ISO 13408-3:2006
Aseptic processing of health care products - Part 3: Lyophilization

Standard No.

ISO 13408-3:2006

Release Date

2006

Published By

International Organization for Standardization (ISO)

Latest

ISO 13408-3:2006

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.

ISO 13408-3:2006 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*， 2006-11-01 Update
• ISO 9001 Quality management systems - Requirements [Spanish version]

ISO 13408-3:2006 history

• 2006 ISO 13408-3:2006 Aseptic processing of health care products - Part 3: Lyophilization