Getting Cold Chain Data in Real Time
Want to know where your shipment is, and what its condition might be?
There is, to put it mildly, a wide range of practices when it comes to monitoring and tracing the shipments of temperature-sensitive materials and products in life sciences. The baseline, if you will, is: nothing at all. A considerable number of shipments in the US and globally (less so for countries, or companies, adhering to strict GDP standards) are set up based on two assumptions:
a) the trade lane along which the shipment is passing has been tracked and measured, enabling shippers to predict the conditions under which the shipment has been made and attest to their accuracy to a regulator;
b) the stability data on the material being shipped has been tested and analyzed, enabling the shipper to affirm the quality of the shipment within a limited duration of out-of-range temperature.
Over the past few years, many global pharma companies have beefed up their stability data archives, enabling them to present data to customs inspectors or health ministry officials that a drug meets its label claims even if a specific shipment’s temperature experience wasn’t recorded. But that approach creates a degree of uncertainty: an inspector’s policy might change; or the shipment might have experienced an extreme temperature event, unknown because it wasn’t being tracked. High-value shipments, or highly risky shipments (such as vaccines that are inactivated by freezing conditions) don’t allow for this degree of uncertainty.
The traditional approach, for many years, has been to include a datalogging device with the shipment. These electronic units, which incorporate a reliable temperature sensor, a short-duration battery (providing power for several months) and the necessary circuitry to record data at set intervals for the duration of the shipment, and to provide an output that can be readily downloaded at the end of the shipment (and when the carton containing the shipment is opened). For a long time, the Sensitech Temp Tele has been the market leader in this application, but now there are many competitors, including Elpro, Berlinger, SpotSee and others.
These devices were differentiated by how their output was produced: a simple ASCII file; a PDF, or other data formats that could then be ported to various data systems (such as a spreadsheet program). Some vendors also provided overall data-management systems, either as programs to install, or as a SaaS system connected with online, to manage the data of multiple dataloggers and multiple shipments. The availability of such systems assists users to manage the data efficiently—with hundreds if not thousands such dataloggers in circulation at any given time, and with the quality-management controls that dictate proper storage of such data, that task is not an easy one.
However, one of the key stumbling blocks of using these dataloggers (which goes for more sophisticated systems as well) is first, ensuring that the device was turned on before it was dropped in a shipping carton; and second, that the data was retrieved at the end of the shipment. For well-run logistics organizations and warehouse staffs, these tasks are no-brainers; for organizations with less training and preparation, chasing down the data is a problem.
Connected, real-time monitoring
Partly for these limitations, and mostly because the technology has now become more widely offered—and less expensive—various vendors and service providers are setting up networks that can provide automatic, continuous monitoring. The networks make use of cellular WiFi connectivity, and might involve dedicated routers located at international cargo hubs (sea and airports). Data collection certainly includes temperature, but can also include humidity, light (an indication that a package has been opened), vibration and other environmental conditions and—most critically—location. Location tracking, matched with environmental conditions, give the shipper definitive information on where its products are, and where they’re going.
Shippers have multiple choices when it comes to these Internet-of-Things (IoT) networks: dedicated service vendors, such as Sendum, Controlant, OnAsset Intelligence and others; datalogging vendors such as Sensitech or Elpro; or logistics providers and cargo carriers (air, sea and ground) that offer their own networked service. Some container providers, such as Sonoco ThermoSafe and its PharmaPort, and Envirotainer, are also enabled.
There are so many choices, in fact, that global pharma companies must negotiate with their datalogging, container, transportation and networking providers to set up systems that collect all the data. This is becoming increasingly desirable as those same companies set up Global Security Operations Centers (GSOCs), where such data can be continuously monitored. These days, the data about a shipment can be as critical to a company’s well-being as the shipment itself.