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.
Directives related to this standards.
PUBLISHED
SSH EN ISO 13408-1:2015
IN_DEVELOPMENT
prSSH EN ISO 13408-1:2024
40.20
DIS ballot initiated: 12 weeks
10 shk 2025
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