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TRANSPORTATION PACKAGING

Transport Containers Go the Distance

New passive and active shippers promise steady temperatures for long hauls.

By David Vaczek
Senior Editor

Entropy Solutions’ Greenbox container doubles cargo space, with PCM technology that prevents thermal shocking of the payload.

Although prequalified off-the-shelf container solutions meet the require- ments of many transport scenarios, temperature-sensitive drug shippers increasingly seek customized packaging developed to withstand the rigors of defined transport itineraries. For tailoring packaging to customers’ specific needs, package suppliers have focused on reducing the cost of package materials and shipping, without sacrificing functional performance.

Tegrant Corp., ThermoSafe Brands (Arlington Heights, IL) offers prequalified systems in disposable containers in its Nomadic line of shippers, and in a range of roto-molded polyethylene durable containers with polyurethane insulation. These upright and chest-style durable units provide refrigerated and deep freeze packaging for bulk-sized payloads.

As the global transport market matures, customers are requiring proprietary package configurations. Tegrant will reengineer and test disposable or durable designs according to customers’ needs, says Rich Ellinger, director of marketing and development, ThermoSafe Brands.

“Customers moving product in air transport frequently come to us without a firm requirement,” Ellinger says. “They don’t have a complete packaging solution. Based on their payload size and temperature needs, we can create a custom system that may help reduce their costs without compromising the payload.”

“There is always the ability to be more creative with engineering,” he adds. “If you can decrease refrigerant or insulation, you can increase container space, or reduce cube on the truck. We are constantly searching for more elegant and cost-effective design.”

Customers are more likely to develop their own data, creating the need for testing to custom ambient profiles and temperature ranges. “Most companies use the ISTA profiles as a jump point for developing their own profiles based on measured field data,” he says. “We consistently recommend that companies perform temperature monitoring throughout the logistics chain to
understand what their profile will be.”

DIALING IN TEMPERATURES

The AcuTemp RKN features a heating coil and high-performance insulation for supporting flat line temperatures in adverse circumstances.

New passive system technology features tight temperature maintenance for bio-pharma products and increased cargo space, and it promotes portability for the U. S. armed services.

Entropy Solutions Inc. (Minneapolis) uses proprietary phase-change technology in thermal shippers offering twice the payload space in some sizes compared with standard designs. The company’s Greenbox Thermal Management System maintains narrow temperature ranges for up to five days, through extreme summer and winter conditions.

Entropy’s system uses two PCMs with different phase points. One is packed out in solid form, the other in liquid form. The technology of the PCM material combined with the two-PCM configuration extends the maintenance of the narrow compartment temperatures. The company has developed 21 various organic-oil based PCMs that can be configured for temp ranges of ­–20°C to 50°C, says Eric Lindquist, president.

“Our PCMs have very tight tolerances [phasing in narrow temperature windows],” says Lindquist. “By combining two different materials with very specific phase change points, we can dial in a very specific temperature range.”

The system’s key is exchange of energy that occurs between the solid PCM and a liquid PCM with higher phase point. Interplay between the two PCMs prevents thermal shocking of the payload at the outset of the packout.

Refrigerated 2° to 8°C packouts, for example, are commonly held within a tight 5°C range. “The solid and the liquid panels are absorbing or releasing energy. As the energy in the cargo compartment rises, the frozen PCM liquefies, transferring energy to the liquid PCM. The liquid PCM (packed closest to the product) will start to solidify, however it will not become completely solid. The liquid PCM will never go below zero degrees, where it could thermally shock the payload,” Lindquist says.

The packout for 48, 72, and 96-hour shippers includes Thermal-Lok insulation panels with patented nanotechnology. Its core structure impedes thermal energy transfer by enabling the vacuum evacuation of virtually all air. The outer carton is a durable, water-resistant HDPE.

Entropy Solutions has demonstrated packouts sustaining temperatures for 200-plus hours in extreme conditions using its in-house test chambers. “We are working on a packout now that will go for 30 days,” Lindquist says. “We know we have the technology that will allow us to eventually achieve that.”

Entropy’s solution gives bio-drug manufacturers the ability to dial in specific temperature ranges previously unachievable in passive systems—for example a 20° to 25°C range, Lindquist asserts.

“You can’t hit those tight temperature ranges with standard gel packs that are limited to certain wide temperature ranges,” he says. “If required, our PCM technology allows bio-pharma manufacturers the opportunity to maintain temperature ranges previously only attainable with mechanical systems.”

The system’s format provides expanded payload size and better payload efficiency (useable payload divided by container size). The 96-hour shipper, for example, has payload size of 400 cubic inches, and 23% payload efficiency, versus the 125 cube and 2.1% payload efficiency of a leading competitor, Entropy says.

All components allow repeated reuse, including PCMs that the company says incur no thermal degradation after 20,000 uses. As the product name implies, Greenbox shippers are enviro-friendly. “Every component of the Greenbox system is either recyclable or made from a recycled material,” Lindquist says.

CRITICAL REACH

Minnesota Thermal Science (Plymouth, MN) has adapted its thermal container technology to a new use for delivering biopharmaceuticals to soldiers on the battlefield. U.S. Special Forces awarded the firm a contract for a thermal container to convey emergency dosages of Coagulation Factor VIIa, introduced in the United States by Novo Nordisk as the brand NovoSeven, is a genetically engineered drug that promotes blood clotting.

“Factor VIIa is an injectable drug that costs $3500 a vial,” says Karl Schlenker, vice president, sales and marketing. “Special Forces was experimenting with it for improving life expectancy in severely wounded soldiers, but they had no way to deliver it to the battlefield. They asked us for a smaller, lighter weight version of our Golden Hour thermal container technology.”

The 5 inch-by 3 inch-by 7½-inch-high container features the same technology used in the Golden Hour systems. A thermally protected container holds a thermal insulation chamber (TIC) that can be removed for transport. Phase change materials in the TIC panels eliminate wet and dry ice.

The pack holds two vials, with two packs designed to fit into a standard Golden Hour medic pack. The three-pound Factor VII container holds refrigerated temperature for 48 hours in extremes of heat and cold.

“If a team is out on an extended mission, the medic pack becomes the staging unit for the Factor VIIa pack, providing extended performance capability for seven to 10 days,” says Schlenker.

Minnesota Thermal has developed Golden Hour containers for the U. S. armed forces for handling payloads of up to 17 blood units, and that lock in frozen temperatures for blood nearing the end of its usable life. Among solutions that avoid the use of wet or dry ice, it provides an Army shipper for storing blood platelets at room temperature for up to 36 hours. In the commercial area, the firm has contracted with American’s Blood Banks, providing a –20°C shipper and a platelet shipper, says Schlenker.

“We do a full battery of ISTA summer and winter profile testing, but for military requirements, we always test at constant temperature ambience,” he says. “The ISTA profile might have a range as great as 15° to 20°C from coldest to warmest, and they typically do not test at the extremes at which we are testing.”

Awarded the Army’s Greatest Invention Award in 2004, the original Golden Hour medic pack transports 4 units of blood (2 liter payload) at 5°C for 72 hours under minus 20° to 45°C ambient conditions.

The Walter Reed Army Institute of Research sought bids and awarded Minnesota Thermal Science the contract to develop the medic pack, after a 2002 incident in Afghanistan highlighted the urgent need for a portable blood transport system for reaching wounded soldiers.

Jason Cunningham, a Special Forces parajumper, packed two units of blood in his rucksack against procedure to treat bleeding casualties on the ground, when a helicopter was downed at 17,000 feet on Robert’s Ridge. After landing in a heavily-damaged rescue medvac helicopter, Cunningham took a high-velocity round to the hip, transfused the wounded, and bled to death, without availability of additional blood supply.

COOLING AND HEATING

Airlines and freight forwarders are expanding deployments of active containers, often as components of structured cold chain products. In exclusively focusing on the pharma segment, Envirotainer (Lagga Marma, Sweden) launched its Qualified Envirotainer Provider (QEP) program in 2006 for training and accrediting airline ground handlers. The firm is building out its fleet of fan-and-dry-iced based LD3 and LD9 containers, and coil-and-compressor driven heating and cooling e1 shippers.

Delta Cargo said it will use the company’s RKN t2 and RAP t2 containers in its worldwide network, and plans to participate in the QEP training. Continental Airlines Cargo is implementing the training, with plans to expand use of Envirotainer shippers in its ClimateSecure service.

Kuehne & Nagel is the first freight forwarder to earn QEP accreditations, after training at 29 stations worldwide. Envirotainer has further described key partner agreements with Emirates SkyCargo, Air Canada Cargo, and an extended contract with its biggest customer, Air France-KLM Cargo.

Carriers outside the United States are using Envirotainer’s e1 unit, while the firm awaits FAA endorsement for use on U.S. airlines.

In October, FAA granted approval for domestic airline use of the AcuTemp RKN from AcuTemp Thermal Systems (Dayton, OH). The pallet shipper has since been adopted by FedEx Custom Critical to supplement its active container fleet (see Bio-Pharma Transport column, page 30).

Marketed to the air cargo industry by AcuTemp partner AmSafe Bridport (Phoenix), the AcuTemp AX2100L features an active heating element, for protecting product from freezing temperatures on the ground and in aircraft cargo holds. The unit holds tight temperature tolerances for over 100 hours before battery recharging, at set points of 4° to 25°C.

Vince Reidy, vice president, sales and marketing, AcuTemp, says internal and ambient temperatures are logged every five minutes, with data held in memory for up to 30 days, for downloading via USB port to an Excel document for analysis. FedEx has exclusive use of the shipper for a defined period of time. “The number of units in service is ramping up each month, with the expectation that several hundred units will be in service by the end of 2008,” Reidy says.

FedEx Custom Critical will deploy the RKN in its Air Expedite service, providing the Temp Assure Air and Validated Air services. The FedEx Corp. subsidiary draws on integrated support from FedEx Express for transport of temperature-sensitive freight, tapping the FedEx Express airline network for non-stop, door-to-door service with coast-to-coast and international itineraries, says Ryan Henary, communications supervisor, FedEx Custom Critical.

In its Temp-Assure Validated Ground service, Custom Critical revalidates about half the trucks in its temperature-controlled truck fleet every 18 months to ensure they meet performance standards.“We will secure the container, precondition it, and take it to the customer’s loading point,” says Henary. “The FedEx Express personnel are alerted about the incoming Custom Critical freight, which is visually identified with blue tape.”

The company’s thermal-mapped aircraft support the Validated Air service in international routes. “We can dictate on the front end an optimal container position, because we know what the
temperatures are at different cargo compartments and container positions,” he adds.

Copyright ©2008 Pharmaceutical & Medical Packaging News