Abstract
PreviewISO 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.
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Status: PublishedPublication date: 2008-06
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Edition: 2Number of pages: 45
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- ICS :
- 11.080.01 Sterilization and disinfection in general
Buy this standard
Format | Language | |
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std 1 166 | ||
std 2 166 | Paper |
- CHF166
Life cycle
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Previously
WithdrawnISO 13408-1:1998
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Now
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00
Preliminary
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10
Proposal
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20
Preparatory
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30
Committee
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40
Enquiry
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50
Approval
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60
Publication
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90
Review
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95
Withdrawal
Corrigenda / Amendments
PublishedISO 13408-1:2008/Amd 1:2013
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00
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Revised by
Under developmentISO 13408-1
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