3. 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.
4. Why have the Cold Chain?
If vaccines are exposed to excessive
They lose their potency
Heat
Light
Freezing
5. 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
6. Cold chain Equipment
• Walk in freezers
• Walk in coolers (WIC)
• Deep freezers
• ILR-Basket
• Dial Thermometer
• Cold boxes
• Vaccine carriers
• Day carriers
8. Cold Chain Equipment: District
Level
Cold Box
Deep Freezer (DF) 300 ltr
Ice-Lined Refrigerator(ILR) 300 ltr
9. Cold Chain Equipment: Unit Level
Ice-Lined Refrigerator(ILR) 140 ltr
Deep Freezer (DF) 140 ltrCold BoxVaccine Carriers
10. 1. Walk-in Cooler & Freezer
Walk-in Cooler
(+2o
C to +8o
C)
Walk-in Freezer
(-15o
to -25o
C)
11. 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
12. 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.
13. • 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
14. 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 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
15. 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
16. 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
17. 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
18. 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.
19. 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.
20.
21. 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
22. 5. Cold Boxes
Size: 20 ltr and 5 ltr
Level: District / PHC
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
23. • 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
24. 6. Vaccine Carriers
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
25. 7. Ice Packs
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
Time to Freeze: 48 hours in DF at
- 20˚C
26. 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
27. 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
28. 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
29.
30.
31. Vaccines vulnerable to heat
BCG (after reconstitution)
OPV
Measles
DPT
BCG (before reconstitution)
DT
TT
Hep B
33. 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
34. 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)
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
35. 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 inoculation
2. Reactions due to faulty techniques
3. Reactions due to hypersensitivity
4. Neurological involvement
5. Provocative reactions
6. Others
36. • 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.
37. • 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.
38. • Use of improperly sterilized syringes and
needles carry the hazard of hepatitis B
virus, and staphylo - and streptococcal
infection
39. • 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.
40. • 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.
41. • 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.
42. • 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).
43. Irritability, malaise &
systemic symptoms
COMMON, MINOR REACTIONS
Fever
>38o
C
BCG
Hib
HepB
Measles/
MMR
Polio
(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)
44. 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
333
33
1-50
5-12 days
15-35 days
0-1 hour
Febrile seizures
Thrombocytopaenia
Anaphylaxis
Measles
/MMR
1-2
5
0-1 hour
1-6 weeks
Anaphylaxis
Guillain Barré syndrome
Hep B
Nil knownHib
100-1000
1-700
2
2-6 months
1-12 months
1-12 months
Suppurative lymphadenitis
BCG osteitis
Disseminated BCG
BCG
Rate per million
doses
Onset
interval
ReactionVaccine
45. RARE, MORE SERIOUS REACTIONS (2)
1000-60 000
570
570
20
0-1
0-24 hours
0-3 days
0-24 hours
0-1 hour
0-3 days
Persistent (>3 hrs)
inconsolable screaming
Seizures
Hypotonic, hyporesponsive
episode (HHE)
Anaphylaxis/shock
Encephalopathy
DPT
Nil extra to tetanus reactionsTetanus-diphtheria
5-10
1-6
6-10
2-28 days
0-1 hour
1-6 weeks
Brachial neuritis
Anaphylaxis
Sterile abscess
Tetanus
Rate per
million doses
Onset
interval
ReactionVaccine
46. 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
Rate per million
doses
Onset intervalReactionVaccine
Editor's Notes
Common, minor reactions
These occur within a day or two of immunization (except for measles/MMR - 6 to 12 days after immunization) and they only last one to a few days.
Local reactions include pain, swelling and/or redness at the injection site and can be expected in about 10% of vaccinees, except for those injected with DTP, or tetanus boosters, where up to half can be affected. BCG causes a specific local reaction that starts as a papule (lump) two or more weeks after immunization that then becomes ulcerated and heals after several months, leaving a scar. Individuals with dormant tuberculosis infection often have an accelerated response to BCG. Keloid (thickened scar tissue) from the BCG lesion is more common among Asian and African populations.
Systemic reactions include fever and occur in about 10% or less of vaccinees, except for DTP where it is again about half. Other common systemic reactions (e.g., irritability, malaise, ‘off-colour’, anorexia) can also occur after DTP. For measles/MMR and OPV the systemic reactions arise from vaccine virus infection. Measles’ vaccine causes fever, rash and/or conjunctivitis, and affects 5-15% of vaccinees. It is very mild compared to ‘wild’ measles, but for severely immunocompromised individuals, it can be severe, even fatal. Vaccine reactions for mumps (swollen parotid gland) and rubella (arthralgia and swollen lymph nodes) affect less than 1% of children. Rubella vaccine causes symptoms more often in adults, with 15% suffering from arthralgia. Systemic reactions from OPV affect less than 1% of vaccinees with diarrhoea, headache, and/or muscle pain.
Rare, more serious reactions
Most of the rare and more serious vaccine reactions (e.g., seizures, thrombocytopaenia, hypotonic-hyporesponsive episodes, persistent inconsolable screaming) do not lead to long term problems. Anaphylaxis, while potentially fatal, is treatable without leaving any long term effects. Although encephalopathy is included as a rare reaction to measles or DTP vaccine, it is not certain that this is in fact caused by these vaccines.
Seizures are mostly febrile and risk depends on age, with much lower risk in infants under the age of 4 months or over the age of six years.
Reactions to measles/MMR (except allergic and anaphylaxis) do not occur if already immune (~90% of those receiving a second dose).
Rare, more serious reactions
Most of the rare and more serious vaccine reactions (e.g., seizures, thrombocytopaenia, hypotonic-hyporesponsive episodes, persistent inconsolable screaming) do not lead to long term problems. Anaphylaxis, while potentially fatal, is treatable without leaving any long term effects. Although encephalopathy is included as a rare reaction to measles or DTP vaccine, it is not certain that this is in fact caused by these vaccines.
Seizures are mostly febrile and risk depends on age, with much lower risk in infants under the age of 4 months or over the age of six years.
Reactions to measles/MMR (except allergic and anaphylaxis) do not occur if already immune (~90% of those receiving a second dose).
Rare, more serious reactions
Most of the rare and more serious vaccine reactions (e.g., seizures, thrombocytopaenia, hypotonic-hyporesponsive episodes, persistent inconsolable screaming) do not lead to long term problems. Anaphylaxis, while potentially fatal, is treatable without leaving any long term effects. Although encephalopathy is included as a rare reaction to measles or DTP vaccine, it is not certain that this is in fact caused by these vaccines.
Seizures are mostly febrile and risk depends on age, with much lower risk in infants under the age of 4 months or over the age of six years.
Reactions to measles/MMR (except allergic and anaphylaxis) do not occur if already immune (~90% of those receiving a second dose).