Cold chain managment

PREPARED BY NESSIMA MOHAMMED 02161/12

NATNAEL SHISHIGE 00388/12
Acknowledgment

 We would like to express our gratitude to instructor Feysel for

providing us with this opportunity
 We would also like to extend our gratitude to worku endalamaw
00235/12 for his valuable and helpful recommendations during the
preparation of this power point.
 Out line
 Introduction
 Steps in the cold chain to consider
 Cold chain breach
 Importance of cold chain and cold chain managment
 Potential impact of cold chain breach
 transport and storage
 Equipments
Storage equipments
Transport equipments
 Temprature monitoring devices
 Monitoring vaccine refrigrator temprature
 Arranging the vaccines in side cold chain equipment
Introduction

 Cold chain is the system used for storing vaccine in good

condition.
 It is a series of links that are designed to keep vaccines with
WHO recommended temprature ranges from the point of
manufacture to the point of immunization
 It is the system of transporting and storing vaccines with in the
temprature range of +2°c and +8°c
Steps in the cold chain to consider

1. Vaccine manufacture
2. Road transport to the air port
3. Air transport
4. Road transport to storage facility
5. primary vaccine storage
6. Road transport to local pharmacies
7. pharmacy storage
8. cold box transport to department vaccine fridges
9. vaccine fridge storage
10. Nurse preparation of vaccine and transport to the patient/ consumer
11. Administration to the patient / consumer
What is cold chain breach?

 A breach occurs when the vaccines and medications are stored

outside of +2°c and +8°C.
 Out side this range the vaccine will die and medications will
not work.
Common issues resulting in cold
chain breaches

 Over stocking
 Variety of refrigerators and data loggers
 Irregular servicing of vaccination and medication refrigerators
 Staff unsure of quarantine procedures
 Transporting from pharmacy to the ward
The potential impact of a cold chain
breach

 Patient recall and revaccination

 Administration of ineffective medications
 Loss of faith in the organisation
 Litigation
 Staff hours spent on patient recall and managment of incidents
 Reduction in supply of potent vaccines avaliable for use
 Significant cost of replacement of inactive vaccines
Cont..

 Imagine receiving a call from the public health unit telling you
to bring your baby back to the facility for another vaccine.
Importance of cold chain managment

 Health professionals have a responsibility to ensure that clients

receive effective health products (i.e. vaccines andmedications
that have not been adversely affected by heat or cold).
 Good vaccine managment precludes the need to revaccinate
clients who may, under circumstances of poor vaccine
managment, receive an ineffective vaccine.
Importance of cold chain

 Storing and transporting the vaccine

 Maintaining the supply of vaccine
 Keeping the vaccine at low temprature
 Protecting the vaccine from sunlight exposure
Transport and storage

 For successful cold chain system, three elements are essential

1. Personnel: to manage vaccine storage and distribution
2. Equipments: to store and transport vaccine and to monitor
temprature
3. Procedure: to ensure the vaccines are stored and transport at
appropirate temprature.
Cont..

 Among all vaccines, polio is the most heat sensetive, requiring

storage at 2°c
 Polio and measles vaccines must be stored in the freezer
compartment.
 TPD, TD, TT, BCG Typhoid and diluents of vaccines must be
stored in the cold part and never allow to freeze
 Vaccine must be protected from sunlight and contact of
antiseptic
Cont..

 Vaccines are sensitive biological products.

 Some vaccines are sensitive to freezing, some to heat and
others to light.
 Vaccine potency, meaning its ability to adequately protect the
vaccinated patient, can diminish when the vaccine is exposed
to inappropriate temperatures.
 Once lost, vaccine potency cannot be regained.
Cont..

 Note that the heat stability information shown for freeze-dried

vaccines applies only to unopened vials;
 most freeze-dried vaccines rapidly lose potency after
reconstitution.
 In addition, it is important to keep opened multi-dose vaccine
vials that do not contain preservative – whether lyophilized or
liquid – cooled at temperatures between +2 °C and +8 °C
during the immunization session, or within six hours after
opening, whichever comes first.
Freeze sensitive vaccines

 Cholera
 DTaP-hepatitis B-Hib-IPV (hexavalent)
 DTwP or DTwP-hepatitis B-Hib (pentavalent)
 Hepatitis B (Hep B)
 Hib (liquid)
 Human papillomavirus (HPV)
 Inactivated poliovirus (IPV)
 Influenza
 Pneumococcal
 Rotavirus (liquid and freeze-dried)
 Tetanus, DT, Td
Sensetivity to light

 BCG,
 measles,
 measles-rubella,
 measles-mumps-rubella and
 rubella
Cont..

 To protect from light damage vaccine should be supplied in

dark glass vials
 They should also be kept in their secondary packaging.
 1. Walk in cold rooms (WIC)

• Installed in all of the states and larger

Divisional head quarters.

• They maintain the temprature at around -20c

• Bulk storage of OPV and also to prepare Frozen

ice packs at state stores.

• Used at regional level

• Storage up to three months and serve 4-5

 2. Deep freezers

• At district and PHC level

• At PHC level, used only for the preparation
of ice packs
• Temp: -15c to -25c
• They are used for polio and measles
vaccine.
• Can maintain the cabinet tempratute for 18-22
hrs
• 300 - 140 ltr Foraking ice packs and for
storing capacity available in deep freezer
 3.Ice lined Refrigerator
(ILR)

• Both at district and PHC level

• Temp: +2c to +8c
• IRL'S are top Opening, can hold air inside better
than font opening refrigerator.
• Are used for storing all UIP vaccines.
• The bottom of ILR is the coldest part. DPT, DT, TT
and diluents should not be kept directly on the
floor of ILR as they can freeze and get denatured.
Cont…

• Temprature of the ILR should be recorded twice a

day with the dial thermometer which should be
kept inside the ILR, even if there is an in built
thermometer.
 1. Cold boxes

• Used for transport and also for storing of vaccines

during failure of electric supply
• Fully frozen ice packs packed at the bottom and
sides before placing the vaccines in it.
• The vaccines should first be packed in cartoons or
polyethylene bags and then to be kept inside the
cold box.
• DPT, TT, DT and diluents should not be kept in direct
Contract
Cold box
 2. Vaccine carriers

• Used to carry small quantities of vaccines (16 to 20

vials)
• For out of reach session
• 4 ice packs are used for lining the sides of the
carriers
• DTP, DT, TT and diluents should not be placed in
direct conttact of frozend ice packs and the carrier
must be closed tightly.
 3. Day carriers

• Used to carry very small quantities of

vaccines (6 to 8 vials)
• For a near by session
• 2 ice packs are uses
• For only two hours period
• Ice-packs are flat, square plastic bottles that are
filled with water and frozen.
• They are used to keep vaccines cool inside the
vaccine carrier or cold box.
 To freeze an Ice-Pack

• Fill with water leaving a little air space at the top

• Hold each ice-pack upside down and squeeze it
to make sure it does not leak
• Put Ice-packs upright on their sides in the freezer
• Let the air circulate in between the ice-packs
Temprature monitoring
devices
Monitoring heat exposure using vaccine vial monitoring
(VVM)

 A VVM is a chemical indicator label attached to the vaccine

container (vial, ampoule or dropper) by the vaccine manufacturer.
 As the container moves through the supply chain, the VVM records
its cumulative heat exposure through a gradual change in colour


 If the colour of the inner square is the same colour or darker than
the outer circle, the vaccine has been exposed to too much heat and
should be discarded.


 There are currently four types of VVM, chosen to match the heat
sensitivity of the vaccine.
Cont..

 These four types are VVM2, VVM7, VVM14 and VVM30.

 The VVM number is the time in days that it takes for the inner
square to reach the colour indicating a discard point if the vial
is exposed to a constant temperature of 37 °C
Cont..

 VVMs do not measure exposure to freezing temperatures.

 If the vaccine is freeze-sensitive and freezing is suspected,
then the Shake Test must be conducted
Where is the VVM?

 There are two different locations for VVMs and each is associated with
specific guidance for handling opened multi-dose vials of vaccine:
1. WHO-prequalified vaccines, where the VVM, if attached, is on the label of
the vaccine.
 The vaccine vial, once opened, can be kept for subsequent immunization
sessions up to 28 days, regardless of the formulation of the product (liquid
or freeze-dried).
Cont..

 2. WHO-prequalified vaccines where the VVM is attached in a location

other than on the label (e.g., cap or neck of ampoule).
 In this instance, the vaccine vial, once opened, must be discarded at the end
of the immunization session or within six hours of opening, whichever
comes first.
 This is regardless of the formulation of the product (liquid or freeze-dried).
 This would apply, for example, to a reconstituted product of which the
vaccine vial cap, which has a VVM attached, has been discarded after
opening
30-day electronic temprature loggers
(30 DTR)

 These devices are placed with the vaccine load in a vaccine

refrigerator.
 They record the refrigerator temperature at no more than 10-minute
intervals and show the temperature history for any day in the last 30
days.
 They also record and display a 30-day history of any heat and freeze
alarms that have occurred.
 Alarms are triggered if the temperature of the refrigerator drops to
−0.5 °C or below for 60 minutes or if it exceeds +10 °C for a
continuous period of 10 hours.
 As long as the temperature has remained within the recommended
range, the device displays “OK” or a tick symbol
Cont..

 30 DTRs should not be used in vaccine freezers

 If the refrigerator is used to store vaccines that are not freeze-
sensitive, place the device on top of the load, in the warmest part of
the refrigerator.


 If the refrigerator is used to store any freeze-sensitive vaccines, the

device should preferably be placed in the coldest part of the
refrigerator that is being used to store
 these vaccines.
 This will be the bottom of a basket in chest refrigerators or nearest to
the evaporator plate in front-opening models and absorption units.

Electronic freeze indicators

 These are small digital devices that are placed with freeze-
sensitive vaccines during transport or storage.
 The devices have a visual indicator that shows whether the
vaccine has been exposed to freezing temperatures.
 Once the alarm indicator is triggered, the device is no longer
usable and should be discarded
Monitoring vaccine
refrigerator temprature
Cont..

 Monitor fridge temprature twice daily, during department

operating hours and record on the approved temprature chart
 Reset the min/max thermometer after reading
 Record any events, such as deliveries, on the temprature
monitoring chart.
 Perform annual checks of all vaccine and medication storage
equipment
 Follow cold chain breach protocol if temprature out side +2°c
to +8°c
Refrigerator monitoring equipment

 All vaccine and medication refrigerators must have a data

logger
 each fridge must be continuously monitored using a data
logger
 Each manager responsible for a fridge will receive the data
logger report weekly
 Data logger report must be printed, reviewed for excursions
outside +2°c to +8°c (known as a cold chain breach) and
reported.
Arranging the vacines in side
cold chain equipment
Do arrange the vaccines in the health facility refrigerator like this:

 Wherever possible, store vaccines and diluents in a refrigerator

that is reserved for this purpose only.
 Always arrange vaccines and diluents so that air can circulate
freely; this also makes it easier to handle the vaccines.
 If vaccines or diluents are supplied in their original cartons,
arrange the boxes so that there is at least a two-centimetre
space between stacks.
Cont..

 If vaccines or diluents are supplied as individual containers

(vials, ampoules or tubes), use a plastic tray, plastic box or
other arrangement to store the vaccines in an orderly fashion.
 If diluent is packaged with the vaccine, store the complete
packaged product in the refrigerator.
 If diluents are supplied separately from the vaccine, store them
in the refrigerator if there is adequate space.
 If there is not adequate space, move the diluents to the
refrigerator at least 24 hours before they are needed so they are
cooled.
Cont..

 Place vaccines with VVMs that show the most heat exposure
(darker squares) in a separate container in the refrigerator,
clearly marked “Heat-exposed vials – use first”.
 If there are other vaccines of the same type in the refrigerator,
the vaccines with the darkest squares should always be used
first even if the expiry date is later than the vaccines with the
lighter squares.
Cont..

 If a multi-dose vial policy is in place, follow the instructions

for handling opened multi-dose vials exactly as described in
the national policy.
 If an opened multi-dose vial will be used for the next session,
the vials must be placed in a separate container in the
refrigerator, which is clearly marked “Opened vials – use
first.”
Summary of WHO Multi-dose Vial Policy (MDVP),
2014

All opened WHO-prequalified multi-dose vials of vaccines should be

discarded at the end of the immunization session, or within six hours
of opening, whichever comes first, unless the vaccine meets all four
of the criteria listed below.
If the vaccine meets the four criteria, the opened vial can be kept and
used for up to 28 days after opening. The criteria are as follows:

1. The vaccine is currently prequalified by WHO.

2. The vaccine is approved for use for up to 28 days after opening the
vial, as

determined by WHO.
Cont..

3. The expiry date of the vaccine has not passed.

4. The vaccine vial has been, and will continue to be, stored at WHO- or
manufacturer-recommended temperatures; furthermore, the vaccine vial
monitor, if one is attached, is visible on the vaccine label and is not past its
discard point, and the vaccine has not been damaged by freezing.

If ALL of the criteria cited above are present, the vaccine vial may be kept
and used

for up to 28 days after opening, or until all the doses are administered
DON’T arrange the vaccines in the health facility
refrigerator like this:

 Never store food or drink in a vaccine refrigerator.

 Do not open the door or lid unless it is essential to do so. Frequent
opening raises the temperature inside the refrigerator.
 If there is a freezer compartment, do not use it to store vaccines and
diluents.
 Do not keep expired vaccines in the refrigerator.
 Do not keep vaccines with VVMs that have reached, or are beyond, their
discard point.
 Do not keep reconstituted vaccines for more than six hours, or after the
end of an immunization session.
 Discard all these items immediately according to your national
guidelines.
The shake test

 The Shake Test is used to check whether freeze-sensitive

vaccines have been damaged by exposure to temperatures
below 0 °C.
 After it has thawed, a vial of vaccine that has been frozen no
longer has the appearance of a cloudy liquid, but tends to form
flakes that settle at the bottom of the vial.



 Cont..

 The Shake Test requires two vials of the same vaccine from the same
manufacture and with the same batch number.
 One of these is a vial that you suspect has been frozen and
 the other is a vial that you have deliberately frozen solid overnight.
 Allow the frozen test vial to melt completely, shake the two vials in the same
hand, place them side-by-side and watch the contents settle.
 If the suspect vial settles at the same speed as the frozen
 vial you know that it has been frozen.
 If it settles more slowly, it has not been frozen.
When is the Shake Test needed?

If a freeze indicator is activated, or temperature recordings show

negative temperatures,

freeze-sensitive vaccines may have been damaged. If this occurs,

notify your supervisor.

If they decide to proceed, carry out the Shake Test on a sample of

the freeze-sensitive vaccines.
 How to maintain cold chain
equipment

 Vaccine refrigerators:
 A refrigerator works well only if it is properly installed, cleaned and
defrosted regularly.
 Thick ice in the freezer compartment does not keep the refrigerator cool, it
makes the refrigerator work harder and use more power, gas or kerosene
 You should DEFROST the refrigerator when the ice becomes more than 0,5
cm thick or once a month.
 How to defrost and clean a
refrigerator

 Take out all the most heat sensitive vaccines (OPV, measles, BCG, yellow fever)
and transfer them to a cold box lined with frozen ice-packs
 Take out all the freeze sensitive vaccines (DTP, DT, Td, hepatitis B, ) and diluents,
and transfer them to a cold box lined with conditioned ice-packs
 Turn off the power supply to the refrigerator
 Leave de door open and wait for the ice to melt
 Clean the inside and the door seal with a clean wet cloth and turn the refrigerator
on again.
Cont..

 When the inside temperature in the main section falls to 2°C- 8°C return
the vaccines, diluents and ice packs in appropriate places.
 If a refrigerator needs to be defrosted more than once a month, check for
these common problems:
Staff are opening the door too often (more than three times daily).
The door is not closing properly.
The door seal needs to be replaced.
Tips

 Don't put vaccines or medications in your pocket, even for a

short time
 Don't leave the refrigerator door open
 Angle the refrigerator up slightly at the front to facilitate auto-
closing of the door
 Only remove vaccines for immediate use
 Check temprature before opening the door everytime
 Check expiry dates and use oldest first
 Ensure valid medication order is present before removing
vaccine
Thank you