JP2011519680A - 滅菌プロセス管理装置、及び方法 - Google Patents

滅菌プロセス管理装置、及び方法 Download PDF

Info

Publication number
JP2011519680A
JP2011519680A JP2011508589A JP2011508589A JP2011519680A JP 2011519680 A JP2011519680 A JP 2011519680A JP 2011508589 A JP2011508589 A JP 2011508589A JP 2011508589 A JP2011508589 A JP 2011508589A JP 2011519680 A JP2011519680 A JP 2011519680A
Authority
JP
Japan
Prior art keywords
solid body
sterilization
sterilant
container
space
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.)
Pending
Application number
JP2011508589A
Other languages
English (en)
Japanese (ja)
Other versions
JP2011519680A5 (OSRAM
Inventor
イー. フォルツ,ウィリアム
エス. キルクコフ,スティーブン
ディー. フォスラー,ローレンス
エム. シュミッツ,ジョシュア
ダブリュ. ロボル,バリー
エム. ハーライン,チャド
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.)
3M Innovative Properties Co
Original Assignee
3M Innovative Properties 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 3M Innovative Properties Co filed Critical 3M Innovative Properties Co
Publication of JP2011519680A publication Critical patent/JP2011519680A/ja
Publication of JP2011519680A5 publication Critical patent/JP2011519680A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26Accessories or devices or components used for biocidal treatment
    • A61L2/28Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/22Testing for sterility conditions

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Biophysics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • General Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Genetics & Genomics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Investigating Or Analyzing Materials Using Thermal Means (AREA)
JP2011508589A 2008-05-05 2009-05-05 滅菌プロセス管理装置、及び方法 Pending JP2011519680A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US5051308P 2008-05-05 2008-05-05
US61/050,513 2008-05-05
US11214908P 2008-11-06 2008-11-06
US61/112,149 2008-11-06
PCT/US2009/042790 WO2009137442A1 (en) 2008-05-05 2009-05-05 Sterilization process challenge device and method

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2014187876A Division JP6448269B2 (ja) 2008-05-05 2014-09-16 滅菌プロセス管理装置、及び方法

Publications (2)

Publication Number Publication Date
JP2011519680A true JP2011519680A (ja) 2011-07-14
JP2011519680A5 JP2011519680A5 (OSRAM) 2012-06-21

Family

ID=40722158

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2011508589A Pending JP2011519680A (ja) 2008-05-05 2009-05-05 滅菌プロセス管理装置、及び方法
JP2014187876A Expired - Fee Related JP6448269B2 (ja) 2008-05-05 2014-09-16 滅菌プロセス管理装置、及び方法
JP2017000158A Pending JP2017074457A (ja) 2008-05-05 2017-01-04 滅菌プロセス管理装置、及び方法

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2014187876A Expired - Fee Related JP6448269B2 (ja) 2008-05-05 2014-09-16 滅菌プロセス管理装置、及び方法
JP2017000158A Pending JP2017074457A (ja) 2008-05-05 2017-01-04 滅菌プロセス管理装置、及び方法

Country Status (8)

Country Link
US (1) US9114186B2 (OSRAM)
EP (2) EP2291201B1 (OSRAM)
JP (3) JP2011519680A (OSRAM)
CN (2) CN102076363A (OSRAM)
BR (1) BRPI0908293A2 (OSRAM)
CA (1) CA2725078A1 (OSRAM)
ES (1) ES2522967T3 (OSRAM)
WO (1) WO2009137442A1 (OSRAM)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021535770A (ja) * 2018-08-21 2021-12-23 ゲーカーエー ゲーエムベーハー マルチ・ステージ・プロセス・チャレンジ・デバイス、インジケーター・システム、およびプロセス・チャレンジ・デバイス・システム

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2291201B1 (en) 2008-05-05 2014-08-20 3M Innovative Properties Company Sterilization process challenge device and method
ES2599008T3 (es) * 2008-11-06 2017-01-31 3M Innovative Properties Company Dispositivo y método de control de un proceso
CN102271717B (zh) * 2008-11-06 2015-04-22 3M创新有限公司 过程验证设备和方法
CN102688512B (zh) * 2011-12-30 2014-03-19 明尼苏达矿业制造医用器材(上海)有限公司 一种灭菌过程挑战测试管
CA2897209A1 (en) * 2013-01-04 2014-07-10 Noxilizer, Inc. Process challenge device for gas sterilization
CN105229163B (zh) * 2013-05-21 2023-03-17 3M创新有限公司 纳米结构化孢子载体
WO2017044906A2 (en) * 2015-09-11 2017-03-16 Stryker Corporation Sterilization enclosure for surgical instruments
CN113443226B (zh) * 2016-03-08 2023-06-20 大日本印刷株式会社 内容物填充系统中的初始菌确认方法以及无菌性验证方法
US10792383B2 (en) 2016-05-05 2020-10-06 3M Innovative Properties Company Method of disinfecting a medical device
CN106075516A (zh) * 2016-07-26 2016-11-09 张剑 一种压力蒸汽灭菌过程验证装置及其灭菌效果监测方法
US11596704B2 (en) * 2016-12-08 2023-03-07 3M Innovative Properties Company Process monitoring device
US10786141B2 (en) * 2017-03-31 2020-09-29 American Sterilizer Company Cap assembly for endoscope
CN109045335A (zh) * 2018-08-31 2018-12-21 衡水诺盾生物科技有限公司 一种预真空压力蒸汽灭菌化学挑战包
CN108844682A (zh) * 2018-08-31 2018-11-20 衡水诺盾生物科技有限公司 一种压力蒸汽灭菌b-d真空测试包
CN109045334A (zh) * 2018-08-31 2018-12-21 衡水诺盾生物科技有限公司 一种预真空压力蒸汽灭菌快速生物挑战包
CN113164637B (zh) * 2018-11-12 2023-03-03 Gke德国有限责任公司 在过程挑战装置中使用的渐缩指示物
US11850320B2 (en) * 2018-12-20 2023-12-26 Asp Global Manufacturing Gmbh Liquid-chemical sterilization system with biological indicator
CN113260387B (zh) 2018-12-28 2024-01-30 爱思帕全球制造有限公司 处理指示器、其制造方法及其使用方法
US11603551B2 (en) 2020-12-02 2023-03-14 Steritec Products Mfg. Co., Inc. Biological indicators, and systems and methods for determining efficacy of sterilization
WO2024089533A2 (en) * 2022-10-25 2024-05-02 Solventum Intellectual Properties Company Process challenge device and method of manufacturing thereof

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH03121072A (ja) * 1989-09-22 1991-05-23 Minnesota Mining & Mfg Co <3M> 蒸気またはガス式滅菌器用の使い拾て式試験パック
JPH03159650A (ja) * 1989-11-16 1991-07-09 Py Mah Corp 滅菌インジケータを受容する装置及び滅菌装置の効力を試験する装置
WO1999020790A1 (en) * 1997-10-20 1999-04-29 Minnesota Mining And Manufacturing Company Testing the effectiveness of a sterilization procedure
JP2002516677A (ja) * 1998-06-02 2002-06-11 スリーエム イノベイティブ プロパティズ カンパニー 化学的に安定化した酵素を用いた滅菌表示装置
JP2004517675A (ja) * 2000-10-27 2004-06-17 スリーエム イノベイティブ プロパティズ カンパニー 滅菌を判定するためのインジケータシステム
JP2006296850A (ja) * 2005-04-22 2006-11-02 Olympus Medical Systems Corp 滅菌状態確認ツール

Family Cites Families (46)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE364117B (OSRAM) 1969-06-05 1974-02-11 Minnesota Mining & Mfg
US3981683A (en) * 1975-04-14 1976-09-21 Bio-Medical Sciences, Inc. Temperature responsive sterility indicator
US4115068A (en) * 1977-04-06 1978-09-19 Sybron Corporation Air detecting device for steam or gas sterilizers
EP0012012A1 (en) 1978-11-30 1980-06-11 W. Christie (Industrial) Limited Method of securing together interengaging parts by means of screwthreaded fasteners, tensioning apparatus, and assembly comprising interengaging parts and fastener
US4612872A (en) * 1983-07-08 1986-09-23 Roger S. Sanderson Method of operating an expandable chamber with delay valve
US4692307A (en) 1984-04-30 1987-09-08 Warner-Lambert Company Adjustable test pack
US4636472A (en) * 1985-05-16 1987-01-13 Warner-Lambert Company Disposable sterilization biological test pack
US4717661A (en) * 1986-01-21 1988-01-05 Castle Company Biological indicator for sterilization processes
US4743537A (en) 1986-01-21 1988-05-10 Castle Company Biological indicator for sterilization processes
US4748003A (en) * 1986-03-11 1988-05-31 Riley Medical Incorporated Container for flash sterilization
US4914034A (en) * 1987-05-15 1990-04-03 American Sterilizer Company Disposable biological indicator test pack for monitoring steam and ethylene oxide sterilization cycles
US4863867A (en) * 1988-05-18 1989-09-05 Becton, Dickinson And Company Gas permeable bio-test pack
US5252484A (en) 1988-11-29 1993-10-12 Minnesota Mining And Manufacturing Company Rapid read-out biological indicator
US5271893A (en) * 1989-11-24 1993-12-21 Duncan Newman Apparatus for steam sterilization of articles
US5066464A (en) * 1990-01-17 1991-11-19 Propper Manufacturing Company, Inc. Prevacuum steam sterilization test pack
EP0460323B1 (en) * 1990-06-06 1993-08-04 Propper Manufacturing Co., Inc. Sterilization biological test pack
AU676743B2 (en) 1993-05-20 1997-03-20 Minnesota Mining And Manufacturing Company Biological sterelization indicator for use with or without test pack materials or devices
EP0628814A1 (de) 1993-06-14 1994-12-14 Ulrich Dr. Kaiser Prüfkörpersystem zum Überprüfen der Luftentfernung und/oder Sterilisationskontrolle kompletter Chargen in Dampfsterilisatoren
AU2599195A (en) * 1994-05-27 1995-12-21 Minnesota Mining And Manufacturing Company Electronic test pack using parametric measurements for sterilizers
US6323032B1 (en) * 1996-10-07 2001-11-27 3M Innovative Properties Company Sterilizer testing systems
US5830683A (en) * 1996-01-22 1998-11-03 North American Science Associates, Inc. Indicator systems for determination of sterilization
US6653096B1 (en) * 1996-07-29 2003-11-25 Process Challenge Devices Process challenge device and method
US5942408A (en) * 1996-07-29 1999-08-24 Christensen; Dennis E. Process challenge device and method
US5916816A (en) * 1996-09-27 1999-06-29 Minnesota Mining And Manufacturing Company Steam sterilization indicator compositions
US5872004A (en) * 1997-04-08 1999-02-16 Steris Corporation Test pack for assessing the efficiency of a sterilization process
US5789175A (en) * 1997-08-04 1998-08-04 Steris Corporation Pressure actuated exposure mechanism for sterilant indicator
US6815206B2 (en) * 1997-09-19 2004-11-09 Ethicon, Inc. Container monitoring system
US6630352B1 (en) * 1997-12-22 2003-10-07 3M Innovative Properties Company Sterilant challenge device for a sterilization monitoring system
US20010006610A1 (en) 1998-02-03 2001-07-05 Michael J Miller Contained indicators for determining sterilizations
US6051187A (en) * 1998-03-30 2000-04-18 Hughes; Charles A. Reusable steam test pack
US7045343B2 (en) * 1998-06-02 2006-05-16 3M Innovative Properties Company Sterilization indicator test packs
US6352837B1 (en) * 1999-02-22 2002-03-05 3M Innovative Properties Company Rapid readout sterilization indicator for liquid peracetic acid sterilization procedures
US20020081228A1 (en) 1999-12-21 2002-06-27 Hui Henry K. Monitoring sterilant concentration in diffusion-restricted regions as a basis for parametric release
US6664786B2 (en) 2001-07-30 2003-12-16 Rockwell Automation Technologies, Inc. Magnetic field sensor using microelectromechanical system
US20030072674A1 (en) 2001-10-16 2003-04-17 Richard Melker Microwaveable container for sterilizing objects
US7091042B2 (en) * 2001-11-02 2006-08-15 Ethicon, Inc. Variable resistance sterilization process challenge device and method
DE10156935B4 (de) * 2001-11-15 2004-02-26 Aesculap Ag & Co. Kg Sterilbehälter
ES2246027T3 (es) 2003-03-28 2006-02-01 Ulrich Dr. Kaiser Dispositivo de prueba especial para controlar las caracteristicas de penetracion de un agente esterilizante en los procesos de esterilizacion.
EP1550467B1 (de) 2003-12-15 2008-02-27 Ulrich Dr. Kaiser Prüfkörper zur Überprüfung der Penetrationseigenschaften eines Sterilisationsmittels in Sterilisationsprozessen
US20050268573A1 (en) 2004-01-20 2005-12-08 Avantec Vascular Corporation Package of sensitive articles
US8043845B2 (en) * 2006-09-20 2011-10-25 American Sterilizer Company Sterilization indicator
US8895239B2 (en) 2006-09-20 2014-11-25 American Sterilizer Company Genetically engineered biological indicator
EP2384432B1 (en) * 2007-06-21 2016-12-28 Gen-Probe Incorporated Instrument and receptacles for performing processes
EP2291201B1 (en) 2008-05-05 2014-08-20 3M Innovative Properties Company Sterilization process challenge device and method
CN102271717B (zh) 2008-11-06 2015-04-22 3M创新有限公司 过程验证设备和方法
ES2599008T3 (es) 2008-11-06 2017-01-31 3M Innovative Properties Company Dispositivo y método de control de un proceso

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH03121072A (ja) * 1989-09-22 1991-05-23 Minnesota Mining & Mfg Co <3M> 蒸気またはガス式滅菌器用の使い拾て式試験パック
JPH03159650A (ja) * 1989-11-16 1991-07-09 Py Mah Corp 滅菌インジケータを受容する装置及び滅菌装置の効力を試験する装置
WO1999020790A1 (en) * 1997-10-20 1999-04-29 Minnesota Mining And Manufacturing Company Testing the effectiveness of a sterilization procedure
JP2002516677A (ja) * 1998-06-02 2002-06-11 スリーエム イノベイティブ プロパティズ カンパニー 化学的に安定化した酵素を用いた滅菌表示装置
JP2004517675A (ja) * 2000-10-27 2004-06-17 スリーエム イノベイティブ プロパティズ カンパニー 滅菌を判定するためのインジケータシステム
JP2006296850A (ja) * 2005-04-22 2006-11-02 Olympus Medical Systems Corp 滅菌状態確認ツール

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021535770A (ja) * 2018-08-21 2021-12-23 ゲーカーエー ゲーエムベーハー マルチ・ステージ・プロセス・チャレンジ・デバイス、インジケーター・システム、およびプロセス・チャレンジ・デバイス・システム

Also Published As

Publication number Publication date
EP2666485A1 (en) 2013-11-27
WO2009137442A1 (en) 2009-11-12
JP2017074457A (ja) 2017-04-20
CN107050490A (zh) 2017-08-18
EP2291201B1 (en) 2014-08-20
ES2522967T3 (es) 2014-11-19
JP2015051270A (ja) 2015-03-19
US9114186B2 (en) 2015-08-25
CA2725078A1 (en) 2009-11-12
CN102076363A (zh) 2011-05-25
JP6448269B2 (ja) 2019-01-09
BRPI0908293A2 (pt) 2015-07-21
US20110064606A1 (en) 2011-03-17
CN107050490B (zh) 2020-07-07
EP2291201A1 (en) 2011-03-09

Similar Documents

Publication Publication Date Title
JP6448269B2 (ja) 滅菌プロセス管理装置、及び方法
CN102271717B (zh) 过程验证设备和方法
CA1337259C (en) Disposable biological indicator test pack for monitoring steam and ethylene oxide sterilization cycles
US4914034A (en) Disposable biological indicator test pack for monitoring steam and ethylene oxide sterilization cycles
US7247482B2 (en) Variable resistance sterilization process challenge device and method
US20020058296A1 (en) Contained indicators for determining sterilization
EP0419282B1 (en) Disposable test packs for steam or gas sterilizers
US20090053103A1 (en) Non-linting sterilization packaging material
US20160228593A1 (en) Process challenge device and methods
AU2004224765A1 (en) Testing body, particularly for verifying the penetration properties of a sterilizing agent in sterilization processes
US9265846B2 (en) Air removal test strip
AU2014395476B2 (en) Air removal test strip
US20150335777A1 (en) Process challenge device for gas sterilization

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20120426

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20120426

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20121129

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20130108

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20130405

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20130412

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20130708

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20140513

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20140916

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20140929

A912 Re-examination (zenchi) completed and case transferred to appeal board

Free format text: JAPANESE INTERMEDIATE CODE: A912

Effective date: 20141205

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20151102