- Standard No.
- EN ISO 13408-3:2011
- Release Date
- 2011
- Published By
- European Committee for Standardization (CEN)
- Latest
-
EN ISO 13408-3:2011
- Replace
-
EN 13824:2004
- 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 notaddress the physical/chemical objectives of a lyophilization process.
EN ISO 13408-3:2011 Referenced Document
- ISO 13408-1 Aseptic processing of health care products — Part 1: General requirements*， 2023-06-01 Update
- ISO 13408-4 Aseptic processing of health care products - Part 4: Clean-in-place technologies
- ISO 13408-5 Aseptic processing of health care products - Part 5: Sterilization in place
- ISO 9001 Quality management systems - Requirements [Spanish version]
EN ISO 13408-3:2011 history
- 2011 EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) has been changed from EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements.