Temperature control tools and supply chain …5 Conclusions: This study showed that the lack of...

T.Prusik,Ph.D.

Temperaturecontroltoolsand

supplychainmanagement

1

UmitKartoglu-WHO

2

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


Coldchainmonitor(CCM)cards•  OnlyusedforinternaHonalshipmentofOPVpackedwithdryice•  CumulaHveexposuretotemperaturesupto+34°Cisindicatedby

bluestainingalongthelengthofthewhiteindicatorstripmarkedA,B,C.

•  Exposuretoasingleeventabove+34°CisindicatedbybluestainingofthewhitedotinsecHonDoftheindicator

•  Shippingdetailssarerecordedonthecarditselfbythemanufactureratthepointofdispatchandbythereceivingstoreatthepointofarrival

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Electronicshippingindicators•  RecordthetemperatureatHmeintervalsof10minutesorless

forupto20days•  Theyhavedigitaldisplaysandpre-setalarmthresholdsto

reflecttheheatand/orfreezesensiHvityofthevaccinebeingshipped

•  Somebrandsareabletodownloadthetemperaturedatatoacomputer.


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/


•  Storestypicallyhaveoneormorevaccinerefrigeratorsandmaybeavaccinefreezer

•  HealthfaciliHesareonenwithasinglevaccinerefrigerator•  ThetablebelowsetsouttheopHonsinorderofpreference


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


Electronicfreezeindicators•  Thesearesmalldigitaldevicesthatareplacedwithfreeze-sensiHvevaccinesduringtransportorstorage•  Thedeviceshaveavisualindicatorthatshowswhetherthevaccinehasbeenexposedtofreezing

temperatures•  Oncethealarmindicatoristriggered,thedeviceisnolongerusableandshouldbediscarded.Otherwise

thedevicecanbeusedunHlthebuilt-inbaVeryexpires.Thesestand-alonedevicesareplacedwiththevaccineloadinavaccinerefrigerator


Coldboxesandvaccinecarriers


Transportbyrefrigeratedvehicles


Userprogrammabletemperatureloggers•  TheprincipaltoolforconducHngcoldchaintemperaturemonitoringstudies,fortransportrouteprofiling

andfortemperaturemappingincoldrooms,freezerroomsandrefrigeratedvehicles•  Currentlyprequalifiedmodelsareaffordableanduser-friendlyandcanbeusedseveralHmes•  Theusercandefinealarmthresholds,setthefrequencyoftemperaturerecordingsandprogrammestart

andstopHmes•  Attheendofthestudy,datacanbedownloadedtoacomputerforanalysis•  Mostmodelshavebuilt-inbaVeries(whenthebaVeryexpiresthedeviceisdiscarded);othershave

replaceablebaVeriesandcanbereused

Manyresourcesavailable

18

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/

ChallengesintheimmunizaHonsupplychain


GrowingconcernsAcceleraHngpaceofvaccineintroducHons

24R.Steinglass–Technet–Thailand2015

ConcernMorestoragespacerequiredfornewvaccines


ConcernAvailabilityofexisHngvaccines


ConcernBasicvaccinemanagement


GrowingconcernsNewrealiHesfortodayandthefuture


ImmunizaHonsupplychainandlogisHcsACalltoAcHon

29hVp://www.who.int/immunizaHon/call-to-acHon_ipac-iscl.pdf

R.Steinglass–Technet–Thailand2015

ImmunizaHonsupplychainandlogisHcsACalltoAcHon


Casestudy-Turkey

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33Technet2013

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Applied2Dbarcodes-Examples

EachvialsareinsingledosepresentaHons

Package

Box

PrimaryPackage

Parcel

36Technet2013

37Technet2013

IntegratedHealthInforma1onSystem

Family Medicine

Information System (AHBS)

TemperatureControl

StockControl

Management

Vaccine Information

System (Aşı-net)

Hospital Information

System (HBS)

Decision Support

System (KDS)

UNICEFeLearningcourse

48

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Temperature control tools and supply chain …5 Conclusions: This study showed that the lack of...

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Transcript of Temperature control tools and supply chain …5 Conclusions: This study showed that the lack of...