Reference number
ISO 13408-1:2023
© ISO 2025
International Standard
ISO 13408-1:2023
Aseptic processing of health care products — Part 1: General requirements
Edition 3
2023-08
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Published (Edition 3, 2023)

ISO 13408-1:2023

Language
Format
CHF 199
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Abstract

This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.

This document includes requirements and guidance relative to the overall topic of aseptic processing.

Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.

General information

  • Status
     : Published
    Publication date
     : 2023-08
    Stage
    : International Standard published [60.60]
  • Edition
     : 3
    Number of pages
     : 72
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.01 
  • RSS updates

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