DK3877737T3 - System og fremgangsmåde til test af lukkeintegriteten af en forseglet beholder ved kryogene temperaturer - Google Patents

System og fremgangsmåde til test af lukkeintegriteten af en forseglet beholder ved kryogene temperaturer Download PDF

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Publication number
DK3877737T3
DK3877737T3 DK19824050.9T DK19824050T DK3877737T3 DK 3877737 T3 DK3877737 T3 DK 3877737T3 DK 19824050 T DK19824050 T DK 19824050T DK 3877737 T3 DK3877737 T3 DK 3877737T3
Authority
DK
Denmark
Prior art keywords
cryogene
temperatures
testing
sealed container
closure integrity
Prior art date
Application number
DK19824050.9T
Other languages
English (en)
Inventor
Louis J Brasten
James Mccaw
Original Assignee
West Pharmaceutical Services 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 West Pharmaceutical Services Inc filed Critical West Pharmaceutical Services Inc
Application granted granted Critical
Publication of DK3877737T3 publication Critical patent/DK3877737T3/da

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01MTESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00Investigating fluid-tightness of structures
    • G01M3/02Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/04Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
    • G01M3/20Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material
    • G01M3/22Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators
    • G01M3/226Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators for containers, e.g. radiators
    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02Preservation of living parts
    • A01N1/0236Mechanical aspects
    • A01N1/0263Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
    • A01N1/0268Carriers for immersion in cryogenic fluid, both for slow-freezing and vitrification, e.g. open or closed "straws" for embryos, oocytes or semen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06Ampoules or carpules
    • A61J1/065Rigid ampoules, e.g. glass ampoules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1412Containers with closing means, e.g. caps
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082Test tubes per se
    • B01L3/50825Closing or opening means, corks, bungs

Landscapes

  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Examining Or Testing Airtightness (AREA)
DK19824050.9T 2018-11-27 2019-11-25 System og fremgangsmåde til test af lukkeintegriteten af en forseglet beholder ved kryogene temperaturer DK3877737T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862771664P 2018-11-27 2018-11-27
PCT/US2019/063006 WO2020112634A1 (en) 2018-11-27 2019-11-25 System and method for testing closure integrity of a sealed container at cryogenic temperatures

Publications (1)

Publication Number Publication Date
DK3877737T3 true DK3877737T3 (da) 2023-01-09

Family

ID=68965996

Family Applications (1)

Application Number Title Priority Date Filing Date
DK19824050.9T DK3877737T3 (da) 2018-11-27 2019-11-25 System og fremgangsmåde til test af lukkeintegriteten af en forseglet beholder ved kryogene temperaturer

Country Status (8)

Country Link
US (1) US11280695B2 (da)
EP (1) EP3877737B1 (da)
JP (1) JP6993539B2 (da)
CN (1) CN113196028A (da)
DK (1) DK3877737T3 (da)
PL (1) PL3877737T3 (da)
RS (1) RS63845B1 (da)
WO (1) WO2020112634A1 (da)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11642280B2 (en) 2020-11-10 2023-05-09 Corning Incorporated Glass containers and sealing assemblies for maintaining seal integrity at low storage temperatures
US20230105652A1 (en) 2021-09-30 2023-04-06 Corning Incorporated Glass containers for storing pharmaceutical compositions
CN118103141A (zh) * 2021-11-09 2024-05-28 康宁股份有限公司 包含具有填充物材料的密封组装件的药物容器
WO2024056680A1 (en) * 2022-09-13 2024-03-21 F. Hoffmann-La Roche Ag Positive control system and method for validating positive control of container closure integrity testing

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FR2142139A5 (da) 1971-06-14 1973-01-26 Commissariat Energie Atomique
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Also Published As

Publication number Publication date
EP3877737A1 (en) 2021-09-15
CN113196028A (zh) 2021-07-30
PL3877737T3 (pl) 2023-02-27
EP3877737B1 (en) 2022-10-19
JP2021535402A (ja) 2021-12-16
JP6993539B2 (ja) 2022-01-13
US20210396624A1 (en) 2021-12-23
WO2020112634A1 (en) 2020-06-04
US11280695B2 (en) 2022-03-22
RS63845B1 (sr) 2023-01-31

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