ISO-13408-1 › Historical Revision Information
Aseptic processing of health care products - Part 1: General requirements
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
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.
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Document Number
ISO-13408-1
Revision Level
FOR 2ND EDITION AMENDMENT 1 SEE
Status
Superseded
Publication Date
May 1, 2013
Committee Number
ISO/TC 198