JP6993539B2 - 密封容器の閉塞の完全性を極低温で検査するためのシステムと方法 - Google Patents
密封容器の閉塞の完全性を極低温で検査するためのシステムと方法 Download PDFInfo
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- JP6993539B2 JP6993539B2 JP2021529392A JP2021529392A JP6993539B2 JP 6993539 B2 JP6993539 B2 JP 6993539B2 JP 2021529392 A JP2021529392 A JP 2021529392A JP 2021529392 A JP2021529392 A JP 2021529392A JP 6993539 B2 JP6993539 B2 JP 6993539B2
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- Prior art keywords
- hollow tube
- cryogenic
- storage container
- container
- vial
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- G01M3/00—Investigating fluid-tightness of structures
- G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
- G01M3/04—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
- G01M3/20—Investigating 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
- G01M3/22—Investigating 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
- G01M3/226—Investigating 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
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION 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
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0236—Mechanical aspects
- A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
- A01N1/0268—Carriers for immersion in cryogenic fluid, both for slow-freezing and vitrification, e.g. open or closed "straws" for embryos, oocytes or semen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/065—Rigid ampoules, e.g. glass ampoules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1412—Containers with closing means, e.g. caps
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
- B01L3/5082—Test tubes per se
- B01L3/50825—Closing or opening means, corks, bungs
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- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Sampling And Sample Adjustment (AREA)
- Examining Or Testing Airtightness (AREA)
Description
[実験例]
-精度-
-中間精度-
-特異性、MDL、分析器に対するロバスト性、サンプルの種類に対するロバスト性-
Claims (14)
- 密封容器の閉塞の完全性を極低温で検査するためのシステムであって、
閉塞具によって密封された開口部を含み、ヘリウムを収容している密封容器と、
開口部のある第1端と、その反対側に位置する第2端とを含み、少なくとも一部が極低温の流体で満たされている極低温貯蔵容器と、
前記極低温貯蔵容器の外側に位置する第1端と、その反対側にあって前記極低温貯蔵容器の内側に位置する第2端とを含み、前記極低温貯蔵容器の開口部を通して伸びている中空管と、
第1端と、その反対側にあって前記密封容器に嵌まるように構成されている第2端とを含み、前記中空管の第1端にある開口部を通して前記中空管の中へ取り外し可能に挿入されることにより、前記中空管の第2端またはその近傍に前記密封容器が位置するように構成されている治具と、
前記中空管に接続されている漏れ検出装置と
を備えているシステム。 - 前記極低温が約-150℃以下である、請求項1に記載のシステム。
- 前記極低温の流体が液体窒素である、請求項1に記載のシステム。
- 前記極低温貯蔵容器がデュワーである、請求項1に記載のシステム。
- 前記極低温貯蔵容器の開口部内に固定され、前記中空管の少なくとも一部を囲む結合器
を更に備えている、請求項1に記載のシステム。 - 前記結合器が、前記極低温の流体によって発生するガスを排出するための排気口を少なくとも1つ含む、請求項5に記載のシステム。
- 前記治具が柔軟なワイヤーを含み、前記ワイヤーの一部が前記密封容器の少なくとも一部に巻き付けられる、請求項1に記載のシステム。
- 前記治具の第2端が、前記密封容器の一部を掴むための爪を複数含む、請求項1に記載のシステム。
- 前記漏れ検出装置がヘリウム質量分析器である、請求項1に記載のシステム。
- 密封容器の閉塞の完全性を極低温で検査する方法であって、
ヘリウムを収容している密封容器を用意するステップと、
開口部のある第1端と、その反対側に位置する第2端とを含む極低温貯蔵容器を、少なくとも一部が極低温の流体で満たされている状態に用意するステップと、
前記極低温貯蔵容器の開口部の中に中空管を設置して、前記中空管の第1端を前記極低温貯蔵容器の外側に置き、前記中空管の反対側の第2端を前記極低温貯蔵容器の内側で前記極低温の流体の界面下に置くステップと、
前記密封容器を治具の先端に固定するステップと、
前記治具を前記中空管の中へ挿入して、前記中空管の第2端またはその近傍に前記密封容器を配置するステップと、
前記中空管を漏れ検出装置へ接続して、前記極低温の前記密封容器から逃げ出す前記ヘリウムの流量を測定するステップと
を備えている方法。 - 前記極低温が約-150℃以下である、請求項10に記載の方法。
- 前記極低温の流体が液体窒素である、請求項10に記載の方法。
- 前記極低温貯蔵容器がデュワーである、請求項10に記載の方法。
- 前記漏れ検出装置がヘリウム質量分析器である、請求項10に記載の方法。
Priority Applications (1)
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JP2021113292A JP7189281B2 (ja) | 2018-11-27 | 2021-07-08 | 密封容器の閉塞の完全性を極低温で検査するためのシステムと方法 |
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US201862771664P | 2018-11-27 | 2018-11-27 | |
US62/771,664 | 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 |
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JP2021113292A Division JP7189281B2 (ja) | 2018-11-27 | 2021-07-08 | 密封容器の閉塞の完全性を極低温で検査するためのシステムと方法 |
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JP2021535402A JP2021535402A (ja) | 2021-12-16 |
JP6993539B2 true JP6993539B2 (ja) | 2022-01-13 |
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Country Status (8)
Country | Link |
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US (1) | US11280695B2 (ja) |
EP (1) | EP3877737B1 (ja) |
JP (1) | JP6993539B2 (ja) |
CN (1) | CN113196028A (ja) |
DK (1) | DK3877737T3 (ja) |
PL (1) | PL3877737T3 (ja) |
RS (1) | RS63845B1 (ja) |
WO (1) | WO2020112634A1 (ja) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
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US11642280B2 (en) | 2020-11-10 | 2023-05-09 | Corning Incorporated | Glass containers and sealing assemblies for maintaining seal integrity at low storage temperatures |
KR20240064724A (ko) | 2021-09-30 | 2024-05-13 | 코닝 인코포레이티드 | 약제학적 조성물을 보관하기 위한 유리 용기 |
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 |
Citations (1)
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JP3195935B2 (ja) | 1996-09-30 | 2001-08-06 | グリゴリエビッチ アレクセイエフ セルゲイ | 血漿分析装置 |
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2019
- 2019-11-25 DK DK19824050.9T patent/DK3877737T3/da active
- 2019-11-25 PL PL19824050.9T patent/PL3877737T3/pl unknown
- 2019-11-25 JP JP2021529392A patent/JP6993539B2/ja active Active
- 2019-11-25 CN CN201980077985.9A patent/CN113196028A/zh active Pending
- 2019-11-25 WO PCT/US2019/063006 patent/WO2020112634A1/en unknown
- 2019-11-25 US US17/296,524 patent/US11280695B2/en active Active
- 2019-11-25 EP EP19824050.9A patent/EP3877737B1/en active Active
- 2019-11-25 RS RS20221167A patent/RS63845B1/sr unknown
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US11280695B2 (en) | 2022-03-22 |
EP3877737A1 (en) | 2021-09-15 |
PL3877737T3 (pl) | 2023-02-27 |
WO2020112634A1 (en) | 2020-06-04 |
RS63845B1 (sr) | 2023-01-31 |
CN113196028A (zh) | 2021-07-30 |
EP3877737B1 (en) | 2022-10-19 |
DK3877737T3 (da) | 2023-01-09 |
JP2021535402A (ja) | 2021-12-16 |
US20210396624A1 (en) | 2021-12-23 |
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