairy products and beverages.
  • the biopharm sampling manifold 20 generally comprises a manifold assembly 22 fluidically connected to one or more secondary housing assemblies 24, which are fluidically connected to a respective one or more sample collection vessels 26.
  • the manifold assembly 22 comprises a manifold block 28 having internal fluid conduits 30 defined therein.
  • the fluid conduits 30 communicate with a sanitary coupling 32 disposed on the manifold body 28 and a plurality of secondary conduits 34 extending from the manifold block.
  • a primary flow control valve assembly 36 is disposed within the block body 28 to regulate the flow of fluids through the internal fluid conduits 30.
  • the primary valve assembly 36 comprises a valve 38 actuatable by a handle 40, as shown in FIG. 6.
  • the valve element 42 seals against the valve seat 44 to prevent flow of fluid through the manifold 28 when the valve 38 is in the closed position.
  • An operator may open the valve 38 by rotating the valve handle 40, which causes the threaded actuator
  • valve element 42 which is preferably a bellows-type sanitary valve, such as a manual five-turn needle valve.
  • the interior 48 of the bellows 50 is vented through a valve port 52 to permit retraction of the bellows 50.
  • the secondary conduits 34 are inserted into the manifold block 28 and securely retained by the placement of a lock ring 54.
  • the secondary housing assemblies 24 each comprise a housing body 56, a vent assembly 58, a secondary valve 60 and an outlet 62 for transmitting process fluid to the sample collection vessel 26.
  • the secondary conduit 34 communicates fluid to the housing body 56 from the manifold assembly 22.
  • the secondary conduit 34 is preferably constructed of an upper portion 64 and a lower portion 66 that are welded together along an interface 68 during the manufacturing process (as shown in FIG. 1). Such welding may be accomplished by infrared welding techniques, known to those having skill in the art. 5
  • the process fluid flows through the housing body 56 until reaching the secondary valve 60, which is preferably a quarter-turn stopcock valve.
  • the secondary valves 60 selectively permit the passage of process fluid into the collection vessels 26.
  • the secondary valves 60 also include an actuator 70.
  • the actuator 70 may be either a manual type or an automated type as part of an automated sampling process.
  • Each secondary housing 24 may be provided with a filter or vent assembly 58 in communication with the collection vessel 26. This communication takes place via a gas conduit 72 defined within the secondary housing 56. Communication through the gas conduit 72 may be selectively permitted by operation of the secondary valve 60.
  • the filter assembly 58 prevents contaminants from compromising the sterility of the sampling 5 manifold 20 if the inner pressure of the vessel 26 becomes lesser than the ambient pressure. Additionally, the filter assembly 58 will filter any gas expelled during a filling operation.
  • the filter assembly 58 according to a preferred embodiment is depicted in FIG. 4.
  • a primary filter membrane 74 is provided over the air intake 76 of the secondary housing.
  • the retainer 78 holds the primary filter 74 in place.
  • the primary filter 74 is preferably a commercially available .22 micron filter. However, those skilled in the art will recognize that alternative filter types may be used to accomplish the filtering function without departing from the scope of the present invention.
  • the retainer 78 includes a gas or air passage 80.
  • the air passage 80 receives a secondary filter assembly 82, which includes a
  • the secondary filter assembly 82 has its own interior gas or air passage 83 that communicates with air passage 80.
  • the secondary filter 81 is preferably a .22-micron hydrophobic filter.
  • the vent assembly 58 eliminates the need for negative pressure within the sample collection vessel 26 to collect a desired sample because air in the vessel 26 can escape during a filling procedure.
  • the retainer 84 is a two-piece design having a removable cap 86 engaged with a retainer ring 88.
  • the cap 86 is threaded to engage the ring 88, which prevents gas from entering or escaping through the primary filter membrane 74.
  • the cap 86 is removed to permit exchange of air and/or gas.
  • the sample collection vessels 26 may take many shapes, sizes and forms to accommodate varied fluids and sample volumes.
  • the secondary housing assembly 24 is provided with an outlet 62 that is configured to seal against the sample collection vessel 26. This seal may be accomplished by way of plastic welding or a tongue and groove interface with the neck of a vessel 26. Other methods of joining the vessel 26 and the outlet 62, such as threads and interference fits are contemplated by the present invention.
  • the manifold assembly is coupled to a steam-in-place (SIP) coupling assembly 92.
  • SIP's 92 are known to those skilled in the art and available from commercial sources.
  • the SIP 92 is additionally coupled to the primary conduit 94 and in fluidic communication with the bioreactor or fermentor 96.
  • the SIP 92 allows the manifold assembly 22 to be coupled with the primary conduit 94 and sterilized in-place before process fluid flows therethrough. Steam or other sterilizing means is used to ensure that the contact surfaces at the point of coupling with the sanitary coupling of the manifold assembly is sterile.
  • a platform 98 is optionally provided to support the sampling manifold 20 and vessels 26.
  • the sampling manifold 20 depicted in FIGS. 1-6 is configured to receive five sample collection vessels 26.
  • the sampling manifold 20 according to the present invention may be configured to provide as few as one or more than five vessels 26. Most preferably the sampling manifold 20 is configured for two to eight sample collection vessels 26.
  • the sampling manifold 20 is assembled from its various components and assemblies.
  • the manifold 20 is then preferably purged with a non-reactive gas, such as nitrogen.
  • a non-reactive gas such as nitrogen.
  • a non-reactive gas such as nitrogen.
  • the manifold 20 is sealed as part of the purging procedure to maintain a positive pressure, such as 3 pounds of pressure per square inch. Maintaining this slight pressure assists in preventing contaminants from entering the sealed manifold 20.
  • the manifold 20 is then sterilized, preferably by use of Gamma-type irradiation. Then the sterile manifold 20 may be double-bagged to preserve the sterility and conveyed to the location of use. Although the pressurization may be reduced during transport or storage, it has been found to greatly facilitate the providing of a highly clean apparatus.
  • the sterile sampling manifold 20 is coupled to the SIP 92 via the sanitary coupling 32.
  • the coupling action creates a possible source of contamination where the sanitary coupling 32 contacts the SIP 92. Therefore, the coupling 32 and SIP 92 are sterilized to eliminate any contaminants at the points of contact. Sterilization is accomplished preferably by the use of steam, although those of skill in the art will recognize that other methods may be employed without departing from the spirit and scope of the present invention.
  • the primary valve 38 When a sample is desired, the primary valve 38 is opened, thereby permitting process fluid to flow into the internal conduit 30 and the secondary conduit 34. At this point, the internal conduit 30 and secondary conduit 34 may have sterile air trapped within.
  • the secondary valve 60 is then opened to permit trapped sterile air to escape through the vent 58 and process fluid to flow into a particular vessel 26.
  • the action of opening the secondary valve 60 opens the filtered vent assembly 58 to permit positive pressure during sample collection. Any ambient air that may enter the vessel 38 during sampling must pass through the filter element 74 to remove contaminants. The operator may open more than one secondary valve 60 simultaneously obtain multiple samples.
  • the secondary valve 60 When a desired amount of process fluid has been delivered to the vessel 26, the secondary valve 60 is closed to prevent further flow.
  • the primary valve 38 is then closed to seal off the primary conduit 94 from the sampling manifold 20.
  • the vessels 26 are removed by severing a respective secondary conduit 34 with a cutting tool.
  • the sealed aseptic or sterile sample can then be transported to a separate location, if desired, to remove the sample from the container 26.
  • the remaining portions of the manifold assembly 20 may then be discarded or recycled.
  • the various components of the sampling manifold 20, as described herein, are preferably constructed of non-metallic material, such as PFA, PTFE and other fluoropolymers. Such materials are capable of being irradiated with Gamma radiation for sterilization. The use of Gamma irradiation to sterilize components is known to those of skill in the art.
  • the components of the manifold of irradiatable materials By constructing the components of the manifold of irradiatable materials, the entire assembly can be sterilized in its assembled state. Referring to FIGS. 8-10, another embodiment of the present invention is illustrated.
  • a three-way valve 100 is utilized in the manifold block 102.
  • the three-way valve 100 allows the operator or automated control equipment to selectively supply process fluids to a first sample receptacle 104 while maintaining a second sample receptacle 106 isolated from the process fluid. Such isolation allows the user to take separate samples at two different times. A four-way valve will allow three different sampling times.
  • the manifold block 102 is shown without a secondary housing or a filter assembly. Secondary valves 108 are included within the manifold block 102 to selectively permit flow into the collection vessels 104 and 106.
  • the three way valve according to a preferred embodiment is disclosed in co- pending U.S. Provisional Patent Application Serial No. , entitled
  • FIG. 11 illustrates the positioning of the primary control valve 100.
  • the valve 100 may be rotated from the off 110, or no flow, position to the left 112, which permits flow to the left sample receptacle 104.
  • the valve may then be rotated right 114, passing through the closed position 110, permitting flow to the right sample receptacle 106.
  • the secondary valves 108 may also utilize the design disclosed in co-pending U.S.
  • the three way valve design selectively permits communication between closed 116, fill 118 and purge 120 positions.
  • the valve includes a purge port 122, disposed thereon.
  • the closed position 116 prevents flow to the sample collection vessel 26.
  • the fill position 118 permits flow to the sample collection vessel 26.
  • the purge position 120 allows gas or fluids to escape the manifold. This may occur during a filling operation or during the nitrogen purge procedure, as described hereinabove.
  • One or both of the primary 100 or secondary valves may also include a position lock mechanism 124, which is also disclosed in co-pending U.S. Provisional Patent
  • the lock mechanism allows the respective valve to be secured in a given position. For example, all the valves of the manifold device may be locked in the closed position after the purging procedure.

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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)
  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Abstract

L'invention concerne un appareil et un procédé, qui permettent d'obtenir des échantillons de bioréacteurs ou analogues. Dans un mode de réalisation, l'appareil peut comprendre un ensemble collecteur, qui comprend un corps de collecteur délimitant un circuit d'écoulement du liquide et une soupape principale disposée à l'intérieur du corps pour réguler l'écoulement du liquide. Une soupape secondaire est disposée à l'intérieur d'un boîtier secondaire communiquant avec l'ensemble collecteur pour réguler l'écoulement du liquide vers l'intérieur de cuves d'échantillonnage individuelles. L'appareil d'échantillonnage peut être constitué de plastique fluoré permettant de stériliser l'ensemble complet par irradiation. Le procédé peut consister à: stériliser un collecteur d'échantillonnage par irradiation; raccorder le conduit du liquide de traitement du collecteur; ouvrir une soupape d'écoulement principale, puis une soupape d'écoulement secondaire pour permettre l'écoulement d'un débit vers l'intérieur d'une cuve d'échantillonnage. Un filtre peut également être mis en place pour filtrer le gaz pénétrant dans l'appareil.
PCT/US2002/035974 2001-11-08 2002-11-08 Collecteur d'echantillonnage WO2003039961A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US33678201P 2001-11-08 2001-11-08
US60/336,782 2001-11-08

Publications (2)

Publication Number Publication Date
WO2003039961A2 true WO2003039961A2 (fr) 2003-05-15
WO2003039961A3 WO2003039961A3 (fr) 2003-08-14

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/035974 WO2003039961A2 (fr) 2001-11-08 2002-11-08 Collecteur d'echantillonnage

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3285073A1 (fr) * 2016-08-16 2018-02-21 Sartorius Stedim Biotech GmbH Unité et système de transport automatique
CN107882553A (zh) * 2017-12-13 2018-04-06 李振文 注聚物在线密闭取样装置
US11987784B2 (en) 2020-06-16 2024-05-21 Saint-Gobain Performance Plastics Corporation Sampling system and method of using the same

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4454772A (en) * 1981-11-06 1984-06-19 Texaco Inc. Method for sampling a fluid from a well
US4974456A (en) * 1988-02-24 1990-12-04 The Dow Chemical Company Zero head space sampling method

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3285073A1 (fr) * 2016-08-16 2018-02-21 Sartorius Stedim Biotech GmbH Unité et système de transport automatique
WO2018033579A1 (fr) * 2016-08-16 2018-02-22 Sartorius Stedim Biotech Gmbh Unité et système de transport automatisés
CN110088630A (zh) * 2016-08-16 2019-08-02 自动化合作关系（剑桥）有限公司 自动运输单元和系统
US11175299B2 (en) 2016-08-16 2021-11-16 The Automation Partnership (Cambridge Limited) Automated transport unit and system
CN110088630B (zh) * 2016-08-16 2022-12-16 自动化合作关系（剑桥）有限公司 自动运输单元和系统
CN107882553A (zh) * 2017-12-13 2018-04-06 李振文 注聚物在线密闭取样装置
US11987784B2 (en) 2020-06-16 2024-05-21 Saint-Gobain Performance Plastics Corporation Sampling system and method of using the same

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Publication number Publication date
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