ISO 13408-4:2005
p
ISO 13408-4:2005
39781

Abstract

 Preview

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.


General information 

  •  : Published
     : 2005-11
  •  : 1
     : 14
  •  : ISO/TC 198 Sterilization of health care products
  •  :
    11.080.01 Sterilization and disinfection in general

Buy this standard

en
Format Language
std 1 92 PDF
std 2 92 Paper
  • CHF92

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)