Standard Swedish standard · SS-EN ISO 13408-4:2011

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

Status: Valid

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.

Subjects

Sterilization and disinfection in general (11.080.01) General (11.120.01)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

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

Article no: STD-80778

Edition: 1

Approved: 7/12/2011

No of pages: 32

Replaces: SS-EN 13824:2005