1、BRITISH STANDARD BS EN 13311-2:2001 Biotechnology Performance criteria for vessels Part 2: Pressure protection devices The European Standard EN 13311-2:2001 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 13311-2:2001 This B
2、ritish Standard, 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 37599 4 National foreword This British Standard is the official Engl
3、ish language version of EN 13311-2:2001. 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 Briti
4、sh Standards which 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 purp
5、ort to include all 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
6、 committee any enquiries 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
7、2 to 8, an inside 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 EN133112 March2001 ICS07.080;07.100.01 Englishversion
8、 BiotechnologyPerformancecriteriaforvesselsPart2: Pressureprotectiondevices BiotechnologieCritresdeperformancedesrcipients Partie2:Dispositifsdeprotectionvisvisdelapression BiotechnikLeistungskriterienfrBehlterTeil2: Druckentlastungseinrichtung ThisEuropeanStandardwasapprovedbyCENon4February2001. CE
9、NmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENm
10、ember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,B
11、elgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussel
12、s 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN133112:2001EPage2 EN133112:2001 Contents Page Foreword 3 Introduction4 1 Scope .4 2 Normativereferences.4 3 Termsanddefinitions 4 4 Hazards 4 5 Performanceclasses5 6 Classificationandverification
13、ofperformance 5 7 Markingandpackaging 5 8 Documentation5 AnnexA(informative)Guidanceontestmethodsfordeterminingleaktightnessof pressureprotectiondevices .6 AnnexB(informative)Informationonpressureprotectiondevices .7 Bibliography.8Page3 EN133112:2001 Foreword ThisEuropeanStandardhasbeenpreparedbyTec
14、hnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichisheldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbySeptember2001,and conflictingnationalstandardsshallbewithdrawnatthelatestbySeptember2001. ThisEu
15、ropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommissionandtheEuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forvessels.Thesestandardsare: EN133111 BiotechnologyPerformancecriteriaforvesselsPart1:General performancecrit
16、eria. EN133112 BiotechnologyPerformancecriteriaforvesselsPart2:Pressureprotection devices. EN133113 BiotechnologyPerformancecriteriaforvesselsPart3:Glasspressure vessels. EN133114 BiotechnologyPerformancecriteriaforvesselsPart4:Bioreactors. EN133115 BiotechnologyPerformancecriteriaforvesselsPart5:Ki
17、lltanks. EN133116 BiotechnologyPerformancecriteriaforvesselsPart6:Chromatography columns. AnnexesAandBareinformative. Thisstandardincludesabibliography. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austr
18、ia,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom.Page4 EN133112:2001 Introduction Pressureprotectiondevicespreventequipmentfrombeingsubjectedtopressuresbeyond theirnominalpressur
19、e.Maintypesofpressureprotectiondevicesareburstingdiscsand reliefvalves. UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationof pressureprotectiondeviceswithregardtosafeperformanceinbiotechnologicalprocesses. Theclassificationiseasilyunderstandableandreadilyutilizablefortheuser
20、andthe regulatoryauthorities. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforpressureprotectiondevicesused inbiotechnologicalprocesseswithrespecttothepotentialhazardstotheworkerandthe environmentfrommicroorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseofpressureprotectionde
21、vices includeshazardousorpotentiallyhazardousmicroorganismsusedinbiotechnological processesorwhereexposureoftheworkerortheenvironmenttosuchmicroorganismsis restrictedforreasonsofsafety. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromother publications.T
22、hesenormativereferencesarecitedattheappropriateplacesinthetextand thepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publica
23、tionreferredtoapplies(includingamendments). EN133111:2001, BiotechnologyPerformancecriteriaforvesselsPart1:General performancecriteria. 3 Termsanddefinitions Forthepurposesofthisstandard,thetermsanddefinitionsgiveninEN133111:2001apply. 4 Hazards Thefollowinghazardsshallbetakenintoaccount. a)Releaseo
24、fmicroorganismscausedbypressurerelease. NOTEFollowingruptureofaburstingdisc,thevesselwillremainopenandcan continuetoreleasemicroorganisms. b)Releaseofmicroorganismscausedbybreakingofaburstingdiscbeforethenominal pressureratingisreachedduetomechanicaland/orthermaltensions.Page5 EN133112:2001 c)Releas
25、eofmicroorganismscausedbyopeningofapressurereliefvalvebeforethe nominalpressureratingisreached. RecommendationsforproperdesignandhandlingareincludedinannexB. 5 Performanceclasses Thepressureprotectiondevicesshallbeclassifiedforleaktightness,cleanabilityand sterilizabilityinaccordancewith5.1to5.4ofEN
26、133111:2001. Theselectionoftheappropriateclassforperformanceofapressureprotectiondeviceshall bemadeinaccordancewith5.5ofEN133111:2001. 6 Classificationandverificationofperformance Thepressureprotectiondevicesshallconformtothegeneralrequirementsgiveninclause6 ofEN133111:2001. Guidanceontestmethodsfor
27、determiningleaktightnessofpressureprotectiondevicesis giveninannexA. 7 Markingandpackaging Thepressureprotectiondevicesshallconformtotherequirementsgiveninclause7of EN133111:2001. 8 Documentation Thepressureprotectiondevicesshallconformtotherequirementsgiveninclause8of EN133111:2001.Page6 EN133112:2
28、001 AnnexA (informative) Guidanceontestmethodsfordeterminingleaktightnessofpressureprotection devices AlistoftestmethodsforleaktightnessisgivenintableA.1ofEN12298(see9).Fromthat listsuitabletestmethodstothetestingofpressureprotectiondevicesaregivenintableA.1. TableA.1Suitablealternativeleaktightness
29、testmethodsforpressureprotection devices Number Testmethod 1 Pressurelossgas/air 2 Pressurelossliquid 3 Heliumprobe 4S F 6 ,e.g.Freon a probe 5 Thermalconductivity 6 Ultrasonics 8 Tracerliquiddyes 11 Electronicparticlecounting 12 Traceraerosol(NaCl) 14 Qualitativebioaerosolmonitoring 15 Quantitative
30、bioaerosolmonitoring 16 Surfaceswabbing 17 Surfaceconductivity 19 Bacteriatightness NOTERestrictiveuseofSF 6shouldbeconsideredduetoenvironment protection a Freonisanexampleofasuitableproductavailablecommercially.This informationisgivenfortheconvenienceoftheuserofthisStandardand doesnotconstituteanen
31、dorsementofCENoftheseproducts.Page7 EN133112:2001 AnnexB (informative) Informationonpressureprotectiondevices B.1 Pressurereliefsystemsonfermenters Apressurereliefsystemisrequiredonallfermentersasasafetyfeaturetocomplywith pressurevesseldesignregulations.Thesearegenerallyburstingdiscsorspringloaded
32、pressurereliefvalveslocatedonthefermentertopplate. B.2 Burstingdiscs Usually,forbioreactorsburstingdiscsareused,whichconsistofametaldomedtype constructionwithweakenedsections,sothatthedomeblowsapartwithoutfragmentingon bursting.Versionsspeciallydesignedforfoodandpharmaceuticalindustries,arebeginning
33、 toemerge.Forexamplediscstosafeguardagainstdamagebothbyvacuumand overpressure.ConstructedofstainlesssteelwithaPTFEmembraneonitsconcaveside,the deviceisclaimedtomeet“strictsanitarystandards“allowingitsuseinhygienicapplications suchasthoseencounteredinthefoodandpharmaceuticalindustries. B.3 Pressurere
34、liefvalves Pressurereliefvalvesgenerallyconsistofaspringactivatedmechanismwhichkeepsthe valveclosedundernormaloperation.Ifpressureinthesystemincreases,thevalvespring becomescompressedtoapointwherethevalveopensandpressureisrelievedatthe nominalpressure.Somepressurereliefvalveshaveafixedpressuresettin
35、g,somecanbe adjustedbyalteringthespringtension. B.4 Handlingofthedischargeofapressurereliefsystem Variousoutletsystemsareconceivableforthetreatmentofdischargefrompressurerelief systemsdependingonthepotentialhazardsinvolved(see1to8).Considerationisalso neededconcerningseveralfermenterssharingthesamew
36、astelinetopreventcross contamination. B.5 Relativemeritsofburstingdiscsandpressurereliefvalves Burstingdiscsingeneralarecheaperthanreliefvalvesandwouldappeartothesystemof choiceformostfermentations.Page8 EN133112:2001 Bibliography 1 Barnsley,J.H.(1990).“ContainmentofLargeScaleCellCultureFermenter Sy
37、stems“,PaperpresentedatISPEconference,ContainmentinthePharmaceutical Industry,StratforduponAvon,England,1213June1990. 2 DeansJ.S.(1990).IndustrialBiosafetyProjectMinutes,May1990,WarrenSpring Laboratory,Stevenage,UK. 3 GiorgioR.J.andWuJ.J.(1986).“DesignofLargeScaleContainmentFacilitiesfor recombinant
38、DNAFermentations“,TIBTECHMarch,pp6065. 4 GrosselSS(1990).“AnOverviewofEquipmentforContainmentandDisposalof EmergencyReliefSystemEffluents“,JLossPrev.ProcessInd.Vol3,Jan.,pp 112124. 5 HambletonP.(1990).“AHighContainmentPolymodalPilotPlantFermenterDesign Concepts“,IBPResearchNotes,May1990,agendaitem3.
39、3.(Paperalsoduetobe publishedinJ.ChemTechBiotechnol.). 6 KearnsM.(1990).“ContainmentinthePharmaceuticalIndustry“,InternationalSociety ofPharmaceuticalEngineersconference,StratforduponAvon,England,1213June 1990,ISPE,223ChaussedeBruxelles,Boite4,B1410,Waterloo,Belgium. 7 MatthewHall(1987).“Pressureand
40、VacuumReliefSystemsforAsepticPlant“, PPFB/5/1987,AvailablefromDTIMTdivision,123VictoriaStreet,London. 8 ISO6718,Burstingdiscsandburstingdiscdevices1991/Cor.1:1993. 9 EN12298:1998,BiotechnologyEquipmentGuidanceontestingproceduresfor leaktightness.blankBS EN 13311-2:2001 BSI 389 Chiswick High Road Lon
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