ISO ISO 13408-1:2008 [EN]

ISO 13408-1:2008 PDF Download

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ISO 13408-1:2008 Sample

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

SKU151278151 Published by International Organization for Standardization ISO Publication Date2008-06 Pages CountPages54

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.

ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Details
Edition2
ICS Codes11.080.01 - Sterilization and disinfection in general
Language(s)English
File Size665.6 KB
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