ISO 13408-1:2008

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

Publication date: Jun 10, 2008

General information

Current stage: 90.92 Effective date: Oct 23, 2018

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

ICS: 11.080.01

Languages: English French Russian

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Status: Published

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Scope

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.
ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Life cycle

PREVIOUSLY

Revises
ISO 13408-1:1998

NOW

PUBLISHED
ISO 13408-1:2008
90.92 Standard to be revised
Oct 23, 2018

CORRIGENDA / AMENDMENTS

Amended by
ISO 13408-1:2008/Amd 1:2013

REVISED BY

IN_DEVELOPMENT
ISO/FDIS 13408-1

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