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

MD Atlas
Documents

International standard

ISO 13408-1:2023

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

Published Aug 15, 2023

ENFR

Standard details

Reference: ISO 13408-1:2023
Edition: 3
Committee: ISO/TC 198
ICS: 11.080.01
Status: Published
Published: Aug 15, 2023
Languages: EN, FR
Source

ISO

Scope

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.

Contains information from ISO Open Data (https://www.iso.org/open-data.html), made available under the ODC Attribution License (ODC-By) v1.0.

Preview on ISO OBP View on ISO

History & related editions

ReplacesISO 13408-1:2008/Amd 1:2013
Withdrawn · Apr 17, 2013
ReplacesISO 13408-1:2008
Withdrawn · Jun 10, 2008