Melissa Abd Raffur

Pegawai Farmasi U41

Hospital Hulu Terengganu
An Integrated, Planned And Coordinated
System Of Ordering, Transporting And
Storing Vaccines With Specific Safe
Temperature Ranges To Ensure Potency
And Efficacy
 Vaccine / Cold Medicine Potency

1. Excessive heat or cold exposure damages vaccine/ cold

medicine, resulting in loss of potency. Once potency is lost,
it can never be restored.

2. Each time vaccine/cold medicine is exposed to heat or cold,

the loss of potency increases and eventually, if the cold
chain is not correctly maintained, all potency will be lost,
and the vaccine becomes useless.
 Appearance of Medicine After Exposure to Inappropriate
Storage Conditions

1. Some medicine may show physical evidence of altered

potency (eg. clumping in the solution that does not go away
when the vial is shaken)

2. Other medicine may look perfectly normal.

Eg. inactivated vaccines exposed to freezing temperatures
(i.e. 0°C or colder) may not appear frozen and give no
indication of loss of potency.
 Loss of vaccine potency due to improper storage
conditions is a costly mistake.
 Patients receiving vaccine with decreased potency caused
by improper storage conditions may not be fully
protected against the vaccine-preventable disease.

 Recalling patients to repeat vaccine doses because vaccine

has been stored improperly can damage public
confidence in vaccines and in your practice.

 Vaccines are also expensive. Avoid extra expenses by

following procedures to maintain the cold chain
• An insulated container that
can be lined with ice-packs to
keep vaccines and diluents
cold during transportation and
/or for short period storage
( 2-7 days)

• Selected according to their

cold life

• Made of polyurethane
material – durable and robust
• Insulated container like cold box but
smaller in size that can be lined with
ice-packs to keep vaccines and diluents
cold during transportation or
temporary storage, to outreach sites or
immunization sessions.

• Stay cold at a maximum of 48 hour

with lid closed.

• Used to store vaccines when

refrigerator is out of order or
defrosted.
• A soft foam that fits on top of the ice-packs in the vaccine
carrier.

• Incision are made on it to allow vaccines to be inserted in

the foam

• Serve as a temporary lid to keep unopened vaccines inside

the carrier cool while providing a surface to hold, protect
and keep cool opened vaccine vials.
• Flat, square plastic bottles that are filled
with water and frozen.

• Used to keep vaccines cool inside the vaccine

carrier / cold box
0.3L
• The number of ice-pack required for a cold
box or vaccine carrier varies.

• It takes 24 hours to freeze 1 ice-pack

0.6L
 To keep track of the temperature to which vaccines and
diluents are exposed during transportation and storage.

a. Vaccine Vial Monitors

b. Vaccine Cold Chain Monitoring Card

c. Thermometer and Thermostat

d. Freeze Watch
 A label that changes color when the vaccine has
been exposed to heat over a period of time .
1. Indicator strip
changes color from
white to blue when
vaccines are exposed
to temperature that
are too high, +10C to
more +34C for at
least 2 hours.

2. VCCM is used to
estimate the length of
time that the vaccine
has been exposed to
high temperature.
• Records the day’s high and low
temperature

• Right side- register the

maximum temperature since the
last setting while the left side
shows the minimum
temperature

• Temperature ranges from 0 - ±

300C / 500C.
 The needle moves around the scale, pointing to plus
(+) numbers when it is warmer and to minus (-)
numbers when it is colder
• Indicator changes color
from white to red when
vaccines are exposed at
temperature below 0 C for
1 hour.

• Used to warn of freezing

and is packed with
vaccines that are sensitive
to freezing temperature :
DTP, TT, DT, Td (titik
beku -6.5°C), Hepatitis B (-
0.5°C), Liq.Hib
• Cold Chain equipment, including refrigerators, cold boxes
and vaccine carrier must be loaded correctly to maintain
the temperature of the vaccines and diluents inside.

• There should be one person who has the main

responsibility for the refrigerator :
1. Storing vaccines, diluent and ice-pack
2. Checking and recording the temperature twice daily, even
on week-ends
3. Maintain the cold chain equipment
1. Do not put vaccines on the door shelves. The
temperature is too warm to store vaccines. When the
door is opened, shelves are instantly exposed to room
temperature
2. Do not keep expired vaccines or reconstituted vaccines
more than six hours
3. Food and drinks should not be stored in a vaccine
refrigerator
4. Do not open the refrigerator door frequently since this
will raises the temperature inside the refrigerator
1. Fill with water leaving a little air space at the top and
put the cap on tightly.

2. Hold each ice-pack upside down and squeeze it to make

sure it does not leak

3. Put each ice-pack upright or on their sides in the freezer

so that the surface of each ice-pack is touching the
evaporator plate, close the door

4. Leave ice-pack in the freezer at least 24 hours to freeze

solid
5. Keep extra unfrozen ice-packs on the bottom part of the
refrigerator to keep cold in case of a power failure

6. Do not store frozen ice packs in the refrigerator

compartment as this will increase risk of freezing.

7. Allow ice-pack to start melting before putting them in

the cold box containing freeze-sensitive vaccine to
prevent from freezing.
 Thermometer , Thermostat and Temperature Chart

1. Set the refrigerator thermostat during the coldest part

of the day to around +2° C to +4 ° C

2. Monitor temperature first thing in the morning and

before you leave. If the temperature is bet. +2° C to
+8° C, do not adjust the thermostat

3. Continue to monitor the temperature twice a day on

weekdays, weekends and holidays
4. If the temperature is too LOW ( below +2° C)
a) Turn the thermostat knob to a lower number to make the
refrigerator warmer.

b) Check whether the door of the freezer closes properly.

The seal may be broken.

c) Check freeze-sensitive vaccines ( DPT, DT, Td, TT, Hep

B, ) to see whether they have been damaged by freezing
by using the shake test.
 Freezing damaged
adsorbed vaccines
(DTP, DT, Td, TT or
Hepatitis B)
5. If the temperature is too HIGH ( above +8° C)
a. Make sure that the refrigerator is working, check the
power supply.

b. Check whether the door of the refrigerator or freezer

closes properly. The seal may be broken.

c. Check whether frost is preventing cold air in the freezing

compartment from entering the refrigerator
compartment. Defrost if necessary.
d. Turn the thermostat knob to a higher number to
make the refrigerator cooler.

e. If the temperature cannot be maintained between 2°

C to 8° C, store vaccine in another place until
refrigerator is repaired

f. Do not adjust thermometer to a higher (cooler)

setting after a power cut or when vaccines arrives.
This could freeze the vaccines.
Vaccine Refrigerators

a. Defrost when the ice becomes > 0.5 cm thick, or once a

month, which ever comes first

b. Thick ice does not keep the refrigerator cool. Instead it

makes the refrigerator work harder and use more power
Vaccine Refrigerators
c. To defrost and clean refrigerator:
 Take out all the most heat-sensitive vaccines and
diluents, and transfer to a cold box lined with frozen
ice-packs.
 Take out all the freeze-sensitive vaccines and diluents,
and transfer to a cold box lined with conditioned ice-
packs.
 After cleaning, wait till the temperature in the main
section falls to +8° C or lower before return the
vaccines, diluents and ice-packs to their appropriate
place.
When vaccine refrigerator is out of order…

 If < 4 hours, do not open the refrigerator, the

temperature will rise 1° C / hour
 If > 4 hour, transfer to another refrigerator or cold
box or vaccine carrier lined with conditioned ice-
packs for temporary storage.
 Always keep a freezer indicator with the freeze-
sensitive vaccines to monitor eventual freezing.
Cold Box & Vaccine Carrier.

• Must be well dried after use. If they are left wet with
lids closed, they will becomes moldy. Mould may affect
the seal of the cold boxes and vaccines carriers. Stored
with lid open when not in used.

• Protect from knocks and sunlight which can cause

cracks in the wall and lids which may exposed the
vaccines to heat
 
Primary Intermediate Health Health
Region District Centre Post
6 monthsa 3 months 1 month 1 month Daily use

OPV -15oC to -25oC

BCG WHO no longer recommends that
Measles freeze-dried vaccines be stored at
MMR –20°C. Storing them at –20°C is
MR not harmful but it is unnecessary.
Instead, these vaccines should be
Yellow Fever kept in refrigeration and
Hib freeze-dried transported at +2°C to +8°C. +2oC to +8oC
Hep B  
 
DTP-Hep B  
Hib liquid
DTP
DT
TT
Td
Note a. 6 months is the maximum recommended storage time at primary level. This includes
the period required to obtain clearance from the National Regulatory Authority.
1. Some vaccines are very sensitive to strong light and their
exposure to ultraviolet light causes loss of potency. The
must be protected against sunlight or fluorescent ( neon)
like.

2. BCG, measles, MR, MMR and rubella vaccines are

equally sensitive to light ( as well as to heat)

3. Normally , these vaccines are supplied in vials made from

dark brown glass to protect them against light damage,
but care must still be taken to keep them covered and
protected from strong light at all times
1. ORDERING
- DO NOT OVERSTOCK
Max – 6wks stock , min 3 wks stock

- Quantity estimation consider :

- Qty. used since last order
- Safe max. volume for your fridge.
- Left over stock
- Seasonal variation
- Disease outbreak & special programs

- Use vaccines with shortest exp. date first

2. RECEIVING
 Check packing/ice pack still cool upon receiving
 Check the contents match the order
 Check the monitor cards & record status
 Immediately store vacc. in fridge
 3. STORING
- leave vacc. in their packaging as this provide insulation
& protect against thermal insult.
- keep monitor cards together with the vacc.
- Fill the door & drawer with bottles of water.
- Vaccine stock not exceed 50% of domestic fridge vol., P’ceutical fridge –
90%.
- Allow for air circulation in fridge.

4. VACCINES MUST NOT

 Be stacked against the refrigerator walls
 Placed by the rear freeze plate or icebox of refrigerator
 Placed in refrigerator door

5. EQUIPMENT (FRIDGE)
 In a well ventilated room
 Away from direct sunlight
 Away from any heat source (autoclave, heater)