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
