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temperature-mapping-study-protocol-procedure (1)

Temperature mapping study and Temperature qualification study are carried out generally in pharmaceutical industry. There are different kind of medicines and vaccines which need to be stored and transported at certain temperatures. Majority of these medicines and vaccines are under two categories viz. Those to be stored between 2 to 8 Degree Centigrade and those to be stored between 15 to 25u00b0C.<br>

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temperature-mapping-study-protocol-procedure (1)

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  1. DETAILED PROCEDUREAND GUIDELINES ON TEMPERATURE MAPPING STUDY & QUALIFICATION OF COLD ROOMS, WAREHOUSES,VANS, TRUCKS, REEFERS, REFRIGERATORS&BOXES FOR PHARMACEUTICAL INDUSTRY Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  2. TABLEOFCONTENTS • 1.TemperatureMappingStudy/Temperature& HumidityMappingstudy...................................3 • 1.1.1.Why would you require Temperature Mapping Study(akaTemperature Distribution study)?.....3 1.1.2.Howdo we carryouttemperature mappingstudy?.................................................................4 1.2.Whatistemperatureandhumiditymappingstudy?................................................................5 • Doyourequireatemperaturemappingortemperature&humiditymapping?..........................5 • Whatistherecommendedhumiditylevelforstorageofmedicines?........................................5 • Howtoreducethehumidityforcoldroomsandwarehousesformedicinestorage?..................5 • 1.3.Documentationrequiredpriortocommencementof amapping study......................................6 1.4.Acceptancecriteriaforthemappingstudy?............................................................................6 • 1.5.Howtodecidethesamplingintervalofdatacollectionforthemappingstudy..........................6 1.6.Howtousetheresultsoftemperaturemappingstudy............................................................7 • 1.7.Temperature mappingstudy/ Temperature &Humiditymapping studyforvarious assets ........7 1.7.1.TemperaturemappingstudyofReefertrucks&vans..............................................................7 • 1.7.2.Temperaturemappingstudyofawarehouse........................................................................8 • 1.7.3.TemperaturemappingstudyofColdroom.............................................................................8 • 1.7.4.Temperaturemappingstudyofarefrigerator.........................................................................8 • 1.7.5.Temperaturemappingstudyof ashipping box.......................................................................8 • 1.8.ReportsgeneratedinTemperatureMappingstudy.................................................................9 • WhatisTemperatureQualificationstudy?(orTemperature&HumidityQualificationstudy)......9 • DifferencebetweenTemperaturemappingstudyandTemperaturequalificationstudy...........10 • HowtodecidewhetheryouneedTemperatureMappingstudyorTemperatureQualification Study?10 • ...DoyourequireaTemperaturequalificationstudyorTemperatureandhumidityqualification? • ..............................................................................................................................................10 • AdvantagesofaTemperaturequalificationstudyoveramappingstudy................................10 • Documentation required prior to commencementofa qualification process ...........................11 2.6.Reports of a Temperature qualification study.......................................................................11 3.ReasonsforfailureofaMappingstudy................................................................................11 • 3.1.Reasonsforfailureof mappingstudyof avan......................................................................11 • 3.2.Reasonsforfailureofmappingstudyofacoldroom............................................................12 • 3.3.ReasonsforfailureofmappingstudyofaWarehouse.........................................................12 • 3.4.Whatisthevalidity periodofatemperaturemappingstudyandtemperaturequalification study?13 • 4.Howtoimprovetheresultsof thetestandeliminatechancesof failure?...............................13 4.1.Advantagesofatrialstudy.................................................................................................13 Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  3. 4.2.Howtocarryoutatrialstudy?............................................................................................144.2.Howtocarryoutatrialstudy?............................................................................................14 5.DocumentsrelatedtoMappingstudy&Qualification............................................................14 Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  4. TemperaturemappingstudyandTemperaturequalificationstudyarecarriedoutgenerallyin pharmaceuticalindustry.Therearedifferentkindofmedicinesandvaccineswhichneedto bestoredandtransportedatcertain temperatures.Majority ofthesemedicinesandvaccines areundertwocategories viz. Thosetobestoredbetween 2to8DegreeCentigradeand thosetobe storedbetween15 to25°C. • Itisimportantfortheefficacyofthemedicine thatthe samebe stored andtransportedattherecommended temperature limitsas above.Ifthemedicine orvaccine goesabove thesetemperature limits,themedicinal propertieswillbegraduallylostandmostimportantly theproductswillnotshowanyindicationthatithas beencompromised.Insuchcasetheultimatedistributor anduserwill be unawareof the efficacyof themedicine. • The storageis doneinwarehouses,coldroomsor refrigeratorsandtransportationis carriedoutin boxes, vans,reefersandcontainers. • Thewhole setofstudy is carried out to analyzethetemperature distribution inawarehouse, cold room, refrigerator, vanorreefer truckstofind out whether the temperature inside such facilityisalways maintainedbetweenthe desired temperature. • TemperatureMappingStudy/Temperature&HumidityMapping study • ThisarticlebriefaboutmappingstudyforTemperature &Humidity • TemperatureMappingStudy/Temperaturedistributionanalysis • Firstlywewillexplainabouttemperaturemappingstudyandthereafterabout temperature&humiditydistribution. • Why wouldyourequire Temperature Mapping Study (aka TemperatureDistribution study)? • Ifyouare involved in manufacturing, transportation, storageordistributionofmedicines and vaccines,youwillbeinterestedtoknowmoreabouttemperaturemappingstudy.Inall these casesyourmedicine iskeptinside an enclosed area such asawarehouse, cold room, temperature controlledvan,reefertruck,refrigerator,insulated boxesetc. Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  5. Insuchcasesyouneedtoensurethatthetemperatureinsidetheenclosedareaiswithin the desired limits. eg. Ifyouwant to keep the medicine between2 to 8°C andyouare keepinginsideacoldroom,howdoyouensurethatall theentirecold roomis betweenthesetemperature limits?Youmightbekeepingthemedicineatoneshelf insidethecoldroom. Youwillnothaveanyidea whetherthisparticularplaceiswithinthelimits. Generallyyouwill have an indicator connectedtothe coolingunit todisplaythecurrenttemperature.This display picks up the temperature just from one sensor placed atacertain location near the duct openingofthe cooling unit, basedonwhich the cooling unit has its switchONandOFFcycles.Thismightbeindicatinga temperature between2and8°C.Most ofustend tobelieve that this displayed temperature isthe temperature acrossthe entire coldroom. Howeverhowabout various shelves and cornersofthe coldroom where youarekeeping yourmedicineswhichare farawayfromthisparticularsensor? How does athird party like an auditor can check whether the entire coldroomis under correcttemperature? Howcan youensure thatthedisplayatthefront doorisexactinrelationwiththe correspondingsensor? Howdoyouknowaboutthevariationswhenadoorisopened?Thesensormightbefar away from thedoorand hence may not reflectanyvariation. However it really happens that the area nearthedoorsuddenlygoesabove8°C. Allthesedoubtscan beclarifiedonlythrough atemperaturemappingstudy. 1.1.2.Howdowecarryouttemperaturemappingstudy? In principleatemperature mapping study involves recording the temperatureofthe cold compartment under various conditions.The datawillberecorded fordays orweeks asper the natureofthe asset. Numerous temperature data loggers willbeplaced inside the testing area at various heightsanddatawillbecontinuously recorded. Dependingonthe natureof the property,thefollowingconditionswillbetested: Testingunderemptyconditionstoanalyzethedistributionoftemperaturewhen there are noloadsinthearea. Testingunder60%loadedconditiontoanalyzethedistributionwhentheareais loadedupto60%offull capacity. Testingunder100%loadedconditiontoanalyzethedistributionwhentheareais loaded infullcapacity. Dooropeningtesttounderstandtheeffectsontemperatureduringandafteradoor opening. Powerfailuretesttoanalyzetheeffectsintheeventofapowerfailure. Startuptesttocheckthetimerequiredforstabilizingofthetemperatureinsidethe area. Recoverytesttocheckthetimetakenfor temperaturerecoveryafteradooropening. Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  6. Whatistemperature andhumiditymappingstudy? • Themethodology is same asatemperature mapping study. However in this case humidity also willberecorded for the same duration and willbeanalyzed. Ifthereare dehumidifiers alreadyinstalled,thesettingsofthesamealsowillberecordedtocompareagainstthe actualresults.Nowadaysformanyofthestorageareas,humidityalsoisimportantand hence needto be includedinthe study. • Doyourequire a temperature mapping or temperature & humidity mapping? • Asmentionedearlier,thisneedtobedecidedbythemanufacturerofthemedicinesoras peryourinternalqualitypolicy.Forawarehouse, • generallyitispreferredthathumidityalsobeincludedin • thestudybecauseawarehouseisdirectlyaffectedby the external ambient conditions.For acold room the humidity cangoto extreme high levelsofup to 100% becauseofits natureofoperation.Generallythedoor ofthe coldroomopensto awarehouse which is ata higher temperature.Sincethe coldroomis atalower temperature, it will attract the moisture and hence will alwayshaveahigherhumidity.Henceirrespective ofthe • medicine beingkeptin the cold room,itis ideal that the coldroom beanalyzed for humidity aswell.Howeverthiscan be decidedbyyouandyourpharma manufacturer. • Werecommend that for warehouses and cold rooms temperature and humidity mapping study needto becarriedout. Forvans, reefers, refrigerators andboxes,only temperature mappingstudymightbesufficientunlessotherwise specified. • What istherecommended humidity level for storage of medicines? • This generally dependsonthetype ofmedicineandthe packaging beingkeptin the storage area either forcoldroom orwarehouse. Hence this is generally recommendedbythe medicine manufacturers. Generally mostofthe manufacturersarerecommending that the humidityshouldbemaintainedunder amaximumlimitof65%underall conditions. • Howtoreducethehumidity for cold rooms and warehousesformedicinestorage? • Humidity canbereduced mainly utilizing dehumidifiers. These are electrical devices which absorb humidity from theairandconvertitintowater. Thewaterthus extractedcan beremovedeithermanually or automatically. In theautomaticmethod there isawater pump attachedtothe dehumidifier which will pump the watertoan external outlet. In the manual method the watergetsfilled up inatry underneath andhasto be manuallydrainedperiodically. Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  7. Inordertodecidethenumberandtypedehumidifiers,specialcalculationsneedtobe carriedoutconsidering thepresenttemperature, humidity, desiredhumidityetc. Generallyforwarehouses,desiccanttypeandforcoldrooms,rotarytypedehumidifiers haveto beused. 1.3.Documentationrequiredpriortocommencementofa mappingstudy Thecustomerhastoprovidethelayoutdrawingoftheassetincludingdetailsandlocations of coolingunitsand dehumidifiersif any. Basedonthesedocumentsaprotocolwillbepreparedbyuswhichhastobereviewedand approvedbythe customer. Thetestswillbecarriedoutbyusbasedonthisprotocolpriortocommencementofthe temperature mappingstudy. 1.4. Acceptancecriteriaforthemappingstudy? Theresultsofthe distribution study willbeeither passorfail. Also it canbefailorpasswith some deviations.Thecriteria for acceptanceof thestudy willbedefined in the protocol and typicalonesare asunder: Allreadingsofthedataloggersshouldbewithinthedesiredlimitsoftemperature& humidity MeanKineticvalueshouldbewithindesiredlimits(Wedonotencouragethiscriteria unlessinsistedbytheclient.Howeverwewill indicatethevaluein ourreports) During dooropeningtests,the values should bewithin limits andshouldreturnto normalcywithinthedesireddurationasdefinedinthe protocol. 1.5. Howtodecidethesamplingintervalofdatacollection forthemappingstudy Sampling interval is the frequencyof datarecordingof the dataloggers.Generallythe dataloggerscan be programmed torecordthe dataatdifferentintervals such as 10seconds, 30 seconds,1minute etc. If the samplinginterval ofatemperature dataloggeris programmedfor 5minutesitmeansthatthe temperature isrecorded every5minutes. Samplinginterval ofdatacollectionshouldbekept ideallyasfollowsforatemperaturemappingstudy: 3minutesfor2-8°Cassetssuchascoldrooms,vehicles,boxes, refrigeratorsetc. 5minutesfor 15-25°Cvehicles. 10-15minutesforwarehousesmaintainedat15-25°C Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  8. This is mainly basedonthe goods tobestored inside the asset. Eg. Ifamedicine which shouldnotgoabove8°Cfor2minutesisstoredinsidearefrigerator,itmeansthatyou should keepasampling intervalofat least1minute.For amedicine which is permittedtogo above 8°Cfor10minutes,a samplingintervalof3minutesissufficient. Thisalsodependsontherangeofthetemperature.2-8°Cisaverynarrowrangeandcan goabove this range even for minor fluctuations. Hence ideallyasampling interval should not be more than3minutes. Forawarehouse,15-25°Cisawiderrangeandtheriseintemperaturewillbeslow.Hence a samplinginterval of10minutesissufficient. 1.6.Howtousetheresults oftemperaturemapping study Fromthe summaryofthe reportsof atemperature mapping study, the following details will be usefulfor yourpracticalapplications When youdecide toplacemonitoringdevices suchas dataloggers orrealtimemonitoring devices, those shouldbeplaced inHotand cold points.Hotand cold points willbementioned in ourreports. Thereport will indicate the duration within which the temperature willexceedthe permitted levels upondooropening.eg. ifsuchdurationis 5 minutes, youshould takecarethat thedoor openingshouldbefor averyshortduration. Thereportwillindicatethedurationwithinwhich thetemperaturewillexceedthepermittedlevelsintheeventofpowerfailure.Soin caseof apower failure,youshould not open thedoorand shouldbein closed condition ifyouexpect that power willberestored within suchaduration. Ifyoudo notexpectpowerrestorationwithinsuchadurationthemedicinesshouldbeshifted toanalternate facilitysuch asa temperaturecontrolledvanorreefer. 1.7. Temperaturemappingstudy/Temperature &Humidity mappingstudyforvariousassets Briefdetailsofthestudyforvariouskindofassetsaredetailedhereunder 1.7.1.TemperaturemappingstudyofReefertrucks&vans Foralltype ofvehicles,primarilythefollowingtestsarecarriedout: Distributionanalysisunderemptyconditions(24hours) Distributionanalysisunder60%loaded conditions(24hours) Distributionanalysisunderfullloadconditions(24hours) Powerfailuretest Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  9. e.Door openingtest Thepercentageloadingcanbedecidedbytheclientasperhisusual loadingpattern. 1.7.2.Temperaturemappingstudyofawarehouse Forawarehousethefollowingtestsarecarriedoutaspart ofatemperaturemappingstudy Temperatureandhumiditydistributionanalysisiscarriedoutunderloaded conditions. Dooropeningteststoanalyze the effects Foranexistingwarehouseitwillbedifficulttocarryoutothertestssuchasemptytest, power failure test etc. since it maybedifficulttoremove the existing goods form the warehouse.For awarehouse the distribution analysis is carried typically for 7-14 days. The testsshould alsoincludeholidayssothatthepatternscanbeanalyzed. Samplingintervalof datacollectionshouldbekeptideallyat10-15minutes. 1.7.3.TemperaturemappingstudyofCold room Foralltypeofcoldrooms,primarilythefollowingtests are carried out: Distributionanalysisunderemptyconditions(24 hours) Distributionanalysisunder60%loaded conditions(24hours) Distributionanalysisunderfullloadconditions (24hours) Powerfailuretest Dooropeningtest Thepercentageloadingcan bedecided bythe clientasperhisusualloadingpattern. Samplingintervalwill begenerallykeptat3minutes. 1.7.4.Temperaturemappingstudyofarefrigerator Forrefrigerators, primarilythefollowingtestsarecarriedout: Distributionanalysisunderemptyconditions(24hours) Distributionanalysisunder60%loaded conditions(24hours) Powerfailuretest Dooropeningtest(fordifferentdurationssuchas60seconds,120seconds,180 secondsetc.,sinceforarefrigeratorthedooropeningwillbemorefrequent comparedtootherassets) Thepercentageloadingcan bedecided bythe clientasperhisusualloadingpattern. Samplingintervalwill begenerallykeptat1-2minutes. 1.7.5.Temperaturemappingstudyofashipping box Forshippingbox,the followingtestsare carriedout: a.Distributionanalysisunderemptyconditions(24hours) Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  10. Distributionanalysisunder60%loaded conditions(24hours) Powerfailuretest(foractivecooling boxes) Dooropeningtest Foractiveboxes,thetestswillbeconductedinsideavanaswellasinsidea warehouse Thepercentage loading canbedecidedbytheclient as per his usual loading pattern. Samplingintervalwill begenerallykeptat3minutes. 1.8.Reports generatedinTemperatureMappingstudy The reportsof amappingstudywillincludethe followingdetails: Temperature distribution–Pass /Fail Humiditydistribution–Pass/Fail Hotand cold pointsoftheasset.Thesewillbe the hottest and coldest pointsofthe area. Data loggersneedto beplacedin these areas Analyticalgraphsforallthe tests Anyrecommendationsforimprovement Timetakentoreachthedesiredtemperature afterstartup Durationforwhichthetemperatureremains within the limitsafter apowerfailure Durationwithinwhichthetemperatureexceedsthelimitsduring adooropening 2.Whatis Temperature Qualification study?(or Temperature& Humidity Qualification study) Temperature qualification studyisavery detailed sequenceoftests and analysistoensure that the asset is designed and installed in suchaway that it is capableofmaintaining the desired temperature. After these seriesoftestandverification the asset is certifiedto be qualifiedforachievingandmaintainingthedesiredlevelsoftemperatureandhumidity levels.Thevarioustestscoveredunderthequalificationprocessingeneralareasunder: Designqualificationprocess–toverifytheequipmentaredesignedtogeneratethe desiredtemperature and humidityconditions Installationqualificationprocess–Toverifywhethertheinstallationiscarriedoutas perthedesignandaspertheinstallationproceduresrecommendedbythe respective manufacturersofcriticalequipment. Operationqualificationprocess–Toverifythattheoperationsarecarriedoutasper the recommendedproceduresofthemanufacturersofthe criticalequipment Documentverification–Toverifywhetheralldocumentsaremaintainedbytheuser includingSOP,calibrationcertificatesetc. Temperaturemappingstudy(andHumidityifrequired)–Thistestismoreorless same asdefinedinthe firstpartof thisarticle. Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  11. 2.1. Difference betweenTemperaturemappingstudyand • Temperaturequalificationstudy • In atemperaturemappingstudy,onlydistribution of temperature&humidity are analyzed. This study makes sure that the distribution is always within the permitted range oftemperatureandhumidityasapplicable. Howeverthemappingstudy doesnotcheckvarious criteria such as SOP, whether installation has beendone correctly, whether the machines are working as per the design,whetherwrittenproceduresaremaintained, whether these written procedures are sufficient etc. All suchparametersarecoveredin atemperature qualification study. • Atemperaturequalificationstudy incudesmappingstudy,butnotviceversa. • Howtodecidewhether youneed Temperature Mapping study orTemperatureQualificationStudy? • Ifyouwanttocheck only distributionoftemperature&humidity,amapping studyis sufficient. Ifyouwanttocheck whether thewholeasset is designed, installed and operated correctly,itisdesirabletocarryouta temperaturequalification study. • Aqualification study is consideredtomoreofinternational acceptance. An auditor from another partofthe world may notbefamiliar with various installation and operational parametersofthe asset. If an asset is qualified the asset is consideredto be afully satisfactorysystem. • Do yourequire aTemperaturequalificationstudyor Temperatureand humidityqualification? • Pleaseseeourexplanationforsimilar queryundertemperaturemappingstudy. • If yourmajorparameterisonlytemperature,they youmaylimit toatemperature qualificationstudy.Ifyoualsorequirehumidity,atemperature&humidityqualification studywillbe required. 2.4. Advantages ofaTemperaturequalificationstudyovera mappingstudy Thetemperature qualification studyis consideredmoreofinternational acceptance.Soif yourclients and suppliers are from various countries it is preferredto have aqualification process done. As anexampleeach country has theirown type of design,installation and operation procedures foracold room. Henceyourclient from anothercountrymay not be familiar with such parameters inyourcountry. Ifatemperature qualification studyiscarried outonthis cold room,theclient need not checkanydetails at all since the coldroomis fully qualifiedtoensurefullcompliance tokeepatemperaturebetween 2-8°C Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  12. 2.5. Documentation requiredpriortocommencementofa qualificationprocess Priortocommencementofatemperaturequalificationstudy,werequirethefollowing document/detailsfromthe customer. • The customerhastoprovidethelayout drawingoftheasset • Alldetailsofcoolingunitssuchassl.nos.,detailsofsensors,operationmanuals, design drawingsetc.have to beprovided. • Similardetailsofdehumidifiersalsohavetobeprovided. • Alldetails oftemperature monitoring systems(ifany)tobeprovided. • Basedonthesedocumentsaprotocolwillbepreparedbyuswhichhastobereviewedand approvedbythe customer. • The testswillbecarried outby usbasedonthis protocol. • 2.6.Reportsof aTemperaturequalification study • Thereportsof atemperature qualification study will contain the following details in general. Pleasenote thesemayvarydepending onthenature ofthe asset. • Design qualification process –PassorFail • Installationqualificationprocess–Passor Fail • Operation qualificationprocess–PassorFail • Documentverification–Pass orFail • Emptymappingstudy–Pass orFail • Loadedmappingstudy–PassorFail • Powerfailuretestresults • Recoverytestresults • Startuptestresults • Hotandcoldpoints • Deviationifany • Recommendations • Correctiveactions • If all theabovetests are passed satisfactorily during the temperature qualification study, we issueacertificate indicating that the asset is fully qualified.Thedetailsofthe asset willbe indicatedin the certificate. • Reasonsforfailureof aMapping study • Commonreasonsforfailureofatemperaturemappingstudyorahumiditymappingstudy are listedhere: • Reasonsforfailureof mapping studyofavan • Weare mentioningofsmall and medium sized vans. There are many reasons for failureof these vehicles duringatemperature mapping study and temperature qualification.Themain onesare listedhere: Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  13. Thetemperature shown in the display unitofthe cooling unit may notbematching with actual inside temperature. Probably the sensor is reading is not correct. This can happen for many reasons. Overaperiodoftime the accuracyofthesensormaybe lost. Eg. the display unit mightbeshowing 5°C and the driver willbeconfident that thecoldcabinisat5°C.Howeveritispossiblethattheinsidetemperatureisat7°C. In ordertoavoid suchasituation placea dataloggernext tothe sensorofthe cooling unit and record for few hours. Set thecoolingunit at desired temperature. Aftercouple ofhoursdownloadthe dataand analyze. Thegraphwillbein continuous up anddowncycles. Check the highest and lowest temperatureofthese cycles. If these valuesareclosetothe set point,itmeans that the sensor and display unit are working correctly.Eg.if the set point is 5°C, the highest and lowest readings shouldbe7°C&4°C.(Thisvaries basedonthetype ofcooling unit, programmed settingofupperandlowercutofflimitsetc.Howeverthiswillgiveanindication aboutcorrelationofthedisplayedtemperatureandactualsensortemperature. • Temperaturegoestoextremelowandhighpointsatallcycles.Eg.Thesetpointis • 5°C.Howeverthetemperature goesregularly to9°Cand3°Cregularly.This happenedbecausethecoolingunitisprogrammedaccordingly.ie.Ithasahighcut off at 4°Cabovethe set point andlowcut offof2°C below the set point. This canbe programmed for 2°C forbothhigh andlow cutoff points. Thereafterthehigher& lower cut off willbe 7 &3°C respectively. (This feature is basedonthe manufacturer andmodels ofthe coolingunit) • Temperatureononeendofthevehiclegoesbeyondlimits.Thishappensmainlyin • vehicleswhichhasonecoolingunitandhavingfanonlyatoneend.Itispossible that the other endofthe cold cabin is not properly receiving the air. If the fan unit is not producing strong air flow it may happen. Otherwise air flow ductswillhaveto be provided from the cooling unittothe other endofthe cooled cabin. Thus the air will bedivided through multiple ducts and distributedatfrontandrear endofthe vehicle. • Temperaturegoeshigh at certain points during loaded test. This may happen mainly duetolimitedairflow.Duringaloadedtest(andduringactualloadedconditions), • goodsshould notbeplaced directly in front ofthe air flow. Also sufficientspace shouldbe lefton allsidesandonthetopforefficientairflow. • Reasonsforfailureofmapping studyofacold room • Generalreasonsforfailure of a coldroomareas under: • Thedisplayunitfixedattheoutsideofthecoldroommaynotbedisplayingthe correcttemperatureof the coldroom. • Theloadinganddistributionoftheshelvesmaynotbeuniformthushinderingproper • airflow • Humiditymaybehigherthanthepermittedlevels • Thepositioningofthecoolingunitsmaynotbeinperfectlocationthusaffecting uniformdistribution • Air curtainsmayberequiredatthedoors • Reasonsforfailureof mapping studyofaWarehouse Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  14. Forwarehousesthemostcommonreasonsforfailureare: • Thenumberofcooling unitsorthecapacityofthecoolingunits maynotbesufficient • The location oftheductsmaynotbeproper • Humiditymaybehigherthandesiredlevels • 3.4.What isthevalidity period of atemperaturemapping study and temperaturequalification study? • There are no generalrulesapplicable for the same. However foranew facility we suggest thatthestudyreportcanbeconsideredvalidforaperiodof3years. • If any modifications are carried out relatedtoshape and layoutoftheasset,modificationor replacementofcooling units, rearrangementofracks etc., the original report cannotbe considered valid.Thereasoning is that anyofthese changes will affect the distributionof temperature andhumidity. • Howtoimprovetheresults ofthetest and eliminate chances of failure? • It is ideal that beforecarryingout the actual study,youmay carry outatrial study with few numberof dataloggerstoanalyze the data. This trial study will help youtoevaluate major problems if any. Forall contracts being undertakenbyus, we carry outatrial study before commencementoftheactualtest.Thiswillsave valuabletimeandmoneyforthecustomer. • Advantagesofatrialstudy • Majoradvantageof conductinga trialstudyare: • Saving time and money–After conductingafull testyoumay end up with some deviations. In such caseyouwill havetocarry outaretest after undertaking the correctiveactions.Bythistimeyoumaybeinthemidstofaclimatechangeand hence will havetowaitforthenextseason. Ifatrial study is planned properly, this canbe avoided. • Correct settings for cooling units–sometimes justbychanging the settingsofthe cooling unitsyoumay have better results.Youmay not have noticed this so far becauseyourcurrent recording devices werenotplaced at the correcthotand cold points. • Requirementofdehumidifier–Inmanycaseshumiditydistributionwasnotproperly • analyzedandhencemayrequire installationofdehumidifiers. This isaprocess involving time and money and hence ifunderstoodat the proper stage, suitable actionscanbe undertaken. Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

  15. 4.2.Howtocarry outatrialstudy? Beforecommencingtheactualtests,wewillsentyousomedataloggersforplacingat certainlocationsasperthedrawings.Thedataneedtobecollectedforacertainduration and thedataloggers haveto bereturned.Wewill analyze thedataandwill providesuitable recommendations. Generally we includeonetrial study inourscopetoassist customers(To be finalizedatthetimeof finalizingthe order) 5.Documents relatedtoMappingstudy&Qualification Casestudyof atemperaturequalificationstudyonacoldroom Protocol/SOPforTemperaturequalificationstudyofcold room Protocol/SOP for Temperaturemappingstudyofwarehouse NB:Foreaseofunderstanding, we generally mentioned about temperature throughout the article. However all mentions about Temperature mapping study are equally applicablefor Temperature &Humiditymappingaswell.Similarlyallmentions ofaTemperature qualificationstudyareequallyapplicablefor Temperature &Humidityqualificationstudy. AlsotemperaturemappingstudyisknownasTemperaturedistributionanalysis. Vacker LLClPO Box92438lDubailUAE Phone:(+971)42 661144lFax :(+971)426611 55 email:sales.uae@vackerglobal.com Part of VackerGlobal Group Ouroffices:UAE (Corp.Office), India,Oman , Kuwait, USA www.vackerglobal.com

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