AAMI ANSI/AAMI/ISO 13408-4:2005/(R)2014

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

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AAMI ANSI/AAMI/ISO 13408-4:2005/(R)2014

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

PUBLISH DATE 2012
AAMI ANSI/AAMI/ISO 13408-4:2005/(R)2014
This document 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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