Process Plant andEquipment工藝廠房及設備Information sheetRiboflavin testforlow-germorsterileprocesstechnologiesFluorescence testforexaminationofcleanabilityForfood,aseptic,pharmacyandchemistry信息表核黃素低細菌或無菌工藝技術的試驗熒光測試是對食品，無菌，制藥和化學清潔能力的 檢驗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無菌工藝工程部編寫的“核黃素測試”工作。這是作為一個可下載的文件根據/verfahrenstechnik。為改進和補充的建議，可發送到下面的地址。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@ 的互聯網：/ verfahrenstechnik1. IntroductionTestsforexaminationofcleanabilityplayamajorroleinsterileprocesstechnology.Avarietyoftestsareappliedinpractice,dependingontherespectiveusecase,suitabilityorrequirements.Thisinformationsheetdoesnotspecifyfurtherdetailsinthisrespect.Thedescribedfluorescencetestisfirstandforemostsuitableforthecomponentsnamedinthescope,asfarasthesecanbeexaminedbymeansofvisualinspection.Thisbeingthecase,thefluorescencetestisnotintendedtoreplaceotherwell-establishedtests,butrathertosupplementavailablepossibilitiesinthissector.清潔度的檢查測試，在無菌工藝技術發揮的重要作用。各種測試在實踐中應用，根據各自的使用情況， 是否適合或要求。 此信息表沒有指定在這方面的進一步細節。首先是所描述的熒光測試適合范圍命名的組件， 因為這些都可以通過目測檢查。在這種情況下，熒光測試的目的不是取代其他行之有效測試，而是為了補充在這一領域的可能性。Theobjectiveofthisinformationsheetistoprovidemanufacturers,suppliersanduserswithadocumentthatcansimplifytheaccord,planning,carryingoutanddocumentationofafluorescencetest.Indoingso,theinformationsheetsummarizesdifferenttestscommonlyusedinpracticeaswellascomprehensiveexperiencegatheredwiththeseteststoprovideapossiblecoarseofaction.Mannersofprocedureoraccordsthatdeviateinpartorcompletelyare,however,expresslypossible.這個資料片的目的是提供制造商，供應商和用戶文檔，可以簡化協議，規劃，展了熒光測試文件。 這樣做，信息表總結了在實踐中常用的測試以及全面積累的經驗，這些測試提供了可能采取的行動的指導。 禮儀程序或協議偏離或完全是符合明確可能。

開2. ScopeThescopeofthisinformationsheetcoverscomponents,apparatuses,machineryandplants(alsoreferredtointhisinformationsheetas‘components’)forlow-germorsterileprocesstechnologieswithhighorhighestrequirementsregardingcleanability,asfarastheseareaccessibleforvisualinspection.Thesecomponentsareusedinthefood,asepticprocessing,pharmaceuticalandchemicalssector,e.g.vessels,reactors,filterequipment,pumps,agitators,centrifuges,pasteurizers,fillingsystemsetc.includingfittingsandperipheralequipment.本資料報表的范圍涵蓋元件，儀器，機械和植物（也稱為在此為“組件”的資料片）低細菌或無菌工藝技術關于清潔度高或最高的要求，盡可能目測訪問。這些元件可用于食品，無菌加工，制藥和化工行業，如船舶，電抗器，過濾設備，泵，攪拌器，離心機，巴氏滅菌，灌裝等在內的系統配件和外圍設備。Noteonuse:Thisinformationsheetgivesadvicestotheuser.Itis,however,incumbentupontheuseroftheinformationsheettoverifyorconsiderrequirements,thecurrentvaliditythereofandnecessarymeasuresconcerningtheuser’sconcreteusecase.Thisconcernsinparticularalllaws,ordinances,directivesetc.thatcouldberelevantfortherespectivecaseofuse.使用注意事項：這個資料片提供給用戶的意見。但是，用戶有責任驗證或考慮信息手冊關要求，當前的有效性及其必要措施根據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。Terms,definitions術語，定義oFluorescencetestTestusingafluorescentsubstanceforexaminationofcleanabilityofcomponents熒光測試一個元件清潔度的檢查，測試使用熒光物質oCleanabilityCompleteremovalofthetestsolutionbythecleaningmediumunderapplicationoftheselectedconditionswithregardtothecleaningelements,cleaningprocessorthedesignofthecomponent。清潔能力由選定的條件下，應用清洗介質清洗元素方面，清潔的過程或組件的設計徹底清除的測試解決方案oCleanabilitytestTestforcompletecleanabilityundertheconditionsselectedforthefluorescencetest清潔度測試熒光測試選定的條件下完成的清潔能力測試oWeakpointtestTestforlocalizingcriticalpoints;Usuallyparametervaluesofthecleaningprocedureareusedwhichdeviatefromthoseofthecleanabilitytest(reducedpressureorthroughputofthecleaningmediumordurationofcleaningprocess)薄弱點測試測試定位關鍵點;用一般的清洗程序的參數值偏離清潔度測試（減少壓力或清洗劑用量或清洗過程中的時間）oOptimizationtestStepwiseoptimizationandtestingofthesuitabilityofnewparametervaluesthroughseparate,newcleanabilitytests優化測試逐步優化和測試新的參數值的適用性，通過獨立的，新的清潔度測試oTestsolutionSolutionforcarryingoutthefluorescencetest測試解決方案開展熒光測試解決方案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關鍵點，是難以清潔和可徹底清洗oNon-criticalpointsPointsthatareeasytocleanandcanbecleanedcompletely非關鍵點易清洗，可完全清除oNon-cleanablepointsPointsthatcannotbecleanedcompletely非清洗的點不能徹底清洗點oCleaningelementElementfortargetedapplicationofcleaningliquidtothecomponenttobeexamined;Examplesofcleaningelements:sprayball,rotatingjetcleaner,cleaningnozzle,spraylance清潔元素有針對性的清洗液進行審查的組件應用;清潔元素的例子：噴球，旋噴清潔劑，清洗噴嘴，噴槍的元素oSurfacestobeexaminedAreasofthecomponentbeingexaminedthataretobeaccountedforinthefluorescencetest表面進行檢查正在檢查的組件區域要需要熒光測試oSurfacestobewettedSurfacestobeexaminedonwhichthetestsolutionistobeapplied表面浸濕表面檢查要應用測試方案oCarryingoutthetestApplicationandremovalofthetestsolutionaswellasthesubsequentinspectionforremainingfluorescence○開展的測試測試解決方案的應用和清除以及隨后的檢查剩余的熒光oWorkplacelimitvalue1Limitforthetime-dependentaverageconcentrationofasubstanceintheairattheworkplace,inrelationtoagivenreferenceperiod.工作場所限制值時間依賴的平均濃度在空氣中的一種物質，在工作場所關系到一個給定的參考期間，限額。4.Aimofthefluorescence test熒光測試的目的Thefluorescencetestdescribedinthisinformationsheetisfortheexaminationofcleanability.Thisiscarriedoutbytheexaminationofthebasicaccessibilityto,aswellasthecompletewettingofallareasinwhichaverificationofcleanabilitythroughthecleaningmediumisrequired.此信息表中描述的熒光檢測的清潔度檢查。這是開展基本無障礙，以及在核查通過清洗介質的清潔度要求的所有領域的完全潤濕檢測。Thecleanabilitytestisaimedtoverifycompletecleanability;theresultofthetestisaqualitativestatement.Inadditiontothis,thestep-by-steporrepeatedcarryingoutofthefluorescencetestalsoenablesqualitativestatementsorexaminationofmeasuresforimprovingoroptimizingthecleaningprocess.Table1specifiesthegoalsthatcanbeachievedwiththefluorescencetest:清潔度測試旨在驗證完整的清潔能力測試的結果是一個定性的陳述。除了這個，一步一步或重復運載熒光試驗也使定性陳述或檢查措施，改善或優化清洗過程。表1指定與熒光測試，可以實現的目標：Fluorescencetest: Aimofthetest: Criterionofqualityafterthetest:Weakpointtest Localizingcriticalpoints;providedasoptionalpreliminarystagetothecleanabilitytest.Cleanabilitytest Verificationoffullcleanability.Optimizationtest Stepwiseoptimization andcheckingofsuitabilityofnewparametervaluesthroughseparate,newcleanabilitytests.

Visiblefluorescence2atcriticalpoints(acc.definitioninClause3);thesearetobeconfirmedthroughacleanabilitytest.Novisiblefluorescence2Novisiblefluorescence2.Improvedparametervalues(e.g.reducedwaterconsumption,shortercleaningtime)熒光測試測試的目的試驗后的質量標準薄弱點測試局部的關鍵點;-可見熒光2關鍵點（根據第3條的定提供選擇性的初步階段的清潔度測義），這些都是要通過清潔度測試證實。試。清潔度測試驗證全面清潔度無肉眼可見的熒光優化試驗新參數的適用性的逐步優化和檢查-無可見熒光通過獨立的，新的清潔度測試值。-改進的參數值（例如，減少水的消耗，縮短清洗時間）Table1:Achievablegoalsusingfluorescencetestacc.toinformationsheet表1：使用熒光試驗累計實現的目標。 資料報表5.Instatallation, equipment, specifications andcarrying outthetest5.1General notes andpoints tobeobserved5。安裝，設備，技術規格和開展測試5.1一般注意事項和觀察點Regulationsanddirectivesrelatingtooccupationalhealthandsafetymustalwaysbeobservedwhencarryingoutthetest.Furthermore,specialreferenceismadetothefollowing:有關職業健康和安全的法規和指令必須始終進行測試時 遵守的。此外，特別提到了以下內容：oTestingpersonnel:Nospecificrequirementsareplacedwithregardtotheeducationoftestingpersonnel.Testingpersonnelshould,however,besuitablyandtrainedtocarryingoutthetestorguidedbyin-houseworkinstructions.測試人員：放置與測試人員的教育方面沒有具體要求。然而，檢驗人員應當有適當的培訓，開展試驗或由內部工作指示為指導。oUVlamp:TheuseofaUVlampcancausedamagetoeyesthroughpenetratingUVrays.ItisthereforenecessarytowearsafetygogglesandtoobserveanyadditionalprotectionmeasuresspecifiedbythemanufactureroftheUVlamp.?紫外燈：紫外燈的使用可能會導致通過穿透性紫外線對眼睛的傷害。 因此，必須佩戴護目鏡，并觀察紫外燈制造商所指定的任何額外的保護措施。oOccupationalsafety:AstheUVlampisalwaysusedinamoistenvironmentpersonalfuseprotectionoftheelectricalsupplyshouldbeprovided,e.g.usingisolatingtransformers3.IfitisnecessarytolightupavesselwithaUVlampwhencarryingoutthetestandtoenteravessel,thisprecautionarymeasureisstronglyadvised.?職業安全：由于紫外線燈總是在潮濕的環境下供電的個人保險絲保護應提供使用，例如： 使用隔離變壓器。點亮紫外燈時進行測試，并進入容器，如果有必要，這種預防性措施，是強烈建議。oDegreasingagent:Thesafetydatasheetofthesuppliermustbeavailableandmustbeobserved.○脫脂劑：供應商的安全數據表必須是可用的，必須遵守。oFluorescentsubstance:Thesafetydatasheetofthesuppliermustbeavailableandmustbeobserved.熒光物質供應商提供的安全數據表必須是可用的，必須遵守。oDryingout:Whencompletelydriedthereisnohomogeneousthicknessoftheappliedlayeroffluorescentsubstance.Reproducibleverificationofthecleanabilityisnotpossibleinthiscase.Withpartialorincompletedryingthereisalsonoreproducibleconditionwithregardtotheremovalordissolvingofthefluorescentsubstance.Dryingoutofthetestsolutionmustthereforebeavoided.干燥：完全干燥后，表面沒有均勻厚的度熒光物質。在這種情況下，清潔度是不可能重復性驗證的；與部分或不完整的干燥，也就沒有關于溶解去除熒光物質的重復的狀況。因此，干燥測試必須有解決方案。5.2Testbuild-upThetestbuild-upforperformingafluorescencetestcanbecarriedoutincompliancewiththearrangementshowninAnnex8.2,Fig.1.5.2試驗方案可進行熒光測試的測試建立在遵守附件 8.2，圖1中所示的安排。5.3Testequipment andspecificationsEST設備和規格5.3.1Testsolution測試解決方案Atestsolutionhastobepreparedpriortocarryingoutthetest.Table2inAnnex8.1specifiesIngredientsandrecipesoftestsolutions.Theseingredientsandrecipeshaveprovedtheir;通過吸入空氣worthinfluorescencetestsinpracticeandintrialcarriedoutduringthepreparationofthisinformationsheet.測試方案進行測試之前，必須準備。附件 8.1表2指定成分和配方的測試方案。這些成分和配方的熒光測試在實踐中證明自己的價值， 并在試驗期間進行 資料報表的編制。Itisbasicallyalsopossibletouseotherpartiallyorcompletelydeviatingingredientsorrecipesforthetest.Deviationsandtheeffectthesemayhavearetobetakenintoaccountorarrangedseparately,ifnecessary.它基本上可以用于測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.注意對含乙醇的處方：有些配方需要在水中加乙醇測試（改善潤濕性，有利于干燥）。這需要有一個保護，針對爆炸，職業健康和安全的影響，必須單獨考慮，如果有必要。Accordingtocalculationsandassumingrealisticconditions,itmustbeexpectedthatthelimitvaluefortheworkplacewillbeexceeded;theethanolintakethroughinhaledaircancauseasignificantincreaseinthebloodalcohollevel(allowingfortypicalvegetativephysiologicalvaluesforbreathingrateetc.).Underrealistictemperaturesitmayalsooccurthatthelowerignitionlimitoftheethanolairmixtureinthegasphaseisexceeded.據測算，假設現實條件，它必須被預計將超過工作場所的限制值中的乙醇攝入能導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。）在現實的溫度，它也可能會出現較低的乙醇在氣相空氣混合物點火限制被超過。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自己的觀察，測量和 或/適當的措施知道。5.3.2Waterused toprepare thetestsolution水用來準備測試解決方案Thequalityofthewaterusedforpreparingthetestsolutionshouldhaveatleastthesamequalityasthatofthecleaningwater(seeClause5.3.3).Toavoiddepositsofmineralssuchaslime,demineralizedwatershouldalwaysbeusedasaminimumqualityforpreparingthetestsolution.Thewaterforthetestsolutionshouldbeatroomtemperature準備測試解決方案所用的水的質量，應該有至少相同的質量，清潔水（見5.3.3條）。為了避免礦物質如石灰沉積，軟化水應始終被用來作為最低質量準備測試解決方案。水的測試解決方案應該是在室溫下5.3.3Cleaning waterWaterofatleastdrinkingwaterqualityistobeusedascleaningwater.Thetemperatureofthecleaningwateristobeintherangeof12—25°CAt.temperatureslowerthanthis,adeclineinthecleaningresultistobeexpected.至少飲用水質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料之中的5.3.4DarkeningItmustbepossibletodarkentheareaofthesurfacestobeexamined;thisonlyappliesifthesurfacestobeexaminedarenotautomaticallyinthedarkduetotheirarrangement(e.g.ontheinsideofvessels).必須在變暗中進行表面審查;如果要檢查面不在黑暗中，由于他們的安排（例如容器內）。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第5.1條的測試解決方案。用于熒光檢測的紫外燈的波長為365納米。5.3.6Surfaces tobeexamined表面進行審查Surfacesforexaminationsareusuallytheinsidesurfacesofacomponentbeingexaminedincludingfittingsand,wherevercleaningelementsareavailableforcleaningoutersurfaces,alsothecorrespondingoutersurfaces.考察表面通常是檢查一個組件，包括配件和內表面， 只要清潔元件是可用于清洗 內外表面Note:Tosavetime,itmaybeexpedientwhentestinglarge,interconnectedsurfaces,nottowetallpartswiththetestsolution.Thiscanbethecase,forexample,withpartsoflarge,interconnectedsurfacesofavesselwall,aslongasitcanbeassumedthatthesesurfaceswillreactinthesamewayastheadjacent,fullywettedpartswhencleaningoffthetestsolution注：為了節省時間，它可能是權宜之計大，相互連接的表面進行測試時，不要弄濕與測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試解決方案時，會以同樣的方式作出反應，Surfacesnottobewettedarestilltobeattributedtothesurfacestobeexaminedandaccountedforincarryingoutthetestanddocumentation.不被潤濕的表面仍然 應歸于表面進行審查，并進行測試和文檔記錄。Ifpartsofthesurfacetobeexaminedarenottobewettedwithtestsolution,thisistobearrangedinadvanceanddocumentedbeforecarryingoutthetest.如果零件表面進行審查與測試解決方案將不濕，這是要提前安排和之前進行的測試記錄。5.3.7Pre-cleaning預清洗Thesurfacestobeexaminedmustlookcleanandbegreasefree.要檢查表面看起來很干凈，無油脂Note:Ifduetothedesignoroperationitisnotpossibletomakethesurfacecompletelygreasefreeitmustbetakenintoaccountthatatthesepointstherewillbereducedadherenceandconsequentlyeasierremovalofthetestsolution.Thewettabilityoftheseareascanthereforenotbeevaluatedusingthefluorescencetest.注：如果由于設計或操作是不可能使表面完全無油脂， 它必須考慮在內，在這些點，應使用容易去除的方案。這些地區的潤濕性，不能使用熒光測試評估。5.3.8Adjustment ofcomponents調整組件Thecomponenttobeexamined,e.g.avesselorpieceofequipmentmustbepositionedasinstructed.Anydeviationsaretobecorrectedordocumentedifnecessary.要檢查的組件，例如容器或設備必須定位指導。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/或噴嘴對要檢查的組件必須安裝符合規范（如施工圖，裝配指令）組件進行審查。操作所需的所有配件的清洗過程中必須安裝。5.3.10Pressure andflow ratemeasurement壓力和流量測量Priortoeveryconnectionofasprayball/nozzleapressureandflowratemeasurementshouldbecarriedout(ideallyrequiredasstandard).Ifthisisnotpossible,theconditionsattheindividualsprayballs/nozzlesmustbecalculatedusingtheavailabledata.Thenumber,positionandarrangementofpumps,pressureandflowratemeasurementsandsprayballs/nozzlesshouldthereforebeoutlined.(comp.Clause7.1).噴霧球/噴嘴壓力和流量測量每個連接之前，應進行（理想標準的要求）。如果這是不可能的，在個人噴霧球 /噴嘴的條件，必須使用現有的數據計算。因此，應概述泵，壓力和流量測量和噴霧球 /噴嘴的數量，位置和安排。 （comp.7.1條）。

的第5.3.11Cleaning procedure清潔程序Thecleaningprocedureforthetestiscarriedoutusingcleaningwater(seeClause5.3.3).Thedurationoftheactualcleaningprocesshastobeadjustedtotheactualdegreeofcontaminationduringthelateruse.使用清潔水清洗測試程序進行（見5.3.3條）。實際清洗過程的持續時間進行調整以后使用過程中的實際污染程度Thecleaningprocedureisusuallyspecifiedbythesupplierofthecomponentbeingexamined(pletevessel,equipmentetc.includingfixturesincompliancewithClause2).Indoingso,theaimofthefluorescencetest(seeClause4,Table1)istobeobserved.Thespecificationforthecleaningprocedureshouldcontaindetailson清潔過程通常被指定由供應商 正在檢查組件（例如完整的容器， 設備等，包括在遵守第2條的裝置）。這樣做，目的是觀察熒光試驗（見第4，表1）。清洗程序的規范應包含的細節oduration,opressure,oflowrateandsequence?持續時間，O壓力，O流率和程序ofthecleaningelementapplication.Itshouldalsocontaindetailson清潔元素的應用。它也應該包含細節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運動速度主動元件/Asuitablecleaningproceduremayinvolvetheapplicationthecleaningelementsorelement-freeconnectionswithwater,orthemovement/speedofrotationofmovingelementsinorthroughcleaningwater.Beyondthis,anappropriatecleaningprocedurecanalsocomprisearandomcombinationthereof.一個合適的清洗過程可能涉及到應用清潔的 元件與水或元素的連接，或清潔水或通過移動元件的旋轉運動/速度。除此之外，適當的清洗程序，也可以包括一個隨機兩者兼而有之。5.4Carrying outthetestNotes:BeforecarryingoutthetestitisimportanttoobservethepointsdescribedinClauses5.1,5.2and5.3.Thedocumentation priortoperformanceofthetestisdescribedinClause7.1.開展測試之前，重要的是要觀察在第5.1，5.2和5.3點。性能測試前的文件是在第7.1條所述。Carryingoutthetest:1.Applytestsolutiontosurfacestobewettedusinganatomizernozzle.Thesurfacestobewettedmustbewettedcompletely.應用測試解決方案，使用霧化噴嘴濕潤的表面。要濕潤表面必須完全浸濕。Asanalternativethesurfacestobeexaminedcanalsobewettedwithtestsolutionthroughfloodingandsubsequentemptyingofthecomponentbeingexamined.Whenflooding,alwaysmakesurethatthecomponentcanbecompletelyflooded.作為替代方案進行審查的表面也可潤濕與測試解決方案，通過水浸和正在檢查的組件隨后排空。水浸時，始終確保該組件可以被完全淹沒。Bringcomponenttobeexaminedintocorrectoperatingcondition.把組件納入正確的操作條件審查。CarryoutthecleaningproceduredescribedinClause5.3.11.開展清潔過程中第 5.3.11VisuallyinspectthesurfacestobeexaminedfordetectablefluorescenceusingaUVlamp.目視檢查表面，可使用熒光紫外燈檢查。6.Evaluation ofthefluorescence test熒光檢測的評價ThefluorescencetestisconsideredassuccessfullypassedwhenthecriterionofqualitydescribedinTable1ismetaftercompletionofthetest.符合質量標準表 1中所述的測試完成后，被認為是熒光測試順利通過Ifthecleanabilitytestforthecomponentbeingexaminedisfailed,thecauseofthisfailuremustbedetermined.Thetestisthenrepeatedaftercorrectionmeasureshavebeencarriedout(e.g.modificationofthecleaningprocedure)andpossiblycoordinationwiththeclient.Thenewtestconditionsmustbedocumented如果為正在檢查的組件清潔度測試失敗，必須確定這種失敗的原因。改正措施后，已進行了（如清潔程序的修改），并與客戶的協調，然后重復測試。新的測試條件下，必須記錄Whencarryingouttheweakpointtestitmayoccurthatitisnottheassociatedcriterionofqualitythatismet,butratherthatofthecleanabilitytest.Inthiscase,itisrecommendedtomutuallyacknowledgetheweakpointtestascleanabilitytest.開展的薄弱點測試時，它可能會發生不符合相關的質量標準，而是在于清潔能力測試。在這種情況下，建議相互承認的薄弱點測試清潔度能力。7.Documentation ofthefluorescence test熒光測試文件Thefollowinglisteditemsaretobedocumented:下列項目將被記錄在案：7.1Documentation offluorescence testbefore carrying outthetest熒光測試文件進行測試之前a)Testbuild-upoDescription,sketches/shopdrawings,orpicturesoftheinstallationoWavelengthofusedUVlampa）測試建立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（可能是版本號）進行審查的組件O串行數字或工廠要檢查的組件?當某些部分不被潤濕與測試解決方案：表面進行審查（comp.的5.3.6;如果需要使用圖紙或草圖圖指定）c)MeasuringdevicesandreferencemeasuringdevicesusedforthetestoNameandtestequipmentnumberoftheusedreferencemeasuringdevicesoCalibrationprotocolsoftheusedmeasuringequipmentc）用于測試設備和參考測量設備，名稱所用的參考測量設備和測試設備的數量?使用的測量設備校準協議d)Testsolution/cleaningwateroQualityofwaterusedtopreparetestsolutionoTemperatureofwaterusedforpreparingtestsolution(roomtemperature:yes/no)oRecipeoftheusedtestsolution(seeAnnex,Clause8.1)oQualityandtemperatureofcleaningwater(seeClause5.3.3)d）測試解決方案 /清潔水水質用來準備測試解決方案的水溫用于準備測試解決方案（室溫：是?配方使用的測試解決方案（見附件，第o質量和清潔水的溫度（見第5.3.3）

/否）8.1條）7.2Documentation offluorescence testduring carrying outthetest熒光測試期間開展的測試文件DescriptionoftestincompliancewithTable1(e.g."weakpointtest")Cons.numberoftestDate,testbegins(timeofday)d)Confirmation'testsolutionfluorescing ’Confirmationthatsurfacestobewettedhavebeencompletelywettedwiththetestsolution,orthecomponenthasbeencompletelyfilledwithtestsolutionf)Confirmation‘componentisincorrectoperatingcondition'StartofcleaningprocedureApplicationofcleaningelements,ifapplicable:odurationopressureoflowrateosequenceFillinglevelsofthecomponent,ifapplicableValvepositions,ifapplicablePositionsand/ormovement/speedofrotationofactiveelementsofthecomponent,ifapplicableEndofcleaningprocedureCarryingoutandresultofvisualinspectionusingaUVlampa）說明符合表 1（如“薄弱點測試”的測試）B）缺點。測試數C）日期，測試開始（時間）D）認可的測試解決方案的熒光 'E）確認，潤濕表面已完全潤濕與測試解決方案，或組件測試解決方案已完全充滿F）確認的組成部分，是在正確的 操作條件“）開始清潔程序H）應用清潔 元件，如適用：時間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