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>BSI Standards >11 HEALTH CARE TECHNOLOGY>11.080 Sterilization and disinfection>11.080.01 Sterilization and disinfection in general>BS EN ISO 13408-3:2011 Aseptic processing of health care products Lyophilization
immediate downloadReleased: 2011-10-31
BS EN ISO 13408-3:2011 Aseptic processing of health care products Lyophilization

BS EN ISO 13408-3:2011

Aseptic processing of health care products Lyophilization

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Standard number:BS EN ISO 13408-3:2011
Pages:24
Released:2011-10-31
ISBN:978 0 580 72610 1
Status:Standard
DESCRIPTION

BS EN ISO 13408-3:2011


This standard BS EN ISO 13408-3:2011 Aseptic processing of health care products is classified in these ICS categories:
  • 11.080.01 Sterilization and disinfection in general

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.