Vaccine Storage and Handling

Published by Nick Barrowclough on

vaccine temperature monitoring

In this document, we will detail the best practices for vaccine handling, storage and transportation. It is important that all temperature-sensitive vaccines are kept between at a temperature between 2°C – 8°C (35°F – 46°F). Freeze sensitive vaccines should also be protected from freezing. This ensures the efficacy of the vaccine and its ability to immunize the patient.

Cold Chain Vaccine Storage and Handling

What is the cold chain?

The cold chain is the process that ensures the maintenance of temperature conditions during the transportation, storage and handling of temperature-sensitive goods. In the case of vaccines, this starts at the manufacturer and ends with the administration of the vaccine to the patient. In order to have a safety margin the recommended temperature to aim for is 5°C (41°F).

Breaking the cold chain

If there is a break in the cold chain, there is a probability of a temperature excursion occurring. This is when the temperature exceeds the limitations prescribed for the storage of the temperature-sensitive vaccine. It might be a high or low excursion. Low excursions are particularly problematic as many vaccines are damaged much more by freezing than by temporary exposure to slightly elevated temperatures. The damage by exposure is cumulative, which is why many pharmaceuticals have established a drug stability budget, this is the amount of time the vaccine can be exposed before it is no longer effective. Any damage is permanent and strikes at the potency of the vaccine.

Refrigerators for vaccine storage

The type of refrigerator used should ideally be a medical type, designed for maintenance of the required temperatures. These are known as vaccine, medical or laboratory refrigerators. A domestic, frost free refrigerator may be used, but with care. Different compartments in these refrigerators are designed to maintain different temperatures so a study using temperature monitoring probes should be conducted first.

The refrigerators should be affixed with a sign that warns “Do Not Unplug” and the circuit into which it is connected should have a notice on the breaker panel “Vaccine Refrigerator Circuit, Do Not Disconnect”.

Do’s and Don’ts

  • A vaccine refrigerator should store only the vaccines, no food or beverages for human consumption should be stored in the same refrigerator.
  • First to expire, First out policy. Rotate vaccines so the newest are at the back and those with the nearest expiration date are at the front.
  • Clearly label any vaccines that have experienced. temperature excursion but are deemed to still be viable. These should be used first.
  • The refrigerator should be in a well-ventilated area and away from walls
  • Keep the refrigerator out of direct sunlight
  • DO NOT store vaccines on the door shelves
  • Store water bottles on empty shelves and in the door compartments
Vaccine Storage and Handling

Thermometers

The refrigerator should be equipped with a thermometer that. is placed on the middle shelf of the refrigerator, not near the back or near the door. This will provide the most accurate readings. A digital thermometer with LCD readout is recommended. Digital temperature data loggers are ideal as they provide constant monitoring and downloadable data for review. More advanced temperature monitoring systems can be installed that provide early warnings and alarms.

vaccine temperature monitoring chart
example of daily log sheet

Daily logs should be kept, at a minimum the morning and evening temperature is recorded of the room and the refrigerator maximum and minimum temperature. After taking readings the max/min should be reset. Records must be kept for a minimum of three years.

temperature excursion graph
example of data logger graph showing temperature excursion

Transportation

The transportation methods of vaccines varies depending on the quantity being moved. For a small number of vaccines being moved to a rural area for an immunization program however typically poses the greatest threat. Insulated coolers are often used with ice packs inside. In an effort to maintain coolness, it is often that accidental vaccine freezing can occur. Ice packs should be conditioned prior to being placed in the cooler, to ensure they are not too cold. Some innovative technologies such as those developed by Isobar help to tackle this problem.

Data loggers should be placed inside the coolers, so an audited trail of the temperature can be downloaded.

Insulating materials should be used to isolate vaccines from having direct contact with the ice packs. Insulating blankets or gel packs at the temperature of. the refrigerator can be used. Paper towels are not sufficient.

The vaccine trip should be kept. as short as possible, and unpacked. as soon as delivery is made.

Power Backup Plan

In the event of a power outage, the refrigerator must be able to maintain temperature. Short outages are not usually a problem as a well-insulated refrigerator can keep the temperature for an hour or more. However, you never know how long the outage may last, so having a backup power plan is essential. Here’s some tips :-

  • If the power outage is expected to be less than 4 hours, keep the refrigerator door closed.
  • Record the time and temperature as soon as possible after the power outage occurs
  • Place a DO NOT USE sign on the front of the refrigerator
  • If the outage is expected to last longer, move the vaccines to a portable cooler with conditioned ice packs. Always have ice packs on hand
  • Have knowledge of a nearby facility with backup generators which you could transfer the vaccines too in the event of an extended outage.
  • Record the time and temperature when power is restored.

4 Comments

How Often Should the Temperature of a Medical Fridge be Monitored? - Pharma-Mon · September 21, 2020 at 3:23 am

[…] A medical fridge must be able to attain and maintain a stable temperature of between 2°C and 8°C (36°F and 46°F). A good practice is to set the temperature at the midway point between the minimum and maximum storage temperature to compensate for occasional opening of the door for access. Ensure that the chosen temperature meets the specific requirements of the medications being stored. […]

Super-Cooled COVID-19 Vaccine will be a logistics nightmare - Pharma-Mon · September 21, 2020 at 4:01 am

[…] It is anticipated when a viable vaccine becomes available, that 10 billion doses will need to be distributed across the globe, including regions that have no road network. Innovative technologies such as Isobar could help, but many of these have been developed with existing traditional vaccines in mind. These only require temperatures of between 2°C (35°F) and 8°C (46°F) […]

How to Calculate Vaccine Volumes for Cold Chain Requirements - Pharma-Mon · November 23, 2020 at 6:34 am

[…] to distribution activities, vaccines require an uninterrupted series of refrigeration. Known as the cold chain, this process is a temperature-specific supply chain where certain degrees dictate the virility of […]

Importance of Monitoring Pharmaceutical Storage Temperature · November 23, 2020 at 7:05 am

[…] Live virus vaccines tolerate freezing temperatures but rapidly deteriorate after removal from storage. Damage to inactivated vaccines occurs when exposed to temperature fluctuations. It is crucial that the proper storage and handling are adhered to. […]

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