Building a cold-chain data network

FedEx’s SenseAware device

One of the longstanding essentials of transporting temperature-sensitive pharma products has been documenting the conditions experienced during a shipment: usually, the temperature of the product payload; increasingly, conditions such as humidity, the status of containers holding the payload (open, shut, powered, etc.), and the ambient conditions. For some shippers, there’s value in combining the temperature data with logistics data, such as geolocation, truck driver check-ins, and the security status of locks and protective devices. In an era where consumer-operated smartphones can essentially be used to handle the entirety of life’s tasks, from making a phone call to ordering a cab service to monitoring one’s pulse rate, it’s only natural that those capabilities can be brought to the pharma cold chain.

However, the question for many pharma shippers is, how much datalogging do I need, and how much added expense do I incur? The gradual move toward managing the temperature conditions of even controlled room-temperature (CRT) products, which is written into the latest Good Distribution Practice (GDP) guidelines, could eventually mean that all pharma shipments are temperature-controlled, or at least “temperature aware.” Products that specifically require refrigerated conditions (2-8°C) constitute 5-10% of most distributor inventories; are we heading for an era where all pharma products (and, increasingly, medical devices that incorporate therapeutic or diagnostic pharmaceutical products) are in insulated containers with dataloggers and temperature-management devices?

The answer, according to industry experts, is, “It depends.” The bulk of pharmaceutical products are not shipped with temperature management and monitoring, and many shippers—even of products that require refrigeration—take advantage of the so-called “stability budget” that demonstrates that a product is still efficacious if it has been outside its label temperature range for a limited period of time. For other products, whether requiring refrigeration or not, “it’s a matter of applying a risk-based approach,” says David Bang, manager of LifeConEx (Plantation, FL), a business unit of DHL Global Forwarding that manages life-sciences transportation. FDA specifically, and regulators generally, look for the higher-risk situations that could affect product safety; FDA inspectors will request documentation that a product has been transported and stored safely, and the burden is on the shipper to demonstrate that performance.

Thus, shippers, and the container, data-gathering, logistics-services and carrier vendors they depend on, have a range of options when preparing a shipment, with escalating complexity and cost:

• Establishing a profile of shipments according to their trade lanes (north to south, across the country, or across oceans)
• Using temperature indicators (generally, a “yes/no” indication that temperatures have been kept within an acceptable range)
• Incorporating dataloggers into the container to produce a minute-by-minute profile of the temperatures experienced by the payload
• Equipping dataloggers with communications capabilities (cellular or satellite) to provide real-time tracking of the shipment
• Engaging with a logistics provider (3PL) to not only monitor a shipment’s condition, but to actively engage in addressing transportation and shipment handoffs among carriers.

The upper end of this range—active management of real-time shipment conditions—is arguably the area of greatest technology advances and cost. But for shipments that could contain multimillion-dollar payloads of products that, ounce for ounce, far outweigh the cost of, say, pure gold—the cost can easily be justified.

Temperature indication

For many years, the easiest and lowest-cost option is to apply a temperature indicator to the shipment. Usually, the device has a chemical reaction when a certain temperature has been reached, which then turns color if high or low temperature limits have been exceeded; checking the status is fairly easy when the shipment is delivered. In recent years, chemical indication has been supplanted by electronic indicators—with the cost of printed circuits continually falling, they can be an economic alternative to chemical-based devices.

A leading vendor of indicators is TempTime Corp. (Morris Plains, NJ), which offers heat/freeze indicators and devices branded as TransTracker, for signaling when a temperature range has been exceeded for a specified amount of time. A 2012 study performed by the company highlights an important leg of a temperature-controlled shipment: from a specialty pharmacy to the patient. Patients who receive a dose (generally, through the mail) want assurance that the product is still safe; the temperature indicator provides that assurance.

American Thermal Instrument (Dayton, OH), as well as many providers of cold chain packaging offer indicators. Sensitech (Beverly, MA), well known for its TempTale dataloggers, also has a temperature indicator line.

Dataloggers such as TempTale have been the workhorse of the industry, used widely for many refrigerated shipments. The Sensitech product line has been broadened to include devices for biologics specifically, and for monitoring clinical materials with tailored temperature probes. The product lines are supplemented with a software package, ColdStream, to gather temperature data after a shipment has been completed.

Another leading datalogger vendor is Elpro (US HQ: Marietta, OH), whose dataloggers are designed to generate PDF reports independently of the software system into which the device’s stored data are ported. “There’s a differing perspective in the pharma industry between logistics managers, who want to complete shipments and move on, and quality managers, who want to document shipment conditions clearly. I’ve been surprised at how infrequently the data are properly stored,” notes Micalyn Harris, marketing manager at Elpro. The company promotes its LiberoManager system, which streamlines the data-download process.

There are a wide range of datalogger suppliers, including Berlinger (Ganterschwil, Switzerland), Deltatrak, (Pleasanton, CA), Testo (Sparta, NJ) and others. Many cold-chain packaging vendors also offer branded dataloggers.

The ultimate in datalogging is a self-contained communications device that provides both monitoring and data transmission back to the shipper. OnAsset Intelligence (Irving, TX) was one of the first with such a device; FedEx launched the SenseAware device several years ago, as did DHL with its SmartSense device.

At the upper end of the service range, shippers have the option of depending on logistics providers, or making arrangements with telecommunications providers for a company-specific network. The global logistics firms—UPS, FedEx, DHL, Panalpina, Kuhne + Nagel and others—have dedicated, branded services. UPS’ is Temperature True; FedEx has its Custom Critical business unit; DHL has Thermonet and LifeConEx. Clients arrange for a varying set of services, ranging from real-time tracking to active management of shipments.

3PL-independent services for tracking shipments, tailored to life sciences needs, are available from such vendors as TSS (Taby, Sweden), Sendum (Burnaby, BC),BT9 (US HQ: San Diego, CA), and others.

Karl Kussow, manager at Custom Critical, notes that dataloggers contained within a pallet are certainly helpful in monitoring a shipment, but that a more comprehensive solution monitors the entire environment with a vehicle (such as a truck); FedEx Custom Critical provides that environment within its vehicles, which, in theory, obviates the need for the shipper to do it. “We provide the equivalent of a GMP-level Performance Qualification of every shipment,” he says. FedEx Custom Critical is expanding this service to include performance data of the vehicles themselves, which essentially combines condition monitoring with cargo security and overall transportation management.

At LifeConEx, David Bang notes that real-time monitoring only makes sense when you can respond to process upsets, taking such actions as rerouting a shipment to preserve its quality. Additionally, LifeConEx is broadening a service it calls Conexion, which incorporates analytics of shipment performance into the datalogging and reporting. “The ultimate goal here is to be a true partner with the shipper, looking not just at the performance of a shipment, but how well it integrates into the overall logistics processes of the shipper.”