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EU24CEMAR1/SES201 - Parametric Release a Smart Way for Sterile Products

‐ Mar 12, 2024 11:15am

Parametric Release is not even an alternative for product sterility tests. It secures a better statistical coverage for the entire batch while it allows to speed up the release process at the same time.  By setting it up right it offers a win win situation improving manufacturers productivity and strengthening patient safety at the same time.  The presentation will invite you into Bipso´s journey towards parametric release, gives an overview about the regulatory background and  elucidates practical aspects and challenges for implementation.