Vaccines & cold chain

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Vaccines &
Cold Chain
Prepared By Tirtharaj Acharya,
H.A/BPH
hiddenlightsl.blogpost.com

Vaccine
• an antigenic preparation used to establish immunity to a
disease.
• Vaccines can be prophylactic or therapeutic
• The immune system recognizes vaccine agents as
foreign, destroys them, and 'remembers' them. When
the virulent version of an agent comes along, the
immune system is thus prepared to respond, by
– neutralizing the target agent before it can enter cells,
and
– by recognizing and destroying infected cells before
that agent can multiply to vast numbers.
2

Vaccination
– The process of distributing and administrating vaccines.
3

Types of vaccines-1
• Killed microorganisms - previously virulent micro-organisms that have
been killed with chemicals or heat.
Examples: flu, cholera, plague, & hepatitis A.
• Live, attenuated cultivated under conditions that disable their virulent
properties.
Examples: yellow fever, measles, rubella, and mumps.
• Toxoids - these are inactivated toxic compounds from micro-organisms in
cases where these cause illness.
Examples: tetanus and diphtheria.
• Subunit - rather than introducing a whole inactivated or attenuated
micro-organism to an immune system, a fragment of it can create an
immune response.
Examples: HBV
4

Types of vaccines-2
• Conjugate - certain bacteria have polysaccharide outer coats that are
poorly immunogenic. By linking these outer coats to proteins (e.g.
toxins), the immune system can be led to recognize the
polysaccharide as if it were a protein antigen. Eg. Haemophilus
influenzae type B vaccine.
• Recombinant Vector - by combining the physiology of one micro-
organism and the DNA of the other, immunity can be created against
diseases that have complex infection processes
• DNA vaccination- It works by insertion into human or animal cells, of
viral or bacterial DNA. Advantage of DNA vaccines is that they are
very easy to produce and store. DNA vaccination is still experimental
5

Vaccination schedule
– SELF STUDY (might have covered in other subjects)
6

Cold chain
– The 'cold-chain' is the system of transporting and storing
vaccines within the safe temperature range of from the
place of manufacture to the point of administration.
– Maintenance of system requires that processes are in place
to ensure that a potent vaccine reaches recipients.
7

Supply chain
– A supply chain, is a coordinated system of organizations,
people, activities, information and resources involved in
moving a product or service in physical or virtual manner
from supplier to customer.
8

Validation
– The output can be assured by the following ways:
– Design Qualification
– Installation Qualifications
– Operational Qualification
– Performance Qualification
– The validation is required for machine and the processes to
ensures the desired out put
9

The vaccines can be stored
in
– Cold room
– Refrigerator (Special refrigerator & domestic refrigerator)
– Cold box
10

Vaccine storage on domestic
refrigerator-1
• Door openings should be kept to a minimum
• Temperatures should be checked and recorded daily
• One person should be given responsibility for adjusting the
refrigerator control
• Defrosting should done regularly and ice is not allowed to
build up.
• The refrigerator should be dedicated to vaccine storage as
possible.
• Do not store food or drink in vaccine refrigerators.
• Vaccines should only be stored on the middle and upper
shelves in normal domestic refrigerators.
11

Vaccine storage on domestic
refrigerator-2
• If using a bar fridge, the middle shelf should be used, as
vaccines stored near the evaporation plate or on the top shelf
of a bar fridge can be inadvertently frozen.
• The lower shelves, drawers and the door of normal domestic
refrigerators become to warm (above 10°C) if the refrigerator
is opened frequently.
• Do not crowd the vaccines by overfilling the refrigerator; allow
room for the cold air to circulate within the refrigerator.
• Fill the lower drawers and the door with plastic bottles filled
with salt (1-2tbs) water.
• Allow space between the bottles for good air circulation.
12

Maintaining and monitoring
refrigerator temperatures-1
• Should have a minimum/maximum thermometer placed on a
middle shelf and temperatures should be checked and
recorded daily.
• digital type of thermometer is recommended with a probe
(sensor). Do not put the probe into fluid.
• the probe should be placed directly in contact with the
vaccine vial
• The recommendation of keeping the vaccine storage temp at
between 2°C to 8°C is based on air, not fluid temperatures.
• The refrigerator temperature should be read around the same
time each day, preferably in the middle of the day.
13

• One person only should be responsible for adjusting the
refrigerator to maintain the temperature.
• The door should be kept closed as much as possible.
• Door openings should be kept to a minimum.
• During a power failure of 4 hours or less, the refrigerator
door should be left closed.
• If the power fails for more than 4 hours, store vaccines in a
pre-cooled, insulated container with ice packs to keep
them cool
14

• Refrigerator breakdowns should be repaired immediately.
• The door seals should be in good condition so that the door
closes securely.
• Ice build-up can reduce the efficiency and performance of a
refrigerator.
• During defrosting or cleaning of the refrigerator, move the
vaccines to a second refrigerator.
• This temporary storage refrigerator must also be monitored to
ensure the correct temperature is maintained.
• vaccines can be stored in a pre-cooled insulated container
with ice packs or ice until the normal vaccine refrigerator is
ready for use again.
15

Unpacking vaccines after
transport
• Do not remove vaccines from their packaging regardless of
their bulkiness.
• Removal from original packaging exposes vaccines to room
temperature and/or lighting.
• Check cold-chain monitors when the vaccines arrive to ensure
they have not been exposed to temperatures above 8°C or
below 0°C.
• If cold-chain monitors (CCM) have not been included, check
that the ice packs are still partially frozen; if they are
completely melted, the vaccines have not been kept
sufficiently cold and may not be effective.
16

Cold-chain monitors (CCM)
• Cold-chain monitors (CCM) include time-temperature (heat monitors) and
freeze monitors.
• The CCM should accompany all vaccines during any long distance vaccine
transport.
• A minimum/maximum thermometer is an acceptable alternative for
monitoring temperature inside cold boxes during transport to outreach
settings.
• The CCM should not be removed from the (cold box) container until all
vaccines have been removed for use or stored.
• The index on the time-temperature or freeze monitor (or alternatively, the
minimum/maximum thermometer if working in an outreach setting)
should be checked when a vaccine is removed from the cold box.
• Any changes should be recorded.
17

Time-temperature monitors
(for monitoring exposure to
heat over time)
• These CCM work by showing colour change on an indicator
strip when the temperature reaches or exceeds a set
threshold.
• The indicator strip should be attached to a card on which
instructions for use are printed, in accordance with World
Health Organization (WHO) format.
• The indicators and their criteria depend on the
manufacturer & their models.
18

Freeze indicators
– Freeze indicators work by a colour spot change at threshold
temperature at or below freezing. There are different
models available.
19

Procedures to be observed when
using vaccines-1
• Vaccines should remain in the refrigerator until they are
required and all unused vaccines should be immediately
returned to the refrigerator.
• BCG vaccine that has been taken in and out of refrigeration
during a clinic session should be discarded at the end of the
clinic day.
• OPV will not lose potency if it is quickly thaw and then
refrozen.
• Most domestic refrigerators (with freezer compartments)
are not capable of achieving this temperature.
20

Procedures to be observed when
using vaccines-2
• A minimum/maximum thermometer can be used to check
the freezer temperature.
• Opened multi dose vials of OPV can be used in subsequent
sessions if the following three conditions are met:
• the expiry date has not passed;
• the cold-chain is maintained (between 2°C to 8°C);
• the vaccine has not been taken away from the health centre
(eg. outreach immunization setting).
21

Transporting vaccines in insulated
containers-1
• Refrigerated transport is the best way to distribute vaccines
from the central vaccine centre to the door of the
immunization service provider
• This transport should include appropriate temperature
control and monitoring equipment. When this is not
feasible, other methods can be used to achieve an effective
cold chain.
• Containers specifically designed for transporting vaccines
should be used if available.
22

What if such a container is not available?
• Before packing, remove the ice packs from the freezer at least 30 min
prior to packing and allow them to 'sweat‘ which reduces the risk of
freezing vaccines.
• Place vaccines Styrofoam container ('six-pack' container). Close the lid
and secure with tape.
• Close and secure the lid of the large container. The vaccines must not
be in direct contact with the ice packs because of the risk of freezing.
• Ensure the vaccines, CCM, ice packs and 'filler' material are packed to
ensure they do not move around during transport. The cold air can
circulate freely around the vaccine.
• Remove vaccines only as they are required, making sure the lids are
replaced on the lids of both small and large containers each time
• If the time-temperature monitors and/or freeze indicators are used,
they should be checked before administering the vaccine.
23

Stability of vaccines at different
temperatures
– High temperatures affect all vaccines whereas freezing
damages others. If concerned about loss of vaccine
potency, contact your immunization coordinator.
24

Vaccines unstable at room
temperature and must not be
exposed to light
– BCG (Bacille Calmette-Guérin) vaccine;
– Reconstituted measles-mumps-rubella (MMR) vaccine; and
– Oral Polio Vaccine (OPV)
25

Do not freeze
• Diphtheria-tetanus-pertussis containing vaccines;
• Haemophilus influenzae type b (exception PRP-T);
• Hepatitis B;
• Hepatitis A;
• Influenza;
• Pneumococcal;
• Meningococcal;
• All reconstituted vaccines;
• All combinations of these vaccines; and
• Vaccine diluents
• Rabies, typhoid, and yellow fever
26

Shake Test
– This test should be performed if you suspect of lapses in
the maintenance in cold-chain
– Usually performed before vaccine use (at the site of
vaccination)
27

Vaccines &amp; cold chain

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