BS EN ISO 13408-1:2024 - TC

This standard BS EN ISO 13408-1:2024 - TC Tracked Changes. Aseptic processing of health care products is classified in these ICS categories:

• 11.080.01 Sterilization and disinfection in general

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.