EN 13311-2:2001

Biotechnology - Performance criteria for vessels - Part 2: Pressure protection devices

This European Standard specifies performance criteria for pressure protection devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of pressure protection devices includes hazardous or potentially hazardous microorganisms used in biotechnological processes.

Biotechnik - Leistungskriterien für Behälter - Teil 2: Druckentlastungseinrichtungen

1 Anwendungsbereich
Diese Europäische Norm legt Leistungskriterien für bei biotechnischen Verfahren verwendete Druckent-
lastungseinrichtungen im Hinblick auf potentielle Gefährdungen für die Beschäftigten und die Umwelt
fest, die von den im Verfahren verwendeten Mikroorganismen ausgehen.
Diese Europäische Norm gilt, sobald die vorgesehene Anwendung von Druckentlastungseinrichtungen
den Gebrauch gefährlicher oder potentiell gefährlicher Mikroorganismen in biotechnischen Verfahren
einschließt, oder wenn die Exposition der Beschäftigten oder der Umwelt gegenüber solchen Mikroorga-
nismen aus Sicherheitsgründen eingeschränkt wird.

Biotechnologie - Critères de performance des récipients - Partie 2: Dispositifs de protection vis-à-vis de la pression

Domaine d'application
La présente norme européenne spécifie les critères de performance des dispositifs de protection vis-à-vis de la pression utilisés dans les procédés biotechnologiques vis-à-vis des dangers potentiels que les microorganismes utilisés représentent pour l'opérateur et pour l'environnement.
La présente norme européenne s'applique lorsqu'il est prévu que les dispositifs de protection vis-à-vis de la pression impliquent l'utilisation de microorganismes dangereux ou potentiellement dangereux dans les procédés biotechnologiques ou lorsque l'exposition de l'opérateur ou de l'environnement à de tels microorganismes est limitée pour des raisons de sécurité.

Biotehnologija - Merila za delovanje posod - 2. del: Zaščitna oprema pred tlakom

General Information

• Status: Published
• Publication Date: 20-Mar-2001
• Withdrawal Date: 29-Sep-2001
• ICS: 07.080 - Biology. Botany. Zoology
• ICS: 07.100.01 - Microbiology in general
• Technical Committee: CEN/TC 233 - Biotechnology
• Drafting Committee: CEN/TC 233/WG 4 - Equipment
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 01-Oct-2025
• Completion Date: 08-Oct-2025
• Directive: 90/219/EEC - Contained use of genetically modified micro-organisms
• Directive: 90/220/EEC - Deliberate release into the environment of genetically modified organisms
• Directive: 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 13311-2:2002 - Biotechnology - Performance criteria for vessels - Part 2: Pressure protection devices

Overview

EN 13311-2:2001 (CEN) - "Biotechnology - Performance criteria for vessels - Part 2: Pressure protection devices" defines performance criteria for pressure protection devices used in biotechnological processes where hazardous or potentially hazardous microorganisms are present. The standard focuses on preventing release of microorganisms to protect workers and the environment, and complements the general vessel performance requirements in EN 13311-1:2001.

Key topics and requirements

• Scope and purpose: Applies when pressure protection devices (bursting discs, relief valves) may discharge hazardous microorganisms or when exposure is restricted for safety reasons.
• Hazard identification: Addresses main risks including
  • Release after bursting disc rupture (continuous release until closed),
  • Premature mechanical or thermal failure of bursting discs,
  • Early opening of pressure relief valves below nominal set point.
• Performance classification: Devices are classified for leaktightness, cleanability and sterilizability in accordance with EN 13311-1:2001. Selection of performance class is based on process risk.
• Verification and testing: Guidance on leaktightness test methods is provided (Annex A). Suitable methods include:
  • Pressure loss tests (gas/liquid),
  • Helium or tracer gas probes (e.g., SF6),
  • Tracer aerosol and electronic particle counting,
  • Qualitative/quantitative bioaerosol monitoring,
  • Surface swabbing and bacteria-tightness checks.
• Design and handling guidance: Annex B describes device types (bursting discs, spring-loaded relief valves), sanitary design variants (e.g., stainless steel with PTFE membrane), discharge handling, and relative merits (bursting discs are typically lower cost).
• Marking, packaging, documentation: Devices must meet marking and documentation requirements referenced to EN 13311-1.

Applications and users

EN 13311-2 is intended for:

• Equipment manufacturers designing and certifying pressure protection devices for bioreactors, fermenters, kill tanks and containment vessels.
• Process, safety and validation engineers in biotech, pharmaceutical and food industries developing containment strategies.
• Regulatory authorities and facility safety officers evaluating compliance for operations involving hazardous microorganisms.
• QA/QC teams selecting leaktightness and sterilizability requirements for vessel components.

Practical uses:

• Specifying appropriate relief devices for contained fermentations,
• Choosing test methods for leaktightness and bioaerosol containment verification,
• Designing discharge and waste lines to avoid cross-contamination.

Related standards

• EN 13311-1:2001 - General performance criteria for vessels
• EN 13311-3 to EN 13311-6 - Other vessel-specific parts (glass vessels, bioreactors, kill tanks, columns)
• EN 12298:1998 - Guidance on testing procedures for leaktightness
• ISO 6718 - Bursting discs and bursting disc devices

Keywords: EN 13311-2:2001, pressure protection devices, biotechnology, leaktightness, bursting discs, relief valves, bioreactor containment, sterilizability, performance criteria, CEN.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Leistungskriterien für Behälter - Teil 2: DruckentlastungseinrichtungenBiotechnologie - Criteres de performance des récipients - Partie 2: Dispositifs de protection vis-a-vis de la pressionBiotechnology - Performance criteria for vessels - Part 2: Pressure protection devices07.100.01Mikrobiologija na splošnoMicrobiology in general07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:EN 13311-2:2001SIST EN 13311-2:2002en01-januar-2002SIST EN 13311-2:2002SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13311-2March 2001ICS 07.080; 07.100.01English versionBiotechnology - Performance criteria for vessels - Part 2:Pressure protection devicesBiotechnologie - Critères de performance des récipients -Partie 2: Dispositifs de protection vis-à-vis de la pressionBiotechnik - Leistungskriterien für Behälter - Teil 2:DruckentlastungseinrichtungThis European Standard was approved by CEN on 4 February 2001.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2001 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13311-2:2001 ESIST EN 13311-2:2002

Page 2EN 13311-2:2001ContentsPageForeword.3Introduction.41Scope.42Normative references.43Terms and definitions.44Hazards.45Performance classes.56Classification and verification of performance.57Marking and packaging.58Documentation.5Annex A (informative)
Guidance on test methods for determining leaktightness ofpressure protection devices.6Annex B (informative)
Information on pressure protection devices.7Bibliography.8SIST EN 13311-2:2002

Page 3EN 13311-2:2001ForewordThis European Standard has been prepared by Technical Committee CEN/TC 233"Biotechnology", the secretariat of which is held by AFNOR.This European Standard shall be given the status of a national standard, either bypublication of an identical text or by endorsement, at the latest by September 2001, andconflicting national standards shall be withdrawn at the latest by September 2001.This European Standard has been prepared under a mandate given to CEN by theEuropean Commission and the European Free Trade Association.This standard is one of a series of European Standards concerned with performance criteriafor vessels. These standards are :EN 13311-1Biotechnology - Performance criteria for vessels - Part 1: Generalperformance criteria.EN 13311-2Biotechnology - Performance criteria for vessels - Part 2: Pressure protectiondevices.EN 13311-3Biotechnology - Performance criteria for vessels - Part 3: Glass pressurevessels.EN 13311-4Biotechnology - Performance criteria for vessels - Part 4: Bioreactors.EN 13311-5Biotechnology - Performance criteria for vessels - Part 5: Kill tanks.EN 13311-6Biotechnology - Performance criteria for vessels - Part 6: Chromatographycolumns.Annexes A and B are informative.This standard includes a bibliography.According to the CEN/CENELEC Internal Regulations, the national standards organizationsof the following countries are bound to implement this European Standard: Austria, Belgium,Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the UnitedKingdom.SIST EN 13311-2:2002

Page 4EN 13311-2:2001IntroductionPressure protection devices prevent equipment from being subjected to pressures beyondtheir nominal pressure. Main types of pressure protection devices are bursting discs andrelief valves.Use of this European Standard will aid the equipment manufacturer in the classification ofpressure protection devices with regard to safe performance in biotechnological processes.The classification is easily understandable and readily utilizable for the user and theregulatory authorities.1ScopeThis European Standard specifies performance criteria for pressure protection devices usedin biotechnological processes with respect to the potential hazards to the worker and theenvironment from microorganisms in use.This European Standard applies where the intended use of pressure protection devicesincludes hazardous or potentially hazardous microorganisms used in biotechnologicalprocesses or wh
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