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30 October 2020 | By Abu Manju (Eindhoven University of Technology), David Jones (Rapid Micro Biosystems), Edwin van den Heuvel (Eindhoven University of Technology), Jaime Brosseau (Rapid Micro Biosystems), Niloufar Parsaei (Rapid Micro Biosystems)
This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.
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