CEN - EN ISO 13408-1
Aseptic processing of health care products - Part 1: General requirements
|Publication Date:||1 June 2015|
|ICS Code (Sterilization and disinfection in general):||11.080.01|
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.