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

Status : Published (Under review)

This standard was last reviewed and confirmed in 2019. Therefore this version remains current.
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Format Language
std 1 96 PDF
std 2 96 Paper
  • CHF96
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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.

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General information

  •  : Published
     : 2005-11
    : International Standard confirmed [90.93]
  •  : 1
     : 14
  • ISO/TC 198
    11.080.01 
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Life cycle

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This standard contributes to the following Sustainable Development Goal

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