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
38、is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions British Standards are updated by amendment or revision. Users of British Standards should make s
39、ure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee respon
40、sible, the identity of which can be found on the inside front cover. Tel: 020 8996 9000. Fax: 020 8996 7400. BSI offers members an individual updating service called PLUS which ensures that subscribers automatically receive the latest editions of standards. Buying standards Orders for all BSI, inter
41、national and foreign standards publications should be addressed to Customer Services. Tel: 020 8996 9001. Fax: 020 8996 7001. Standards are also available from the BSI website at http:/www.bsi-. In response to orders for international standards, it is BSI policy to supply the BSI implementation of t
42、hose that have been published as British Standards, unless otherwise requested. Information on standards BSI provides a wide range of information on national, European and international standards through its Library and its Technical Help to Exporters Service. Various BSI electronic information serv
43、ices are also available which give details on all its products and services. Contact the Information Centre. Tel: 020 8996 7111. Fax: 020 8996 7048. Subscribing members of BSI are kept up to date with standards developments and receive substantial discounts on the purchase price of standards. For de
44、tails of these and other benefits contact Membership Administration. Tel: 020 8996 7002. Fax: 020 8996 7001. Further information about BSI is available on the BSI website at http:/www.bsi-. Copyright Copyright subsists in all BSI publications. BSI also holds the copyright, in the UK, of the publicat
45、ions of the international standardization bodies. Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, photocopying, recording or otherwise without prior written permission from BSI. This does not preclude the free use, in the course of implementing the standard, of necessary details such as sy