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Sterilization Q&A

  • Asked April 23rd, 2009

    Heat is the oldest and possibly the most recognized agent of microbial destruction and is the most popular method of terminal sterilization used in the pharmaceutical industry. Costs for moist-heat sterilization, if contracted out, are similar to that of EO sterilization, in that you typically pay by the chamber where chamber sizes can range from 1 to 30 pallet sizes. Moist-heat sterilization is typically performed at 121 to 134 °C. A major concern is the degradation of materials by heat or moisture. Moist heat, however, can be successful with a range of products such as acetal,  glass, liquids, polypropylene , PTFE, fibers, and celluloses. 

    Moist-heat sterilization, in that it is a terminal sterilization process, can be validated to an SAL of 10-6. This, of course, provides a greater assurance of not producing a “non-sterile” product as compared to filtration.

    AAMI TIR 17:2008, Compatibility of materials subject to sterilization, provides excellent information with regarding to Moist-Heat sterilization, as well as all other methods of terminal sterilization, and its effects on materials. You can purchase AAMI TIR 17:2008 at www.aami.org

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