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CEN - EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements

active, Most Current
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-processed health care products.

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.

Document History

EN ISO 13408-1
June 1, 2015
Aseptic processing of health care products - Part 1: General requirements
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...
June 1, 2011
Aseptic processing of health care products - Part 1: General requirements
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing...
June 1, 2011
Aseptic processing of health care products - Part 1: General requirements
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing...

References

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