all about Temperature Data Loggers
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This document discusses different types of data loggers and their applications in cold chain monitoring of pharmaceutical products. It provides details on 12 different applications for data loggers in cold chain monitoring and the specific requirements for each. It also describes the history and evolution of data loggers, from chart recorders to modern Bluetooth and real-time options. Key hardware types are outlined, including single-use, multi-use, and real-time data loggers, as well as indicators and loggers with external sensors.
all about Temperature Data Loggers
- 1. TheOptimalDataLoggerSolutionforYourProcesses Thechoiceofdataloggersforyourpharmaceuticalproductshasanimpactonyourlogisticscosts,efficiencies in your supplychain processes, and compliance with regulatory guidelines. Whatisrightforone product and area, may not be suitable for another.This practical guide describes how certain typesof dataloggers make the most sense depending on the monitoring requirements, such as one-waytransport, outbound and return transport, and storage. What if personnel at your receiving site are not well trained or do not have access to computers if data needs tobedownloadedviaUSBoruploadedtothecloud?Whatifthepallethasalreadybeenprepackagedat your sending site and stored until the shipment date, but data collection must be started without opening the pallet?Thisguidewillhelpyouanswerthe“whatif”questionssothatyoucanbetterdecidewhichtypesof data loggers are the best fit for your products and supply chain processes.
- 2. TheHistoryof Data Loggers The history of data loggers used for monitoring tempera- ture in GMP- and GDP-regulated environments goes back tochartrecorders.Upuntilthe1970s,theywereusedto measure and archive the temperature and humidity of facilities, trucks, and equipment. Chart recorders, however, have significant disadvantages, including low accuracy, regular paper changes, noalarm function, andno ability to digitally process data. Theinventionofstandardmicroprocessorsenabledthe development of simplified, battery-driven temperature data loggerswithawiderangeofapplications–fromlaborato- riesanddentalcaretofoodprocessingandtransportation. The device recorded temperature data using internal or externalsensorsandmeasuredtemperatureandrelative humidity. Inthelate1990s,thefirstsingle-usedataloggerswere brought to the market and produced a simple measure- ment series, the so-called “temperature curve.” Although theystillneededacable,areadoutstation,andsoftware todownloadthedata,thiswasanimportantstep.This wasalsothemomentwhendataloggerproductsbegan to specialize and split into two segments: > Morecomplexmulti-channeldataloggerswithnetwork accessformingtheacquisitioninstrumentforcentral monitoring systems. > Simplersingle-usedataloggersbringingdowncosts for one-way transport – today known as “cold chain monitoring.” In 2008, ELPRO invented the first PDF data logger and revolutionizedthecoldchainmarket.Previoussingle-use dataloggers stillneeded adocking stationandsoftware to downloadthedata,whichwasverycumbersome,especially whenshippingtoalargenumberofdestinationswithout trainedpersonnel.PDFdataloggersthatautomatically generateaPDFreportwhenconnectedviaaUSBportto acomputerrepresentedahugesimplification,makingthe processmorestableandcost-efficient.APDFdocumenthas various advantages: > PDF reports can be viewed from any device without ad- ditionalsoftware,andalsobeusedasdocumentationof the release (OK or ALARM). > PDF reports are compliantwith the ISO19005 standard for long-term archiving of digital documents. > PDFreportscanbewrite-protectedandprotectedfrom manipulationbyinsertinganencrypteddatablock. Thankstosmartengineeringandmassproduction,costs per unit have been reduced to a small double-digit amount. Thehigh-qualityGAMP5validateddevicescomplywith 21CFRPart11oftheUSFoodandDrugAdministration (FDA)regulationandevenhaveanNISTcalibrationcertifi- catethatistraceableinaccordancewithISO17025.
- 3. One-way transport on product Requirements and Applications of DataLoggers in Cold Chain Monitoring Cold Chain Monitoring of pharmaceuticals is more than just monitoring a product in transit from A to B. Over the years, many different applications have emerged. The following list shows the most important applications and their specific requirements: A data logger is used to monitor the temperature of sen- sitiveproductsintransit(frompackagingatthesenderto unpackingatthedestination)anddocumenttherelease atthedestination.Thedataloggerisonlyusedforaspecific pallet or package containing a product with a specific sensitivity and stability budget. The stability budget and acceptance criteria are stored either in the data loggeror inthedatabase.HardwareexamplesincludePDFdata loggers and real-time temperature sensors. A data logger is used to monitor a delivery unit or a trans- port vehicle used to transport temperature-sensitive products (from packing at the sender to unpacking at the destination) and to documentthe release at the destina- tion.Thedataloggerisonlyusedforaspecificdeliveryunit (e.g.twopalletsofproductx)oraspecifictransportvehicle (atruckorcontainerwiththreepalletsofproducty).A deliveryunitortransportvehiclemaycontainmultiplepro- ductswithdifferentsensitivitiesandstabilitybudgets.The stability budget and acceptance criteria are only stored in thedatabase.HardwareexamplesincludePDFdataloggers and real-time temperature sensors. What are the requirements for this application? > Configurable data logger as stand-alone product or as part of a database solution > Batterylife:100days(sufficientevenforverylong ocean freightshipments) > Stability budget (warning limits with permissible deviations) > Start/stop function > Display showing the status > Identifier(e.g.palletID)connectingthedatalogger with the specific product (and remaining stability budget) during transit What are the requirements for this application? > Configurable data logger as part of a database > Batterylife:100days(sufficientevenforverylong ocean freightshipments) > Warning limits > Start/stop function > Display showing the status > Identifier (e.g. delivery ID) connecting the data logger withthespecificdeliveryortransportvehicleID > Databasefunctionthatallowsadeliveryunitortransport vehicletobesplitintomultiplelineitemswithseparate stability budget and release assignments One-waytransportondelivery unit or in transport vehicle
- 4. A data logger is used to monitor the temperature of sen- sitive productsintransit(from packagingatthesender to unpackingatdestination)anddocumentthereleaseatthe destination.Aftertransport,thedataloggerremainswith the product in an on-site coldroom and continues to moni- tor the product’s stability budget. The stability budget and acceptance criteria are stored either in the data logger or in thedatabase.HardwareexamplesincludePDFdataloggers and real-time temperature sensors. Adatalogger(orelectronicindicator)isusedtomonitor thetemperatureofasensitiveproductthroughoutthe supply chain (from filling to patient/consumer) and indicate theproductstatus:OKtouse(TOR<stabilitybudget)vs. ALARM, do not use (TOR> stability budget). The device is started,attacheddirectlytotheproductboxorsalesunit, andstaysthereuntilitsfinaldestination(patientorconsu- mer).IncaseofanALARM,thestatusandstatisticalvalues needtobedocumentedandtheproductownerneedsto be informed. Amulti-usetemperaturedataloggermonitorsaproductin transit during one-way shipment (only for a specific productortransportvehicle)andisreturnedtothesender for reuse. The reuse concept is either organized by the shipper or facilitated by a service provider (temperature monitoring as a service). What are the requirements for this application? > Configurable data logger as stand-alone product or as part of a database solution > Battery life: three years (sufficient for transport and storage) > Stability budget (warning limits with permissible deviations) > Start function (no stop) > Multi-reportfunction:dataloggermustbeable to generate multiple reports What are the requirements for this application? > Configurable electronic indicatorthatcantrack the stability budget (warning limits with permissible deviations) > Batterylife:fiveyears(sufficientforentireshelflife) > Start function (no stop) > Download function for statisticalvalues andescalationprocessincaseofalarm What are the requirements for this application? > Multi-use data loggerallowing forreconfiguration > Battery life: minimum of one year > Returnconceptor“monitoringasaservice”package > Warning limits > Start/stop function > Display showing the status > DatabasefunctionallowingthesamedataloggerID to be used for different shipments One-way transport onproductandduring storage End-to-end on product One-way transport on product with return
- 5. Samples(forgenetherapy,diagnosis,anti-doping)arecol- lectedfrompatientsandtransportedbacktothelaboratory at a controlled temperature. The data logger is started at a remote location by untrained personnel. Amulti-usetemperaturedataloggerwithexternalsensor ismountedtoatruckorcontainertransportingtemperatu- re-sensitive products. Container-specific processes include: start data logger in alarm-off state, start assessment, pause assessmentforrefilling,stopdataloggeratdestination,and readout.Afterreadoutatthedestination,thedataloggeris returnedto itsowner togetherwiththetruck orcontainer. Monitoring can be restarted to generate the next shipment report. A temperature sensor (or data logger) ismounted inside a mobilecontainerortruck forcontinuous temperature andlocationmonitoring.Theprimarypurposeofthedata logger is asset management and backup monitoring.Pro- duct-specificreleasedecisions(timeoutofthecoldchainin relationtothestabilitybudget)andreleasedocumentation are not the focus here. What are the requirements for this application? > Preconfiguration of device by sender > Sufficientshelflifeandbatterylifefordistributionto samplinglocations,aswellasforstorageuntiluseand for monitoring during transport > Simple, safe start-up (worst-case scenario: forgetting tostart the data logger) > Display of successful start What are the requirements for this application? > Multi-use data loggerallowing forreconfiguration > Externalsensorandbracketformountingoutside containers(e.g.cryocontainerdownto–196°C) > Real-time temperature and location logging for asset tracking > Battery life: minimum of one year > Start, pause, and stop function > Display showing the status > Touchless readout > Bracket for theft protection What are the requirements for this application? > Multi-year data logger with replaceable battery > Reliable transmission and archiving of data > Real-time temperature and location logging for asset tracking > Bracket for theft protection and waterproof design (IP 65) for heavy-duty use Collection on product Round-trip on container Continuous in transport vehicle
- 6. Atemperaturesensor(ordatalogger)mountedinsidea room oronequipmentcontinuously monitors temperatu- re. The data logger monitors the temperature and issues analarm messagein theevent of deviations. Using a data loggerisusefulifonlyafewmeasurementpointsare monitoredoriftheobjectsarelocatedatdifferentremote locations.Thealarmmessagecanbeoutputlocally(data logger)orcentrallyviaaclouddatabase(IoTsensor). A multi-use temperature data logger with internal or exter- nal sensor is used to measure and store temperature or hu- miditydataofa processduringa limited periodoftime.The dataloggermustbestarted;itreportswhenlimitvaluesare reached, and mustthen be stoppedandanalyzed. A data logger with internal sensor is usedaspartofthermal mappingduringqualificationofawarehouse,atruck,or equipment.Dataloggersmustbecalibratedandclearlyla- beledforplacementwithintheroomatthespecifiedmap- pingpoints.Functions:start,stop,readout,andoverlay,or temperatureduringthedefinedtimeperiod;searchforthe highestandlowesttemperatureofallmeasurementpoints. What are the requirements for this application? > Batterylife:oneyear(orIoT-sensorwith replaceable battery) > Reliable transmission and/or archiving of data > Local or central alarm function > Efficient deviationanalysis > Convenient reporting What are the requirements for this application? > Multi-use data loggerallowing forreconfiguration > Internal or external sensor > Batterylife:twotothreeyears;minimumofoneyear > Start, pause, and stop function > Display showing the status > Touchless readout > Bracket for theft protection What are the requirements for this application? > Single- or multi-use data logger > USBreadoutwithautomatedreportfunctionality or real-time readout and overlay > Reporting with min/max temperature Continuousinremoterooms or equipment Process monitoring Temperature mapping
- 7. Different hardware types of data loggers Thefirstdata loggers were limited to monitoring tempe- raturesbetween–10°Cto+50°C.Storagespaceandsensor elementswereexpensive.Intoday’sworld,hardware ischeapandcloudcomputingallowsthecollectionand processing of huge amounts of data. If hardware is cheap and computing power is not alimitingfactor,whyistherestillmorethanone dataloggertype?Thesearethereasons: 1. Single-use: Pharmaceutical companies transporting large volumes of data loggers tend to purchase sin- gle-use data loggers. Efficiency in design and production means reducing the devices to the essentials. 2. Boxlevelunit:Thenewtrendofend-to-endmonitoring at the Box level unit means that very compact devices are also in demand. 3. Validation:ColdchaindataloggersareusedinGxP regulated environments and must be designed and validatedinaccordancewiththeGAMP5model.Each additionalsensorandfunctionaddsmorecomplexity without increasingquality. 4. Extremely low temperatures: Electronic components are sensitive to extremely low temperatures. The lowest temperaturestandardformilitaryequipmentreaches downto–40°C.However,dryiceisverycommonfor transporting samplesandbiopharmaceuticals. Thelistonpage9describesthemostimportanthardware categories in the area of cold chain monitoring and indi- cates possible applications for the individual hardware types. USB or Bluetooth® data logger? MillionsofPDF data loggerswithsimpleUSB interfacesare stillinusetoday.Thishasanumberofdisadvantages: > Manualstartrequired:aftera dataloggerhasbeenpack- aged,itisnotpossibletosetastartflagonthedevice. > Reactive: since data can only be analyzed subsequently, no intervention is possible during transport. > Manualstopandreadoutrequired:afterthedatalogger arrivesatthedestination,itmustbestoppedmanually. The data must then be uploaded to the cold chain data- base. Bluetooth® is a very commonwireless data transmission technologyforcoldchaindataloggers.Itisaninexpensive, widelyusedstandardavailableonmostmodernsmart devicessuchasnotebooks,tablets,andsmartphones. Communication via Bluetooth® consumes very little energy, whichisimportantforabattery-powereddatalogger. Does Bluetooth® allow for real-time transmission? Bluetooth®iswireless,butnotreal-time.Thismeansthat datacannotbetransmittedfromanywhereatanytime. Bluetooth®wasoriginallydesignedforperipheraldevices andrequiresaconnectionbetweentheantennaandthe datalogger.Thisconnectionismanagedbyanapplication installedonthecomputerormobiledevice,suchasa smartphone app. Itisunlikely thatnetworked mobile de- vices will be available along the transport route. Therefore, locationandtemperaturecannotnormallybetransmitted fromaBluetooth®dataloggerduringtransport.Conse- quently,thereisnoreal-timedatatransmission.Thetable belowprovidesacomparisonofthedifferenttechnologies: USB Data Logger Bluetooth® Data Logger Real-time Data Logger Start Manual Wireless with smart device Automated with geofence Intervention during shipment – – Yes Stop Manual Wireless with smart device Automated with geofence Readout/upload Manual Wireless at arrival Automated in real-time
- 8. Application One-way transport on product One-way transport on delivery unit or in transport vehicle One-way transport on product and during storage En-to-end on product One-way transport on product with return Collection on product Round-trip on container Continuous in transport vehicle Continuous in remote rooms or equipment Process monitoring Temperature mapping Data Logger Hardware Type Description Multi-use temperature data logger Classic data logger with battery life of at least one year and typically with Bluetooth®/USB interface for generating PDF reports Single-use temperature data logger Low-cost classic datalogger withbatterylifeof110days and typically with Bluetooth®/USB interface for generating PDF reports Real-time data logger Multiplesensorswithbatterylife of at least one year and cloud connectionviapublicnetwork (GSM or Mobile IoT) End-to-end temperature indicator Ultra-thin and compactelectronic temperatureindicatorwithlong batterylifeandmonitoringofthe stability budget of a product Data logger with external sensor Dataloggerwithexternalsensor withtemperaturerangefrom –200°Cto+200°Candbatterylife ofatleastoneyear,usuallywith Bluetooth®/USB interface for generating PDFreports Dry ice temperature data logger Single-usedatalogger with specialhardwaredesignand larger batteries; engineered to be exposed directly to dry ice Humidity data logger Data logger for temperature and relative humidity, typically with Bluetooth®/USB interface for generating PDF reports
- 9. Application Challenges in the Supply Chain Solution with Bluetooth® Round-trip on container (e.g. cryocontainer) At sending site: The data logger is attached to a container andyoudon’twanttoremoveitforconfigurationand startup. Wireless configuration and startwithsmartphone app via Bluetooth® At receiving site: The data logger is attached to a container andyoudon’twanttoremoveittostopandreadout. Wireless stop and readout with smartphone app via Bluetooth® One-way transport on product At sending site: Pallet is prepacked and stored. Onthedayofshipment,thedata logger mustbestarted without opening the pallet. Wirelessstartwith smartphone app via Bluetooth® At receiving site: Pallet arrives and is stored immediately. Data logger mustbe stopped without opening the pallet or box. Wireless stop and readout with smartphone app via Bluetooth® Remote storage Data logger should not be removed from the cold room when reading out. Wireless readout with smartphone app via Bluetooth® SoisBluetooth®actuallygoodfor?Below,weoutlinesome challenges inthesupplychain, and how Bluetooth® data loggers can solve them. Bluetooth® data loggers represent an interest- ingevolutionofPDFdataloggersthatoffernew options for wireless communication with the data logger. Data loggers with external sensors Comparedtointernalsensors,externaltemperaturesen- sors are very expensive. Yet using external temperature sensors on temperature data loggers is necessary for some applications: > Cryogenic shipments: Liquid nitrogen reaches a tempera- ture of –196 °C. > Accesstoresults/displayfromoutside:Somecustomers preferdirectaccessandvisualinspectionofthetempera- ture without opening the box. > Ambienttemperatures:Mostdataloggerswithexternal sensorsalsohaveaninternalsensor.Therefore,theycan monitornotonlytheproducttemperature, butalsothe ambient temperature, and provide valuable information Howrelevantisa humiditydatalogger in cold chain monitoring? Pharmaceuticalproductsaresensitiveinopenformasac- tive pharmaceutical ingredients (APIs) or during processing andfillingwithregardtovariousenvironmentalfactors, suchastemperatureandhumidity,butalsowithregard toaircontaminationbyparticles.However,assoonasthe pharmaceuticalproductisinitsprimarypackaging(blister pack,syringe,orvial),itspotencyandqualityisnolonger affectedbyhumidity.Ofcourse,humiditycancausepaper orcardboardpackagingtobecomewavy,andtherefore harmthevisualappearanceofthepharmaceuticalpackag- ing.Inwarehouseswithatemperatureof+15°Cto+25°C, it has proved useful to add a measuring point for humidity. Humidityishardlyever activelymonitored continuously duringtransportation.Ifthereareproblemswiththedew pointwhenopeningincomingcontainers,selectivehumi- dity measurements can be useful. Dry ice data loggers Dry ice is the solid form of carbon dioxide. It is a cost-ef- ficientcoolantandiswidelyavailableatairportsandin industrializedzonesasblocks,discs,orpallets.Dryice sublimatesat–78.5°Candleavesnoresidues,asitmixes withtheambientairinagaseousstate.Wheneverthere arenomechanicalcoolingoptionsduringtransportandlow temperaturesareimportant,dryiceistheperfectcoolant. Many frozen pharmaceutical products are transported on dry ice since it is safe and inexpensive. What most people donotknowisthatdryicecanproducemuchlowertem-
- 10. peratures than expected. Due to various physical effects, the temperature in dry ice containers can drop to as low as –95°C: > The sublimation temperatureofdryicedepends onthe atmosphericpressure.Thehigherthealtitude,thelower thesublimationtemperature.Aircraftcabinandcargo holdsaretypicallypressurized toanaltitudeof3,000 m abovesealevel,resultinginasublimationtemperature that is a few degrees lower. > Vibration andair flow canincrease the sublimation rate ofdry iceandthereforealsolower thesublimationtem- perature. > Pollutionofthedryice(dust,particles)canalsoincrease thesublimationrateandthereforelowerthesublimation temperature. The development of a dry ice temperature data logger that isdirectly exposedtotemperatures of–78°C(orlower)isa hugechallenge.Thelowesttemperaturestandardforelec- troniccomponentsusedformilitary purposesranges down to–40 °C.Evenlower temperatures require agreatdealof engineeringtoreducepowerconsumption,sincebatteries provide less power the lower the temperature. When the device isremoved from thedry ice atthedestination, the display must be ready for immediate use and provide a reli- able,efficientreadingandthusacorrectreleasedecision. Since there is not enough power formobile IoT communication, dry ice devices are typically USB/PDF devices. Special requirements when using dataloggersforairfreightshipments Whenusing dataloggersforairshipments,twoaspects may berelevant: 1. Some data loggers contain lithium battery cells. Lithium batterycellsareconsidereddangerousgoodsandmust therefore comply with all relevant Dangerous Goods Regulations(DGR)forairfreightshipments.There arerestrictionsonthenumberoflithiumbatterycells allowedinatransportunit.Inaddition,IATArequires lithiumbatterycellstobedeclaredintheshipping documents. Werefer to thisaspect as“IATAbattery compliance.” 2. Real-timedataloggerscommunicatingactivelyviaGSM orLPWANaresubjecttoapprovalonboardaircrafts.We callthisaspect“airlineapprovalforreal-timedevices.” IATA battery compliance Lithium batteries are characterized by their high energy density; ifdamaged, they canheatup.Due to anaccident inwhichalargenumberoflithiumbatteriescaughtfireina cargoairplane (fortunately ontheground) and otherdocu- mentedcasesofdevicescatchingfire,IATAissuedits“Guide to Lithium Batteries inAir Transport” in2017.Theregula- tionispartoftheDangerousGoodsRegulations(DGR).It requiresthatalllithiumbatterycellsandlithiumbatteries of all types have passed the tests set out in subsection 38.3 oftheUnitedNations“ManualofTestsandCriteria.”The numberofdataloggerscontaininglithiumbatteriesincylin- drical form that may be transported per shipment is limited and must be declared in the shipping documents. Devices containing lithium batteries in the form of button cells oralkaline batteries are excluded from the IATAlithium battery regulation. There is no restriction onthenumberofdevicespershipmentforthistype ofdevice.Theyalsodonotneedtobedeclaredinthe Airline approval of real-time devices TheUSFederalAviation Administration (FAA)specified in AC21.91-1Cthatactivedevices usedinaircraftsthatemit radioemissionsaresubjecttoapproval.TheUSRadioTech- nicalCommissionforAeronautics(RTCA)DO-160standard requirescargotrackingdevicestocomplywithradiatedRF emissionlimitsinallmodesofoperation.Thekeycertifica- tionrequirementisasfollows:thedevicemusthaveatleast twoindependentdevicesthatcanbeusedtocompletely shutdownthedevice inflight,shutdownthecellular func- tions,orcompletely shutdownboththecellular functions andthedevice.Acombinationofaccelerationandpressure measurementisatypicalsolution,sincetheseparameters changesignificantlyduringaccelerationanddeceleration andduringtakeoffandlanding.TheEuropeanAviation Safety Agency (EASA) carries out a preliminary test of the devicesandissuesaso-calledEuropeanTechnicalStandard Order (ETSO). Theapprovalofreal-timedevices onboard an aircraft hastobedonebytherespectiveairlinebasedonthe assessmentintheETSO.Ofcourse,real-timedevices alsocontainbatteries.However,iftheycontainalkaline batteries, they are excluded from the IATA regulation forlithiumbatteriesandcanbetransportedwithout restrictions and without declaration.
- 11. Process and configuration options Whileyoucanusuallyonlysettheloggingintervalwith traditional data loggers,mostmodern data loggers have manydifferentconfigurationoptionsforsafetyandprocess efficiencyatsendingandreceivingsites.Itisdifficultto reviewallthedifferentconfigurationoptionsandnaturally, noteveryfunctionmakessenseforeveryapplication.The followinglistgivesafewexamplesoftypicalcoldchaindata logger functions and their benefits: Process step Feature Description Benefit Sender Preconfiguration Quality-related configuration options are preset; only oneshipmentnumbercanbe specifiedbythesender. Process efficiency at sending site Configuration password Configuration is protected from manipulation/change. Safety Start by ERP system Startflag is set by theERP system or shipping system by connecting to the cold chain database. Automation Automatic start Startflagissetautomaticallywhenthespecified shipping temperature is reached after packaging. Convenience and safety Prepacking Prepackthepalletanddatalogger,storethepalletandset thestartflagwhenthepalletleavesthefacility(viaBlue- tooth®, ERP system, or real-time device). Efficiency Preparation Monitorthepreparationofacontainer(e.g.whenadding liquidnitrogentoacryocontainer),starttheevaluation basedonalarmconditionlater(e.g.afteraddingtheproduct samples), pause the evaluation (e.g. to refill liquid nitrogen). Safety Restart for new shipments Downloadpreviousreportandrestartthesameconfiguration (e.g.viaBluetooth®usingsmartphoneapp)fornextround-trip shipment. Convenience Start by geofencing Startflagisautomaticallysetwhenleavingadefinedgeofence (real-timetemperaturedetectionandtrackingdevices). Safety and convenience Alarming Alarm when limit value is exceeded/not met Instandardalarming,onlyanupperandloweralarmlimit valuewithasingledelaytimeareconsidered.Forreal-time devices,theupperandlowerlimitsareoftenusedastriggers fornotifications toa servicedeskthatprocessesreal-time alarm messages about the monitored shipments. Early intervention Multi-level alarm Thelogicofthemulti-levelalarmmodelsthestabilitybudget ofaparticularproductinthedatabase(ordatalogger).Upto eight different temperature zones with allowable or cumulati- vedeviations.State-of-the-artsystemsalsoconsiderproduct freeze/thawcycles.Theuseofstabilitybudgetsforproduct evaluation reduces false negative results. Cost savings Alarm for MKT Anupper alarmlimitcanalsobesetfor themean kinetic temperature (MKT). Safety Alarm for location Thealarmistriggeredwhenleavingorreachingadefinedgeo- fence (real-time temperature detection and tracking devices). Efficiency, big data
- 12. Process step Feature Description Benefit Recipient Stop by ERP system Stop flag is set by the ERP system or shipping system by connecting to the cold chain database. Automation Stop by button or during readout Manualorautomaticstopanduploadofdataforassessment. Automation Hide information Hideinformationonthedisplayand/orPDFreport for the recipient. Safety Stop by geofencing Stopflagisautomaticallysetwhenleavingadefinedgeofence (real-timetemperature detectionandtracking devices). Safety and convenience Release Assessment Assessmentof the measurement series based on the allowed stability budget. Quality release Heat maps Bigdataanalysis,inwhichthesignificanceofaphenomenon isdisplayedincolorintwodimensions(examples:cityor airport with the most deviations, automatic roadmap generation, automatic temperature profile for qualification). Automation Integration Integration of data into other systems via RestAPI. Automation Long-termarchiving:Howcantemperaturedata be read 15 years from now? “If data is electronic, it will be available forever.”That’s our firstthoughtaboutdata archiving. However,intheworld ofinformationtechnology,theclockisticking.Ifyoutryto open old files from your previous notebook, you may find thatthe old formatcannot beread with thenew versionof thesoftware.TheISO19005PDF/Astandardwasdeveloped for easy archiving. It is the only standard that ensures that thedatacanbedisplayedunchangedbyfuturesoftware andcomputerplatforms.PDFisthereforetheonlystandard for data backup archives of data loggers and cold chain databases. PDF/A documents according to the ISO 19005 standard are always black and white. A PDF document generated by a data logger is just a “picture.”Butwheredoyoukeepthe“rawdata,”the measurementserieswithallthetimestampsandstatistics? Especiallyifyouwanttostorethetransportdatainacold chaindatabaseandperformfurtheranalysis,youneedthe rawdata. Most providers solve this problem by producing a second raw data file on the USB data logger.Another more elegant solution is to encryptthe raw data and embed it in aprotectedsectionofthePDFdocument.Inthisway,the data logger produces only one document that contains all the data for further analysis. Working with encrypted raw data embedded in the PDFfileincreasesconvenienceandsafety.
- 13. Summary You might think that choosing the right data loggers is a simple matter.But as this practical guide shows, it is important to choose the right data loggers that deliver specificbenefitsorprocessoutcomesforyoursupplychain. Especiallyasyourshipmentvolumesincrease,youneedto choose carefully to ensure minimal human error and maxi- mum processefficiency.
- 14. PRACTICAL GUIDE | TEMPERATURE DATA LOGGERS 15 PG_TemperatureDatLoggers_V1E