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
Overview
EN 12075:1997 - published by CEN - is a European Standard titled Biotechnology - Large-scale process and production - Procedures for fermentation and downstream processes. The standard sets out the principles for assessing and selecting fermentation and downstream operations so they are performed in ways that protect personnel and the environment while ensuring product quality and safety. EN 12075:1997 is a principles-based guidance document: it does not give detailed descriptions of individual unit operations or specific equipment, and it recognizes that particular production processes may require additional, process-specific measures.
Key Topics
The standard focuses on high-level requirements and considerations for large-scale biotechnology production, including:
- Process assessment and selection - criteria for choosing suitable fermentation and downstream technologies based on safety, environmental impact, and product quality.
- Safety of personnel and environment - principles for containment, exposure control, and minimizing environmental release during fermentation and downstream processing.
- Product quality and safety - measures to ensure that large-scale processes consistently produce safe, high-quality biological products.
- Operational controls - monitoring, control strategies and decision criteria for scaling and operating fermentation and downstream steps.
- Waste and effluent handling - considerations for managing by-products and waste streams to reduce environmental risk.
- Documentation and auditability - emphasis on records, procedural documentation and traceability for regulatory review and auditing.
- Applicability limits - clarification that individual unit operations are not described in detail and specific equipment needs may fall outside this standard.
Applications
EN 12075:1997 is practical for organizations and activities such as:
- Scale-up and design of fermentation plants and downstream processing lines in industrial biotechnology.
- Production of enzymes, bio-based chemicals, food ingredients, and biopharmaceutical intermediates where fermentation is central.
- Risk assessment and process selection during plant engineering and commissioning.
- Internal and external audits, regulatory review, and compliance checks by authorities and certification bodies.
- Guiding operational teams on high-level safety and quality principles without prescribing proprietary equipment.
Who Uses This Standard
- Process engineers and plant designers
- Manufacturing and operations managers
- Quality assurance and regulatory affairs personnel
- Auditors and compliance officers
- Consultants and technology licensors working in biotechnology and fermentation-based industries
Related Standards (context)
EN 12075:1997 is complementary to other regulatory and management frameworks such as Good Manufacturing Practice (GMP), biosafety guidelines, and environmental management systems (for example ISO 14001). Users should combine the principles in EN 12075 with process-specific standards and national regulations when developing detailed operating procedures.
Keywords: EN 12075:1997, biotechnology standard, large-scale fermentation, downstream processes, CEN, process selection, safety, product quality.
Standards Content (Sample)
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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Frequently Asked Questions
EN 12075:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Large-scale process and production - Procedures for fermentation and downstream processes". This standard covers: 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.
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.
EN 12075:1997 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12075:1997 is associated with the following European legislation: EU Directives/Regulations: 90/219/EEC, 90/220/EEC, 90/679/EEC; Standardization Mandates: M/BC/CEN/91/19. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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