1、BRITISH STANDARD BS EN 13312-2:2001 Biotechnology Performance criteria for piping and instrumentation Part 2: Couplings The European Standard EN 13312-2:2001 has the status of a British Standard ICS 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 13312-2
2、:2001 This British 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 April 2001 BSI 04-2001 ISBN 0 580 37457 2 National foreword This British Standard is the
3、 official English language version of EN 13312-2:2001. 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-referen
4、ces The British Standards which implement international or European publications referred to in this document 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 Catalog
5、ue. A British Standard does not purport 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;
6、 present to the responsible European 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 fr
7、ont cover, the EN title page, pages 2 to 9 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 EN133122 February2001 ICS07.080;07.100.
8、01 Englishversion BiotechnologyPerformancecriteriaforpipingand instrumentationPart2:Couplings BiotechnologieCritresdeperformancepourtuyauteries etinstrumentationPartie2:Raccords BiotechnikLeistungskriterienfrLeitungssystemeund InstrumentierungTeil2:Verbindungsstcke ThisEuropeanStandardwasapprovedbyC
9、ENon13January2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManage
10、mentCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstand
11、ardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeSt
12、assart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN133122:2001EPage2 EN133122:2001 Contents Page Foreword.3 Introduction 4 1 Scope.4 2 Normativereferences .4 3 Termsanddefinitions.5 4 Hazards5 5 Performanceclasses 5 6 Classif
13、icationandverificationofperformance.6 7 Markingandpackaging 6 8 Documentation6 AnnexA(informative)Guidanceontestmethodsfordetermining leaktightness,cleanabilityandsterilizabilityofcouplings .7 AnnexB(informative)Design,installationandmaintenanceofcouplings8 Bibliography .9Page3 EN133122:2001 Forewor
14、d ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichisheldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbyAugust2001,and conflictingnationalstandardsshallbewith
15、drawnatthelatestbyAugust2001. ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommissionandtheEuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forpipingandinstrumentation.Thesestandardsare: EN133121, BiotechnologyPerf
16、ormancecriteriaforpipingandinstrumentationPart1: Generalperformancecriteria. EN133122, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart2: Couplings. EN133123, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart3: Samplingandinoculationdevices. EN133124, BiotechnologyPerfor
17、mancecriteriaforpipingandinstrumentationPart4: Tubesandpipes. EN133125, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart5: Valves. EN133126, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart6: Equipmentprobes. ThisstandardincludesaBibliography. AccordingtotheCEN/CENELECI
18、nternalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom.Page4 EN
19、133122:2001 Introduction Couplingsareusedforjoiningtubularsections,andforconnectingothercomponentsof equipmentintotheprocesssystem,whereequipmentisdesignedtobedisassembled.In manycasescouplingsaremadeofstainlesssteelandareusedinallfood,beverage, pharmaceuticalandbiotechnologicalprocesses. Detailedde
20、signspecificationsarenecessarytoensureinterchangeabilityandconnectability, sincefrequentlythevariouspartsofacouplingwillbemanufacturedbydifferent organisations.Asanexample,controlandmeasuringdevicesareoftensuppliedwith couplingsontheconnectingportswhichhavetobesecuredtotubesystemswithmating partsand
21、gasketssuppliedbythirdparties. Couplingsaredesignedtobeleakproofundernormaloperatingconditions.In biotechnologicalapplicationstheyshouldinrelevantcasespreventthereleaseof microorganismsintotheatmosphereandingressintotheprocesssystem.Couplingsshould enableprocessequipmenttobecleanedinplaceordismantle
22、dformanualcleaningand/or sterilizationinanautoclave.Typicalcouplingstandardsaregiveninbibliography3to10. Inrelevantcasescouplingsthemselvesshouldbecapableofbeingcleanedand/orsterilized inplace. Thecontinuouslyreliableperformanceofacouplingisdependentonfeaturesand conditionswhicharenotintegralpartsof
23、thisEuropeanStandard,andthereforeattentionis drawntotherecommendationsfordesign,installationandmaintenanceinannexB. UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationof couplingswithregardtosafeperformanceinbiotechnologicalprocesses.Theclassification iseasilyunderstandablean
24、dreadilyutilizablefortheuserandtheregulatoryauthorities. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforcouplingsusedin biotechnologicalprocesseswithrespecttothepotentialhazardstotheworkerandthe environmentfrommicroorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseofthecoupli
25、ngincludeshazardous orpotentiallyhazardousmicroorganismsusedinbiotechnologicalprocessesorwhere exposureoftheworkerortheenvironmenttosuchmicroorganismsisrestrictedforreasons ofsafety. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromother publications.Thes
26、enormativereferencesarecitedattheappropriateplacesinthetextand thepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicatio
27、nreferredtoapplies(includingamendments).Page5 EN133122:2001 EN133121:2001, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart 1:Generalperformancecriteria. 3 Termsanddefinitions Forthepurposesofthisstandard,thetermsanddefinitionsgiveninEN133121:2001 apply. 4 Hazards Thefollowinghazardss
28、hallbetakenintoaccount. a)Releaseofmicroorganismscausedby: noncompatibilityofcouplings,gasketsand/orfittings; misalignmentofthecouplingduringassembly; replacementofthespecialisedgaskets,specifiedforaparticularprocessand couplingdesign,withsimilarproduct,forexampleOrings,whicharenotsuitablefor theser
29、vicedemanded; loosenessofcouplingsinserviceresultingfromexpansion,contractionand vibrations; NOTE1Theextenttowhichthegasketmaterialcanbecompressedorexpandedby mechanical,heatorvacuumconditionsiscontrolledbythechoiceofcouplingdesign, materialsusedandmanufacturingtolerances. misalignmentresultingfromr
30、epetitiveuseofgasketsforclampcouplings. b)Overtighteningofcouplingsdesignedtohaveasealwhichisflushedwiththeinner boreofthetubesystemcancausethegaskettoextrudeintotheboreorcandamagethe surfaceoftheseal,therebyreducingtheeffectivenessofcleaningandsterilization. c)Protectionofviablehazardousmicroorgani
31、smsincracksandfissureswithinthe elastomer.Gasketmaterialsdegradeatvaryingrates,canbepermeatedwith microorganismsandcanentrapsoilormicroorganismswithincouplingsealcavitiesthus reducingtheefficiencyofcleaningandsterilization. NOTE2Repeatedexpansionandcontractionofelastomergasketsduetovariable pressure
32、sandtemperaturescancausedeteriorationoftheelastomer. 5 Performanceclasses Thecouplingshallbeclassifiedforleaktightness,cleanabilityandsterilizabilityin accordancewith5.1to5.4ofEN133121:2001. Theselectionoftheappropriateclassforperformanceofacouplingshallbemadein accordancewith5.5ofEN133121:2001.Page
33、6 EN133122:2001 6 Classificationandverificationofperformance 6.1 General Thecouplingshallconformtothegeneralrequirementsgivenin6.1ofEN133121:2001. Couplingsthatareanintegralpartofaunitofequipment,i.e.avesselwithinletandoutlet ports,shallmeettheperformancerequirementsforthatunitofequipment. NOTEStand
34、ardsforhygieniccouplingscannotguaranteeconformanceto processeswherepotentiallyhazardousmicroorganismsareused. Referencestotestmethodstotesttheperformanceofcouplingswithregardto leaktightness,cleanabilityandsterilizabilityaregiveninannexA. 6.2 Leaktightness Thecouplingshallconformtotherequirementsgiv
35、enin6.2ofEN133121:2001. NOTEGenerallycouplingsaredesignedtobeleaktighttoaspecifiedmaximum pressureandcanbeverifiedbypressuretestingwhennecessary.Pressuretesting aloneisnotproofofleaktightnessformicrobiologicaluse. 6.3 Cleanability Thecouplingshallconformtotherequirementsgivenin6.3ofEN133121:2001. 6.
36、4 Sterilizability Thecouplingshallconformtotherequirementsgivenin6.4ofEN133121:2001. 7 Markingandpackaging Thecouplingshallconformtotherequirementsgivenin clause7ofEN133121:2001. 8 Documentation Thecouplingshallconformtotherequirementsgivenin clause8ofEN133121:2001.Page7 EN133122:2001 AnnexA(informa
37、tive) Guidanceontestmethodsfordeterminingleaktightness,cleanabilityand sterilizabilityofcouplings A.1 Leaktightness AlistoftestmethodsforleaktightnessisgivenintableA.1ofEN12298(see11).From thatlistsuitabletestmethodstothetestingofcouplingsaregivenintableA.1. TableA.1Suitablealternativeleaktightnesst
38、estmethodsforcouplings Number Testmethod 1 Pressurelossgas/air 2 Pressurelossliquid 3 Heliumprobe 4S F 6 ,e.g.Freon a probe 8 Tracerliquiddyes 11 Electronicparticlecounting 12 Traceraerosol(NaCl) 13 Productaerosol(nonmicrobial) 14 Qualitativebioaerosolmonitoring 15 Quantitativebioaerosolmonitoring 1
39、6 Surfaceswabbing 18 Visualinspection(onlyqualitative) 19 Bacteriatightness NOTERestrictiveuseofSF 6shouldbeconsideredduetoenvironment protection a Freonisanexampleofasuitableproductavailablecommercially.This informationisgivenfortheconvenienceoftheuserofthisStandardand doesnotconstituteanendorsemen
40、tofCENoftheseproducts A.2 Cleanability Asuitablemethodfortestingcleanabilityisdescribedin1. A.3 Sterilizability Asuitablemethodfortestingsterilizabilityisdescribedin2.Page8 EN133122:2001 AnnexB(informative) Design,installationandmaintenanceofcouplings B.1 Couplingsdesign Couplingscanbedesignedtoenab
41、lerepeatedcleaninginplace(CIP)andsterilizingin place(SIP)operationstobecarriedoutattherequiredtemperaturesandtimecycles withoutaffectingthetightnessoftheconnectionorcausingunduedeteriorationofthe gasketmaterial.Ideally,thegasketsurfaceistobeflushedwiththeinternalboresurfacesof thecouplingsduringnorm
42、aloperationofthesystemreducingtheinstancesofcavitiesand flowrestrictions. B.2 Couplingsinstallation B.2.1 General Whencouplingsareinstalled,thefollowingdisciplinesshouldbeobserved. B.2.2 Thecomponentsshouldbeexaminedandpreassembledtoensurethattheywillfit togethercorrectly,particularlywithrespecttoth
43、ealignmentoftheboresandthefitofthe gaskets. B.2.3 Componentsgetpreferablyconnectedbytheorbitalweldingprocess.Careshould betakentoensurethatthecouplingcomponenthasnotbeendistortedbythewelding procedure.TIG 1) weldingshouldbeusedforallweldsincontactwithproduct.Internal penetrationofrootpassesshouldbes
44、moothandlimitedinsize. B.2.4 Careshouldbetakentoensureproperalignmentofthetwohalvesofacoupling whenassembled,particularlywherepipeworkisconcerned.Assembledmisalignmentisthe mostcommonfaultcausingleakage. B.2.5 Allcouplingsshouldbecheckedandfinallytightenedbeforetheequipmentof processsystemisputintoservice. B.3 Maintenance B.3.1 Themanufacturerorusershoulddefinethe
