This method entails passing a quantity of drug product through two canisters, each with a microorganism-retention filter Sterility Testing is done using two different methods. The first is membrane filtration, which is the preferred method according to USP 71> if the drug product being tested is filterable. This is followed by a rinse to ensure that no drug product remains on the filter, which could inhibit microorganism growth. Fill each canister with one of the two media types described below as the final step.
Direct inoculation is the second sterility test method. This entails directly injecting the drug product into each of the two growth media with a predetermined amount of drug product sample.The absence of viable microorganisms is defined as sterility. However, the conditions that ensure absolute sterility are often too harsh for active ingredients, so sterility for medicinal products must be defined in functional terms.
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