The document discusses guidelines for maintaining an effective cold chain system for storing and transporting vaccines. It outlines key aspects of cold chain management including: - Proper arrangement of vaccines in the refrigerator by type and expiration date - Monitoring refrigerator temperature twice daily and recording readings - Appropriately packing vaccines in cold boxes with ice packs during transportation - Procedures for reconstituting vaccines and conducting shake tests to check for freezing damage - Steps to take if a breach in the cold chain occurs, such as separating affected vaccines and communicating details to experts The cold chain is critical for ensuring vaccines remain potent and effective for immunization programs.

1. Pharmacy Services
PERISHABLE DRUG
CONTROL

2. Content
Cold Chain System
Arrangement of Fridge
Arrangement of Drugs in Fridge
How to Pack Cold Box
Thermometer Monitoring & Recording
Vaccine Reconstitution & Administration
Breach in Cold Chain
Vaccine Shake Test

3. Cold chain
A cold chain is a temperature-controlled supply chain.
An unbroken cold chain is an uninterrupted series of
storage & distribution activities which maintain a given
temperature range.
The cold chain is a series of tools & activities directed
toward maintaining the temperature of the product
between 2oC – 8oC during its transportation & storage from
the production facilities until its use in the field.
Pharmacy PSH

4. Cold Chain
It is used to help extend & ensure the shelf life of products
such as fresh agricultural produce, seafood, frozen food,
photographic film, chemicals, & pharmaceutical items.
Pharmacy PSH

5. Cold Chain System

6. Cold Chain System
1. Personnel - who use & maintain the equipment.
2. Equipment - for safe storage & transportation of vaccines.
3. Procedures - to manage the program, control distribution & use of the vaccines.

7. Cold Chain System
“.. even the most expensive & sophisticated equipment will not ensure an effective cold
chain if not correctly used & managed by qualified personnel”

8. Cold Chain System
“ It is obviously pointless to immunize with impotent
vaccine, & efforts to reach extremely high levels of
immunization coverage will be useless if the vaccine
administered has insufficient potency to give the
necessary protection. “

9. List of Vaccine
1. Tetanus
2. BCG
3. DPT + Polio + Hib (Pediacel®)
4. Hep A
5. Hep B
6. Hep A + B
7. Measles + Mumps + Rubella
8. Influenza (Vaxigrip®)
9. Meningococcal
10. Pneunomoccal (Prevenar®)
11. Varicella
12. Typhoid
13. HPV (Gardasil)
14. Immunoglobulin (Hepabig®)

10. Arrangement of Fridge
Fridge should not be near a heat source e.g.
radiator or hot pipe.
Placed the fridge away from direct sunlight.
Located 30cm from side wall, 20cm from back
wall & 40cm from ceiling.

11. Arrangement of Fridge
Shall have supply from UPS or from a generator. Power failure –
report immediately.
Monitor & record temperature twice daily.
Bottles filled with water stored in the bottom of the fridge.

12. Arrangement of drugs in fridge
All vaccines & thermolabile items shall be:
1. Stored in pharmaceutical refrigerator &
maintain temperature between 2oC – 8oC.
2. Separated according to their types.
3. Placed in holed containers & space of 2cm
between rows of vaccines allowed to enable
free movement of air.
Leave about 5 cm space between each tray to
allow the cold air to move around.

13. Arrangement of drugs in fridge – cont.

14. Arrangement of drugs in fridge – cont.
All vaccines & thermolabile items shall be:
4. Removed from the refrigerator once expired @ defective.
5. Packed with ice if needs to be transfer to other places.

15. Arrangement of drugs in fridge – cont.
Top shelf (coldest part) - measles & polio
Middle shelf - BCG, DPT, DT, HepB, Hib & TT vaccines (do not freeze).

16. Arrangement of drugs in fridge – cont.
No vaccine shall:
1. Touch the plate at the back of the top compartment of the refrigerator.
2. Be stored at the lowest compartments & at the side of the door.
Do not store the same kind of vaccines together in one tray.
Pharmacy PSH

17. How to Pack Cold Box
1. Ice packs are placed on the bottom, top & at the sides.
2. DPT, DT, TT, HepB & Hib vaccines - wrap them in paper to protect from freezing.
3. Keep measles & polio vaccines very cold – place on bottom of the cold box, next to the ice
packs.
4. BCG can be placed anywhere in the box.
5. Keep the lid firmly closed & the box out of the sun.
6. Keep a thermometer or temperature monitor in the cold box and maintain the temperature.

18. Ice pack conditioning
Remove frozen ice pack from the freezer.
Allow the frozen ice-packs to sit at room temperature for 5 - 10 minutes, until the ice begins to
melt and water starts to form.
Wait until the ice pack reaches 0°C before put in a cold box to avoid temperatures below 0°C (-
0°C )
WHY? To prevent the ice-packs from freezing the vaccines inside a cold box, and damaging the
freeze-sensitive vaccines.

19. Ice pack conditioning

20. Suggested Ice Pack Arrangement Procedures in the Cooler Box

21. Temperature Monitoring & Recording
Temperature monitoring should be implemented to ensure the cold chain product is in the
correct range.
Readings should be recorded 2 times a day.
The min/max thermometer needs to be reset every time after recorded.
The temperature chart must be signed after recording the temperature.
The temperature chart should be checked and verified by the supervisor every month and kept
for review or audit purposes.

22. Steps to read and record Min/Max fridge temperature

23. Vaccine Reconstitution & Administration
1. Reconstitution should be preformed away from direct sunlight.
2. After reconstitution – keep in the dark place in the cold chain.
3. Needle used for reconstitution should not be left in the rubber stopper.
4. Reconstitution vials should never be allowed to become wet or submerged in water.

24. Breach in Cold Chain – What To Do?
1. Put drug/vaccine back in the refrigerator.
2. Separate the affected vaccine from the rest.
3. Identify the 5 parameter:
type of vaccine
Maximum temperature of exposure
Maximum duration of exposure
Previous storage conditions
Expiry date
4. Communicate these element to a competent person.

25. Repeated exposure to
high temperature
has cumulative damaging effect on vaccine
activity

26. Vaccine Shake Test
PURPOSE : To determine whether adsorbed vaccines (DPT, DT, Td, TT, Hepatitis B, Hib, and/or
combinations of these) have been affected by freezing.
Conducted when temperature monitoring devices indicates temperature exposure below 0ºC.

27. Vaccine Shake Test
1. Shake the vial & place it in a cool place where there is enough light to see, but not in direct
sunlight.
2. Wait 15 minutes. If the solution is still smooth and cloudy, the vaccine can be used.
3. If the solution at the top is clear, but there is a sediment at the bottom, the vaccine has lost
its strength, & become ineffective.

29. GENERAL RULES
If vaccines that have experienced a breach of
the cold chain can still be used,
they must be used as a PRIORITY & RAPIDLY,
otherwise discard.

30. Thank you