Cold Chain Guide for Medical Officers
Cold Chain Guide for Medical Officers
Vaccine Air Transport Primary Store Refrigerated State Store Insulated Van
Manufacturer ( 2 to 8 C (GMSD & State) Insulated Van WIC ( 2 to 8 C) & ( 2 to 8 C &
& -15 to WIC ( 2 to 8 C) ( 2 to 8 C & WIF (-15 to -25 C) -15 to -25 C)
-25 C) & WIF (-15 to -15 to -25 C)
-25 C)
Mother & Sub-Centre Vaccine Primary Health Insulated Van District Vaccine
Child Session Sites Carrier ( 2 Centre ( 2 to 8 C) Store
to 8 C) ILR 2 to 8 C & ILR ( 2 to 8 C) &
All Vaccines in ILR DF (-15 to -25 C)
As MO, you need to ensure that cold-chain equipment is functional, storage temperatures
are correctly maintained and recorded and that adequate stock of vaccines and logistics are
available and issued. A vaccine and cold-chain handler (VCCH) is trained and designated to
maintain the cold chain. It is also necessary to look into the dry storage areas, i.e. storage of
syringes and diluents, and ensure that they are safely stored and accessible.
Personnel
In case more than one MO is posted in the centre, designate one MO for RI, who can also
be the focal point for the cold chain.
Vaccine and cold-chain handler At every ILR point, designate a senior male or female HW
(pharmacist staff nurse ANM LHV MPW health supervisor) as the VCCH. He she should
be responsible for forecasting, indenting, receiving, storing and distributing vaccines and
logistics, maintaining cold-chain equipment and related records. They will require training
or update of knowledge and skills in order to perform their roles effectively. (refer Handbook
for Vaccine Cold Chain Handlers)
Cold chain equipment Cold chain equipment, both electrical and non-electrical, is used
for storing vaccines and or transporting them at appropriate temperatures. Figure .2
summarizes the cold chain equipment supplied under the UIP. The NCCMIS (National Cold
Chain Management Information System) website is the platform where all information on
the cold chain equipment and management is being collated.
Fig Overview of cold-chain equipment
TEMPERATURE
ASSOCIATED
STORAGE TRANSPORTATION MONITORING
EQUIPMENT
DEVICES
WIC – walk-in cooler; WIF – walk-in freezer; ILR – ice-lined refrigerator; DF – deep freezer
Holdover time
In the event of power failure, “holdover time” for any functional healthy cold-chain
equipment is defined as “the time taken by the equipment to raise the inside cabinet
temperature from its cut-off temperature to the maximum temperature limit of its
recommended range”, e.g. in the case of ILR, if the temperature is C, then the time taken
to reach 8 C from C will be the holdover time for that ILR.
Holdover time of ILR depends on the following factors
• Ambient temperature more the ambient temperature, less will be the holdover time
• Frequency of opening of lid and use of basket
• uantity of vaccines kept inside with adequate space between the containers
(equipment empty loaded)
• Condition of the ice pack lining (frozen partially frozen melted) inside electrical non-
electrical cold-chain equipment.
Note: DF does not have holdover time like ILR as it does not have an ice lining inside its wall.
It is dependent on the number of frozen ice packs kept inside it.
Fig. 4.4
4.4. Storing vaccines in ILR
NEVER keep any vials that are expired, frozen or with VVMs beyond the
end point in the cold chain, as they may be confused with those contain-
ing potent vaccines eep them in the red bag for disinfection and dispos-
al
IDENTIF A DR SPACE FOR STORING
E PIRED UNUSABLE VACCINES BEFORE FINAL DISPOSAL
Freezing ice packs in the DF maintains the cabinet temperature between -15 C and -25 C.
Unlike the ILR, the DF has little or limited holdover time, which is dependent on the number
of frozen ice packs in it (See Fig. .5 and .6 for correct placement of ice-packs in the DF)
and the frequency of opening (See Table .3 for Dos and dont’s on use of DFs).
• At the PHC level, DF is used only for preparation of ice packs.
• At the district headquarters, DFs have been supplied for storage of recommended
vaccines such as OPV and preparation of ice packs.
Table Dos and dont s for DF use
Dos Dont s
9 Use DF only for preparation of ice ¾ Do not keep any vaccine in the DF at
packs at the sub-district level cold- sub-district level
chain points(PHC CHC SC) ¾ Never keep diluents in the deep
9 Use DF to store OPV at district level freezer
9 Keep frozen ice packs in the vaccine ¾ At district level do not use the same
storing DF to increase the holdover DF for simultaneously storing vaccines
time and preparing ice packs
Small
compartment
Arrange and
store frozen
icepacks
horizontally, in
Un-frozen layers.
icepacks
Also store in
for
cold boxes
freezing
Large compartment
Store frozen
Wipe dry and
icepacks only
arrange 20-25
up to half the
unfrozen icepacks
height of the
horizontally (never
large
flat) in a crisscross
compartment
pattern with space
for air circulation
Dos
Fig and don’ts for use ice
Brick layered of DFs is given
packs infreezer
in deep Table 4.3.Brick-layered ice packs in a DF is
Domestic refrigerators
Voltage stabilizer
A voltage stabilizer is electronic equipment that ensures a constant output voltage of 220
volts whatever be the variation in input voltage, and thus safeguards equipment from
excessive voltage variation. This is suitable for the working of the ILR and DF. Each ILR or
DF should be connected to the mains through its own independent voltage stabilizer with
proper earthing.
• ellow switch (In ILR control panel only) It is a thermostat bypass switch used when
the ambient temperature is more than 5 C or when it requires lowering down inside
temperature quickly.
• Thermometer Shows the inside temperature of the equipment.
• Thermostat A thermostat is a component which senses the temperature of inside the
cabinet of the cold-chain equipment so that the system’s temperature is maintained
near a desired set point. The thermostat does this by switching the compressor on or
off to maintain the correct temperature.
Vaccine van
A vaccine van is an insulated van used for transporting of vaccines in bulk. Vaccines should
be transported only in cold boxes with the desired number of conditioned ice packs. These
cold boxes should be loaded in the vaccine van immediately a er packing with vaccines and
unloaded at the destination as soon it is reached. Vaccines should be removed from the
cold boxes and placed in the ILR immediately a er reaching the destination.
Cold box
A cold box is an insulated box used for transportation and emergency storage of vaccines
and ice packs. It is available in two sizes, large and small. It is used to
• collect and transport large quantities of vaccines
• store vaccines for transfer up to 5 days, if necessary for outreach sessions or when
there is a power cut
• store vaccines in case of breakdown of ILR, as a contingency measure
• also used for storing frozen ice packs, e.g. during emergencies and before campaigns.
Packing a cold box (See Fig )
• Place conditioned ice packs at the bottom and sides of the cold box.
• Load the vaccines in cardboard cartons or polythene bags.
• Never place freeze-sensitive vaccines in direct contact with the ice packs. Surround
them with OPV BCG JE vaccines.
• Keep a thermometer in the cold box.
• Place two rows of conditioned ice packs above the vaccine vials.
• Place a plastic sheet to cover the ice packs kept on top to ensure full holdover time.
• Securely close the lid of the cold box.
acking a c
Ice packs
Ice packs are plastic containers filled with water. These are hard frozen in the deep freezer.
They are placed inside a vaccine carrier and cold box to improve and maintain the holdover
time. They are also used in ILRs as inside lining to improve and maintain holdover time
during electricity failure. Dos and dont’s for use of ice packs is given in Table .7.
About 20 25 ice packs (8 10 kg of ice) and 35 0 ice packs (12 1 kg of ice) can be frozen
in one day in small and large deep freezers, respectively. Standard ice packs used in UIP for
cold box and vaccine carrier are of 0.4 litre capacity.
Note The personnel involved in preparing the vaccine carriers and conditioned ice
packs may include other staff of the health centre
It is essential to train these staff as well on the importance and method of condi-
tioning ice packs
Ice packs come out of the freezer at a temperature of about -20 C. They need to be kept at
room temperature for a period of time to allow the ice at the core of the ice pack to rise to
0 C. This takes up to one hour at 20 C and rather less at higher temperatures. This process
is called “conditioning” (Fig. .8).
• Conditioning of ice packs prevents freezing of vaccines (freeze-sensitive vaccines such
as Hep B and T series) during transportation.
• Freeze-sensitive vaccines can be damaged if they come in direct contact with the frozen
ice packs.
• At the start of session day, take all the frozen ice packs that you need from the freezer
and close the door. Lay these out on a table leaving a 5 cm space all round each ice
pack.
• Lay out ice packs preferably in single rows but never in more than two rows.
• Wait until there is a small amount of liquid water inside the ice packs.
• Shake one of the ice packs every few minutes. The ice is conditioned as soon as it
begins to move about slightly inside its container.
Fig Conditioning of ice packs
Vaccine sensitivities
Vaccines lose their potency due to exposure to heat (temperatures above 8 C) ,cold
(temperatures below 2 C) and light .
Reconstituted BCG, measles MR and JE vaccines are the most heat and light sensitive.
Since these live vaccines do not contain preservatives, there is risk of contamination with
Staphylococcus aureus leading to toxic shock syndrome and, therefore, they should be
used within hours of reconstitution. These light-sensitive vaccines are supplied in amber-
coloured vials.
Under the open vial policy (OVP), any open vaccine vial returned from the field has to be
used within weeks (28 days) from the date of opening, provided the vaccine vial monitor
(VVM) is in usable condition, vaccine has not been frozen and is within expiry date. The
vaccines that come under this policy are Hep B, OPV, DPT, pentavalent, TT and IPV.
Only those diluents that are provided with the vaccine by the manufacturer should be
used. Keep diluents in an ILR at between 2 C and 8 C at least 2 hours before use to
ensure that the vaccine and diluent are at the same temperature when being reconstituted.
Keep diluents with the vaccines in a plastic zipper bag inside the vaccine carrier during
transportation.
Sensitivity of various vaccines to heat, light and freezing is given in Table .5.
Table Sensitivity of vaccines to heat, light and freezing
Vaccine Exposure to heat light Exposure to cold
Heat and light sensitive vaccines
OPV Sensitive to heat Not damaged by freezing
Measles MR Sensitive to heat and light Not damaged by freezing
BCG, RVV and JE Relatively heat stable, but Not damaged by freezing.
sensitive to light
Freeze sensitive vaccines
HepB Penta PCV Relatively heat stable Freezes at -0.5 C
(Should not be frozen)
IPV, DPT and TT Relatively heat stable Freezes at -3 C
(Should not be frozen)
At the PHC level, all vaccines are kept in the ILR for a period of one month at tempera-
ture of C to C
Vaccines sensitive to heat
accines sensitive to heat
Vaccines sensitive to freezing
accines sensitive to ree ing
accines
BCG sensitive to heat
(a er reconstitution) Most accines sensitive to ree Most
ing
C a ter reconstit tion ost ost
COPV,a Rota
ter reconstit tion sensitive
ost ost sensitive
accines sensitive to heat accines
e sensitive to ree ing
IPV I e HepB
I enta
easles
MR Ceasles R
a ter reconstit tion ost enta ost
R
Rotavir s I
PCV
Rotavir s
Rotavirus I e
I Penta
easles R enta
JE
C
Rotavir e ore
s reconstit tion IPV
I
CDPT e ore reconstit tion
east
DPT
BCG (before enta reconstitution)
e east TT
enta east
eC e ore reconstit Least
tion
east TT,
Least
sensitive east
Penta, HepB, enta PCV e sensitive
o to chec vaccines or correct maintenance o cold chain
o to chec east vaccines or correct maintenance o cold chain
Do not keep any vials that are expired, frozen or with VVM beyond the
end
o point in thevaccines
to chec cold chain,orascorrect
they may be confused with
maintenance those
o cold contain-
chain
ing potent vaccines
Vaccines need to be checked both for damage from excessive heat as well as from freezing.
However, the physical appearance of a vaccine may remain unchanged even a er it is
damaged.
VVM is a label containing a heat-sensitive material to record cumulative heat exposure over
time. The combined effect of time and temperature causes the inner square of the VVM
to darken gradually and irreversibly. Before opening a vial, check the status of the VVM
(Fig. .9). If the VVM shows change in colour to the end point, then discard the vaccines.
Fig Different stages of vaccine vial monitor
DPT, TT, IPV, HepB and penta vaccines lose their potency if frozen. Moreover, the
risk of adverse events following immunization (AEFIs) such as sterile abscesses may
increase. Freezing can occur at any level in the cold chain. Discard the vial if it is
frozen or it contains floccules a er shaking. Conduct the shake test (as given below)
if you suspect that a large number of vials at the cold-chain point could have been frozen.
Information on vaccine sensitivities is given in Table .5, Dos and dont’s in cold chain are
given in Table .6. (Shake test NOT applicable for IPV)
Sedimentation
nformation ypes of
VVMs are unique to each vaccine.
There are four types of VVM - VVM 30, VVM 1 , VVM 7 and VVM 2. The
number corresponds to the number of days the vaccine remains potent with
exposure at 37 C. In combined vaccines the VVM corresponds to the most
heat sensitive component of the vaccines, e.g. in DPT vaccine the VVM
corresponds to the Pertussis component of the vaccine.
Only use the diluents supplied packaged by the manufacturer with the vaccine, since the
diluents are specifically designed for the needs of that vaccine, with respect to volume, pH
level and chemical properties.
The diluents should be stored in the ILR at the last cold chain point. If the ILR has space
constraints then the diluents may be stored outside the cold chain. However diluents must
be kept in ILR at least hours before use or issuing to sessions to ensure that vaccines
and diluents are at same temperature (i.e. 2 C to 8 C) during reconstitution. Otherwise,
it can lead to thermal shock that is, the death of some or all the essential live organisms in
the vaccine. Store the diluents and droppers with the vaccines in the vaccine carrier during
transportation.
Do s Dont s
9 Keep all vaccines in ILR at 2 C to 8 C ¾ Do not keep in the cold chain
at PHC o Expired vials,
9 Use diluent provided by the manufac- o Frozen vials or
turer with the vaccine o Vials with VVM beyond the end
9 Keep diluents in ILR at 2 C to 8 C point
atleast 24 hours before use ¾ Do not use Rotavirus vaccines or re-
9 Use Rotavirus vaccine, reconstituted constituted BCG, JE and Measles MR
BCG, JE and measles MR within vaccines a er hours
hours
9 Discard all damaged vials for disinfec-
tion and disposal
Vaccine carrier
It is an insulated box used for carrying vaccines (16 20 vials) and diluents from the PHC
cold-chain point to session sites and to bring back the open vials (under the open vial policy)
from the session sites to the cold-chain point on the same day a er the session for storage
and subsequent use. Vaccine carrier (with conditioned ice packs) maintains the inside
temperature between 2 C and 8 C for 12 hours, if not opened frequently.
9 Confirm that there are no cracks in the walls of the vaccine carrier.
9 Take out the required number of ice packs from the deep freezer and wipe them dry.
9 Keep them outside for conditioning before placing into the carrier.
9 Place four conditioned ice packs into the vaccine carrier along the sides.
9 Wrap vaccine vials and ampoules in thick paper, e.g. plain white paper before pu ng
in a polythene bag so as to prevent them from touching the ice packs. Place some
packing material between “T” series vaccine and the ice packs to prevent them from
touching the ice packs.
9 Place the plastic bag in the centre, away from the ice packs. This will prevent labels
from peeling off from the vials.
9 Place foam pad on top of the ice packs.
9 If more than one vaccine carrier is being carried, keep the whole range of vaccines
required for the day’s use in each carrier so that only one carrier is opened at a time.
Fig rrect ofacking
Correct packing the
a vaccine carrier accine arrier
1 repare Ice- acks r Freezing 2 n i n Fr zen Ice- acks
• Fill the Ice-Pack with water to mark. Check
water level before every use. Do NOT add salt • Place frozen Ice-Packs in the open till there is
to this water. liquid water inside the ice packs
• Fit the stopper and screw on the cap tightly • Check if an Ice-Pack has been conditioned by
shaking it and listening for movement of ice inside
• Make sure the Ice-Pack does not leak the ice pack
• Wipe the Ice-Pack dry and place in the Deep • Unconditioned Ice-Packs may damage freeze
Freezer sensitive vaccines (DPT, TT, IPV, Penta and HepB)
3
ack the accine arrier
•Place four conditioned Ice- packs against the
sides of the carrier
PCV
Temperature monitoring
Temperature recording is done in order to ensure that the vaccines are kept at recommended
temperatures and the cold-chain equipment is working properly. A break in the cold chain
is indicated if the temperature rises above 8 C or falls below 2 C in the ILR and above
-15 C in the DF. Different type of thermometers and instruments are used to measure the
temperature during storage and transport of vaccines as given below.
Dos and dont’s in temperature monitoring of vaccines is given in Table .8.