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THE COLD CHAIN SYSTEM

The cold chain is a system that ensures that vaccines are kept in a potent state during
transportation from the manufacturer to the people to be immunized or recipients. It consists of
transportation links during which adequate refrigeration is ensured.
A break at any level of the cold chain would destroy the potency of the vaccines. Once vaccines
lose their potency they cannot be rejuvenated through refrigeration or any other means.

Diagram of the Cold Chain System

Manufacturer

Airport (Ghana)

Central store

Regional store

District store

Sub-district store

Recipient (Clinic)

Manufacturer
The manufacturer produces the vaccine and sends telex to the airport of the receiving country.
The telex contains the quantity of vaccines that are coming to the country, the type, the date and
time the vaccines will reach the airport.

Airport
Vaccines are carried in special planes with refrigerators. The national cold chain staff is supposed
to be at the airport before the plane arrives with cold vans.

Central Cold Store or National


Vaccines are carried in cooling vans from the airport to the central cold store (national level), at
the correct temperature. The vaccines are kept in special cooling rooms built purposely to store
vaccines at the correct temperatures.

Regional Cold Store


Vaccines are carried in cooling vans from national cold store to the regional cold store at their
correct temperatures in deep freezers and refrigerators
District Cold Store
Cold boxes are used to carry vaccines from the regional cold store to the district cold store. At
the district, they are kept in big deep freezers and big refrigerators according to their required
temperatures with deep freezers, refrigerators, cold boxes and vaccine carriers

Sub-district or Health Centre Store


Vaccines are carried from the district store to the health centre in vaccine carriers.
They are stored in refrigerators, cold boxes, freezers, and vaccine carriers at the sub-district.

Recipient
Vaccines are carried in vaccine carriers from the health centre store to the recipient on the field.
Vaccines when reconstituted or removed from the carrier are placed in ice cubes to maintain the
potency before it is given to the recipient.

Cold Chain Equipment


Freezer / refrigerator
Deep freezers
RCW 42 EK
Cold box
Vaccine carrier
RWC vaccine carrier

Current Recommended Vaccine Storage Condition


Vaccine 6 months 3 months 1 month 1 month Static/outreach
national regional district health care daily
OPV -15 to -25
degree
BCG +2 to +80 +2 to +8 degrees
measles degree
Yellow fever
DPT/HibHepB.
TT. +2 to +8 degrees

Adopted from the Field Guide for the Ghana Immunization Programme

The killed or dead organisms and toxoid, that is, DPT/HibHepB and tetanus vaccines should be
kept above freezing point (2 – 8 degrees).
The other live vaccines should be kept below 8 degrees but they are not damaged by freezing.
NB: all live vaccines are sensitive to heat and light.

Essential Elements of the Cold Chain


To manage the cold chain effectively, it is essential to:
1. Identify people to manage and organize the vaccine direct, for example, those to record
the temperature daily.
2. To have enough effective equipments to store and transport the vaccines. Examples are
cold boxes, refrigerators, deep freezers.
3. Ensure that the following activities are performed throughout the length of the cold chain:
 Obtain enough vaccines
 Maintain equipment
 Maintain vaccines

Managing Cold Chain Equipment


1. Freezer – make sure they are well fueled with either kerosene, gas or electric or solar energy,
depending on the type
2. Cold box – it should be cleaned and must be of the correct temperature.
3. Vaccine carriers:
 They should be cleaned and ensured that there are no cracks.
 They should not be put in the sun.
 They should have well fitting lids / covers.
 Ice packs should be well frozen to be able to keep the potency of the vaccines.

Routine Maintenance of Your Refrigerator


The refrigerator should be placed in the shade, in a cool and well ventilated room. Closeness to
the walls should be at least 30cms. When the refrigerator has no wheels, it should be placed on
the supplied stand to elevate it 3-5cms. It must be leveled on the floor.

Defrost your refrigerator when the ice on the walls of the freezing compartment becomes more
than 5mm thick. As ice builds up, the refrigerator gets rather warmer, but not colder.

How to Defrost Your Refrigerator


 You need another refrigerator or a cold box to keep your vaccines in
 If you need extra ice packs, freeze them the day before. Let the ice packs stay in the room
temperature for 10 minutes before loading them into the cold box. Put a thermometer in
the cold box to check and ensure that the temperature is within +2 and +8 degree Celcius
before packing DPT/Hib/HepB vaccines into the cold box.
 Turn of the refrigerator, and leave all doors open
 As soon as it is possible to remove ice with your fingers, do so
 Never use knives or sharp instruments
 When all the ice has melted, wipe the inside walls with a clean cloth
 Clean and dry the lid / door rubber seals and put some talcum powder on them if
available
 Close the refrigerator, turn it on and wait until the temperature inside the main
compartment is +2 degrees before putting the vaccines back
 The oldest vaccines should be placed in front, so as to be used first.

Note: if you have to defrost your refrigerator more than once a month, the door is probably open
too often. If this is not the case, contact your supervisor for technical check-up by a cold chain
technician.

If Your Refrigerator Fails


 Be prepared for an emergency
 If possible, identify in advance another refrigerator where you can store the vaccines.
 You must always have a cold box and enough frozen icepacks ready in storage.
 Report immediately to your supervisor in case of problems with the refrigerator.

Regulating the Temperature in the Refrigerator


If the temperature rises above +8 degrees or falls below +2 degrees, turn the thermostat knob to
colder or warmer, just a little and check again every six hours, until the temperature has
stabilized. It takes one day for the temperature inside the fridge to change.

Check the power supply, the door, hinges and seals, for any defect.
Be sure that the door is opened as few times as possible.

Maintaining Vaccines’ Potency


Things to remember
1. Ensure you have enough cold chain equipment to store vaccines you collect.
2. Check that the types and amount of vaccine diluents are the same as you estimated.
3. Check that expiration date has not passed.
4. Convey vaccines to outreach using shortest route.
5. Select vaccinated site that is cool.
6. Open vaccine containers only when necessary.
7. Vaccines being used should be placed in ice cubes.
8. Use one syringe and needle per child.
9. Fridge must not contain food or water but ice packs only.
10. Open fridge two times in the day, one to take vaccines and two to replace vaccines.
11. Use shortest routes when conveying vaccines.

Estimation of Vaccines Needed


To have an effective immunization programme it is important to have enough quantity of
vaccines at all times.
It is therefore essential to be able to calculate and estimate the number of vaccines needed to
match the number of children less than 1 year.
 Know the population to be vaccinated
 Know the targets (95%)
 Know the vaccine administration rate. It is 0.5mls for all other vaccines and 0.75mls for
measles.
 BCG is given only once a year.
1. 5 in 1 is triple dose to each child.
2. Polio is 4 times a year to a child.
3. Measles and yellow fever is once a year to a child.
 30% of each vaccine is added for reserve stock when calculating vaccines.

For example, a community of 100,000 people:


Children 0 – 11 months = 4 × 1000,000
100
= 4000

Coverage target = 80%


= 80 × 4000
100
= 3200

VAR (BCG 0.5) = 3200 × 0.5


= 1600 + 3200
= 4800

Reserve stock = 30 × 4800


100
= 1440

Actual BCG vaccine needed with reserve stock


= 4800 + 1440
= 6240 doses for 1 year.

How to Order Vaccines


1. Always use the standard vaccine requisition and vaccine delivery forms when ordering and
receiving vaccines. Keep the receipts in the vaccine files at the clinic.
2. If you receive vaccines without a label, send it back.
3. If you receive vaccine which has expired or will expire before you use it, send it back.
4. Always rotate your stock by moving old stock to the front (or the top) and use first in or first to
expire, first out policy for vaccine use.

How to Keep Track of Vaccine Stock and Consumption


Keep careful records. Standard stock ledgers with separate sheet for each batch of vaccine must
be used and updated at the end of each issue. These records will show how much vaccines have
been used.

Maintaining Immunization Records for Progress


Evaluation of immunization activities should be done weekly, monthly and quarterly. This helps
to assess and plan activities to improve services.
 All immunization centres normally maintain client registers. The personal details of the
clients are recorded. By studying the registers, the number of immunizations given can be
obtained.
 Tally sheets are also used to record the immunizations given. From the tally sheet
records, the number of immunizations given can be compiled.
 Visual records in the form of bar charts help to indicate the progress made on
immunization activities within every month.
 From the monthly record, totals of cumulative use can be calculated by adding the
number of immunizations given, month- by-month.

How to Complete an Immunization Monitor Chart


Three immunization monitoring charts should be prepared by health facilities providing EPI at
the beginning of each year and monthly updated:- one to monitor BCG, Measles and Yellow
Fever. The second for DPT/HibHepB3/OPV3, and another one to monitor TT immunization
activities (TT2+for pregnant women)
At Okyereko CHPS zone the children immunized for the half year 2007 is as follows:
Table: 5.1
MONTH BCG MEASLES YELLOW FEVER
JAN 25 10 15
FEB 20 15 10
MAR 32 10 20
APR 30 20 10
MAY 30 15 10
JUN 25 10 15

Chart: 5.1

Table: 5.3
Jan Feb Mar Apr May Jun Cumulative
total for the
year
BCG 25 20 32 30 30 25 162
Measles 10 15 10 20 15 10 80
Yellow Fever 15 10 20 10 10 15 80
Total immunized 50 45 62 60 55 50 322
this month

From chart: 5.1 connect the new dot to the previous month’s dot with a straight line.

After you have completed the EPI monthly routine report, fill in the number of doses given in
that month for each monitored antigen into the “total immunized this month” space in table: 5.2.

Add the present month’s total to the previous month’s cumulative total to calculate the current
cumulative total (that is the total number of vaccinations given so far this year).

Calculate the annual target population that is to receive immunization. For infants less than 1
year of age and pregnant women, multiply the estimated total population in the catchment area
by 0.04 (=4%).

If you have more accurate figures for these target populations use them. (for example a health
centre with a catchment population of 15,000 will have a target population of 600 children < 1
year of age and 600 expected pregnant women).

Complete the information at the top of the chart (name of health facility, year, annual target
population, minimum target coverage (or the vaccine being monitored).

Label the intervals on the left side of the chart with the monthly target population figures (that is
the annual target population divided by 12, (for example 600 divided by 12 =50; look at the chart
example).

Label the boxes at the bottom of the chart with the name and doses of the vaccine (for example
BCG, DPT3 OPV3, and measles on chart1, and TT2+ for pregnant women on chart 2).

Exact dropout rates can be calculated by using the following formula:


DPT/HibHepB3 (Total DPT/HibHepB1 immunized – total DPT/HibHepB3 immunized)
Total DPT/HibHepB1

BCG – Measles: (Total BCG – Total Measles) × 100


Total BCG

Measles– Yellow Fever: (Total Measles – Total Yellow Fever) × 100


Total Measles
How to Analyze the Immunization Monitor Chart
To find out if your immunization programme is on course, compare the chart line (cumulative
total line) with the target line:
If it is above or on the coverage target line, good progress is being made.
If it is below but still close to the target line, moderate progress is being made.
If it is far below the coverage target line, a serious problem exists.
Estimate the coverage rate: you will get an approximate coverage of where you are in relation to
your annual target.
Each interval on the right hand side of the chart represents 7-S percentage points. Look at the
first point plotted and compare with 25%, 50% and 75% indicated lines to get an indication as to
where you are.
If you for example are close to the 25% line, you will not achieve a target of 50% by the end of
the year if you do not increase your immunization activities.

Compare the current month’s number of immunization with that of the previous month: were
there any changes? Has the number increased or decreased? Why? And what can be done in the
subsequent month?

If there is a problem with dropouts or left outs in your clinic, look at the chart if the distance
between BCG and DPT/HibHepB3/OPV3 or measles is growing wider. If there is more than
10% difference between the numbers for the two doses being compared, there is a problem with
dropouts. For example, there is a big problem with dropouts if 65 BCG immunizations have been
given and only 30 DPT/HibHepB3.

The Role of Stakeholders in Immunization


 WHO and UNICEF provide vaccines and equipment.
 The state and local radio, newspapers, television stations are involved in publicity for
immunization programmes.
 Chiefs and other influential persons in the community may assist in the campaign for
immunization.
 NGO’s such as Rotary Club, Lions Club, Plan International Ghana and so on, also
contribute during National Immunization Programmes (NID).
 The Ghana Private Road Transport Union (GPRTU) provides vehicles to transport
participants to and from immunization points.
 The District Assembly also assists with transportation and staff during immunization
programmes. Assembly members and unit committees assist in identifying appropriate
sites for the activities.
 Target populations such as school children, parents are motivated to spread the news
about immunization activities.

Some Possible Reasons for Defaulting Immunization


 Low motivation of parents due to lack of understanding of the importance of
immunization
 Fear of side effects on the child
 Poor access to immunization services (long distances)
 Long waiting time at the facility
 Some health workers charging for what should be free
 Lack of reliable services staff are not present to immunize when they are supposed to
 Unpleasant attitudes of some health staff
 Disappointment from non-availability of vaccines and other essential supplies

Transportation of Vaccines from the Health Centre to the Clinic


 Pick up your vaccine carrier and check for cracks.
 0clean the carrier and make sure the lid is well fitted.
 Take the required ice packs at the appropriate temperature.
 Estimate and take only the quantity needed.
 Take polio BCG, measles, yellow fever, DPT/HibHebB, which are live vaccines first, and
cover with foil.
 Put other vaccines like tetanus toxoid vaccines on the foil and cover with another foil.
 Put the diluents on top of the foil.
 Take the shortest and fastest possible route to the clinic.
 Put vaccine carrier under a shade always.
 The vaccine carrier should be opened only when necessary.
 Remove vaccines needed at a time into a gallipot with ice cubes.
 If the Geostyle type of vaccine carrier is used, put the vaccine needed at a time in the
perforation in the foam.
 The lid of carrier must be securely tight after opening.

Monitoring the Transport of Vaccines


Transport of vaccines to direct cold stores and to distant health facilities (duration of transport
more than 4 hours) should be monitored using a dial thermometer.

The Vaccine Vial Monitor (VVM)


A vaccine vial monitor (VVM) is a label containing a heat-sensitive material which is placed on
a vaccine vial to register cumulative heat exposure over time. The combined effects of time and
temperature cause the inner square of the VVM to darken, gradually and irreversibly.
A direct relationship exists between the rate of colour change and temperature:
 The lower the temperature, the slower the colour changes.
 The higher the temperature, the faster the colour changes.
The VVM is a circle with a small square inside it. It can be printed on a product label, attached to
the cap of a vaccine vial or tube, or attached to the neck of the ampoule.
At the starting point, the inner square is a lighter colour than the outer circle. From then on, until
the temperature and /or duration of heat reaches a level known to degrade the vaccine.
Beyond acceptable limits, the inner square remains lighter than the outer circle.
At the discard point, the inner square is the same colour as the outer circle. This shows that the
vial has been exposed to an unacceptable level of heat and the vaccine degraded beyond
acceptable limits. The inner square will continue to darken with heat exposure until it is much
darker than the outer circle. Whenever the inner square matches or is darker than the outer circle,
the vial must be discarded.
The Vaccine Vial Monitor
Cumulative heat
exposure
VVM start colour Discard point

Stage 3 Stage 4
Stage 1 Stage 2

VVM start colour is never snow Beyond discard point


white. It always has a bluish – grey Square colour is
tinge. From then on, until the darker than the
temperature and/or duration of heat outer circle
reaches a level known to degrade the
vaccine beyond acceptable limits, the
inner square remains lighter than the
outer circle.

use this
vaccine Do Not Use This Vaccine
Inform Your Supervisor

How to Read A VVM


The point to focus on is the colour of the inner square relative to the colour of the outer circle:
Rule 1: if the inner square is lighter than the outer circle, the vaccine may be used.
Rule 2: if the inner square is the same colour, or darker than the outer circle, the vaccine must not
be used.

Ensuring the Quality of the Vaccine


 It is important to keep the vaccine as cool as possible at all times. Open the vaccine
carrier as little as possible. Keep the vaccine carrier in the shade.
 The vaccine vial monitor (VVM) assists you in deciding whether the vaccine can still be
used.
 Before giving the vaccine, always check the VVM. If the VVM changes colour to the
point of DO NOT USE (stage 3 or 4) the vaccine should not be used.
 In such cases record the number in your ledger or notebook and keep them out of the
fridge in a polythene bag or box and label them as VVM change.

Handling Vaccines after Immunization Session


1. Return unused vials of vaccines back to the clinic / health centre in vaccine carrier.
2. Discard all opened vaccines.
3. If ice packs in the vaccine carrier are still solid, mark the unopened (leftover) vaccines
and place them in a special container and put in the fridge.
4. If ice packs have melted for less than 24 hrs in the carrier keep marked vials and put in
the fridge.
5. Be sure to take marked vaccines first during the next clinic session, and use them first at
the next clinic.
6. If ice packs have melted for more than 24 hours, destroy all vaccines.
7. Do not take the same marked vials to the clinic three times. (destroy)
8. Keep records of vaccines used in the field and enter them in the appropriate note books.
9. Enter the vaccines collected in the vaccine supply book for field. That is, the number
taken out, number used, number left (returned) in the supply book at their appropriate
columns

How to Use Vaccine Carrier


1. Dust the vaccine carrier with a clean towel and inspect it for cracks.
2. Inspect the lids for cracks and whether it will fit the vaccine carrier.
3. Remove ice packs from the freezer, and place the frozen ice packs around and under the
vaccine carrier.
4. Pack vaccines and diluents into the carrier according to their sensitivity.
5. Take care to prevent DPT/HibHepB and Tetanol Toxoid from freezing.

Packing a Cold Box or a Vaccine Carrier


Remember that a cold box or a vaccine carrier cannot make a vaccine cold, it only keeps them
cold. Before use, check them for cracks and broken hinges or lids. If correctly packed and used,
the cold life in cold boxes is usually 2-7 days and 24-36 hours in vaccine carriers. There is
adequate cold life if the icepacks have not completely melted by the end. Ice packs should be
50% defrosted before use. You need as many 50% defrost packs as the box or carrier is designed
for.

Before putting the ice packs inside the cold box or the vaccine carriers, place them on a table for
20 to 30 minutes until the outside frost has melted. Place a thermometer and which indicates a 3
M cold chain monitor card in the center of the cold box or the vaccine carrier. Make sure the
temperature in the vaccine carrier or cold box is in the range of +2 to +8 degree Celsius.

Place measles and polio vaccines at the bottom, then BCG. Above them, place DPT-HibHepB
and Tetanol Toxoid vaccines and diluents.
Close the lid tightly and keep it closed as much as possible.

How to Keep Vaccine Carrier in Good Condition


1. Leave the vaccine carrier opened after each use and turn it upside down to keep it dry.
2. Clean the inside with a clean towel.
3. Examine the inside and outside after each use for cracks and repair immediately.
4. Request for a new vaccine carrier if cracked carrier has not been repaired.
5. Paint the outer surface when it becomes faint or dull.
6. Keep vaccine carrier out of direct contact with sunlight to avoid cracks.
7. Be careful not to drop vaccine carriers to damage them.

Ice Packs
They are used to pack vaccines in cold boxes and carrier to keep and maintain the vaccines’
potency.
1. Always use ice packs filled with water.
2. Do not use ice packs which have gel in them because they melt quickly.

How to Use the Ice Pack


1. Before freezing packs, check for cracks. If they are found to have holes destroy them
because they are not to be repaired.
2. Do not freeze spare ice packs because excessive expansion will damage them.
3. Put spare ice packs in the lower shelf of the fridge. This will help to maintain the
temperature of the vaccine when light goes off for few minutes.
4. Ice packs should be ¾ filled with water.
5. Pack frozen ice packs around the inside of the vaccine carrier with the top of the ice
packs facing upwards.

What Damages Vaccines


1. Vaccines can be damaged if not properly cared for.
2. All vaccines loose their potency after a certain period of time even with adequate care
(expire).
3. Heat destroys vaccines e.g. BCG (live vaccines).
4. Sunlight destroys all vaccines.
5. Disinfectants (dettol, izal) and other detergent, antiseptives like spirit destroy vaccines.
6. All vaccines have their expiry date printed on the vial or ampoule.
7. It loses its potency when it expires.
8. Freezing can also damage some vaccines e.g. T.T

Temperatures for Storing Vaccines


The coldness and hotness of something is what defines temperature. The instrument used for
measuring temperature is called thermometer.
All temperature below 0 degree are negative (-) and freezing.
Temperature above 0 degree are positive (+) range. Currently vaccines are stored between +2
centigrade to +8 degrees (+2 to +8 degree Celsius)

Types of Thermometers for Cold Chain Management


1. Dial thermometer: with this type of thermometer, there is a needle which moves around
the scale pointing to it when it is warmer and when it is colder.
2. Bulb thermometer: there is colour fluid in the bulb which moves up to the scale as it
becomes warmer and down the scale when it becomes cooler.
3. Liquid crystals thermometer: it contains fluid/liquid crystals in a circle. It changes
colours with changes in temperature. When the temperature is warm, the colour changes
to the green nature. At green if the circles are at the numbers 2, 4, 6 or 8 then it is safe for
storing vaccines.

Evaluation of Immunization Programmes


Everybody who works during immunization programme needs to evaluate his / her work. This
could be a manager or a service provider.
Purpose of evaluation is to:
1. Know how successful work has been
2. Identify what you need to do.
3. Improve on your programme
4. Identify what help you need from your supervisors.

What to Evaluate
According to the field guide for The Ghana immunization Programme, one should ask these
questions:
1. Did you hold all immunization sessions as planned?
2. Did you have enough vaccines to reach at your target?
3. Did you check your refrigerator everyday to record the temperature?
4. Were your temperatures recorded in safe ranges?
5. Did you check the immunization status of all children and women in child bearing age?
6. Did you inform them about the immunizations that they will need and when to have
them?
7. Did you have enough needles and syringes as well as other equipment?

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