WO2001013964A8 - Device to assess efficacy of sterilization procedure - Google Patents

Device to assess efficacy of sterilization procedure

Info

Publication number
WO2001013964A8
WO2001013964A8 PCT/US1999/019230 US9919230W WO0113964A8 WO 2001013964 A8 WO2001013964 A8 WO 2001013964A8 US 9919230 W US9919230 W US 9919230W WO 0113964 A8 WO0113964 A8 WO 0113964A8
Authority
WO
WIPO (PCT)
Prior art keywords
indicator
efficacy
challenge
culture medium
sterilization procedure
Prior art date
Application number
PCT/US1999/019230
Other languages
French (fr)
Other versions
WO2001013964A1 (en
Inventor
Dennis Christensen
R Daniel Webster
Harvey A Markinson
Original Assignee
Process Challenge Devices
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 Process Challenge Devices filed Critical Process Challenge Devices
Priority to AU55819/99A priority Critical patent/AU5581999A/en
Priority to PCT/US1999/019230 priority patent/WO2001013964A1/en
Publication of WO2001013964A1 publication Critical patent/WO2001013964A1/en
Publication of WO2001013964A8 publication Critical patent/WO2001013964A8/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/22—Testing for sterility conditions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Packages (AREA)

Abstract

A process challenge device tailored to mimic the resistance of particular product-package combination to a particular biological inactivation, disinfection, or sterilization process. The device is used to challenge the process, this providing a means to validate the efficacy of the process. In one embodiment, the process indicator includes a biological indicator organism stored on a carrier enclosed within a chamber formed by a barrier film material. The process challenge device may also comprise a separate second chamber filled with an appropriate culture medium or enzyme substrate that is separated from the chamber containing the process indicator by a separation means, such as a valve, a clip or a frangible separation. The separation means between the two chambers is capable of being removed on demand after completion of the process thus allowing the culture medium or enzyme substrate to contact the process indicator. This initiates the beginning of the culture phase or enzyme activity test which confirms the efficacy of the sterilization procedure.
PCT/US1999/019230 1999-08-24 1999-08-24 Device to assess efficacy of sterilization procedure WO2001013964A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU55819/99A AU5581999A (en) 1999-08-24 1999-08-24 Device to assess efficacy of sterilization procedure
PCT/US1999/019230 WO2001013964A1 (en) 1999-08-24 1999-08-24 Device to assess efficacy of sterilization procedure

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1999/019230 WO2001013964A1 (en) 1999-08-24 1999-08-24 Device to assess efficacy of sterilization procedure

Publications (2)

Publication Number Publication Date
WO2001013964A1 WO2001013964A1 (en) 2001-03-01
WO2001013964A8 true WO2001013964A8 (en) 2001-09-27

Family

ID=22273440

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/019230 WO2001013964A1 (en) 1999-08-24 1999-08-24 Device to assess efficacy of sterilization procedure

Country Status (2)

Country Link
AU (1) AU5581999A (en)
WO (1) WO2001013964A1 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0110191D0 (en) * 2001-04-25 2001-06-20 Oxford Instr Plasma Technology Sterilization method
US7091042B2 (en) 2001-11-02 2006-08-15 Ethicon, Inc. Variable resistance sterilization process challenge device and method
DE10213361B3 (en) * 2002-03-26 2004-01-08 Dunkelberg, Hartmut, Prof., Dr. Procedure for testing a sterilization packaging unit for effectiveness against recontamination
US7874128B2 (en) 2003-05-15 2011-01-25 Hartmut Dunkelberg Test unit and method for testing whether a sterilizing packaging unit is effective against recontamination, and container packaging suitable for applying said method
ES2654140T3 (en) 2009-07-20 2018-02-12 3M Innovative Properties Company Indicator of biological sterilization and method of use thereof
FR3064918B1 (en) * 2017-04-10 2019-06-14 Patrice Slupecki PROCESS FOR VALIDING THE TREATMENT CYCLE OF A DOOR DYNAMIC INSTRUMENT
US11603551B2 (en) 2020-12-02 2023-03-14 Steritec Products Mfg. Co., Inc. Biological indicators, and systems and methods for determining efficacy of sterilization

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2521906B1 (en) * 1982-02-19 1986-07-25 Steril Packing Syst Lab FILM FOR MAKING STERILIZATION ENVELOPES OR BAGS AND ENVELOPE THUS PRODUCED
DE3217002A1 (en) * 1982-05-06 1983-11-10 Merck Patent Gmbh, 6100 Darmstadt BIOINDICATOR
CA1256360A (en) * 1984-02-10 1989-06-27 John W. Bornhoeft Apparatus and method for determining the effectiveness of sterlization
US4743537A (en) * 1986-01-21 1988-05-10 Castle Company Biological indicator for sterilization processes
KR0150454B1 (en) * 1989-10-03 1998-10-01 제임스 리센펠드 Sterilizer test pack
US5516648A (en) * 1994-08-18 1996-05-14 Steris Corporation Encapsulated biological indicator
US5942408A (en) * 1996-07-29 1999-08-24 Christensen; Dennis E. Process challenge device and method
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

Also Published As

Publication number Publication date
AU5581999A (en) 2001-03-19
WO2001013964A1 (en) 2001-03-01

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