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CEN - EN ISO 13408-3

Aseptic processing of health care products - Part 3: Lyophilization

active, Most Current
Organization: CEN
Publication Date: 1 June 2011
Status: active
Page Count: 24
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

This part of ISO 13408 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.

Document History

EN ISO 13408-3
June 1, 2011
Aseptic processing of health care products - Part 3: Lyophilization
This part of ISO 13408 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It...

References

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