What needs to be considered when validating a sterility test method?
If you have decided to carry out sterility testing, you must follow the specifications of the pharmacopoeia. In addition to the test itself, appropriate supporting tests are required. The sterility test must be carried out under aseptic conditions. For this purpose, the use of isolators with a personnel-free and sterilized environment is recommended. The working conditions must be monitored by appropriate environmental controls.
[GMP Compliance Adviser, Chapter 12.F]
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