Manage Supply Chain Risk with Cold Chain Monitoring
By Mary Vessele, Product Marketing Manager, Test & Measurement, Cole-Parmer
The cold chain industry has become much more than just keeping products cold from point A to point B. It is an integral process involving science and technology working together to ensure temperature-sensitive items are kept at a specific temperature range from the time they are placed into cold storage through to their destination points.
Many popular products today use cold chain logistics including all fresh foods, fruits and vegetables, meats, dairy, pharmaceuticals, chemicals. As you can see, a very large player relying on the cold chain is the food industry. It is obvious that without the cold chain, the food industry would never have evolved to what it is today. The industry would be severely handicapped. Distribution would be hindered, and the overall business model would need to change. This segment’s entire livelihood is dependent on being able to transport goods safely all around the world—even to remote locations—without products spoiling or becoming compromised by changes in temperatures along the way. Even a small shift in acceptable temperature ranges could cause products to unknowingly be exposed to bacteria and food born illnesses.
In the past, food manufacturers reacted to food contamination issues by holding mass product recalls protecting consumers. In 2011, The Food Safety Modernization Act was passed into law requiring food companies to have a food safety plan in place. The goal of the Food Safety Modernization Act was initiated to try to prevent illness outbreaks resulting from human and animal food by forcing food manufacturers to do a better job of instilling safe manufacturing practices that prevent food born illnesses. The act gives the FDA more inspection authority and recall power, enticing food manufacturers to either improve their operations with safer processes or risk being fined or shut down due to a lack of compliance in safety measures. The rule expands the FDA’s reach so now they have the power to oversee the entire cold chain process from farm to fork.
A specific area of interest to the logistics industry is that it also extends to the transportation of food products to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads and failure to properly protect food. No longer is reacting to a food born illness enough to protect our cold chain. The FDA is now instilling strict demands upon manufacturers to try to prevent the consumers from food contamination born illness.
The hot topic of compliance, regulation, safety and prevention applies to not only the food industry but also to the chemical, drug, clinical, laboratory, life science, IT and electronics industry as well. These industries all have products that need to have temperature monitoring throughout the entire cold chain. Some are regulated and some simply need to maintain the integrity of the products being shipped. For example, the vaccine industry has regulations in place that mandate strict monitoring of temperature for vaccines throughout the entire cold chain. Even a small shift in acceptable temperature ranges can cause vaccines to become virtually ineffective. The electronic industry chooses to monitor electronics to ensure the quality of the products are not affected by shifts in temperature. Just about every industry uses the cold chain at some point between the manufacturing process all the way through to distribution to the end user.
See Key Regulations for Cold Chain for compliance and regulation guidelines.
The cold chain has evolved with new technology capabilities that enhance the quality, safety and efficiency of products. How would a manufacturer improve the safety of their temperature-sensitive products during all of the different phases of the manufacturing and distribution process without investing these new technologies? With the ability of the FDA to audit the cold chain at any time, it would be ideal if your process was monitored with a system that would allow you to pull data showing a history of data to track the temperature of products. Having your products monitored around the clock and being able to check the data to see that the correct temperature is being maintained would give you great peace of mind, especially when the FDA is involved. Today’s technologies are providing options to the logistics industry that are not only helping them provide reliable monitoring solutions along the cold chain but also giving them the capabilities and the benefits of IoT to improve record keeping, trend analysis and accountability.
Cold chain monitoring during transport has advanced to now collecting as much data as possible on the conditions of the product throughout the entire transport process. Cold chain temperature data loggers need to be customized according to the cargo/product needs so that if the temperature falls out of range the customer is alerted. With cloud data storage and Bluetooth® technology now available, the amount of data stored is unlimited and can be exported to CSV or secured PDF.
There is the option to subscribe to cloud-based services to upload data which is ideal for evaluating data from multiple loggers. The devices can be configured from your phone or tablet to start, stop, change memory mode, unit preference, alarm settings, logging intervals, enable/disable alarm. Once all the parameters are set the user simply presses start on the logging device to begin monitoring. Once the shipment is delivered, the device will transmit the data to your mobile device. These devices will give the user the data needed to ensure the cargo remained in the correct temperature range for the entire cold chain transport process.
Monitoring environmental conditions of reagents, clinical samples, vaccines, pharmaceuticals, and food items often require NIST-traceable calibration of the data loggers so meeting the demands of quality and regulatory compliance for ISO, FDA, cGMP, CAP, CLIA and the Joint Commission has never been easier. Once the data logger is received, it is ready to be used out of the box as many of them will go through an intense vetting process for calibration and will arrive with a NIST certification. The NIST certification means that the data logger has been accredited by a 17025-calibration test lab, so it arrives to you calibrated and meeting all specifications.
Some data loggers are disposable and very convenient. After the trip, data is downloaded, and the device does not have to be shipped back to origination. It can be simply disposed. These disposable data loggers are waterproof and can be used in damp environments with ice or cold packs. Another benefit of a disposable data loggers is, depending on the brand, it will arrive pre-calibrated and the user will never have to worry about recalibrating them because they are one-time use.
The cold chain is not only used for the distribution of items, it also includes the manufacturing and storing of products at the manufacturing site. Tracking the conditions of samples and products in the upstream stage of manufacturing is just as important as tracking the conditions in the downstream stage. No matter where your product is in the cold chain process, temperature is critical and can be monitored remotely. There are data logging thermometers available that use Wi-Fi to securely connect your smartphone, tablet or personal computer to your products. Monitoring can take place 24/7 with mobile push notifications, emails, or texts informing the user of out of range conditions. Current temperature conditions can be monitored for your critical products no matter the time of day or your location.
The advancements of temperature monitoring devices have quickly evolved with the surge in popularity of the IoT and the need for quick data access. The cold chain is benefiting from evolving temperature data transmitting devices making it a safer more secure process at every stage along the cold chain.
Learn more about real time cold chain temperature monitoring solutions from TraceableLIVE®.
Learn more about Cold Chain: What is Cold Chain?