BS EN 13311-1-2001 Biotechnology - Performance criteria for vessels - General performance criteria《生物技术 容器的性能标准 一般性能标准》.pdf

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

2、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 May 2001 BSI 05-2001 ISBN 0 580 37396 7 National foreword This British Standard is the official Eng

3、lish language version of EN 13311-1:2001. 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 secretary. Cross-references The Briti

4、sh 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. A British

5、 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; present to t

6、he 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 cover, th

7、e 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 EN133111 March2001 ICS07.080;07.100.01 Englishversi

8、on BiotechnologyPerformancecriteriaforvesselsPart1: Generalperformancecriteria BiotechnologieCritresdeperformancedesrcipients Partie1:Critresgnrauxdeperformance BiotechnikLeistungskriterienfrBehlterTeil1: AllgemeineLeistungskriterien ThisEuropeanStandardwasapprovedbyCENon4February2001. CENmembersare

9、boundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. This

10、EuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Czec

11、hRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN A

12、llrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN133111:2001EPage2 EN133111:2001 Contents Page Foreword 3 Introduction 4 1 Scope. 4 2 Normativereferences. 4 3 Termsanddefinitions 5 4 Hazards . 8 5 Performanceclasses 8 6 Classificationandverificationofperf

13、ormance 11 7 Markingandpackaging 12 8 Documentation . 12 Bibliography. 13Page3 EN133111:2001 Foreword ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichisheldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherby publication

14、ofanidenticaltextorbyendorsement,atthelatestbySeptember2001,and conflictingnationalstandardsshallbewithdrawnatthelatestbySeptember2001. ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommissionandtheEuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsc

15、oncernedwithperformancecriteria forvessels.Thesestandardsare: EN133111, BiotechnologyPerformancecriteriaforvesselsPart1:Generalperformance criteria. EN133112, BiotechnologyPerformancecriteriaforvesselsPart2:Pressureprotection devices. EN133113, BiotechnologyPerformancecriteriaforvesselsPart3:Glasspr

16、essure vessels. EN133114, BiotechnologyPerformancecriteriaforvesselsPart4:Bioreactors. EN133115, BiotechnologyPerformancecriteriaforvesselsPart5:Killtanks. EN133116 BiotechnologyPerformancecriteriaforvesselsPart6:Chromatography columns. Thisstandardincludesabibliography. AccordingtotheCEN/CENELECInt

17、ernalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom.Page4 EN13

18、3111:2001 Introduction UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationof pressureprotectiondevices,glasspressurevessels,bioreactors,killtanksand chromatographycolumnswithregardtosafeperformanceinbiotechnologicalprocesses. Theclassificationiseasilyunderstandableandreadilyu

19、tilizablefortheuserandthe regulatoryauthorities. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforvesselsusedinbiotechnological processeswithrespecttothepotentialhazardstotheworkerandtheenvironmentfrom microorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseoftheequipmentinclude

20、s hazardousorpotentiallyhazardousmicroorganismsusedinbiotechnologicalprocessesor whereexposureoftheworkerortheenvironmenttosuchmicroorganismsisrestrictedfor reasonsofsafety. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromother publications.Thesenormativ

21、ereferencesarecitedattheappropriateplacesinthetextand thepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationreferred

22、toapplies(includingamendments). EN16722, FoodprocessingmachineryBasicconceptsPart2:Hygienerequirements. EN12296, BiotechnologyEquipmentGuidanceontestingproceduresforcleanability. EN12297, BiotechnologyEquipmentGuidanceontestingproceduresforsterilizability. EN12298, BiotechnologyEquipmentGuidanceonte

23、stingproceduresforleaktightness. ENISO4287, GeometricalProductSpecifications(GPS)Surfacetexture:Profilemethod Terms,definitionsandsurfacetextureparameters(ISO4287:1997). ENISO4288, GeometricalProductSpecifications(GPS)Surfacetexture:Profilemethod Rulesandproceduresfortheassessmentofsurfacetexture(IS

24、O4288:1996).Page5 EN133111:2001 3 Termsanddefinitions Forthepurposesofthisstandard,thefollowingtermsanddefinitionsapply. 3.1 arithmeticalmeandeviationoftheprofile( R a ) arithmeticalmeanoftheabsolutevaluesoftheprofiledepartureswithinthesamplinglength ENISO4287 3.2 bioreactor vessel,togetherwithauxil

25、iarycomponentsofequipment,usedforthecontrolledcultivation ofmicroorganisms NOTEForbiosafetypurposes,auxiliarycomponentsofequipmentsuchasvalves, pipes,sensorsandstirrersarerestrictedtothosewhichcancomeincontactwiththe targetmicroorganism.Feedvesselsanddosingpumpsarepartofthebioreactorif theyarecouple

26、dtothebioreactorduringthecultivationprocess. 3.3 burstingdisc discdesignedtowithstandaspecifiedpressurebeyondwhichitwillburstinordertorelease pressurefromthesystem 3.4 clean conditionof(a)product,surface,device,gasesand/orliquidswithresidualsoilbelowa definedthresholdlevel 3.5 cleanability abilityto

27、bemadeclean 3.6 closedsystem systemwhereabarrierseparatesmicroorganismsororganismsfromtheenvironmentEN 1620 3.7 glasspressurevessel vesselconstructedcompletelyorprimarilyfromglass,whichmaybesubjectedtopressures of50kPa(0,5bar)ormore,aboveorbelowatmosphericpressureduringnormaloperation NOTEAglasspres

28、surevesselintheintentionofthisstandardisalsoconstructed completelyfromglassifsomepartsliketopcoverand/orbottomand/orconnecting devicesaremadefromdifferentmaterial.Astainlesssteelvesselcontainingaglass windowisnotaglasspressurevesselintheintentionofthisstandard.Page6 EN133111:2001 3.8 hazard intrinsi

29、cpropertyorabilityofsomething(e.g.anyagent,equipment,materialorprocess)to causeharmEN1620 NOTEHarmisaninjuryordamagetohealthofpeopleand/ortotheenvironment. 3.9 inactivation destructionofmicroorganisms 3.10 killtank vesselusedtoinactivateatargetmicroorganism NOTEKilltankscanbecontinuousorbatchoperate

30、dsystems. 3.11 leakage egressfromequipment 3.12 leaktightness abilityofcomponentofequipmentorunitofequipmenttolimitegress 3.13 microorganism anymicrobiologicalentity,cellularornoncellular,capableofreplicationoroftransferring geneticmaterialEN1619 NOTEForthepurposesofthisstandard,thetermmicroorganism

31、coverstheterm biologicalagent,accordingtotheDirective90/679/EEC:microorganisms,including thosewhichhavebeengeneticallymodified,cellculturesandhumanendoparasites whichmaybeabletoprovokeanyinfection,allergyortoxicity. 3.14 pressureprotectiondevice deviceusedtopreventvesselsfrombeingsubjectedtopressure

32、sbeyondthenominal pressure 3.15 pressurereliefvalve valvethatopensatasetthresholdpressurePage7 EN133111:2001 3.16 processmicroorganism microorganismusedforproductionpurposesinabiotechnologicalprocessorconstituting (partof)theproductitself 3.17 residualsoil soilleftaftercleaning 3.18 risk combination

33、oftheprobabilityandthedegreeofthepossibleinjuryordamagetohealthina hazardoussituationEN1070 3.19 samplingdevice devicefortakingsamplesfromcomponentofequipmentand/orunitofequipment 3.20 soil anyunwantedmatter(includingproductresidues,microorganisms,dustanddebris) ISO/DIS14159 3.21 sterile stateofbein

34、gfreefromviablemicroorganisms NOTE1Inpracticenosuchabsolutestatementregardingtheabsenceofviable microorganismscanbeproven.However,sterileconditionscanberegardedas establishedbyusinganacceptedorrecognizedmethodofsterilization. NOTE2Theprocessofinactivationofviablemicroorganismsduringasterilization pr

35、ocedureisusuallydescribedbyanempiricalmathematicalfunction,commonlyan exponentialfunction.Bytheirmathematicalnature,suchfunctionscanbereducedto verylownumbers,butnottozero.However,theseempiricalfunctionscanbeapplied tocontrolorassesstheprocessparametersofasterilizationproceduretorealizea desireddegr

36、eeofinactivationofviablemicroorganisms. 3.22 sterilizability abilityofcomponentsofequipment,unitsofequipmentorprocessplantstobemadesterile 3.23 sterilization processusedtoreachasterilestatePage8 EN133111:2001 3.24 sterilizinginplace(SIP) sterilizationwithoutopeningordismantlingofcomponentsofequipmen

37、tand/orunitof equipment 3.25 targetmicroorganism processmicroorganismand/orothermicroorganismsrelevantforaspecificprocess NOTEForsafetytestingprocedures,nonpathogenicmicroorganismsshouldbeused wherepossible. 3.26 user manufacturerresponsibleforthebiotechnologicalprocesswhousesequipmentand materialsa

38、sinput 4 Hazards Typicalhazardsandexamplesofcausesandmeasuresforspecificequipmentaregivenin theotherPartsofthisEuropeanStandard. NOTEThehazardsidentifiedcanbeusedasaninputfortheriskanalysisas describedinEN12460(see7). 5 Performanceclasses 5.1 General Theequipmentshallbeclassifiedforthefollowingperfo

39、rmancecriteriawithregardtothe containeduseofmicroorganisms: leaktightness; cleanability; sterilizability. Theperformanceoftheequipmentshallbedeterminedseparatelyforeachofthesecriteria inaccordancewithtables1,2and3. NOTEEquipmentcanforexamplebeinclassSIAforsterilizability,butinclassLIC forleaktightne

40、ss. 5.2 Leaktightness Theperformanceclassesforleaktightnessoftheequipmentaregivenintable1.Page9 EN133111:2001 Table1Leaktightnessperformance Performanceclassforleaktightness LeaktightnessIndex(LI) Descriptionofperformanceclass LIA leakageoftargetmicroorganismnot defined LIB leakage a oftargetmicroor

41、ganismdetected andquantifiedunderdefinedconditions LIC leakage a oftargetmicroorganismtested underdefinedconditionsandleakage belowdetectionlimitorthresholdvalue b a BasedonleakageassessmentbyBATNEEC(BestAvailableTechniquesNotEntailingExcessiveCosts) * b Prescribedthresholdvalueshouldbebasedonthereq

42、uiredsafetylevelandcanforexamplebethe detectionlimitofanapprovedBATNEEC UseofBATNEECdoesnotmeanthatfinancialissuesmoderatethedegreeofsafety.Whereseveral methodsareavailable,theusercanchoosethemostconvenient,providedthatitgivesresultsofthe necessaryquality. 5.3 Cleanability Theperformanceclassesforcl

43、eanabilityoftheequipmentaregivenintable2. Table2Cleanabilityperformance Performanceclassforcleanability CleanabilityIndex(CI) Descriptionofperformanceclass CIA visiblesoilorcleanlinessnotdefined CIB cleanability a testedandquantifiedunder definedconditionsordesignedwithregard tospecifiedtechnicalcri

44、teria CIC cleanability a testedandquantifiedunder definedconditionsandsoilbelowdetection limitorthresholdvalue b a BasedonassessmentbyBATNEEC(BestAvailableTechniquesNotEntailingExcessiveCosts) * b Prescribedthresholdvalueshouldbebasedontherequiredsafetylevelandcanforexamplebethe detectionlimitofanapprovedBATNEEC UseofBATNEECdoesnotmeanthatfinancialissuesmoderatethedegreeofsafety.