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CEN

EN 12075:1997

(Main)

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

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

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.

Biotechnik - Verfahren im Großmaßstab und Produktion - Vorgehensweise für die Bereiche Fermentation und Aufarbeitung

Diese Europäische Norm beschreibt Grundlagen für die Bewertung und Auswahl von Fermentations- und Aufarbeitungsvorgängen, so daß diese unter Sicherstellung der Sicherheit des Personals und der Umwelt und der Sicherheit und Qualität des Produktes durchgeführt werden. Die Norm ist für diejenigen bestimmt, die sich mit der Auslegung und/oder Ausführung von Verfahren befassen, für Aufsichtsbehörden, Auditoren und andere Beteiligte. Grundoperationen werden im einzelnen nicht beschrieben.

Biotechnologie - Procédé à grande échelle et production - Procédures pour les procédés de fermentation et de traitement aval

La présente norme européenne décrit les principes pour l'évaluation et le choix des opérations de fermentation et de traitement aval à mettre en oeuvre de façon à garantir la sécurité du personnel et de l'environnement et la qualité et la sécurité du produit. Elle est destinée à ceux qui conçoivent et/ou mettent en oeuvre les procédés, aux instances réglementaires et aux personnes chargées des contrôles, et à toute partie interessée. Les opérations unitaires ne sont pas décrites en détail.

Biotehnologija - Procesi in proizvodnja v industrijskem obsegu - Fermentacijski in zaključni procesi

General Information

Status
Published
Publication Date
18-Feb-1997
ICS
07.080 - Biology. Botany. Zoology
Technical Committee
CEN/TC 233 - Biotechnology
Drafting Committee
CEN/TC 233/WG 2 - Large-scale process and production
Current Stage
9093 - Decision to confirm - Review Enquiry
Completion Date
11-Apr-2022
Directive
90/219/EEC - Contained use of genetically modified micro-organisms
90/220/EEC - Deliberate release into the environment of genetically modified organisms
90/679/EEC - Protection of workers from risks related to exposure to biological agents at work
Mandate
M/BC/CEN/91/19 - Mandate for CEN on biotechnology
Ref Project
SIST EN 12075:1999 - Biotechnology - Large-scale process and production - Procedures for fermentation and downstream processes

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Verfahren im Großmaßstab und Produktion - Vorgehensweise für die Bereiche Fermentation und AufarbeitungBiotechnologie - Procédé a grande échelle et production - Procédures pour les procédés de fermentation et de traitement avalBiotechnology - Large-scale process and production - Procedures for fermentation and downstream processes07.080Biologija. Bot
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