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ISO 13408-1:2008

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

standard by International Organization for Standardization , 06/15/2008

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Full Description

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.

 

Product Details

Published:
06/15/2008
File Size:
1 file , 660 KB
Same As:
AAMI/ISO 13408-1:2008/(R)2017 & A1:2013/(R)2017, DIN EN ISO 13408-1, BS EN ISO 13408-1:2011, BS EN ISO 13408-1:2011+A1:2013, BS EN ISO 13408-1:2015
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 13408-1:2023


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

    • Most Recent

  2. ISO 13408-1:2008

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    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
 

Amendments, rulings, supplements, and errata

  1. ISO 13408-1:2008/Amd1:2013


    - Amendment 1

  2. ISO 13408-1:2008/Amd1:2013


    - Amendment 1