1、BRITISH STANDARD BS EN 13312-5:2001 Biotechnology Performance criteria for piping and instrumentation Part 5: Valves The European Standard EN 13312-5:2001 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 13312-5:20
2、01 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 37460 2 National foreword This British Standard is the of
3、ficial English language version of EN 13312-5:2001. 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
4、 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 Catalogue.
5、 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; pr
6、esent 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 front
7、 cover, the EN title page, pages 2 to 10, 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 EN133125 February20
8、01 ICS07.080;07.100.01 Englishversion BiotechnologyPerformancecriteriaforpipingand instrumentationPart5:Valves BiotechnologieCritresdeperformancepourtuyauteries etinstrumentationPartie5:Robinetterie BiotechnikLeistungskriterienfrLeitungssystemeund InstrumentierungTeil5:Ventile ThisEuropeanStandardwa
9、sapprovedbyCENon13January2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicatio
10、ntotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethen
11、ationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCe
12、ntre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN133125:2001EPage2 EN133125:2001 Contents Page Foreword3 Introduction .4 1 Scope4 2 Normativereferences 4 3 Termsanddefinitions4 4 Hazards.4 5 Performanceclasses .
13、5 6 Classificationandverificationofperformance5 7 Markingandpackaging .5 8 Documentation.5 AnnexA(informative)Guidanceontestmethodsfordetermining leaktightness,cleanabilityandsterilizabilityofvalves 6 AnnexB(informative)Guidanceonmaterials,designandmanufacture 7 AnnexC(informative)Exampleofvalves.8
14、Bibliography 10Page3 EN133125:2001 Foreword ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichisheldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbyAugust2001,a
15、nd conflictingnationalstandardsshallbewithdrawnatthelatestbyAugust2001. ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommissionandtheEuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forpipingandinstrumentation.Thes
16、estandardsare: EN133121, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart1: Generalperformancecriteria. EN133122, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart2: Couplings. EN133123, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart3: Samplingandinocula
17、tiondevices. EN133124, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart4: Tubesandpipes. EN133125, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart5: Valves. EN133126, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart6: Equipmentprobes. Thisstandardinclude
18、saBibliography. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Swede
19、n,SwitzerlandandtheUnited Kingdom.Page4 EN133125:2001 Introduction UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationof valveswithregardtosafeperformanceinbiotechnologicalprocesses.Theclassificationis easilyunderstandableandreadilyutilizablebytheuserandtheregulatoryauthoriti
20、es. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforvalvesusedinbiotechnological processeswithrespecttothepotentialhazardstotheworkerandtheenvironmentfrom microorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseofthevalvesincludeshazardousor potentiallyhazardousmicroorganismsus
21、edinbiotechnologicalprocessesorwhere exposureoftheworkerortheenvironmenttosuchmicroorganismsisrestrictedforreasons ofsafety. ThisEuropeanStandardappliestothesterilizabilityandcleanabilityofvalvesandto microbialleaktigtnessofvalvesbreachingthephysicalcontainmentoftheintendedclosed systeminanunwantedm
22、anner. NOTEThisimpliesbothleakagetotheenvironmentaswellaswithincompartments oftheprocesssystem. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromother publications.Thesenormativereferencesarecitedattheappropriateplacesinthetextand thepublicationsarelisted
23、hereafter.Fordatedreferences,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationreferredtoapplies(includingamendments). EN133121:2001, BiotechnologyPerformancecriteri
24、aforpipingandinstrumentationPart 1:Generalperformancecriteria. 3 Termsanddefinitions Forthepurposesofthisstandard,thetermsanddefinitionsgiveninEN133121:2001 apply. 4 Hazards Thefollowinghazardsshallbetakenintoaccount. a)Releaseofmicroorganismscausedbyaninappropriateselectionofavalve.Ingeneral valves
25、inwhichtheoperatingmechanismisnotincontactwithprocessmaterialareapplied whentheequipmentneedstobesterilizedandleaktightnessisrequired.Page5 EN133125:2001 b)Releaseofmicroorganismsand/orcrosscontaminationcausedbyanaccumulationof soilduetolackofcirculationofcleaningmedia.Thisaccumulationofsoilcanaffec
26、t mechanicalfunctioningand/orsterilizabilityofthevalve. c)Releaseorbackflowofmicroorganismscausedbyinadequateinformationontheactual positionofthevalve. NOTEItisadvisabletousefailsafeactuatorsforautomaticallycontrolledsystems. d)Releaseofmicroorganismscausedbyrepeatedovertighteningofvalvesthatcanresu
27、ltin damagethemembraneseal. e)Releaseofmicroorganismscausedbyinappropriateinstallationofthevalveforexample sothatitisnotselfdrainingandcannotbecleanedadequately. f)Releaseofmicroorganismscausedbyalossofcomponentintegrityresultingfrom deteriorationofnonmetallicmaterialsbyexcessivethermalorchemicalexp
28、osure,or ageing,andinappropriatemaintenance. 5 Performanceclasses Thevalvesshallbeclassifiedforleaktightness,cleanabilityandsterilizabilityinaccordance with5.1to5.4ofEN133121:2001. Theselectionoftheappropriateclassforperformanceofavalveshallbemadein accordancewith5.5ofEN133121:2001. 6 Classification
29、andverificationofperformance Thevalvesshallconformtothegeneralrequirementsgiveninclause6ofEN133121:2001. GuidanceontestmethodsfordeterminingleaktightnessofvalvesisgiveninannexA. Guidanceonmaterials,designandmanufactureisgiveninannexB. 7 Markingandpackaging Thevalvesshallconformtotherequirementsgiven
30、in clause7ofEN133121:2001. 8 Documentation Thevalvesshallconformtotherequirementsgivenin clause8ofEN133121:2001.Page6 EN133125:2001 AnnexA(informative) Guidanceontestmethodsfordeterminingleaktightness,cleanabilityand sterilizabilityofvalves AlistoftestmethodsforleaktightnessisgivenintableA.1ofEN1229
31、8:1998(see4). FromthatlistsuitabletestmethodstothetestingofvalvesaregivenintableA.1. TableA.1Suitablealternativeleaktightnesstestmethodsforvalves Number Testmethod 1 Pressurelossgas/air 2 Pressurelossliquid 3 Heliumprobe 4S F 6 ,e.g.Freon a probe 5 Thermalconductivity 8 Tracerliquiddyes 11 Electroni
32、cparticlecounting 12 Traceraerosol(NaCl) 13 Productaerosol(nonmicrobial) 14 Qualitativebioaerosolmonitoring 15 Quantitativebioaerosolmonitoring 16 Surfaceswabbing 18 Visualinspection(onlyqualitative) 19 Bacteriatightness NOTERestrictiveuseofSF 6shouldbeconsideredduetoenvironment protection a Freonis
33、anexampleofasuitableproductavailablecommercially.This informationisgivenfortheconvenienceoftheuserofthisStandardand doesnotconstituteanendorsementofCENoftheseproducts.Page7 EN133125:2001 AnnexB(informative) Guidanceonmaterials,designandmanufacture B.1 Materials Thematerialshouldbeappropriateforthein
34、tendeduse,dependinguponthepropertiesof theprocessandcleaningfluidsandanycouplingorweldingrequirements.Thematerial mostcommonlyusedisstainlesssteelandshouldbeinaccordancewithEN100881(see 3)orsimilarbutvalvesforbiotechnologicalprocessapplicationsaremadefromawide rangeofmaterialsincludingnonferrousmeta
35、lsandplasticssuchasPVCand polypropylene. ElastomericmaterialscommonlyusedforsealsanddiaphragmsincludeEPDM(Ethylene propylenedienemonomer),NBR(Acrylenitrilebutadienerubber),CSM(chlorosulphonated polyethylene),VMQ(vinylmethylpolysiloxanee.g.siliconerubber)andFKM(Fluor caoutchouce.g.viton).Siliconerubb
36、erandvitonaresuitableforhightemperatureusage(up to180 o C).Otherinertmaterialscanbeused. Thematerialshouldbechemicallyinertandresistant,andthermallystable,retainingits integrityandprincipalworkingpropertiesduringthespecifiedlifespan. B.2 Design Thereshouldbeaccessforcleaningandvisibleinspection.Dead
37、spacesorgapsinwhich soilcouldaccumulateshouldbeavoided.Gaplengthtowidthratiosshouldbesufficiently largetoallowfreeflowofcleaningfluid.Boltholes,blindholesandotherdeadendsshould beavoided.Exposedthreadsshouldbeavoided.Thedesignandorientationofthevalve andfittingsshouldbesuchthattheyareselfdraining. I
38、nternalsurfacesshouldhaveasurfaceroughnessof R a =0,2mto R a =1,6mandbe freefromcrevices.FurtherdesigncriteriaarespecifiedinPart1ofthisEuropeanStandard. Thebodyofthevalveshouldbeequippedwithcouplingsforweldingorpipecouplingswhich complywiththecriterialaiddownforcouplingsusedin biotechnologicalproces
39、sesasgiven inEN133122:2001.Orbitalweldingmethodsarepreferred. Oringsealsshouldbefittedascloseaspossibletotheproductareatoavoidgaps. RotatingsealsshouldbeselectedinaccordancewiththeguidancegiveninEN12690:1999 (see2). Themanufacturerorsuppliershouldindicatethesealsusedandhowtoreplacethem. B.3 Manufact
40、ureandcontroloversuitabilityofproduct Manufacturingmethodsshouldbeselectedatthediscretionofthemanufacturertomeetthe needsoftheapplicationasdefinedbythemanufacturerandendusertogether. Thecontrolovertheproductssuitabilitymayconsistofcheckingthequalityofthe manufacturerproductionsystem,orconductingprac
41、ticaltests.Page8 EN133125:2001 AnnexC(informative) Exampleofvalves C.1 Valveselection Theprincipalcharacteristicsconsideredintheselectionofavalvetypeformostapplications arethefluidtobehandled(e.g.gas,liquid,slurry),thefunctionalrequirements(e.g.on/off, flowthrottling,flowdiversion),theoperatingcondi
42、tions(e.g.pressure,temperature, flowrate),thevalvesize,andanyspecialneeds(e.g.safetywithregardtoboththe environmentandtheworker).Valvesaremadefromavarietyofmaterialsincludingplastics. C.2 Ballvalves Ballvalvescompriseaballwithacylindricalholewhichcanberotatedwithinthebodyofthe valvetoaligntheholewit
43、hthepipetoallowthefluidtoflowornormaltothepipetoprevent fluidflow.Sealsoneithersideoftheballandatthestemlimittheleakageoffluid.Ball valvesdesignedforCIP(Cleaninginplace)shouldensurethatthevolumeexposedtothe processlinebetweentheball,thebodyandthesealsissufficientlylargetoallowthrough flowofcleaningf
44、luid. C.3 Butterflyvalves Butterflyvalvescompriseadiscortwohalfdiscswhichcanberotatedtosealagainstthe wallofthebody.Flexiblesealsarenormallyincludedinthebodyorthediscs.Butterfly valvesareusedinthefoodindustry,whenhygienicoperationisrequired. C.4 Diaphragmvalvesormembranevalves Diaphragmvalvescompriseacontinuous,flexible
