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BSI BS EN ISO 13408-1:2024

Aseptic processing of health care products -- General requirements
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BSI BS EN ISO 13408-1:2024

Aseptic processing of health care products -- General requirements

PUBLISH DATE 2024
PAGES 94
BSI BS EN ISO 13408-1:2024
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 ISO 13408 series.
SDO BSI: British Standards Institution
Document Number ISO 13408-1
Publication Date April 24, 2024
Language en - English
Page Count 94
Revision Level
Supercedes
Committee CH/198
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