Pharma firms tap RF-enabled logistics services for sensitive products shipping
When it comes to complying with government regulations, pharmaceutical manufacturers have special needs. Requirements surrounding the tracking and monitoring of temperature sensitive products—such as such as vaccines, cultures, and tissue samples used in clinical trials—during shipping are a prime example.
Industry insiders refer to the shipping of temperature sensitive items as “cold-chain” management, and countries around the world—e.g., Canada, Ireland, China and Singapore—have their own guidelines for this process. All this has pharmaceutical firms, their packaging suppliers, freight forwarders, and shippers creating shipping processes that are both safe and cost-effective. Technology definitely offers a number of solutions—some of which are already in use—and others, such as RFID, that the industry is hoping to apply, in earnest, soon.
In the United States, cold-chain shipments are governed by a document called U.S. Pharmacopoeia 1079 Good Storage and Shipping Practices . This directive, released in November 2005 and viewed by some industry experts as the most comprehensive set of cold-chain shipping guidelines yet, requires manufacturers to think of the big picture while paying close attention to the details.
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 also be analyzed to ensure that they don’t have any negative effects on the products they are storing.
“It’s important to recognize that there are generally several temperature ranges that need to be observed in order to preserve product integrity, and there is a plethora of packaging solutions that are available to accomplish this,” says Mark A. Mohr, manager of product development and specialty sales at Continental Airlines Cargo in Houston, Texas. The biggest issue is ambient temperature conditions during product handling not only in warehouses, but on trucks and aircraft. “When it’s 110 degrees in Phoenix, in terms of ambient conditions, it’s got to be handled properly.”
FedEx has a special business unit that handles the shipment of sensitive materials like those in the pharmaceutical cold chain. The trucks used by this unit—called FedEx Custom Critical—are temperature-mapped, and FedEx gives customers a complete audit trail when shipments arrive at their designated locations. “We provide the hard-copy temperature data receipt at the end so that customers can use it to support their compliance obligations,” explains Karl Kussow, manager of quality and validation at FedEx Custom Critical in Green Ohio.
While the trucks are on the road, temperature readings from the cargo area are forwarded to the FedEx dispatch center every 30 minutes. Customers can also view this information via FedEx’s secure Web site. Active alarms are in place so that FedEx staff can proactively adjust temperatures within the range specified by the client. “One of the strengths of our program is that we monitor as proactively as possible using today’s technology,” Kussow says. “We are monitoring the shipments 24/7 as they go from the shipper to the final destination. We are able to very quickly respond when temperatures are moving toward the limit of the range that the customer needs.”
RFID technology offers the ability to track shipments in near-real time. RF-enabled temperature data loggers can transmit data wirelessly as the product moves through the supply chain, as long as it is in the vicinity of a reader. If it is reported that the product has been subjected to temperatures that were either too high or too low, the shipper, in conjunction with Sensitech, a cold-chain products and services firm based in Beverly, Mass . In addition to the efficiencies of automated data collection, RFID-enabled temperature data loggers provide enhanced supply chain visibility through the addition of location data to traditional cold-chain time-temperature records.
There have, however, been some issues with RFID. First, signals from some RFID tags are susceptible to interference when traveling through liquids and metals. While there have been some technological improvements in this area, there are still questions about how RF signals affect biologic product shipments.
“There are some studies going on right now to determine if there are any negative effects on biologics due to RF energy, both from a thermal and molecular perspective,” Hawkins says. “As soon as that technological question is answered, I think we will see more interest in RF as a potential solution to cold chain monitoring.”
The results from two studies—one sponsored by the FDA and one sponsored by a major pharmaceutical manufacturer—are due out this summer.
Still, RFID is viewed by many as a means of streamlining a rather complex process. “Because of the increasing requirements related to being able to trace back and recall products, we see there is a greater need for using devices like RFID tags, because that is what will enable a pharmaceutical company to recall products if something goes wrong,” says Eric Raemdonck, manager of special cargoes at the 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.”
Carolyn Heinze can be reached at email@example.com