Name:
ISO 13408-1:2008 PDF
Published Date:
06/15/2008
Status:
Active
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.
| File Size : | 1 file , 660 KB |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Published : | 06/15/2008 |
| Same As : | ISO 13408-1:2008 |