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Sterility Testing
Sterility Testing
There are set guidelines for sterility testing of biologics in various pharmacopoeia and also section 21 of the CFR (Code of Federal Regulations) and Food and Drug Administration. Every biological product manufactured under GMP conditions requires sterility testing performed under GMP guidelines. HiMedia provides a complete set of sterility testing media and rinse solutions as per various pharmacopoeias. Two common types of sterility test methods widely described are Direct Inoculation or Immersion and Membrane Filtration. The Direct Inoculation or Immersion method involves the test article to be inoculated directly into specified media. While in the Membrane Filtration method the test article has to first pass through size exclusion membrane capable of retaining microorganisms and that filter is rinsed and transferred to the specified test medium. In both test methods the test article or membrane is incubated for 14 days in the test media. The majority of biological samples will be tested using the immersion method. But if it deals with large volumes then membrane filtration method may be required.
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