Pharmaceutical firms look to logistics providers, RFID to manage shipping of sensitive goods

When it comes to complying with government regulations, pharmaceutical manufacturers have special needs. Shipping temperature-sensitive items, referred to as “cold-chain” management, is a prime example. Canada, Ireland, China, and Singapore all have their own guidelines for this process, which has the entire pharmaceuticals supply chain working to create safe and cost-effective shipping processes.

In the U.S., cold-chain shipments are governed by the U.S. Pharmacopeia 1079 Good Storage and Shipping Practices document, which is viewed by some industry experts as the most comprehensive set of cold-chain shipping guidelines yet.

Using packaging that guarantees the maintenance of a certain temperature range for a certain amount of time isn't enough. Temperature and humidity within warehouses, shipping containers, and trucks must be analyzed to ensure they don't have any negative effects on the products they are storing.

“There are several temperature ranges that need to be observed to preserve product integrity, and there is a plethora of packaging solutions to accomplish this,” says Mark A. Mohr, manager of product development and specialty sales for Houston-based Continental Airlines Cargo. The biggest issue is ambient temperature conditions during product handling. “When it's 110 degrees in Phoenix, in terms of ambient conditions, it's got to be handled properly,” he says.

Trucks used by a special unit of FedEx—called FedEx Custom Critical—are temperature-mapped. FedEx provides customers with complete audit trails when shipments arrive at their designated locations. While the trucks are on the road, temperature readings from the cargo area are forwarded to the FedEx dispatch center, and customers also can view this information from a secure FedEx Web site.

“We are monitoring shipments 24/7 as they go from the shipper to the final destination, says Karl Kussow, a quality manager at FedEx Custom Critical. “We quickly respond when temperatures are moving toward the limit of the range.”

Radio frequency (RF)-enabled temperature data loggers can transmit data as the product moves through the supply chain, as long as it is in the vicinity of a reader. If a product is subjected to temperatures either too high or too low, the shipment can be rerouted, or a replacement can be initiated for delivery.

RFID allows hands-off accumulation of data, says Jeff Hawkins, strategic marketing manager at Sensitech, a cold-chain products and services provider based in Beverly, Mass. RFID-enabled temperature data loggers enhance supply chain visibility via location data to traditional cold-chain time-temperature records.

Typical issues still exist concerning signals from RFID tags that show interference when traveling through liquids and metals. While there have been improvements in this area, there are still questions about how RF signals affect biological product shipments. Results from two studies—one sponsored by the FDA and one by a pharmaceutical manufacturer—will offer more insight in the coming months.

Still, RFID is streamlining a rather complex process. “Because of requirements for tracing back and recalling products, we see a greater need for devices like RFID tags, because they will enable a pharmaceutical company to recall products if something goes wrong,” says Eric Raemdonck, manager of special cargo at International Air Transport Association in Montreal. “It's a matter of extending this control through the supply chain, and that's what we see happening these days.”