SIST EN 13311-4:2002

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnoogija - Merila za delovanje posod - 4. del: BioreaktorjiBiotechnik - Leistungskriterien für Behälter - Teil 4: BioreaktorenBiotechnologie - Criteres de performance des récipients - Partie 4: BioréacteursBiotechnology - Performance criteria for vessels - Part 4: Bioreactors07.100.01Mikrobiologija na splošnoMicrobiology in general07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:EN 13311-4:2001SIST EN 13311-4:2002en01-januar-2002SIST EN 13311-4:2002SLOVENSKI
STANDARD



SIST EN 13311-4:2002



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13311-4March 2001ICS 07.080; 07.100.01English versionBiotechnology - Performance criteria for vessels - Part 4:BioreactorsBiotechnologie - Critères de performance des récipients -Partie 4: BioréacteursBiotechnik - Leistungskriterien für Behälter - Teil 4:BioreaktorenThis 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 13311-4:2001 ESIST EN 13311-4:2002



Page 2EN 13311-4:2001ContentsPageForeword.3Introduction.41Scope.42Normative references.43Terms and definitions.44Hazards.45Performance classes.46Classification and verification of performance.57Marking and packaging.58Documentation.5Annex A (informative)
Guidance on test methods for determiningleaktightness of bioreactors.6Annex B (informative)
Typical hazards and preventive measures.7Bibliography.10SIST EN 13311-4:2002



Page 3EN 13311-4:2001ForewordThis 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.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 13311-4:2002



Page 4EN 13311-4:2001IntroductionUse of this European Standard will aid the equipment manufacturer in the classification ofbioreactors with regard to safe performance in biotechnological processes. The classificationis easily understandable and readily utilizable for the user and the regulatory authorities.1ScopeThis European Standard specifies performance criteria for bioreactors used inbiotechnological 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 bioreactors includes hazardousor potentially hazardous microorganisms used in biotechnological processes or whereexposure of the worker or the environment to such microorganisms is restricted for reasonsof safety.2Normative referencesThis European Standard incorporates by dated or undated reference, provisions from otherpublications. These normative references are cited at the appropriate places in the text andthe publications are listed hereafter. For dated references, subsequent amendments to orrevisions of any of these publications apply to this European Standard only whenincorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).EN 13311-1:2001Biotechnology - Performance criteria for vessels- Part 1 : General performance criteria3Terms and definitionsFor the purposes of this standard, the terms and definitions given in EN 13311-1:2001 apply.4HazardsTypical examples for potential hazards of bioreactors and recommendations for properdesign and handling are included in annex B.5Performance classesThe bioreactors shall be classified for leaktightness, cleanability and sterilizability inaccordance with 5.1 to 5.4 of EN 13311-1:2001.The selection of the appropriate class for performance of a bioreactor shall be made inaccordance with 5.5 of EN 13311-1:2001.SIST EN 13311-4:2002



Page 5EN 13311-4:20016Classification and verification of performance6.1GeneralThe bioreactors shall conform to the general requirements given in 6.1 of EN 13311-1:2001.If the components are classified, the using of an indirect test method to the assembledbioreactor is sufficient for classification.If the bioreactor is made by assembly of components, it shall be tested to verify its overallclassification.NOTE
EN 12460 provides guidance on selection and installation of equipmentrelevant to bioreactors.6.2LeaktightnessThe bioreactor shall conform to the requirements given in 6.2 of EN 13311-1:2001.If the bioreactor contains microorganisms for which the release shall be minimized, riskanalysis shall indicate whether the off-gas has to be treated. If the bioreactor containsmicroorganisms for which the release shall be prevented, the off-gas shall be treated.Guidance on test methods for determining leaktightness of bioreactors is given in annex A.6.3CleanabilityThe bioreactor shall conform to the requirements given in 6.3 of EN 13311-1:2001.6.4SterilizabilityThe bioreactor shall conform to the requirements given in 6.4 of EN 13311-1:2001.7Marking and packagingThe bioreactor shall conform to the requirements given in clause 7 of EN 13311-1:2001.8DocumentationThe bioreactor shall conform to the requirements given in clause 8 of EN 13311-1:2001.SIST EN 13311-4:2002



Page 6EN 13311-4:2001Annex A(informative)Guidance on test methods for determining leaktightness of bioreactorsA list of test methods for leaktightness is given in table A.1 of EN 12298 (see [13]). From thatlist suitable test methods to the testing of bioreactors are given in table A.1.Table A.1 - Suitable alternative leaktightness test methods for biore
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