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COLD CHAIN
Dr Md Tanwir Alam, MD
Assistant Professor, Dept. of PCM,
Govt. Tibbi College & Hospital, Patna
Tanveernium@gmail.com
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.
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Vaccines vulnerable to heat
BCG (after reconstitution)
OPV
Measles DPT
BCG (before
reconstitution)
DT TT
Hep B
8
Vaccines vulnerable to Freezing
Hep- B
DPT
DT
TT
9
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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 12
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)
Sensitive Sensitive +2˚C to +8˚CBCG
(live attenuated)
Measles
(live attenuated)
Sensitive Sensitive
Okay to freeze (before
reconstitution)
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
+2˚C to +8˚C
TT
(toxoid)
Relatively
heat stable
Freezes at- .5˚C.
Discard if frozen.
Freezes at -3˚C.
Discard if frozen.
+2˚C to +8˚C
13
Why have the Cold Chain?
If vaccines are exposed to excessive
They loose their potency
Heat
Freezing
Light
14
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
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Cold Chain Equipment: Various
Levels –State
Refrigerator
Truck
Walk-in Freezer
Walk-in Cooler
21
Cold Chain Equipment: District Level
Cold Box
Deep Freezer (DF) 300 ltr
Ice-Lined Refrigerator(ILR) 300 ltr
22
Cold Chain Equipment: Unit Level
Ice-Lined Refrigerator(ILR) 140 ltr
Deep Freezer (DF) 140 ltrCold BoxVaccine Carriers
23
Walk-in Cooler & Freezer
Walk-in Cooler
(+2o C to +8o C)
Walk-in Freezer
(-15o to -25o C)
24
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 25
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.
26
•
•
•
•
Vaccine delivery vans
Transportation of vaccines
from Regional centers to
districts
From districts to PHCs
Temperature maintained at
+2o to +8o C.
Refrigerated Truck
27
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
28
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
29
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
30
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.
31
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.
32
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.
• Don’t fill ice packs to the top.
• Don’t keep ILR and deep freezer hugging
together.
33
34
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
35
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
36
• Cold boxes. For transportation.
• Fully frozen packs at the sides and bottom
• Vac. 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
37
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
38
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
39
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
40
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
41
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
42
43
Solar Cold Chain Equipment
Solar refr. battery drive
 Same principle but low voltage
(12-24V)
 DC instead of AC Compressor
 Battery charged by solar
energy
 PUF insulation around
 Battery char, Charge controller
& Solar panel
 Refrigerator cum freezer
 Separate DC Compressor
 Vaccine Storage: +2 - +8C
 Freezer: up to -7C
Solar refr. direct drive
 Direct Drive technology
 Sun energy to freezer
water
 Cooling from ‘ice bank’ to
keep the refrigerator cold
during night and cloudy
days
 Refrigerators wired
directly to photovoltaic
generators
24/11/16tanveernium@gmail.com 44
Solar Col Chain Equipments
24/11/16tanveernium@gmail.com 45
Open
Vial
Policy
2015
24/11/16tanveernium@gmail.com 46
Open
Vial
Policy
2015
24/11/16tanveernium@gmail.com 47
Shake Test
24/11/16tanveernium@gmail.com 48
24/11/16tanveernium@gmail.com 49
Correct storage & Use of Diluents
▪ Only those supplied by the manufacturer along with
vaccines
▪ Coz specifically designed
 With respect to Volume, pH level
 Chemical properties
▪ Store diluents & dropper with the vaccine during transport
▪ Diluents should not come in direct contact with ice packs
▪ Storage: +2 - +8 C in the ILR
▪ If not may be outside- but must be cooled for 24Hrs
 Ensure the same Temp of vaccine & Diluents when being reconstituted
▪ Otherwise – thermal shocks- death of some/all essential
live organisms in the vaccines
24/11/16tanveernium@gmail.com 50
24/11/16tanveernium@gmail.com 51
24/11/16tanveernium@gmail.com 52
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Cold chain

  • 1. COLD CHAIN Dr Md Tanwir Alam, MD Assistant Professor, Dept. of PCM, Govt. Tibbi College & Hospital, Patna Tanveernium@gmail.com
  • 2. 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. 2
  • 7. 7
  • 8. Vaccines vulnerable to heat BCG (after reconstitution) OPV Measles DPT BCG (before reconstitution) DT TT Hep B 8
  • 9. Vaccines vulnerable to Freezing Hep- B DPT DT TT 9
  • 12. 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 12
  • 13. 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) Sensitive Sensitive +2˚C to +8˚CBCG (live attenuated) Measles (live attenuated) Sensitive Sensitive Okay to freeze (before reconstitution) 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 +2˚C to +8˚C TT (toxoid) Relatively heat stable Freezes at- .5˚C. Discard if frozen. Freezes at -3˚C. Discard if frozen. +2˚C to +8˚C 13
  • 14. Why have the Cold Chain? If vaccines are exposed to excessive They loose their potency Heat Freezing Light 14
  • 15. 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 15
  • 21. Cold Chain Equipment: Various Levels –State Refrigerator Truck Walk-in Freezer Walk-in Cooler 21
  • 22. Cold Chain Equipment: District Level Cold Box Deep Freezer (DF) 300 ltr Ice-Lined Refrigerator(ILR) 300 ltr 22
  • 23. Cold Chain Equipment: Unit Level Ice-Lined Refrigerator(ILR) 140 ltr Deep Freezer (DF) 140 ltrCold BoxVaccine Carriers 23
  • 24. Walk-in Cooler & Freezer Walk-in Cooler (+2o C to +8o C) Walk-in Freezer (-15o to -25o C) 24
  • 25. 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 25
  • 26. 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. 26
  • 27. • • • • Vaccine delivery vans Transportation of vaccines from Regional centers to districts From districts to PHCs Temperature maintained at +2o to +8o C. Refrigerated Truck 27
  • 28. 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 28
  • 29. 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 29
  • 30. 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 30
  • 31. 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. 31
  • 32. 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. 32
  • 33. 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. • Don’t fill ice packs to the top. • Don’t keep ILR and deep freezer hugging together. 33
  • 34. 34
  • 35. 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 35
  • 36. 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 36
  • 37. • Cold boxes. For transportation. • Fully frozen packs at the sides and bottom • Vac. 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 37
  • 38. 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 38
  • 39. 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 39
  • 40. 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 40
  • 41. 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 41
  • 42. 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 42
  • 43. 43
  • 44. Solar Cold Chain Equipment Solar refr. battery drive  Same principle but low voltage (12-24V)  DC instead of AC Compressor  Battery charged by solar energy  PUF insulation around  Battery char, Charge controller & Solar panel  Refrigerator cum freezer  Separate DC Compressor  Vaccine Storage: +2 - +8C  Freezer: up to -7C Solar refr. direct drive  Direct Drive technology  Sun energy to freezer water  Cooling from ‘ice bank’ to keep the refrigerator cold during night and cloudy days  Refrigerators wired directly to photovoltaic generators 24/11/16tanveernium@gmail.com 44
  • 45. Solar Col Chain Equipments 24/11/16tanveernium@gmail.com 45
  • 50. Correct storage & Use of Diluents ▪ Only those supplied by the manufacturer along with vaccines ▪ Coz specifically designed  With respect to Volume, pH level  Chemical properties ▪ Store diluents & dropper with the vaccine during transport ▪ Diluents should not come in direct contact with ice packs ▪ Storage: +2 - +8 C in the ILR ▪ If not may be outside- but must be cooled for 24Hrs  Ensure the same Temp of vaccine & Diluents when being reconstituted ▪ Otherwise – thermal shocks- death of some/all essential live organisms in the vaccines 24/11/16tanveernium@gmail.com 50