ISO 13408-3:2006

Aseptic processing of health care products — Part 3: Lyophilization

Publication date: Sep 1, 2006

General information

Current stage: 90.20 Effective date: Jul 15, 2026

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

ICS: 11.080.01

Languages: English French

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Status: Published

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Scope

ISO 13408-3:2006 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical/chemical objectives of a lyophilization process.

Life cycle

NOW

PUBLISHED
ISO 13408-3:2006
90.20 Standard under periodical review
Jul 15, 2026

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