1、BRITISH STANDARD BS EN 13312-1:2001 Biotechnology Performance criteria for piping and instrumentation Part 1: General performance criteria The European Standard EN 13312-1:2001 has the status of a British Standard ICS 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIG
2、HT LAWBS EN 13312-1:2001 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 37456 4 National foreword This Brit
3、ish Standard is the official English language version of EN 13312-1:2001. 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 secre
4、tary. Cross-references 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
5、 Electronic Catalogue. 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 u
6、nderstand the text; 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
7、cover, an inside front cover, the EN title page, pages 2 to 13 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 EN133121 February20
8、01 ICS07.080;07.100.01 Englishversion BiotechnologyPerformancecriteriaforpipingand instrumentationPart1:Generalperformancecriteria BiotechnologieCritresdeperformancepourtuyauteries etinstrumentationPartie1:Critresgnrauxde performance BiotechnikLeistungskriterienfrLeitungssystemeund InstrumentierungT
9、eil1:AllgemeineLeistungskriterien ThisEuropeanStandardwasapprovedbyCENon13January2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesco
10、ncernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentreha
11、sthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPEN
12、DENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN133121:2001EPage2 EN133121:2001 Contents Page Foreword.3 Introduction 4 1 Scope.4 2 Normativereferences .4
13、 3 Termsanddefinitions.5 4 Hazards8 5 Performanceclasses 8 6 Classificationandverificationofperformance.11 7 Markingandpackaging 12 8 Documentation12 Bibliography .13Page3 EN133121:2001 Foreword ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichish
14、eldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbyAugust2001,and conflictingnationalstandardsshallbewithdrawnatthelatestbyAugust2001. ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommi
15、ssionandtheEuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forpipingandinstrumentation.Thesestandardsare: EN133121, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart1: Generalperformancecriteria. EN133122, BiotechnologyPerform
16、ancecriteriaforpipingandinstrumentationPart2: Couplings. EN133123, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart3: Samplingandinoculationdevices. EN133124, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart4: Tubesandpipes. EN133125, BiotechnologyPerformancecriteriafor
17、pipingandinstrumentationPart5: Valves. EN133126, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart6: Equipmentprobes. ThisstandardincludesaBibliography. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropean
18、Standard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom.Page4 EN133121:2001 Introduction UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationof coup
19、lings,samplingandinoculationdevices,tubesandpipes,valvesandequipmentprobes withregardtosafeperformanceinbiotechnologicalprocesses.Theclassificationiseasily understandableandreadilyutilizablebytheuserandtheregulatoryauthorities. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforpipingandinst
20、rumentationused inbiotechnologicalprocesseswithrespecttothepotentialhazardstotheworkerandthe environmentfrommicroorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseoftheequipmentincludes hazardousorpotentiallyhazardousmicroorganismsusedinbiotechnologicalprocessesor whereexposureoftheworke
21、rortheenvironmenttosuchmicroorganismsisrestrictedfor reasonsofsafety. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromother publications.Thesenormativereferencesarecitedattheappropriateplacesinthetextand thepublicationsarelistedhereafter.Fordatedreferenc
22、es,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationreferredtoapplies(includingamendments). EN16722, FoodprocessingmachineryBasicconceptsPart2:Hygienerequirements.
23、EN12296, BiotechnologyEquipmentGuidanceontestingproceduresforcleanability. EN12297, BiotechnologyEquipmentGuidanceontestingproceduresforsterilizability . EN12298, BiotechnologyEquipmentGuidanceontestingproceduresforleaktightness. ENISO4287, Geometricalproductspecifications(GPS)Surfacetexture:Profile
24、method Terms,definitionsandsurfacetextureparameters(ISO4287:1997). ENISO4288, GeometricalProductSpecifications(GPS)Surfacetexture:Profilemethod Rulesandproceduresfortheassessmentofsurfacetexture(ISO4288:1996).Page5 EN133121:2001 3 Termsanddefinitions Forthepurposesofthisstandard,thefollowingtermsand
25、definitionsapply: 3.1 clean conditionof(a)product,surface,device,gasesand/orliquidswithresidualsoilbelowa definedthresholdlevel. 3.2 cleanability abilitytobemadeclean. 3.3 cleaning removalofsoil. 3.4 cleaninginplace(CIP) cleaningwithoutdismantlingofcomponentsofequipmentand/orunitofequipment. 3.5 clo
26、sedsystem systemwhereabarrierseparatesmicroorganismsororganismsfromtheenvironment EN1620. 3.6 coupling deviceenablingtwocomponentsofequipmenttobeassembledanddisassembled. 3.7 equipmentprobe deviceinsertedintoacomponentofequipmenttomeasuresomephysicalorchemical propertyofinterestfortheprocess. NOTEPr
27、obescanbefixedorremovable,e.g.slidingprobes.Page6 EN133121:2001 3.8 hazard intrinsicpropertyorabilityofsomething(e.g.anyagent,equipment,materialorprocess)to causeharmEN1620. NOTEHarmisaninjuryordamagetohealthofpeopleand/ortotheenvironment. 3.9 inoculationdevice deviceforaddingmicroorganismstoaproces
28、s. 3.10 leakage egressfromequipment. 3.11 leaktightness abilityofcomponentofequipmentorunitofequipmenttolimitegress. 3.12 microorganism anymicrobiologicalentity,cellularornoncellular,capableofreplicationoroftransferring geneticmaterialEN1619. NOTEForthepurposesofthisstandard,thetermmicroorganismcove
29、rsthetermof biologicalagent,accordingtotheDirective90/679/EEC:microorganisms,including thosewhichhavebeengeneticallymodified,cellculturesandhumanendoparasites whichmaybeabletoprovokeanyinfection,allergyortoxicity. 3.13 processmicroorganism microorganismusedforproductionpurposesinabiotechnologicalpro
30、cessorconstituting (partof)theproductitself. 3.14 risk combinationoftheprobabilityandthedegreeofthepossibleinjuryordamagetohealthina hazardoussituationEN1070.Page7 EN133121:2001 3.15 samplingdevice devicefortakingsamplesfromcomponentofequipmentand/orunitofequipment. 3.16 soil anyunwantedmatter(inclu
31、dingproductresidues,microorganisms,dustanddebris) ISO/DIS14159:1999. 3.17 sterile stateofbeingfreefromviablemicroorganisms. NOTE1Inpracticenosuchabsolutestatementregardingtheabsenceofviable microorganismscanbeproven.However,sterileconditionscanberegardedas establishedbyusinganacceptedorrecognizedmet
32、hodofsterilization. NOTE2Theprocessofinactivationofviablemicroorganismsduringasterilization procedureisusuallydescribedbyanempiricalmathematicalfunction,commonlyan exponentialfunction.Bytheirmathematicalnature,suchfunctionscanbereducedto verylownumbers,butnottozero.However,theseempiricalfunctionscan
33、beapplied tocontrolorassesstheprocessparametersofasterilizationproceduretorealizea desireddegreeofinactivationofviablemicroorganisms. 3.18 sterilizability abilityofcomponentsofequipment,unitsofequipmentorprocessplantstobemadesterile. 3.19 sterilization processusedtoreachasterilestate. 3.20 sterilizi
34、ngInPlace(SIP) sterilizationwithoutopeningordismantlingofcomponentsofequipmentand/orunitof equipment.Page8 EN133121:2001 3.21 targetmicroorganism processmicroorganismand/orothermicroorganismsrelevantforaspecificprocess. NOTEForsafetytestingprocedures,nonpathogenicmicroorganismsshouldbe usedwhereposs
35、ible. 3.22 valve componentofequipmentusedforisolatingorcontrollingphasesinaplantoraunitof equipment,consistingofabody,closingmechanismandsealingmechanism. 4 Hazards Typicalhazardsandexamplesofcausesandmeasuresforspecificequipmentaregivenin theotherPartsofthisEuropeanStandard.Thehazardsidentifiedcanb
36、eusedasaninput fortheriskanalysisasdescribedinEN12460. 5 Performanceclasses 5.1 General Theequipmentshallbeclassifiedforthefollowingperformancecriteria withregardtothe containeduseofmicroorganisms: leaktightness; cleanability; sterilizability. Theperformanceoftheequipmentshallbedeterminedseparatelyf
37、oreachofthesecriteria inaccordancewithtables1,2and3. NOTEEquipmentcanforexamplebeinclassSIAforsterilizability,butinclassLIC forleaktightness. 5.2 Leaktightness Theperformanceclassesforleaktightnessoftheequipmentaregivenintable1.Page9 EN133121:2001 Table1Leaktightnessperformance Performanceclassforle
38、aktightness LeaktightnessIndex(LI) Descriptionofperformanceclass LIA leakageoftargetmicroorganismnot defined LIB Leakage a oftargetmicroorganismdetected andquantifiedunderdefinedconditions LIC Leakage a oftargetmicroorganismtested underdefinedconditionsandleakage belowprescribedthresholdvalue b a Ba
39、sedonleakageassessmentbyBATNEEC(BestAvailableTechniquesNotEntailingExcessiveCosts) * b Prescribedthresholdvalueshouldbebasedontherequiredsafetyleveland canforexamplebethe detectionlimitofanapprovedBATNEEC *UseofBATNEECdoesnotmeanthatfinancialissuesmoderatethedegreeofsafety.Whereseveral methodsareava
40、ilable,theusercanchoosethemostconvenient,providedthatitgivesresultsofthe necessaryquality . 5.3 Cleanability Theperformanceclassesforcleanabilityoftheequipmentaregivenintable2. Table2Cleanabilityperformance Performanceclassforcleanability CleanabilityIndex(CI) Descriptionofperformanceclass CIA visib
41、lesoilorcleanlinessnotdefined CIB Cleanability a testedandquantifiedunder definedconditionsordesignedwithregard tospecifiedtechnicalcriteria CIC Cleanability a testedanquantifiedunder definedconditionsandsoilbelowdetection limit/thresholdvalue b a BasedonassessmentbyBATNEEC(BestAvailableTechniquesNo
42、tEntailingExcessiveCosts)* b Prescribedthresholdvalueshouldbebasedontherequiredsafetyleveland canforexamplebethe detectionlimitofanapprovedBATNEEC *UseofBATNEECdoesnotmeanthatfinancialissuesmoderatethedegreeofsafety.Whereseveral methodsareavailable,theusercanchoosethemostconvenient,providedthatitgiv
43、esresultsofthe necessaryquality . Cleanabilityappliesasaperformancecriterionfortheequipmentwhere: depositsofsoilintheequipmentcouldjeopardizethesterilizationprocedureif thesterilizationmediadonotreachallpartsoftheequipmentoriftherequired temperatureisnotreached;Page10 EN133121:2001 cleaningprocedure
44、sareintendedtoremoveandinactivatemicroorganismsto maketheequipmentsafeforhandlingwithoutusinganyothersterilizationor inactivationprocedure. 5.4 Sterilizability Theperformanceclassesforsterilizabilityoftheequipmentaregivenintable3. Table3Sterilizablityperformance Performanceclassforsterilizability SterilizabilityIndex(SI) Descriptionofperformanceclass SIA equipmentnotsuitableornottestedfor
