BAS EN ISO 13408-3:2012
Aseptic processing of health care products - Part 3: Lyophilization
General Information
Status: Published
No. of pages: 17
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 08.06.2012
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
98/79/EC, In vitro diagnostic medical devices;
93/42/EEC, Medical devices;
98/79/EC, In vitro diagnostic medical devices;
...
Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 13408-3:2011, identical
- ISO 13408-3:2006, identical