Aseptic processing of health care products — Part 1: General requirements
Also Known As:
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
Edition | 2 |
ICS Codes | 11.080.01 - Sterilization and disinfection in general |
Language(s) | English |
File Size | 665.6 KB |
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