Cold Chain

Dr Ravindra Singh Department of Community medicine S N Medical College, Agra, U P

Cold Chain
The Cold Chain is a system of storing and transporting vaccines at recommended temperatures from the point of manufacture to the point of use.

Vaccine Sensitivities

Vaccine Damage
The physical appearance of the vaccine may remain unchanged even after it is damaged. However, the loss of potency due to either exposure to heat or cold is permanent and can not be regained.

Checking for heat damage

The Vaccine Vial Monitor (VVM): A VVM is a label containing a heatsensitive material which is placed on a vaccine vial to register cumulative heat exposure over time.

The combined effects of time and temperature cause the inner square of the VVM to darken gradually and irreversibly.
Before opening a vial, check the status of the VVM.

Does a VVM measure vaccine potency ?

No, the VVM does not directly measure vaccine potency It gives information about the main factor that affects potency: heat exposure over a period of time.

The physical appearance of the vaccine may remain unchanged even after it is damaged.
However, the loss of potency due to either exposure to heat or cold is permanent and cannot be regained. The VVM does not, however measure exposure to freezing that contributes to the degradation of freeze-sensitive vaccines.

FREEZE DAMAGE
Hepatitis B, DPT, DT, and TT vaccines lose their potency if frozen. Freezing dissociates the antigen from the adjuvant alum thus interfering with the immunogenicity of the vaccine. Moreover, the risk of adverse events following immunization, such as sterile abscesses, may increase. Therefore, always store 'T-series' vaccines (DPT, DT, TT) and Hep.B vaccine between +2C and +8C.

FREEZE DAMAGE
Diluents must be cooled for at least 24 hours before use to ensure that vaccines and diluents are at +2C and +8C when being reconstituted. If the vials are found to be frozen or contain floccules, discard the vials. Conduct the shake test if you suspect that vials could have been frozen.

Shake Test
Step 1- prepare a frozen control sample by freezing the vial until the contents are solid. Step 2- choose a test sample. Step 3- shake the control & test sample for 10-15 second. Step 4- allow to rest both vials by placing them on a table. Step 5- compare sedimentation rate of both vials, if the sedimentation rate is similar the test vial has probably been damaged by freezing and should not be used.

Shake Test

REMEMBER
Do not keep in the cold chain, any vials that are expired, frozen or with VVMs beyond the discard point, as they may be confused with those containing potent vaccines. Keep them in the red bag for disinfection and disposal.

Cold Chain Equipment

Cold chain equipment, both electrical and non-electrical, is used for storing vaccines and/or transporting them at appropriate temperatures.

Equipments
Walk in Freezers (WIF) -They are located at state, regional & district head quarters - Meant to store OPV in bulk & to freeze ice packs - Maintain temperature -20C. Walk in cold rooms (WIC)- They are located at regional level. - Meant to store vaccines upto 3months & serve 4-5 Districts - Maintain temperature +2 to +8C.

Summary of cold chain equipment

Equipment Electrical Deep freezer Large(300 ltr) Temperature
-15 to -25C

Storage Capacity
200 ice packs or OPV stocks for 3 month(1,20,0001,80,000) BCG, DPT, TT, Measles, Hep. B stock for 3 months (60,000 doses) 100 ice packs BCG, DPT, TT, Measles, Hep. B stock for 1 month(25,000 doses)

ILR Large (300/240ltr)

+2 to + 8C

Deep freezer small (140ltr)

-15 to -25C +2 to +8C

ILR Small(140 ltr)

Summary of cold chain equipment

Equipment Nonelectrical Cold Box large (20 ltr) +2 to + 8C All vaccines are stored for transport or power failure(72-96 ice packs) All vaccines are stored for transport or power failure(36 ice packs) All vaccines are carried for 12 hrs (4 ice packs & 20 vials) Temperature Storage Capacity

Cold Box small (5ltr)

+2 to + 8C

Vaccine Carrier (1.7 ltr) +2 to + 8C

Keep all Electrical Cold Chain equipment

At least 10 cm away from walls Protected from rain or flooding and away from direct sunlight Level and on wooden blocks Properly connected to one Voltage stabilizer per equipment Locked and keys accessible to designated personnel

DEEP FREEZERS (DFs)

Maintain a cabinet temperature between -15C to -25C Store OPV and prepare ice packs at the district level. At the PHC level, Deep freezers are used only for preparation of ice packs and are not to be used for storing UIP vaccines. About 20-25 icepacks can be prepared by a 140 Liter DF in 24 hours with at least 8 hours of continuous electricity supply.

ICE LINED REFRIGERATORS (ILRs):

Maintain a cabinet temperature between +2C to +8C
used to store all UIP vaccines at the PHC level. ILRs are lined with ice packs filled with water which freezes and keeps the internal temperature at a safe level despite electricity failure. ILRs can keep vaccine safe with as little as 8 hours continuous electricity supply in a 24-hour period. Since ILRs are top-opening, they can hold the cold air inside better than a front-opening refrigerator.

VACCINE VANS:
Are insulated vans used for transporting the vaccines in bulk. The vaccines should be transported to the last cold storage point only through vaccine vans. Vaccines should be transported only in Cold boxes with the desired number of conditioned ice packs.

COLD BOXES
Are insulated boxes, used for transportation and emergency storage of vaccines and icepacks. Place conditioned ice packs at the bottom and sides of the cold box before loading the vaccines in cartons or polythene bags.

COLD BOXES
Always keep a thermometer inside the cold box. Do not place DPT, DT, Hep B and TT vials in direct contact with conditioned ice packs. Do not place weights or other cold boxes on the lid since it will damage the rubber

COLD BOX

VACCINE CARRIERS
With 4 conditioned ice packs, maintain the inside temperature between +2C to +8C for 12 hours, if not opened frequently. They are used for carrying vaccines (16-20 vials) and diluents from PHCs to session sites. Never use day carriers which contain 2 ice packs for routine immunization. Never use any screw driver or any other sharp shaft to open the lid of vaccine carrier.

VACCINE CARRIERS
Ensure the return of unused vaccine vials from session sites to the PHC on the same day in the cold chain through alternate vaccine delivery. Keep a unused vaccines that can be used in subsequent sessions. Discard vaccines that have been returned unopened. Do not keep any used vials in the cold chain.

Correct packing of the vaccine carrier

1. Prepare ice packs for freezing-Fill ice pack with water to mark. -DO NOT ADD SALT TO WATER -Fit the stopper & screw on the cap tightly -Make sure the ice pack does not leak. -Wipe the ice pack dry & place in the deep freezer. 2. Condition frozen Ice pack- Place frozen ice packs in the open till they sweat (some condensation or droplets of water). - Check if an ice pack has been conditioned by shaking it & listening for water.

3. Pack the vaccine carrier- Place four conditioned ice pack against the sides of the carrier. - Place the plastic bag containing all vaccines & diluents in the centre of the carrier.
4. Remember to-collect vaccines in the carrier on the session day (vaccine carriers not store vaccines effectively beyond 12 hrs.). -Do not drop or sit on vaccine carrier. -Do not leave in sunlight, keep in shade. -Do not leave the lid open once packed.

ICE-PACKS
Are plastic containers filled with water. These are frozen in the deep freezer and when placed in nonelectrical cold chain equipment such as vaccine carriers and cold boxes, help increase the holdover time. The most common cause of exposure of freeze sensitive vaccines to freezing temperatures is the failure to correctly condition ice packs prior to transport.

Condition Icepacks
Conditioning prevents freezing of freezesensitive vaccines. When icepacks are removed from a freezer, at say - 25C, they need to be kept at room temperature for long enough to allow the temperature of the ice at the core of the icepack to rise to 0C. This process is called conditioning.

An ice pack is adequately conditioned as soon as beads of water cover its surface and the sound of water is heard on shaking it.

Ice Pack

Immunization services
Strategy1. Routine immunizationa. At health centre b. In field- at fixed day & fixed site or place Health centre will fix the periodicity depending upon the no. of children/ doses i.e. daily or on alternate day, while at village level/ outreach visits, it is once in a month by health workers (ANM) 2. Special immunization campaigns- IPPI , NIDs

National Immunization Schedule

For Infants At birth At 6 weeks -BCG, OPV (zero dose) -BCG (if not given at birth) DPT-1,OPV-1,Hep B-1* -DPT-2,OPV-2,Hep B-2* -DPT-3,OPV-3,Hep B-3* -Measles, Vit A^ -DPT & OPV booster -DPT(2doses if not given earlier at an interval of 1month) -TT

At 10 weeks At 14 weeks At 9 months At 16-24 months At 5-6 Years

At 10 & 16 years *- In some disricts ^- in every 6 month till 5years of age

National Immunization Schedule

For pregnant femalesEarly in pregnancy -TT- 1/booster (during 1st visit) One month after TT-1 - TT-2

Doses & site/route

1. BCG - 0.1ml given I/D 2. OPV - 2drops given oral 3. DPT - 0.5 ml given I/M 4. Hep B - 0.5 ml given I/M 5. Measles -0.5ml given S/C 6. Vit A - <1yr spoon >1yr 1 spoon 7. TT - 0.5 ml given I/M

How to hold a immunization session

In the field (outreach) - Sessions should be held regularly at fixed day & fixed site and in the shade. - Sufficient no. of syringes & needles s/be available also the vaccines, and start giving vaccine when sufficient no. of children are collected. - Do not return the child unimmunized for minor reasons - Opened vials should not be used on next day/ session

- Return the unopened vials in cold chain. - Vaccines are issued to S/C or ANM on same day. - Check that all the 4 icepacks are fully frozen, first wipe the ice pack, keep diluent also. - Scheduled session should not be cancelled unless there is some emergency. - Report the serious side effects to PHC. - Do not open the vaccine carrier until necessary. - Do not sit over it, close the lid tightly. - Only AD syringes are used now.

- Reconstituted measles vaccine should be used with in 4 hrs & BCG vaccine with in 3 hrs. - Diluents of vaccine should be kept separate from other drugs. - Check the diluents & see that it should be at low temp. before mixing. - Keep the vials on the ice pack during session. - At PHC or district, follow the principle of first come, first issue of vaccine. - Issuing of amount of vaccine should be based on the no. of doses to be consumed which can be calculated.

Adverse Events following Immunization (AEFI)

As no vaccine is 100 % effective, none is without risk & severe life threatening events can occur but extremely rare. They are- Anaphylactic shock. - CNS complication due to pertusis antigen. - Lymphadenitis d/t BCG. - Abscess d/t faulty techniques. - Traumatic neuritis - nerve injury by injection. - Accidental use of another drug.

 Toxic shock syndrome (TSS)-due to use of measles vaccine which has been contaminated by unsterlized needle for taking out the vaccine from the vials and vial being used later on same day or next day. - Cause is the growth of staphylococcus aureus. Symptoms- watery diarrhoea, vomiting & high fever within few hours of giving such vaccine. progress to hypotensive shock & death with in 48 hours. CFR is very high.

Management- TSS is an emergency and no time should be lost in taking the patient to a hospital. before that 1. A broad spectrum antibiotic & 2. I.V. fluids s/be started Management in hospital include- I.V. fluids - Antibiotics - Steroids - Antipyretics - Supportive therapy. If no improvement shift to ICU.

Planning of an Immunization session

The building block of planning for routine immunization is the sub-center microplan, which is compiled at the PHC and further at the district level.

Components of the Immunization Micro plan

At sub center Level An estimation of beneficiaries An estimation of vaccines, and logistics A work plan, including: -Who will provide the services? -Who will assist in provision of the services (AWW, ASHA, Social mobilizers, Gram Panchayat members, NGOs etc) -Where will the services be provided (selection of sites)? -When will the services be provided (planning of sessions)?

At sub center /PHC

Medical officer has the responsibility for development of action plan preparation.

The health personnel (ANM) should formulate the micro plan at least annually.
An Area Map (with villages, hamlets, hard to reach areas) at the SC-level will be prepared. For the block level, the map includes SC boundaries, with alternate vaccine delivery routes and

Vaccine storage points.

At PHC/District
A plan for Supervision should be ready. A budget that includes the costs of transport, meetings, social mobilization and other activities.

IEC and Training Plans should be prepared.

Guidelines while preparing action plans

Prepare list of villages and hamlets in the area. Prepare an operational map showing population & distance from health facility.
Estimate total no. of beneficiaries.

 Remember to follow fixed day & fixed site principle

Immunization sessions are organized on Wednesdays & Saturdays. The session on Ist Wednesday of each month should be organized at the sub center.

 All attempts should be made to ensure that no planned sessions are cancelled ,In case because of any reason the planned session is not held, it should be conducted on the next working day.
Consult the AWW, ASHA, TBAs, PRI and the community leaders to select accessible immunization session sites (government buildings such as SCs or AWCs).

Remember
All vaccines should be available during the immunization session.

No child should be returned due to nonavailability of vaccines (missed opportunity)

Remember
A child can be given more than one vaccine at the same session such as BCG, DPT, OPV and measles, if previous ones were missed, but at different sites & with different syringes & needles. No child should be returned unimmunized just to reduce wastage rates of vaccines.

Estimating beneficiaries for immunization programme

Total live births in the area= Population of the area birth rate 1000 Estimated pregnant women in the area= Total live births in the area+10% of live births (add 10% for pregnancy wastage in the form of abortions & still births) Total no. of infants dying = total live births in the area IMR during one year Infants alive at one year of age= Total live births in the areainfants dying during one year

Estimation of number of contacts

Each visit to the immunization site for vaccination is called a contact. Minimum four contacts (three contacts for BCG,DPT & polio and one contact for measles) are required for one child to receive the complete series of vaccination, so the total number of contacts will be four times the number of children in the target population. In case if zero polio dose is given within first 15 days of life the no. of contacts should be five.

Calculations for total vaccine requirments for each immunization are as follows=total infants & pregnant women no. of doses of vaccines WMF WMF is wastage multiplication factor, it is the maximum vaccine wastage allowed. Under new guidelines WMF is 1.33 for all the vaccines. WMF is a maximum available wastage. This does not mean that wastage to WMF level should be taken for granted. All efforts should be made to minimize wastage of vaccine as far as possible.

Estimation of AD syringes requirement

Total no. of injections=total no. of pregnant women no. of doses of each vaccine The calculation of AD syringes is as followsBeneficiary Pregnant women Children Vaccine & doses TT- 2 doses BCG- 1 dose DPT-3doses+1booster=4doses Measles-1dose DT-1dose Required ADS 2 1 7

TT-1 dose

 Thus requirement of ADS 0.5 ml is 9 (7 injections for each child & 2 injections for each mother) like wise for BCG inoculation,1 ADS 0.1ml is required. A wastage factor if 10% is added to above estimation to take care of wasting of syringes due to locking or breakage. New 5 ml disposable syringes are required every time mixing diluents to measles or BCG vaccine. Here again a wastage factor of 10 % is applicable.

Thank You