ISO 13408-1:2023
International Standard
Current Edition
·
Approved on
15 August 2023
·
Aseptic processing of health care products — Part 1: General requirements
ISO 13408-1:2023 Files
null Pages
Current Edition
ISO 13408-1:2023 Scope
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
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