STERILITY TEST
Sterility testing is widely used in both the medical device and pharmaceutical industries. As a USP test, it is the official procedure for testing the sterility of pharmaceutical products There are different methods to test the sterility of the products.
Direct Transfer-Immersion
Membrane Filtrartion - open system
Membrane Filtrartion by Millipore Steritest Methodä -a closed system
Membrane filtration of the product, with either an open or a closed system, is the preferred sterility test method. If the product cannot be filtered, then direct inoculation, immersion, in-situ incubation or combination methods as appropriate are acceptable.
Soya-bean casein digest (SCD) and fluid thioglycollate media (FTM) are used in accordance to Pharmacopoeial method. The sample is transferred directly to test media or flushed with test media and incubated accordingly..
All test containers are incubated at specific temperatures for at least 14 days, regardless of whether filtration or direct inoculation test methodology is used. B& F test is required to validate the test.
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