Superseded
Standard
Historical
DIN EN ISO 13408-1:2015-12
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015
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Summary
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.
Technical characteristics
| Publisher | Deutsche Institut für Normung e.V. (DIN) |
| Publication Date | 12/01/2015 |
| Page Count | 70 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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