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T.Prusik,Ph.D.
Temperaturecontroltoolsand
supplychainmanagement
1
UmitKartoglu-WHO
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Whybotherabouttemperaturemonitoring
B.Schreiber–Technet–Thailand2015
3
TemperaturesensiHvityofvaccines
PrinciplesandconsideraHonsforaddingavaccinetoanaHonalimmunizaHonprogrammeFROMDECISIONTOIMPLEMENTATIONANDMONITORINGhVp://apps.who.int/iris/bitstream/10665/111548/1/9789241506892_eng.pdf?ua=1
CurrentlyheatexcursionsareeasiertodetectthanfreezingifVVMisapplied
4B.Schreiber–Technet–Thailand2015
5
Conclusions:Thisstudyshowedthatthelackofvaccineeffec/venessobservedwithLAIVintheUSagainstH1N1pdm09viruseswasassociatedwithexposureofsomeLAIVlotstotemperaturesaboverecommendedstoragecondi/onsduringUSdistribu/on,andislikelyexplainedbytheincreasedsuscep9bilityoftheA/California/7/2009(H1N1pdm09)LAIVstraintothermaldegrada9on.
LiveaVenuatedinfluenzavaccinelackseffecHvenessduetohightemperatureexposureinUSdistribuHon
Vaccine.2016Sep30;34(42):5066-72.doi:10.1016/j.vaccine.2016.08.079.Epub2016Sep6
NoVVMusedinUSIneffec1veinfluenzavaccineadministeredtochildren
Device Int. transport
Primary store
In-country transport
Intermediate store
In-country transport Service level
Electronic temperature monitor with LCD screen
Vaccine cold chain monitor
Vaccine vial monitor
Freeze indicator
Multi-channel computerized temperature recording sys.
Electronic refrigerator temperature logger
Downloadable electronic temperature data logger
Dr.UmitKartoglu-WHO
ExamplesandmainuseofWHOrecommendedtemperaturemonitoringdevicesforstorageandtransporta1onofvaccines
Vaccinevialmonitors(VVMs)• OnlytemperaturemonitoringdevicesthatrouHnelyaccompany
vaccinesthroughtheenHresupplychain• Appliedbyvaccinemanufacturers• VVMsrecordcumulaHveheatexposurethroughagradualcolor
change• Ifthecoloroftheinnersquareisthesameordarkerthantheouter
circle,thevaccineshouldbediscarded• VVMsdonotrecordexposuretofreezingtemperatures
7hVp://apps.who.int/iris/bitstream/10665/183583/1/WHO_IVB_15.04_eng.pdf?ua=1
8hVp://apps.who.int/iris/bitstream/10665/183583/1/WHO_IVB_15.04_eng.pdf?ua=1
Coldchainmonitor(CCM)cards• OnlyusedforinternaHonalshipmentofOPVpackedwithdryice• CumulaHveexposuretotemperaturesupto+34°Cisindicatedby
bluestainingalongthelengthofthewhiteindicatorstripmarkedA,B,C.
• Exposuretoasingleeventabove+34°CisindicatedbybluestainingofthewhitedotinsecHonDoftheindicator
• Shippingdetailssarerecordedonthecarditselfbythemanufactureratthepointofdispatchandbythereceivingstoreatthepointofarrival
9
Electronicshippingindicators• RecordthetemperatureatHmeintervalsof10minutesorless
forupto20days• Theyhavedigitaldisplaysandpre-setalarmthresholdsto
reflecttheheatand/orfreezesensiHvityofthevaccinebeingshipped
• Somebrandsareabletodownloadthetemperaturedatatoacomputer.
10hVp://apps.who.int/iris/bitstream/10665/183583/1/WHO_IVB_15.04_eng.pdf?ua=1
Programmableelectronictemperatureandeventloggersystems–bestop1onforprimaryandsubna1onalstores• Temperaturesensorsshouldbeplacedineverycoldroom,freezerroom,vaccinerefrigeratororvaccine
freezerinthestoreanddirectlylinkedtoacentralcomputer-basedmonitoringpointviawiredorwirelessconnecHons
• Centraldatastorageallowstemperaturerecordstobeanalyzedelectronically,andthesystemcanbeconfiguredtoproduceperiodicreports
• SystemscanalsobeconfiguredwithsensorswhichmonitordooropeningsaswellasotherperformancecharacterisHcssuchasrelaHvehumidityandvoltagefluctuaHons
• Canalsobeequippedwithlocalaudiblealarmsand/oralarmstrobesandconfiguredtosendalertstoresponsiblestaffviaauto-dialer,emailandSMS
• InternetorintranetconnecHvityopHonsarealsoavailable;theseallowforremotemonitoringandalarmreporHngfrommulHplesitesonanaHonalbasis.
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Remotetemperaturemonitoringdevices
hVp://apps.who.int/immunizaHon_standards/vaccine_quality/pqs_catalogue/
12hVp://apps.who.int/iris/bitstream/10665/183583/1/WHO_IVB_15.04_eng.pdf?ua=1
• Storestypicallyhaveoneormorevaccinerefrigeratorsandmaybeavaccinefreezer
• HealthfaciliHesareonenwithasinglevaccinerefrigerator• ThetablebelowsetsouttheopHonsinorderofpreference
13hVp://apps.who.int/iris/bitstream/10665/183583/1/WHO_IVB_15.04_eng.pdf?ua=1
30-dayelectronictemperaturerecorders(30DTRs):• Thesestand-alonedevicesareplacedwiththevaccineloadinavaccinerefrigerator• Theylogtherefrigeratortemperatureat10-minuteintervalsorlessfor30consecuHvedaysonarolling
basis• Theyalsorecordanddisplaya30-dayhistoryofanyheatandfreezealarmviolaHonsthathaveoccurred• Alarmsaretriggeredifthetemperatureintherefrigeratordropsto-0.5°Corbelowfor60minutesorifit
exceeds+8°CforaconHnuousperiodof10hours• Aslongasthetemperaturehasremainedwithintherecommendedrange,thedevicedisplaysOKoraHck
symbol• Onnewermodels,datacanalsobedownloadedtoacomputerviaaUSB(universalserialbus)interface.• 30DTRsarenotdesignedtobeusedinvaccinefreezers
14hVp://apps.who.int/iris/bitstream/10665/183583/1/WHO_IVB_15.04_eng.pdf?ua=1
Electronicfreezeindicators• Thesearesmalldigitaldevicesthatareplacedwithfreeze-sensiHvevaccinesduringtransportorstorage• Thedeviceshaveavisualindicatorthatshowswhetherthevaccinehasbeenexposedtofreezing
temperatures• Oncethealarmindicatoristriggered,thedeviceisnolongerusableandshouldbediscarded.Otherwise
thedevicecanbeusedunHlthebuilt-inbaVeryexpires.Thesestand-alonedevicesareplacedwiththevaccineloadinavaccinerefrigerator
15hVp://apps.who.int/iris/bitstream/10665/183583/1/WHO_IVB_15.04_eng.pdf?ua=1
Coldboxesandvaccinecarriers
16hVp://apps.who.int/iris/bitstream/10665/183583/1/WHO_IVB_15.04_eng.pdf?ua=1
Transportbyrefrigeratedvehicles
17hVp://apps.who.int/iris/bitstream/10665/183583/1/WHO_IVB_15.04_eng.pdf?ua=1
Userprogrammabletemperatureloggers• TheprincipaltoolforconducHngcoldchaintemperaturemonitoringstudies,fortransportrouteprofiling
andfortemperaturemappingincoldrooms,freezerroomsandrefrigeratedvehicles• Currentlyprequalifiedmodelsareaffordableanduser-friendlyandcanbeusedseveralHmes• Theusercandefinealarmthresholds,setthefrequencyoftemperaturerecordingsandprogrammestart
andstopHmes• Attheendofthestudy,datacanbedownloadedtoacomputerforanalysis• Mostmodelshavebuilt-inbaVeries(whenthebaVeryexpiresthedeviceisdiscarded);othershave
replaceablebaVeriesandcanbereused
Manyresourcesavailable
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hVp://www.who.int/immunizaHon/documents/IIP2015_Module2.pdf?ua=1hVp://www.who.int/immunizaHon/documents/financing/who_ivb_15.04/en/hVp://apps.who.int/iris/bitstream/10665/183584/1/WHO_IVB_15.03_eng.pdfhVp://www.who.int/immunizaHon/programmes_systems/supply_chain/evm/en/hVp://epela.net/epela_web/evvm.htmlhVp://epela.net/epela_web/introducHon.htmlhVp://apps.who.int/immunizaHon_standards/vaccine_quality/pqs_catalogue/
19B.Schreiber–Technet–Thailand2015
ChallengesintheimmunizaHonsupplychain
20B.Schreiber–Technet–Thailand2015
ChallengesintheimmunizaHonsupplychain
21B.Schreiber–Technet–Thailand2015
ChallengesintheimmunizaHonsupplychain
22B.Schreiber–Technet–Thailand2015
ChallengesintheimmunizaHonsupplychain
23B.Schreiber–Technet–Thailand2015
GrowingconcernsAcceleraHngpaceofvaccineintroducHons
24R.Steinglass–Technet–Thailand2015
ConcernMorestoragespacerequiredfornewvaccines
25R.Steinglass–Technet–Thailand2015
ConcernAvailabilityofexisHngvaccines
26R.Steinglass–Technet–Thailand2015
ConcernBasicvaccinemanagement
27R.Steinglass–Technet–Thailand2015
GrowingconcernsNewrealiHesfortodayandthefuture
28R.Steinglass–Technet–Thailand2015
ImmunizaHonsupplychainandlogisHcsACalltoAcHon
29hVp://www.who.int/immunizaHon/call-to-acHon_ipac-iscl.pdf
R.Steinglass–Technet–Thailand2015
ImmunizaHonsupplychainandlogisHcsACalltoAcHon
30R.Steinglass–Technet–Thailand2015
Casestudy-Turkey
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33Technet2013
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Applied2Dbarcodes-Examples
EachvialsareinsingledosepresentaHons
Package
Box
PrimaryPackage
Parcel
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36Technet2013
37Technet2013
IntegratedHealthInforma1onSystem
Family Medicine
Information System (AHBS)
TemperatureControl
StockControl
Management
Vaccine Information
System (Aşı-net)
Hospital Information
System (HBS)
Decision Support
System (KDS)
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UNICEFeLearningcourse
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THANKYOU!!