Standard

NS-EN ISO 13408-4:2011

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Abstract

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.

Document information

  • Standard from SN
  • Published:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • ICS 11.080.01
  • National Committee CEN/TC 204

Legal references

EU law: 90/385/EEC, 93/42/EEC, 98/79/EC

Product Relations

Product life cycle