- THE MAGAZINE
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Incidents like the deaths of 128 children in India caused regulatory agencies throughout the world to reexamine pharmaceutical goods distribution practices.
Meanwhile, technological advances in cooling and monitoring have extended reliable temperature maintenance. Those developments may have been visible to users of cold-chain distribution channels.
Another significant development is that life sciences’ cold-chain options have grown from specialty carriers to global entities with extensive networks.
Despite the occasional headline to the contrary, the cold chain is safer and more reliable than ever before.
During the past several years, the pharmaceutical industry has developed a research, development and manufacturing presence in Asia and Latin America. Increasingly, clinical trials also are being conducted in BRIC nations, which involve shipping not only medications but often medical specimens between and within nations.
Simultaneously, the increase in temperature-sensitive vaccines and biologic therapies is growing rapidly. According to the Biopharma Cold Chain Sourcebook 2012, within four years, eight of the top 10 drugs, and 27 of the top 50 drugs, will be cold-chain products.
Realizing the opportunity before them, the number of cold-chain carriers has grown from five or six specialty carriers to roughly 30, as many of the world’s largest cargo carriers enter the field.
“One of the key strengths of global players is their global network,” says Tony Wright, CEO, Exelsius Cold Chain Management Consultancy. “They are seeking opportunities in business sectors resilient to economic changes to prevent dilution of their cargo business.”
To many, that means the life sciences market. As these carriers expand, they are beginning to function as consultants in healthcare shipments, providing, detailed information on healthcare guidances and regulations as well as the shipping regulations to specific countries. Consequently, they can direct shippers to the forms and processes they will need.
In the cold chain, the risk management aspect is evolving. Data loggers, as a deterrent to product failure and to cargo diversion, are garnering interest among insurers as well as manufacturers, according to Matt Groppe, director of global business development, DHL Same Day.
With data loggers, if cargo were diverted or tampered with, that can be proven using sensors that monitor temperature, humidity, air pressure, light, vibration, shock and/or location. Consequently, the point of diversion can be pinpointed.
Advanced cold-chain packaging has much longer hold times. For example, liquid nitrogen dry-vapor shippers now can hold even deep frozen temperatures (-150°C) for 10 days, and active packaging batteries for containers have extended lifespans to about 16 days. Dry ice, in contrast, is good for two to three days without recharging.
Additional options are also emerging. FedEx, for the first time, chartered an entire temperature-controlled plane for a healthcare customer in April. This is one of the new, more innovative ways it is using its fleet. According to Richard W. Smith, managing director of life sciences and specialty services, FedEx temperature-controlled charters can maintain either room temperature or the 2° to 8°C that is mandated for many healthcare products (and which are the most common temperature recommendations for pharmaceutical products).
“Clients are talking about weekly charters, because temperature controlled shipments eliminate so much cost and complexity,” Smith says. For example, he says, shipping large quantities of product using a freight forwarder could take weeks. Chartering an entire plane for long flights allows faster delivery, minimizes handling and risk, and can be less expensive. “It’s all about contingency and risk management.”
FedEx’s temperature-controlled charters are being augmented with an option that eliminates the need for shippers to purchase or rent expensive temperature-controlled containers. This ancillary service wraps cold-chain packages in thermal blankets and transports them to and from temperature-controlled aircraft in refrigerated trucks. This service originated in FedEx facilities in India. “That removes a lot of the logistics headaches from our customers,” Smith says.
American Airlines Cargo launched ExpediteTC Passive last September to complement its active temperature-controlled service. ExpediteTC Passive is designed specifically for passive, shipper-validated thermal packaging that uses phase-change material, cool packs or dry ice.
“Our target time to express-handle these critical temperature-controlled shipments from the cargo facility to the airplane is 90 minutes. By the time it arrives, they are loading the aircraft, minimizing shipment exposure time on the ramp,” Tom Grubb, manager of cold chain strategy for American Airlines Cargo, says. “In contrast, at a hub like New York, general cargo is pulled two to three hours before the flight.”
Carriers increasingly are providing temperature-controlled facilities. FedEx, for example, has 43 facilities with cold storage. At least 33 locations offer re-icing for shipments using dry ice. A few also offer cryogenic storage, although, Smith says, “Typically, shippers would use liquid nitrogen dry vapor packaging for those deep frozen shipments. They hold temperatures at -150°C for 10 days.” Federal Express has environmental rooms in its gateway facilities that hold temperature in the 2° to 8°C range, as well as an ambient temperature room for active and passive cooling containers.
American Airlines Cargo now offers Controlled Room Temperature (CRT) facilities in key locations that maintain temperatures between 15° and 25°C to help the packaging do its job. “American has built five CRT facilities in the past year and is planning three more before the end of the year. We also have designated certain areas within warehouses as thermally neutral to further protect shipments,” Grubb says.
These new services greatly enhance temperature stability. Coupled with wireless data monitors, they also give unprecedented visibility into the cold chain. Monitors may include pressure, light levels, vibration, shock and humidity. Monitoring, particularly at this level, isn’t needed for every package but provides options that protect high-value, sensitive cargo.
Similar technology also can be deployed to build an electronic fence around sensitive shipments so the customer knows when the package enters and leaves a geographic point, like a warehouse, or for last mile services. DHL’s Groppe says it can be customized to create highly secure corridors so that “if a driver even stops for gas, we can get a message.”
Wright predicts a near-term explosion in the use of data monitors. “Shippers want temperature monitoring and visibility without opening the package, and wireless data loggers are providing it,” he says. The usual technology provides continual monitoring, but new, programmable devices are becoming available that extend battery life by reporting at predetermined intervals or by reporting only threshold incidents.
Typically, carriers closely monitor temperature-controlled packages. With data loggers, they are alerted when weather, bureaucracy, customs inspections or other issues delay delivery. This allows them to intervene before temperature excursions (temperature differences due to environmental factors) occur. They can either move the shipment along or dispatch local representatives to provide freshly charged packaging to maintain the temperature.
The FedEx SenseAware program is similar to data loggers. The device runs on quad-band cellular radio rather than wireless Internet to push GPS latitude and longitude information and local, location-based information to the user. It also may include sensors for temperature, light, pressure, humidity or other parameters.
“This platform allows shippers to manage data in near real time so shippers can respond to events to prevent temperature excursions. Combined with Priority Alert, it becomes very powerful,” Smith says. “Location, temperature and light are the three main features,” he says. The program is most valuable for high value, high security and perishable products.
At DHL Same Day, the specialty courier service of DHL Express, the Smart Sentry wireless locator device for high-value cargo provides real-time tracking and real-time visibility in transit, according to Groppe. Smart Sentry combines condition monitoring and a GPS signal that can be turned off automatically in flight. “The solution is flight safe and tested with airlines,” he adds. “It’s the first we’ve seen that can be IATA certified.”
Importantly, the monitoring rate can be configured to extend battery life. Two batteries are available. One has a life of about 100 hours. The extended battery pack has a lifespan of approximately 400 hours. If those thresholds are approached, DHL is alerted so it can intervene.
Approximately 36 nations now have regulations or guidances governing the cold chain for the pharmaceutical industry and more are being developed.
In July, the International Air Transport Association (IATA) plans to implement revisions to its cargo regulations, “Air Transport Logistics for Time and Temperature-Sensitive Healthcare Products,” mandating application of the IATA Time and Temperature Sensitive Label. “Lithium batteries in data loggers always have been subject to IATA’s dangerous goods regulations, but are being given greater visibility to address safety in transport,” according to IATA spokesman Perry Flint.
More importantly, IATA also has proposed changes to Chapter 17, Section 13, “Additional Environmental Considerations,” affecting electrical devices that are intentionally active during transport. Effective July 1, shippers must verify the potential electromagnetic radiation associated with such devices during flight do not interfere with aircraft systems, Flint says.
“The scramble now is with data logger manufacturers to understand the guidelines and to comply by the July 1 deadline,” Exelsius’ Wright observes.
To meet these requirements, DHL has a backup battery in the wings, to mitigate any effects from the IATA regulations.
“Maintaining global compliance is a big task,” Wright says. Much of the regulatory focus today is on carriers and freight forwarders. “Regulators see transportation as an extension of the manufacturer and hold manufacturers responsible,” he says. Additionally, as countries and organizations promulgate guidances and regulations, “There’s a lack of harmonization.”
Wright advises carriers, in particular, to stay current with best practices and to develop a compliance management system using established goods distribution practices and such guidances as USP 1079 and IATA Chapter 17. wt