Use of biological indicators designed for steam or ethylene oxide to monitor a liquid chemical sterilization process. 1993

R C Kralovic
STERIS Corp., Mentor, OH 44060-1868.

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

UI MeSH Term Description Entries
D011786 Quality Control A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed) Control, Quality,Controls, Quality,Quality Controls
D003013 Clostridium A genus of motile or nonmotile gram-positive bacteria of the family Clostridiaceae. Many species have been identified with some being pathogenic. They occur in water, soil, and in the intestinal tract of humans and lower animals.
D004864 Equipment and Supplies Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures. Apparatus and Instruments,Devices,Medical Devices,Device, Medical,Devices, Medical,Equipment,Inventories,Medical Device,Supplies,Device,Instruments and Apparatus,Inventory,Supplies and Equipment
D005027 Ethylene Oxide A colorless and flammable gas at room temperature and pressure. Ethylene oxide is a bactericidal, fungicidal, and sporicidal disinfectant. It is effective against most micro-organisms, including viruses. It is used as a fumigant for foodstuffs and textiles and as an agent for the gaseous sterilization of heat-labile pharmaceutical and surgical materials. (From Reynolds, Martindale The Extra Pharmacopoeia, 30th ed, p794) Oxirane,Oxide, Ethylene
D006268 Health Facilities Institutions which provide medical or health-related services. Facilities, Health,Facility, Health,Health Facility
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001407 Bacillus A genus of BACILLACEAE that are spore-forming, rod-shaped cells. Most species are saprophytic soil forms with only a few species being pathogenic. Bacillus bacterium
D013171 Spores, Bacterial Heat and stain resistant, metabolically inactive bodies formed within the vegetative cells of bacteria of the genera Bacillus and Clostridium. Bacterial Spores,Bacterial Spore,Spore, Bacterial
D013227 Steam Water in its gaseous state. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed) Water Vapor,Steams,Vapor, Water,Vapors, Water,Water Vapors
D013242 Sterilization The destroying of all forms of life, especially microorganisms, by heat, chemical, or other means.

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