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AAMI/ISO 13408-4:2005 (R2014)

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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.

Author ANSI/AAMI/ISO
Editor AAMI
Document type Standard
Format File
Confirmation date 2014-10-13
ICS 11.080.01 : Sterilization and disinfection in general
Cross references ISO 13408-4 (2005-11), IDT
Year 2005
Document history
Country USA
Keyword ANSI 13408;ANSI/AAMI/ISO 13408;13408;ANSI/AAMI/ISO 13408-4-2005 (R2014)