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Pharma Supply Chain change materials like dry-vapor liquid nitrogen are quite effective at maintaining temperatures for several days. Although these materials may be more expensive than the packaging they replace, they can reduce overall costs by reducing weight and, therefore, freight costs. DEVELOP SOPs FOR COLD CHAIN HANDLING At Pfizer, Cafone says, "We develop specific instructions regarding how shipments are loaded, transported, and received. We define who is responsible for each hand-off, when and how temperature-controlled containers must be recharged, how they are recharged, etc." The documents average 45 pages and should be available to package handlers. The objective is to ensure that carriers are capable of handling the product, understand the products' requirements, and have procedures to minimize mistakes and remediate them when they occur. "We spend a lot of time teaching service providers and encouraging them to invest in education and equipment to maintain the cold chain, based upon the requirements of the products they handle. That includes identifying destination conditions and ensuring that customs offices and the final recipients have the equipment and procedures to protect shipments from thermal excursions. You have to examine the whole chain of custody," Cafone emphasizes. KNOW THE SHIPPING ENVIRONMENT Understanding the partners and their resources, as well as the product's chemistry, becomes even more critical when switching transportation modes. Some companies are moving part of their air cargo to ocean freight, reducing costs but altering risks. Logistics experts talk about reefers disconnected from ships' power and never reconnected, and about partially charged batteries that were drained during handoffs. "Ocean shippers aren't good at handoffs," Cafone says. Therefore, they prefer to avoid transporting pharmaceuticals. They are, however, doing it — particularly for products that don't require close temperature control. "Active containers for ships may not operate within the same tolerances expected of air carriers," says Jamie Chasteen, product development manager at Cold Chain Technologies. Part of the issue relates to the larger sizes of marine containers. To help remedy this potential temperature differential, Kussow recommends loading products in active containers so air flows around the product's sides. Active containers also are at risk when disconnected from ships' power. That risk can be mitigated by deploying passive packaging as a buffer inside the active containers. Amgen's products are shipped in intermodal reefers and lifted from trucks to the ship, where they are plugged into the ship's power. "The reefers have batteries, and all of ours have temperature indicators inside the containers. We know the key profile the product experiences and can reject it if it experienced temperature excursions," says VanTrieste. Advanced monitors incorporate wireless and radio-based communications and real-time monitoring that can alert shippers to pending excursions. Although intervention is possible, it's often impractical because the containers may be inaccessible inside the cargo bay. 42 LifeScienceLeader.com April 2013 COLDER ISN'T BETTER "Distributors and wholesalers often have the mindset that colder is better. It's not," Chasteen says. Freezing substantially diminishes the efficacy of many compounds. "That concept is new to various segments of the industry." Shipments packaged to withstand extreme heat may be damaged when they are used in less severe situations. "A very common problem we see is customers using data loggers who have had no problems with multiple shipments, but who suddenly have a cold excursion. Approximately 95% of the time, when the temperature suddenly hovers between 0° and 2°C, the package was placed in a refrigerator. Invariably, a new employee was stressed about keeping the package cool until the carrier arrived." CONSIDER THE LAWS OF THERMODYNAMICS Solar radiation also is just beginning to be considered in packaging. Chasteen recalls one pharmaceutical shipment that sat on a tarmac at 25°C. "The temperature monitor on the package registered more than 50°C." The differential was caused by the reusable, clear plastic covers that protect pallets from the weather and from abrasion from cargo netting. "The covers created a greenhouse effect." Even without the covers, solar radiation has an effect. "Historically, more than 90% of temperature-sensitive boxes were white lined corrugate," Pringle says. That's changing as shippers realize that white marks packages as high value. The less expensive brown lined corrugate, however, absorbs more solar radiation than white and must be factored into cold chain decisions. Positioning matters, too. "High-density products may exhibit the right temp on the surface but not in the center," Cafone notes. Palletized products, too, will have temperature differences between products at the center of the pallet and those along its exterior. "We conduct studies to understand how long to prechill products to achieve the correct, consistent temperature gradient throughout the pallet. "We also work with surface carriers and airlines to ensure products are placed in the right position in cargo bays. For example, if a refrigeration unit is at the front of the truck, cargo in the front will be colder than cargo near the back. Also, it's warmer over the wheel wells," Cafone says. Aircraft have similar issues, with hot spots near heating elements and toiletry equipment. Depending upon placement, temperatures may range from 8°C to 25°C in a cargo hold. The differences vary even among the same model of plane, so no single solution is effective fleet-side. Some carriers, like FedEx Custom Critical and Panalpina, can control temperatures inside their cargo planes. But, temperature-controlled packaging is still required to ensure proper temperatures are maintained. "The packaging environment is very dynamic, as companies validate new technologies and put them in place," Valko says. "The key is to understand the science behind the packaging, the product's sensitivity, and the complexity of moving that package, and to ensure that material handlers are qualified and understand how temperature excursions affect people's health."