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Sterility Testing of Vaccines
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In addition to sterility tests on samples taken throughout the production process, further tests are made on samples of final vaccine (aqueous and oil) and inactivated viral antigens intended for strategic storage.
Thioglycollate and Soya Bean Casein Digest Media are commonly used because of their ability to support a wide range of organisms which are potential contaminants of vaccines.
Media are either inoculated directly with sample or potential contaminants collected by membrane filtration and the membrane incubated with media.
The sample fails the sterility test if there is any evidence of microbial growth.
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