SRPS ISO 13408-4:2010

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

Scope

ISO 13408-4:2005 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.
ISO 13408-4:2005 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.
ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer.
ISO 13408-4:2005 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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.