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ISO 13408-3

Aseptic processing of health care products Part 3: Lyophilization

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Organization: ISO
Publication Date: 15 September 2006
Status: active
Page Count: 18
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

ISO 13408-3
September 15, 2006
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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