EN 13311-6:2001

Biotechnology - Performance criteria for vessels - Part 6: Chromatography columns

This European Standard specifies performance criteria for chromatography columns 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 chromatography columns includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

Biotechnik - Leistungskriterien für Behälter - Teil 6: Chromatographiesäulen

1 Anwendungsbereich
Diese Europäische Norm legt Leistungskriterien für bei biotechnischen Verfahren verwendete Chromato-
graphiesäulen 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 Chromatographiesäulen den
Gebrauch gefährlicher oder potentiell gefährlicher Mikroorganismen in biotechnischen Verfahren ein-
schließt, oder wenn die Exposition der Beschäftigten oder der Umwelt gegenüber solchen Mikroorganis-
men aus Sicherheitsgründen eingeschränkt wird.
Wenn wesentliche Teile des Gehäuses aus Glas oder anderen Materialien hergestellt sind, gilt diese
Norm in Verbindung mit anderen einschlägigen Normen.

Biotechnologie - Critères de performance des récipients - Partie 6: Colonnes de chromatographie

Domaine d'application
La présente Norme européenne spécifie les critères de performance des colonnes de chromatographie utilisées 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 colonnes de chromatographie 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.
Lorsque des parties importantes de la colonne de chromatographie sont fabriquées en verre ou en tout autre matériau, il convient d'utiliser la présente norme conjointement avec les autres normes appropriées.
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Biotehnologija - Merila za delovanje posod - 6. del: Kromatografske kolone

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 13311-6:2002 - Biotechnology - Performance criteria for vessels - Part 6: Chromatography columns

Overview - EN 13311-6:2001 (Chromatography columns)

EN 13311-6:2001 is a CEN European Standard that defines performance criteria for chromatography columns used in biotechnological processes where hazardous or potentially hazardous microorganisms are handled. The standard focuses on reducing risks to workers and the environment by specifying requirements for classification, verification, marking, packaging and documentation of chromatography columns used with biological materials. It is one part of the EN 13311 series on biotechnology vessel performance.

Key topics and technical requirements

• Scope and intent
  • Applies when chromatography column use involves microorganisms or when exposure is restricted for safety reasons.
  • Intended to aid manufacturers, users and regulators in selecting and assessing safe equipment.
• Hazard considerations
  • Primary hazards addressed include:
    • Release from improperly connected bottom plates or adapters
    • Release due to dissolution of joints or seals from aggressive chemicals/solvents
    • Rupture of housings caused by swelling of chromatography media
• Performance classification
  • Columns are classified for leaktightness, cleanability and sterilizability in accordance with the general rules in EN 13311-1:2001.
  • Notes clarify that these attributes cover the housing, connections and sealing gaskets, and also the chromatography media.
  • Sterilization of media is typically carried out chemically and must be considered in class selection.
• Verification and testing
  • Guidance on leaktightness test methods is provided in informative Annex A. Suitable methods include:
    • Pressure loss (gas/air or liquid), helium probe, tracer aerosol (NaCl), electronic particle counting, bioaerosol monitoring, surface swabbing and bacteria-tightness testing.
  • EN 12298 is referenced for detailed leaktightness testing procedures.
• Marking, packaging and documentation
  • Requirements follow the general provisions of EN 13311-1 to ensure traceability and safe use.

Applications and users

• Who benefits:
  • Equipment manufacturers (design and classification)
  • Bioprocess and process engineers (equipment selection and integration)
  • Validation, QA/QC and facility managers (testing, cleanability and sterilizability verification)
  • Regulatory authorities assessing equipment safety for containment
• Typical uses:
  • Design and selection of chromatography columns for downstream bioprocessing
  • Risk assessment and containment planning in facilities handling hazardous microorganisms
  • Protocols for cleaning, sanitization and leak testing during commissioning and maintenance

Related standards

• EN 13311 series (Part 1: General performance criteria; Parts 2–5: pressure protection devices, glass vessels, bioreactors, kill tanks)
• EN 12298:1998 - Guidance on leaktightness testing procedures
• Published by CEN; official versions in English, French and German

Keywords: EN 13311-6:2001, chromatography columns, biotechnology, performance criteria, leaktightness, cleanability, sterilizability, CEN, chromatographic media, bioprocess safety.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija - Merila za delovanje posod - 6. del: Kromatografske koloneBiotechnik - Leistungskriterien für Behälter - Teil 6: ChromatographiesäulenBiotechnologie - Criteres de performance des récipients - Partie 6: Colonnes de chromatographieBiotechnology - Performance criteria for vessels - Part 6: Chromatography columns07.100.01Mikrobiologija na splošnoMicrobiology in general07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:EN 13311-6:2001SIST EN 13311-6:2002en01-januar-2002SIST EN 13311-6:2002SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13311-6March 2001ICS 07.080; 07.100.01English versionBiotechnology - Performance criteria for vessels - Part 6:Chromatography columnsBiotechnologie - Critères de performance des récipients -Partie 6: Colonnes de chromatographieBiotechnik - Leistungskriterien für Behälter - Teil 6:ChromatographiesäulenThis 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 13311-6:2001 ESIST EN 13311-6:2002

Page 2EN 13311-6:2001ContentsPageForeword.3Introduction.41Scope.42Normative references.43Terms and definitions.44Hazards.45Performance classes.56Classification and verification of performance.67Marking and packaging.68Documentation.6Annex A (informative)
Guidance on test methods for determining leaktightness ofchromatography columns.7Bibliography.8SIST EN 13311-6:2002

Page 3EN 13311-6:2001ForewordThis 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 13311-1, Biotechnology - Performance criteria for vessels - Part 1: General performancecriteria.EN 13311-2, Biotechnology - Performance criteria for vessels - Part 2: Pressure protectiondevices.EN 13311-3, Biotechnology - Performance criteria for vessels - Part 3: Glass pressurevessels.EN 13311-4, Biotechnology - Performance criteria for vessels - Part 4: Bioreactors.EN 13311-5, Biotechnology - Performance criteria for vessels - Part 5: Kill tanks.EN 13311-6, Biotechnology - Performance criteria for vessels - Part 6: Chromatographycolumns.Annex A is 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 13311-6:2002

Page 4EN 13311-6:2001IntroductionChromatography columns are containers filled with a stationary phase calledchromatography medium, used for a separation of components from the feed stream. Theyare used in a wide variety of biotechnological processes, and vary considerably in scale andfunction. Materials used for filling chromatography columns are chromatography media suchas dextrane, agarose, coated glass and polymer beads whereas chromatography columnwalls, top and bottom plates may be made of glass, stainle
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