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Use of Biological Indicators Designed for Stream or Ethylene Oxide to Monitor a Liquid Chemical Sterilization Process

Published online by Cambridge University Press:  21 June 2016

Raymond C. Kralovic
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Abstract

Objective:

To determine the ability of a commercially available biological indicator (BI), used to monitor steam and ethylene oxide sterilization, to biologically monitor a liquid sterilization process consisting of a sterile processor, a proprietary peracetic acid sterilant, and a sterile rinse system.

Design:

Analysis of spore survival in BIs tested in STERIS SYSTEM 1™ liquid chemical sterilization processor and in vitro.

Setting:

STERIS Corp. research laboratory.

Methods:

In vitro tests were performed in the STERIS SYSTEM 1 Processor using 12-minute and 6-minute sterilant exposure cycles. D values (time to inactivate one log of spores), spore washoff and outgrowth time, and inhibitory effects of the sterilant were determined.

Results:

Sterilization of the spore-inoculated filter paper strips in the BIs was ascertained in both processor testing and in vitro tests using conditions identical to those in the processor. The extensive washing and dilution during the processor cycle resulted in only 0.2% and 1.8% removal of the spores from Bacillus stearother-mophilus and Bacillus subtilis inoculated spore strips, respectively.

Carryover of the diluted sterilant to the culture medium did not inhibit the outgrowth of the spores, and D values could be obtained. B Stearothermophilus was two to three times more resistant to the sterilant than B subtilis. However, either spore meets the performance specifications applicable to BIs for monitoring sterilization processes.

Conclusions:

The data demonstrate that the commercial Bis evaluated are reproducible and verifiable indicators of the liquid chemical sterilization process. The same kind of performance specifications for producing BIs used to monitor steam or ethylene oxide systems also apply to the evaluated liquid chemical sterilization system.

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 14 , Issue 6 , June 1993 , pp. 313 - 319
Copyright
Copyright © The Society for Healthcare Epidemiology of America 1993

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References

1. American National Standard, Association for the Advancement of Medical Instrumentation. American National Standard for Biological Indicators for Ethylene Oxide Sterilization Processes in Health Care Facilities. Arlington, VA: AAMI; 1986.Google Scholar
2. American National Standard, Association for the Advancement of Medical Instrumentation. American National Standard for Biological Indicators for Steam Sterilization Processes in Health Care Facilities. Arlington, VA: AAMI; 1986.Google Scholar
3. The United States Pharmacopeia (USPI XXII, the National Formulury (NF). Rockville, MD: The United States Pharmacopeial Convention, Inc; 1990:171–175.Google Scholar
4. Spicher, G. Biological indicator and monitoring systems for validation and cycle control of sterilization processes. Zuntrablatt fur Bakteriologie und Hygiene 1988 A267:468–484.Google Scholar
5. Association of Official Analytic Chemists. Sporicidal activity of disinfectants. First Action 1984;67:72–73.Google Scholar
6. United States Environmental Protection Agency. Eficacy Data Requirements-Sterilizers. DIS/TSS. Washington, DC: Offic of Pesticide Program; 1985.Google Scholar
7. Natrella, MG. Experimental Statistics. National Bureau of Standards Handbook 91. Washington, DC: US Government Printing Office; 1966.Google Scholar
8. Collins, CH, Lyne, PM. Microbiological Methods. 5th ed. London, England: Butterworths;1984.Google Scholar
9. Kralovic, RC, Badertscher, DC. Bactericidal and sporicidal efficacy of a peracetic acid-based liquid chemical sterilant. In: Abstracts of the Annual Meeting American Society for Microbiology. Miami Beach, FL, May 8-13,1988 Google Scholar
10. Stumbo, CR, Murphy, R, Cochran, J. Nature of thermal death time curves for EA. 3679 and Clostridium botulinum . Food Technology 1950;4:321–326.Google Scholar
11. Graham, GS, Boris, C. The effect of recovery medium and test methodology on biological indicators. Medical Device & Diagnostic Industry 1985;7:43–48.Google Scholar
12. Joslyn, LJ. Sterilization by heat. In: Block, SS, ed. Disinfection, Sterilization, and Preservation. Philadelphia, PA: Lea & Febiger;1991:495–526.Google Scholar
13. Oxborrow, GF, Berube, R Sterility testing: validation of sterilization processes and sporicidal testing. In: Block, SS, ed. Disinfection, Sterilization, and Preservation. Philadelphia, PA: Lea & Febiger; 1991:1047–1057.Google Scholar
14. Nyström, B. Disinfection of surgical instruments. J Hosp Infect 1981;2:263–368.CrossRefGoogle ScholarPubMed
15. Prince, HN, Rubino, JR. Bioburden dynamics: the viability of microorganisms on devices before and after sterilization. Medical Device &Diagnostic Industry 1984;6:47–53.Google Scholar
16. DeRisio, RJ. Sterilization concepts and methods of sterilization employed by the hospital industry. In: Gaughran, RL, Morrissey, RF, You-sen, W, eds. Sterilization of Medical Products. Montreal, Canada: Polyscience Publications, Inc.; 1986:17–31.Google Scholar
17. Outschoom, AS. Chemical and biological monitors of sterilization processes. In: Gaughran, RL, Morrissey, RF, You-sen, W, eds. Sterilization of Medical Products. Montreal, Canada: Polyscience Publications, Inc.; 1986:140–144.Google Scholar