Process Plant andEquipment工藝廠房及設(shè)備Information sheetRiboflavin testforlow-germorsterileprocesstechnologiesFluorescence testforexaminationofcleanabilityForfood,aseptic,pharmacyandchemistry信息表核黃素低細(xì)菌或無(wú)菌工藝技術(shù)的試驗(yàn)熒光測(cè)試是對(duì)食品，無(wú)菌，制藥和化學(xué)清潔能力的 檢驗(yàn)Edition December 2007版2007年12月Contents1.Introduction............................................................................................................32.Scope...........................................................................................................................333.Terms,definitions......................................................................................................334.Aimofthefluorescencetest....................................................................................45.Installation,equipment,specificationsandcarryingoutthetest.......................55.1Generalnotesandpointstobeobserved..............................................................55.2Testbuild-up................................................................................................................55.3Testequipmentandspecifications............................................................................55.3.1Testsolution............................................................................................................55.3.2Waterusedtopreparethetestsolution................................................................65.3.3Cleaningwater........................................................................................................65.3.4Darkening65.3.5Inspectionlamp(UVlamp)....................................................................................65.3.6Surfacestobeexamined....................................................................................65.3.7Pre-cleaning.........................................................................................................65.3.8Adjustmentofcomponents...............................................................................65.3.9Sprayballs/nozzlesandfittings.......................................................................665.3.10Pressureandflowratemeasurement.........................................................65.3.11Cleaningprocedure........................................................................................65.4Carryingoutthetest...........................................................................................76.Evaluationofthefluorescencetest....................................................................77.Documentationofthefluorescencetest..............................................................87.1Documentationoffluorescencetestbeforecarryingoutthetest..................87.2Documentationoffluorescencetestduringcarryingoutthetest...................87.3Documentationofthefluorescencetestaftercarryingoutthetest................88.Annex..........................................................................................................................998.1Ingredientsandrecipesoftestsolutions..........................................................98.2Schematicsketchofaninstallationforcarryingoutafluorescencetest....101..323334.45...............................................55.1.........................................................2....................................................................7..65.3.865.3.9/65.3.10...............................................................................5.476............................................................................................77........................................................................................87.1...................................................87.2...................................................87.3...............................................8898.1.....................................................98.2......................................10Thispublicationhasbeenpreparedbythe"RiboflavinTest"WorkingPartyoftheSterileProcessEngineeringGroupofVDMA.Itisavailableasadownloadablefileunder/verfahrenstechnik.Suggestionsforimprovementsandadditionscanbesenttotheaddressbelow.本刊物由VDMA無(wú)菌工藝工程部編寫的“核黃素測(cè)試”工作。這是作為一個(gè)可下載的文件根據(jù)/verfahrenstechnik。為改進(jìn)和補(bǔ)充的建議，可發(fā)送到下面的地址。VDMAVerfahrenstechnischeMaschinenundApparateLyonerStr.1860528FrankfurtamMainTelephone+49696603-1432Fax+49696603-1421E-mailvtma@Internet:/verfahrenstechnikVDMA的verfahrenstechnische>公司>UNDApparatelyonerSTR。1860528法蘭克福上午主要電話：+49696603-1432傳真：+49696603-1421電子郵箱 vtma@ 的互聯(lián)網(wǎng)：/ verfahrenstechnik1. IntroductionTestsforexaminationofcleanabilityplayamajorroleinsterileprocesstechnology.Avarietyoftestsareappliedinpractice,dependingontherespectiveusecase,suitabilityorrequirements.Thisinformationsheetdoesnotspecifyfurtherdetailsinthisrespect.Thedescribedfluorescencetestisfirstandforemostsuitableforthecomponentsnamedinthescope,asfarasthesecanbeexaminedbymeansofvisualinspection.Thisbeingthecase,thefluorescencetestisnotintendedtoreplaceotherwell-establishedtests,butrathertosupplementavailablepossibilitiesinthissector.清潔度的檢查測(cè)試，在無(wú)菌工藝技術(shù)發(fā)揮的重要作用。各種測(cè)試在實(shí)踐中應(yīng)用，根據(jù)各自的使用情況， 是否適合或要求。 此信息表沒(méi)有指定在這方面的進(jìn)一步細(xì)節(jié)。首先是所描述的熒光測(cè)試適合范圍命名的組件， 因?yàn)檫@些都可以通過(guò)目測(cè)檢查。在這種情況下，熒光測(cè)試的目的不是取代其他行之有效測(cè)試，而是為了補(bǔ)充在這一領(lǐng)域的可能性。Theobjectiveofthisinformationsheetistoprovidemanufacturers,suppliersanduserswithadocumentthatcansimplifytheaccord,planning,carryingoutanddocumentationofafluorescencetest.Indoingso,theinformationsheetsummarizesdifferenttestscommonlyusedinpracticeaswellascomprehensiveexperiencegatheredwiththeseteststoprovideapossiblecoarseofaction.Mannersofprocedureoraccordsthatdeviateinpartorcompletelyare,however,expresslypossible.這個(gè)資料片的目的是提供制造商，供應(yīng)商和用戶文檔，可以簡(jiǎn)化協(xié)議，規(guī)劃，展了熒光測(cè)試文件。 這樣做，信息表總結(jié)了在實(shí)踐中常用的測(cè)試以及全面積累的經(jīng)驗(yàn)，這些測(cè)試提供了可能采取的行動(dòng)的指導(dǎo)。 禮儀程序或協(xié)議偏離或完全是符合明確可能。

開(kāi)2. ScopeThescopeofthisinformationsheetcoverscomponents,apparatuses,machineryandplants(alsoreferredtointhisinformationsheetas‘components’)forlow-germorsterileprocesstechnologieswithhighorhighestrequirementsregardingcleanability,asfarastheseareaccessibleforvisualinspection.Thesecomponentsareusedinthefood,asepticprocessing,pharmaceuticalandchemicalssector,e.g.vessels,reactors,filterequipment,pumps,agitators,centrifuges,pasteurizers,fillingsystemsetc.includingfittingsandperipheralequipment.本資料報(bào)表的范圍涵蓋元件，儀器，機(jī)械和植物（也稱為在此為“組件”的資料片）低細(xì)菌或無(wú)菌工藝技術(shù)關(guān)于清潔度高或最高的要求，盡可能目測(cè)訪問(wèn)。這些元件可用于食品，無(wú)菌加工，制藥和化工行業(yè)，如船舶，電抗器，過(guò)濾設(shè)備，泵，攪拌器，離心機(jī)，巴氏滅菌，灌裝等在內(nèi)的系統(tǒng)配件和外圍設(shè)備。Noteonuse:Thisinformationsheetgivesadvicestotheuser.Itis,however,incumbentupontheuseroftheinformationsheettoverifyorconsiderrequirements,thecurrentvaliditythereofandnecessarymeasuresconcerningtheuser’sconcreteusecase.Thisconcernsinparticularalllaws,ordinances,directivesetc.thatcouldberelevantfortherespectivecaseofuse.使用注意事項(xiàng)：這個(gè)資料片提供給用戶的意見(jiàn)。但是，用戶有責(zé)任驗(yàn)證或考慮信息手冊(cè)關(guān)要求，當(dāng)前的有效性及其必要措施根據(jù)用戶的具體使用情況。特別是這涉及的所有法律，法令，指令等，可能與各自的使用情況有關(guān)。Terms,definitions術(shù)語(yǔ)，定義oFluorescencetestTestusingafluorescentsubstanceforexaminationofcleanabilityofcomponents熒光測(cè)試一個(gè)元件清潔度的檢查，測(cè)試使用熒光物質(zhì)oCleanabilityCompleteremovalofthetestsolutionbythecleaningmediumunderapplicationoftheselectedconditionswithregardtothecleaningelements,cleaningprocessorthedesignofthecomponent。清潔能力由選定的條件下，應(yīng)用清洗介質(zhì)清洗元素方面，清潔的過(guò)程或組件的設(shè)計(jì)徹底清除的測(cè)試解決方案oCleanabilitytestTestforcompletecleanabilityundertheconditionsselectedforthefluorescencetest清潔度測(cè)試熒光測(cè)試選定的條件下完成的清潔能力測(cè)試oWeakpointtestTestforlocalizingcriticalpoints;Usuallyparametervaluesofthecleaningprocedureareusedwhichdeviatefromthoseofthecleanabilitytest(reducedpressureorthroughputofthecleaningmediumordurationofcleaningprocess)薄弱點(diǎn)測(cè)試測(cè)試定位關(guān)鍵點(diǎn);用一般的清洗程序的參數(shù)值偏離清潔度測(cè)試（減少壓力或清洗劑用量或清洗過(guò)程中的時(shí)間）oOptimizationtestStepwiseoptimizationandtestingofthesuitabilityofnewparametervaluesthroughseparate,newcleanabilitytests優(yōu)化測(cè)試逐步優(yōu)化和測(cè)試新的參數(shù)值的適用性，通過(guò)獨(dú)立的，新的清潔度測(cè)試oTestsolutionSolutionforcarryingoutthefluorescencetest測(cè)試解決方案開(kāi)展熒光測(cè)試解決方案oCIPcleaningCleaningofcomponentsinassembledcondition(CleaningInPlace)在裝配條件的清潔元件（就地清洗）oCleaningwaterWaterforcleaningthecomponentbeingexamined清潔水水清洗被檢查的組件oFullydemineralisedwaterFullydesalinatedwater;alsoreferredtoAquapurificata(AP)orPurifiedWater?全軟化水完全淡化水;到，也稱為水族 purificata（AP）或純凈水oWFIwaterWaterForInjectionoCriticalpointsPointsthataredifficulttocleanandcanbecleanedcompletely關(guān)鍵點(diǎn)，是難以清潔和可徹底清洗oNon-criticalpointsPointsthatareeasytocleanandcanbecleanedcompletely非關(guān)鍵點(diǎn)易清洗，可完全清除oNon-cleanablepointsPointsthatcannotbecleanedcompletely非清洗的點(diǎn)不能徹底清洗點(diǎn)oCleaningelementElementfortargetedapplicationofcleaningliquidtothecomponenttobeexamined;Examplesofcleaningelements:sprayball,rotatingjetcleaner,cleaningnozzle,spraylance清潔元素有針對(duì)性的清洗液進(jìn)行審查的組件應(yīng)用;清潔元素的例子：噴球，旋噴清潔劑，清洗噴嘴，噴槍的元素oSurfacestobeexaminedAreasofthecomponentbeingexaminedthataretobeaccountedforinthefluorescencetest表面進(jìn)行檢查正在檢查的組件區(qū)域要需要熒光測(cè)試oSurfacestobewettedSurfacestobeexaminedonwhichthetestsolutionistobeapplied表面浸濕表面檢查要應(yīng)用測(cè)試方案oCarryingoutthetestApplicationandremovalofthetestsolutionaswellasthesubsequentinspectionforremainingfluorescence○開(kāi)展的測(cè)試測(cè)試解決方案的應(yīng)用和清除以及隨后的檢查剩余的熒光oWorkplacelimitvalue1Limitforthetime-dependentaverageconcentrationofasubstanceintheairattheworkplace,inrelationtoagivenreferenceperiod.工作場(chǎng)所限制值時(shí)間依賴的平均濃度在空氣中的一種物質(zhì)，在工作場(chǎng)所關(guān)系到一個(gè)給定的參考期間，限額。4.Aimofthefluorescence test熒光測(cè)試的目的Thefluorescencetestdescribedinthisinformationsheetisfortheexaminationofcleanability.Thisiscarriedoutbytheexaminationofthebasicaccessibilityto,aswellasthecompletewettingofallareasinwhichaverificationofcleanabilitythroughthecleaningmediumisrequired.此信息表中描述的熒光檢測(cè)的清潔度檢查。這是開(kāi)展基本無(wú)障礙，以及在核查通過(guò)清洗介質(zhì)的清潔度要求的所有領(lǐng)域的完全潤(rùn)濕檢測(cè)。Thecleanabilitytestisaimedtoverifycompletecleanability;theresultofthetestisaqualitativestatement.Inadditiontothis,thestep-by-steporrepeatedcarryingoutofthefluorescencetestalsoenablesqualitativestatementsorexaminationofmeasuresforimprovingoroptimizingthecleaningprocess.Table1specifiesthegoalsthatcanbeachievedwiththefluorescencetest:清潔度測(cè)試旨在驗(yàn)證完整的清潔能力測(cè)試的結(jié)果是一個(gè)定性的陳述。除了這個(gè)，一步一步或重復(fù)運(yùn)載熒光試驗(yàn)也使定性陳述或檢查措施，改善或優(yōu)化清洗過(guò)程。表1指定與熒光測(cè)試，可以實(shí)現(xiàn)的目標(biāo)：Fluorescencetest: Aimofthetest: Criterionofqualityafterthetest:Weakpointtest Localizingcriticalpoints;providedasoptionalpreliminarystagetothecleanabilitytest.Cleanabilitytest Verificationoffullcleanability.Optimizationtest Stepwiseoptimization andcheckingofsuitabilityofnewparametervaluesthroughseparate,newcleanabilitytests.

Visiblefluorescence2atcriticalpoints(acc.definitioninClause3);thesearetobeconfirmedthroughacleanabilitytest.Novisiblefluorescence2Novisiblefluorescence2.Improvedparametervalues(e.g.reducedwaterconsumption,shortercleaningtime)熒光測(cè)試測(cè)試的目的試驗(yàn)后的質(zhì)量標(biāo)準(zhǔn)薄弱點(diǎn)測(cè)試局部的關(guān)鍵點(diǎn);-可見(jiàn)熒光2關(guān)鍵點(diǎn)（根據(jù)第3條的定提供選擇性的初步階段的清潔度測(cè)義），這些都是要通過(guò)清潔度測(cè)試證實(shí)。試。清潔度測(cè)試驗(yàn)證全面清潔度無(wú)肉眼可見(jiàn)的熒光優(yōu)化試驗(yàn)新參數(shù)的適用性的逐步優(yōu)化和檢查-無(wú)可見(jiàn)熒光通過(guò)獨(dú)立的，新的清潔度測(cè)試值。-改進(jìn)的參數(shù)值（例如，減少水的消耗，縮短清洗時(shí)間）Table1:Achievablegoalsusingfluorescencetestacc.toinformationsheet表1：使用熒光試驗(yàn)累計(jì)實(shí)現(xiàn)的目標(biāo)。 資料報(bào)表5.Instatallation, equipment, specifications andcarrying outthetest5.1General notes andpoints tobeobserved5。安裝，設(shè)備，技術(shù)規(guī)格和開(kāi)展測(cè)試5.1一般注意事項(xiàng)和觀察點(diǎn)Regulationsanddirectivesrelatingtooccupationalhealthandsafetymustalwaysbeobservedwhencarryingoutthetest.Furthermore,specialreferenceismadetothefollowing:有關(guān)職業(yè)健康和安全的法規(guī)和指令必須始終進(jìn)行測(cè)試時(shí) 遵守的。此外，特別提到了以下內(nèi)容：oTestingpersonnel:Nospecificrequirementsareplacedwithregardtotheeducationoftestingpersonnel.Testingpersonnelshould,however,besuitablyandtrainedtocarryingoutthetestorguidedbyin-houseworkinstructions.測(cè)試人員：放置與測(cè)試人員的教育方面沒(méi)有具體要求。然而，檢驗(yàn)人員應(yīng)當(dāng)有適當(dāng)?shù)呐嘤?xùn)，開(kāi)展試驗(yàn)或由內(nèi)部工作指示為指導(dǎo)。oUVlamp:TheuseofaUVlampcancausedamagetoeyesthroughpenetratingUVrays.ItisthereforenecessarytowearsafetygogglesandtoobserveanyadditionalprotectionmeasuresspecifiedbythemanufactureroftheUVlamp.?紫外燈：紫外燈的使用可能會(huì)導(dǎo)致通過(guò)穿透性紫外線對(duì)眼睛的傷害。 因此，必須佩戴護(hù)目鏡，并觀察紫外燈制造商所指定的任何額外的保護(hù)措施。oOccupationalsafety:AstheUVlampisalwaysusedinamoistenvironmentpersonalfuseprotectionoftheelectricalsupplyshouldbeprovided,e.g.usingisolatingtransformers3.IfitisnecessarytolightupavesselwithaUVlampwhencarryingoutthetestandtoenteravessel,thisprecautionarymeasureisstronglyadvised.?職業(yè)安全：由于紫外線燈總是在潮濕的環(huán)境下供電的個(gè)人保險(xiǎn)絲保護(hù)應(yīng)提供使用，例如： 使用隔離變壓器。點(diǎn)亮紫外燈時(shí)進(jìn)行測(cè)試，并進(jìn)入容器，如果有必要，這種預(yù)防性措施，是強(qiáng)烈建議。oDegreasingagent:Thesafetydatasheetofthesuppliermustbeavailableandmustbeobserved.○脫脂劑：供應(yīng)商的安全數(shù)據(jù)表必須是可用的，必須遵守。oFluorescentsubstance:Thesafetydatasheetofthesuppliermustbeavailableandmustbeobserved.熒光物質(zhì)供應(yīng)商提供的安全數(shù)據(jù)表必須是可用的，必須遵守。oDryingout:Whencompletelydriedthereisnohomogeneousthicknessoftheappliedlayeroffluorescentsubstance.Reproducibleverificationofthecleanabilityisnotpossibleinthiscase.Withpartialorincompletedryingthereisalsonoreproducibleconditionwithregardtotheremovalordissolvingofthefluorescentsubstance.Dryingoutofthetestsolutionmustthereforebeavoided.干燥：完全干燥后，表面沒(méi)有均勻厚的度熒光物質(zhì)。在這種情況下，清潔度是不可能重復(fù)性驗(yàn)證的；與部分或不完整的干燥，也就沒(méi)有關(guān)于溶解去除熒光物質(zhì)的重復(fù)的狀況。因此，干燥測(cè)試必須有解決方案。5.2Testbuild-upThetestbuild-upforperformingafluorescencetestcanbecarriedoutincompliancewiththearrangementshowninAnnex8.2,Fig.1.5.2試驗(yàn)方案可進(jìn)行熒光測(cè)試的測(cè)試建立在遵守附件 8.2，圖1中所示的安排。5.3Testequipment andspecificationsEST設(shè)備和規(guī)格5.3.1Testsolution測(cè)試解決方案Atestsolutionhastobepreparedpriortocarryingoutthetest.Table2inAnnex8.1specifiesIngredientsandrecipesoftestsolutions.Theseingredientsandrecipeshaveprovedtheir;通過(guò)吸入空氣worthinfluorescencetestsinpracticeandintrialcarriedoutduringthepreparationofthisinformationsheet.測(cè)試方案進(jìn)行測(cè)試之前，必須準(zhǔn)備。附件 8.1表2指定成分和配方的測(cè)試方案。這些成分和配方的熒光測(cè)試在實(shí)踐中證明自己的價(jià)值， 并在試驗(yàn)期間進(jìn)行 資料報(bào)表的編制。Itisbasicallyalsopossibletouseotherpartiallyorcompletelydeviatingingredientsorrecipesforthetest.Deviationsandtheeffectthesemayhavearetobetakenintoaccountorarrangedseparately,ifnecessary.它基本上可以用于測(cè)試部分或完全背離的 成份或配方。這些偏差和效果可能要考慮或另行安排，如果有必要的。Noteonrecipescontainingethanol:Somerecipesareusedwhichrequiretheadditionofethanolinwaterforthepreparationoftestsolutions(forimprovedwettability,butalsoincreasingthedryingtendency).Thiscanhaveanimpactontheprotectionagainstexplosion,occupationalhealthandsafetyandmustbeconsideredseparately,ifnecessary.注意對(duì)含乙醇的處方：有些配方需要在水中加乙醇測(cè)試（改善潤(rùn)濕性，有利于干燥）。這需要有一個(gè)保護(hù)，針對(duì)爆炸，職業(yè)健康和安全的影響，必須單獨(dú)考慮，如果有必要。Accordingtocalculationsandassumingrealisticconditions,itmustbeexpectedthatthelimitvaluefortheworkplacewillbeexceeded;theethanolintakethroughinhaledaircancauseasignificantincreaseinthebloodalcohollevel(allowingfortypicalvegetativephysiologicalvaluesforbreathingrateetc.).Underrealistictemperaturesitmayalsooccurthatthelowerignitionlimitoftheethanolairmixtureinthegasphaseisexceeded.據(jù)測(cè)算，假設(shè)現(xiàn)實(shí)條件，它必須被預(yù)計(jì)將超過(guò)工作場(chǎng)所的限制值中的乙醇攝入能導(dǎo)致在血液中酒精含量顯著增加（為典型植物呼吸速率等生理值。）在現(xiàn)實(shí)的溫度，它也可能會(huì)出現(xiàn)較低的乙醇在氣相空氣混合物點(diǎn)火限制被超過(guò)。Ifnecessary,effectsresultingfromtheuseofrecipescontainingethanolaretobeaccountedforthroughownobservations,measurementsand/orappropriatemeasures.如果有必要，從使用含有乙醇的 處方造成的影響是通過(guò)自己的觀察，測(cè)量和 或/適當(dāng)?shù)拇胧┲馈?.3.2Waterused toprepare thetestsolution水用來(lái)準(zhǔn)備測(cè)試解決方案Thequalityofthewaterusedforpreparingthetestsolutionshouldhaveatleastthesamequalityasthatofthecleaningwater(seeClause5.3.3).Toavoiddepositsofmineralssuchaslime,demineralizedwatershouldalwaysbeusedasaminimumqualityforpreparingthetestsolution.Thewaterforthetestsolutionshouldbeatroomtemperature準(zhǔn)備測(cè)試解決方案所用的水的質(zhì)量，應(yīng)該有至少相同的質(zhì)量，清潔水（見(jiàn)5.3.3條）。為了避免礦物質(zhì)如石灰沉積，軟化水應(yīng)始終被用來(lái)作為最低質(zhì)量準(zhǔn)備測(cè)試解決方案。水的測(cè)試解決方案應(yīng)該是在室溫下5.3.3Cleaning waterWaterofatleastdrinkingwaterqualityistobeusedascleaningwater.Thetemperatureofthecleaningwateristobeintherangeof12—25°CAt.temperatureslowerthanthis,adeclineinthecleaningresultistobeexpected.至少飲用水質(zhì)量的水是必須使用清潔水。清潔水的溫度范圍在12-25°C。在溫度低于此，清洗效果的下降是預(yù)料之中的5.3.4DarkeningItmustbepossibletodarkentheareaofthesurfacestobeexamined;thisonlyappliesifthesurfacestobeexaminedarenotautomaticallyinthedarkduetotheirarrangement(e.g.ontheinsideofvessels).必須在變暗中進(jìn)行表面審查;如果要檢查面不在黑暗中，由于他們的安排（例如容器內(nèi)）。5.3.5Inspection lamp(UVlamp)檢查燈（紫外線燈）AUVlampisusedtomakethefluorescenceofthetestsolutionvisible,safetynotesinthisrespectaregiveninClause5.1.ThecommonwavelengthforUVlampsusedforthefluorescencetestis365nm.使用熒光紫外燈，在這方面的安全注意事項(xiàng)第5.1條的測(cè)試解決方案。用于熒光檢測(cè)的紫外燈的波長(zhǎng)為365納米。5.3.6Surfaces tobeexamined表面進(jìn)行審查Surfacesforexaminationsareusuallytheinsidesurfacesofacomponentbeingexaminedincludingfittingsand,wherevercleaningelementsareavailableforcleaningoutersurfaces,alsothecorrespondingoutersurfaces.考察表面通常是檢查一個(gè)組件，包括配件和內(nèi)表面， 只要清潔元件是可用于清洗 內(nèi)外表面Note:Tosavetime,itmaybeexpedientwhentestinglarge,interconnectedsurfaces,nottowetallpartswiththetestsolution.Thiscanbethecase,forexample,withpartsoflarge,interconnectedsurfacesofavesselwall,aslongasitcanbeassumedthatthesesurfaceswillreactinthesamewayastheadjacent,fullywettedpartswhencleaningoffthetestsolution注：為了節(jié)省時(shí)間，它可能是權(quán)宜之計(jì)大，相互連接的表面進(jìn)行測(cè)試時(shí)，不要弄濕與測(cè)試解決方案的所有部件。這可能的情況下，例如，大型零件，互連的容器表面，只要它可以推定，這些表面相鄰，完全浸濕部件清洗測(cè)試解決方案時(shí)，會(huì)以同樣的方式作出反應(yīng)，Surfacesnottobewettedarestilltobeattributedtothesurfacestobeexaminedandaccountedforincarryingoutthetestanddocumentation.不被潤(rùn)濕的表面仍然 應(yīng)歸于表面進(jìn)行審查，并進(jìn)行測(cè)試和文檔記錄。Ifpartsofthesurfacetobeexaminedarenottobewettedwithtestsolution,thisistobearrangedinadvanceanddocumentedbeforecarryingoutthetest.如果零件表面進(jìn)行審查與測(cè)試解決方案將不濕，這是要提前安排和之前進(jìn)行的測(cè)試記錄。5.3.7Pre-cleaning預(yù)清洗Thesurfacestobeexaminedmustlookcleanandbegreasefree.要檢查表面看起來(lái)很干凈，無(wú)油脂Note:Ifduetothedesignoroperationitisnotpossibletomakethesurfacecompletelygreasefreeitmustbetakenintoaccountthatatthesepointstherewillbereducedadherenceandconsequentlyeasierremovalofthetestsolution.Thewettabilityoftheseareascanthereforenotbeevaluatedusingthefluorescencetest.注：如果由于設(shè)計(jì)或操作是不可能使表面完全無(wú)油脂， 它必須考慮在內(nèi)，在這些點(diǎn)，應(yīng)使用容易去除的方案。這些地區(qū)的潤(rùn)濕性，不能使用熒光測(cè)試評(píng)估。5.3.8Adjustment ofcomponents調(diào)整組件Thecomponenttobeexamined,e.g.avesselorpieceofequipmentmustbepositionedasinstructed.Anydeviationsaretobecorrectedordocumentedifnecessary.要檢查的組件，例如容器或設(shè)備必須定位指導(dǎo)。任何偏差，如果有必要予以糾正或記錄5.3.9Spray balls/nozzles andfittings噴霧球/噴嘴及配件Sprayballs/nozzlesinoronthecomponenttobeexaminedmustbemountedincompliancewiththespecification(e.g.shopdrawing,assemblyinstructions)ofthecomponenttobeexamined.Forthecleaningprocessallfittingsrequiredfortheoperationmustbeinstalled.噴霧球/或噴嘴對(duì)要檢查的組件必須安裝符合規(guī)范（如施工圖，裝配指令）組件進(jìn)行審查。操作所需的所有配件的清洗過(guò)程中必須安裝。5.3.10Pressure andflow ratemeasurement壓力和流量測(cè)量Priortoeveryconnectionofasprayball/nozzleapressureandflowratemeasurementshouldbecarriedout(ideallyrequiredasstandard).Ifthisisnotpossible,theconditionsattheindividualsprayballs/nozzlesmustbecalculatedusingtheavailabledata.Thenumber,positionandarrangementofpumps,pressureandflowratemeasurementsandsprayballs/nozzlesshouldthereforebeoutlined.(comp.Clause7.1).噴霧球/噴嘴壓力和流量測(cè)量每個(gè)連接之前，應(yīng)進(jìn)行（理想標(biāo)準(zhǔn)的要求）。如果這是不可能的，在個(gè)人噴霧球 /噴嘴的條件，必須使用現(xiàn)有的數(shù)據(jù)計(jì)算。因此，應(yīng)概述泵，壓力和流量測(cè)量和噴霧球 /噴嘴的數(shù)量，位置和安排。 （comp.7.1條）。

的第5.3.11Cleaning procedure清潔程序Thecleaningprocedureforthetestiscarriedoutusingcleaningwater(seeClause5.3.3).Thedurationoftheactualcleaningprocesshastobeadjustedtotheactualdegreeofcontaminationduringthelateruse.使用清潔水清洗測(cè)試程序進(jìn)行（見(jiàn)5.3.3條）。實(shí)際清洗過(guò)程的持續(xù)時(shí)間進(jìn)行調(diào)整以后使用過(guò)程中的實(shí)際污染程度Thecleaningprocedureisusuallyspecifiedbythesupplierofthecomponentbeingexamined(pletevessel,equipmentetc.includingfixturesincompliancewithClause2).Indoingso,theaimofthefluorescencetest(seeClause4,Table1)istobeobserved.Thespecificationforthecleaningprocedureshouldcontaindetailson清潔過(guò)程通常被指定由供應(yīng)商 正在檢查組件（例如完整的容器， 設(shè)備等，包括在遵守第2條的裝置）。這樣做，目的是觀察熒光試驗(yàn)（見(jiàn)第4，表1）。清洗程序的規(guī)范應(yīng)包含的細(xì)節(jié)oduration,opressure,oflowrateandsequence?持續(xù)時(shí)間，O壓力，O流率和程序ofthecleaningelementapplication.Itshouldalsocontaindetailson清潔元素的應(yīng)用。它也應(yīng)該包含細(xì)節(jié)ofillinglevelsofthecomponentovalvepositionsaswellaspositionsand/ormovement/speed ofrotationofthecomponentsactiveelements○組件的填充水平?閥門位置以及位置和組件的旋轉(zhuǎn)運(yùn)動(dòng)速度主動(dòng)元件/Asuitablecleaningproceduremayinvolvetheapplicationthecleaningelementsorelement-freeconnectionswithwater,orthemovement/speedofrotationofmovingelementsinorthroughcleaningwater.Beyondthis,anappropriatecleaningprocedurecanalsocomprisearandomcombinationthereof.一個(gè)合適的清洗過(guò)程可能涉及到應(yīng)用清潔的 元件與水或元素的連接，或清潔水或通過(guò)移動(dòng)元件的旋轉(zhuǎn)運(yùn)動(dòng)/速度。除此之外，適當(dāng)?shù)那逑闯绦?，也可以包括一個(gè)隨機(jī)兩者兼而有之。5.4Carrying outthetestNotes:BeforecarryingoutthetestitisimportanttoobservethepointsdescribedinClauses5.1,5.2and5.3.Thedocumentation priortoperformanceofthetestisdescribedinClause7.1.開(kāi)展測(cè)試之前，重要的是要觀察在第5.1，5.2和5.3點(diǎn)。性能測(cè)試前的文件是在第7.1條所述。Carryingoutthetest:1.Applytestsolutiontosurfacestobewettedusinganatomizernozzle.Thesurfacestobewettedmustbewettedcompletely.應(yīng)用測(cè)試解決方案，使用霧化噴嘴濕潤(rùn)的表面。要濕潤(rùn)表面必須完全浸濕。Asanalternativethesurfacestobeexaminedcanalsobewettedwithtestsolutionthroughfloodingandsubsequentemptyingofthecomponentbeingexamined.Whenflooding,alwaysmakesurethatthecomponentcanbecompletelyflooded.作為替代方案進(jìn)行審查的表面也可潤(rùn)濕與測(cè)試解決方案，通過(guò)水浸和正在檢查的組件隨后排空。水浸時(shí)，始終確保該組件可以被完全淹沒(méi)。Bringcomponenttobeexaminedintocorrectoperatingcondition.把組件納入正確的操作條件審查。CarryoutthecleaningproceduredescribedinClause5.3.11.開(kāi)展清潔過(guò)程中第 5.3.11VisuallyinspectthesurfacestobeexaminedfordetectablefluorescenceusingaUVlamp.目視檢查表面，可使用熒光紫外燈檢查。6.Evaluation ofthefluorescence test熒光檢測(cè)的評(píng)價(jià)ThefluorescencetestisconsideredassuccessfullypassedwhenthecriterionofqualitydescribedinTable1ismetaftercompletionofthetest.符合質(zhì)量標(biāo)準(zhǔn)表 1中所述的測(cè)試完成后，被認(rèn)為是熒光測(cè)試順利通過(guò)Ifthecleanabilitytestforthecomponentbeingexaminedisfailed,thecauseofthisfailuremustbedetermined.Thetestisthenrepeatedaftercorrectionmeasureshavebeencarriedout(e.g.modificationofthecleaningprocedure)andpossiblycoordinationwiththeclient.Thenewtestconditionsmustbedocumented如果為正在檢查的組件清潔度測(cè)試失敗，必須確定這種失敗的原因。改正措施后，已進(jìn)行了（如清潔程序的修改），并與客戶的協(xié)調(diào)，然后重復(fù)測(cè)試。新的測(cè)試條件下，必須記錄Whencarryingouttheweakpointtestitmayoccurthatitisnottheassociatedcriterionofqualitythatismet,butratherthatofthecleanabilitytest.Inthiscase,itisrecommendedtomutuallyacknowledgetheweakpointtestascleanabilitytest.開(kāi)展的薄弱點(diǎn)測(cè)試時(shí)，它可能會(huì)發(fā)生不符合相關(guān)的質(zhì)量標(biāo)準(zhǔn)，而是在于清潔能力測(cè)試。在這種情況下，建議相互承認(rèn)的薄弱點(diǎn)測(cè)試清潔度能力。7.Documentation ofthefluorescence test熒光測(cè)試文件Thefollowinglisteditemsaretobedocumented:下列項(xiàng)目將被記錄在案：7.1Documentation offluorescence testbefore carrying outthetest熒光測(cè)試文件進(jìn)行測(cè)試之前a)Testbuild-upoDescription,sketches/shopdrawings,orpicturesoftheinstallationoWavelengthofusedUVlampa）測(cè)試建立O描述，草圖/車間圖紙，或安裝的圖片使用紫外燈的波長(zhǎng)b)ComponenttobeexaminedoDesignationofthecomponenttobeexaminedoDrawingnumber(possiblyrevisionnumber)ofthecomponenttobeexaminedoSerialnumberorfactorynumberofthecomponenttobeexaminedoJustwhensomepartsarenottobewettedwithtestsolution:surfacestobeexamined(comp.5.3.6;ifnecessaryusingdrawingsorsketchdiagramstospecify)B）要檢查的組件指定要檢查的組件圖紙編號(hào)（可能是版本號(hào)）進(jìn)行審查的組件O串行數(shù)字或工廠要檢查的組件?當(dāng)某些部分不被潤(rùn)濕與測(cè)試解決方案：表面進(jìn)行審查（comp.的5.3.6;如果需要使用圖紙或草圖圖指定）c)MeasuringdevicesandreferencemeasuringdevicesusedforthetestoNameandtestequipmentnumberoftheusedreferencemeasuringdevicesoCalibrationprotocolsoftheusedmeasuringequipmentc）用于測(cè)試設(shè)備和參考測(cè)量設(shè)備，名稱所用的參考測(cè)量設(shè)備和測(cè)試設(shè)備的數(shù)量?使用的測(cè)量設(shè)備校準(zhǔn)協(xié)議d)Testsolution/cleaningwateroQualityofwaterusedtopreparetestsolutionoTemperatureofwaterusedforpreparingtestsolution(roomtemperature:yes/no)oRecipeoftheusedtestsolution(seeAnnex,Clause8.1)oQualityandtemperatureofcleaningwater(seeClause5.3.3)d）測(cè)試解決方案 /清潔水水質(zhì)用來(lái)準(zhǔn)備測(cè)試解決方案的水溫用于準(zhǔn)備測(cè)試解決方案（室溫：是?配方使用的測(cè)試解決方案（見(jiàn)附件，第o質(zhì)量和清潔水的溫度（見(jiàn)第5.3.3）

/否）8.1條）7.2Documentation offluorescence testduring carrying outthetest熒光測(cè)試期間開(kāi)展的測(cè)試文件DescriptionoftestincompliancewithTable1(e.g."weakpointtest")Cons.numberoftestDate,testbegins(timeofday)d)Confirmation'testsolutionfluorescing ’Confirmationthatsurfacestobewettedhavebeencompletelywettedwiththetestsolution,orthecomponenthasbeencompletelyfilledwithtestsolutionf)Confirmation‘componentisincorrectoperatingcondition'StartofcleaningprocedureApplicationofcleaningelements,ifapplicable:odurationopressureoflowrateosequenceFillinglevelsofthecomponent,ifapplicableValvepositions,ifapplicablePositionsand/ormovement/speedofrotationofactiveelementsofthecomponent,ifapplicableEndofcleaningprocedureCarryingoutandresultofvisualinspectionusingaUVlampa）說(shuō)明符合表 1（如“薄弱點(diǎn)測(cè)試”的測(cè)試）B）缺點(diǎn)。測(cè)試數(shù)C）日期，測(cè)試開(kāi)始（時(shí)間）D）認(rèn)可的測(cè)試解決方案的熒光 'E）確認(rèn)，潤(rùn)濕表面已完全潤(rùn)濕與測(cè)試解決方案，或組件測(cè)試解決方案已完全充滿F）確認(rèn)的組成部分，是在正確的 操作條件“）開(kāi)始清潔程序H）應(yīng)用清潔 元件，如適用：時(shí)間O壓力O流率O序列i）灌裝組件的水平，如適用j）閥門位置，如適用K）的