EN 12075:1997

Biotechnology - Large-scale process and production - Procedures for fermentation and downstream processes EN 12075:1997

Publication date:   Oct 23, 2003

General information

90.93 Standard confirmed   Apr 11, 2022


CEN/TC 233 Biotechnology

European Norm

07.080   Biology. Botany. Zoology



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This European Standard describes the principles for the assessment and selection of fermentation and downstream operations so that they are carried out in a manner which ensures the safety of personnel and the environment and quality and safety of the product. It is intended for use by those designing and/or operating processes, by regulatory bodies and auditors, and by other interested parties. Unit operations are not described in detail and individual production processes can require specific equipment or unit operations which are not described here.

Related legislation

Legislation related to this standard


Deliberate release into the environment of genetically modified organisms


Contained use of genetically modified micro-organisms


Protection of workers from risks related to exposure to biological agents at work

Life cycle


EN 12075:1997
90.93 Standard confirmed
Apr 11, 2022