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
-
Status : PublishedPublication date : 2008-06
-
Edition : 2Number of pages : 45
-
- ICS :
-
Sterilization and disinfection in general
Buy this standard
| Format | Language | |
|---|---|---|
| Paper |
- CHF158
Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
-
Previously
ISO 13408-1:1998
-
Now under review
ISO 13408-1:2008 -
Corrigenda/Amendments
ISO 13408-1:2008/Amd 1:2013
-
Will be replaced by
ISO/NP 13408-1
Got a question?
Check out our FAQs
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information