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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 PDF

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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
Application number
PCT/US1999/005027
Other languages
English (en)
Inventor
Eugenie Hainsworth
Eugene K. Achter
Original Assignee
True Technology, 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 True Technology, Inc. filed Critical True Technology, Inc.
Priority to AU29003/99A priority Critical patent/AU2900399A/en
Publication of WO1999046572A1 publication Critical patent/WO1999046572A1/fr

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

La présente invention concerne un procédé et un dispositif de recherche non destructif des fuites dans un emballage imperméable hermétiquement fermé contenant du gaz et/ou un liquide volatile servant de gaz indicateur. Le procédé consiste à placer dans une chambre d'essai l'emballage imperméable hermétiquement fermé contenant un gaz indicateur et à faire le vide dans la chambre d'essai. A intervalles réguliers, on mesure la pression dans la chambre d'essai pour vérifier que l'emballage ne comporte pas de fuite grossière. Après avoir effectué une purge gazeuse dans la chambre d'essai, on en fait descendre la pression jusqu'à un niveau défini. On admet à un débit défini le gaz d'étalonnage dans la chambre d'essai pendant une période définie. On mesure le rapport entre gaz indicateur et gaz d'étalonnage. Une comparaison entre ce rapport et un rapport préalablement établi entre le gaz indicateur et le gaz d'étalonnage pendant la période considérée permet de vérifier que l'emballage hermétiquement fermé est bien étanche.
PCT/US1999/005027 1998-03-11 1999-03-08 Procede et dispositif de detection des fuites dans des emballages hermetiques WO1999046572A1 (fr)

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)

* Cited by examiner, † Cited by third party
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
EP1202042A3 (fr) * 2000-10-02 2002-07-03 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
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
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系统及其使用方法
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系统
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系统和方法
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
WO2023237258A1 (fr) * 2022-06-10 2023-12-14 Pfeiffer Vacuum Installation de détection de fuites et procédé de contrôle de l'étanchéité
WO2023237338A1 (fr) * 2022-06-10 2023-12-14 Pfeiffer Vacuum Procédé de détection de fuite amélioré et dispositif associé

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EP0422814A2 (fr) * 1989-10-02 1991-04-17 Canon Kabushiki Kaisha Appareil d'exposition
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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
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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
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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

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Cited By (48)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6415642B1 (en) * 1999-12-14 2002-07-09 Hans Rudolph, Inc. DLco calibration syringe apparatus
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
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
EP1202042A3 (fr) * 2000-10-02 2002-07-03 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
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
US8499609B2 (en) 2009-06-04 2013-08-06 Sensirion Ag Method and apparatus for processing individual sensor devices
EP2259027B1 (fr) * 2009-06-04 2012-12-05 Sensirion AG Procédé et appareil de traitement de dispositifs de capteurs individuels
WO2011012730A3 (fr) * 2010-08-10 2013-03-28 Wilco Ag Procédé et appareil pour soumettre des contenants à un essai d'étanchéité
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
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
US8975576B2 (en) 2010-08-10 2015-03-10 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
RU2539782C2 (ru) * 2010-08-10 2015-01-27 Вилко Аг Способ и установка для испытания контейнеров на утечку
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
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
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
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
US9841345B2 (en) 2012-07-23 2017-12-12 Adixen Vacuum Products Detection method and facility for checking sealed products for leaks
WO2014016308A1 (fr) * 2012-07-23 2014-01-30 Adixen Vacuum Products Procede et installation de detection pour le controle d'etancheite de produits scelles
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
CN111093741B (zh) * 2017-09-14 2022-08-16 隆萨有限公司 用于改进密封完整性测试的设备和方法
WO2019053113A1 (fr) * 2017-09-14 2019-03-21 Lonza Ltd Dispositif et procédé pour test amélioré d'intégrité de fermeture
US10895514B2 (en) 2017-09-14 2021-01-19 Lonza Ltd Device and method for container closure integrity testing
JP2020533132A (ja) * 2017-09-14 2020-11-19 ロンザ・リミテッド 改良された容器完全性試験ための装置および方法
CN111093741A (zh) * 2017-09-14 2020-05-01 隆萨有限公司 用于改进密封完整性测试的设备和方法
WO2019215339A1 (fr) * 2018-05-11 2019-11-14 Marposs Societa' Per Azioni Procédé de test de fuite d'un élément de batterie et système de test de fuite associé
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系统及其使用方法
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系统和方法
CN114096822B (zh) * 2019-06-26 2024-03-15 赛多利斯斯泰迪姆Fmt有限公司 用于验证柔性袋的完整性的测试系统和测试方法
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系统
WO2023237258A1 (fr) * 2022-06-10 2023-12-14 Pfeiffer Vacuum Installation de détection de fuites et procédé de contrôle de l'étanchéité
WO2023237338A1 (fr) * 2022-06-10 2023-12-14 Pfeiffer Vacuum Procédé de détection de fuite amélioré et dispositif associé
FR3136550A1 (fr) * 2022-06-10 2023-12-15 Pfeiffer Vacuum Procédé de détection de fuite amélioré et dispositif associé
FR3136551A1 (fr) * 2022-06-10 2023-12-15 Pfeiffer Vacuum Installation de détection de fuites et procédé de contrôle de l’étanchéité
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

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