BS EN 13311-5-2001 Biotechnology - Performance criteria for vessels - Kill tanks《生物技术 容器的性能标准 杀灭罐》.pdf

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1、BRITISH STANDARD BS EN 13311-5:2001 Biotechnology Performance criteria for vessels Part 5: Kill tanks The European Standard EN 13311-5:2001 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 13311-5:2001 This British Standard,

2、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 37398 3 National foreword This British Standard is the official English language vers

3、ion of EN 13311-5:2001. 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 The British Standards which

4、 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 Standard does not

5、 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 the responsible Eur

6、opean 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, p

7、ages 2 to 11 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 EN133115 March2001 ICS07.080;07.100.01 Englishversion BiotechnologyPe

8、rformancecriteriaforvesselsPart5:Kill tanks BiotechnologieCritresdeperformancedesrcipients Partie5:Cuvesdedcontamination BiotechnikLeistungskriterienfrBehlterTeil5: Abttungsbehlter ThisEuropeanStandardwasapprovedbyCENon4February2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhi

9、chstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English

10、,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Icel

11、and,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved

12、worldwideforCENnationalMembers. Ref.No.EN133115:2001EPage2 EN133115:2001 Contents Page Foreword 3 Introduction 4 1 Scope . 4 2 Normativereferences 4 3 Termsanddefinitions. 4 4 Hazards 4 5 Performanceclasses 5 6 Typesofkilltanks . 5 7 Classificationandverificationofperformance. 6 8 Markingandpackagin

13、g 7 9 Documentation 7 AnnexA(informative)Guidanceontestmethodsfordeterminingleaktightness ofkilltanks . 8 AnnexB(informative)Examplesofkilltanksystems . 9 AnnexC(informative)Guidanceonmaterials,designandmanufacture. 10 Bibliography. 11Page3 EN133115:2001 Foreword ThisEuropeanStandardhasbeenpreparedb

14、yTechnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichisheldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbySeptember2001,and conflictingnationalstandardsshallbewithdrawnatthelatestbySeptember2001. Th

15、isEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommissionandtheEuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forvessels.Thesestandardsare: EN133111, BiotechnologyPerformancecriteriaforvesselsPart1:Generalperformance

16、 criteria. EN133112, BiotechnologyPerformancecriteriaforvesselsPart2:Pressureprotection devices. EN133113, BiotechnologyPerformancecriteriaforvesselsPart3:Glasspressure vessels. EN133114, BiotechnologyPerformancecriteriaforvesselsPart4:Bioreactors. EN133115, BiotechnologyPerformancecriteriaforvessel

17、sPart5:Killtanks. EN133116, BiotechnologyPerformancecriteriaforvesselsPart6:Chromatography columns. AnnexesA,BandCareinformative. Thisstandardincludesabibliography. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanSt

18、andard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom.Page4 EN133115:2001 Introduction Killtanksareusedtoinactivatemicroorganismsinliquidsorslurriesbysubjectingthemto stea

19、m,heat,chemicalsorradiation.Killtanksarepartoftheclosedsystembutcanbeused aswellfortreatmentofwastewaterfromforexamplesewersandshowers.Killtankscanbe continuousorbatchoperatedsystems.ExamplesofkilltanksystemsaregiveninannexB. Killtanksareusedtoinactivateprocessmicroorganismspriortoreleasefromtheclos

20、ed systemortofurtherdownstreamprocessinginuncontainedconditions. UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationofkill tankswithregardtosafeperformanceinbiotechnologicalprocesses.Theclassificationis easilyunderstandableandreadilyutilizablefortheuserandtheregulatoryauthori

21、ties. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforkilltanksusedinbiotechnological processeswithrespecttothepotentialhazardstotheworkerandtheenvironmentfrom microorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseofkilltanksincludeshazardousor potentiallyhazardousmicroorgani

22、smsusedinbiotechnologicalprocessesorwhereexposure oftheworkerortheenvironmenttosuchmicroorganismsisrestrictedforreasonsofsafety. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreferences,provisionsfromother publications.Thesenormativereferencesarecitedattheappropriateplacesint

23、hetext,and thepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationreferredtoapplies(includingamendments). EN133111:20

24、01 BiotechnologyPerformancecriteriaforvesselsPart1:General performancecriteria 3 Termsanddefinitions Forthepurposesofthisstandard,thetermsanddefinitionsgiveninEN133111:2001apply. 4 Hazards Thefollowinghazardsshallbetakenintoaccount. a) Releaseofmicroorganismsbyleakagebeforeorduringoperation. b) Rele

25、aseofmicroorganismsbyexhaustgases. c) Releaseofmicroorganismscausedbyinsufficientinactivationwhentheloadofthekill tankisdischargedorfurtherprocessedorwhenthekilltankisopenedordismantled.Page5 EN133115:2001 5 Performanceclasses Thekilltanksshallbeclassifiedforleaktightness,cleanabilityandsterilizabil

26、ityin accordancewith5.1to5.4ofEN133111:2001. Theselectionoftheappropriateclassforperformanceofakilltankshallbemadein accordancewith5.5ofEN133111:2001. 6 Typesofkilltanks 6.1 TypeIkilltank AkilltankmeetingthefollowingrequirementsshallbeclassifiedastypeI: a) thekilltankshallbecapableofbringingitsloadt

27、otimeandtemperatureconditionsor otherconditionsknowntodestroyorinactivatealltargetmicroorganismsintheload; and b) thekilltankshallhaveasaminimumtheperformanceratinggivenintable1. 6.2 TypeIIkilltank AkilltankmeetingthefollowingrequirementsshallbeclassifiedastypeII: a) thekilltankshallbecapableofbring

28、ingitsloadtotimeandtemperatureconditionsor otherconditionsknowntodestroyorinactivatealltargetmicroorganismsintheload; b) thekilltankshallhaveasaminimumtheperformanceratinggivenintable1;and c) thekilltankshallhaveadditionalcontainmentfeatureswhichpreventreleaseofliving microorganismstotheenvironmentb

29、eforeorduringtheoperatingcycle. NOTE1Releaseofmicroorganismscanoccurbytheexhaustairescapingfromthe killtankwhileoperatingtemperatureandpressurearebeingreached,orwhenconden sateforexamplefromexhaustfiltersisreleasedduringoraftertheoperatingcycle. NOTE2Appropriatemeasurestopreventlossofcontainmentcani

30、ncludeprovisionof filtersabletodecontaminateexhaustair,anddischargeofcondensatetophysical containedequipmentsuchasvesselscontaininginactivatingliquids.Page6 EN133115:2001 Table1MinimumperformanceratingfortypeIandtypeIIkilltanks Performance criterion c TypeIkilltank TypeIIkilltank Killtank Auxiliary

31、equipment a Killtank Auxiliary equipment a Leaktightness LIA LIA LIC LIC Cleanability CIB b CIA b CIB b CIB b Sterilizability SIB SIA SIC SIC a Allpartsandcomponentsbeyondtheactualsiteofinactivation,forexamplepipingandvalves. b Residualsoilshouldnotnegativelyaffectsterilizability.Ingeneralthiswillre

32、quireCIBfor cleanabilitybutalsoCIAisacceptableifitisvalidatedthattheresidualsoildoesnotaffectthe sterilizationresults. c PerformanceindiceslikeLIAetc.areexplainedinPart1ofthisstandard. NOTE3ItisuptocompetentauthoritiestodecidewhetheraprocessrequiresatypeI oftypeIIkilltank.However,itmaybeadvisabletou

33、seatypeIIkilltankwhen microorganismsof,forexample,group3orgroup4asdescribedintheCouncil Directive90/679/EEC(see1)areusedintheprocess.Formicroorganismsfallingin group2,ariskanalysiscanindicatetheappropriatetypeofkilltank. 7 Classificationandverificationofperformance 7.1 General Thekilltankshallconfor

34、mtothegeneralrequirementsgivenin6.1ofEN133111:2001. Ifthecomponentsareclassified,theusingofanindirecttestingtotheassembledkilltankis sufficientforclassification. Ifthekilltankismadebyassemblyofcomponents,itshallbetestedtoverifyitsoverall classification. NOTEEN12460providesguidanceonselectionandinsta

35、llationofequipment relevanttokilltanks. Guidanceonmaterials,designandmanufactureisgiveninannexC. 7.2 Leaktightness Thekilltankshallconformtotherequirementsgivenin6.2ofEN133111:2001. Ifthekilltankcontainsmicroorganismsforwhichthereleaseshallbeminimized,risk analysisshallindicatewhethertheoffgashastob

36、etreated. Ifthekilltankcontainsmicroorganismsforwhichthereleaseshallbeprevented,theoffgas shallbetreated. GuidanceontestmethodsfordeterminingleaktightnessofkilltanksisgiveninannexA.Page7 EN133115:2001 7.3 Cleanability Thekilltankshallconformtotherequirementsgivenin6.3ofEN133111:2001. 7.4 Sterilizabi

37、lity Thekilltankshallconformtotherequirementsgivenin6.4ofEN133111:2001. 8 Markingandpackaging Thekilltanksshallconformtotherequirementsgivenin clause7ofEN133111:2001. 9 Documentation Thekilltanksshallconformtotherequirementsgivenin clause8ofEN133111:2001.Page8 EN133115:2001 AnnexA (informative) Guid

38、anceontestmethodsfordeterminingleaktightnessofkilltanks AlistoftestmethodsforleaktightnessisgivenintableA.1ofEN12298(see8).Fromthat listsuitabletestmethodstothetestingofkilltanksaregivenintableA.1. TableA.1Suitablealternativeleaktightnesstestmethodsforkilltanks Number Testmethod 1 Pressurelossgas/ai

39、r 2 Pressurelossliquid 3 Heliumprobe 4S F 6 ,e.g.Freon a probe 5 Thermalconductivity 6 Ultrasonics 8 Tracerliquiddyes 10 Bubbleformation(onlyqualitative) 11 Electronicparticlecounting 12 Traceraerosol(NaCl) 13 Productaerosol(nonmicrobial) 14 Qualitativebioaerosolmonitoring 15 Quantitativebioaerosolm

40、onitoring 16 Surfaceswabbing 17 Surfaceconductivity 18 Visualinspection(onlyqualitative) 19 Bacteriatightness NOTERestrictiveuseofSF 6shouldbeconsideredduetoenvironment protection a Freonisanexampleofasuitableproductavailablecommercially.This informationisgivenfortheconvenienceoftheuserofthisStandar

41、dand doesnotconstituteanendorsementofCENoftheseproducts.Page9 EN133115:2001 AnnexB (informative) Examplesofkilltanksystems B.1 Batchoperatedsystems Thesimplestsystemisabatchwiseoperatedagitatedtank,inwhichtheliquidsorslurriesto beinactivatedarecollected.Duetothetypicalresidencetimedistributiontheexa

42、cttimeof applicationofphysicalandchemicalparameterscanbeguaranteed.Inanagitatedtankall partsaresubjectedtoanapplicationofphysicaland/orchemicalparametersduringsimilar treatmenttime.Thisiscontrarytononagitatedsystemswherepoorlytreatedzonescan occur.Thereforetheadequatetreatmentcanbebetterdefinedinagi

43、tatedtanks. Forapplicationtocontinuouslyproducedwastestreamstwokilltankscanbecombinedtoa systemwherealwaysonekilltankrunsininactivationmodeandtheotherincollecting mode. Theadvantageisalsothatdischargingofatankloadcanbedoneafterexplicitdecision aboutcorrectinactivation. B.2 Continuousoperatedsystems Continuouslyoperatingsystemsconsistofacollectingtankandsomeheatexchangersor mixingdevicesandaholdingpipe.Theresidencetimedistributioninsuchasystemshould beascloseaspossibletoanidealplugflowsystem. Theadvantageofthosesystemsisashorterapplicationtimeusinghighertemperatureor chemicalconcent