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ISO 13408-1:2008 PDF
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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 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.
| Edition | 2008 |
|---|---|
| Standard Part No | 1 |
| Published Date | 2008 |
| Published By | International Standardization Organisation |
| Page Count | 45 |
