cold chain vaccine
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Core Topic 8Storage and handling of
vaccine
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Learning Outcome
To follow correct procedures
for storage and handling of
vaccines
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Learning Objectives
Describe the cold chain and the importance of its maintenance
Specify minimum/maximum temperatures for vaccine storage
Describe the effects of temperature on potency and efficacy of
vaccine
Describe the requirements for the correct ordering, delivery andstorage of vaccines in the workplace
Identify vaccines sensitive to light heat and freezing
Know how to manage breakdowns in the cold chain, where
to dispose of damaged vaccine, who to inform and what action totake
Explain how to audit current management of cold chain within their
practice area.
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Cold Chain
The cold chain is the system oftransporting and storing vaccines
within the safe temperature range of2C to 8C. For frozen vaccines theoptimum temperature is -15C orlower. In addition, protection fromlight is a necessary condition forsome vaccines.
(Nayda C., Kempe A., Miller N. Keep it Cool: the Vaccine Cold Chain. Guidelines for Immunisation
Providers on Maintaining the Cold Chain. Second edition. Commonwealth of Australia 2001)
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Cold chain system Immunization program are
widely recognized as one ofthe most effective types ofhealth interventions.
However, for manycountries, the delivery ofsafe injection practices andquality vaccines is asignificant challenge.
The cold chain system,when implemented properly,can help overcome this
challenge.
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The cold chain systemVaccines are sensitive biological substances that,with time, lose their potency, especially whenexposed to heat, sunlight or fluorescent light and,in some cases, when cold.
Once potency has been lost, it cant be restored.
To provide protection against disease, vaccinesneed to be distributed, stored and administeredat recommended temperatures
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The cold chain systemThe cold chain system ismeans of deliveringeffective vaccinationsinchildren.
The common elements ofall cold chain systems area series of storage andtransport links through anetwork of :
fridges, freezers and
cold boxes
that keep vaccines atasafe temperaturethroughout their journey.
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Typical cold chain system
As shown in the
diagram, atypical coldchain systembegins whenvaccine ismanufacturedand ends with
the childbeingimmunized.
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How long is the cold chain?
Manufacturer to airport; cold storage at airport
Transport at the correct temperature from airport to
storage in central, regional and district stores and in
health centers
Transported at the correct temperature to outreach
sites
Kept at correct temperature during immunization
sessions
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Why is the cold chain
important?
1. Vaccines are:
Biological products
lose potency with time
Process irreversible and
accelerated if proper storage
conditions are not adhered to.
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Why is the cold chain important?
2. Assurance/confidence in potent product andvaccine programmes
Professional responsibility Confident the vaccines you give will be effective
Public Health responsibility Public confidence in immunisation programmes
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Why is the cold chain
important?
3. Ensuring maximum benefit from
immunisations
Responsibility not to waste scarce
NHS resources
Reduce wastage from errors
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Why is the cold chain
important?
4.Compliance with Manufacturer
Any vaccine that has not been stored at a temperature
of 2-8C as per its licensing conditions is no longer alicensed product
Responsibility/ liability rests with immunisation
provider and PCT.
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Vaccine Stability
Sensitivity to HEAT
BCG
Varicella
MMR
MenC
Hepatitis B
DT and/oraP/IPV/HIB
Sensitivity to COLD
HepB andcombination
DTand/or
aP/IPV/HIBInfluenza
MenC
*MMR
*Varicella*BCG
(*Freeze dried)
Immunisation Department, Centre for Infections
LEAST
SENSITIVE
MOSTSENSITIVE
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Light Sensitive
Sensitive to strong light, sunlight,ultraviolet, fluorescents (neon)
BCG
MMR
Varicella
Meningococcal C ConjugateMost DTaP containing vaccines
Immunisation Department, Centre for Infections
Vaccines should
always be stored
in their original
packaging until
point of use to
protect them from
light
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Vaccine Storage
Use a dedicated vaccine fridge
Safeguard electricity supply
No more than 50% full
Place vaccines in clearlylabelled plastic mesh baskets
Group vaccines by type(Paediatric, Adult, Adolescent)
Defrost/calibrate fridgeregularly
Ensure back up facilities areavailable in the event of fridgefailing
Immunisation Department, Centre for Infections
X No food o r medica l
specimens
X Do not p lace fr idge in
direct sunl igh t or near heat
source
X Do not remov e vaccines
f rom original boxes unt i l
ready to us e
X Do not store vaccines in
fr idge doors or in sol id
plast ic trays/con tainerswith in the fr idge
X Keep v accines away from
fr idge wal ls and cold air
vents
Picture taken from www.medisave.co.uk
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Temperature Monitoring
Use max/min thermometer
Probe should be placed in thecentre of fridge
Temperature should be
recorded at least once a day
Reset daily
Calibrate as recommended
Take immediate action if
temperature is outsiderecommended range
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Sample refrigerator temperature recordchart
Immunisation Department, Centre for InfectionsAvai lable at: http:/ /www 2.cdc.gov/nip/ isd/ immto olki t /cont ent/vacstorage/ logs.htm
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Storage temperature
Never exceed 8C or fall below 2C
Aim for 5C Aim to maintain vaccine fridge as close as
possible to 5C as this gives a safety margin of +or 3c
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Loading Vaccine Refrigerators
Put vaccines and diluents on the top and middle shelves
of the main section
OPV and measles vaccine on the top shelf
BCG, Pentavalent and TT vaccines on the middleshelves
Diluents next to the vaccines with which they were
supplied
Arrange the boxes of vaccine in stacks between whichthe air can move.
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Choosing a Refrigerator and Freezer1. Temperature Zone, the average temperature during the hottest/coldest
months should be taken as criteria for the
determination of the zones.
There are three temperature zones for which cold chain refrigerators and
freezers will be classified: Hot zone, 0C to +43C
Temperate zone, 0C to + 32C
Cold zone, -5C to +32C
2. Vaccine storage capacity, how much vaccines must be stored at 0-+8Cor -20C
3. Ice pack freezing capacity, how many icepacks should be frozen per24 hours 23
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4. Power source, electricity, kerosene or bottled gas. Is supply
Continuous or not
5. Holdover time, How many hours will the vaccine remain below 10C
6. Reliability, Repair facilities and spare parts are available
7. Price, Which refrigerator meets requirements at the lowest cost
8. Training, Are the users and those in charge of maintenance of
equipment properly trained
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Conti..
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What to do when a vaccine refrigerator is outof order
If your vaccine refrigerator stops working, first protect the vaccines
and then repair the refrigerator.
Protecting the vaccines
Move the vaccines to another place until the refrigerator is repaired.If you think that the problem will last only a short time, you may
use a cold box or vaccine carrier lined with conditioned ice-packs
for temporary storage. For a longer duration, use another
refrigerator. Always keep a freezer indicator with the freeze-
sensitive vaccines to monitor eventual freezing.
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Restoring the refrigerator to working order
Check the power, gas or kerosene supply. If there is no power,
make other arrangements (e.g. store the vaccine in a household
refrigerator) until power is restored. If there is no gas or
kerosene, get it as soon as possible.
If a lack of power, gas or kerosene is not the problem, repair the
refrigerator or report to your repair technician or supervisor.
Record the breakdown on the daily temperature recording chart.
Note: Concerning the routine maintenance and the servicing of
refrigerators, WHO technical manuals exist for each kind of
refrigerator. 26
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All the vaccines should be stored in thebasket provided with the refrigerator
1. Measles,BCG and OPV in the bottom only2. Freeze-sensitive vaccines (Penta, TT) in the top
only.
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Different Types ofRefrigerators/Freezers
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ILR Mk 074Solar Powered
De
e
p
Chest freezer
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General rules about refrigerators
Opening the refrigerator door raises the temperature.
Before you open the door, plan what you are going to
do.
When you open the door, do what you have to do
quickly and close the door as soon as possible.
Try not to open the refrigerator door more than three
times a day.
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Storage Principles
Vaccines must not be kept:
In the door compartments of domestic refrigerators
In the salad trays at the bottom of the refrigerator
In contact with the evaporator plateMust not be confused with other heat sensitive
pharmaceuticals
Diluents must be stored at the same temperature
at the point of use. This prevents damage to the
potency of the vaccine
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Contingency Plans
Each facility should have a contingency plan for power
failures and these must be visible placed on the
fridge
It must be include an alternative storage area/place
and it must be adequate
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Walk-in Type Cold Room
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Combination Walk-in Type Cold/Freezer Room
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Cold chain monitoringequipment: thermometers
Health centre staff use dial thermometers, as recommended
by WHO to monitor the temperature of
refrigerators, cold boxes and cooler boxes.
Max-min thermometers are not recommended as training is
required
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Dial type Thermometer
Type of Vaccine Thermometer
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Bar type Thermometer
(r ead safety zone as 20to 80C & not as 00to 80)
Type of Vaccine Thermometer
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Maintaining cold boxes and vaccinecarriers
Vaccine carriers and cold boxes must be well dried after their use.
If they are left wet with their lids closed, they will become
mouldy. Mould may affect the seal of the cold boxes and vaccine
carriers. If possible, store cold boxes and vaccine carriers with thelid open, when not being used.
Knocks and sunlight can cause cracks in the walls and lids of cold
boxes and vaccine carriers. If this happens the vaccines inside will
be exposed to heat.
If a cold box or vaccine carrier wall has a small crack you may be
able to repair it with adhesive tape until you can get an
undamaged one. 38
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Packing a cooler box
1. Take all the frozen ice packs you need from the
freezer and condition them.
2. Put ice packs against each of the four sides of
the cold box or vaccine carrier.
3. Take all the vaccines and diluent you need from
the main section of the refrigerator and close
the door.
4. Put the vaccines and diluent in the middle ofthe cold box or carrier. Vials may be kept in
their boxes or packed without them, depending
on how many vials you need.39
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Cold Chain & Vaccine Management Training
Cold box and Vaccine Carriers
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Vaccine carrier with vaccine vials in foam pad
Cold box
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Keeping things cool in the field
Keep the lid tightly on the vaccine carrier in transit.
Keep cold boxes and vaccine carriers in the shade. Do
not leave a cold box or vaccine carrier in a vehiclethat is standing in the sun. Take it out of the vehicle
and put it in the shade.
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Ice packs
Ice packs are flat, square plastic bottles that can be
filled with water and frozen. The required number in a
particular cold box or vaccine carrier varies.
Every health centre should have two sets of ice packs,
one being frozen while the other is in use.
Condition the ice packs before use
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Ice packs
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Ice packs
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0.4 liters 0.6 liters
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Vaccines sensitive to heat
OPV
Measles
BCG
TTPentavalent
Most sensitive
Least sensitiv
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Vaccines sensitive to cold
Pentavalent
TT
Most sensitive
Least sensitive
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VaccinesNational Provincial District Facility
6 months 3 months 2 months 1 month
OPV -15C to -25C
BCG
Measles
Penta
TTNote:
1.BCG and Measles can be stored and transported at +2C to +8C. It is not
2.Diluent vials must never be frozen, they must be stored and transported at
+2C to + 8C when packed together with the vaccine.
Level/Max stock in months
+ 2C to + 8C
harmful to store them at minus temperature but it is unnecessary.
Recommended Storage Temperature for Vaccines
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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.
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What is a vaccine vial monitor?
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VVM (Vaccine Vial Monitor)
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R di V i Vi l M it
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Reading a Vaccine Vial Monitor
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S d ti t h l l ft
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Some recommendations at each level after
the assessment:
1. Provision of Freeze tag for all freeze sensitive
vaccines.2. Completing of cold chain monitor at federal,
provincial and district level
3. Observe strictly vaccine ordering and stock keeping4. Designate & train cold chain staff at all levels
5. Observe Multi dose vial policy
6. Perform Ice pack conditioning for freeze sensitive
vaccines
7. Adapt an effective vaccine distribution system
8. Monitor stock and expiry datesImmunisation Department, Centre for Infections
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Vaccine and Cold Chain Monitoring Devices
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Cold Chain Equipment
The recommended
equipment typically used
for vaccine storage are :
cold rooms,
refrigerators and
freezers.
For transporting vaccines
equipment such as
cold boxes, vaccine carriers and
international containers
are commonly used.
All cold chain equipment has to comply with a set of performance
standards defined by the WHO EPI program and
United Nations Childrens Fund (UNICEF), or national policy.
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Cold chain equipment
for transporting vaccine
Coldbox
Vaccine carrier
Ice
bags
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Cold chain equipment
For vaccine storage
Cold room
refrigerators
Freezer
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Controlling and monitoring temperatures
There are different typesof monitoring devices formeasuring, controllingand recording storagetemperature of vaccines.
Refrigerators, freezersand cold boxes normallyhave thermometers thatmeasure the internaltemperature.
Most refrigerators andfreezers are fitted with anadjustable thermostat tocontrol and correctstorage temperature.
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Controlling and monitoring temperatures
A designatedperson in chargeof cold chainequipment shouldread and recordstorage
temperature on arecord sheet atleast twice daily oraccording to policy
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Controlling and monitoring
temperatures A Cold Chain Monitor card
(CCM) approved by theWHO is always packagedwith each consignment ofvaccine supplied byUNICEF.
All CCMs have temperature-sensitive indicators thatmonitor heat exposurethroughout the entire journeyof vaccine, frommanufacturer to health
facility.
This indicator changesirreversibly from white toblue if exposed totemperatures higher than +10and +34C to monitorconditions in transit and instorage.
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Controlling and monitoring temperatures
FreezeWatchindicators are CCMs
used to monitorstorage conditions ofcold-sensitivevaccines.
Stop! Watches
comprise of CCM andFreezeWatch devicesto monitor high andlow storagetemperatures in arefrigerator.
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Controlling and monitoring temperatures
A Vaccine Vial Monitor (VVM) is alabel
on a vaccine vial that is marked by acircle with a small square inside.
A heat-sensitive material on the labelregisters cumulative heat exposure ofeach individual vaccine vial overtime.
When the inner square matches or isdarker than the outer circle, itindicates that the vaccine has lost itspotency and must be discarded.
VVMs are NOT substitutes for expirydates.
Vaccines must never be used aftertheir expiry dates.
VV
M
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Keeping vaccines in the domestic
refrigerator at health center
1. The refrigerator must be placed in the coolestplace away from direct sunlight with adequate
air circulation around it (1215 inches awayfrom the wall)
2. It must be kept locked and opened only whennecessary
3. It must be defrosted regularly
4. Its temperature must be recorded twice daily5. Both monitor and thermometer are placed in
the refrigerator, while temperature chart isstuck on the outer-surface of the refrigeratordoor
Arrangement of vaccines in the refrigerator
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g g
MMR
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Shake test
Shake test should beperformed on a sample of
vaccine vial in question andon the sample of the samebatch/manufacture whichis known to have beenfrozen.
The two vials should beshaken vigorously for fewminutes, and observed forthe rate of sedimentation
DPT, DT, dT, TT
These vaccines are damaged
by freezing
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Ordering and Deli er
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Ordering and Delivery
Named trained designated person and deputy who haveoverallresponsibility for ordering, receipt and care of vaccines.
Responsibilities include:
Ensuring cold chain has been maintained during transport andmanaging receipt of vaccines directly into refrigeration
Checking delivery for leakage, damage and discrepancies
Rotation of stock
Maintaining stock information system to keep track of orders,expiry dates and running total of vaccines
Ensuring adequate supply/ Minimising over ordering or stockpiling
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Cool Boxes and Transporting vaccines
Use a validated cool box and ice packs from recognised medical
supply company
Monitor maximum/minimum temperature, recording at regular
intervals
Vaccines should be wrapped in bubble wrap or similar insulation material to preventdirect contact with ice packs
Use insulating material to fill any spaces within the cool box
Only take enough vaccine for particular session and minimise exposure of the
vaccines to room temperatures
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What to do if there has been aCold Chain failure
Prior to administration Any vaccine that has not been stored at a temperature of 2-8C as per its
licensing conditions is no longer a licensed product
Where there is any doubt that cold chain has not been maintained,vaccines should not be used until further advice has been soughtfrom the vaccine manufacturer
Written procedure for the disposal of vaccines by incineration should be
available locally
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Post administration
Treat as Serious Untoward Incident
Inform Practice Manager/Line Manager/PCT of the
incident
Suspend all immunisation clinics until resolved
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Best practice in Cold Chain compliance
Defined local policies should be in place and written in accordance with
PGDs, SPCs, DH Green Book
Regular audit of current practice
Training
Local multidisciplinary support
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Useful resources
Immunisation Department, Centre for Infections
Poster and plug stickers available to
order from DH publications orderline
(www.dh.gov.uk)
Chapter 3&4 Green Book: Storage,
distribution and disposal of vaccines
and Immunisation Procedures
CDC Vaccine Storage and Handling Toolkithttp://www2a.cdc.gov/vaccines/ed/shtoolkit/
WHO. Temperature sensitivity of vaccines.
August 2006. http://www.who.int/vaccines-
documents/DocsPDF06/847.pdf
http://www2a.cdc.gov/vaccines/ed/shtoolkit/http://www2a.cdc.gov/vaccines/ed/shtoolkit/http://images.google.co.uk/imgres?imgurl=http://img.dailymail.co.uk/i/pix/2008/01_01/plug0201_468x542.jpg&imgrefurl=http://www.dailymail.co.uk/pages/live/articles/technology/technology.html?in_page_id=1965&in_article_id=505613&h=542&w=468&sz=19&hl=en&start=74&tbnid=1QYLsw1YNZzncM:&tbnh=132&tbnw=114&prev=/images?q=plug&start=60&gbv=2&ndsp=20&hl=en&sa=N -
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Minimum slide set created by:
Immunisation Department,
Centre for Infections,
Health Protection Agency
to assist teaching of the Core Curriculum for Immunisation Training
(see http://www.hpa.org.uk/infections/topics_az/vaccination/training_menu.htm)