RE: sterility testing Contribution from Bernd Renger written on 10/9/2008 at 00:32
Original contribution: sterility testing written by Nadia on 10/7/2008 at 08:27) Sterility cannot be guaranteed by a sterility test run in a quality control laboratory. It must be guaranteed via your process validation that included the assessment of cold spots to assure the process always works in overkill.
The official (legal) requirements for sterility tests in Europe are currently those specified in the most recently issued European Pharmacopoeia (Ph Eur)
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