Name:
DANSK DS/EN ISO 13408-1 PDF
Published Date:
07/06/2015
Status:
[ Revised ]
Publisher:
Dansk Standard
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 : | 15# |
| File Size : | 2 files , 3.2 MB |
| Number of Pages : | 74 |
| Product Code(s) : | DS-061, DS-061 |
| Published : | 07/06/2015 |