Reference number
ISO 13408-1:2023
International Standard
ISO 13408-1:2023
Aseptic processing of health care products — Part 1: General requirements
Edition 3
2023-08
Read sample
ISO 13408-1:2023
77151
Published (Edition 3, 2023)

ISO 13408-1:2023

ISO 13408-1:2023
77151
Language
Format
CHF 194
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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

  •  : Published
     : 2023-08
    : International Standard published [60.60]
  •  : 3
     : 72
  • ISO/TC 198
    11.080.01 
  • RSS updates

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