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ANSI/AAMI/ISO 13408-5-2006/(R)2015

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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