Cold chain system for vaccines

Age Vaccine

1. At birth BCG, OPV-0 , Hep B-0

2. 6 weeks OPV-1, pentavalent-1

3. 10 weeks OPV-2, , pentavalent-2

4. 14 weeks OPV-3, , pentavalent-3

5. 9 months Measles-1, Vitamin A-1

6. 16-24 months DPT booster, OPV booster, measles 2nd dose, Vitamin A 2nd dose

7. 5-6 Years DPT Booster

8. 10 & 16 years TT

9. Early in pregnancy TT-1

10. 4 weeks after TT-1 TT-2

11. If received 2 TT doses in a pregnancy within last 3 years

TT booster

Cold chain system for vaccines

The Cold Chain

• The "cold chain" is a system of storage and transport of vaccines at low temperature from the manufacturer to the actual vaccination site.

• The cold chain system is necessary because vaccine failure may occur due to failure to store and transport under strict temperature controls.

Why have the Cold Chain?If vaccines are exposed to excessive

They lose their potency

Heat

Light

Freezing

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

Cold chain Equipment

• Walk in freezers

• Walk in coolers (WIC)

• Deep freezers

• ILR-Basket

• Dial Thermometer

• Cold boxes

• Vaccine carriers

• Day carriers

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: Unit Level

Ice-Lined Refrigerator(ILR) 140 ltr

Deep Freezer (DF) 140 ltrCold BoxVaccine Carriers

1. Walk-in Cooler & Freezer

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

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

Walk-in-Freezers (WIF)• used for bulk storage of OPV, and also to

prepare frozen ice packs at state stores.

• Maintain a temperature around (-) 20oC.

• available in sizes of 16.5 Cum. and 32 Cum.

• Provided with two identical cooling units and standby generator.

• installed in all of the states

• Serves 4-7 districts

Walk-in-Coolers (WIC)• used for bulk storage of vaccines at State and

Regional/Divisional Stores.• maintain a temperature of +2oC to +8oC.• Available in sizes of 16.5 Cum. and 32 Cum. • used for storage of large quantities of vaccines, like

DPT, DT, TT, Measles, BCG, Hepatitis B • also provided with temperature recorder and alarm• WIC/WIF store vaccines of three months requirement

and 25% buffer stock for the districts they cater.• Cater 4-5 districts• 3 deep freezers and 10 cold boxes.

• Vaccine delivery vans• Transportation of vaccines

from Regional centers to districts

• From districts to PHCs• Temperature maintained at

+2o to +8o C.

2. Refrigerated Truck

3. Ice-Lined Refrigerator (ILR)

Size: 300 ltr / 140 ltr

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

Temperature: +2˚C to +8˚C

Utilization: BCG, DPT, OPV, Measles, TT, Hep-B vaccine

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

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

4. Deep Freezer (DF)

Size: 300 ltr / 140 ltr

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

Temperature: -15o to -25o C

Utilization:

1. Preparation of ice packs

2. Storing measles and OPV (only district)

Holdover time: 24 hours with 8 hours supply

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

Do’s for Deep freezer and ILR• Make one person responsible for loading, unloading,

maintenance and temperature recording.• Install it in a cool and well ventilated room.• Place them at least 10-20 cm away from the wall.• Insure that it is LEVELLED.• Let the electrician fix the cable permanently inside the

socket.• Use voltage stabilizer• Tape the switches in ON position so that there s no

accidental switching off.• FIFO and EEFO

Contd…

• Check the temperature at least every morning and evening.

• Adjust the thermostat knob if the temperature is not correct.

• Note the expiry date of all vaccines.• Clean and dry the chamber before loading.• Keep the lid locked.• Place the ILR and deep freezer in the same room.

Donts for deep freezer and ILR

• Do not open the lid too often..• Do not store other drugs• Don’t keep drinking water or food• Don’t keep more than one month supply• Don’t keep outdated Vac.s• Don’t fill ice packs to the top.• Don’t keep ILR and deep freezer hugging

together.

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

5. Cold Boxes

Size: 20 ltr and 5 ltr

Level: District / PHC


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

• Cold boxes. For transportation.

• Fully frozen packs at the sides and bottom

• Vac.s in polythene bags

• DPT, DT, TT & diluents not to be kept in direct contact with frozen ice packs

• Vaccine carriers: 4 frozen packs at the sides.

• For small quantities

6. Vaccine Carriers

Size: 1.7 ltr

Level: PHC/ Sub Centre


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

7. Ice Packs

Size: 763 X 90 X 33 mm

Ice capacity: 360 ml

Weight: 80 gm

Level: District / PHC/ Sub Centre


Utilization: line the walls of vaccine carrier/cold box

Time to Freeze: 48 hours in DF at

- 20˚C

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

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

Vaccines vulnerable to heat

BCG (after reconstitution)

OPV

Measles

DPT

BCG (before reconstitution)

DT

TT

Hep B

Vaccines vulnerable to Freezing

Hep- B

DPT

DT

TT

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 notpassed, 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

Summary of Vaccine Vulnerabilities

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)


Freezes at- .5˚C.

Discard if frozen.

+2˚C to +8˚C

TT(toxoid)


Freezes at -3˚C. Discard if frozen.

+2˚C to +8˚C

HAZARDS OF IMMUNIZATION• No immune response is entirely free from the

risk of adverse reactions or remote squeal. The adverse reactions that may occur may be grouped under the following heads:

1. Reactions inherent to inoculation2. Reactions due to faulty techniques 3. Reactions due to hypersensitivity4. Neurological involvement5. Provocative reactions 6. Others

• 1. Reactions inherent to inoculation:

These may be local general reactions. The local reactions may be pain, swelling, redness, tenderness and development of a small nodule or sterile abscess at the site of injection.

• The general reactions may be fever, malaise, headache and other constitutional symptoms. Most killed bacterial vaccines (e.g., typhoid) cause some local and general reactions. Diphtheria and tetanus toxoids and live polio vaccine cause little reaction.

• 2. Reactions due to faulty techniques:

Faulty techniques may relate to • faulty production of vaccine (e.g. inadequate inactivation of the

microbe, inadequate detoxication), • too much vaccine given in one dose, • improper immunization site or route, • vaccine reconstituted with incorrect diluents, • wrong amount of diluent used, • drug substituted for vaccine or diluent, • vaccine prepared incorrectly for use (e.g., an adsorbed vaccine not

shaken properly before use), • vaccine or dliluent contaminated, • vaccine stored incorrectly, • contraindications ignored (e.g. a child who experienced a severe

reaction after a previous dose of DPT vaccine is immunized with he same vaccine),

• reconstituted vaccine of one session of immunization used again at the subsequent session.

• Use of improperly sterilized syringes and needles carry the hazard of hepatitis B virus, and staphylo - and streptococcal infection

• 3. Reactions due to hypersensitivity:

• Administration of antisera (e.g., ATS) may occasionally give rise to anaphylactic

shock and serum sickness. Many viral vaccines contain traces of various

antibiotics used in their preparation and some individuals may be sensitive to

the antibiotic which it contains. Anaphylactic shock is a rare but dangerous

complication of injection of antiserum. There is bronchospasm, dyspnoea, pallor,

hypotension and collapse.

• The symptoms may appear within a few minutes of injection or may be delayed

up to 2 hours. Some viral vaccines prepared from embryonated eggs (e.g.,

influenza) may bring about generalized anaphylactic reactions. Serum sickness

is characterized by symptoms such as fever, rash, oedema and joint pains

occurring 7 -12 days of injection of antiserum.

• 4. Neurological involvement:

• Neuritic manifestations may be seen after the

administration of serum or vaccine. The well-known

examples are the post vaccinial encephalitis and

encephalopathy following administration of anti -rabies

and smallpox vaccines.

• Guillain Barre syndrome in association with the swine

influenza vaccine is another example.

• 5. Provocative reactions:

• Occasionally following immunization there may occur a

disease totally unconnected with the immunizing agent

(e.g., provocative polio after DPT or DT administration

against diphtheria).

• The mechanism seems to be that the individual is

harboring the infectious agent and the administration of

the vaccine shortens the incubation period and produces

the disease or what may have been otherwise only a

latent infection is converted into a clinical attack.

• 6. Others:

• These may comprise damage to the fetus

(e.g., with rubella vaccination);

displacement in the age-distribution of a

disease (e.g., a potential problem in mass

vaccination against measles, rubella and

mumps).

Irritability, malaise & systemic symptoms

COMMON, MINOR REACTIONS

Fever >38oC

BCG

Hib

HepBMeasles/MMRPolio (OPV)

DTP(pertussis)

Tetanus

90-95%

5-15%

Adults: 15%; Children: 5%

~10%

-

Up to 50%

~10%*

-

2-10%

-

5-15%

<1%

Up to 50%

~10%

-

-1-6%

5% rash

<1%**

Up to 55%

~25%

* Rate of local reactions likely to increase with booster doses, up to 50-85%

** Symptoms include diarrhoea, headache, and/or muscle pains

Vaccine Local reaction (pain, swelling, redness)

RARE, MORE SERIOUS REACTIONS

0.76-1.3 (1st dose)0.17 (subsequent doses)0.15 (contacts)

4-30 daysVaccine-associated paralytic poliomyelitis (VAPP)

Risk is higher for first dose, adults, and immunocompromised

OPV

333331-50

5-12 days15-35 days0-1 hour

Febrile seizuresThrombocytopaeniaAnaphylaxis

Measles/MMR

1-25

0-1 hour1-6 weeks

AnaphylaxisGuillain Barré syndrome

Hep B

Nil knownHib

100-10001-7002

2-6 months1-12 months1-12 months

Suppurative lymphadenitisBCG osteitisDisseminated BCG

BCG

Rate per million doses

Onset interval

ReactionVaccine

RARE, MORE SERIOUS REACTIONS (2)

1000-60 000

570570

200-1

0-24 hours

0-3 days0-24 hours

0-1 hour0-3 days

Persistent (>3 hrs) inconsolable screamingSeizuresHypotonic, hyporesponsive episode (HHE)Anaphylaxis/shockEncephalopathy

DPT

Nil extra to tetanus reactionsTetanus-diphtheria

5-101-66-10

2-28 days0-1 hour1-6 weeks

Brachial neuritisAnaphylaxisSterile abscess

Tetanus


Onset interval

ReactionVaccine

RARE, MORE SERIOUS REACTIONS (3)

500-4000 in infants<6 months

5-20

7-21 days

0-1 hours

Post-vaccination Encephalitis

Allergic reaction/anaphylaxis

Yellow fever

10-1000

1-2.3

Serious allergic reaction

Neurological event

Japanese encephalitis


Onset intervalReactionVaccine

Health & Medicine

Cold chain system for vaccines