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Explaining Sterile Validation in a Cleanroom


Whether using sterilization methods such as moist heat, dry heat, gamma or electron radiation, filtration, UV, hydrogen peroxide, etc., a validation study must follow established procedures. It requires looking at sterility assurance level (SAL) or the probability a single unit that has been sterilized in fact remains nonsterile. There’s never a 0% chance a microorganism hasn’t survived, and one can’t prove all of them have been eliminated.

In general, a sterilization process must deliver an SAL of one in a million.

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