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.