AAMI CR513:2024

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Guidance on radiation validation and routine maintenance for single-use systems used for pharmaceutical and biopharmaceutical manufacturing

Association for the Advancement of Medical Instrumentation , 07/16/2024

Pages: 14

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AAMI CR513:2024 PDF

This consensus report provides guidance on simplified approaches for validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing sterilized by radiation.