Temperature Mapping Protocols Designed for COVID-19 Vaccines

The COVID-19 global pandemic has highlighted the necessity of reliable supply chain management across many industries – and those supply chains for essential goods are still on shaky ground. Carefully developed supply chains are also crucial for shipping pharmaceutical products that patients around the world rely on. 

Pharmaceutical supply chains have come into the spotlight because they are required to transport COVID-19 vaccines and medications that have shown promise in treating the virus. Moreover, many medical products, including COVID-19 vaccines, must be stored at low temperatures while they are being transported to patients. 

As a result, temperature-controlled supply chains and logistics must be set up to keep vaccines at appropriate temperatures. Referred to as cold chain storage in the industry, temperature-controlled supply chains must be established using various technologies and procedures. Temperature mapping is among the most important strategies to keep cold chain storage systems operational. 

Since temperature mapping protocols are so crucial for transporting COVID-19 vaccines, let’s explore how they are implemented.

Necessary Storage Conditions for COVID-19 Vaccines

The major COVID-19 vaccines must each be stored at specific temperatures. The Moderna vaccine must be stored between -25 degrees Celsius and -15 degrees Celsius. 

The Moderna COVID vaccine can also be refrigerated at temperatures ranging from 2 degrees to 8 degrees Celsius. However, when kept at this temperature, it will expire after 30 days.

The Pfizer COVID vaccine has more rigid storage requirements. It must be stored at temperatures between -80 degrees Celsius and -60 degrees Celsius. It can also be stored at temperatures between 2 degrees and 8 degrees Celsius before mixing for a maximum of 5 days or 120 hours. 

The Johnson and Johnson COVID vaccine must be stored at temperatures between 2 degrees and 8 degrees Celsius. After the vial is punctured, it can be stored between 2 degrees and 8 degrees for a maximum of 6 hours or at room temperature for a maximum of 2 hours.

Data Loggers and Ambient Temperature Monitoring

Given the highly specific storage requirements for these vaccines, it makes sense that the CDC has stringent regulations pertaining to the tools companies use to oversee storage conditions as part of the medical supply chain. Specifically, the CDC and other regulatory agencies require that companies use ambient temperature monitors or digital data loggers to monitor the temperature of storage facilities that house vaccines. 

Data loggers are small electronic devices that collect environmental data such as temperature, humidity, or differential pressure from their surroundings. This data is typically stored in the device’s internal memory before it is transferred to external computer systems where it can be analyzed, formatted, and submitted to regulators. Regulators can then review this data to ensure that storage conditions have been kept at appropriate temperatures.

Pharmaceutical companies can program data loggers to collect temperature data at specific time intervals and detect if vaccines were exposed to warmer temperatures and for how long. Typically, companies program data loggers to record temperatures every 30 minutes or even more frequently.

Many data loggers use a thermal buffer such as a Teflon block, glass beads, or a glycol bottle affixed to a probe to dampen temporary temperature fluctuations caused by doors being opened and closed. The CDC Storage and Handling Toolkit document now specifies that data loggers must be calibrated according to the National Institute of Standards and Technology traceability.

The CDC also recommends that companies record daily minimum and maximum temperatures when storing the Johnson and Johnson and Moderna vaccines. The same applies to the Pfizer vaccine. However, in the case of a vaccine, additional temperature measurements must be taken. 

This is because the Pfizer vaccine is normally stored with dry ice to keep it at the extremely low temperatures it must be stored in to remain stable. In fact, Pfizer vaccines are typically shipped in a shipping container equipped with dry ice and a data logger that monitors storage temperatures. 

Pfizer makes use of internet-connected data loggers to send real-time data to the manufacturer about storage temperatures and conditions. Internet-enabled data loggers represent a serious innovation in temperature monitoring and data management equipment since they allow cold chain management professionals to see storage temperatures in real-time. 

Internet-connected data loggers can also be used in conjunction with cloud storage platforms, enabling pharmaceutical companies to collect, record, and analyze temperature data without maintaining their own IT infrastructure. That can save companies significant expenses while making their data more secure and shareable. 

The Importance of Temperature Mapping

As accurate as data loggers are, their readings can sometimes fail to present the full picture of storage conditions. This is because temperatures can actually vary in different areas of the same storage unit. 

While temperatures in one part of a storage unit might be within acceptable ranges, a variety of factors can make another area in the unit too hot. These factors can include ventilation, door position, inventory load, and storage unit placement. 

To solve this problem, companies employ a temperature mapping protocol. This involves companies placing data loggers in different areas of a storage unit. This allows managers to see the temperature range of the storage unit at large.

According to Dickson, the placement of several different data loggers also allows companies to create a visual representation of the temperatures within the storage units. 

Several factors that can cause temperature fluctuations must be considered when executing a temperature mapping protocol. Supply chain managers must consider airflow in and around the unit. Packaging, product placement, and air conditioning must also be considered when integrating a temperature mapping strategy, as should windows, doors, and roof composition.

Pharmaceutical companies must also regularly inspect all equipment to make sure they’re optimized for functionality. This is generally part of a larger validation process in which management verifies that equipment is collecting data accurately. 

In the case of the Pfizer COVID vaccine, the shipping container used to store vaccines is equipped with an interface that healthcare workers can use to confirm that the vaccines have arrived safely at healthcare facilities. Workers can also examine the container to make sure that all equipment is working optimally and that temperatures are in acceptable ranges. 

To sum up, a temperature mapping protocol is crucial when it comes to the storage and distribution of COVID-19 vaccines. Moreover, temperature mapping is a multifaceted process that incorporates validation, data loggers, and cooling technologies.