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ISO 13408-1:2023

Aseptic processing of health care products - Part 1: General requirements
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ISO 13408-1:2023

Aseptic processing of health care products - Part 1: General requirements

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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 ISO: International Organization for Standardization
Document Number ISO 13408
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 198
Publish Date Document Id Type View
Not Available ISO 13408-1:2023 Revision