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AAMI/ISO 13408-4:2005 (R2014)

AAMI/ISO 13408-4:2005 (R2014)

Aseptic processing of health care products - Part 4: Clean-in-place technologies

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Specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of 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 cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP that may come in contact with the product.

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