Cold chain with field fact


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This presentation contains Complete cold chain system, Importance and requirement of cold chain, detail of each equipment of cold chain system.
This presentation contain brief detail of THE SHAKE TEST, Reverse cold chain.
This is fully equipped with knowledge of Field facts of cold chain system.

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Cold chain with field fact

  1. 1. Dr. Dhruvendra PandeyDepartment of community medicineMGM Medical College, Indore
  2. 2. DiscussionWhat is cold chain?Importance of cold chainVaccine sensitive to heat, freeze & LightEquipments of cold chainIdeal methods of utilizationCold chain monitoringVaccine vial monitorThe Shake testField FactsReverse cold chain
  3. 3. What is cold chain?A cold chain is a temperature-controlled supplychain. An unbroken cold chain is an uninterruptedseries of storage and distribution activities whichmaintain a given temperature range. It is used to helpextend and ensure the shelf life of products.
  4. 4. Defination The cold chain is the system of transporting andstoring vaccines consumables within the safetemperature range of 2oC to 8oC (For frozen vaccinesthe optimum temperature is -15°C or lower)from theplace of manufacture to the point of administrationensuring people receive an effective vaccine that haveretained their viability and have not had exposure totemperature excursions (i.e. hot and cold both)This will prevent potential costly wastage.
  5. 5. Cold Chain DiagramProper storagetemperaturesmust bemaintained atevery link in thechain.
  6. 6. Importance of cold chainVaccines are sensitive biological products which maybecome less effective, or even destroyed, whenexposed to temperatures outside the recommendedrange.Cold-sensitive vaccines experience an immediate lossof potency following freezing.Vaccines exposed to temperatures above therecommended temperature range experience someloss of potency with each episode of exposure.Repetitive exposure to heat episodes results in acumulative loss of potency that is not reversible.
  7. 7. Reasons of maintainingpotency of vaccinesThere is a need to ensure that an effective product isbeing used. Vaccine failures caused by administrationof compromised vaccine may result in the re-emergence or occurrence of vaccine preventabledisease.Careful management of resources is important.Vaccines are expensive and can be in short supply.Loss of vaccines may result in the cancellation ofimmunization clinics resulting in lost opportunities toimmunize.
  8. 8. Revaccination of people who have received anineffective vaccine is professionally uncomfortableand may cause a loss of public confidence in vaccinesand/or the health care system. An estimated 17% to 37% of healthcare providers expose vaccines to improper storagetemperatures. When a cold chain break is identified after a vaccine has been administered, consultyour local public health office or immunization program* for advice. The type ofvaccine, duration and temperature of the exposure will be taken into account whenassessing the situation. Serological testing or revaccination may be suggested.
  9. 9. The Effective Cold ChainThree main elements combine to ensure proper vaccinetransport, storage, and handling.Trained personnelTransport and storage equipmentEfficient management proceduresEquipmentPeopleProcedures
  10. 10. OPVMeasles, MR, MMRDPT, DPT+HepB, DPT+Hib,DPT+HepB+Hib , Yellow fever VBCGDT, HibTT , Td, hep B, JE
  11. 11. hep BHib liquidDPT, DPT+HepB, DPT+Hib,DPT+HepB+HibDT,TdTT
  12. 12. Light sensitive vaccinesBCGMeaslesMRMMR
  13. 13. Among all the vaccines, polio vaccine is most sensitiveto the heat, requiring storage at minus 20oc.Freezer compartment: Polio & Measles (P & M)Cold compartment: “T” series (DPT, TT, DT), HepatitisB, Hib vaccine, BCG and diluents.Vaccines must be protected from sunlight andprevented from contacts with the antiseptics.At the health centre , most vaccines (except polio) canbe stored up to 5 weeks if the refrigerator temperatureis strictly kept at +2oc - +8oc .Reconstituted BCG vaccine and measles vaccine can bekept at +2oc - +8oc for maximum 4 hours and JE vaccinefor 2 hours.To be on safe side, write the time of reconstitution onthe label of these vaccine vials.
  14. 14. Vaccine Heat Light Freezing Temperature atPHCOPV(live attenuated)Sensitive Sensitive Okay to freeze +2˚C to +8˚C(-15˚C to -25˚C atstate, regional anddistrict stores)BCG(live attenuated)Sensitive Sensitive Okay to freeze (beforereconstitution)+2˚C to +8˚CMeasles(live attenuated)Sensitive Sensitive Okay to freeze (beforereconstitution)+2˚C to +8˚C(-15˚C to -25˚C atstate, regional anddistrict stores)DPT(toxoid, killed)Relatively heatstableFreezes at -3˚C. Discard iffrozen.+2˚C to +8˚CHep B(recombinant)Relatively heatstableFreezes at- .5˚C.Discard if frozen.+2˚C to +8˚CTT(toxoid)Relatively heatstableFreezes at -3˚C. Discard iffrozen.+2˚C to +8˚CSummary of vaccine vulnerability
  15. 15. RefrigeratorTruck Walk-in FreezerWalk-in CoolerCold Box Deep Freezer (DF) 300 ltrIce-Lined Refrigerator(ILR) 300 ltr
  16. 16. Ice-Lined Refrigerator(ILR) 140 ltrDeep Freezer (DF) 140 ltrCold BoxVaccine Carriers
  17. 17. Refrigerator truck• Transportation ofvaccines fromRegional centersto districts• From districts toPHCs
  18. 18. Walk in cooler and freezerThey are located at the regional level.Store vaccines up to 3 months and 4-5 districts.Walk-in Freezer(-15oto -25oC)Walk-in Cooler(+2oC to +8oC)
  19. 19. Size: 300 ltr / 140 ltrLevel: District (300 ltr) / PHC,CHC(140 ltr)Temperature: -15oto -25oCUtilization:1. Preparation of ice packs (at thePHC, CHC)2. Storing measles and OPV (onlydistrict) only for 1 monthHoldover time: 18- 22 hours In caseof power cut.Storage capacity:300 ltr: 150, 000 to 200, 000 doses140 ltr : Approx. 20-25 Ice Packswith 8 hour of continuous supply
  20. 20. Size: 300 ltr / 140 ltrLevel: District (300 ltr) / PHC (140 ltr)Temperature: +2˚C to +8˚CUtilization: At PHC for storing allvaccine for 1 monthHoldover time: 24 hrs after 8 hrscontinuous power supplyStorage capacity:300 ltr: 60,000 doses of mixedantigen & 20,000 doses of OPV140 ltr : 25,000 doses of mixedantigen & 18,000 doses of OPV** OPV and Measles for 1 monthonly. Store in DF if longer than amonth
  21. 21. Arrange the vaccine In the order Top to bottom in ILRHepatitis BTT, DPTBCGMEASLESOPVFollow the early expiry date first outKeep the space between boxesMeasles and OPV can be kept over two rows of empty ice packs on the floor of the ILR
  22. 22. • Keep all vaccines in baskets• Avoid placing vaccines at bottomof ILR. (never diluents, freeze sensitive)• Leave space between thevaccine boxes• Place a thermometer in thecenter of the ILR.• Same vaccines in same area.• Diluent / freeze sensitive/ Closer expirydate vaccines on top• Heat sensitive / Further expiry datevaccines in the bottom of basket
  23. 23. Dos (for ILR and Deep freezer)Keep the equipment in cool room away from directsun light.Keep the equipment labeledFix the equipment through the voltage stabilizerKeep the vaccine nearly with space between thestacks for circulation of air.Keep the equipment locked and open only whennecessory.Defrost periodically.Supervise the temperature records
  24. 24. Donot (for ILR and Deep freezer)Donot keep any object on these equipmentDonot store any drugDonot keep food and drinking water in themDonot keep moor then one month requirments atPHC level.Donot keep expiry date vaccine.
  25. 25. Size: 20 ltr and 5 ltrLevel: all peripheral levelTemperature: +2˚C to +8˚CUtilization: All vaccines can be storedfor transportation or in case of powerfailureHoldover time: 5 days (20 ltr) and 3days (5 ltr) if unopenedStorage capacity:20 ltr: 52 Ice Packs & 6000 doses ofmixed antigens5 ltr: 20 Ice Packs & 1500 doses ofmixed antigens
  26. 26. Before the vaccines are placed in the cold boxes, fullyfrozen ice packs are placed at the bottom and sides.The vaccine are kept in the cartons and polythenebags.The vials of DPT, DT, TT vaccines and diluentsshould not placed in direct contact with frozen icepacks.Day carriers: used to carry small (6 -8 vial) quantity ofvaccine . 2-4 fully frozen ice packs are used. Used onlyfor few hours.
  27. 27. Size: 1.7 ltrLevel: PHC/ Sub CentreTemperature: +2˚C to +8˚CUtilization: All vaccines can becarried in small quantity forvaccination sessionsHoldover time: 12 hoursStorage capacity: 4 Ice Packs &15-20 vials of mixed antigens
  28. 28. Size: 763 X 90 X 33 mmIce capacity: 360 mlWeight: 80 gmLevel: District / PHC/ Sub CentreTemperature: +2˚C to +8˚CUtilization: line the walls of vaccinecarrier/cold box/day boxesTime to Freeze: 48 hours in DF at- 20˚C
  29. 29. • Fill icepacks with water to mark• Fit the sealing plug and screw on thelid tightly• Hold each ice-pack upside down andsqueeze it to make sure it does notleak.• Place the icepacks in the deep freezer.• Ice-packs need not be refilled everytime they are used. The same water canbe used repeatedly.• Do not use saline water for filling
  30. 30. • On the session day, takethe frozen ice-packs youneed from the freezer andplace on a table• Allow ice-packs to sweatat room temperature for15 minutes• Shake the ice pack tolisten to melted for water.• This will prevent freeze-sensitive vaccines fromfreezing.A Conditioned an ice-pack
  31. 31. Material: Soft FoamThickness: 30 mm with at least 6incisionsUtilization:• temporary lid for unopenedvaccines inside the carrier• surface to hold, protect and keepcool opened vaccine vials
  32. 32. Verify Daily the Temperature of theCold Chain Storage at theHealth Centers and Out PostsHealth Centers and Out Posts+2°C to+ 8°CDPT,DT & TetanusToxoidOPV (Polio), BCG,Measles,0°C-15°C to-25°CIce Packs in deep Freezers
  33. 33. Ice Packs in Deep Freezer- SideView
  34. 34. Maintenance of EquipmentBreakdown/Repairs:Early reporting & timely repairs is good cold chainmanagement.Handy spares reduces down time & speeds repair.Condemned units to be removed/ replaced by standbyunits.Contingency/Emergency Plan:Identify alternate storage points incase of equipmentfailure.Funds approval, manpower & mobility to be geared upin advance.
  35. 35. Vaccine Distribution & Re useVaccines are not stored at the sub-centre level and must besupplied on the day of useNote manufacturer, batch no., VVM statusWHO pre qualified vaccines should be used for SIAsmOPV for selected areas in Western UP, Bihar,Mumbai/ThaneUse VVM stage-II vaccine near the cold chain point (do notdistribute to remote areas)Partially used OPV vials can be returned to the field thenext day, if the VVM has not reached discard point
  36. 36. Return of vials and reuseReturn all used and unused vials to PHCMatch OPV consumed with children immunizedSee VVM of unused vialsReplace stage-I and II vials in DF/ILR after markingthem / separately packing themUse returned vials first on subsequent day afterchecking VVMEnsure OPV is not left in Vaccine Carriers at the endof the dayRe-evaluate requirement of teams and rationalizedistribution
  37. 37. Vaccine Basics............. Follow “First-in-First - out rule” (FIFO) Also “First to expire - First out” (FEFO)T series, Hep B and Hib and diluents should never be frozen.BCG, OPV & Measles (light) are sensitive to heat & lose potencyfast.Potency lost due to heat exposure does not change the appearanceof the vaccine.VVM is an effective tool in monitoring OPV potency.Damage to vaccine cannot be reversed by re-freezing. Discard frozen T series vaccine & Hepatitis B Vaccines.
  38. 38. Vaccine Vial Monitor - Interpretation
  39. 39. The Shake TestThe “Shake test” can help give an idea whetheradsorbed vaccines (DPT, DT, Td, TT or Hepatitis B)have been subjected to freezing temperatures likely tohave damaged them.After freezing, the vaccine no longer has theappearance of an homogenous cloudy liquid, buttends to form flakes which settle at the bottom of thevial after shaking.Sedimentation is faster in a vial which has beenfrozen than in a vial, from the same manufacturer,which has not been frozen.
  40. 40. The test should be conducted for all boxes wherefreeze indicators are found to be activated ortemperature recordings show negative temperatures.Procedure:Step 1 — Prepare a frozen control sample: Take a vialof vaccine of the same type and batch number as thevaccine you want to test, and from the samemanufacturer.Freeze the vial until the contents are solid (at least 10hours at -10°C) and then let it thaw. This vial is thecontrol sample.Mark the vial clearly so that it is easily identifiableand will not be used by mistake.
  41. 41. Step 2 — Choose a test sample: Take a vial (s) ofvaccine from the batch (es) that you suspect has beenfrozen. This is the test sample.Step 3 — Shake the control and test samples: Holdthe control sample and the test sample together inone hand and shake vigorously for 10–15 seconds.Step 4 — Allow to rest: Leave both vials to rest byplacing the vials on a table and not moving themfurther.Step 5 — Compare the vials: View both vials againstthe light to compare the sedimentation rate.
  42. 42. If the test sample shows a much slowersedimentation rate than the control sample, the testsample has most probably not been frozen and can beused.If the sedimentation rate is similar, the vial hasprobably been damaged by freezing and should not beused.Note that some vials have large labels which concealthe vial contents. This makes it difficult to see thesedimentation process. In such cases, turn the controland test vials upside down and observe sedimentationtaking place in the neck of the vial.If the shake test procedure indicates that the testsample has been damaged by freezing, you should
  43. 43. Identify and separate all vaccines that may have beenfrozen and ensure that none are distributed or used.
  44. 44. Cold Chain Issues in Field…Inadequate maintenance of cold chain equipmentHigh cold chain sickness rateLong response time to breakdown of equipmentNot enough cold chain engineers / refrigeratormechanics in states and districtsLack of adequate trainingLack of adequate equipmentsVoltage fluctuation, equipments not attached tostabilizers, lack of proper wiring and earthingImproper cleaning and defrosting of equipment
  45. 45. Poor Monitoring of the Cold ChainSlackness in the field regarding cold chainmaintenance by ANM and MPW malePoor supervision, monitoring, contingency planCondemned equipment not disposed off timelyShortage of accessories like thermometers, stabilizers,equipment stands, freeze tag, etc.Inadequate recording and documentation- Power cuts / generator running / defrosting notdocumented in log books- Temperature charting not done meticulously/regularly
  46. 46. Vaccine Management……..Different batches of vaccinesmixed with missing labelsMixed Vaccine Vials with missinglabels
  47. 47. Vaccine Potency………..Frozen DT atbottom of ILR
  48. 48. Vaccine deliveryVaccine carrier lying inarea 5 days after SIAcompletedVaccine left in carrier afteractivity
  49. 49. Preparation & Storage of Ice Packs
  50. 50. Polio team !!!
  51. 51. Monitoring…………. Do we maintain Temperature Chart? Do we have sufficient Cold Chain Equipments(ILR/DF/Vaccine Carrier/ice pack)? Is the vaccine potent & the one recommended? Do we maintain daily stock of vaccine distributed during SIA? Do we have vaccine delivery plans(Route) in place? Do we have an ice packs freezing plan? Do we make provisions to resupply ice packs? Do we supply sufficient ice at regular intervals to teams? Do we return balance stock of mOPV to DHQ? Do we ensure return of all Vaccine Carriers with all ice packs to PHC (SIA/RI)? Do we maintain all Cold Chain equipment at its optimum level?
  52. 52. Minimizing vaccine wastageVACCINES ARE EXPENSIVE!DPT = Rs 1.30 per doseTT = Rs 0.66 per doseDT = Rs.1.30 per doseOPV = Rs 8.00 per doseMeasles = Rs 8.34 per doseBCG = Rs 1.50 per doseHepatitis B = Rs 17 per dose
  53. 53. Reverse cold chainThe process of maintaining the cold chain when heatsensitive items are stored and transported in thereverse direction i.e. upwards from the clinic to adepot or laboratory. This process is also used fortransporting specimen samples.Used in Acute Flaccid Paralysis (AFP) Surveillance inpolis eradication program to carry out the stoolsample of suspected case.
  54. 54. THANK YOU!!!!!!!!