Storage and Delivery of Vaccine Total Session Time: 60 minutes
Session 50: Storage and Delivery of Vaccine Total Session Time: 60 minutes
Pre-requisites
Students Learning Tasks
By the end of this session students are expected to be able to:
Resources Needed:
SESSION OVERVIEW
|Step |Time |Activity/ |Content |
| | |Method | |
|1 |5 minutes |Presentation |Introduction, Learning Tasks |
|2 | 20 minutes|Presentation |The Pharmaceutical cold chain |
|3 |10 minutes |Presentation |Components of a pharmaceutical |
| | | |cold chain |
|4 |50 minutes |Presentation |Cold Chain Equipment |
|5 |25 minutes |Presentation |Quality and vaccine delivery |
|6 |5 minutes |Presentation |Key Points |
| 7|5 minutes |Presentation |Evaluation |
SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing
STEP 2: Pharmaceutical Cold Chain (20 minutes)
other temperature sensitive items) at recommended temperature from the
point of manufacture to the point of use
is 2 to 8 °C
o Vaccines are biological product which lose potency with time
o They ensure that maximum benefits are obtained from immunization
i.e. reduce wastage of vaccines
o They ensure quality of vaccines is maintained in order to gain
confidence of the public on immunization programmes
o They ensure compliance with manufacturers’ recommendation
STEP 3: Components of Pharmaceutical Cold Chain (10 minutes)
o Personnel
nature and importance of delivering safe vaccines to save lives
o Equipment
safety and quality of vaccines
STEP 4: Cold Chain Equipment (50 minutes)
for transporting and storing vaccine and diluent at the correct
temperature
and cold boxes (for transportation)
carriers
o Walk-in cold rooms
low temperature is maintained for storage of large quantities
of vaccines
to 3 months
o Deep freezers
o Ice lined refrigerators
inside better than front opening refrigerators
other than vaccines
alternative sources of power
health facility
vents
o Refrigerated vehicles
o Cold boxes
frozen ice packs to keep vaccines and diluent cold
transport monthly vaccine supplies from district stores
out of order or being defrosted
determined by:
vaccine will be stored in the box
transported, e.g., by motor vehicle or bicycle
Figure56.1: A small vaccine cold box
[pic]
o Vaccine carriers
with frozen ice packs to keep vaccines and diluents cold
walking, but they stay cold for as long as 24-72 hours
vials)
outreach sites and for temporary storage during health centre
immunization sessions
Figure 56.2: A large vaccine carrier
[pic]
o Ice packs
with water and frozen. The required number in a particular cold
box or vaccine carrier varies.
boxes and 0.4 litre for vaccine carriers
being frozen while the other is in us
o Day carriers
vials)
o Some vaccines are more sensitive to heat than others and they
include BCG, Hepatitis B vaccine
o Other vaccines are sensitive to cold and thus they must not be
allowed to freeze
o Other vaccines are also sensitive to sunlight, ultraviolet light,
and fluorescents (neon) lights and hence must be stored in their
original packaging until point of use to protect them from light
o Because of the above facts, there must be a system to monitor
quality of vaccines
o The purpose of cold-chain monitoring equipment is to keep track of
the temperature to which vaccine and diluent are exposed during
transportation and storage
o
o Tools used to monitor quality of vaccines include;
to monitor the temperature of refrigerators, cold boxes and
vaccine carriers.
refrigerators because they do not operate at temperatures
below freezing
when vaccine is exposed to temperatures that are too high
vaccine has been exposed to high temperature
[pic]
and measles vaccines supplied by WHO/UNICEF
liquid attached to a white card and covered in plastic
located drops below 0° C for more than one hour, and the
vaccine must then be destroyed.
vaccines to monitor them during transportation and storage
liquid attached to a white card and covered in plastic
located drops below 0° C for more than one hour, and the
vaccine must then be destroyed.
vaccines to monitor them during transportation and storage
tells whether vaccine has been exposed to temperatures above
+10° C. The other indicates whether the temperature has
dropped below -4° C.
vaccine vials to record cumulative heart exposure over time
square to darken gradually and irreversibly
o Stage 1: inner square is lighter than the outer circle
o Stage 2: Inner square still lighter than the outer circle
o Stage 3: colour of inner square matches the outer circle
o Stage 4: Colour of inner square darker than outer circle
[pic]
Source: http://ispub.com/IJPN/9/2/11781
o Liquid formulations of aluminium-based vaccines against
diphtheria, pertussis, tetanus, hepatitis B and Haemophilus
influenzae type b, alone or in combination (adsorbed vaccines),
should not be frozen
o When a vaccine is damaged by freezing, the potency lost can never
be restored – the damage is permanent
o Freeze-damaged vaccines have lower immunogenicity and are more
likely to cause local reactions, such as sterile abscesses
o The shake test is designed to determine whether adsorbed vaccines
have been affected by freezing
o In shake test, two vials, one that might have been frozen and one
that has never been frozen are shaken together side-by-side by the
health worker to determine if a vaccine has been frozen
o The two vaccines are then allowed to settle by placing them on a
table side by side
o The two vaccines are observed immediately after shaking and 30
minutes after
frozen appears as a uniformly cloudy liquid
particles and not uniform
frozen will appear clear with no sediment (passed the test)
will appear almost clear with a thick sediment at the bottom of
the vial (failed the test)
o Vaccines failing the shake test should not be used and must be
discarded
STEP 5: Quality and Vaccine Delivery (25 minutes)
o Immunization delivery in a fixed health facility
o Outreach immunization sessions
immunization session to locations outside the health facility
but they return on the same day
o Mobile immunization sessions
distant from any health facility. They usually stay out at
least one night
needed
o National immunization days
campaigns to deliver vaccine.
(WHO) to deliver supplemental doses of oral poliovirus vaccine
to interrupt the circulation of wild polioviruses
o Problems in the cold chain
o Immunization practices
o Exposure to high temperatures during immunization sessions
o Exposure to sunlight
o Manufacturing practices
STEP 6: Key Points (5 minutes)
other temperature sensitive items) at recommended temperature from the
point of manufacture to the point of use
and cold boxes (for transportation), district stores need freezers,
refrigerators and cold boxes while primary health facilities need
refrigerators, cold boxes and vaccine carriers
cold and can be damaged by freezing
of use
STEP 7: Evaluation (5 minutes)
References
Hugo and Russell (2011), Pharmaceutical Microbiology 8th Edition, Willey-
Blackwel publications
Karen C. Carroll et al (2013); Jawetz, Melnick and Adelberg’s Medical
Microbiology 26th Ed. McGraw Hill Co. Inc.
Greenwood et al (2012); Medical Microbiology, 18th edition Churchill
Livingstone
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