GSO ISO 13408-4:2014

ISO 13408-4:2005
Gulf Standard   Current Edition · Approved on 25 December 2014

Aseptic processing of health care products -- part 4 : clean-in-place technologies

GSO ISO 13408-4:2014 Files

English 14 Pages
Current Edition Reference Language

GSO ISO 13408-4:2014 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.

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