Standard

ISO 13408-1:2008

Historical draft

Note: This standard has a new edition: ISO 13408-1:2023

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Abstract

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Document information

  • Standard from ISO
  • Published:
  • Withdrawn:
  • Expires:
  • Edition: 2
  • Version: 1
  • Document type: IS
  • ICS 11.080.01
  • ISO TC ISO/TC 198

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