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
