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New packaging options monitor and protect temperature-sensitive products.
New products for maintaining the cold chain emerge on a regular basis. One new insulated shipper is designed to protect temperature-sensitive pharmaceuticals or vaccines for as many as five days. This protection is more than twice as long as that of older designs.
Hallie Forcinio (ENTROPY SOLUTIONS)
The reusable shipper consists of three US-made components: a high-density polyethylene (HDPE) corrugated box, vacuum-sealed insulating panels with an R value of 40, and biodegradable phase-change material ("Greenbox" insulated shipper, Entropy Solutions , Minneapolis, MN).
The shipper's insulating panels use nanotechnology to slow the transmission of heat or cold. A tortuous path through pores of carbon silica compresses a high level of protection into a narrow space ("Thermal-Lok" insulating panels, Entropy Solutions).
Phase-change material is supplied in a rigid plastic container ("E-Pack," Entropy Solutions) or flexible pillow pouch. The material shifts from liquid to solid or vice versa at preset temperatures. In this way, various combinations of color-coded packs or pouches maintain the shipper's contents within a narrow temperature range. Color-coding also expedites packing of shippers and reduces the chance of packing errors.
Small, medium, and large stock-box sizes offer payload areas of 288, 600, and 1,156 in.3, respectively. The small and medium boxes are rated for 72 h, the large size for 96 h. Entropy Solutions is developing a 30-day box that can be used as a mobile vaccine center.
Extremely durable components made of tough plastics and other materials allow shippers to withstand 100 trips or more. If a shipper is not used in a closed-loop system, the recipient sends it to a reclamation center where it is inspected, cleaned, and returned for reuse. If a component fails, the recipient returns it to the manufacturer for recycling. After a shipper's last use, all components (i.e., the box, insulated panels, and phase-change material) are recycled.
Reusable shippers provide great savings compared with traditional foam-based insulated shippers. Savings come from the elimination of overnight shipments and waste, minimization of product loss caused by temperature abuse, reduction of packing time, and reduction in warehouse space requirements. Based on a lifetime of 30 trips, the Greenbox cuts costs by an estimated 65% compared with traditional insulated shippers.
Coldchain Technology Services (Spring Branch, TX), a provider of consulting and logistics services, is one early adopter of the reusable system. The company uses the system exclusively to ship temperature-sensitive products, primarily vaccines, to its customers. The firm maintains 100 shippers for one medical group that sets up mobile flu-shot clinics for businesses and other organizations. At press time, each shipper had made an average of 10 trips.
"They still look brand new," reports Wayne Williams, Coldchain's executive director. "Even if something happened, for example, the outside shell got ripped or cut, you just replace that. You never have to replace the entire system unless it accidentally gets thrown away instead of being returned. [After one trip,] foam-based insulated shippers may change and no longer meet standards. We know Greenbox doesn't change at all."
The corrugated HDPE shipper establishes the narrow 2–8 °C temperature window that flu vaccine requires and maintains it for at least 72 h. Companies can thus use ground shipping rather than expensive overnight delivery services. The corrugated HDPE shipper is about 50% lighter than traditional insulated shippers. Its light weight reduces shipping costs and makes it easier for one person to handle.
The HDPE shipper also requires less space in freezers, refrigerators, warehouses, and trucks than traditional models do. Conventional insulated shippers take 35 min to pack because they rely on frozen or chilled gel packs and require a detailed packing protocol that often varies with the season. In contrast, personnel can pack the new shipper in 5 min. The corrugated HDPE shipper also eliminates waste because it can be returned to Coldchain. The company recycles components when they are no longer usable.
As a result, "We've seen tremendous time savings, cost savings, and customer satisfaction across the board," says Williams. He estimates that Coldchain Technologies achieves a return on its investment in six trips, even though the initial cost of the reusable system is about six times more than that of a traditional foam-based insulated shipper. "It's an easy transition," he adds. "We were comfortable adopting the technology" because of Entropy's arduous testing program, which included temperature mapping and independent verification of results.
A container's shipment cycle
Coldchain ships boxes of vaccine to its medical group customer by ground. Shipments generally arrive at their destination by 10:30 in the morning, and the boxes include return labels. After recipients unpack the boxes, they label them and set them out for pickup that afternoon. A box's round trip takes three to five days, including a day or two in ground transit on each end. Transit time lasts one or two weeks if boxes transport vaccines to mobile clinics before they are returned.
A reusable shipper combines a high-density polyethylene corrugated box, insulating panels, and color-coded biodegradable phase-change material to protect temperature-sensitive products for five days.
The medical customer's mobile teams like the boxes because they are easy to use and eliminate the need to haul a refrigerator. When a team returns from a mobile clinic, "they put the vaccine and phase-change material in the refrigerator for overnight storage, repack the box, and return to the field the next day," says Williams.
When empty boxes return to Coldchain, employees wipe down their outer surfaces, inspect their interior components, and recharge phase-change material in a freezer or refrigerator. "We can turn around boxes in 12 h compared with at least 24 h for gel-pack systems, which require a longer conditioning time," reports Williams.
FedEx adopted AcuTemps "AX2100L" compressor-driven air cargo container for its "Custom Critical" and "Express services."
"We've had zero issues with shipments, even in situations where boxes were misdirected or misplaced during distribution," he says. One shipment took nine days to arrive at an Arkansas clinic because of delivery missteps before and after a holiday weekend. When the recipients unpacked the box, they discovered that the contents were undamaged. The loss of $12,000 worth of vaccines had been prevented. "No foam shipper would have been able to manage that," claims Williams.
To ensure that optimal conditions are maintained in transit, each of Coldchain's shipments carries a freeze indicator and a label that changes color if temperatures rise above a preset threshold. Shipments also include instructions to call an 800 number if either temperature indicator is activated.
Millions of dollars worth of vaccines are lost each year or rendered ineffective because they expire before reaching patients. Reusable insulated-shipper technology can help prevent this problem. Because the packing protocol for the Greenbox is so easy, a facility with an oversupply of vaccine that will expire soon can quickly send it to a facility that can use it immediately. "This really hasn't been possible before," says Williams. "The [savings] potential here is huge," he concludes.
Coldchain uses passive temperature sensors in its temperature-sensitive shipments, but active technology also is available. One new product, a validated temperature indicator, protects freeze-sensitive pharmaceutical products by integrating reliable, electronic temperature measurement into a compact, easy-to-use device.
Designed as an alternative to chemical freeze indicators, the electronic device is validated and calibrated to the requirements of the National Institute of Standards and Technology. The unit offers custom time and temperature alarm thresholds so a customer can tailor settings to reduce the chance of product damage and false alarms. A simple liquid-crystal display helps the user make immediate accept–reject decisions about incoming shipments “FreezeAlert” indicator, Sensitech, Beverly, MA).
Sensitechs FreezeAlert monitor helps users make accept-reject decisions.
Other new, reusable cold-chain shipping systems include a 36-L container with a tough exterior fabricated to Air Transport Association requirements. An 11-L size model with a carrying handle features the same rugged exterior, enhanced thermal efficiency, and light weight.
Neither unit needs gel packs to maintain refrigerated shipments at temperatures between 2 and 8 °C. The systems maintain this temperature for at least five days in an average ambient temperature of 25 °C. An on-board data logger monitors internal and external temperatures ("ATA R36C" container, "R11TC" container, Kodiak Thermal Technologies, Houston, TX).
The first compressor-driven air cargo container approved by the Federal Aviation Administration is now cleared for use in the cargo holds of aircraft. Designed to transport bulk temperature-sensitive products, the container holds shipments on standard 48 × 40-in. pallets. A combination of advanced insulation and temperature-management technologies allows the container to maintain a constant temperature for more than 100 h, a duration four times longer than that of dry-ice containers.
An adjustable operator interface allows the user to select temperature set points between 4 and 25 °C. An integral data-logging system verifies that the required temperature is maintained. In addition to recording internal and ambient temperature data, the system monitors battery power, door openings and power-mode changes from AC to battery ("AcuTemp AX2100L" refrigeration container, AcuTemp Thermal Systems, Dayton, OH, marketed as "AcuTemp RKN," AmSafe, Phoenix, AZ).
A related pallet-size container delivers similar protection for ground shipments and eliminates the need for refrigerated trucks in closed-loop or over-the-road, less-than-truckload settings ("AcuTemp AX2100LG," AcuTemp Thermal Systems).
Temperature-sensitive biotechnology products are multiplying. Temperature abuse causes the loss of millions, if not billions, of dollars worth of vaccines and drugs each year. In this environment, cold-chain management will remain a major responsibility for the pharmaceutical industry. Fortunately, new tools to maintain products at the proper temperature are being introduced to the market constantly. Not only do these tools help prevent products from becoming too warm or too cold, but they also may reduce shipping costs, occupy less space in the warehouse, simplify packaging and handling and meet today's demands for sustainability.
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, firstname.lastname@example.org