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Norm

ISO 13408-1:2008

Issue date: 2008 06 10

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

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of t...
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Withdrawn : 2023 08 15
Publisher:
International Organization for Standardization
Format:
Digital | 45 Pages
Language:
English

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.

ISO 13408-1:2023
2023 08 15
Aseptic processing of health care products — Part 1: General requirements
Norm
ISO 13408-1:2008
2008 06 10
Aseptic processing of health care products — Part 1: General requirements
Norm
ISO 13408-1:1998
1998 07 23
Aseptic processing of health care products — Part 1: General requirements
Norm
Norm
ISO 13408-1:2023
Issue date : 2023 08 15
Aseptic processing of health care products — Part 1: General requirements