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AAMI/ISO 13408-5:2006(R2015)

AAMI/ISO 13408-5:2006(R2015)

Aseptic processing of health care products - Part 5: Sterilization in place

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Specifies the general requirements for sterilization in place (SIP) applied to product contact
surfaces of the equipment used in the manufacture of sterile health care products by aseptic
processing and offers guidance on qualification, validation, operation and control. This document
applies to processes where sterilizing agents are delivered to the internal surfaces of the
equipment that can come in contact with the product.

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