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    BS EN 13311-4-2001 Biotechnology - Performance criteria for vessels - Bioreactors《生物技术 容器的性能标准 生物反应器》.pdf

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    BS EN 13311-4-2001 Biotechnology - Performance criteria for vessels - Bioreactors《生物技术 容器的性能标准 生物反应器》.pdf

    1、BRITISH STANDARD BS EN 13311-4:2001 Biotechnology Performance criteria for vessels Part 4: Bioreactors The European Standard EN 13311-4:2001 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 13311-4:2001 This British Standard,

    2、 having been prepared under the direction of the Sector Committee for Materials and Chemicals was published under the authority of the Standards Committee and comes into effect on 15 May 2001 BSI 05-2001 ISBN 0 580 37600 1 National foreword This British Standard is the official English language vers

    3、ion of EN 13311-4:2001. The UK participation in its preparation was entrusted to Technical Committee CII/ 58, Biotechnology, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards whic

    4、h implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include al

    5、l the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any en

    6、quiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 10, an insid

    7、e back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN133114 March2001 ICS07.080;07.100.01 Englishversion BiotechnologyPe

    8、rformancecriteriaforvesselsPart4: Bioreactors BiotechnologieCritresdeperformancedesrcipients Partie4:Bioracteurs BiotechnikLeistungskriterienfrBehlterTeil4: Bioreaktoren ThisEuropeanStandardwasapprovedbyCENon4February2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulate

    9、theconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,Ger

    10、man).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland

    11、,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwidefo

    12、rCENnationalMembers. Ref.No.EN133114:2001EPage2 EN133114:2001 Contents Page Foreword 3 Introduction 4 1 Scope 4 2 Normativereferences. 4 3 Termsanddefinitions 4 4 Hazards . 4 5 Performanceclasses . 4 6 Classificationandverificationofperformance 5 7 Markingandpackaging 5 8 Documentation . 5 AnnexA(in

    13、formative)Guidanceontestmethodsfordetermining leaktightnessofbioreactors. 6 AnnexB(informative)Typicalhazardsandpreventivemeasures 7 Bibliography. 10Page3 EN133114:2001 Foreword ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichisheldbyAFNOR. ThisE

    14、uropeanStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbySeptember2001,and conflictingnationalstandardsshallbewithdrawnatthelatestbySeptember2001. ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommissionandthe

    15、EuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forvessels.Thesestandardsare: EN133111, BiotechnologyPerformancecriteriaforvesselsPart1:Generalperformance criteria. EN133112, BiotechnologyPerformancecriteriaforvesselsPart2:Pressureprotectio

    16、n devices. EN133113, BiotechnologyPerformancecriteriaforvesselsPart3:Glasspressure vessels. EN133114, BiotechnologyPerformancecriteriaforvesselsPart4:Bioreactors. EN133115, BiotechnologyPerformancecriteriaforvesselsPart5:Killtanks. EN133116, BiotechnologyPerformancecriteriaforvesselsPart6:Chromatogr

    17、aphy columns. AnnexesAandBareinformative. Thisstandardincludesabibliography. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Irel

    18、and,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom.Page4 EN133114:2001 Introduction UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationof bioreactorswithregardtosafeperformanceinbiotechnologicalprocesses.Theclassification iseasilyun

    19、derstandableandreadilyutilizablefortheuserandtheregulatoryauthorities. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforbioreactorsusedin biotechnologicalprocesseswithrespecttothepotentialhazardstotheworkerandthe environmentfrommicroorganismsinuse. ThisEuropeanStandardapplieswheretheintend

    20、eduseofbioreactorsincludeshazardous orpotentiallyhazardousmicroorganismsusedinbiotechnologicalprocessesorwhere exposureoftheworkerortheenvironmenttosuchmicroorganismsisrestrictedforreasons ofsafety. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromother p

    21、ublications.Thesenormativereferencesarecitedattheappropriateplacesinthetextand thepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatestedition

    22、ofthe publicationreferredtoapplies(includingamendments). EN133111:2001 BiotechnologyPerformancecriteriaforvessels Part1:Generalperformancecriteria 3 Termsanddefinitions Forthepurposesofthisstandard,thetermsanddefinitionsgiveninEN133111:2001apply. 4 Hazards Typicalexamplesforpotentialhazardsofbioreac

    23、torsandrecommendationsforproper designandhandlingareincludedinannexB. 5 Performanceclasses Thebioreactorsshallbeclassifiedforleaktightness,cleanabilityandsterilizabilityin accordancewith5.1to5.4ofEN133111:2001. Theselectionoftheappropriateclassforperformanceofabioreactorshallbemadein accordancewith5

    24、.5ofEN133111:2001.Page5 EN133114:2001 6 Classificationandverificationofperformance 6.1 General Thebioreactorsshallconformtothegeneralrequirementsgivenin6.1ofEN133111:2001. Ifthecomponentsareclassified,theusingofanindirecttestmethodtotheassembled bioreactorissufficientforclassification. Ifthebioreact

    25、orismadebyassemblyofcomponents,itshallbetestedtoverifyitsoverall classification. NOTEEN12460providesguidanceonselectionandinstallationofequipment relevanttobioreactors. 6.2 Leaktightness Thebioreactorshallconformtotherequirementsgivenin6.2ofEN133111:2001. Ifthebioreactorcontainsmicroorganismsforwhic

    26、hthereleaseshallbeminimized,risk analysisshallindicatewhethertheoffgashastobetreated.Ifthebioreactorcontains microorganismsforwhichthereleaseshallbeprevented,theoffgasshallbetreated. GuidanceontestmethodsfordeterminingleaktightnessofbioreactorsisgiveninannexA. 6.3 Cleanability Thebioreactor shallcon

    27、formtotherequirementsgivenin6.3ofEN133111:2001. 6.4 Sterilizability Thebioreactorshallconformtotherequirementsgivenin6.4ofEN133111:2001. 7 Markingandpackaging Thebioreactorshallconformtotherequirementsgiveninclause7ofEN133111:2001. 8 Documentation Thebioreactorshallconformtotherequirementsgivenincla

    28、use8ofEN133111:2001.Page6 EN133114:2001 AnnexA (informative) Guidanceontestmethodsfordeterminingleaktightnessofbioreactors AlistoftestmethodsforleaktightnessisgivenintableA.1ofEN12298(see13).Fromthat listsuitabletestmethodstothetestingofbioreactorsaregivenintableA.1. TableA.1Suitablealternativeleakt

    29、ightnesstestmethodsforbioreactors Number Testmethod 1 Pressurelossgas/air 2 Pressurelossliquid 3 Heliumprobe 4S F 6 ,e.g.Freon a probe 5 Thermalconductivity 6 Ultrasonics 8 Tracerliquiddyes 10 Bubbleformation(onlyqualitative) 11 Electronicparticlecounting 12 Traceraerosol(NaCl) 13 Productaerosol(non

    30、microbial) 14 Qualitativebioaerosolmonitoring 15 Quantitativebioaerosolmonitoring 16 Surfaceswabbing 17 Surfaceconductivity 18 Visualinspection(onlyqualitative) 19 Bacteriatightness NOTERestrictiveuseofSF 6shouldbeconsideredduetoenvironment protection a Freonisanexampleofasuitableproductavailablecom

    31、mercially.This informationisgivenfortheconvenienceoftheuserofthisStandardand doesnotconstituteanendorsementofCENoftheseproducts.Page7 EN133114:2001 AnnexB (informative) Typicalhazardsandpreventivemeasures B.1 General Cleaningaswellassterilizationisfacilitatediftherearenodeadorstagnantareasinall equi

    32、pmentincludingpipework,whichpreventsselfdraining.Afterdrainingstagnantareas withadepthofnotmorethan5mmorinpipingdeadlegslessthan2timestheinternalpipe diametersareconsideredasnotpreventingcleaningandsterilization. Anyopeningorcreviceinthesurfaceofthematerialincontactwiththeprocessfluidcan preventclea

    33、ningandsterilizationiftheirshapedoesnotallowgoodcleaningagent penetrationandrinsingaswellassteampenetration. Itisgoodpracticetoperformmaintenanceonthebioreactoronlyafterapplicationof appropriatetargetmicroorganismreductionprocedures,thatcanbecleaninginplaceor sterilizationofthewholesystem. B.2 Backf

    34、lowoftargetmicroorganisms Backflowoftargetmicroorganismfromthebioreactorintovesselsorcontainersusedfor additionsduringcultivation(forexamplevesselsforadditionoffeed,acid,alkali,antifoamor nutrient)shouldbepreventedforexamplethroughtheuseofnonreturnvalveor overpressure. B.3 Malfunctioningofsteamtraps

    35、 Theeffectiveoperationofsteamtrapsduringsterilizationisoneofthecriticalrequirements ofeffectivesterilization.Properdesignforoperationandaccessibilityduringmonitoringare recommended. B.4 Hazardsassociatedwithcouplings,valvesandpipes Improperusageisahazardassociatedwithcouplings.Ifapplicableweldingins

    36、teadof couplingscanimprovecleanability,sterilizabilityandleaktightnessandthereforeminimize therisks.PerformanceofcouplingsaredescribedinEN133122(see5). Reinforcedflexibletubes(e.g.metalmantled)canwithstandpressureencounteredduring normalsterilization.Ifapplicablebendingispreferable,automaticweldingi

    37、spreferableto improvecleanability.PerformanceoftubesandpipesaredescribedinEN133124(see6). B.5 Leakagethroughvalves Stemsofvalvescanbeespeciallywellsealed,forexamplebyusingbonnetpackingringsor Oringsorbyincorporatingastaticmembranebetweenstemandvalvechamber. PerformanceofvalvesisdescribedinEN133125(s

    38、ee7).Page8 EN133114:2001 B.6 Leakagethroughseals Sealsarerequiredforprimarycontainmentwhereshaftspassthroughthewallofthe bioreactor,likestirrershafts,samplingdevices,probefittingsandallotherfittings.Ifsealsor gasketsareclosetotheproductsidepossibilityofcreatingcrevicesisreduced.Orings shouldbeusedas

    39、staticsealsbetweennonmovingsurfaces. Appropriatesealsforrotatingstirrershaftarelipsealsormechanicalseals.Theprobability ofleakagecanforexamplebereducedbyusingadoublemechanicalsealwithan overlayingsealingfluidwhichiskeptatahigherpressurethanthemedium.Inspecificcases theneedforsuchsealscanbeovercomeby

    40、theuseofmagneticcouplings.However, aspectslikesterilizabilityandcleanabilityshouldbeconsideredwithcare.Anothersolution canbetheuseofforexampleairliftfermenters.Insuchcasesoffgastreatmentshouldbe properlyconsidered. Byadditionofdisinfectantstothesealingfluidormaintenanceofadequatehigh temperaturesmic

    41、roorganismspenetratingthesealafterbreakagecanbeinactivated.To controltheintegrityofthesealaleveltransmitterorapressureindicatorandalarmsystem canbeinstalledintothecircuitsystem.PerformanceofsealsisdescribedinEN12490 (see8). B.7 Releaseofmicroorganismsthroughoffgassystems Treatmenttominimizeleakageca

    42、nincludetheuseofsuitablecentrifugalseparators(for examplecyclones).Treatmenttopreventleakagecanincludeheattreatmentoftheoffgas stream,orpassagethroughsuitablefilters(forexampledepthfiltersorhydrophobic membranefilters).Considerationcanbegiventotheuseoftwofiltersinseriesincaseof failureoftheprimaryfi

    43、lter.PerformanceofoffgassystemsisdescribedinEN13095 (see9). B.8 Releaseofmicroorganismsbyfoaming Excessivefoamingcanbeamajorhazardinbioreactoroperation.Microorganismscanbe releasedbyfoamleavingthebioreactororfoamcanblockexhaustfilters.Blockedexhaust filterscancauseoverpressureinthebioreactor. Wheref

    44、oamformationislikely,suitablemeansforcontrollingofthefoamshouldbeputinto place.Suchmeasurescaninclude: theuseofmechanicalfoambreakers; foamprobewithantifoamagentaddition; theuseofcentrifugalseparator,linkedtoafoamprobe; highlevelalarmfoamprobeandshutoffvalveintheexhaustairducttogetherwith reductionofaerationrate; reducedbioreactor


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