CA2725078A1 - Sterilization process challenge device and method - Google Patents

Sterilization process challenge device and method Download PDF

Info

Publication number
CA2725078A1
CA2725078A1 CA2725078A CA2725078A CA2725078A1 CA 2725078 A1 CA2725078 A1 CA 2725078A1 CA 2725078 A CA2725078 A CA 2725078A CA 2725078 A CA2725078 A CA 2725078A CA 2725078 A1 CA2725078 A1 CA 2725078A1
Authority
CA
Canada
Prior art keywords
solid body
sterilant
walls
container
sterilization
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.)
Abandoned
Application number
CA2725078A
Other languages
English (en)
French (fr)
Inventor
William E. Foltz
Steven S. Kirckof
Lawrence D. Fosler
Joshua M. Schmitz
Barry W. Robole
Chad M. Herrlein
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 CA2725078A1 publication Critical patent/CA2725078A1/en
Abandoned legal-status Critical Current

Links

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)
CA2725078A 2008-05-05 2009-05-05 Sterilization process challenge device and method Abandoned CA2725078A1 (en)

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

Publications (1)

Publication Number Publication Date
CA2725078A1 true CA2725078A1 (en) 2009-11-12

Family

ID=40722158

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2725078A Abandoned CA2725078A1 (en) 2008-05-05 2009-05-05 Sterilization process challenge device and method

Country Status (8)

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

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0908293A2 (pt) 2008-05-05 2015-07-21 3M Innovative Properties Co "método e dispositivo de desafio do processo de esterilização"
WO2010054033A1 (en) 2008-11-06 2010-05-14 3M Innovative Properties Company Process challenge device and methods
ES2627678T3 (es) * 2008-11-06 2017-07-31 3M Innovative Properties Company Dispositivo y método de control de un proceso
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
JP2016502893A (ja) * 2013-01-04 2016-02-01 ノクシライザー, インコーポレイテッドNoxilizer, Incorporated ガス滅菌のための工程試験用具
CA2912766C (en) * 2013-05-21 2021-09-07 3M Innovative Properties Company Nanostructured spore carrier
CN113244418B (zh) 2015-09-11 2023-06-13 史赛克公司 用于外科器械的灭菌封装
CN108698722B (zh) * 2016-03-08 2021-08-27 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、内容物填充系统的验证方法和培养基
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
CN119896762A (zh) * 2016-12-08 2025-04-29 舒万诺知识产权公司 过程监测装置
US10786141B2 (en) 2017-03-31 2020-09-29 American Sterilizer Company Cap assembly for endoscope
CN112469448A (zh) * 2018-08-21 2021-03-09 Gke德国有限责任公司 多级过程挑战装置、指示剂系统和过程挑战装置系统
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
DE112018008133T5 (de) * 2018-11-12 2021-07-29 Gke-Gmbh Konischer Indikator zur Verwendung in Prozess-Prüfkörpern
US11850320B2 (en) 2018-12-20 2023-12-26 Asp Global Manufacturing Gmbh Liquid-chemical sterilization system with biological indicator
MX2021007674A (es) 2018-12-28 2021-08-16 Asp Global Mfg Gmbh Un indicador de tratamiento, un metodo de produccion del mismo y un metodo de uso del mismo.
US11603551B2 (en) 2020-12-02 2023-03-14 Steritec Products Mfg. Co., Inc. Biological indicators, and systems and methods for determining efficacy of sterilization
CN120018866A (zh) * 2022-10-25 2025-05-16 舒万诺知识产权公司 过程质询装置及其制造方法

Family Cites Families (52)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE364117B (enExample) 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
US4743537A (en) 1986-01-21 1988-05-10 Castle Company Biological indicator for sterilization processes
US4717661A (en) * 1986-01-21 1988-01-05 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
AU647041B2 (en) 1989-09-22 1994-03-17 Minnesota Mining And Manufacturing Company Disposable test packs for steam or gas sterilizers
AU5762790A (en) 1989-11-16 1991-05-23 Pymah Corporation Integrator test pack for ethylene oxide sterilization
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
JP3558635B2 (ja) * 1993-05-20 2004-08-25 ミネソタ・マイニング・アンド・マニュファクチュアリング・カンパニー テストパック材料または装置を用いたまたは用いない生物学的滅菌インジケーター
EP0628814A1 (de) 1993-06-14 1994-12-14 Ulrich Dr. Kaiser Prüfkörpersystem zum Überprüfen der Luftentfernung und/oder Sterilisationskontrolle kompletter Chargen in Dampfsterilisatoren
CN1151703A (zh) 1994-05-27 1997-06-11 美国3M公司 对消毒器进行参数测量的电子测试装置
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
US5866356A (en) 1997-10-20 1999-02-02 Minnesota Mining And Manufacturing Company Protective housing for biological indicator for testing the effectiveness of a sterilization procedure
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
US6355448B1 (en) 1998-06-02 2002-03-12 3M Innovative Properties Company Sterilization indicator with chemically stabilized enzyme
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
US6528277B1 (en) 1999-11-22 2003-03-04 3M Innovative Properties Company Indicator systems for determination of sterilization
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
JP4383382B2 (ja) 2005-04-22 2009-12-16 オリンパスメディカルシステムズ株式会社 滅菌状態確認ツール
US8895239B2 (en) * 2006-09-20 2014-11-25 American Sterilizer Company Genetically engineered biological indicator
US8043845B2 (en) * 2006-09-20 2011-10-25 American Sterilizer Company Sterilization indicator
EP2175999B1 (en) * 2007-06-21 2017-01-04 Gen-Probe Incorporated Receptacles for use in performing processes
BRPI0908293A2 (pt) 2008-05-05 2015-07-21 3M Innovative Properties Co "método e dispositivo de desafio do processo de esterilização"
ES2627678T3 (es) 2008-11-06 2017-07-31 3M Innovative Properties Company Dispositivo y método de control de un proceso
WO2010054033A1 (en) 2008-11-06 2010-05-14 3M Innovative Properties Company Process challenge device and methods

Also Published As

Publication number Publication date
ES2522967T3 (es) 2014-11-19
JP2011519680A (ja) 2011-07-14
EP2666485A1 (en) 2013-11-27
BRPI0908293A2 (pt) 2015-07-21
JP2017074457A (ja) 2017-04-20
CN107050490A (zh) 2017-08-18
WO2009137442A1 (en) 2009-11-12
JP2015051270A (ja) 2015-03-19
EP2291201A1 (en) 2011-03-09
EP2291201B1 (en) 2014-08-20
CN107050490B (zh) 2020-07-07
US20110064606A1 (en) 2011-03-17
US9114186B2 (en) 2015-08-25
JP6448269B2 (ja) 2019-01-09
CN102076363A (zh) 2011-05-25

Similar Documents

Publication Publication Date Title
US9114186B2 (en) Sterilization process challenge device
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
US7091042B2 (en) Variable resistance sterilization process challenge device and method
US4914034A (en) Disposable biological indicator test pack for monitoring steam and ethylene oxide sterilization cycles
US20160228593A1 (en) Process challenge device and methods
CA2694416C (en) Sterilization challenge specimen holder
AU710085B2 (en) Self-contained biological indicator
US5830683A (en) Indicator systems for determination of sterilization
US7790105B2 (en) Sterilization challenge specimen holder
EP0419282B1 (en) Disposable test packs for steam or gas sterilizers
JPH07148232A (ja) 独立生物標示装置
EP0879064B1 (en) Indicator systems and material compression and insertion devices for preparing same
US20150335777A1 (en) Process challenge device for gas sterilization
JP2003070884A (ja) 滅菌処理適合性を改善するためのアルミニウム合金の表面処理

Legal Events

Date Code Title Description
FZDE Dead

Effective date: 20130506