BS EN 13311-6-2001 Biotechnology - Performance criteria for vessels - Chromatography columns《生物技术 容器的性能标准 色谱柱》.pdf

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1、BRITISH STANDARD BS EN 13311-6:2001 Biotechnology Performance criteria for vessels Part 6: Chromatography columns The European Standard EN 13311-6:2001 has the status of a British Standard ICS 07.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 13311-6:2001 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 37601 X National foreword This British Standard is the official English l

3、anguage version of EN 13311-6:2001. 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 St

4、andards which implement these international or European publications 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 purport t

5、o 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 European comm

6、ittee 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, pages 2 to

7、8, an inside back cover 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 EN133116 March2001 ICS07.080;07.100.01 Englishversion Biot

8、echnologyPerformancecriteriaforvesselsPart6: Chromatographycolumns BiotechnologieCritresdeperformancedesrcipients Partie6:Colonnesdechromatographie BiotechnikLeistungskriterienfrBehlterTeil6: Chromatographiesulen ThisEuropeanStandardwasapprovedbyCENon4February2001. CENmembersareboundtocomplywiththeC

9、EN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexist

10、sinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Fin

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

12、ninanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN133116:2001EPage2 EN133116:2001 Contents Page Foreword 3 Introduction 4 1 Scope. 4 2 Normativereferences. 4 3 Termsanddefinitions 4 4 Hazards . 4 5 Performanceclasses 5 6 Classificationandverificationofperformance 6 7 Markingan

13、dpackaging 6 8 Documentation . 6 AnnexA(informative)Guidanceontestmethodsfordeterminingleaktightnessof chromatographycolumns. 7 Bibliography. 8Page3 EN133116:2001 Foreword ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichisheldbyAFNOR. ThisEuropea

14、nStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbySeptember2001,and conflictingnationalstandardsshallbewithdrawnatthelatestbySeptember2001. ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommissionandtheEurope

15、anFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forvessels.Thesestandardsare: EN133111, BiotechnologyPerformancecriteriaforvesselsPart1:Generalperformance criteria. EN133112, BiotechnologyPerformancecriteriaforvesselsPart2:Pressureprotection devi

16、ces. EN133113, BiotechnologyPerformancecriteriaforvesselsPart3:Glasspressure vessels. EN133114, BiotechnologyPerformancecriteriaforvesselsPart4:Bioreactors. EN133115, BiotechnologyPerformancecriteriaforvesselsPart5:Killtanks. EN133116, BiotechnologyPerformancecriteriaforvesselsPart6:Chromatography c

17、olumns. AnnexAisinformative. Thisstandardincludesabibliography. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Lu

18、xembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom.Page4 EN133116:2001 Introduction Chromatographycolumnsarecontainersfilledwithastationaryphasecalled chromatographymedium,usedforaseparationofcomponentsfromthefeedstream.They areusedinawidevarietyofbiotechnologicalproce

19、sses,andvaryconsiderablyinscaleand function.Materialsusedforfillingchromatographycolumnsarechromatographymediasuch asdextrane,agarose,coatedglassandpolymerbeadswhereaschromatographycolumn walls,topandbottomplatesmaybemadeofglass,stainlesssteel,polymersor combinationshereof. UseofthisEuropeanStandard

20、willaidtheequipmentmanufacturerintheclassificationof chromatographycolumnswithregardtosafeperformanceinbiotechnologicalprocesses. Theclassificationiseasilyunderstandableandreadilyutilizablefortheuserandthe regulatoryauthorities. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforchromatograp

21、hycolumnsusedin biotechnologicalprocesseswithrespecttothepotentialhazardstotheworkerandthe environmentfrommicroorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseofchromatographycolumns includeshazardousorpotentiallyhazardousmicroorganismsusedinbiotechnological processesorwhereexposureoft

22、heworkerortheenvironmenttosuchmicroorganismsis restrictedforreasonsofsafety. Whensubstantialpartsofthechromatographycolumnaremadeofglassorfromother materials,thisstandardshouldbeusedinconjunctionwithotherrelevantstandards. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreferen

23、ceprovisionsfromother publications.Thesenormativereferencesarecitedattheappropriateplacesinthetextand thepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoor revisionofanyofthesepublicationsapplytothisEuropeanStandardonlywhenincorporated initbyamendmentorrevision.Forundatedrefe

24、rencesthelatesteditionofthepublication referredtoapplies(includingamendments). EN133111:2001, BiotechnologyPerformancecriteriaforvesselsPart1:General performancecriteria. 3 Termsanddefinitions Forthepurposesofthisstandard,thetermsanddefinitionsgiveninEN133111:2001apply. 4 Hazards Thefollowinghazards

25、shallbetakenintoaccount.Page5 EN133116:2001 Releaseofmicroorganismscausedbyimproperconnectionofbottomplatesand/or adaptertothecolumnhousewall. Releaseofmicroorganismscausedbydissolutionofjointsorsealingsresultingfromthe useofaggressivechemicalsorsolvents. Releaseofmicroorganismscausedbyruptureoftheh

26、ousingresultingfromswellingof thechromatographymedium. 5 Performanceclasses 5.1 General Thechromatographycolumnsshallbeclassifiedforleaktightness,cleanabilityand sterilizabilityinaccordancewith5.1ofEN133111:2001. 5.2 Leaktightness FortheuseofthisEuropeanStandard,5.2ofEN133111:2001applies. NOTEForchr

27、omatographycolumnsleaktightnessreferstotheleaktightnessofthe housing,itsconnections,suchasrubberorsiliconepiping,andtheleaktightnessofthe sealinggaskets. 5.3 Cleanability FortheuseofthisEuropeanStandard,5.3ofEN133111:2001applies. NOTEForchromatographycolumnscleanabilityreferstothehousing,itsconnecti

28、ons andsealinggasketsandtothesanitationofthechromatographymedia. 5.4 Sterilizability FortheuseofthisEuropeanStandard,5.4ofEN133111:2001applies. NOTE1Forchromatographycolumnssterilizabilityreferstothehousing,its connectionsandsealinggasketsandthechromatographymedia. NOTE2Sterilizationofchromatography

29、columnscontainingchromatographymediais usuallycarriedoutwithchemicals. 5.5 Useofperformanceclassesinequipmentselection Theselectionoftheappropriateclassforperformanceofachromatographycolumnshallbe madeinaccordancewith5.5ofEN133111:2001.Page6 EN133116:2001 6 Classificationandverificationofperformance

30、 Thechromatographycolumnshallconformtothegeneralrequirementsgiveninclause6of EN133111:2001. NOTELeaktightnessoftheadaptorsealcangenerallybedetectedbyvisual examination. Guidanceontestmethodsfordeterminingleaktightnessofchromatographycolumnsis giveninannexA. 7 Markingandpackaging Thechromatographycol

31、umnshallconformtotherequirementsgiveninclause7of EN133111:2001applies. 8 Documentation Thechromatographycolumnshallconformtotherequirementsgiveninclause8of EN133111:2001applies.Page7 EN133116:2001 AnnexA (informative) Guidanceontestmethodsfordeterminingleaktightnessofchromatographycolumns Alistoftes

32、tmethodsforleaktightnessisgivenintableA.1ofEN12298(see1).Fromthat listsuitabletestmethodstothetestingofchromatographycolumnsaregivenintableA.1. TableA.1Suitablealternativeleaktightnesstestmethodsforchromatography columns Number Testmethod 1 Pressurelossgas/air 2 Pressurelossliquid 3 Heliumprobe 4S F

33、 6 ,e.g.Freon a probe 5 Thermalconductivity 6 Ultrasonics 8 Tracerliquiddyes 11 Electronicparticlecounting 12 Traceraerosol(NaCl) 14 Qualitativebioaerosolmonitoring 15 Quantitativebioaerosolmonitoring 16 Surfaceswabbing 17 Surfaceconductivity 19 Bacteriatightness NOTERestrictiveuseofSF 6shouldbecons

34、ideredduetoenvironment protection a Freonisanexampleofasuitableproductavailablecommercially.This informationisgivenfortheconvenienceoftheuserofthisStandardand doesnotconstituteanendorsementofCENoftheseproducts.Page8 EN133116:2001 Bibliography 1 EN12298:1998, BiotechnologyEquipmentGuidanceontestingpr

35、oceduresfor leaktightness. 2 Druckbehlterverordnung,In:Bundesgesetzblatt1,(1989),Nr.20,S.843869. Bundersanzeigerverlag. 3 TechnicalNote211:“SanitizationofBioProcessGlassColumnswithSodium Hydroxide“,PharmaciaBiotech1993. 4 Sofer&Nystrm:“ProcessChromatography,APracticalGuide“,1989,p93105, AcademicPres

36、s,London(containingfurtherreferences). 5 P.Meyerin“BioprocessEngineering,Systems,EquipmentandFacilities“,ed. Lydersenetal.,1994,p191214(generalconsiderationsonvessels,surfacefinish etc.). 6 P.W.Thomsonin“BioprocessEngineering,Systems,EquipmentandFacilities“, ed.Lydersenetal.,1994,p473497(cleaning).

37、7 T.Oakleyin“BioprocessEngineering,Systems,EquipmentandFacilities“,ed. Lydersenetal.,1994,p500521(sterilization). 8 Brunhowetal.,“Cleaningandcleaningvalidation“,ABiotechnologyPerspective, PDA,1996.blankBS EN 13311-6:2001 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI

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