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Middlesex-London Health Unit

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Vaccine Storage and Handling

The materials, equipment and procedures used to maintain temperatures of vaccines from the time of manufacturing until the vaccines are administered is called “cold chain”. Most vaccines require storage between +2⁰C and +8⁰C at all times, included during transportation.

Maintaining cold chain is crucial to the stability and integrity of vaccines.
Vaccines stored outside of the recommended temperatures (higher or lower) may lose their potency resulting in a lack of protection against vaccine preventable diseases. It is important to carefully monitor storage conditions to ensure that administered vaccines are both safe and effective.

Please refer to the Ministry of Health and Long-Term Care’s Vaccine Storage and Handling Guidelines (PDF) for the recommendations and requirements to store publicly funded vaccines.

 

Cold Chain Inspections

The province of Ontario mandates that public health units conduct annual routine cold chain inspections at all locations that order and store publicly funded vaccines.

The cold chain inspection involves a public health nurse or inspector visiting the vaccine ordering location(s) to ensure that all the minimum requirements to safely monitor and store vaccines are in place.

Is your health care location planning to offer immunizations?

If you would like to start offering immunizations, please contact the Middlesex-London Health Unit's Vaccine Preventable Disease Team at 519-663-5317 to discuss the requirements and arrange a time for your initial cold chain inspection.


Vaccine Fridges

All health care providers storing publicly funded vaccine will be required to have a proper vaccine storage fridge. Below are some comparisons on which type of fridges are available.

Purpose-built fridge

  • Specifically designed to store vaccines and is highly recommended, especially for those storing larger inventories
  • Available in a variety of sizes based on the inventory requirements
  • Experience fewer temperature fluctuations due to the internal temperature regulation mechanisms
  • Quick temperature recovery system
  • Almost all internal space can be used to store vaccine
  • Although more costly to purchase, the management is much less demanding and provides more confidence over time that vaccines are being properly stored

Domestic frost-free (kitchen) or bar fridge (requires modifications)

  • Although not preferred, can be used to store vaccine but require some modifications:
    • Vaccine cannot be stored on the door shelves or in drawers due to temperature fluctuations in those areas.
    • Empty shelves, doors and drawers should be filled with full water-bottles.
    • Only open the fridge when necessary (bar and domestic fridges are more prone to rapid shifts in temperature when the fridge door is open).
    • Bar fridges often have the freezer compartment in close range to the top shelf of the fridge. This can lead to unstable temperatures when ice builds up. Freezer must be defrosted when there is more than 1 cm (1/4 inch) of ice in the freezer compartment. A bar fridge without a freezer compartment is preferable.
  • Designed to store food and drink and not the special temperatures requirements of vaccines
  • May experience more frequent temperature fluctuations
  • Less expensive, but may be more complicated to manage

General fridge guidelines

  • Fridge should be placed in a well-ventilated room or area that gets locked at the end of the day and is not accessible to the public.
  • Fridge should be placed away from direct sunlight and external walls to allow for proper temperature stabilization.
  • Plan to only store vaccine in the vaccine fridge (no food or other specimens).
  • Ensure the electrical outlet and fridge plug are secured to prevent accidental unplugging.
  • Ensure vaccine fridge door is shut and sealed after each time fridge is opened and at the end of the day.
  • Minimize the number of times the fridge door is opened.
  • Keep icepacks in a freezer to use for transporting vaccines. Additionally, if there is a power outage or fridge malfunction, icepacks can be placed in the fridge to help prevent the temperature from going up.

Temperature Monitoring

Every vaccine refrigerator and insulated cooler used for vaccine storage or transport must have its own temperature monitoring device such as a thermometer and/or data logger.

Fridge temperatures must be checked and recorded twice daily on the days that the location is open, once at the beginning of the work day and once at the end of the work day.

It is recommended that each location storing vaccine have one designated person to be in-charge of vaccine fridge monitoring, as well as a back-up person if the in-charge person is not available.

 

 
  • Vaccine Temperature Log BookVaccine Temperature Log Book
    Download and print the Vaccine Temperature Log Book. Printed booklets may also be requested with your vaccine order and picked up at the Health Unit or requested during your annual cold chain inspection.
 

Temperature Monitoring Devices

Thermometers

Data Loggers

Thermometers

A min/max thermometer displays the current, maximum and minimum temperatures reached over the period of time since the last time the thermometer was cleared/reset. The thermometer must have the following features:

  • Display current, minimum, and maximum temperatures
  • Must record temperature increments by 0.1 degrees C
  • Ability to reset or clear min/max readings

A variety of models and brands are available for purchase. It is important to ensure that you are obtaining a min/max “IN/OUT” thermometer with a clearing/reset button that reads to a 0.1 decimal place.

The Health Unit can provide a Ministry of Health sourced thermometer at no cost to health care providers. However, some health care providers may choose to source and purchase their own thermometers or upgrade to a glycol-encased probe thermometer or one with a larger display screen.

Tips for getting started:

  • Thermometer probe should be placed inside an empty vaccine box to protect it from exposure to warm or cold air when the fridge is opened. The box should be labelled “PROBE”
  • The probe should be placed on the middle shelf of the fridge to ensure accurate readings
  • The display screen should be positioned outside of the fridge next to the temperature log book
  • Batteries in all temperature monitoring devices should be changed every 6 months

Steps to read and record your fridge temperatures using a min/max thermometer:

  1. Write the date AND time you are recording for the temperatures
  2. View the current “OUT” temperature. Record in the vaccine log book.
  3. View the min and max “OUT” temperatures. Record both in the vaccine log book.
  4. Sign your initials below your temperature recordings in the space provided.
  5. Once all your temperatures are recorded, clear/reset the thermometer min/max history. IMPORTANT: the thermometer must be cleared AFTER each time you record the fridge temperatures.
  6. If any of the temperatures recorded are outside of the +2⁰C to +8⁰C temperature range, contact the Health Unit at 519-663-5317 to speak with a Vaccine Public Health Nurse who will assist you with troubleshooting and confirming vaccine stability.
 

Sample temperature log book

Download sample temperature log

Vaccine Temperature Log Book

Download Vaccine Temperature Log Book


Data Loggers

Data loggers record fridge temperatures continuously and keep a history of temperature readings. This is particularly helpful when there is a temperature excursion. Having a complete history can help identify the exact time the vaccine went out of temperature range and for how long (example – during a weekend power outage).

  • Often can be used in conjunction with a min/max thermometer but should also have digital display so the temperature can be viewed when going in and out of the fridge.
  • A data logger can be used to record current/min/max readings twice daily. This usually requires it to be plugged into a computer and downloaded.
  • Print temperatures out weekly and retain for 1 year, or until your annual inspection by the Heath Unit.

NOTE: Even with a data logger, temperatures must be checked and recorded twice daily in the temperature log book.


Vaccine Fridge Organization

Keeping a well-organized fridge is important to maintain ample air circulation, minimize time with an open fridge door and decreasing risk of administering an expired product.

  • Keep vaccines away from walls, floors, and vents in the fridge
  • Never store vaccines in domestic or bar fridge door shelves or drawers
  • Organize vaccines by type of product (baskets may be helpful to separate products)
  • Leave space between packages in order to allow for air circulation
  • Always store vaccines in their original packaging - this allows for proper identification of vaccines and protects them from light
  • Regularly check vaccine expiry dates and do not keep expired vaccine in the fridge – keeping a list of expiry dates near the fridge may help to monitor expiry dates and to ensure expired vaccine is not kept in fridge
  • Use vaccines with shortest expiry dates first - put them to the front of the fridge so they get used first
  • Not all diluents require refrigeration. However, storing diluent with the appropriate vaccines ensures correct diluent is used. Note: It is recommended to store COVID-19 Pfizer diluent out of the fridge at 20-25 ⁰C. Any diluents stored out of the fridge should be in labelled baskets to ensure the correct diluent is used with the correct vaccine.
  • Do not store more than 1 month of vaccine supply in the fridge at a time. This prevents overcrowding and minimizes vaccine wastage in the event of a cold chain incident. If you have a smaller fridge, you may need to store less than a 1-month supply at a time.

 

Vaccine Storage Requirement

Download PDF


Vaccine Transport and Insulated Containers

Cold chain must be maintained at all times, which includes during vaccine storage and transport. An insulated container (cooler) will be required in order to transport vaccine between locations. There may also be additional times when an insulated cooler may be required for temporary storage such as an offsite clinic, while cleaning the fridge, or for emergency storage during a power outage.

Items required for temporary storage or transporting vaccine:

  • Hard-sided, insulated container/cooler with a lid. NOTE: More than one cooler will be necessary if you plan to transport or store larger quantities of vaccine.
  • Icepacks or frozen gel packs
  • Temperature monitoring device
  • Bubble wrap or packing material
  • Flexible refrigerated blankets stored in the fridge at 2-8 ⁰C

 

Picture showing items required for temporary storage or transporting vaccine

Items required for temporary storage or transporting vaccine

How to pack your vaccine transport cooler

Learn how to pack your vaccine
transport cooler


Steps for preparing to store and/or transport vaccine in an insulated cooler.

Conditioning your insulated cooler and icepacks is the process that ensures that your cooler is the correct temperature BEFORE placing vaccine inside.

  1. Place 3 ice packs at the bottom of the cooler.
  2. If you have a flexible refrigerated blanket, ensure it is pre-conditioned in your fridge (+2 to +8 ⁰C) and place it on top of the ice packs and add a layer of bubble wrap. If you do not have a flexible refrigerated blanket, place 2 or 3 layers of bubble wrap on top of the ice packs. NOTE: VACCINES SHOULD NEVER BE IN DIRECT CONTACT WITH ICE or GEL PACKS.
  3. Place the temperature monitoring device probe on top of the bubble wrap in the centre of cooler where the vaccine package will be placed.
  4. Add another layer of bubble wrap followed by a pre-conditioned ice blanket on top of the vaccine probe. If you do not have a flexible refrigerated blanket, add a couple layers of bubble wrap and an additional ice or gel pack on top. Place more bubble wrap on top as necessary to fill vertical void.
  5. Close lid for approximately 20-30 mins and monitor the temperature until the current temperature is stable between +2 and +8 ⁰C. Outdoor temperatures and length of time in transport may affect your cooler temperatures. Adjust accordingly. Vaccine can now be placed underneath the flexible water blanket and bubble wrap inside the cooler where the vaccine probe is located.
  6. Close the lid and clear/reset the min/max history for the thermometer. Vaccine can now be transported or stored in the insulated container while monitoring temperatures. Vaccine should not be transported in the trunk of a vehicle due to risk of extreme temperatures. Icepacks may need to be replaced if being stored for more than two hours in an insulated cooler.
 

Place 3 ice packs at the bottom of the cooler.

Step 1 (Packing Your Cooler)

If you have a flexible refrigerated blanket, ensure it is pre-conditioned in your fridge (2-8 ⁰C) and place it on top of the ice packs and add a layer of bubble wrap. If you do not have a flexible refrigerated blanket, place a 2 or 3 layers of bubble wrap on top of the ice packs. **VACCINES SHOULD NEVER BE IN DIRECT CONTACT WITH ICE or GEL PACKS*

Step 2 (Packing Your Cooler)

Place the temperature monitoring device probe on top of the bubble wrap in the centre of cooler where the vaccine package will be placed

Step 3 (Packing Your Cooler)

 

Add another layer of bubble wrap followed by a pre-conditioned ice blanket on top of the vaccine probe. If you do not have a flexible refrigerated blanket, add a couple layers of bubble wrap and an additional ice or gel pack on top. Place more bubble wrap on top as necessary to fill vertical void.

Step 4 (Packing Your Cooler)

Close lid for approximately 20-30 mins and monitor the temperature until the current temperature is stable between 2-8 ⁰C. Outdoor temperatures and length of time in transport may affect your cooler temperatures. Adjust accordingly. Vaccine can now be placed underneath the flexible water blanket and bubble wrap inside the cooler where the vaccine probe is located.

Step 5 (Packing Your Cooler)

Close the lid and clear/reset the min/max history for the thermometer

Step 6 (Packing Your Cooler)

Transporting COVID-19 Vaccine? Handle with extreme care!

  • Label insulated container “Fragile: Handle with Care, Do Not Drop”
  • Thawed COVID-19 vaccine should be transported in the upright position with extra bubble wrap to avoid the vaccine package from moving around in the cooler
  • Careful attention should be taken to avoid dropping the cooler or excess agitation
  • Cooler should be secured in vehicle to avoid sudden movements or tipping over

Temperatures of your insulated cooler should be noted:

  1. After placing the vaccine inside the cooler
  2. At minimum after 1 hour of travel or each time the cooler is opened whichever comes sooner
  3. Before vaccine is removed at the destination location or being returned to the fridge after temporary storage

If temperatures are not between +2 and +8 ⁰C, contact the Health Unit right away. Mark vaccines as DO NOT USE until it can be determined if vaccines are still suitable for use.

IMPORTANT NOTE: Vaccine orders will not be released to couriers or office staff who do not bring proper vaccine packing materials and conditioned cooler to the Health Unit for vaccine pick-up.


COVID-19 Vaccine Storage and Handling

Storage and handling of COVID-19 vaccine are similar to that of other vaccines. However, some modifications are required due to the fragile nature of COVID-19 vaccines.

mRNA COVID-19 vaccines contain mRNA surrounded by a lipid bi-layer. Agitation of the vials can cause the lipid bi-layer to rupture, thus rendering the vaccine spoiled/ineffective. As such, COVID-19 vaccines must be handled with extreme care. Take caution to ensure vials and syringes are not dropped/tipped over.

Thawed COVID-19 vaccines must still be stored between +2 and +8 degrees C, and fridge temperatures checked twice daily and recorded in the temperature log book. If a temperature excursion occurs, follow the same instructions as listed for regular vaccines. Make sure to notify the Health Unit immediately if a temperature excursion is recognized.

Please see the Ontario Ministry of Health's COVID-19 Vaccine Storage and Handling document for in-depth information on storage of COVID-19 vaccines.


How to Order Publicly Funded Vaccines

The Health Unit only provides publicly-funded vaccines to locations who have been pre-approved and have completed a vaccine fridge inspection. For information related to vaccine ordering and return, click here.


Cold Chain Incidents

A cold chain incident occurs when the temperature of the vaccine fridge goes below +2 ⁰C or above +8 ⁰C. This is often called a temperature excursion or Adverse Storage Condition (ASC). Vaccines stored outside the +2 ⁰C to +8 ⁰C range may lose their potency and become unsuitable for use.

Steps to take in the event of a cold chain incident:

1. Place affected vaccines in a bag marked “DO NOT USE”. Keep the bag in the fridge (or an alternate fridge that is monitored between 2-8 ⁰C if vaccine fridge not maintaining temperatures) and refrain from using or discarding the vaccine until further direction from the Health Unit.

2. Call the Health Unit immediately to report the incident. Information you will need to have available when calling:

a. 2 weeks-worth of temperature logs

b. List of affected vaccine inventory, including:

i. Name of vaccine
ii. Lot number
iii. Expiry date
iv. Number of doses of each lot number
v. If any affected multi-dose vials are already opened (i.e. Tuberculin or influenza)
vi. If any affected vaccine is red-dotted which indicates it had a previous exposure

3. You will be asked to submit your temperature logs and list of vaccine inventory to the health unit so it can be determined if the vaccines are suitable for use and to fill out the Cold Chain Incident Report Form.

4. Ensure temperature monitoring device is working:

a. Is probe placed correctly in the middle of the fridge?
b. Does the device need new batteries?
c. Is the OUT temperature being viewed? (some thermometers have a IN/OUT switch so ensure this is set to OUT)

5. Make sure the fridge is plugged in and ambient temperature of room has not changed dramatically. Ensure fridge is closed and door is sealed properly.

6. Ensure that no boxes are blocking the air flow, including the fan.

7. If unable to determine cause of incident, maintenance may need to be done on the fridge. Contact a technician.

8. Await further instruction from the health unit:

a. If vaccines are suitable for use, mark them with a red dot to indicate they have had a previous exposure to a cold chain incident. This is important since exposure time for vaccines is calculated as a cumulative duration. For example, a vaccine exposed to an incident for 4 hours one day, and 6 hours two days later, is considered to have been exposed for 10 hours.

b. If vaccines are unsuitable for use (i.e. spoiled), remove them from the fridge immediately and return them to the Health Unit. NEVER keep spoiled or expired vaccine in the fridge!

What to do during a power outage:

1. Document current/minimum/maximum temperatures in vaccine log book and reset thermometer.

2. If outage is scheduled or time-limited and you can be certain power will be restored within several hours…

a. Keep the fridge door closed!
b. Add icepacks to the fridge if needed to prevent the temperature from rising above 8 ⁰C
c. Continue to monitor fridge temperatures frequently until power restored
d. DO NOT allow the vaccine to remain in a non-functioning fridge for an extended period of time

3. If temperatures are rising above 8⁰C, transfer vaccines to an alternative storage site using proper vaccine transport steps (see above).

4. If an alternative storage site cannot be used, place the vaccine in properly packed/conditioned insulated containers. Ensure you include a temperature monitoring device and record temperatures frequently.

5. Once power is restored, record the current/minimum/maximum temperatures again.

6. If temperatures went outside of range during power outage, call MLHU immediately to report the cold chain incident (see cold chain incident section).


Contingency Planning

Any location storing vaccine should develop a contingency plan, should they experience a fridge malfunction or power outage. Arrange for an alternate storage site (e.g. another office/pharmacy). Facilities will be asked to describe their contingency plan during their annual cold chain inspection by the health unit staff.


What to do with expired or spoiled vaccine?

Vaccines that are expired or spoiled must be returned to the Health Unit for proper disposal. Please follow the instructions for how to return vaccines.

 
Date of creation: February 27, 2013
Last modified on: February 19, 2023
 
 

References

1Ministry of Health and Long-Term Care – Vaccine Storage and Handling Protocol Retrieved from
https://www.health.gov.on.ca/en/pro/programs/publichealth/oph_standards/docs/protocols_guidelines/Vaccine_Storage_and_Handling_Protocol_2018_en.pdf
2Ministry of Health and Long-Term Care – Vaccine Storage and Handling Guidelines Retrieved from
https://www.health.gov.on.ca/en/pro/programs/publichealth/oph_standards/docs/reference/vaccine _storage_handling_guidelines_en.pdf
3Ministry of Health and Long-Term Care - COVID-19 Vaccine Storage and Handling Guidance Retrieved from
https://files.ontario.ca/moh-covid-19-guidance-vaccine-storage-handling-en.pdf