Dr. Dhruvendra PandeyDepartment of community

medicineMGM Medical College, Indore

DiscussionWhat is cold chain?Importance of cold chainVaccine sensitive to heat, freeze & LightEquipments of cold chainIdeal methods of utilizationCold chain monitoringVaccine vial monitorThe Shake testField FactsReverse cold chain

What is cold chain?A cold chain is a temperature-

controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is used to help extend and ensure the shelf life of products.

Defination The cold chain is the system of transporting

and storing vaccines consumables within the safe temperature range of 2oC to 8oC (For frozen vaccines the optimum temperature is -15°C or lower)from the place of manufacture to the point of administration ensuring people receive an effective vaccine that have retained their viability and have not had exposure to temperature excursions (i.e. hot and cold both)

This will prevent potential costly wastage.

Cold Chain DiagramProper storage temperatures must be maintained at every link in the chain.

Importance of cold chainVaccines are sensitive biological products which

may become less effective, or even destroyed, when exposed to temperatures outside the recommended range.

Cold-sensitive vaccines experience an immediate loss of potency following freezing.

Vaccines exposed to temperatures above the recommended temperature range experience some loss of potency with each episode of exposure.

Repetitive exposure to heat episodes results in a cumulative loss of potency that is not reversible.

Reasons of maintaining potency of vaccinesThere is a need to ensure that an effective

product is being used. Vaccine failures caused by administration of compromised vaccine may result in the re-emergence or occurrence of vaccine preventable disease.

Careful management of resources is important. Vaccines are expensive and can be in short supply. Loss of vaccines may result in the cancellation of immunization clinics resulting in lost opportunities to immunize.

Revaccination of people who have received an ineffective vaccine is professionally uncomfortable and may cause a loss of public confidence in vaccines and/or the health care system.

An estimated 17% to 37% of healthcare providers expose vaccines to improper storage temperatures. 

When a cold chain break is identified after a vaccine has been administered, consult your local public health office or immunization program* for advice. The type of vaccine, duration and temperature of the exposure will be taken into account when assessing the situation. Serological testing or revaccination may be suggested.

The Effective Cold ChainThree main elements combine to ensure proper

vaccine transport, storage, and handling.Trained personnelTransport and storage equipmentEfficient management procedures

Equipment

People

Procedures

OPV

Measles, MR, MMR

DPT, DPT+HepB, DPT+Hib, DPT+HepB+Hib , Yellow fever V

BCG

DT, Hib

TT , Td, hep B, JE

hep B

Hib liquid

DPT, DPT+HepB, DPT+Hib, DPT+HepB+Hib

DT,

Td

TT

Light sensitive vaccinesBCGMeaslesMRMMR

Among all the vaccines, polio vaccine is most sensitive to the heat, requiring storage at minus 20oc.

Freezer compartment: Polio & Measles (P & M)Cold compartment: “T” series (DPT, TT, DT),

Hepatitis B, Hib vaccine, BCG and diluents.Vaccines must be protected from sunlight and

prevented from contacts with the antiseptics.At the health centre , most vaccines (except polio)

can be stored up to 5 weeks if the refrigerator temperature is strictly kept at +2oc - +8oc .

Reconstituted BCG vaccine and measles vaccine can be kept at +2oc - +8oc for maximum 4 hours and JE vaccine for 2 hours.

To be on safe side, write the time of reconstitution on the label of these vaccine vials.

Vaccine Heat Light Freezing Temperature at PHC

OPV(live attenuated)

Sensitive Sensitive Okay to freeze +2˚C to +8˚C(-15˚C to -25˚C at

state, regional and district stores)

BCG(live attenuated)

Sensitive Sensitive Okay to freeze (before reconstitution)

+2˚C to +8˚C

Measles(live attenuated)

Sensitive Sensitive Okay to freeze (before reconstitution)

+2˚C to +8˚C(-15˚C to -25˚C at

state, regional and district stores)

DPT(toxoid, killed)

Relatively heat stable

Freezes at -3˚C. Discard if frozen.

+2˚C to +8˚C

Hep B(recombinant)

Relatively heat stable

Freezes at- .5˚C.

Discard if frozen.

+2˚C to +8˚C

TT(toxoid)

Relatively heat stable

Freezes at -3˚C. Discard if frozen.

+2˚C to +8˚C

Summary of vaccine vulnerability

Refrigerator Truck Walk-in Freezer

Walk-in Cooler

Cold Box Deep Freezer (DF) 300 ltrIce-Lined Refrigerator(ILR) 300 ltr

Ice-Lined Refrigerator(ILR) 140 ltr

Deep Freezer (DF) 140 ltrCold Box

Vaccine Carriers

Refrigerator truck

• Transportation of vaccines from Regional centers to districts

• From districts to PHCs

Walk in cooler and freezerThey are located at the regional level.Store vaccines up to 3 months and 4-5

districts.

Walk-in Freezer(-15o to -25o C)

Walk-in Cooler(+2o C to +8o C)

Size: 300 ltr / 140 ltr

Level: District (300 ltr) / PHC, CHC(140 ltr)

Temperature: -15o to -25o C

Utilization:

1. Preparation of ice packs (at the PHC, CHC)

2. Storing measles and OPV (only district) only for 1 month

Holdover time: 18- 22 hours In case of power cut.

Storage capacity: 300 ltr: 150, 000 to 200, 000 doses 140 ltr : Approx. 20-25 Ice Packs

with 8 hour of continuous supply

Size: 300 ltr / 140 ltr

Level: District (300 ltr) / PHC (140 ltr)

Temperature: +2˚C to +8˚C

Utilization: At PHC for storing all vaccine for 1 month

Holdover time: 24 hrs after 8 hrs continuous power supply

Storage capacity: 300 ltr: 60,000 doses of mixed antigen & 20,000 doses of OPV140 ltr : 25,000 doses of mixed antigen & 18,000 doses of OPV*

* OPV and Measles for 1 month only. Store in DF if longer than a

month

Arrange the vaccine In the order Top to bottom in ILRHepatitis B

TT, DPT

BCG

MEASLES

OPV

Follow 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

• Keep all vaccines in baskets

• Avoid placing vaccines at bottom of ILR. (never diluents, freeze sensitive)

• Leave space between the vaccine boxes

• Place a thermometer in the center of the ILR.

• Same vaccines in same area.• Diluent / freeze sensitive/ Closer expiry date vaccines on top• Heat sensitive / Further expiry date vaccines in the bottom of basket

Dos (for ILR and Deep freezer)

Keep the equipment in cool room away from direct sun light.

Keep the equipment labeledFix the equipment through the voltage

stabilizerKeep the vaccine nearly with space between

the stacks for circulation of air.Keep the equipment locked and open only

when necessory.Defrost periodically.Supervise the temperature records

Donot (for ILR and Deep freezer)

Donot keep any object on these equipment Donot store any drugDonot keep food and drinking water in themDonot keep moor then one month

requirments at PHC level.Donot keep expiry date vaccine.

Size: 20 ltr and 5 ltr

Level: all peripheral level

Temperature: +2˚C to +8˚C

Utilization: All vaccines can be stored for transportation or in case of power failure

Holdover time: 5 days (20 ltr) and 3 days (5 ltr) if unopened

Storage capacity: 20 ltr: 52 Ice Packs & 6000 doses of mixed antigens 5 ltr: 20 Ice Packs & 1500 doses of mixed antigens

Before the vaccines are placed in the cold boxes, fully frozen ice packs are placed at the bottom and sides.

The vaccine are kept in the cartons and polythene bags.

The vials of DPT, DT, TT vaccines and diluents should not placed in direct contact with frozen ice packs.

Day carriers: used to carry small (6 -8 vial) quantity of vaccine . 2-4 fully frozen ice packs are used. Used only for few hours.

Size: 1.7 ltr

Level: PHC/ Sub Centre

Temperature: +2˚C to +8˚C

Utilization: All vaccines can be carried in small quantity for vaccination sessions

Holdover time: 12 hours

Storage capacity: 4 Ice Packs &15-20 vials of mixed antigens

Size: 763 X 90 X 33 mm

Ice capacity: 360 ml

Weight: 80 gm

Level: District / PHC/ Sub Centre

Temperature: +2˚C to +8˚C

Utilization: line the walls of vaccine carrier/cold box/day boxes

Time to Freeze: 48 hours in DF at

- 20˚C

• Fill icepacks with water to mark• Fit the sealing plug and screw on

the lid tightly• Hold each ice-pack upside down

and squeeze it to make sure it does not leak.

• Place the icepacks in the deep freezer.

• Ice-packs need not be refilled every time they are used. The same water can be used repeatedly.

• Do not use saline water for filling

• On the session day, take the frozen ice-packs you need from the freezer and place on a table

• Allow ice-packs to sweat at room temperature for 15 minutes

• Shake the ice pack to listen to melted for water.

• This will prevent freeze-sensitive vaccines from freezing.

A Conditioned an ice-pack

Material: Soft Foam

Thickness: 30 mm with at least 6 incisions

Utilization:

• temporary lid for unopened vaccines inside the carrier

• surface to hold, protect and keep cool opened vaccine vials

Verify Daily the Temperature of the Cold Chain Storage at the

Health Centers and Out PostsHealth Centers and Out Posts

+2°C to + 8°C

DPT,DT & Tetanus Toxoid

OPV (Polio), BCG, Measles,

0°C

-15°C to -25°C

Ice Packs in deep Freezers

Ice Packs in Deep Freezer- Side View

Maintenance of EquipmentBreakdown/Repairs:

Early reporting & timely repairs is good cold chain management.

Handy spares reduces down time & speeds repair. Condemned units to be removed/ replaced by

standby units.Contingency/Emergency Plan:

Identify alternate storage points incase of equipment failure.

Funds approval, manpower & mobility to be geared up in advance.

Vaccine Distribution & Re useVaccines are not stored at the sub-centre level and

must be supplied 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 not distribute to remote areas)

Partially used OPV vials can be returned to the

field the next day, if the VVM has not reached

discard point

Return of vials and reuseReturn all used and unused vials to PHC Match OPV consumed with children

immunizedSee VVM of unused vials Replace stage-I and II vials in DF/ILR after

marking them / separately packing themUse returned vials first on subsequent day

after checking VVMEnsure OPV is not left in Vaccine Carriers at

the end of the dayRe-evaluate requirement of teams and

rationalize distribution

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

potency fast.

Potency lost due to heat exposure does not change the

appearance of 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.

Vaccine Vial Monitor - Interpretation

The Shake TestThe “Shake test” can help give an idea whether adsorbed

vaccines (DPT, DT, Td, TT or Hepatitis B) have been subjected to freezing temperatures likely to have damaged them.

After freezing, the vaccine no longer has the appearance of an homogenous cloudy liquid, but tends to form flakes which settle at the bottom of the vial after shaking.

Sedimentation is faster in a vial which has been frozen than in a vial, from the same manufacturer, which has not been frozen.

The shake test is not a reliable method of testing vaccine potency because a positive shake test may or may not occur after a liquid vaccine has been frozen.

The test should be conducted for all boxes where freeze indicators are found to be activated or temperature recordings show negative temperatures.

Procedure:Step 1 — Prepare a frozen control sample:

Take a vial of vaccine of the same type and batch number as the vaccine you want to test, and from the same manufacturer.

Freeze the vial until the contents are solid (at least 10 hours at -10°C) and then let it thaw. This vial is the control sample.

Mark the vial clearly so that it is easily identifiable and will not be used by mistake.

Step 2 — Choose a test sample: Take a vial (s) of vaccine from the batch (es) that you suspect has been frozen. This is the test sample.

Step 3 — Shake the control and test samples: Hold the control sample and the test sample together in one hand and shake vigorously for 10–15 seconds.

Step 4 — Allow to rest: Leave both vials to rest by placing the vials on a table and not moving them further.

Step 5 — Compare the vials: View both vials against the light to compare the sedimentation rate.

If the test sample shows a much slower sedimentation rate than the control sample, the test sample has most probably not been frozen and can be used.

If the sedimentation rate is similar, the vial has probably been damaged by freezing and should not be used.

Note that some vials have large labels which conceal the vial contents. This makes it difficult to see the sedimentation process. In such cases, turn the control and test vials upside down and observe sedimentation taking place in the neck of the vial.

If the shake test procedure indicates that the test sample has been damaged by freezing, you should notify your supervisor immediately.

Identify and separate all vaccines that may have been frozen and ensure that none are distributed or used.

Cold Chain Issues in Field…Inadequate maintenance of cold chain

equipmentHigh cold chain sickness rateLong response time to breakdown of equipmentNot enough cold chain engineers / refrigerator

mechanics in states and districts Lack of adequate trainingLack of adequate equipmentsVoltage fluctuation, equipments not attached to

stabilizers, lack of proper wiring and earthingImproper cleaning and defrosting of equipment

Poor Monitoring of the Cold ChainSlackness in the field regarding cold chain

maintenance by ANM and MPW malePoor supervision, monitoring, contingency planCondemned equipment not disposed off timelyShortage of accessories like thermometers,

stabilizers, equipment stands, freeze tag, etc.Inadequate recording and documentation

- Power cuts / generator running / defrosting not documented in log books

- Temperature charting not done meticulously /regularly

Vaccine Management……..Different batches of vaccines mixed with missing labels

Mixed Vaccine Vials with missing labels

Vaccine Potency………..

Frozen DT at bottom of ILR

Vaccine deliveryVaccine carrier lying in area 5 days after SIA completed

Vaccine left in carrier after activity

Preparation & Storage of Ice Packs

Polio team !!!

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?

Minimizing vaccine wastageVACCINES ARE EXPENSIVE! DPT = Rs 1.30 per

doseTT = Rs 0.66 per

dose DT = Rs.1.30 per

dose OPV = Rs 8.00 per

dose Measles = Rs 8.34 per doseBCG = Rs 1.50 per

dose Hepatitis B = Rs 17 per

dose

Reverse cold chainThe process of maintaining the cold chain

when heat sensitive items are stored and transported in the reverse direction i.e. upwards from the clinic to a depot or laboratory. This process is also used for transporting specimen samples.

Used in Acute Flaccid Paralysis (AFP) Surveillance in polis eradication program to carry out the stool sample of suspected case.

THANK YOU!!!!!!!!