THE COLD CHAIN SYSTEM

A cold chain or cool chain is a temperature-controlled supply chain that involves the storage,
transportation and distribution of perishable goods such as vaccine, chemical, sea-food, meats
and dairy products.

The “Cold Chain” is the system of transporting and storing vaccines within the temperature
range of 35°F (2°C) to 45°F (8°C). The cold chain begins when vaccine is manufactured, moves
through to the state distribution center and ends with the local immunization provider at the time
of administration

The cold chain has three main components:

 Transport And Storage Equipment

 Trained Personnel
 Efficient Management Procedures.

All three elements must combine to ensure safe vaccine transport and storage

There are two types of cold chain packaging systems:

 Active
 Passive.

Active systems consist of cold chain transport containers featuring advanced electric or battery-
powered temperature controls. Active systems often have built-in cooling units or rely on dry ice
as a coolant.

Cold chain equipment in Health Posts

The common cold chain equipment used in Health Posts are refrigerators, cold boxes,
vaccine carriers, ice-packs and foam pads.

Refrigerators
A refrigerator is a cooling apparatus. Health facility refrigerators may be powered by
electricity, kerosene, paraffin, bottled gas or solar energy. Electric refrigerators are
usually the least costly to run and the easiest to maintain, but they must have a reliable
electricity supply.Different refrigerators have different capacities for storing vaccines and
for freezing and storing ice-packs. A refrigerator in a Health Post should be able to hold:

 One month’s supply of vaccines and diluents in the refrigerator compartment.

 A minimum stock of one to two weeks’ supply of vaccines and diluents (i.e. an
additional 25% of the standard stock).
  Frozen ice-packs (strong, specially made plastic bottles containing frozen water)
standing in the freezer compartment for at least 24 hours to become fully frozen.

 Do not put frozen ice-packs into the main refrigerator compartment, they could
cause the temperature to drop too low and destroy the freeze-sensitive vaccines.
 Unfrozen chilled ice-packs in the refrigerator compartment help to keep the
refrigerator cold for a while if there is a power failure. You can also keep ordinary
plastic bottles filled with chilled water in the refrigerator for the same purpose.

Cold boxes and vaccine carriers

A cold box is an insulated container that can be lined with ‘conditioned’ ice-packs to
keep vaccines and diluents cold but not frozen during transportation of vaccine
supplies from the health centre, or to outreach sites. Cold boxes can also be used for
short periods of vaccine storage (from two to seven days, depending on the
manufacturer) when the refrigerator is out of order or being defrosted, or if vaccines are
being transported in a vehicle for a few days by mobile immunization teams.

Vaccine carriers are also lined with conditioned ice-packs to keep vaccines and diluents
cold during transportation from the collection store at the health centre, or on journeys
to outreach sites, and for temporary storage during Health Post immunization sessions.
They are smaller than cold boxes and are easier to carry if walking, but they do not stay
cold for as long at most 36–48 hours with the lid closed (depending on the type).

Ice-packs

Ice-packs are flat, rectangular plastic bottles filled with water and then either kept at
refrigerator temperature or frozen and then conditioned for use in vaccine carriers and
cold boxes. The number of ice-packs required for a cold box or vaccine carrier varies.

Freezing ice-packs

The proper freezing and conditioning of ice-packs is essential for maintaining the
potency of vaccines.

Conditioned ice-packs and chilled water packs

Conditioned ice-packs have first been fully frozen, and then removed from the freezer
and left at room temperature for a short time (it may take over 30 minutes if the room is
cold). Allow the frozen ice-packs to sit at room temperature until the ice begins to melt
and water starts to form. Check to see if each ice-pack has been conditioned properly
by shaking it and listening for the sound of water moving inside. This prevents the ice-
packs from freezing the vaccines inside a cold box or vaccine carrier, and damaging the
freeze-sensitive vaccines.

Foam pads

A foam pad is a piece of soft foam that fits on top of the conditioned ice-packs in a cold
box or a vaccine carrier. There are some cuts in the foam to allow vaccine vials to be
inserted in the pad. During immunization sessions, the foam pad can be used as a
temporary lid to keep unopened vaccines inside the carrier cool, while providing a
surface to hold and protect opened vaccine vials and keep them cool. Vaccines are
protected from heat damage during an immunization session if they are inserted in the
foam pad above the ice-packs in the vaccine carrier.

Cold chain monitoring equipment

Vaccine vial monitors

A vaccine vial monitor (VVM) is a label that changes colour when the vaccine vial or
ampoule has been exposed to temperatures above 8ºC over a period of time. Before
opening a vaccine container, the status of the VVM must be checked to see whether the
vaccine has been damaged by heat. Manufacturers attach VVMs to vials and ampoules
of most vaccines. The VVM is printed on the label or cap, or the neck of ampoules of
freeze-dried vaccines. It looks like a square inside a circle. As the vaccine vial is
exposed to more heat, the square becomes darker.

Do not use vaccines that have reached the discard point, even if they have not passed
their expiry date. use vaccines where the inner square in the VVM is lighter in colour
than the outside circle. Vials with VVMs in which the inner square has begun to darken,
but is still lighter than the outer circle should be used first, i.e.before vials where the
VVM square has not begun to darken. Vials with VVMs in which the inner square
matches the colour of the outer square, or in which the inner square is darker than the
outer circle, have reached or gone beyond the discard point and should not be used.

Freeze indicators

Freeze indicators are devices used to monitor the exposure of vaccines to freezing.
Freeze indicators are packed with batches of freeze-sensitive EPI vaccines
(pentavalent, PCV10 and TT), as well as with other freeze-sensitive vaccines such as
HepB, which may be used to protect healthcare workers. The most commonly used type
of freeze indicator is the freeze-tag. This is an irreversible temperature indicator that
shows if a product, such as a vaccine, has been exposed to freezing. It consists of an
electronic temperature measuring circuit with a liquid crystal display (LCD). A small
blinking dot of light in the corner of the display shows that the freeze-tag is functioning
correctly.
The shake test

The shake test is how you check whether freeze-sensitive vaccines (pentavalent, PCV,
TT or HepB) have been subjected to freezing temperatures, which are likely to have
damaged them. To perform the shake test, follow the steps below:

Step 1 — Prepare a frozen control vial: 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
is the frozen control vial Mark the vial clearly so that it is easily identifiable and will not
be used by mistake.

Step 2 — Choose a test vial: Take a vial (or vials) of vaccine from the batch that you
suspect has been frozen. This is the suspected frozen test vial

Step 3 — Shake the control and test vials: Hold the frozen control vial and the
suspected frozen test vial together in one hand and shake them vigorously for 10–15
seconds.

Step 4 — Allow the vials to rest: Leave both vials to rest by placing them on a table side
by side and not moving them further. A freeze-sensitive vaccine that has not been
frozen appears as a uniformly cloudy liquid . After freezing, the vaccine tends to form
flakes that quickly settle at the bottom of the vial to form a sediment when you leave it to
rest after vigorous shaking. The speed at which the flakes settle is called
the sedimentation rate. Note that some vials have large labels that 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 vials.

Step 5 — Compare the vials: Observe the difference in sedimentation rates in the
frozen control and suspected frozen test vials for a maximum of 30 minutes. View both
vials against the light to compare the sedimentation rate. If the vaccine in the suspected
test vial shows a much slower sedimentation rate than the vaccine in the frozen control
vial, you can conclude that the test vaccine has most probably not been frozen and can
be used.

Thermometers

A thermometer is an instrument for monitoring the temperature of your cold chain

equipment — refrigerator, cold box or vaccine carrier. It enables you to adjust the
temperature to the correct range for the storage and transport of vaccines
Frequent monitoring of temperatures, humidity levels, and ventilation throughout the
cold chain can help ensure product safety while minimising safety risks and
financial losses from spoilage. Vaccines must be continuously stored in a limited
temperature range – from the time they are manufactured until the moment of
vaccination. This is because temperatures that are too high or too low can cause the
vaccine to lose its potency (its ability to protect against disease).