![]() ISO 11138-1 defines the minimum sample number of four biological indicators for population verification.īiological indicators are assayed following manufacturer’s instruction, usually involving extraction, and sometimes requiring maceration of a paper strip, heat-shocking, serial dilution, pour-plating, incubation, and enumeration. ![]() To verify the spore population of the test organism, samples of biological indicators are selected from each distinct manufacturer batch per delivery received. How to the Population Verification is Performed Manufacturers are required by ISO 11138-1 to provide the name of the test organism instructions for use, storage, testing, and disposal and the nominal population and resistance information with each biological indicator batch. Moist heat and vaporized hydrogen peroxide (VHP) modalities typically use a thermophilic endospore-forming bacteria, Geobacillus stearothermophilus. The transit and storage conditions have not affected the spore population.The spore population is as stated by the manufacturer on the certificate of analysis (COA).This spore population should be verified prior to use for routine sterilization purposes, to ensure that: In ethylene oxide and dry heat sterilization, the test organism used is typically the endospore-forming bacteria, Bacillus atrophaeus, (ISO11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes and ISO11138-4 Biological indicators – Part 4: Biological indicators for dry heat sterilization processes) with each unit having a minimum population of 1 x 10 6. The population of the test organisms upon receipt at the test facility should be verified per ISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements. In a sterilization process where biological indicator (BI) sterility results are used as part of product release criteria, the BIs shall be procured from an approved supplier with a minimum population of test organisms defined. Radiation Request Form Submittal Guidelines.Sterile Barrier Integrity and Seal Strength. ![]() Method Development and Validation Services.Radiation Sterilization Validation Services.Sustainable EO ® Sterilization Services. ![]()
0 Comments
Leave a Reply. |