WO1999046572A1 - Procede et dispositif de detection des fuites dans des emballages hermetiques - Google Patents
Procede et dispositif de detection des fuites dans des emballages hermetiques Download PDFInfo
- Publication number
- WO1999046572A1 WO1999046572A1 PCT/US1999/005027 US9905027W WO9946572A1 WO 1999046572 A1 WO1999046572 A1 WO 1999046572A1 US 9905027 W US9905027 W US 9905027W WO 9946572 A1 WO9946572 A1 WO 9946572A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- gas
- test chamber
- indicator
- calibration
- sealed package
- Prior art date
Links
Classifications
-
- 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
- G01M3/229—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 removably mounted in a test cell
Definitions
- a wide variety of drugs and medical devices are packaged in hermetic packaging that must maintain sterile integrity until the package is opened for use. Examples include glass ampoules or plastic blow/fill/seal ampoules for parenteral drugs, prefilled syringes for parenteral drugs, screw-cap bottles for eye drops, and contact lenses packaged in plastic trays with heat-sealed foil lids.
- the bath is pressurized to drive dye solution into any leaks.
- the ampoules are then removed from the bath, washed, and inspected for uptake of dye, either visually or using a spectrophotometer.
- the disadvantages of this method include that small leaks can contaminate the contents of the ampoule without being detected.
- Containers must be transparent, hence the technique is generally limited to glass ampoules.
- the hermetically sealed package containing an indicator gas is placed in a test chamber.
- the atmosphere is evacuated in the test chamber.
- the pressure in the test chamber after a predetermined interval is measured to determine whether a gross leak exists in the package.
- the atmosphere in the test chamber is purged with a purge gas.
- the atmosphere is evacuated.
- a calibration gas is allowed to accumulate at a predetermined rate in the chamber during an interval of time.
- the ratio of indicator gas to calibration gas is measured at the end of the interval time. The ratio is compared against a predetermined ratio of indicator gas to calibration gas for the interval of time to determine whether a leak exists in the hermetically sealed package.
- Test chamber 18 has a sampling manifold outlet 48 through which a gas sample is withdrawn from test chamber 18 to sampling manifold 50 which is controlled by sampling valve 52.
- the volume of sampling manifold 50 is significantly less than the free volume of test chamber 18 external to test package 12.
- Sampling manifold 50 is connected to second vacuum pump 54 via vacuum valve 56.
- Detector device inlet capillary 58 connects sampling manifold 50 with detector device 60.
- a suitable detector device 60 includes a mass spectrometer, infrared detector, ion mobility spectrograph, etc. that performs the analysis.
- apparatus 10 can also includes a computer and software for automatically interpreting the results of the sample analysis, making a pass/fail decision, reporting faulty ampoules, and logging all results. Sample transfer lines may be heated or specially coated or deactivated to transport water vapor with minimal losses or absorption.
- test chamber 18 is equipped with a fine calibrated leak, such as a small internal diameter capillary, from a source of calibration gas maintained near atmospheric pressure.
- test chamber 18 is purged with purge gas from purge gas source 34 through vent outlet 40. This step can be omitted for applications in which ambient air does not contain significant quantities of the indicator gas or the calibration gas.
- vent valve 42 is closed and test chamber 18 is evacuated to a preset absolute pressure, such as in the range of between about 0.1 and fifty torr.
- Test chamber 18 is then isolated for a preset time interval, such as in the range of between one and ten seconds, to allow accumulation of calibration gas from the calibrated leak and leak indicator gases from any fine leaks in the package under test. If a fine leak is present below the liquid level of the package, volatile liquid 16 leaks out and evaporates.
- Sampling valve 52 is closed. Second vacuum valve 56 is opened. Vent valve 42 is opened to atmosphere. Test chamber door 20 is opened and sealed package is removed.
- an array of test chambers 18A, 18B, 18C, 18D, 18E, 18F, 18G, 18H, 181, 18J is mounted in a rotating carousel 62. Rotating carousel 62 is interfaced to conveyor means (not shown) for delivering test packages to a load position, and unloading conveyor means (not shown) for removing sealed test packages from an unload position.
- Mechanisms are also provided for inserting test packages into the test chamber that is at the load position, and removing test packages from the test chamber that is at the unload position. Means are also provided for rejecting -10-
Landscapes
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Examining Or Testing Airtightness (AREA)
Abstract
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU29003/99A AU2900399A (en) | 1998-03-11 | 1999-03-08 | Method and apparatus for detection of leaks in hermetic packages |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US7749398P | 1998-03-11 | 1998-03-11 | |
US60/077,493 | 1998-03-11 | ||
US10775098P | 1998-11-10 | 1998-11-10 | |
US60/107,750 | 1998-11-10 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999046572A1 true WO1999046572A1 (fr) | 1999-09-16 |
Family
ID=26759328
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1999/005027 WO1999046572A1 (fr) | 1998-03-11 | 1999-03-08 | Procede et dispositif de detection des fuites dans des emballages hermetiques |
Country Status (2)
Country | Link |
---|---|
AU (1) | AU2900399A (fr) |
WO (1) | WO1999046572A1 (fr) |
Cited By (24)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2001046667A1 (fr) * | 1999-12-22 | 2001-06-28 | Inficon Gmbh | Procede d'exploitation d'un detecteur de fuites pelliculaire et detecteur de fuites pelliculaire correspondant pour mettre ledit procede en oeuvre |
EP1202042A2 (fr) * | 2000-10-02 | 2002-05-02 | Mocon, Inc. | Méthode de mesure de fuite de gaz d'emballages scellés |
US6415642B1 (en) * | 1999-12-14 | 2002-07-09 | Hans Rudolph, Inc. | DLco calibration syringe apparatus |
WO2003060455A1 (fr) * | 2002-01-18 | 2003-07-24 | Inficon Gmbh | Procedes et dispositifs de detection de fuites |
US6945092B2 (en) | 1999-12-22 | 2005-09-20 | Inficon Gmbh | Method for operating a film leak indicator and a corresponding film leak indicator for carrying out said method |
EP1522838A3 (fr) * | 2003-10-10 | 2006-10-04 | Wilson Greatbatch Technologies, Inc. | Essai de l'étanchéité de boîtiers hermétiques pour dispositifs implantables de stockage d'énergie |
WO2007012629A1 (fr) * | 2005-07-27 | 2007-02-01 | Boehringer Ingelheim International Gmbh | Procede pour controler le taux de permeabilite d'un recipient ferme |
WO2007118822A2 (fr) * | 2006-04-13 | 2007-10-25 | Klaus Polster | Procédé et dispositif de détermination de l'étanchéité d'un objet à contrôler |
JP2010281820A (ja) * | 2009-06-04 | 2010-12-16 | Sensirion Ag | 個々のセンサデバイスを処理する方法及び装置 |
CN102095559A (zh) * | 2011-01-07 | 2011-06-15 | 山东电力研究院 | Sf6-o2泄漏监控报警仪现场校验装置 |
ITPD20110150A1 (it) * | 2011-05-12 | 2012-11-13 | Eng Service S R L | Apparato per il rilevamento di perdite di un componente a tenuta ed un relativo processo di rilevamento |
WO2011012730A3 (fr) * | 2010-08-10 | 2013-03-28 | Wilco Ag | Procédé et appareil pour soumettre des contenants à un essai d'étanchéité |
FR2993659A1 (fr) * | 2012-07-23 | 2014-01-24 | Adixen Vacuum Products | Procede et installation de detection pour le controle d'etancheite d'emballages de produits scelles |
US8692186B2 (en) | 2010-08-10 | 2014-04-08 | Wilco Ag | Method and apparatus for leak testing containers |
JP2015534088A (ja) * | 2012-11-09 | 2015-11-26 | インフィコン ゲゼルシャフト ミット ベシュレンクテル ハフツングInficon GmbH | 漏れ検出器 |
CN108918028A (zh) * | 2018-05-15 | 2018-11-30 | 珠海三昌电器有限公司 | 一种标定sf6气体泄漏检测装置精度的***及其使用方法 |
WO2019053113A1 (fr) * | 2017-09-14 | 2019-03-21 | Lonza Ltd | Dispositif et procédé pour test amélioré d'intégrité de fermeture |
IT201800005260A1 (it) * | 2018-05-11 | 2019-11-11 | Metodo per il controllo di tenuta di una cella di una batteria e relativo sistema di controllo | |
CN110926731A (zh) * | 2019-12-13 | 2020-03-27 | 中国特种设备检测研究院 | 一种高压气体泄漏扩散联动测量试验*** |
US10895514B2 (en) | 2017-09-14 | 2021-01-19 | Lonza Ltd | Device and method for container closure integrity testing |
CN114096822A (zh) * | 2019-06-26 | 2022-02-25 | 赛多利斯斯泰迪姆Fmt有限公司 | 用于检测用于生物制药产品的柔性袋的完整性的可能损失的***和方法 |
CN115791297A (zh) * | 2022-12-15 | 2023-03-14 | 浙江恒达仪器仪表股份有限公司 | 一种提高降水检测质量的在线检测装置及检测方法 |
WO2023237338A1 (fr) * | 2022-06-10 | 2023-12-14 | Pfeiffer Vacuum | Procédé de détection de fuite amélioré et dispositif associé |
WO2023237258A1 (fr) * | 2022-06-10 | 2023-12-14 | Pfeiffer Vacuum | Installation de détection de fuites et procédé de contrôle de l'étanchéité |
Citations (12)
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SU1132160A1 (ru) * | 1983-10-10 | 1984-12-30 | Предприятие П/Я М-5612 | Способ испытаний изделий на герметичность |
JPS6315133A (ja) * | 1986-07-08 | 1988-01-22 | Toshiba Corp | 真空リ−クチエツク方法 |
US4845977A (en) * | 1987-06-16 | 1989-07-11 | Product Suppliers Ag | Method and an apparatus for detecting a possible leak in a vacuum package |
US4998435A (en) * | 1983-01-18 | 1991-03-12 | Damco Testers, Inc. | Method and apparatus for leak testing of pipe |
EP0422814A2 (fr) * | 1989-10-02 | 1991-04-17 | Canon Kabushiki Kaisha | Appareil d'exposition |
US5162652A (en) * | 1991-08-07 | 1992-11-10 | Pcp, Inc. | Method and apparatus for rapid detection of contraband and toxic materials by trace vapor detection using ion mobility spectrometry |
RU1837183C (ru) * | 1987-10-12 | 1993-08-30 | Головное конструкторское бюро Научно-производственного объединения "Энергия" | Способ контрол герметичности изделий, заключенных в гермочехол |
US5239859A (en) * | 1987-10-28 | 1993-08-31 | Martin Lehmann | Method and apparatus for leak testing a hollow body |
EP0566500A2 (fr) * | 1992-04-17 | 1993-10-20 | Minnesota Mining And Manufacturing Company | Moyen de détection et méthode pour l'utiliser dans l'essai de fermetures hermétiques |
EP0668492A2 (fr) * | 1994-02-18 | 1995-08-23 | The BOC Group plc | Méthode et appareil pour tester des fuites |
EP0742429A1 (fr) * | 1995-05-12 | 1996-11-13 | Alcatel Cit | Détecteur de fuite à gaz traceur |
EP0786654A2 (fr) * | 1997-05-07 | 1997-07-30 | Martin Lehmann | Système d'essai d'étanchéité pour des récipients fermés |
-
1999
- 1999-03-08 AU AU29003/99A patent/AU2900399A/en not_active Abandoned
- 1999-03-08 WO PCT/US1999/005027 patent/WO1999046572A1/fr active Application Filing
Patent Citations (12)
Publication number | Priority date | Publication date | Assignee | Title |
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US4998435A (en) * | 1983-01-18 | 1991-03-12 | Damco Testers, Inc. | Method and apparatus for leak testing of pipe |
SU1132160A1 (ru) * | 1983-10-10 | 1984-12-30 | Предприятие П/Я М-5612 | Способ испытаний изделий на герметичность |
JPS6315133A (ja) * | 1986-07-08 | 1988-01-22 | Toshiba Corp | 真空リ−クチエツク方法 |
US4845977A (en) * | 1987-06-16 | 1989-07-11 | Product Suppliers Ag | Method and an apparatus for detecting a possible leak in a vacuum package |
RU1837183C (ru) * | 1987-10-12 | 1993-08-30 | Головное конструкторское бюро Научно-производственного объединения "Энергия" | Способ контрол герметичности изделий, заключенных в гермочехол |
US5239859A (en) * | 1987-10-28 | 1993-08-31 | Martin Lehmann | Method and apparatus for leak testing a hollow body |
EP0422814A2 (fr) * | 1989-10-02 | 1991-04-17 | Canon Kabushiki Kaisha | Appareil d'exposition |
US5162652A (en) * | 1991-08-07 | 1992-11-10 | Pcp, Inc. | Method and apparatus for rapid detection of contraband and toxic materials by trace vapor detection using ion mobility spectrometry |
EP0566500A2 (fr) * | 1992-04-17 | 1993-10-20 | Minnesota Mining And Manufacturing Company | Moyen de détection et méthode pour l'utiliser dans l'essai de fermetures hermétiques |
EP0668492A2 (fr) * | 1994-02-18 | 1995-08-23 | The BOC Group plc | Méthode et appareil pour tester des fuites |
EP0742429A1 (fr) * | 1995-05-12 | 1996-11-13 | Alcatel Cit | Détecteur de fuite à gaz traceur |
EP0786654A2 (fr) * | 1997-05-07 | 1997-07-30 | Martin Lehmann | Système d'essai d'étanchéité pour des récipients fermés |
Non-Patent Citations (3)
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DATABASE WPI Section Ch Week 8527, Derwent World Patents Index; Class J04, AN 85-164437, XP002103177 * |
DATABASE WPI Section EI Week 9518, Derwent World Patents Index; Class S02, AN 95-138138, XP002103176 * |
PATENT ABSTRACTS OF JAPAN vol. 012, no. 220 (P - 720) 23 June 1988 (1988-06-23) * |
Cited By (50)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6415642B1 (en) * | 1999-12-14 | 2002-07-09 | Hans Rudolph, Inc. | DLco calibration syringe apparatus |
US6945092B2 (en) | 1999-12-22 | 2005-09-20 | Inficon Gmbh | Method for operating a film leak indicator and a corresponding film leak indicator for carrying out said method |
WO2001046667A1 (fr) * | 1999-12-22 | 2001-06-28 | Inficon Gmbh | Procede d'exploitation d'un detecteur de fuites pelliculaire et detecteur de fuites pelliculaire correspondant pour mettre ledit procede en oeuvre |
EP1202042A3 (fr) * | 2000-10-02 | 2002-07-03 | Mocon, Inc. | Méthode de mesure de fuite de gaz d'emballages scellés |
EP1202042A2 (fr) * | 2000-10-02 | 2002-05-02 | Mocon, Inc. | Méthode de mesure de fuite de gaz d'emballages scellés |
WO2003060455A1 (fr) * | 2002-01-18 | 2003-07-24 | Inficon Gmbh | Procedes et dispositifs de detection de fuites |
JP2005515426A (ja) * | 2002-01-18 | 2005-05-26 | インフィコン ゲゼルシャフト ミット ベシュレンクテル ハフツング | 漏れ試験法及び漏れ試験装置 |
EP1522838A3 (fr) * | 2003-10-10 | 2006-10-04 | Wilson Greatbatch Technologies, Inc. | Essai de l'étanchéité de boîtiers hermétiques pour dispositifs implantables de stockage d'énergie |
WO2007012629A1 (fr) * | 2005-07-27 | 2007-02-01 | Boehringer Ingelheim International Gmbh | Procede pour controler le taux de permeabilite d'un recipient ferme |
US8087286B2 (en) | 2005-07-27 | 2012-01-03 | Boehringer Ingelheim International, Gmbh | Method for checking the permeability rate of a closed container |
WO2007118822A2 (fr) * | 2006-04-13 | 2007-10-25 | Klaus Polster | Procédé et dispositif de détermination de l'étanchéité d'un objet à contrôler |
WO2007118822A3 (fr) * | 2006-04-13 | 2008-05-22 | Klaus Polster | Procédé et dispositif de détermination de l'étanchéité d'un objet à contrôler |
JP2010281820A (ja) * | 2009-06-04 | 2010-12-16 | Sensirion Ag | 個々のセンサデバイスを処理する方法及び装置 |
EP2259027B1 (fr) * | 2009-06-04 | 2012-12-05 | Sensirion AG | Procédé et appareil de traitement de dispositifs de capteurs individuels |
US8499609B2 (en) | 2009-06-04 | 2013-08-06 | Sensirion Ag | Method and apparatus for processing individual sensor devices |
RU2539782C2 (ru) * | 2010-08-10 | 2015-01-27 | Вилко Аг | Способ и установка для испытания контейнеров на утечку |
US8975576B2 (en) | 2010-08-10 | 2015-03-10 | Wilco Ag | Method and apparatus for leak testing containers |
WO2011012730A3 (fr) * | 2010-08-10 | 2013-03-28 | Wilco Ag | Procédé et appareil pour soumettre des contenants à un essai d'étanchéité |
CN103210293A (zh) * | 2010-08-10 | 2013-07-17 | 威尔科股份公司 | 用于容器的泄漏检测的方法及设备 |
CN103210293B (zh) * | 2010-08-10 | 2015-10-14 | 威尔科股份公司 | 用于容器的泄漏检测的方法及设备 |
US8692186B2 (en) | 2010-08-10 | 2014-04-08 | Wilco Ag | Method and apparatus for leak testing containers |
AU2010277495B2 (en) * | 2010-08-10 | 2015-03-05 | Wilco Ag | Method and apparatus for leak testing containers |
CN102095559A (zh) * | 2011-01-07 | 2011-06-15 | 山东电力研究院 | Sf6-o2泄漏监控报警仪现场校验装置 |
ITPD20110150A1 (it) * | 2011-05-12 | 2012-11-13 | Eng Service S R L | Apparato per il rilevamento di perdite di un componente a tenuta ed un relativo processo di rilevamento |
WO2012153306A1 (fr) * | 2011-05-12 | 2012-11-15 | Eng Service S.R.L. | Appareil de détection pour détecter des fuites dans un composant hermétique, et procédé de détection s'y rapportant |
CN103635786A (zh) * | 2011-05-12 | 2014-03-12 | Eng服务有限公司 | 用于检测气密部件中的泄漏的检测设备和相关检测过程 |
US9841345B2 (en) | 2012-07-23 | 2017-12-12 | Adixen Vacuum Products | Detection method and facility for checking sealed products for leaks |
US20150211955A1 (en) * | 2012-07-23 | 2015-07-30 | Adixen Vacuum Products | Detection method and facility for checking sealed products for leaks |
JP2015526718A (ja) * | 2012-07-23 | 2015-09-10 | アデイクセン・バキユーム・プロダクト | 密封製品の耐漏洩性を検査するための検出方法及び検出装置 |
WO2014016308A1 (fr) * | 2012-07-23 | 2014-01-30 | Adixen Vacuum Products | Procede et installation de detection pour le controle d'etancheite de produits scelles |
FR2993659A1 (fr) * | 2012-07-23 | 2014-01-24 | Adixen Vacuum Products | Procede et installation de detection pour le controle d'etancheite d'emballages de produits scelles |
CN104541142A (zh) * | 2012-07-23 | 2015-04-22 | 阿迪克森真空产品公司 | 用于检查密封产品的泄漏的检测方法和设备 |
JP2015534088A (ja) * | 2012-11-09 | 2015-11-26 | インフィコン ゲゼルシャフト ミット ベシュレンクテル ハフツングInficon GmbH | 漏れ検出器 |
US10801913B2 (en) | 2017-09-14 | 2020-10-13 | Lonza Ltd | Device and method for improved closure integrity testing |
US10895514B2 (en) | 2017-09-14 | 2021-01-19 | Lonza Ltd | Device and method for container closure integrity testing |
WO2019053113A1 (fr) * | 2017-09-14 | 2019-03-21 | Lonza Ltd | Dispositif et procédé pour test amélioré d'intégrité de fermeture |
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IT201800005260A1 (it) * | 2018-05-11 | 2019-11-11 | Metodo per il controllo di tenuta di una cella di una batteria e relativo sistema di controllo | |
CN108918028A (zh) * | 2018-05-15 | 2018-11-30 | 珠海三昌电器有限公司 | 一种标定sf6气体泄漏检测装置精度的***及其使用方法 |
CN114096822A (zh) * | 2019-06-26 | 2022-02-25 | 赛多利斯斯泰迪姆Fmt有限公司 | 用于检测用于生物制药产品的柔性袋的完整性的可能损失的***和方法 |
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WO2023237338A1 (fr) * | 2022-06-10 | 2023-12-14 | Pfeiffer Vacuum | Procédé de détection de fuite amélioré et dispositif associé |
WO2023237258A1 (fr) * | 2022-06-10 | 2023-12-14 | Pfeiffer Vacuum | Installation de détection de fuites et procédé de contrôle de l'étanchéité |
FR3136551A1 (fr) * | 2022-06-10 | 2023-12-15 | Pfeiffer Vacuum | Installation de détection de fuites et procédé de contrôle de l’étanchéité |
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CN115791297A (zh) * | 2022-12-15 | 2023-03-14 | 浙江恒达仪器仪表股份有限公司 | 一种提高降水检测质量的在线检测装置及检测方法 |
Also Published As
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AU2900399A (en) | 1999-09-27 |
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