EN 1620:1996
(Main)Biotechnology - Large-scale process and production - Plant building according to the degree of hazard
Biotechnology - Large-scale process and production - Plant building according to the degree of hazard
This European Standard specifies design requirements for plant buildings used for the safe handling of microorganisms and the product itself if it presents a biohazard. Note 1: When applying this European Standard, attention is drawn to the existing national regulations such as regulations concerning genetic engineering, water and environmental emission concerning the design requirements.
Biotechnik - Verfahren im Großmaßstab und Produktion - Gebäude entsprechend dem jeweiligen Gefährdungsgrad
Diese Europäische Norm legt Anforderungen an die Konstruktion von Gebäuden für den sicheren Umgang mit Mikroorganismen und mit dem Produkt selbst fest, wenn von ihm eine Biogefährdung ausgeht. Anmerkung 1: Bei Anwendung dieser Europäischen Norm sollten die bestehenden nationalen Rechtsvorschriften mit Blick auf Konstruktionsanforderungen, wie Vorschriften zur Gentechnik, zur Wasser- und Umweltemission, beachtet werden.
Biotechnologie - Procédé à grande échelle et production - Installation industrielle selon le niveau de danger
La présente norme européenne spécifie les exigences de conception pour les installations industrielles pour une manipulation sûre des microorganismes et du produit lui-même s'il présente un danger biologique. Note 1: Lors de l'application de la présente norme européenne, il convient de prendre en considération les réglementations nationales existantes telles que celles qui concernent le génie génétique, l'eau et les émissions dans l'environnement, pour ce qui relève des exigences de conception.
Biotehnologija - Procesi in proizvodnja v industrijskem obsegu - Gradnja objektov glede na stopnjo nevarnosti
General Information
- Status
- Published
- Publication Date
- 23-Jul-1996
- 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 1620:1996 - Biotechnology: Large‑scale process and production - Plant building according to the degree of hazard (CEN) defines design requirements for industrial plant buildings where microorganisms are handled and where the product itself may present a biohazard. The standard guides safe building design and layout to reduce biological risk during large‑scale biotechnology processes. When applying EN 1620:1996, users must also consider applicable national regulations (for example genetic engineering, water discharge and environmental emissions).
Key topics
EN 1620:1996 focuses on design and construction measures driven by the degree of hazard of the biological agents or products. Key technical topics and requirements typically addressed include:
- Hazard‑based building classification - organizing plant areas according to the risk posed by organisms or material handled.
- Site layout and zoning - segregation of production, support and service areas to limit cross‑contamination.
- Containment and access control - building features that control personnel and material flow consistent with hazard degree.
- Ventilation and air handling concepts - principles for maintaining pressure regimes and air change appropriate to the hazard classification.
- Waste and effluent management - design considerations to prevent release of biological contaminants to drains, sewers and the environment.
- Decontamination provisions - architectural and service features to support cleaning, sterilization and emergency decontamination.
- Materials and finishes - selection of construction materials that allow effective cleaning and minimise microbial retention.
- Maintenance and operational considerations - designing for safe maintenance, inspection and routine operation.
- Interface with regulatory requirements - ensuring building design supports compliance with national genetic engineering and environmental rules.
(Note: EN 1620:1996 specifies design requirements at a building level. For project execution, users must consult the full standard text and applicable national regulations.)
Applications
EN 1620:1996 is practical for organisations that design, build or operate large‑scale biotechnology facilities where biological agents or biohazardous products are present. Typical users include:
- Process and facility engineers in industrial biotechnology, fermentation and bioprocessing
- Pharmaceutical and biopharmaceutical plant designers and architects
- Biosafety officers and compliance managers
- Construction contractors and project managers for bioscience plants
- Regulators and auditors assessing plant design against hazard‑based criteria
Applying the standard helps reduce risk of biological release, supports regulatory compliance, and informs safe operational design for industrial biotech plants.
Related standards
Relevant considerations include applicable national genetic engineering, water and environmental emission regulations. Other CEN/ISO standards on laboratory and biosafety infrastructure or HVAC design may also complement EN 1620:1996 when planning detailed facility systems.
Frequently Asked Questions
EN 1620:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Large-scale process and production - Plant building according to the degree of hazard". This standard covers: This European Standard specifies design requirements for plant buildings used for the safe handling of microorganisms and the product itself if it presents a biohazard. Note 1: When applying this European Standard, attention is drawn to the existing national regulations such as regulations concerning genetic engineering, water and environmental emission concerning the design requirements.
This European Standard specifies design requirements for plant buildings used for the safe handling of microorganisms and the product itself if it presents a biohazard. Note 1: When applying this European Standard, attention is drawn to the existing national regulations such as regulations concerning genetic engineering, water and environmental emission concerning the design requirements.
EN 1620:1996 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 1620:1996 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 - Gradnja objektov glede na stopnjo nevarnostiBiotechnik - Verfahren im Großmaßstab und Produktion - Gebäude entsprechend dem jeweiligen GefährdungsgradBiotechnologie - Procédé a grande échelle et production - Installation industrielle selon le niveau de dangerBiotechnology - Large-scale process and production - Plant building according to the degree of hazard07.
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The article discusses the European Standard EN 1620:1996, which specifies the design requirements for plant buildings involved in large-scale biotechnology processes and production. The focus is on ensuring the safe handling of microorganisms and any products that may pose a biohazard. The standard recommends considering existing national regulations related to genetic engineering, water, and environmental emissions when implementing these design requirements.
이 기사는 유전공학, 물 및 환경 배출에 대한 규정과 같은 기존 국가규정에 유의해야 한다는 점을 강조하면서, 유해도에 따라 식물 건축물을 설계 요구사항을 명시하는 유럽 표준 EN 1620:1996에 대해 다루고 있습니다. 이 표준은 대규모 생물공학 공정 및 생산에 사용되는 식물 건축물의 안전한 처리를 위한 디자인 요구사항을 규정합니다. 이는 미생물 및 생산물 자체가 생물위험을 표현하는 경우에 적용됩니다.
この記事は、遺伝子工学、水及び環境排出に関する既存の国内規制に留意しながら、危険度に応じて植物建築の設計要件を規定する、欧州標準EN 1620:1996について説明しています。この標準は、大規模なバイオテクノロジーのプロセスや生産に使用される植物建築の安全な取り扱いを確保するための設計要件を規定しています。特に、微生物や製品自体が生物危険を示す場合に、この標準を適用することが推奨されています。
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