Today’s pharma cold chains are more complex than ever. Bulk shipments of highly valuable biologics and other cold chain products are moving through national and international transits, while meeting tighter regulations for performing to exacting temperature ranges; integrating well with fast-moving logistics processes; and providing greater access to operational data on environmental conditions inside and outside the container. All the while, managers are looking to keep a tight rein on operating costs.
Technology has developed at a pace commensurate with the more complex supply chain. Better insulation materials, higher reliability in cooling processes; and electronics to streamline the collection and documentation of shipment data are more readily available. One of the more competitive areas of pharma cold chain technology is in the movement of pallets of product, whether by air or other transportation modes. This is where Sonoco ThermoSafe’s PharmaPort 360 operates, and recent operational experience demonstrates the benefits of deploying the latest technologies.
“Active (powered) pallet containers are preferred by many biopharma manufacturers because of the reassurance they provide in keeping high value product within specification,” says Chris Day, director of global business development at Sonoco ThermoSafe. “At the same time, the cost of active systems is driving the industry toward less expensive, but more complicated—and less reliable—passive systems. Our experience to date tells us that PharmaPort 360 solves many of the difficulties of active systems, while providing cost economies competitive with passive systems.”
PharmaPort 360 technology
The PharmaPort system has been on the market for several years, but with its acquisition by Sonoco ThermoSafe in 2016, it has undergone comprehensive upgrading since then. While it contains the batteries, refrigeration compressor and heating element that other active systems contain, the heart of the proprietary technology is a multiple eutectic plate design inside a vacuum insulated panel (VIP) shell, which maintains a rock-steady 5°C temperature, for a minimum of 72 hours in constant +30°C heat (and over 100 hours in controlled ambient conditions). (“Eutectic” refers to the plate’s ability to absorb or give up energy while maintaining a designed-in, steady temperature. In fact, the PharmaPort is automatically centered on 5°C without operator adjustment.)
Once the PharmaPort is charged (by simply plugging it into any world power source), the compressor and heater shut off, and fans circulate air within the container, accessing cool or warm air from the eutectic chambers as necessary. As a result of this energy-efficient process, there is no noise or hot air discharge from the container. Operational experience demonstrates that the PharmaPort can maintain its +5°C set temperature to within +/-0.7°C, even during around-the-globe air shipments.
Dimensionally, the PharmaPort 360 is a rectangular box, with rigid walls (see table for dimensions). Use of high-tech vacuum insulating panels help protect shipments while maximizing payload space. On aircraft, the container fits within a standard NAS cookie sheet; depending on customer requirements, even two PharmaPort units can be positioned on the sheet.
PharmaPort has had FAA approval ever since it came on the market; additionally, it has World Health Organization approval for shipping vaccines and other temperature-sensitive materials.
The squared-off dimensions of PharmaPort , combined with a base platform that allows for forklift movement from all four sides, has other, broader implications. PharmaPort can easily be loaded into a ground-transportation truck or trailer, providing an easy, precise LTL service which avoids the need for expensive, hard to fill reefer trucks. PharmaPort has even been used as a static, laboratory-grade refrigeration system, simply by plugging in multiple stationary units in a warehouse. Accommodating temporary refrigerated product overflow is a breeze.
Where PharmaPort really shines, though, is in its built-in telemetry. As the only active container with comprehensive monitoring built into the container structure and approved by the FAA, the PharmaPort provides a wealth of operational and environmental information: monitoring all internal/external temperature, location and mechanical functions; transmitted to the cloud in near real time; and requiring no human involvement to start/stop/retrieve monitors of any kind.
Gone are the days of waiting until the end of a shipment for information, or lost data from an operator losing or forgetting to start or stop a logger, or weeks-long investigation processes while waiting for a logger to return from its next trip. Airlines and freight forwarders can monitor PharmaPort shipments in real time, allowing preventive action throughout a shipment. Subscribing PharmaPort shippers can access their shipment data for the last 5 years in minutes instead of weeks, including the ambient temperature lane data gathered by the PharmaPort.
The fact that all of the sensors and transmitters are built into the PharmaPort allows for full synchronization of all data – time, place, temperature and mechanical. This means at any moment of transmission, the container’s location, internal/external temperature and battery/mechanical statistics are known—simultaneously. The data are securely stored in the cloud for near-instant retrieval.
At the same time, ambient conditions are similarly recorded, and with onboard altimeters and accelerometers, a quick and easy assessment of operational conditions can be made (i.e., shipment in motion; shipment in flight; container loading/unloading, etc.). The telemetry includes software for geofencing (ensuring that the container stays within a specified port or roadway).
In fact, the ease of data collection and retrieval of the PharmaPort makes it an attractive option for conducting lane validation studies. Working with a knowledgeable logistics provider like DHL Global Forwarding (see below), a manufacturer can use the PharmaPort to collect precise ambient data, even while mimicking ground-handling or transfer activities. The PharmaPort might be used for a number of initial runs at product launch, and then the manufacturer and logistics provider have the documentation and performance data to justify shifting to other packaging options as a product reaches full commercial distribution.
“Some of these capabilities exist in piecemeal fashion in the industry, usually not in real time and always requiring human effort to place, program and retrieve devices,” notes Day. “PharmaPort’s built-in ability to securely track all these location, environmental and mechanical conditions just by powering on the container brings significant new capability to the market. Additionally, as the newest vintage active container, our fleet age provides additional relief from mechanical issues present elsewhere.”
Sonoco ThermoSafe has worked with DHL’s Global Forwarding business unit to handle high-value biologics from a major biopharma manufacturer, in this case making a run from Amsterdam, Holland, to Sydney, Australia for the last 18 months. Edwin Groenewoud, Customer Relations Team Leader at DHL Amsterdam, who has been managing these shipments, says that “We’ve had problems with active containers on this shipping lane, due to reliability issues and the lack of visibility in tracking data. The PharmaPort 360 has provided us flawless reliability, no temperature excursions and great visibility through the real-time GPS tracking. Additionally, the Sonoco PharmaPort team has done everything we could have asked, including creating a custom software visibility platform specific to our needs.”
The actual performance of the PharmaPort is shown in two charts: Fig. 3 is operational data from the internal temperature sensors of the container, over several hundred shipments. The steady performance there is even more dramatically demonstrated in Fig. 4, which shows external temperature data collected one shipment of multiple PharmaPort units, some of which took different connecting flights to get to the same destination. Operational managers could not only see the varying conditions on these routes, but also be assured of near-identical internal temperatures of the PharmaPort units.
David Bang, Global Head of DHL Temperature Management Solutions, was the driving force behind introducing the PharmaPort into the DHL portfolio. “Customers routinely come to us for advice on packaging selection. What has attracted us to the PharmaPort 360 solution is its flexibility, reliability and predictability. The telemetry allows us to manage shipments predictably, and between the ground handling capabilities of the DHL network and the reliability of the PharmaPort , we can provide a high level of assurance to our customers.”
Bang notes that PharmaPort has been foundational in building a stronger partnership between DHL and Sonoco ThermoSafe, as the global capabilities of both organizations became recognized by the two. The pharma logistics “game,” so to speak, is in part a balancing act in the availability of containers in the right places at the right times, and with an ability to service them, globally, as needed. “Both organizations have an international footprint, and for us this has been a wake-up call that we can meet demanding client needs successfully,” he says.
Today’s international pharma-logistics market is being buffeted by capacity constraints, growing demand for high-reliability services, and tightening regulatory requirements. At the same time, the biopharma industry is reaching out to more global markets—in some cases, where its quality standards are challenging to meet. Use of the PharmaPort 360, with its reliability, simplicity and predictable performance, can take many of the worries off the plate for supply chain managers and logistics providers alike.