The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials. Four document types are included with an Emprove® Program subscription:
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.
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This page summarizes key considerations related to regulatory expectations for biomanufacturing including chemicals and polymeric materials. For chemicals, topics include nitrosamines and elemental impurities, and for polymeric materials such as filters and single-use assemblies, the focus is qualification and extractable and leachable testing.
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