ISO-13408-1 › Historical Revision Information
Aseptic processing of health care products - Part 1: General requirements

ISO-13408-1 - 3RD EDITION - CURRENT -- See the following: ISO-13408-1-AM1
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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.

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11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO 13408-1:2023

Revision Level

3RD EDITION

Status

Current

Publication Date

Aug. 1, 2023

Committee Number

ISO/TC 198