DIN EN ISO 13408-1:2024-09

Wherever possible, health care products intended to be sterile should be terminally sterilized in their final sealed container by a terminal sterilization process, which has been validated to achieve a specified sterility assurance level (SAL). Where a health care product is intended to be sterile and cannot withstand terminal sterilization in its final container, aseptic processing provides an acceptable alternative for product manufacture. 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 part of ISO 13408 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. This document has been prepared by Technical Committee ISO/TC 198 "Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, United Kingdom) with the participation of German experts. Working Committee NA 176-03-10 AA "Aseptische Herstellung" ("Aseptic processing") at DIN Standards Committee Health Technologies (NAGesuTech).