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ISO 13408-1:2023

Aseptic processing of health care products — Part 1: General requirements

General information
Valid from 15.08.2023
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.08.2023
Main
17.04.2013
Amendment
10.06.2008
Main
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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