Big data has become a driving force in virtually every major industry by giving business owners and relevant stakeholders more insight into actionable information and data points. Companies have developed new and efficient methods for collecting, recording, and analyzing data to give decision makers a more informed perspective. One of the most important classes of data for businesses to gather and analyze is environmental data.
Temperature, humidity, and differential pressure data have become essential information for many businesses to have in order to create reliable supply chains, store valuable products, and function efficiently. As a result, powerful technologies have emerged to help businesses monitor and record temperatures in an automated and accurate manner.
For any company storing or transporting temperature-sensitive products, it’s essential to implement temperature monitoring and mapping procedures. Pharmaceutical companies must collect, record, and report environmental data of medical storage facilities to comply with FDA regulations. Those that neglect to do so risk facing regulatory consequences.
Many pharmaceutical companies struggle with this today, one survey showing that 44.6 percent of participants reported temperature changes throughout the year. Moreover, 41 percent of these changes were over four degrees. This represents a significant threat to temperature-senstive medical products and consumers.
How can pharmaceutical companies, manufacturers, and distributors mitigate these risks and ensure stable temperatures in storage facilities? Let’s explore why and how pharmaceutical temperature mapping is so crucial to that process.
What is Temperature Mapping?
Temperature mapping is where several ambient temperature monitors get set up at specific locations in a particular space so that temperatures can be measured. It’s an important next step for managers to consider after implementing temperature monitoring procedures.
Temperature monitoring is crucial for many sectors in the economy, including the pharmaceutical, food, and beverage industries. A temperature-controlled supply chain, also known as cold chain storage, is essential to safely deliver food to retailers and consumers. Lapses in cold chain storage can result in foodborne illness outbreaks and public health crises.
According to Dickson Data, temperature mapping is an important component of setting up cold chain storage infrastructure. That’s because food storage facilities are often quite large, and temperatures can vary inside. If managers only have one temperature monitor in one part of the facility, they might not be aware that food stored in a different region within it is becoming too hot or even expiring.
That’s why cold chain storage professionals set up temperature monitors in several different areas in a facility. Each temperature monitor then collects data that can be mapped in a computer model to view the temperatures in each area.
Applications of Temperature Mapping
Temperature mapping procedures is a field that is becoming particularly relevant, since medical products like COVID-19 vaccines must be kept at extremely low temperatures to prevent destabalization. It’s vital that each part of the storage facility where these products are stored is kept at sufficiently low temperatures using pharmaceutical temperature mapping.
Temperature mapping is also a regulatory necessity for pharmaceutical companies. The US Pharmacopedia defines specific temperature ranges that define storage categories. Freezer storage ranges from -25 to 10 degrees Celsius. Refrigerated storage is between 2 and 8 degrees Celsius. Cool storage is between 8 and 15 degrees Celsius, and room temperature is defined as ranging between 20 to 25 degrees Celsius.
A variety of refrigerator, freezer, and cooling technologies are used to achieve desired temperature ranges. All of these ranges clearly define the storage instructions for every pharmaceutical product. Although these ranges offer standardized definitions of storage conditions, the required temperatures for any medication will ultimately depend on the product itself. For example, the storage temperature of the Pfizer COVID-19 vaccine is between -90 and -60 degrees Celsius, which often requires the use of an ultra-low temperature freezer.
Many pharmaceutical manufacturers are also required to implement temperature monitoring and mapping procedures to comply with important regulatory requirements, such as Good Manufacturing Practices (GMP). GMP requires manufacturers to regularly test their products to ensure purity and efficacy. Aside from the applications of pharmaceutical temperature mapping, these practices can also be used extensively in weather reporting and analysis.
The Importance of Temperature Sensors and Data Loggers
To institute temperature mapping strategies, companies use data loggers. Data loggers are small electronic devices that gather environmental data from their surroundings. Different data loggers can measure and record temperature, humidity, and differential pressure data from their surroundings. Environmental data is important for storage facilities as well as workplaces.
This data can be stored locally and later be exported to an external computer or hard drive. Some data loggers even allow environmental data to be transmitted to external machines over the internet to be analyzed, formatted, and submitted to regulators.
Data loggers are key for temperature mapping because they can collect temperature data in a clear, accurate, and automated way, able to be calibrated and set up in different areas of a facility and establish an accurate temperature mapping model. Many data loggers are also programmed to send automatic alerts if areas in a facility leave a safe temperature range.
Temperature mapping is essential to getting temperature-sensitive food, beverage, and pharmaceutical products to consumers and retailers. Supply chain breakdowns for these products can potentially cost lives.