BS EN ISO 13408-1:2015 - TC

This standard BS EN ISO 13408-1:2015 - TC Tracked Changes. Aseptic processing of health care products is classified in these ICS categories:

• 11.080.01 Sterilization and disinfection in general

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.