Cold Chain Management and Vaccine Handling

Presented by:
Samah Hamdan
M.Sc. Clinical Pharmacy
[email protected]
Pharmacy Manager
NMCRH-KC Pharmacy Department
 Cold Chain
Is a network of cold/freezer rooms, refrigerators, freezers and cold boxes, that
is organized and maintained by teams of people throughout the world.

To ensure that vaccine is kept at the right temperature, to retain its potency,
from the moment it leaves the vaccine manufacturer, through shipping and
storage, until the moment it’s administered.
 Temperature Monitoring Devices

Cold chain monitoring devices:

are devices that are used during transportation and
storage of vaccines to monitor and record the temperature
of vaccines throughout the supply chain.

The importance of the Temperature Monitoring Devices

• A way to prove that vaccines have been kept at the

right temperature during storage and transportation.

• Temperature monitoring also shows up any problems

with equipment and procedures.

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 Types of Temperature Monitoring Devices

Temperature Reader Condition Indicators Temperature Recorders

• Digital Thermometer • Vaccine Vial Monitor • Data logger

(VVM)

• Freeze Sensitive
Indicators (FSI)

• Freeze Tags
 Temperature Monitoring Devices
1. Temperature Reader

1.1 Digital Thermometer

• Should be attached to the Cold box during

vaccine transport

• Shows the current temperature inside the

cold box. And temperature fluctuations
 Temperature Monitoring Devices
2. Condition Indicators
2.1. Vaccine Vial Monitors (VVM)

• A label that changes colour when the vaccine vial or ampoule has been
exposed to temperatures above 8C

• Are Heat Sensitive Indicators that are placed on the freeze-dried

vaccines like BCG vaccine

• Attached to the cap or neck of the vial

 Temperature Monitoring Devices
2. Condition Indicators
2.1. Vaccine Vial Monitors (VVM)
 Temperature Monitoring Devices
2. Condition Indicators
2.2. Freeze Tags

• It is used for monitoring freeze-sensitive vaccines.

• Should be placed inside the cold box during vaccine transport

• Changes from check” to “cross” when Exposed below 0C for

more than 60 minutes

• A small blinking dot in the bottom right-hand corner of the LCD

display indicates that the device is functioning.

• If the display remains blank keep Freeze-tag at room

temperatures for at least 2 minutes and If the display is still
blank, check expiry date.

• Discard all ink FSIs

 Temperature Monitoring Devices
3. Temperature Recorder
3.1 Data logger

• Records time and temperature data for later download

using internal sensor.

• Should be placed inside the cold box during vaccine

transport, so that temperature daily report will be
generated and documented.

• Provide detailed history for the storage temperature

over (24/7)
 Vaccine Transportation

During transporting vaccines from and to clinics, several precautions must be

followed, in order to avoid loss of potency and reduce shelf life.

Vaccine protection can be achieved by taking the following actions:

✓ Vaccines must be protected from exposure to excessively high or low

transport temperatures.

✓ Develop Standard Operating Procedure (SOPs) for vaccine packing and transport, and train
staff to observe these procedures.

✓ Understand the heat and freeze sensitivity of each vaccine.

✓ Know the duration of the journey.

✓ Choose the correct type and quantity of coolant-packs.

 Packing the Cold Box

Bubble
Cool Packs Cold Box Thermometer Wrap Freeze Tag

Data
Vaccine
Logger
Packing the Cold Box
 Packing the Cold Box
Conditioning Ice packs
Ice packs must be conditioned before use, as direct
contact with vaccines may lead to freezing, cracks and
may destroy the stock.

To condition icepacks take the following steps: Completely Frozen

Don’t Use
1. Take them from the freezer

2. Leave them outside for 15 – 60 minutes depending on

the room temperature, until you can hear water when
you shake them and that the ice is moving freely
inside them

3. Ensure they are fully sealed

Conditioned
4. Ensure they are dry before use
 Requirements for Packing Vaccines in the
Cold Box
1. Choose the appropriate size of cold box or vaccine carrier for the quantity of
vaccines.

2. Take the required number of icepacks from a freezer then Condition them

3. Wipe the icepacks, dry and place the conditioned icepacks against each of four
sides of the cold box/ carrier and on the bottom of the cold box

4. Put the vaccines and diluents carefully in the middle of the cold box or carrier
include data logger/ max‐min thermometer, FSI and CCM (optional)

5. if required, use plastic foam, air bubble wrap or similar material to protect freezing
sensitive vaccines (DTP, TD, DT, PCV 13).
 Requirements for Packing Vaccines in the
Cold Box
6. When package vaccines in the cold boxes:
• OPV and MMR are the most heat sensitive vaccines which must be kept in
closest contact with conditioned ice packs.
• Do not expose freeze sensitive vaccines and diluents to freezing
temperatures or keep them in contact with conditioned ice packs

7. In cold boxes, place conditioned icepacks on top of vaccines

8. Close the lid tightly. Take the necessary precautions to prevent DPT, DT, TT and
Hepatitis B vaccines from being frozen.

9. Thermometer is fixed to the cold box to assure maintained temperature

during transporting . Temperature shall be recorded on delivering time.

10. Clean and dry the internal surface of the carrier after each use.
 How to Prevent Accidental Freezing in the Cold Chain

1. Condition ice packs by keeping

them in the room temperature for
15 to 45 minutes (depending on
the room temperature), until you
can hear water when they shaken.

2. Keep freeze sensitive Indicator with

vaccines
Evidence of Exposure to Freezing
Temperatures
 Shake Test
Detect Freeze Damaged Vaccines

• The “shake test” was designed to determine whether

freeze sensitive vaccines (adsorbed vaccines, such as
DTP, DT, Td, TT, typhoid, and hepatitis B) have been
affected by freezing.

• These vaccines must never be frozen as this reduces

their immunogenicity.

• Freeze Damaged vaccines sediments faster than

vaccines that have not suffered freeze damage.

• If you suspect that a vaccine has been frozen (e.g.,

thermometer marks temperature < 0 C, Cross sign on
Freeze tags) a Shake Test must be performed.
 Shake Test
Detect Freeze Damaged Vaccines
Shake test is how you check whether freeze-sensitive vaccines have been subjected
to freezing temperatures, which are likely to have damaged them

The shake test should be conducted for all vaccines with the following
characteristics:

1. Vaccines packed in boxes that have a freeze indicator (e.g. freeze tag), which is
found to be activated. (Cross sign on Freeze Tag)

2. Refrigerator temperature records that show the temperature has fallen below +2ºC.

3. Where you suspect that the vaccines may have been frozen by mistake, for
example by placing too close to the freezer plate in the refrigerator or touching
frozen ice-packs.

If the vaccine fails, the ‘shake test’ it must be discarded.

There is no need to conduct a shake test if a liquid vaccine vial is already frozen solid,
simply discard it.
 Shake Test
Detect Freeze Damaged Vaccines
How to perform Shake Test
1. Freeze a vial until it is solid; this will be your control vial – call it “FROZEN”.

2. Allow FROZEN vial to thaw completely.

3. Select one sample of each vaccine you suspect has been frozen – call it “SUSPECT”.

4. Step 4. Shake FROZEN and SUSPECT vials.

5. Observe FROZEN and SUSPECT vials side-by side to compare how they sediment (5-15 minutes).
 Temperature Sensitivity of Vaccines
It is essential that all those who handle vaccines and diluents know the temperature
sensitivities and the recommended storage temperatures for all the vaccines in the
national program.

• Freeze Sensitive Vaccine

• Heat Sensitive Vaccines

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 Freeze Sensitive Vaccines

Vaccines that are damaged by

freezing

Pack the freeze sensitive

vaccine at the highest
temperature in the fridge
Away from the evaporator Freeze Sensitive Vaccines

(In the MIDDLE of the fridge)

 Freeze Sensitive Vaccines
Freeze Sensitive Vaccines
• DTaP IPV
• Influenza (inactivated, split)
• HepA, HepB
• Hexa(DTaP-Hib-HepB-IPV)
• Hib
• HPV (HPV2, HPV4, HPV9)
• IPV
• MCV4 (Meningitis ACWY (polysaccharide-protein conjugate)
• PCV (PCV10, PCV13)
• Other Pneumococcal (polysaccharide-protein conjugate)
• Penta (DTP-Hib-IPV)
• PPSV23 (Pneumococcal polysaccharide)
• RV (RV1, RV5) (Liquid)
• Tdap, Tdap-IPV
• Td. Td-IPV
• Tetra (DTaP-Hib)
• TT
• Typhoid
 Heat Sensitive Vaccines

Vaccines that are damaged by

Heat

Heat Sensitive Vaccines

Pack the heat sensitive vaccine
at the lowest temperature in
the fridge, closest to the
evaporator

(At the top of the fridge)

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 Heat Sensitive Vaccines

Vaccines not Affected by freezing

BCG
MMR
bOPV
Varicella

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Heat /Freeze Sensitive Vaccines
 Storage Best Practices for Refrigerated
Vaccines

1. First Expire First Out (FEFO)

Put vaccines that are first to expire in
front.

2. First In First Out (FIFO)

Means that products stored first are
to be retrieved first.
Storage Best Practices for Refrigerated
Vaccines

3. Don’t mix returned with fresh stock

in the same order, returned vaccines
shall be labelled by “ returned vaccines ,
use first

4. Keep loose vaccines in closed container

to protect from light
 Storage Best Practices for Refrigerated
Vaccines
5. Do leave 2 to 3 inches between
vaccine containers and refrigerator
walls.

6. Clinics are allowed to keep daily

need of vaccines only.
Unused vaccines shall be returned
to pharmacy after closing the
clinic.
 Keep in Mind
• Reconstituted vaccines must not be frozen after reconstitution

• Diluent for any vaccine must not be frozen

• Several vaccines are highly sensitive to light; they must be kept in the dark
as far as possible.
For Example: BCG and Measles Vaccine

• It is vitally important to know the CORRECT storage conditions for each vaccine,
and to ensure that each is kept in the recommended storage condition.
 Managing Cold Chain Breach
Handling a Temperature Excursion in Your Vaccine Storage Unit

Temperature Excursion
• Any deviation from the approved storage conditions. It can include exposure to higher or
lower temperatures (including freezing).

• Identify temperature excursions quickly and take immediate actions to correct them. In
order to prevent vaccine waste and the potential need to revaccinate patients

Consequences of a medicine temperature excursion include:

• Degradation and loss of potency, Cost implications, and Treatment delays
 Managing Cold Chain Breach
Handling a Temperature Excursion in Your Vaccine Storage Unit

On notification of a temperature excursion, the following steps should be immediately

taken:

• Access the temperature log and/or confirm details of the temperature excursion

• Correct the problem if possible (e.g., close the fridge door, ensure the fridge is plugged in)

• If fridge is malfunctioning, contact maintenance

• Notify appropriate management staff in the area

• Label the stock “Quarantined - Do not use” and move the stock to another storage area that meets
temperature requirements

• Assess the stock for suitability of use

• Ensure replacement medicines are made available especially those due for patient administration or
required as a life saving medicine.
 Managing Cold Chain Breach
Handling a Temperature Excursion in Your Vaccine Storage Unit

Measures to prevent Temperature Excursions

• Keep your storage units and vaccines within the appropriate

temperature ranges.

• Check and record storage unit min/max temperatures at start

of each workday.

• Check current temperature before accessing and administering

vaccine.

• Ensure the cause of the temperature excursion has been

investigated and addressed (e.g., faulty fridge, power failure,
human error)

• Consider any actions that can be taken to prevent a similar

event (e.g., update of standard operating procedures, training
of staff)
 Refrigerated Medications
• Medications requiring cold storage (Floor stock/Patient medications)
must be stored in the medication area refrigerator.

• Medication refrigerators should not be used to store food and beverages.

• Temperature log sheet should be maintained for all the refrigerators of

the unit.

• To get the floor stock of refrigerated medications nurse need to bring the
cool box to pharmacy to get the medicine, in order to maintain the cold
chain.
 Vaccines Storage and Vaccines Fridge Criteria

• Vaccines shall be stored in the designated vaccination refrigerator ONLY and cold chain
room as per the manufacturer’s instructions.

• All the vaccines shall be stored at 2 – 8 Celsius except Oral polio vaccines which shall be
stored at -15 – 25 Celsius. All the vaccines shall be stored immediately on receipt at the
facility store at 2 – 8 Celsius.

• Vaccines shall be stored in the designated vaccination refrigerator and cold chain room as
per the manufacturer’s instructions.

• Reconstituted vaccines must not be frozen after reconstitution

• Diluents for any vaccine must never be frozen

Cold Chain Audit Preparedness:

• Monthly rounds and audit findings are shared with NSs.

• Training on Cold Chain Policy & vaccines handling .

• Educational posts on fridges .

• Demarcation lines to guide staff on vaccines /fridges placement

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 Vaccines storage and Vaccines Fridge criteria :
• Vaccines shall be stored in the designated vaccination refrigerator ONLY and cold chain room as
per the DoH

• Several vaccines are also highly sensitive to light; they must be kept in the dark as far as possible.

• BCG and Measles are those most sensitive to light.

• It is vitally important to know the CORRECT storage conditions for each vaccine, and to ensure
that each is kept in the recommended conditions.

• All the vaccines shall be monitored for the temperature status during receiving, transporting and
storing.

• Food and drinks should never be stored in the same unit with vaccines.

• Calibrated thermometer shall be kept in the refrigerator and these thermometers should be
recalibrated as recommended by the manufacturer.
 Vaccine Internal Ordering and Transfer:

• Vaccine In charge nurse shall maintain the vaccines inventory of vaccines on daily basis.
• Vaccines stock in the vaccination clinic should be maintained to cover daily consumption only.
• Areas where vaccines are approved for daily storage, should have their own cool boxes
assigned for vaccines transportation.
• Nurse will indent on INSTA the required vaccines as per daily appointment and estimated
consumption.
• The vaccination in charge nurse or second in line will make the request for the vaccine once the
stock level reaches the par level, which will be 50% of last requested stock.
• Any unused vaccines remain after vaccination working day, shall be returned to vaccines storage
fridge in the pharmacy.
• Nurse will come to Pharmacy with prepacked cool box as per DoH standards (Please refer to
Point 6.6 and 6.7). Cool box shall be packed with ice packs as per DoH standards provided with
temperature thermometer, data logger and FSI.
• Vaccines storage and daily refrigerators should be calibrated with thermostat set point +5°C
 Vaccine Internal Ordering and Transfer:

• Nurse and vaccines issuing pharmacist will update the vaccine demand and issue
voucher with current temperature, FSI status and VVM. Assuring that cool box
temperature is maintained within the accepted range.

• Nurses transporting vaccines should ensure that the vaccines are out of the refrigerator
for as short a time as possible.

• Vaccines to be kept immediately in the allocated medical refrigerator in the receiving

unit, after checking vaccines, VVM and recording the temperature and confirming that it
is within the range of 2°C to 8°C on the vaccine demand and issue voucher.

• Temperature graph and report during transport shall be generated from the data logger
and kept attached with the demand voucher at the end of the transport and copy should
be kept in the concerned units .

• The same steps to be implemented if returned vaccines from unit to pharmacy.

 Equipment Maintenance and Cleaning

• Medical Refrigerators should be inspected in each shift for cleanness and overall status
(over stocking, light, medication/ vaccines arrangement and segregation).

• Medication refrigerators to be cleaned weekly and if any findings, by assigned staff or

under their supervision.
 Equipment Maintenance and Cleaning
While cleaning vaccines fridge (internally and externally), below steps to be
carried out:

1. Remove vaccines from the inside of the refrigerator and store them in a functioning
unit such as another vaccine refrigerator or an appropriately cool Box with
temperature 2°C-8°C.
2. Record the fridge temperature on time of cleaning on the cleaning record.
3. Notify the unit that maintenance is taking place
4. Wash all the inside surfaces and shelves with warm, slightly soapy water. (Cleaning
chemicals are not recommended by manufacturers) for cleaning vaccine refrigerators)
5. Never pour water onto or into the unit.
6. Dry the inside surface thoroughly with a clean soft cloth soaked in clean water then
plug in the unit.
7. The refrigerator temperature must reach and stabilize within the proper temperature
range before restocking with vaccines.
8. Remove ice packs and wipe with a clean cloth using mild soapy water, rinse and dry
9. Continue to monitor and record the temperature for a few hours to ensure stability.
10. Walk-in coolers – sweep mop floors as needed, check if spills to be cleaned up
immediately.
 Handling Disposal, Loss, Damaged
and Recalled Vaccines:
• Damaged or expired vaccines should be sent to the provider with a completed record. If
returned from units to IP Pharmacy, responsible nurse shall send them with completed
record of returned quantity and reasons, using Demand and issue voucher (FM/MMU/036).

• Nurse shall check daily vaccines stock in the refrigerator, any loss of vaccines in the unit, to
be reported to pharmacy.

• Pharmacy shall review trend of loss and damaged vaccines incidents on monthly basis using
the vaccine monthly checklist and put corrective action plan accordingly. 4

• vaccine potency is suspected, keep it in the refrigerator in a box and label it clearly “Do not
use” until the responsible person has completed an assessment.
 Partially Used or Empty Vaccine Vials
Disposal:

When the vaccination session has completed:

Discard the used vials/ ampoules, syringes and needles (without recapping) in the sharps
box container except for BCG vaccine vials.

Please refer to point (6.3) ‘Disposal of Partially’ used and empty vaccines vials in the
IMMUNIZATION AND VACCINATION POLICY - PP/PCI/051.
 Recalled Vaccines:

If any recalled vaccines:

• Don’t discard recalled batches and send it to Pharmacy store by

cool box maintained in the temperature range 2°C-8°C.

• Follow DRUG RECALL POLICY (PP/MMU/019).

 Disposal of Partially Used
and Empty Vaccine Vials
• All empty and partially used vaccine vials except for BCG vaccine shall be
disposed by the nursing staff in the puncture resistant and leak-proof
separate designated sharp container .

• Once the designated sharp box used for disposal of vaccine vails is three-
quarter full or after 3months from the date of opening whichever comes
first shall be locked and placed in yellow medical waste polybag.

• For all empty and partially used BCG vaccine vials, the staff must maintain
a record of the doses administered and return the vials to IP pharmacy by
placing in a biohazard specimen bag and transport in a dedicated transport
box along with the record of the pending doses
Disposal of Partially Used
and Empty Vaccine Vials
 Disposal of Partially Used
and Empty Vaccine Vials
• The IP pharmacy shall send the empty and partially used BCG vaccine vials to laboratory
for autoclaving. And maintain record of all the BCG vaccine vials handed over to
laboratory for autoclaving.

• The laboratory staff shall place all the empty and partially used BCG vaccine vials in
autoclavable bags prior to placing in decontamination autoclave and finally dispose in
yellow biohazard polybags after autoclaving.

• The laboratory staff shall maintain a record of the BCG vaccines vials received and
autoclaved.

• Don`t discard expired or confirmed damaged vaccine vials , it must be returned to

inpatient pharmacy, with complete record of Damaged/expired vaccines quantity (using
Demand and issue voucher ( FM/MMU/036)
 Cold Chain Failure and
Emergency Management

Refer to cold chain policy 6.10

 Vaccine Cold Chain Failure Report
On the “Vaccine Cold Chain Failure Report” record:
1. The maximum temperature reached during power failure.

2. Find out how long the power failure will last or how long it will take for the refrigerator
to be repaired.

3. If power cannot be restored or refrigerator fault cannot be rectified immediately and

there is a risk of vaccines being exposed to high temperatures, arrange to transfer the
vaccines to another refrigerator that can store the vaccines at +2°C to + 8°C temporarily.

4. Follow the chart of Managing of Cold Chain Breach in the appendix 8.4.

5. Return vaccines to refrigerator only after power has been restored or when the
refrigerator is functioning normally, and the internal temperature is below +8°C
 Documentation
• Each day’s temperature monitoring should be documented and initiated.

• A log sheet will be placed on the medication refrigerators. It shall be used to record
the temperature on a daily basis (Please see: Daily Temperature Record for Vaccine
Refrigerator FM/FMS/540).

• To ensure proper storage conditions the temperature must be between 2°C to 8°C.

• On Daily Temperature Record for Vaccine Refrigerator, the following shall be

checked properly: FSI Status , Max/Min temperature and over all refrigerator status
(over stocking, crowd, noise, freezing, etc.)

• Temperature daily report generated by data logger should be collected on daily basis
and kept with the Daily Temperature Record for Vaccine Refrigerator form at the
end of each month in each concerned unit file (as Soft or Hard copy
.Readings outside this range should be reported on Sapphire, documented with
actions.
 Documentation

• Actions require pharmacist assessment of contents and whether they must

be discarded, replaced, etc. and adjustment of the dial as per Cold Chain breach
management chart.6.12.6

• Vaccines Demand vouchers shall be kept in the concerned units attached with Temperature
graph/ records during transport, generated from data logger.

• Cleaning log sheets of cold chain equipment's should be kept in the concerned unit Storage and
security of vaccine product related documentation (for a minimum of 3 years)
TA K E C A R E

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