Standard: AAMI 13408-4

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 4: CLEAN-IN-PLACE TECHNOLOGIES

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Scope:

This part of ISO 13408 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 part of ISO 13408 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product.

This part of ISO 13408 is not applicable to processes where equipment is dismantled and cleaned in a washer.

This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 13408-4
Publish Date: 2005-01-01
Page Count: 31
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
AAMI 13408-4 Change Type: REAF Update Date: 2005-01-01 Revision: 05 Status: ACTV
AAMI 13408-4 Change Type: STCH Update Date: 2005-01-01 Revision: 05 Status: ACTV

This Standard References

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