Sterilization Q&A
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Asked March 22nd, 2009
The greatest benefit of terminal sterilization is reducing the risk of a nonsterile product being released to the recipient of the product. Terminal sterilization, using any of the various methodologies (EtO, Radiation, Steam, Dry Heat), can be validated to provide a 10-6 sterility assurance level (SAL) for the products sterilized using terminal sterilization methods. When terminal sterilization is used in conjunction with aseptic manufacture, the risk of a nonsterile is even further reduced. This can be accomplished two ways: 1) terminal sterilization of key components prior to aseptic manufacture and 2) terminal sterilization of the whole product after aseptic manufacture.



