What special factors need to be considered for sterile filtration?
Sterile filtration is one of the most important process steps in the aseptic processing of sterile pharmaceutical products from heat-labile starting materials. In contrast to other sterilization methods, the microorganisms are not inactivated or killed, but removed. Important aspects of sterile filtration are the qualification of the filter, the validation of the filtration process and the execution of filter integrity tests. Sterile filters must be sterilized before use. After filling a batch, at the latest after one working day, the sterile filter should be disposed of. For small batches, reuse as a pre-filter can be considered for cost reasons but requires appropriate validation.
[GMP Compliance Adviser, Chapter 12.E]
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