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ISO 13408-1:2023

Aug 2023 Current

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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.

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Standard from ISO
Published: August 15 2023
Edition: 3
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.080.01
International TC: ISO/TC 198

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Adopted by: NF EN ISO 13408-1:2024
Revises: ISO 13408-1:2008

ISO 13408-1:2023

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ISO 13408-1:2023

ISO 13408-1:2008

ISO 13408-1:1998

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Version history History (3)

ISO 13408-1:2023

ISO 13408-1:2008

ISO 13408-1:1998

Abstract

Products specifications

Product Relations

Product life cycle