The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.
Issue link: https://lifescienceleadermag.epubxp.com/i/118943
Pharma Supply Chain The Cold Chain: What You Don't Know By Gail Dutton, contributing editor P harmaceutical supply chain experts are among the best at managing the cold chain, but new innovative packaging and transportation options are changing some well-established assumptions. "You have to be aware of daily conditions on the shipping lanes," says Jim Cafone, VP of supply network services at Pfizer Global Supply. "If you don't know what's happening, you can't validate the lanes." He advocates monitoring each shipment. Analyzing that data can identify usual shipping conditions but may not reflect the extremes faced during unseasonable weather or delays. Delays are more common for containerized and palletized shipments than for small packages because of the shrinking fleet of wide-body aircraft, he adds. At Amgen, "One of the big 'ahas!' was the need to qualify packaging systems in the same environment in which they would be packed," says Tim Valko, executive director of risk management. "Validate the packaging on the floor where products actually are packaged — not in the lab. And, ensure the process becomes an SOP (standard operating procedure) for the scientists and for the packaging line operators. Validation must not be a paper exercise." PACKAGING EXPECTATIONS ARE CHANGING Currently, most pharmaceutical shippers use dedicated packaging solutions for summer and winter, but universal packaging for clinical trials (where the drugs being shipped) have limited stability data. "With commercial products, the cost of universal packaging is approximately twice that of dedicated packaging. So, if you're shipping commercial products in the same climate range, is it worth the cost of universal packaging to prevent a brief 40 LifeScienceLeader.com excursion of perhaps 2°C?" asks Tom Pringle, principal, Pringle Consulting, LLC. While shippers are trying to streamline their packaging options, regulators are still formulating requirements for their own countries. Currently, "Each regulatory body has different expectations. It's a complex Rubik's cube," Cafone says. For example, some products stored between 2°C and 8°C may withstand temperature excursions of a few days' duration, but some regulators allow excursions of less than three hours while others allow none. Accommodating those differences requires different package engineering and shipping solutions and, therefore, increases costs. Ideally, pharmaceutical manufacturers would develop their products so they don't require the cold chain. As Martin VanTrieste, RPh, senior VP of quality at Amgen, elaborates, "Many biological products are much more heat stable than we originally thought. If you perform the proper studies, you can minimize cold chain needs or ensure that minor excursions are acceptable." UNDERSTAND PACKAGING LIMITATIONS The choice of active packaging systems (that are plugged into electrical current), passive packaging systems (that rely on insulation and coolants like liquid nitrogen or dry ice), or hybrid packaging systems (that combine active and passive systems) depends upon April 2013 the stability, geographic origin, and destination of the product. "For example, Brussels to Chicago has a standard elapsed, door-todoor shipping time of about 36 hours. For that, we can use passive containers with a 120-hour hold time," Cafone says. Shipping from Brussels to an emerging market, however, is less predictable. "It may take 72 hours, or it may take 14 days. For that, we use active systems and hope handlers plug them in." It requires more than plugging them in to ensure products arrive in good condition, though. Although properly operating containers set to 5°C typically are accurate to plus or minus 3°C, "Shippers often overlook the importance of preconditioning the operating container — not just the air inside it — and the product to the same temperature," says Karl Kussow, manager of quality at FedEx Custom Critical. Kussow, who is helping write the upcoming Parenteral Drug Association (PDA) technical report on active containers, says active containers can't truly be validated. "They're mechanical. For the report, we agreed to call the process 'qualification.'" He says the three keys to success using active containers are proper maintenance, attention to the shipping and loading process, and ensuring active control. "Having passive protection inside is a good buffer for transfers between modes," he adds. For passive containers, tailored phase-