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SRPS EN 12075:2013

Biotechnology - Large-scale process and production - Procedures for fermentation and downstream processes

Jan 28, 2013

General information

90.93     Apr 11, 2022

90.00    Apr 11, 2027

ISS

E034-9

European Norm

07.080  

English  

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Scope

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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/220/EEC

Deliberate release into the environment of genetically modified organisms

Directive 90/220/EEC
90/219/EEC

Contained use of genetically modified micro-organisms

Directive 90/219/EEC
90/679/EEC

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

Directive 90/679/EEC

Life cycle

NOW

PUBLISHED
SRPS EN 12075:2013
90.93 Standard confirmed
Apr 11, 2022

Related project

Adopted from EN 12075:1997