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EVS-EN ISO 13408-1:2024

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

General information

Valid from 02.05.2024
Base Documents
ISO 13408-1:2023; EN ISO 13408-1:2024

Standard history

Status
Date
Type
Name
02.05.2024
Main
02.07.2015
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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