EN 12307:1997
(Main)Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel
Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel
This European Standard gives guidance for good practice, procedures, training and control for the operation of large scale biotechnological processes. In addition, this European Standard gives recommendations for education and training of personnel involved in the large scale handling of microorganisms in plant building of containment levels 1, 2, 3 and 4. This European Standard aims at the protection of the workers from biological hazards as well as the environment including plants and animals.
Biotechnik - Verfahren im Großmaßstab und Produktion - Leitfaden für gute Praxis, Arbeitsabläufe, Ausbildung und Überwachung des Personals
Diese Europäische Norm gibt Anleitungen für gute Praxis, Arbeitsabläufe, für die Ausbildung und die Überwachung bei der Durchführung biotechnischer Verfahren im Großmaßstab. Zusätzlich gibt diese Europäische Norm Empfehlungen für die Aus- und Fortbildung des im Umgang mit Mikroorganismen im Großmaßstab in Gebäuden der Sicherheitsstufen 1, 2, 3 und 4 beschäftigten Personals. Diese Europäische Norm zielt auf den Schutz der Mitarbeiter vor Gefährdungen in der Biotechnik sowie auf den Schutz der Umwelt einschließlich von Pflanzen und von Tieren.
Biotechnologie - Procédé à grande échelle et production - Guide de bonnes pratiques, procédures, formation et contrôle pour le personnel
Cette norme européenne présente un guide de bonnes pratiques, des procédures, une formation et un contrôle pour les opérations avec des procédés biotechnologiques à grande échelle. De plus, la présente norme donne des recommandations sur l'éducation et la formation du personnel impliqué dans la manipulation des microorganismes à grande échelle dans des installations de niveaux de confinement 1, 2, 3 et 4. La présente norme vise à protéger le travailleur contre les dangers biotechnologiques, ainsi que l'environnement y compris les plantes et les animaux.
Biotehnologija - Procesi in proizvodnja v industrijskem obsegu - Navodilo dobre prakse, postopkov, šolanja in nadzora osebja
General Information
- Status
- Published
- Publication Date
- 21-Oct-1997
- 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
- Start Date
- 11-Apr-2022
- Completion Date
- 14-Apr-2025
Overview
EN 12307:1997 is a CEN (European) standard titled Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel. It provides guidance and recommendations for the safe operation of large‑scale biotechnological processes and for the education, training and control of personnel who handle microorganisms in plant facilities at containment levels 1, 2, 3 and 4. The primary aim is protection of workers and the environment (including plants and animals) through consistent good practice, documented procedures and competent staffing.
Key topics and requirements
This standard focuses on practical, personnel‑centred elements of large‑scale biotechnology operations, including:
- Good practice and operational procedures: guidance for establishing standard operating procedures (SOPs) and routine controls applicable to large‑scale bioprocessing.
- Personnel training and competence: recommendations for education, skill development and assessment of staff working with microorganisms across containment levels 1–4.
- Access control and supervision: measures for controlling personnel entry, role assignment and oversight in production areas.
- Biosafety and risk awareness: adoption of risk‑based practices to protect workers and limit environmental release of biological agents.
- Monitoring, control and documentation: record keeping, incident reporting, and monitoring systems to ensure compliance and traceability.
- Decontamination and waste handling: procedural guidance for in‑plant decontamination, safe waste management and containment maintenance.
- Emergency preparedness: staff roles, training and procedures for responding to biological incidents, exposure or containment breaches.
(EN 12307 provides guidance rather than prescriptive technical limits; it emphasizes documented procedures, training programs and organizational controls.)
Applications and users
EN 12307 is useful for organizations involved in:
- Large‑scale bioprocess and fermentation plants
- Industrial biotechnology and biomanufacturing
- Pharmaceutical and vaccine production facilities
- Biosafety and laboratory safety officers
- Quality assurance, operations managers and HR/training teams
- Regulatory bodies and auditors seeking harmonized good‑practice guidance
Organizations use this standard to develop SOPs, staff training curricula, access control policies and biosafety management measures aligned with European good practice for large‑scale biotechnology.
Related standards
- Applicable alongside other national and international biosafety, occupational health and GMP guidelines.
- Should be implemented in context with facility‑specific risk assessments and local regulatory requirements.
Keywords: EN 12307, biotechnology standard, large‑scale bioprocesses, biosafety training, containment levels 1‑4, good practice, personnel control, SOPs, biomanufacturing.
Frequently Asked Questions
EN 12307:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel". This standard covers: This European Standard gives guidance for good practice, procedures, training and control for the operation of large scale biotechnological processes. In addition, this European Standard gives recommendations for education and training of personnel involved in the large scale handling of microorganisms in plant building of containment levels 1, 2, 3 and 4. This European Standard aims at the protection of the workers from biological hazards as well as the environment including plants and animals.
This European Standard gives guidance for good practice, procedures, training and control for the operation of large scale biotechnological processes. In addition, this European Standard gives recommendations for education and training of personnel involved in the large scale handling of microorganisms in plant building of containment levels 1, 2, 3 and 4. This European Standard aims at the protection of the workers from biological hazards as well as the environment including plants and animals.
EN 12307:1997 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 07.100.99 - Other standards related to microbiology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12307:1997 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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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija - Procesi in proizvodnja v industrijskem obsegu - Navodilo dobre prakse, postopkov, šolanja in nadzora osebjaBiotechnik - Verfahren im Großmaßstab und Produktion - Leitfaden für gute Praxis, Arbeitsabläufe, Ausbildung und Überwachung des PersonalsBiotechnologie - Procédé a grande échelle et production - Guide de bonnes pratiques, procédures, formation et contrôle pour le personnelBiotechnology - Large-scale process and production - Guidance
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