Vaccine storage.pdf

detailed ddescription of vaccine storage conditions

1. Storageconditionsandstabilityof
officialvaccines
Mr. SajidHussain
Assistant Professor
DepartmentofPharmacy
S.R. INSTITUTIONS, BAREILLY
PharmaceuticalBiotechnology(BP605T)

2. TheColdChain
Definition:Maintainingvaccineswithin
themanufacturer’srecommendedstorage
temperatureduringtransportandstorage
untilthepointofadministration
Whyisthe“Coldchain”soimportant?
Efficacydependsoncorrectstorage
conditions+2°Cto
+8°C
CompliancewithSpecificProduct
Characteristicsand
marketingauthorisation
Assuranceandconfidenceinapotent
product
Ensuringmaximumbenefitfrom
immunisation

3. Livevaccines
toleratefreezing
deterioraterapidlyafterremovalfromfreezer
Inactivatedvaccines
damagedbyexposuretofreezingtemperatures
tolerateshorttimeoutofrefrigeration
EffectofTemperatureonVaccines
Storageofvaccinesoutsiderecommendedstoragetemperatures
canleadto:
Deteriorationinthevaccineandfailuretoproduceasatisfactorylevelof
immunity
–Heatspeedsupdeclineinpotency-↓shelflife
–Freezingcauses
•Increasedreactogenicity &loss ofpotency
•canlead tohairlinecracksinampoules,vialsorpre-filledsyringes
causingcontaminationofcontents

4. TemperatureSensitivity
SensitivetoColdandHeat
LightSensitivity
•Sensitivetostronglight,sunlight,ultravioletand
fluorescentlight (neon)
•Allvaccinesshouldbestoredintheiroriginalpackaginguntil
theyare administered
VaccineStability
StorageandManagementofVaccines
ReceiptandTransport
Storage
Temperaturemonitoring
Useinvaccinationsessions
Disposalandspillage
Disruptionofthecoldchain

5. ReceiptofVaccines
Checkedagainstorderfordiscrepancies
Have vaccinesbeenstoredbetween2
oC–8
oC?
Inspectforleakageanddamage
Signedforandrefrigeratedimmediately
Recordvaccinetype,brand, quantityandbatchnumbers (dateandtime)
TransportofVaccines
Insulatedvalidatedcoolboxes
Coolboxes
–Fridgepacks
–Frozenpacks
Spacesincoolboxfilledwithinsulatingmaterial
Vaccinesshouldnotbeindirectcontactwithcoolpacks

6. StorageofVaccines
Withinrecommendedstoragetemperaturesbetween2
o
C–8
o
C
RefrigeratorSpecifications:
–Designedforstoringmedicines-Lockable
•Minimalopeningtomaintain constanttemperature
•Icebuildupreduceseffectiveness
–No items otherthan medicinesstoredinfridge(e.g. food,drink,clinical specimens)
–Should notbeoverfull
–Ensurecannotbeaccidentallyswitchedoff
Vaccines
–mustnotberemovedfrompackagingduringstorage
–Stocksstored tidily
–Notstoredon shelvesinfridgedoorsorbottomdrawers
–Notstorednext tofreezingcompartments
–Patients/Parentsshouldnotberequestedtostorevaccinesinadomestic
fridge.
–Fridgesshouldbecleanedonaregularbasis
–Emergency storageavailable iffridgefails

7. TemperatureMonitoring
Fridgesmust haveareliablemaximum/minimumthermometer(in
addition toany integral thermometer)
–Calibrateannuallytoensurecorrectfunctioning
Designatedpersonresponsibleforvaccinestorageandfridgemonitoring
–Trainedtoreadandrecordcurrenttemperature,maximumandminimum
temperatures
correctly
Readingsshouldbetakendaily
Keeprecordcharton ornearthe fridge
Retainrecordsuntilnextaudit
Iftherecordedtemperaturegoesoutsidetherange,
contactcommunity servicespharmacyandorthemanufacturer’sfor
advice

8. VaccinationSessions
Use vaccineswithshortestexpiryfirst
Vaccinesshould onlyberemovedatthebeginningofsessionfortheshortest
possibletime
Onlyremovetherequirednumberofdosesforthesession
Priorto administrationchecktheidentityofthevaccine,itsappearanceand
expirydate
Recorddate,brandname,manufacturer,batchnumberanddetailsof any
diluentusedinpatients’notes
Freezedriedvaccinesshould bereconstitutedimmediatelypriortouseand
usedwithinthe
recommendedperiod
Anyremainingvaccineinvialsshouldbedrawnintoasyringeanddisposed
of
•Part vials, prepared unused vaccines and out of date vaccines should be
placed in a sharps box labelled“Vaccinewaste”. Theboxshouldbesealed
whentwothirdsfull

9. DisposalofVaccines
InHealthCentrestheboxwillthenbeeithercollected
by pharmacytechniciansorreturnedtocommunityservices
pharmacyonsecuretransport.
GPpracticesshouldmakearrangementsfordisposalofvaccinewaste
throughtheirwastecontractor.