EN 12460:1998
(Main)Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk
Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk
This European Standard gives guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of these into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new process or significant changes are introduced into an existing plant.
Biotechnik - Verfahren in Großmaßstab und Produktion - Leitfaden zur Auswahl und Installation von Geräten und Ausrüstungen entsprechend dem biologischen Risiko
Diese Europäische Norm gibt Anleitungen für die Auswahl von und die Risikoanalyse bei biotechnischen Geräten und Ausrüstungen und deren anschließende Zusammenstellung zu einer Anlage, um dadurch die jeweils entsprechenden Sicherheitsstufen in Bezug auf biologische Sicherheit zu erreichen. Dies schließt den Nachweis der korrekten Installation, der Funktion und der Wartung ein. Sie gilt auch für die Einführung eines neuen biotechnischen Verfahrens oder bei wesentlichen Veränderungen an einer bestehenden Anlage.
Biotechnologie - Procédé à grande échelle et production - Guide pour la sélection et l'installation des équipements en fonction du risque biologique
La présente norme européenne donne des indications sur la sélection et l'analyse de risque des équipements biotechnologiques, et de leur assemblage ultérieur dans une installation en vue d'obtenir des niveaux de confinement appropriés pour la biosécurité. Ceci comprend la vérification de l'installation, le fonctionnement et la maintenance. Elle s'applique également lorsqu'un nouveau procédé ou des modifications importantes sont introduits dans une installation existante.
Biotehnologija - Procesi in proizvodnja v industrijskem obsegu - Navodilo za izbiro in postavitev opreme glede na biološko tveganje
General Information
- Status
- Published
- Publication Date
- 17-Feb-1998
- 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 12460:1998 is a key European standard developed by CEN that provides comprehensive guidance on the selection and installation of biotechnological equipment for large-scale processes and production. The standard focuses on ensuring biosafety by addressing the biological risks associated with equipment choice, installation, operation, and maintenance within biotechnology plants. It is essential for organizations that design, install, or modify biotechnological plants to comply with this standard to achieve appropriate biosafety containment levels.
This standard is particularly relevant when introducing new processes or making significant changes to existing biotechnological facilities, offering a structured approach to risk analysis and containment strategies.
Key Topics
Biological Risk Assessment
EN 12460:1998 emphasizes thorough risk analysis linked to biological hazards, guiding the selection of equipment capable of mitigating these risks effectively.Equipment Selection Criteria
Specific guidelines help determine suitable biotechnological equipment based on the biological risk level, process scale, and plant requirements.Installation Protocols
The standard outlines best practices for assembling and installing equipment to maintain biosafety containment and operational integrity.Verification and Validation
Detailed recommendations ensure the verification of installation, operational performance, and ongoing maintenance to sustain biosafety standards.Adaptation to Process Changes
Provides procedures for reassessing risks and equipment suitability when new processes or significant modifications are introduced within an existing plant.
Applications
EN 12460:1998 is vital for industries involved in biotechnology production, including:
Pharmaceutical and Biopharmaceutical Manufacturing
Use in designing and upgrading facilities handling live biological agents, cultures, or genetically modified organisms.Industrial Biotechnology Plants
Guidance for process scale-up and safe operation in large-scale fermentation, enzyme production, and bio-product manufacturing.Research and Development Facilities
Application in pilot plants and scaling processes where biosafety containment and risk mitigation around biological materials are crucial.Environmental Biotechnology
Implementation in plants dealing with biodegradation, bioremediation, or waste treatment where biological risk containment is paramount.
Related Standards
To ensure a holistic safety and quality framework, EN 12460:1998 should be considered alongside related standards in biotechnology and biosafety, including:
EN ISO 14644 Series - Cleanroom and associated controlled environments standards for contamination control.
EN 12469 - Performance criteria for microbiological safety cabinets.
ISO 13485 - Quality management systems applicable to medical devices, relevant for biotechnological equipment in healthcare.
Biosafety Guidelines (WHO and CDC) - International recommendations for biosafety levels and containment practices.
EN 12460:1998 plays a crucial role in promoting biosafety and operational excellence in biotechnological production by offering structured guidance on equipment selection and installation based on biological risks. Compliance with this standard enhances safety, efficiency, and regulatory adherence within the biotechnology industry.
Frequently Asked Questions
EN 12460:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk". This standard covers: This European Standard gives guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of these into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new process or significant changes are introduced into an existing plant.
This European Standard gives guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of these into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new process or significant changes are introduced into an existing plant.
EN 12460:1998 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 12460:1998 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 za izbiro in postavitev opreme glede na biološko tveganjeBiotechnik - Verfahren in Großmaßstab und Produktion - Leitfaden zur Auswahl und Installation von Geräten und Ausrüstungen entsprechend dem biologischen RisikoBiotechnologie - Procédé a grande échelle et production - Guide pour la sélection et l'installation des équipements en fonction du risque biologiqueBiotechnology - Large-scale proce
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