This standard was last reviewed and confirmed in 2017. Therefore this version remains current.
Abstract Preview
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.
General information
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Status : PublishedPublication date : 2008-06
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Edition : 2Number of pages : 45
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- ICS :
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Sterilization and disinfection in general
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| Format | Language | |
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| Paper |
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Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
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Previously
ISO 13408-1:1998
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Now under review
ISO 13408-1:2008 -
Corrigenda/Amendments
ISO 13408-1:2008/Amd 1:2013
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Will be replaced by
ISO/AWI 13408-1
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