What are the temperature requirements for Covid-19 vaccines?

Multiple companies around the world are these days getting ready to roll out a COVID-19 vaccine. One of the most prominent of these vaccines by Pfizer & BioNTech shows great promises but has one serious disadvantage, which is that it needs to be stored at -80°C. This creates a range of distribution challenges – especially in some parts of the world.

When storing at -80°C, you need ultra-low temperature (ULT) freezers, which only around 20 companies in the world are currently able to manufacture within the standards set by the medical industry. It is often the most sensitive and valuable items that are stored in a ULT freezer, and it is therefore paramount that it can maintain temperatures properly.

Even the best ULT-freezers sometimes fail, or the team using it open it too often or for too long, why it is important to have ongoing temperature datalogging – preferably wireless with instant SMS/email alarms if temperatures climb above or below the permitted temperature range.


Validating a ULT -80°C for COVID-19 vaccine storage

Before deciding upon a freezer, it is important to follow the V-model in order to ensure the entire solution is able to be validated.

This includes the following steps:

  1. User requirement specification
  2. Risk analysis
  3. Design specification
  4. A building phase description
  5. Installation qualification
  6. Operational qualification
  7. Performance qualification

In other words, it is necessary to consider the entire life-time usage of the ULT freezer in order to perform a proper validation.

Read more about temperature mapping here.

What effect does a validation of a ULT freezer have?

1. You are able to specify a solution that can solve the problems you might encounter when freezing COVID-19 vaccines that require -80°C.

2. You understand how the ULT freezer will behave when a power shortage occurs and how long it takes before temperatures climb above the limit.

3. You understand how the freezer behaves when the door is opened/closed during a “normal” day. Remember that the freezers containing COVID-19 vaccines will be opened and closed more frequently than typical -80°C ULT freezers, that are often used for tissue-samples hidden away in a basement.

4. Remember that the room, in which the ULT freezer is located, should be properly ventilated since a ULT freezer typically has an energy consumption equivalent to a small residential house and consequently generates a lot of heat. You should therefore make sure that proper ventilation is in place, before loading the ULT freezer with life-saving medicine.

As demonstrated above, all new ULT freezers being equipped at vaccination clinics around the globe should be validated properly before use.

This can be in some cases take some time. We have therefore compiled a list below with tips on how to perform a quick temperature mapping study of your ULT freezer as well as potential pitfalls. Lastly, we have included a list with tips on what to consider when choosing between different types of temperature monitoring equipment.

 

Tips on performing fast temperature mapping & potential pitfalls

When rapid temperature mapping is needed, for example in the case of the upcoming distribution challenge of the corona vaccine, there are a series of pitfalls which could hinder a successful temperature mapping of your ULT freezer – or any other professional refrigeration equipment.

Use a wireless system
The most important advice that can be given, is to use a wireless system when doing temperature mappings. The use of a wireless system reduces the risk of losing valuable goods when temperatures are outside specified limits.

When using a wireless system, non-compliant temperatures can be detected just hours after setting up the dataloggers.

Furthermore, the time it takes to extract data from the dataloggers takes away time from the mapping exercise.

Use automated data analysis tools
The use of an automated data analysis tool greatly reduces the time required to analyse data during and after the mapping is performed. When using systems where it is required to perform data analysis in an external tool like Excel, the risk of data corruption is higher, just like the time consumption.

Consider calibration lead time
When planning a mapping study, the lead time on start and end calibration needs to be accounted for. The lead time on start and end calibration can vary depending on the calibration laboratory, and unplanned delays in the mapping process might affect the lead time as well.

Consider ongoing verification of performance
In situations where external influences are varying, and in cases where the temperature-controlled space (fridge, freezer or ULT freezer for) is being heavily used, it is important to keep a close eye on the continuous performance of the equipment.

It is normally advisable to use 1 sensor for enclosures, but it might be advisable to utilize 2 dataloggers in order to monitor the performance of the equipment under heavy load.

Set reasonable requirements
Setting tight requirements for the mapped equipment, which are more strict than necessary, leads to discarding of equipment which could potentially be just fine.

A common example of acceptable levels that are too tight, is the requirement that a fridge should maintain temperatures between 2°C and 8°C at all times, when often small temperature excursions can be accepted.

If packages of even small sizes are used, small excursions can be accepted because they do not influence the actual temperature of the stored products significantly. Use proper time on defining the actual requirements, rather than just using a simple requirement.

Plan – plan – plan
The following could be considered as part of the planning process:

  • The time the equipment needs for stabilizing before mapping.
  • Make sure that the configuration of each piece equipment is correct – both before and during the mapping exercise.
  • Restricted access to mapped equipment during mapping exercises.
  • Communication with the personnel that use the equipment.
  • Consider who can accept deviations from the mapping plan.

Risk based approach
Consider whether some of the equipment can be viewed as off-the-shelf equipment, and therefore can be assumed to have somewhat similar characteristics, and therefore can undergo less stringent mappings.

That was it for the temperature mapping study. In the last section we will look at what to consider when choosing the right equipment for monitoring temperatures.

 

What to consider when monitoring temperatures in a COVID-19 ULT freezer

If temperatures climb above or below the permitted temperature range, you want to be notified, e.g. via SMS, so you can take necessary actions immediately. We, therefore, recommend the following:

1. Get a system that is able to alarm you if the temperature is above a critical limit. If a malfunction occurs, it would be a catastrophe to lose life-saving vaccines!

2. Get a system that automatically stores and generates documentation for the storage – this will save you a great amount of time.

3. Get a system that offers calibration of data loggers or at least makes it easy for an accredited ISO17025 calibration body to perform calibrations on the sensors.

4. Get a system that is easily installed – as you will be in a hurry when the vaccines are released.

5. Get a system with easily accessible support. You simply do not want to experience issues with the monitoring system – it should always work.

Eupry provides all of the above-mentioned solutions and we will be happy to help and guide you. Contact us on our live chat or write to us on contact@eupry.com to learn more.