BS EN ISO 13408-1:2024
Current
The latest, up-to-date edition.
General requirementsAseptic processing of health care products
Hardcopy , PDF
English
24-04-2024
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 ISO13408 series.
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