COLD CHAIN

Discussion
What is cold chain? Importance of cold chain Equipments of cold chain Vaccine sensitive to heat, freeze & Light Ideal methods of utilization Cold chain monitoring Field Facts

Why have the Cold Chain?

If vaccines are exposed to excessive

Heat

Freezing
Light

They lose their potency

In general

All Vaccines lose potency on exposure to heat above +80 C Some Vaccines lose potency when exposed to freezing temperatures The damage is irreversible

Vaccines vulnerable to heat

BCG (after reconstitution) OPV Measles HepB DPT DT BCG (before reconstitution) TT

Vaccines vulnerable to Freezing

Hep- B DPT DT TT

Summary of Vaccine Vulnerabilities

Vaccine OPV
(live attenuated)

Heat
Sensitive

Light
Sensitive

Freezing
Okay to freeze

Temperature at PHC
+2C to +8C
(-15C to -25C at state, regional and district stores)

BCG
(live attenuated)

Sensitive Sensitive

Sensitive Sensitive

Okay to freeze (before reconstitution) Okay to freeze (before reconstitution) Freezes at -3C. Discard if frozen. Freezes at- .5C. Discard if frozen. Freezes at -3C. Discard if frozen.

+2C to +8C +2C to +8C

(-15C to -25C at state, regional and district stores)

Measles
(live attenuated)

DPT
(toxoid, killed)

Relatively heat stable Relatively heat stable Relatively heat stable

+2C to +8C +2C to +8C +2C to +8C

Hep B
(recombinant)

TT
(toxoid)

Cold Chain Equipment: Various Levels State

Refrigerator Truck

Walk-in Freezer

Walk-in Cooler

Cold Chain Equipment: District Level

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

Cold Chain Equipment: Planning Unit Level

Cold Box Vaccine Carriers

Deep Freezer (DF) 140 ltr

Ice-Lined Refrigerator(ILR) 140 ltr

2. Refrigerated Truck
Transportation of vaccines from Regional centers to districts From districts to PHCs Temperature maintained at +2o to +8o C.

1. Walk-in Cooler & Freezer

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

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

4. Deep Freezer (DF)

Size: 300 ltr / 140 ltr
Level: District (300 ltr) / PHC (140 ltr) Temperature: -15o to -25o C Utilization:
1. 2. Preparation of ice packs Storing measles and OPV (only district)

Holdover time: 4 hours Storage capacity: 300 ltr: 150, 000 to 200, 000 doses 140 ltr : Approx. 20 Ice Packs

Other accessories to Walk-in Cooler & Freezer

Alarm and recorder

Back-up generator

The Cold Chain Room

ILRs and deep-freezers to be installed in a room that is
Not directly exposed to sunlight or any other source of heat. Ventilated and protected from rain or flooding.

ILR and deep-freezers should be level, on wooden blocks, at least 10 cms away from wall The plugs should be permanently fixed & labeled DO NOT REMOVE Equipment should be locked and opened only if necessary Keys to the equipment should be accessible

3. Ice-Lined Refrigerator (ILR)

Size: 300 ltr / 140 ltr
Level: District (300 ltr) / PHC (140 ltr) Temperature: +2C to +8C Utilization: BCG, DPT, OPV, Measles, TT, Hep-B vaccine Holdover time: 14 hrs after 8 hrs continuous power supply Storage capacity: 300 ltr: 60,000 doses of mixed antigen & 20,000 doses of OPV 140 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

5. Cold Boxes
Size: 20 ltr and 5 ltr Level: District / PHC Temperature: +2C to +8C 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

6. Vaccine Carriers
Size: 1.7 ltr Level: PHC/ Sub Centre Temperature: +2C to +8C Utilization: All vaccines can be
carried in small quantity for vaccination sessions

Holdover time: 12 hours

Storage capacity: 4 Ice Packs &1520 vials of mixed antigens

7. Ice Packs
Size: 763 X 90 X 33 mm
Ice capacity: 360 ml Weight: 80 gm

Level: District / PHC/ Sub Centre

Temperature: +2C to +8C

Utilization: line the walls of vaccine
carrier/cold box

Time to Freeze: 48 hours in DF at - 20C

8. Foam Pads
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

Right way of keeping vaccines in 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

Full ILR cannot maintain potency of vaccine

Do not open lid of ILR too often

How to use a Deep Freezer (DF)

Freezing ice-packs in a deep freezer

Freezing ice-packs in a deep freezer

To prepare icepacks place about 27 icepacks in a criscross manner. They will be frozen at -20o C for 48 hours.

Leave 10-mm spaces between icepacks After a session put the ice-packs back in the freezer.

Preparing icepacks for use: Filling and Freezing

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

Preparing icepacks for use: Conditioning

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.
A Conditioned an ice-pack

Loading a Vaccine Carrier

Put conditioned ice-packs against each of the 4 sides of the vaccine carrier Take required vaccines and place them inside a plastic bag and place bag In vaccine carriers, place a foam pad on top of the conditioned ice-packs. Close the cold box or carrier lid tightly.

1
2

Never put vaccines in direct touch with Ice packs

Never place vaccines on ice-packs in sessions

Maintenance of Equipment
Breakdown/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.

Power Factor
Generator: Standby power back up facilitydiesel generators of capacity 7.5/10 KVA Voltage Stabilizers: An essential safeguard of 1 KVA capacity connected to all Freezers & ILRs to combat unstable electric supply voltage Servo Stabilizers:A voltage fluctuation stabilizing device connected for safety to all Walk-in-Freezers & Walk-in-coolers

Vaccine Distribution & Re use

Vaccines 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 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 marking them / separately packing them Use returned vials first on subsequent day after checking VVM Ensure OPV is not left in VCs at the end of the day Re-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 refreezing. Discard frozen T series vaccine & Hepatitis B Vaccines.

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?

Vaccine Vial Monitor (VVM)

The square is lighter than the circle. If the expiry date is not passed, use the vaccine The square is lighter than the circle. If the expiry date is not passed, use the vaccine

The square matches the circle. Do not use the vaccine. Inform your supervisor
The square is darker than the circle. Do not use the vaccine. Inform your supervisor

THANK YOU!!!!!!!!