The Ultimate Guide to Data Loggers

Data loggers used for targeted temperature management record temperature using two different technology options. First is the thermistor, which is a resistor that changes resistance based on temperature and has been around for many years. They’re relatively reliable and have a wide range of practical uses, basing their accuracy on a 3-point calibration.

Other temperature management solutions are digital in nature, powered by an internal sensor packaged in a microchip. These come factory-calibrated to measure average temperature, temperature range, and temperature history with extreme accuracy. This sophistication allows a supply chain to capture critical temperature data with mobile devices in industries like Medical Device, Life Sciences, and Food.

MKT, or mean kinetic temperature, is the simplified way of expressing the overall effect of temperature fluctuations during the storage or transit of perishable goods. That’s the simple explanation – it’s actually a highly complex equation that factors on the activation energy of the products to yield a simplified equivalent of temperature exposure. Why is this important?

Here is an example:

Using MKT we can calculate that the temperature profile of the eggs was “thermally equivalent” to storing them at 15.7º C for 7 hours.

In order to maintain the quality within the Pharmaceutical Industry, the FDA has approved MKT as a standard based on a number of various proposals, discussions, and decades of efforts to identify product degradation. MKT takes into consideration temperature velocities (rates of change) based on the product and its exposure to various temperatures. MKT also factors time and thermal mass into the equation. It’s a critically important and often underutilized factor based on industry. Not all data loggers actually display MKT which can provide inaccurate information about a shipment. An increase in loss products based on a lack of captured data means a loss of confidence and revenue for your brand.

This is especially important to monitor what’s called “the last mile,” or the final segment of the supply chain. This is where an item is being delivered to the end-user and average temperature is most susceptible to fluctuations. Often, companies rely on an internal sensor to monitor packages during shipping, but overlook temperature management during the last mile. As a result, the last mile is most shipments lose their integrity when it comes to temperature and humidity exposure.

For example, let’s imagine that a shipment is en route from California to New York and hits a checkpoint in Iowa. The temperature data logger gets read and reveals that somewhere along the route, the shipment fell out of the required temperature range. With this insight, the temperature management teams are able to stop the shipment right there instead of spending the money it would take to continue moving it all the way to New York. A huge cost-saving opportunity!

Temperature management also allows companies to prove compliance with FDA regulations. If rules require that certain drugs need to be kept within a specific temperature range, data loggers give them the ability to prove that a shipment was never exposed to temperatures outside of that range for the entire length of the supply chain.

The more touch points that are in your supply chain, the more opportunities for a loss in efficiency because each of those introduces the possibility of human error, downtime, and exposure to extreme temperatures.

There are many benefits of adding connectivity to your supply chain, but two that instantly become important for any business are visibility and traceability. That comes from having instant availability to data, which is connecting the dots between suppliers, manufacturers, logistics organizations, and all key stakeholders.

That type of connectivity allows Category Managers the ability to have an overarching view into customer safety, product integrity, product availability, and brand protection. From a brand perspective, it gives transparency to everyone involved that the product has been supported, managed, developed, designed, produced, and distributed correctly.

In a data-driven world, we manage by exception. When shipments arrive on time and when products work the way they’re supposed to, there’s no corrective action needed. It’s when things go poorly – AKA the exception – that we need to step in and make adjustments.

Just like with many other things, if you have to constantly oversee every little detail and micromanage, you don’t get anything done. However, if you can manage just the data that is of concern, then you have the opportunity and the freedom to be much more productive and proactive.

Did you know that temperature has affected the healthcare industry for over 170 years? U.S. Physician, John Gorrie, built a refrigerator in 1844 to produce ice for cooling the air for yellow fever patients. According to the Medicines and Healthcare Products Regulatory, almost one third of all critical and major deficiencies uncovered in the storage and transportation of medicines relate to the control and monitoring of temperature.

With the rising complexity of development around personalized medications and biologics, temperature becomes even more critical. While there used to be a heavy focus on the 2°C to 8°C temperature range, the uniqueness of pharmaceuticals now ranges from cryogenic, frozen, chilled, to various controlled room temperatures (CRT’s) up to 40°C. With this wide range comes the need for customized time and temperature solutions than can monitor the product from manufacturing to delivery. The easy answer is data loggers!

Data loggers connect the Pharmaceutical Supply chain by providing digital data that can easily be used for tracking, analytics, trend analysis, and even the auditing process. Having digital temperature data at your fingertips for each temperature-sensitive pharmaceutical product is extremely powerful. There are never any questions as to what temperature and for what length of time each shipment was exposed to.

Even further, storing data in a centralized database not only ensures compliance but provides incredible insight to performance improvements in each distribution channel, shipping partner and packaging choice.

Data is imperative when shipping temperature-sensitive pharmaceutical products and the technology behind electronic data loggers is making it easier to connect key stakeholders within the Pharmaceutical Supply Chain.

We have found that thermal management and temperature monitoring go hand-and-hand. If a temperature-sensitive product is being kept at temperature by use of ice packs, heat packs, PCM’s (phase change materials) or a validated shipper, the manufacturer of that product must be mandated or ultimately concerned of the potential temperature-risk that could affect the quality.

Meeting Regulations Isn’t Enough

Many companies have identified ways to track and store temperature data in order to meet regulatory needs. Some are kept via manual record, whereas others are more sophisticated by keeping their data within their Quality Management System (QMS).

While these solutions may get the job done, data can be collected without any manual effort using a wireless Bluetooth logger. Through the use
of an app on any smart device, data can easily be pulled without ever opening a box or shipment.

With the right supplier, supported cloud solutions can capture the data from there and make it available to any authorized user. This process is done with very little manual effort.

What is a data logger and how is it different from other electronic solutions?

A data logger is an electronic device that records critical data over time. Providing high-quality sensor data around things like temperature humidity, shock, vibration, and more, they assist in product and consumer satisfaction and safety. Several industries ship and store sensitive products that can become compromised based on the environment it either is stored or shipped in. 

Data logger technology typically sits between electronic indicators and data acquisition systems. They can be the perfect “middle of the road” solution for several temperature-sensitive applications.

Here is why:  

VISUAL QUEUES

Electronic indicators can be a valuable solution for products that don’t need detailed sensor data. They can be placed with a product in shipment or storage to provide a visual notification for customized specifications set forth by the user. You will not receive extensive details around the sensor data captured, just a notification that there is a concern based on the data captured. Electronic indicators are typically a cost-effective temperature monitoring solution. 

REAL-TIME TRACKING

Data acquisition systems collect several data points in real-time and store them via external hardware. Through a network, stakeholders can be notified while the product is moving through the logistics channel. While this is a nice feature, data acquisition systems are expensive and require a connection to Wi-Fi to provide the instant notification. Depending on the application or the value of the product that is being monitored, a data acquisition system may not be necessary. 

EASY TO PROGRAM

Data loggers are easy to program, deploy and download data from. They are programmed and deployed based on customized specifications set forth by the user. They are actively gathering data and providing that information back in a detailed report to pinpoint where a possible compromise occurred. Based on the memory size and sampling interval, data can be maintained for months or even years, to follow the shelf life
of a product. Memory is stored internally, so there is no need for external hardware or a Wi-Fi connection. The perfect solution for collecting critical data, data logger technology continues to evolve and become more valuable for several applications.