This presentation contains Complete cold chain system, Importance and requirement of cold chain, detail of each equipment of cold chain system. This presentation contain brief detail of THE SHAKE TEST, Reverse cold chain. This is fully equipped with knowledge of Field facts of cold chain system.

1. Dr. Dhruvendra Pandey
Department of community medicine
MGM Medical College, Indore

2. Discussion
What is cold chain?
Importance of cold chain
Vaccine sensitive to heat, freeze & Light
Equipments of cold chain
Ideal methods of utilization
Cold chain monitoring
Vaccine vial monitor
The Shake test
Field Facts
Reverse cold chain

3. 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.

4. Defination
 The cold chain is the system of transporting and
storing vaccines consumables within the safe
temperature range of 2o
C to 8o
C (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.

5. Cold Chain Diagram
Proper storage
temperatures
must be
maintained at
every link in the
chain.

6. Importance of cold chain
Vaccines 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.

7. Reasons of maintaining
potency of vaccines
There 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.

8. 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.

9. The Effective Cold Chain
Three main elements combine to ensure proper vaccine
transport, storage, and handling.
Trained personnel
Transport and storage equipment
Efficient management procedures
Equipment
People
Procedures

10. OPV
Measles, MR, MMR
DPT, DPT+HepB, DPT+Hib,
DPT+HepB+Hib , Yellow fever V
BCG
DT, Hib
TT , Td, hep B, JE

11. hep B
Hib liquid
DPT, DPT+HepB, DPT+Hib,
DPT+HepB+Hib
DT,
Td
TT

12. Light sensitive vaccines
BCG
Measles
MR
MMR

13. Among all the vaccines, polio vaccine is most sensitive
to the heat, requiring storage at minus 20o
c.
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 +2o
c - +8o
c .
Reconstituted BCG vaccine and measles vaccine can be
kept at +2o
c - +8o
c 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.

14. 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

15. Refrigerator
Truck Walk-in Freezer
Walk-in Cooler
Cold Box Deep Freezer (DF) 300 ltr
Ice-Lined Refrigerator(ILR) 300 ltr

16. Ice-Lined Refrigerator(ILR) 140 ltr
Deep Freezer (DF) 140 ltr
Cold Box
Vaccine Carriers

17. Refrigerator truck
• Transportation of
vaccines from
Regional centers
to districts
• From districts to
PHCs

18. Walk in cooler and freezer
They 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)

19. 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

21. 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 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

22. Arrange the vaccine In the order Top to bottom in ILR
Hepatitis B
TT, DPT
BCG
MEASLES
OPV
Follow the early expiry date first out
Keep the space between boxes
Measles and OPV can be kept over two rows of empty ice packs on the floor of the ILR

23. • 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

24. Dos (for ILR and Deep freezer)
Keep the equipment in cool room away from direct
sun light.
Keep the equipment labeled
Fix the equipment through the voltage stabilizer
Keep 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

25. Donot (for ILR and Deep freezer)
Donot keep any object on these equipment
Donot store any drug
Donot keep food and drinking water in them
Donot keep moor then one month requirments at
PHC level.
Donot keep expiry date vaccine.

26. 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

27. 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.

28. 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

29. 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

30. • 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

31. • 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

32. 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

33. 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

37. Ice Packs in Deep Freezer- Side
View

40. 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.

41. 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

42. 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 Vaccine Carriers at the end
of the day
Re-evaluate requirement of teams and rationalize
distribution

43. 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.

44. Vaccine Vial Monitor - Interpretation

45. The Shake Test
The “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.

46. 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.

47. 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.

48. 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

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

51. Cold Chain Issues in Field…
Inadequate maintenance of cold chain equipment
High cold chain sickness rate
Long response time to breakdown of equipment
Not enough cold chain engineers / refrigerator
mechanics in states and districts
Lack of adequate training
Lack of adequate equipments
Voltage fluctuation, equipments not attached to
stabilizers, lack of proper wiring and earthing
Improper cleaning and defrosting of equipment

52. Poor Monitoring of the Cold Chain
Slackness in the field regarding cold chain
maintenance by ANM and MPW male
Poor supervision, monitoring, contingency plan
Condemned equipment not disposed off timely
Shortage 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

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

54. Vaccine Potency………..
Frozen DT at
bottom of ILR

55. Vaccine deliveryVaccine carrier lying in
area 5 days after SIA
completed
Vaccine left in carrier after
activity

56. Preparation & Storage of Ice Packs

57. Polio team !!!

58. 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?

59. Minimizing vaccine wastage
VACCINES ARE EXPENSIVE!
DPT = Rs 1.30 per dose
TT = Rs 0.66 per dose
DT = Rs.1.30 per dose
OPV = Rs 8.00 per dose
Measles = Rs 8.34 per dose
BCG = Rs 1.50 per dose
Hepatitis B = Rs 17 per dose

60. Reverse cold chain
The 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.

61. THANK YOU!!!!!!!!