By some estimates, the pharmaceutical industry loses approximately $355 billion each year due to temperature control failures. That’s a considerable cost for the sector, so it’s no surprise that companies are doing everything they can to bolster temperature-monitoring efforts to keep their products secure and minimize waste. Many medical products can only be stored at specific temperature ranges and can degrade or lose potency if kept outside of those ranges.
The importance of temperature-controlled supply chains has come into focus recently due to concerns around supply chain problems or breakdowns and the COVID-19 pandemic. To prevent the Covid-19 vaccines from degrading, manufacturers, transporters, and medical personnel must store them at ultra-low temperatures. For example, the Pfizer vaccine works best when kept at -70ºC.
Carefully monitoring the temperature of storage facilities is critical for pharmaceutical companies to guarantee quality assurance standards and minimize waste. It’s also a regulatory necessity that requires pharmaceutical compliance divisions to provide safe, high-quality products or face legal and financial penalties. However, for companies to truly protect their products, they must collect temperature data to execute effective temperature mapping strategies.
Since the industry stands to gain so much from pharmaceutical temperature mapping, let’s explore what temperature mapping is and why it’s so important.
How Companies Use Data Loggers for Temperature Monitoring
Data loggers are small electronic devices that collect and record environmental data from their surroundings, such as temperature, humidity, and differential pressure. The device’s internal storage holds the data before transferring it to an external hard drive or computer, where it can be analyzed and formatted by software, then submitted to regulators.
Some modern data loggers can even transfer data to external computers over the internet in real-time. While internet-connected data loggers must contend with some cybersecurity concerns, they have many benefits. When transferring data over a secured network, data loggers can present supply chain managers with the most current, up-to-date data regarding the storage conditions of medical products. They can even be programmed to send automated alerts to managers if temperatures fluctuate outside the acceptable range.
Some data loggers can detect other critical environmental variables, such as if the doors to a storage facility have been left open. Data loggers, paired with powerful data analysis software, are crucial to maintaining quality control, avoiding temperature control failures, and satisfying regulators. Regulators have even approved specific data logger models for pharmaceutical temperature mapping.
The Need for Temperature Mapping
Though essential, data loggers are just a piece of the temperature control puzzle, and users must pair them with a temperature mapping strategy. The need for mapping is because temperatures of different areas within the same storage facility vary. Therefore, if managers place a data logger in one spot in a storage facility, they might not realize that the temperature of the other side of the facility is significantly different.
Facility managers must account for the temperature of products stored in different building areas. Various factors could cause temperatures to vary within a storage facility, including ventilation, spills, and product location inside the unit. Managers need to consider these variables and conduct regular baseline measurements of the facilities when they are entirely and partially stocked or completely empty.
Even so, the possibility of temperature deviation is unavoidable. As a result, managers must position several data loggers in different locations within each storage container. These data loggers can all independently gather temperature data from their respective areas within the container.
These temperatures can then be exported or transferred over the internet to a computer system that runs software to create a map of all temperatures within the container. Pharmaceutical temperature mapping ensures that all products in each container area are kept by the facility within acceptable temperature ranges. According to Dickson Data, this process is critical to ensure companies comply with temperature monitoring regulatory requirements.
Temperature Mapping in Practice
When executing a temperature mapping strategy, there are things pharmaceutical companies must keep in mind. First of all, there are predetermined temperature ranges for different storage conditions.
Room temperature ranges from 20-25ºC, the same as controlled room temperature. Cool storage ranges from 8-15ºC, and refrigerated storage ranges from 2-8ºC. Freezer storage ranges from -25-10ºC. Moreover, facilities must store many medical products, including the Pfizer COVID-19 vaccine, well below these ranges at ultra-low temperatures.
Additionally, temperature data must be carefully protected and backed up. One of the best ways to backup temperature data is to upload it to the cloud but remember; all devices need to have updated security software and be on a private network.
The kinds of cold storage equipment companies use are also highly specific, it must be medical grade, and pharmaceutical companies must steer clear of equipment that has not been thoroughly tested for pharmaceutical or medical use. The Center for Disease Control (CDC) and the Joint Commission on Accreditation of Hospitals (JCAHO) support this rule.
All facilities and transportation units should perform recovery testing regularly. To do this test, managers record the time it takes for a storage unit to reach its target temperature. Reliable storage equipment should reach target temperatures within the shortest timeframe possible.
Storage equipment should also be maintained and calibrated at regular time intervals. Managers must ensure that temperatures meet NIST, ISO17025, or international calibration standards and calibrate monitoring devices once or twice a year. Those responsible for overseeing the storage equipment must document the calibrations and procedures with careful record-keeping practices.
Finally, cold chain professionals should consider environmental factors outside of temperature that they need to monitor, especially in the face of current supply chain concerns. For example, collecting and analyzing humidity or pressure data might be necessary as part of a comprehensive temperature mapping strategy.
We can see that pharmaceutical temperature mapping is crucial to preventing companies from jeopardizing the quality of their products. It’s also necessary to reduce wasteful spending and comply with state and federal regulations. But the critical reason for accurate mapping of temperature and other environmental factors is that it keeps people healthy and saves lives.