Pharmaceutical and Medical Packaging News
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Originally Published PMPN September 2005
Prequalified Shippers En Route for Clinical Trials
Because clinical trials are increasingly becoming global studies, drug makers are finding that they need to protect sensitive new drugs from a variety of shipping hazards. Trouble is, the long-term stability of some of these products may still be unknown. To maximize the likelihood of a smooth and successful clinical trial, manufacturers often choose to specify that shipments stay within a very narrow temperature range.
Protection is in order, but do packaging professionals need to custom design shippers for drugs that are still just experimental?
Maybe not, thanks to prequalified shippers. These off-the-shelf solutions in standardized sizes and configurations are designed to maintain a predetermined internal temperature range, regardless of the external environment. Tom Pringle, managing director of ThermoSafe Brands’ ISC Labs (Phoenix), is seeing a lot of clinical trial supply managers interested in these shippers, which he calls “one universal pack out” that can be used at any time of the year. “These companies are handling the future blockbuster drugs,” he says. “They need protection, but they can’t wait 3–4 months developing product-specific shippers.”
ISC Labs first worked on its prequalified shipper nearly 15 years ago, now marketing it under ThermoSafe Brands (Arlington Heights, IL) as the Nomadic Prequalified Shipper. One model made of molded polyurethane, the Nomadic E48, is designed to hold drugs and biologicals at 2°–8°C for up to 48 hours in transit, summer or winter. Weighing 24 lb, it features an inner product area measuring 7.5 × 5 × 3.75 in. It is 40% smaller in size and weight than the previous model, Nomadic E280, which weighed 46 lb with inner dimensions of 10 × 8 × 8 in. The Nomadic E48 and other new prequalified shippers were on display this year at such industry trade events as Interphex and EastPack.
Cold Chain Technologies (Holliston, MA) showed its KoolTemp GTS (global transport system), which launched in February 2005. Also maintaining 2°–8°C for 48 hours, this 36-lb shipper holds contents up to 8.75 in. cubed. While it is the firm’s third prequalified shipper, it is its first universal all-season shipper.
“Customers don’t have to be concerned about what time of year it is and how to pack it out,” says Larry Gordon, president of Cold Chain Technologies. Also, “our customers have asked us to make other sizes. Now that we have defined the thermodynamic science, we know how to scale it to other sizes and longer times.”
While shipper design is important, the science behind these shippers may be the temperature-control devices packed inside. ThermoSafe uses three standard 20-oz frozen PolarPack gels to repel heat from the ambient environment and eight 24-oz PolarPack Tough Pack refrigerant gel packs around the product as buffers to stabilize the payload. The KoolTemp GTS from Cold Chain Technologies uses its 30-oz Koolit foam refrigerants.
Phase-change materials are another option. Maurice Barakat, CEO of TCP Reliable (Edison, NJ), explains that the firm’s development of its 72-hour prequalified shipper was driven by that of a “phase-change solution,” he says. “What we found is that the combination of, for example, our Phase 5 Phase Change Material and TCP thermal-control panel would give you a fully controlled volume under a very narrow temperature range of 2°–8°C. From there we’ve developed a 48-hour prequalified shipper, and the results are actually so stable that we’ll be able to extend to 72 hours.” TCP markets its prequalified shippers under the TimeSaver brand with each being supplied with a certificate of authentication. “I think it validates our approach, which is to use the phase-change material as a platform and test the packaging solution under some very demanding temperature profiles.” Barakat adds that the “holy grail for prequalified shippers seems to be five days.”
Pringle says that prequalified shippers will be of particular interest to drug makers that outsource any part of their clinical trial supply chains. “Why risk not proving the efficacy of products during clinical trials? Why risk it with cheaper packaging?”
Copyright ©2005 Pharmaceutical & Medical Packaging News
