BS EN 13312-3-2001 Biotechnology - Performance criteria for piping and instrumentation - Sampling and inoculation devices《生物技术 管道和仪表性能标准 取样和接种装置》.pdf

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1、BRITISH STANDARD BS EN 13312-3:2001 Biotechnology Performance criteria for piping and instrumentation Part 3: Sampling and inoculation devices The European Standard EN 13312-3:2001 has the status of a British Standard ICS 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COP

2、YRIGHT LAWBS EN 13312-3:2001 This British 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 April 2001 BSI 04-2001 ISBN 0 580 37458 0 National foreword This

3、British Standard is the official English language version of EN 13312-3:2001. 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 s

4、ecretary. Cross-references The British Standards 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 Stand

5、ards Electronic Catalogue. A British Standard 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

6、to understand the text; present to the responsible 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 fr

7、ont cover, an inside front cover, the EN title page, pages 2 to 17 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 EN133123 Februa

8、ry2001 ICS07.080;07.100.01 Englishversion BiotechnologyPerformancecriteriaforpipingand instrumentationPart3:Samplingandinoculationdevices BiotechnologieCritresdeperformancepourtuyauteries etinstrumentationPartie3:Dispositifsdchantillonnage etdinoculation BiotechnikLeistungskriterienfrLeitungssysteme

9、und InstrumentierungTeil3:Probenahmeund Beimpfungsvorrichtungen ThisEuropeanStandardwasapprovedbyCENon13January2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelists

10、andbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandn

11、otifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEF

12、ORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN133123:2001EPage2 EN133123:2001 Contents Page Foreword. 3 Introduction 4 1Sc

13、ope .4 2Normativereferences 4 3Termsanddefinitions . 4 4Hazards 5 5Performanceclasses. 5 6Classificationandverificationofperformance. 5 7Markingandpackaging. 5 8Documentation 5 AnnexA(informative)Guidanceondesignforsamplingandinoculation devices6 AnnexB(informative)Examplesofsamplingandinoculationde

14、vices 9 Bibliography . 17Page3 EN133123:2001 Foreword ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC233 “Biotechnology“,thesecretariatofwhichisheldbyAFNOR. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherby publicationofanidenticaltextorbyendorsement,atthelatestbyAu

15、gust2001,and conflictingnationalstandardsshallbewithdrawnatthelatestbyAugust2001. ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbythe EuropeanCommissionandtheEuropeanFreeTradeAssociation. ThisstandardisoneofaseriesofEuropeanStandardsconcernedwithperformancecriteria forpipingandinstrument

16、ation.Thesestandardsare: EN133121, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart1: Generalperformancecriteria. EN133122, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart2: Couplings. EN133123, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart3: Sampling

17、andinoculationdevices. EN133124, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart4: Tubesandpipes. EN133125, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart5: Valves. EN133126, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart6: Equipmentprobes. Thisstand

18、ardincludesaBibliography. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizations ofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,S

19、pain,Sweden,SwitzerlandandtheUnited Kingdom.Page4 EN133123:2001 Introduction Samplingandinoculationdevicesareusedtoremovematerialfromoraddmaterialtothe closedsystem.Inordertoperformasafeoperationthedeviceshouldperforminsuchaway asnottobreachthecontainmentoftheclosedsystem. NOTERecommendationsforsafe

20、operationwithandmaintenanceofsamplingand inoculationdevicesaregiveninEN13092(see1). UseofthisEuropeanStandardwillaidtheequipmentmanufacturerintheclassificationof samplingandinoculationdeviceswithregardtosafeperformanceinbiotechnological processes.Theclassificationiseasilyunderstandableandreadilyutil

21、izablefortheuserand theregulatoryauthorities. 1 Scope ThisEuropeanStandardspecifiesperformancecriteriaforsamplingandinoculationdevices usedinbiotechnologicalprocesseswithrespecttothepotentialhazardstotheworkerand theenvironmentfrommicroorganismsinuse. ThisEuropeanStandardapplieswheretheintendeduseof

22、thesamplingandinoculation deviceincludeshazardousorpotentiallyhazardousmicroorganismsusedin biotechnologicalprocessesorwhereexposureoftheworkerortheenvironmenttosuch microorganismsisrestrictedforreasonsofsafety. Wherethedeviceisincludedasanintegralpartofotherunitsofequipmentorcomponents ofequipment,

23、themanufacturerofthatequipmenthastheresponsibilitytointerpretthe appropriatesafetystandard(relativetothatequipment)asinclusiveofacompletedevice. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfromother publications.Thesenormativereferencesarecitedattheappro

24、priateplacesinthetextand thepublicationsarelistedhereafter.Fordatedreferences,subsequentamendmentstoor revisionsofanyofthesepublicationsapplytothisEuropeanStandardonlywhen incorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationreferredtoapplies(includingamendments

25、). EN133121:2001, BiotechnologyPerformancecriteriaforpipingandinstrumentationPart 1:Generalperformancecriteria. 3 Termsanddefinitions Forthepurposesofthisstandard,thetermsanddefinitionsgiveninEN133121:2001 apply.Page5 EN133123:2001 4 Hazards Thefollowinghazardsshallbetakenintoaccount. a)Releaseofmic

26、roorganismscausedbyexhaustgasesorliquidcondensate. b)Releaseofmicroorganismscausedbyaccidents. c)Releaseofmicroorganismscausedbyexposuretoprocessfluidswhenbreachingthe containmentoftheclosedsystemduringsamplingorinoculation. d)Releaseofmicroorganismscausedbybreakageorburstingofsamplingorinoculum con

27、tainers. NOTEAdditionalinformationonhazardsaccompanyingtheusageofsamplingand inoculationdevicesisgiveninBibliography1. 5 Performanceclasses Thesamplingandinoculationdevicesshallbeclassifiedforleaktightness,cleanabilityand sterilizabilityinaccordancewith5.1to5.4ofEN133121:2001. Theselectionoftheappro

28、priateclassforperformanceofasamplingorinoculationdevice shallbemadeinaccordancewith5.5ofEN133121:2001. 6 Classificationandverificationofperformance Thesamplingorinoculationdeviceshallconformtothegeneralrequirementsgivenin clause6ofEN133121:2001. 7 Markingandpackaging Thesamplingandinoculationsdevice

29、sshallconformtotherequirementsgivenin clause7 ofEN133121:2001. 8 Documentation Thesamplingandinoculationdeviceshallconformtotherequirementsgivenin clause8of EN133121:2001.Page6 EN133123:2001 AnnexA(informative) Guidanceondesignforsamplingandinoculationdevices A.1 Devicesforusewherereleaseofmicroorga

30、nismsisnotlimited Thisclauseconcernsworkwithmicroorganismsthatareregardedaslikelytoposenorisk oranegligiblerisktopeopleand/ortheenvironment(forexamplegroup1ofDirective 90/679/EEC;see2).Hence,forworkwiththesemicroorganismsanytypeofsampling devicecanbeused,rangingfromaladletoasamplingintoareceptacle,a

31、nexampleof whichisshowninfigureB.1.Propercleaningofthepartsthatareincontactwith microorganismsofthesamplingdeviceisrecommendedforobtainingrepresentative samplesbutthisisbeyondthescopeofthisstandard.Consequently,norequirementsare necessarywithregardtobiosafety.Thesameassessmentgoesforinoculationdevic

32、es. A.2 Devicesforusewherereleaseofmicroorganismsshouldbeminimized Thisclauseconcernsworkwithmicroorganismsthatareregardedasposingno(ora negligible)riskoralow risk(forexamplegroup1andgroup2ofDirective90/679/EEC;see 2)topeopleand/ortheenvironment.Forworkwiththesemicroorganismssamplingshould beperform

33、edeitherbyspecialsamplingprobes,anexampleofwhichisshowninfigureB.2, orbypipesortubeswithaspecialcombinationofvalvesandcouplings,anexampleof whichisshowninfigureB.3andinfiguresB.7.1andB.7.2.Othertypesofsamplingdevices areacceptableifacomparablesafetylevelisobtained,e.g.samplingfromanexternalloop ofav

34、esselviaabarrierformicroorganisms(forexampleusedwithonlineanalytical equipment)orviaaseptumthatcanbepiercedbyasyringe.Inthelatterexamplethe receptacleshouldformacontainmentofthesample,theperforatedseptumshouldbe closedaftersamplingandtheoutersurfaceshouldbedisinfectedproperlyaftersampling. Thedesign

35、ofthesamplingdevicesoffiguresB.2,B.3,B.7.1andB.7.2representtwo possibilitiesofalargevarietyofdesigns.Thedesignofthesamplingdeviceshouldensure tolimitegressofmicroorganismstotheenvironmentinallmodesofoperation,despitethe egressintoasamplingreceptacle.Thesamplingreceptacleshouldformacontainmentof thes

36、ample. NOTE Forexample,pouringthesampleintoastandardbeakerisnotanacceptable samplingdeviceforgroup2microorganismsaccordingtoDirective90/679/EEC(see 2). Onepossibilityoutofalargevarietyofdesignsforsamplingreceptaclesisshowninfigure B.4.Thesamplingreceptacleshouldbeclosedduringtransportationandshouldb

37、e protectedagainstdamagessuchasbreaking.Beforeremovingordismantlingofthe samplingreceptacleorthesamplingpipesorthesamplingprobe,thepartsofthesampling devicethatareincontactwithmicroorganismsandthatarenotseparatedfromtheprocess (e.g.inthebioreactor)byabarrier(e.g.byavalve)shouldbeinactivatede.g.byste

38、amor bydisinfectionifappropriate. Releaseofmicroorganismsintotheenvironmentshouldbealsolimitedwhenusing inoculationdevices.Hence,theinoculationdeviceshouldbeclosedduringtransportation andshouldbeprotectedagainstdamagessuchasbreaking.Connectionofaninoculation devicetoaclosedsystem(e.g.toabioreactor)c

39、anbeperformedbypipesortubeswitha specialcombinationofvalves(analogoustotheaboveexpositionsforsamplingdevices)orPage7 EN133123:2001 byothermeans,e.g.viaaseptumthatcanbepiercedbyasyringe.Inthelatterexamplethe syringecanberetainedandfixedattheseptumoritcanberemovedaftertheinoculation procedure.Anapprop

40、riatemethodshouldbeestablishedfordisinfectionandinactivationof microorganisms.Thismethodshouldtobeusedifnecessaryforexamplewhenasyringeis pulledoutoftheinoculationportandnotimmediatelyputbyasleevetocoverthespotsin contactwithmicroorganismsuptoinactivatione.g.inanautoclave. FigureB.5andB.6showtwoexam

41、plesoutofalargevarietyofdesignsforinoculation devices,oneusingtubes,valvesandcouplingsandtheotherusingtheseptumandsyringe technique.Othertypesofinoculationdevicesareacceptableifacomparablesafetylevelis obtained.Theinoculationprocedureisnotaconcernwithrespecttothescopeofthis EuropeanStandard.Properha

42、ndlingandmethodologyforsamplingandinoculationare describedinBibliography1. A.3 Devicesforusewherereleaseofmicroorganismsshouldbeprevented Thisclauseconcernsworkwithmicroorganismsthatareregardedasposingmediumor highrisk(forexamplegroup3andgroup4ofDirective90/679/EEC;see2)topeople and/ortheenvironment

43、.Forworkwiththesemicroorganismssamplingshouldbeperformed eitherbyspecialsamplingprobesorbypipesortubeswithaspecialcombinationofvalves, examplesofwhichareshowninfiguresB.7.1andB.7.2.Othertypesofsamplingdevices areacceptableifacomparablesafetylevelisobtained,e.g.samplingfromanexternalloop ofavesselviaabarrierformicroorganisms. Samplingdevicesusedforworkwiththesemicroorganismsshouldallowasecureand permanentclosureofthesamplingdeviceincaseofmalfunctionofthesamplingdevice itselforofassociatedequipmente.g.forsterilizationorforreceptionofthesample. The