CEN - EN ISO 13408-1
Aseptic processing of health care products - Part 1: General requirements
| Organization: | CEN |
| Publication Date: | 1 June 2015 |
| Status: | active |
| Page Count: | 62 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
This p art of I SO 13408 specifies t he general r equirements
for, a nd offers g uidance on, processes, programmes and procedures
for development, validation and routine control of the
manufacturing process for aseptically-processe
This p art of I SO 13408 i ncludes r equirements a nd guidance relative t o the o verall t opic of a septic processing. Specific r equirements a nd guidance on various s pecialized processes and methods r elated to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.
NOTE This part of ISO 13408 does n ot s upersede or replace n ational r egulatory r equirements, such a s Good Manufacturing Practices ( GMPs) and/or p harmacopoeial requirements t hat pertain i n particular national or r egional jurisdictions.
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