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Validating Pharmaceutical Storage Temperatures

Validating Pharmaceutical Storage Temperatures

Monitoring devices and data loggers can validate storage temperatures to ensure the stability and efficacy of drug products

Ken LaPage

Ken LaPage has been the sales manager at MadgeTech since 2016 and has 30 years of experience in instrumentation and data acquisition.

Q: Why is maintaining ultra-low temperature requirements for COVID-19 vaccines so important? Are there similar challenges associated with maintaining appropriate environmental conditions for other widely available vaccines?

A: The big challenge with the Pfizer COVID-19 vaccine was the ultra-low temperatures required to store it. Normally, the freezers and cold chain infrastructure are in the -86°C range, but when the Pfizer vaccine was first developed, it needed to be stored between -90°C and -100°C. This created challenges for nearly everyone involved, from manufacturers of freezers, and data loggers, to the individuals administering the vaccine. Maintaining appropriate temperatures is so important because it affects the efficacy of the vaccine. If the vaccine is exposed to temperatures outside the specified range, it is not going to last as long or demonstrate the intended efficacy when administered to the patient.  

This is true for other vaccines and pharmaceuticals as well. The CDC has created recommendations for vaccine storage conditions, which specify refrigerator temperatures between 2°C and 8°C, and freezer temperatures below -15°C to -50°C for many products. Pharmaceutical manufacturers provide specifications for how long a product will remain stable outside of the required storage temperature. 

We have encountered situations, with the Vaccines for Children program, for example, where providers have a temperature excursion due to a power outage or other problem and have to discard vaccines that were exposed to temperatures outside the required range for too long. So, there is a lot of money and product that can be wasted. 

Q: How big of a problem is vaccine loss? How does this impact industry and individuals?

A: From my experience, we have sometimes had three or four providers in a quarter let us know that they have had to dispose of vaccines because of temperature excursion—usually a warm excursion—because they have lost power to the refrigerator or freezer and the temperature goes up and puts the vaccine at risk. The other big problem is that vaccines can also degrade when the temperature is too low, and if a refrigerator or freezer is not adjusted properly, the vaccines begin to freeze and degrade and efficacy is reduced. So, there are goal posts for temperature, and it is important to stay between them. That is why data loggers and monitors are so important. 

Q: How do temperature monitoring devices and digital data loggers protect temperature sensitive vaccines? 

A: Well, I think it is important to note that they don’t necessarily protect vaccines because they can’t be used to control temperature, but they do provide a validation of what is happening in the provider’s office. What the devices actually do is tell the operator (provider) that their refrigerator or freezer is within specifications and enables them to monitor conditions. Providers must go through validation activities before they receive vaccines, and the manufacturer needs to see up to a month worth of data that demonstrates that the provider can maintain the refrigerators and freezers within specific temperature ranges. At that point, the provider can accept vaccines from the manufacturer. 

For example, for the Vaccines for Children program, the CDC provides storage temperature guidelines. For a provider to become part of the program, they must go through validation and send monitoring data to the CDC prior to accepting vaccines. 

Further, as part of the CDC guidelines, staff should check the temperature on the digital display twice a day—once in the morning and once in the afternoon to ensure there was no temperature excursion for the day. This is partly because it may be a week before all the monitoring data is downloaded and reviewed. So, for example, if there was an excursion overnight, staff will see it when they check the data logger in the morning and can monitor closely afterward. Data loggers also make it easy to download, export, and send data as a report.   

Q: What are the regulations pertaining to continuous temperature monitoring for vaccines?

A: The CDC issues guidelines—such as the CDC Vaccine Workbook document—but not regulations. The Vaccines for Children program has auditors that visit providers to ensure they are meeting these guidelines. 

Within these guidelines, temperature measurements on refrigerators and freezers must be obtained every 15 to 30 minutes, and logged over a day, week, month, or however long the program or state requires, then the data is submitted. If a temperature excursion occurs, it must be monitored and the provider has to contact the manufacturer directly and provide the measured temperature and duration of the excursion. The manufacturer can then determine if the product should be discarded. It is especially important to avoid repeat excursions, because the effects can be cumulative. 

Q: What other products or applications benefit from continuous temperature monitoring? 

A: The food and beverage industry definitely benefits from this technology. The FDA, USDA, and even the EPA specify refrigerator and freezer temperatures for food storage—most refrigerators need to be set at 40°F and freezers set at 0°F. Individuals running food processing facilities or restaurants have to keep track of these temperatures as well. 

It is also beneficial in the medical field for applications like sterilization. Items such as personal protective equipment or medical devices that are placed inside the body must be sterilized. Sterilization processes require exposure to a specific temperature for a specific amount of time, so monitoring the temperature—and sometimes even the humidity—during the sterilization cycle to make sure all the pathogens are killed is very important. Temperature monitoring is also critical for blood, plasma, biospecimens, and organs to prevent degradation, as they are transported from the donor to the recipient. To me, these are some of the most important processes to monitor, as food and health care impact peoples’ daily lives.