CEN - EN ISO 13408-4
Aseptic processing of health care products - Part 4: Clean-inplace technologies
|Publication Date:||1 June 2011|
|ICS Code (Sterilization and disinfection in general):||11.080.01|
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.