1、BRITISH STANDARD BS EN 13311-3:2001 Biotechnology Performance criteria for vessels Part 3: Glass pressure vessels The European Standard EN 13311-3:2001 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 13311-3:2001 This Britis
2、h 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 37397 5 National foreword This British Standard is the official English l
3、anguage version of EN 13311-3:2001. 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 Sta
4、ndards 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 Stand
5、ard 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 the res
6、ponsible 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, the EN t
7、itle page, pages 2 to 9 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 EN133113 March2001 ICS07.080;07.100.01 Englishversion Biot
8、echnologyPerformancecriteriaforvesselsPart3:Glass pressurevessels BiotechnologieCritresdeperformancedesrcipients Partie3:Rcipientssouspressionenverre BiotechnikLeistungskriterienfrBehlterTeil3: DruckbehlterausGlas ThisEuropeanStandardwasapprovedbyCENon4February2001. CENmembersareboundtocomplywiththe
9、CEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexis
10、tsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Fi
11、nland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitati
12、oninanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN133113:2001EPage2 EN133113:2001 Contents Page Foreword 3 Introduction 4 1 Scope. 4 2 Normativereferences. 4 3 Termsanddefinitions 4 4 Hazards . 5 5 Performanceclasses 5 6 Classificationandverificationofperformance 6 7 Markinga
13、ndpackaging 6 8 Documentation . 6 AnnexA(informative)Guidanceontestmethodsfordeterminingleaktightnessof glasspressurevessels . 7 AnnexB(informative)Informationonglasspressurevessels. 8 Bibliography. 9Page3 EN133113:2001 Foreword ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233 “Biote
14、chnology“,thesecretariatofwhichisheldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbySeptember2001,and conflictingnationalstandardsshallbewithdrawnatthelatestbySeptember2001. ThisEuropeanStandardhasbeenpreparedun
15、deramandategiventoCENbythe EuropeanCommissionandtheEuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forvessels.Thesestandardsare: EN133111, BiotechnologyPerformancecriteriaforvesselsPart1:Generalperformance criteria. EN133112, BiotechnologyP
16、erformancecriteriaforvesselsPart2:Pressureprotection devices. EN133113, BiotechnologyPerformancecriteriaforvesselsPart3:Glasspressure vessels. EN133114, BiotechnologyPerformancecriteriaforvesselsPart4:Bioreactors. EN133115, BiotechnologyPerformancecriteriaforvesselsPart5:Killtanks. EN133116, Biotech
17、nologyPerformancecriteriaforvesselsPart6:Chromatography columns. AnnexesAandBareinformative. Thisstandardincludesabibliography. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic
18、Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom.Page4 EN133113:2001 Introduction Glasspressurevesselsareusedinawidevarietyofbiotechnologicalprocesses,andvary considerablyinscaleandfunction.Glasspressure
19、vesselsusedinbiotechnologycan includeforexamplefermentersandfeedvessels,reactionvessels,centrifugetubesand buckets,chromatographycolumns,samplingbottles,rotaryevaporators,jacketed homogenizers/celldisruptersandvesselsusedincryogenicprocedures. Themechanicalsafetyofpressurevesselswhichcanincludeglass
20、vesselsisdescribedin EN1595(see2)orforexampleanationalpressurevesselcode(see1). UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationof glasspressurevesselswithregardtosafeperformanceinbiotechnologicalprocesses.The classificationiseasilyunderstandableandreadilyutilizablefortheu
21、serandtheregulatory authorities. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforglasspressurevesselsusedin biotechnologicalprocesseswithrespecttothepotentialhazardstotheworkerandthe environmentfrommicroorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseofglasspressurevesselsin
22、cludes hazardousorpotentiallyhazardousmicroorganismsusedinbiotechnologicalprocessesor whereexposureoftheworkerortheenvironmenttosuchmicroorganismsisrestrictedfor reasonsofsafety. ThisEuropeanStandardalsoappliestopressurevesselsusedinbiotechnologicalprocesses thataremadeofotherbrittlematerialssuchasa
23、crylatepolymersorporcelain. ThisEuropeanStandarddoesnotapplytosmallglasspartswhichformanintegralpartof equipmentsuchassightglasses. ThisEuropeanStandardshouldbeusedinconjunctionwithotherrelevantstandardswhen substantialpartsofglassorfromotherbrittlematerialsarepresent. 2 Normativereferences ThisEuro
24、peanStandardincorporatesbydatedorundatedreference,provisionsfromother publications.Thesenormativereferencesarecitedattheappropriateplacesinthetextand thepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen inc
25、orporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationreferredtoapplies(includingamendments). EN133111:2001, BiotechnologyPerformancecriteriaforvesselsPart1:General performancecriteria. 3 Termsanddefinitions Forthepurposesofthisstandard,thetermsanddefinitionsgivenin
26、EN133111:2001apply.Page5 EN133113:2001 4 Hazards Thefollowinghazardsshallbetakenintoaccount. a)Releaseofmicroorganismscausedby: 1)accidentalbreakage; 2)leakagefromthevesselconnectionsduringoperation; 3)explosionorimplosionleadingtoreleaseofvesselcontent; 4)vesselsweakenedduetohairlinefracturescaused
27、byknocksandfurtheraffected duringtemperaturecyclingthatoccursforexampleduringsterilization.Whenthe vesselisthenputunderpressureduringroutineoperation,weaknessesinthe structurecanleadtorupturewithtotalreleaseofcontents; 5)flyingglassintheeventofanexplosion; NOTE1Microbialhazardislikelytobesecondaryto
28、thehazardposedbyflyingglass intheeventofanexplosion. 6)breakagecausedbyovertighteningorlooseninguponrepetitiveheatingorusage whenmakingconnectionstoglassvessels. NOTE2Glasstoglassconnectionsrepresentahigherriskduetomechanicaland thermalstrain. b)Infectionscausedbycutstoworkersfromcontaminatedglassfo
29、llowingbreakageor explosion. NOTE3Contaminatedglassmayallowdirectentryofmicroorganismsintothebody throughcuts. RecommendationsforproperdesignandhandlingaregiveninannexB. 5 Performanceclasses Theglasspressurevesselsshallbeclassifiedforleaktightness,cleanabilityandsterilizability inaccordancewith5.1to
30、5.4ofEN133111:2001. NOTEForglasspressurevesselsleaktightnessusuallyreferstotheleaktightnessof connections,suchasrubberorsiliconepiping,ortheleaktightnessofthesealing gaskets,forexample,betweenthetopplateofafermenter,andtheglassvessel. Theselectionoftheappropriateclassforperformanceofaglasspressureve
31、sselshallbe madeinaccordancewith5.5ofEN133111:2001.Page6 EN133113:2001 6 Classificationandverificationofperformance 6.1 General Theglasspressurevesselsshallconformtothegeneralrequirementsgivenin6.1of EN133111:2001. 6.2 Leaktightness Theglasspressurevesselsshallconformtotherequirementsgivenin6.2ofEN1
32、3311 1:2001. Guidanceontestmethodsfordeterminingleaktightnessofglasspressurevesselsisgivenin annexA.Aleaktightnesstestshouldbeperformedontheassembledcomponents.Vessels showinganysignofdamageshouldbecarefullyexaminedbeforeuse. 6.3 Cleanability Theglasspressurevesselsshallconformtotherequirementsgiven
33、in6.3ofEN13311 1:2001. NOTEGlassvesselscanbepolishedtogiveseveralgradesoffinish.Firepolished glassisoftenusedwhereahighqualityoffinish,givinggoodcleanability,isrequired. 6.4 Sterilizability Theglasspressurevesselsshallconformtotherequirementsgivenin6.4ofEN13311 1:2001.Anyglassvesselshowingvisiblesig
34、nsofdamageshallbecarefullyexamined beforeuse.Alternatively,ifadamagedvesselisrepaired,itshallbereclassified. NOTEGlasspressurevesselscanbesterilizedbyautoclaving,orbysterilizingin place(SIP).Autoclavingisoftencarriedoutonsmallerpiecesofequipment,butcare shouldbetakentoavoidknockingordamagingthevesse
35、lwhentransportingtoor fromthevessel. 7 Markingandpackaging Theglasspressurevesselsshallconformtotherequirementsgiveninclause7of EN133111:2001. 8 Documentation Theglasspressurevesselsshallconformtotherequirementsgiveninclause8of EN133111:2001.Page7 EN133113:2001 AnnexA (informative) Guidanceontestmet
36、hodsfordeterminingleaktightnessofglasspressurevessels AlistoftestmethodsforleaktightnessisgivenintableA.1ofEN12298(see3).Fromthat listsuitabletestmethodstothetestingofglasspressurevesselsaregivenintableA.1. TableA.1Suitablealternativeleaktightnesstestmethodsforglasspressurevessels Number Testmethod
37、1 Pressurelossgas/air 2 Pressurelossliquid 3 Heliumprobe 4S F 6 ,e.g.Freon a probe 5 Thermalconductivity 6 Ultrasonics 8 Tracerliquiddyes 11 Electronicparticlecounting 12 Traceraerosol(NaCl) 14 Qualitativebioaerosolmonitoring 15 Quantitativebioaerosolmonitoring 16 Surfaceswabbing 17 Surfaceconductiv
38、ity 19 Bacteriatightness NOTERestrictiveuseofSF 6shouldbeconsideredduetoenvironment protection a Freonisanexampleofasuitableproductavailablecommercially.This informationisgivenfortheconvenienceoftheuserofthisStandardand doesnotconstituteanendorsementofCENoftheseproducts.Page8 EN133113:2001 AnnexB (i
39、nformative) Informationonglasspressurevessels B.1 Protectivesheathing Glasspressurevesselsaregenerallycoveredwithprotectivesheathing,iftherisk assessmentindicatesanexplosionorimplosionhazard.Inthecaseoffermentervessels, thismaybeametalcasing,orthevesselmaybeenclosedinaprotectiveperspexcabinet. Simil
40、arly,protectivescreeningmaybeplacedbetweenthevesselandtheoperator. B.2 Pressurereliefdevices Pressurereliefdevicesshouldbefittedtoglasspressurevessels,whichcanapproachtheir nominalpressureduringoperation.Theseprotectiondevicesshouldbedesignedtooperate atapredeterminedthresholdvalue. B.3 Designpressu
41、rerelatedtovesseldiameter Thedesignpressureofglassvesselsdecreaseswithincreasingdiameter.Forlarger vessels,thedesignpressurewillbequitelow.Airsupplytoglassfermentersshouldbe regulatedtothatitdoesnotexceedapredeterminedthresholdvalue. B.4 Autoclavingversussterilizinginplace Autoclavingofglassvesselsi
42、softenlessstressfulthansterilizinginplace,asthereisa lowerpressureandtemperaturedifferentialacrosstheglass.However,theactionofplacing thevesselintotheautoclavecanincreasetheriskofdamageduetoknockingthevessel, andalsonecessitatestheremovalofconnectiontubingtoservices,suchasairlines.Thisin turnincreas
43、esthelikelihoodofreleaseduetoincorrectreconnectionofvesselsfollowing sterilization. B.5 Connections Supplylinestoandfromglassvesselsshouldbesecurelyattachedusingappropriate connections.Whenuniversalconnectionsareusedthereisariskfromovertightening, leadingtocrackingorchippingoftheconnectionport.Thisi
44、nturnincreasesthechanceof releasewhenthevesselisunderpressure. B.6 Pressurebuildupduetoclogging Inlinefiltersonoffgaslinesfromglassfermentersarepronetocloggingduetowettingfrom foam.Thiscanleadtoapressurebuildup,resultingintheconnectionstothevesselblowing off,thepressurereliefvalvereleasingmicroorganisms, orthevesselbursting. B.7
