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ISO 13408-1:2023

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

standard by International Organization for Standardization , 08/01/2023

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Full Description

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.
 

Product Details

Published:
08/01/2023
File Size:
1 file , 3.9 MB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 13408-1:2023

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

    • Most Recent

  2. ISO 13408-1:2008


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

    • Historical Version

  3. ISO 13408-1:1998


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

    • Historical Version