WO2006119053A1 - Disposable vessel for the containment of biological materials and corrosive reagents - Google Patents

Disposable vessel for the containment of biological materials and corrosive reagents Download PDF

Info

Publication number
WO2006119053A1
WO2006119053A1 PCT/US2006/016333 US2006016333W WO2006119053A1 WO 2006119053 A1 WO2006119053 A1 WO 2006119053A1 US 2006016333 W US2006016333 W US 2006016333W WO 2006119053 A1 WO2006119053 A1 WO 2006119053A1
Authority
WO
WIPO (PCT)
Prior art keywords
bag
film
fluoropolymer
overwrap
radiation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2006/016333
Other languages
English (en)
French (fr)
Inventor
Lauri Laurene Jenkins
Jay Irving Kennedy
Victor Sisto Lusvardi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
EIDP Inc
Original Assignee
EI Du Pont de Nemours and Co
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 EI Du Pont de Nemours and Co filed Critical EI Du Pont de Nemours and Co
Priority to JP2008509187A priority Critical patent/JP2008539044A/ja
Priority to EP06751823A priority patent/EP1874915A1/en
Publication of WO2006119053A1 publication Critical patent/WO2006119053A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • 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
    • C12M45/00—Means for pre-treatment of biological substances
    • C12M45/22—Means for packing or storing viable microorganisms
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]

Definitions

  • WFI is also well known as being a highly corrosive material, which provides a severe test of extractability of organics (organic compounds) from any polymer container. Resistance to extraction is determined by maintaining the copolymer container being tested and containing 250 ml of the WFI at 4O 0 C for 63 days, followed by analysis of the WFI for organics, that could only come from (by extraction from) the fluoropolymer. For the above- described bag, no organics were found in the WFI present in the bag under the above conditions. The detection limit for the analysis was 50 ppb. Further details on the analysis as part of the extraction test and the application " of ff ⁇ is ' test to other test liquids and other polymers are disclosed later herein.
  • the preferred method of sterilization involves exposing the flexible bag through the overwrap to a sterilizing effective amount of gamma radiation. This sterilizes the container, both its interior and exterior surfaces, and the interior surface of the overwrap and the overwrap maintains the sterilized condition until the package is opened by the user for storage of the biological material.
  • a sterilizing effective amount of gamma radiation For ETFE, the integrity of the container is substantially unaffected by the exposure to gamma radiation.
  • An example of heat sealing of overlapping films of FEP (melting temperature of about 26O 0 C) is as follows: A pair of hot bars are heated to 290°C and pressed against overlapping FEP film having a total film thickness of 5 mils (0.125 mm) under a pressure for 30 psi to provide the fusion seal in 0.5 sec. For ETFE, overlapping films each 4 mils (0.1 mm) thick, the hot bars of the impulse sealer are heated to 230 0 C and a pressure of 60 psi (42 MPa) for about 10 sec to obtain the fusion seal. Lower temperatures can be used for lower melting fluoropolymers. Typically the heat sealing can be completed in no more than 15 sec. Additional information on heat sealing is provided in S.
  • each port is formed from tubing that has valve for opening and closing the tubing.
  • the tubing is heat sealed to the film wall of the container by impulse heating to the film walls of the container, i.e. the tubing is sandwiched between films forming opposite sides of the container and sealed around and to the periphery of the tubing.
  • the port(s) can be integral with a base having tapered ends and the base is heat sealed to the opposing films.
  • the interior volume of this container is 200 liters.

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Sustainable Development (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Wrappers (AREA)
  • Packages (AREA)
PCT/US2006/016333 2005-04-29 2006-04-28 Disposable vessel for the containment of biological materials and corrosive reagents Ceased WO2006119053A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2008509187A JP2008539044A (ja) 2005-04-29 2006-04-28 生体物質および腐食性試薬の封じ込めのための使い捨て容器
EP06751823A EP1874915A1 (en) 2005-04-29 2006-04-28 Disposable vessel for the containment of biological materials and corrosive reagents

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US67634705P 2005-04-29 2005-04-29
US67633905P 2005-04-29 2005-04-29
US60/676,347 2005-04-29
US60/676,339 2005-04-29
US72181905P 2005-09-29 2005-09-29
US60/721,819 2005-09-29

Publications (1)

Publication Number Publication Date
WO2006119053A1 true WO2006119053A1 (en) 2006-11-09

Family

ID=36928281

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/016333 Ceased WO2006119053A1 (en) 2005-04-29 2006-04-28 Disposable vessel for the containment of biological materials and corrosive reagents

Country Status (4)

Country Link
US (1) US20060246244A1 (https=)
EP (1) EP1874915A1 (https=)
JP (1) JP2008539044A (https=)
WO (1) WO2006119053A1 (https=)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007078972A3 (en) * 2005-12-29 2008-04-10 Arkema Inc Multi-layer fluoropolymer films
US9662869B2 (en) 2007-02-08 2017-05-30 Meissner Filtration Products, Inc. Multilayer film, method of making the same and containers formed from the same
US9682526B2 (en) 2007-10-02 2017-06-20 Meissner Filtration Products, Inc. Radio frequency weldable multilayer tubing and method of making the same
WO2025078958A1 (en) * 2023-10-12 2025-04-17 Daikin America, Inc. Fluoropolymer bioprocess bag

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100317102A1 (en) * 2006-01-17 2010-12-16 Tsutomu Suzuki Cell Culture Method and Automatic Culture System Using the Method
KR20100029218A (ko) * 2007-05-29 2010-03-16 씨디아이 실스, 인코포레이티드 단단한 피트먼트를 가지는 블로우 성형된 단일체 용기
US8498729B2 (en) 2008-08-29 2013-07-30 Smp Logic Systems Llc Manufacturing execution system for use in manufacturing baby formula
DE102008058272A1 (de) * 2008-11-20 2010-05-27 Fresenius Medical Care Deutschland Gmbh Einwegbeutel umfassend eine Mehrschichtfolie
BR112016006318A2 (pt) 2013-09-25 2017-08-01 Saint Gobain Performance Plastics Corp recipiente de criopreservação
US20160178490A1 (en) * 2014-12-22 2016-06-23 Saint-Gobain Performance Plastics Corporation Capture system of cells and methods
GB2563760A (en) * 2016-01-29 2018-12-26 Entegris Inc Bag assembly sterilizable by gamma irradiation
EP3572061A4 (en) * 2017-01-18 2020-10-14 Daikin Industries, Ltd. CONTAINER FOR THE ADMINISTRATION, STORAGE, DISTRIBUTION OR TRANSPORT OF A LOW ADSORBABLE PROTEIN OR OF A COMPOSITION CONTAINING PROTEIN, AND APPARATUS FOR THE PRODUCTION OF A PROTEIN OR OF A PROTEIN COMPOSITION
KR20220033491A (ko) * 2019-07-11 2022-03-16 다나팍 플렉시블스 에이/에스 라미네이트 방법 및 제품
EP4386077A1 (en) 2022-09-16 2024-06-19 Solvay Specialty Polymers USA, LLC Container comprising a composite film

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3755042A (en) * 1971-09-15 1973-08-28 Dow Corning Sterile packaging method for surgical devices
EP0164190A2 (en) * 1984-04-05 1985-12-11 Exxon Research And Engineering Company Sterilizable packages and processes
EP0264464A1 (en) * 1985-10-19 1988-04-27 Daikin Industries, Limited culture vessel
US4847462A (en) * 1986-11-06 1989-07-11 American Fluoroseal Corporation Method and apparatus for making fluorocarbon film plastic bags using a laser
US20030155531A1 (en) * 1996-05-22 2003-08-21 Clark Reginald Wayne Sterilization of packages and their contents using light
US20050085785A1 (en) * 2003-10-17 2005-04-21 Sherwin Shang High impact strength film and non-pvc containing container and pouch and overpouch

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3624250A (en) * 1970-01-20 1971-11-30 Du Pont Copolymers of ethylene/tetrafluoroethylene and of ethylene/chlorotrifluoroethylene
US4123602A (en) * 1976-05-24 1978-10-31 Asahi Glass Company, Ltd. Terpolymers of tetrafluoroethylene, ethylene and perfluoroalkyl vinyl monomer and process for producing the same
US4513602A (en) * 1982-09-30 1985-04-30 Sofy Hugh M Transfer device
JPS60248710A (ja) * 1984-05-22 1985-12-09 Daikin Ind Ltd 新規エチレン／テトラフルオロエチレン系共重合体
US6071005A (en) * 1996-06-11 2000-06-06 Merck & Co., Inc. Disposable storage, transport and resuspension system
US5941635A (en) * 1997-06-11 1999-08-24 Hyclone Labortories, Inc. Mixing block for resuspension system
FR2781202B1 (fr) * 1998-07-16 2001-01-12 Stedim Sa Poches pour produits fluides bio-pharmaceutiques
US6432698B1 (en) * 1999-01-06 2002-08-13 Rutgers, The State University Disposable bioreactor for culturing microorganisms and cells
US6287284B1 (en) * 1999-09-27 2001-09-11 Npt, Inc. Silicone bag assembly
IL157188A (en) * 2001-02-06 2004-07-25 Levtech Inc Apparatus and method for mixing materials sealed in a container under sterile conditions
US6684646B2 (en) * 2001-05-22 2004-02-03 Integrated Biosystems, Inc. Systems and methods for freezing, storing and thawing biopharmaceutical material
US6453683B1 (en) * 2001-05-22 2002-09-24 Integrated Biosystems, Inc. Tapered slot cryopreservation system with controlled dendritic freezing front velocity
US20030190272A1 (en) * 2002-04-08 2003-10-09 Dennis Raine Sterilization containers and methods for radiation sterilization of liquid products

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3755042A (en) * 1971-09-15 1973-08-28 Dow Corning Sterile packaging method for surgical devices
EP0164190A2 (en) * 1984-04-05 1985-12-11 Exxon Research And Engineering Company Sterilizable packages and processes
EP0264464A1 (en) * 1985-10-19 1988-04-27 Daikin Industries, Limited culture vessel
US4847462A (en) * 1986-11-06 1989-07-11 American Fluoroseal Corporation Method and apparatus for making fluorocarbon film plastic bags using a laser
US20030155531A1 (en) * 1996-05-22 2003-08-21 Clark Reginald Wayne Sterilization of packages and their contents using light
US20050085785A1 (en) * 2003-10-17 2005-04-21 Sherwin Shang High impact strength film and non-pvc containing container and pouch and overpouch

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007078972A3 (en) * 2005-12-29 2008-04-10 Arkema Inc Multi-layer fluoropolymer films
EP1971485A4 (en) * 2005-12-29 2012-05-30 Arkema Inc MULTILAYER FLUOROPOLYMER FOILS
US9662869B2 (en) 2007-02-08 2017-05-30 Meissner Filtration Products, Inc. Multilayer film, method of making the same and containers formed from the same
US10899114B2 (en) 2007-02-08 2021-01-26 Meissner Filtration Products, Inc. Multilayer film, method of making the same and containers formed from the same
US9682526B2 (en) 2007-10-02 2017-06-20 Meissner Filtration Products, Inc. Radio frequency weldable multilayer tubing and method of making the same
US10131109B2 (en) 2007-10-02 2018-11-20 Meissner Filtration Products, Inc. Radio frequency weldable multi-layer tubing and method of making the same
WO2025078958A1 (en) * 2023-10-12 2025-04-17 Daikin America, Inc. Fluoropolymer bioprocess bag

Also Published As

Publication number Publication date
US20060246244A1 (en) 2006-11-02
EP1874915A1 (en) 2008-01-09
JP2008539044A (ja) 2008-11-13

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