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ISO 13408-1:2008

Aseptic processing of health care products — Part 1: General requirements

Standard Details

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.

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO 13408-1:2008
Document Year: 2008
Pages: 45
Edition: 2
  • Section Volume:
  • ISO/TC 198. Sterilization of health care products
  • ICS:
  • 11.080.01 Sterilization and disinfection in general

Life Cycle

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WITHDRAWN
ISO 13408-1:2008
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