Prequalified Solutions Target Pharma Transport

Five-day trips can use Kodiak’s shipper.

Providers of transport packaging solutions are introducing new offerings with the pharmaceutical industry in mind. Aware of the need to protect these temperature-sensitive formulations, these companies are prequalifying systems to help you get started on your own evaluations.

AcuTemp Thermal Systems (Dayton, OH) has released a temperature-management cargo unit for ground transportation. The AcuTemp AX2100LG allows users to ship pallet-size loads of pharmaceuticals, bio-medical products, medical equipment, electronics, and other temperature-sensitive cargo over the road. Active temperature-management technology employs high-efficiency refrigeration and heating systems coupled with the company’s proprietary ThermoCor high-performance insulation. The AX2100LG is engineered to provide precise temperature control between 4°C (39.2°F) and 25°C (77°F) using either ac or battery power. It can maintain a user-selected internal temperature for more than 100 hours using battery power alone. A data-logging system can help users verify that cargo was maintained at required temperatures during transit. Monitored are internal temperature, ambient temperature, battery state, door openings, and power mode changes (from ac to battery). All reporting data is easily downloadable via electronic serial communication. The AcuTemp AX2100LG accepts standard GMA pallets in any orientation and is equipped with a base that can be lifted by forklift.

Vince Reidy, vice president of sales and marketing, says that the firm has “seen particular interest in the AX2100LG from companies utilizing a closed-looped shipping scenario for transporting temperature-sensitive goods used in manufacturing, drug development, and clinical trial applications. Because the AX2100LG is a self-contained temperature-controlled unit, it does not require using a dedicated refrigerated truck for less than truck load shipments,” says Reidy. “Additionally, since the unit is equipped with sophisticated compressor technology and does not utilize dry ice for cooling, the costs and hazards associated with handling dry ice are eliminated.”

In related news, AcuTemp Thermal Systems and its partner AmSafe Bridport will market a companion thermal pallet unit, the AcuTemp AX2100L, to the air cargo industry later this year. FAA certification of the AcuTemp AX2100L is currently underway.

AcuTemp has also announced that IBC Equipment & Supplies (Greenford, Middlesex, United Kingdom), has joined the company’s network of global distribution partners. IBC Equipment and Supplies will market AcuTemp’s suite of passive and active temperature controlled containers to the pharmaceutical, biotechnology, public health and healthcare markets in Asia and the Middle East.

Kodiak Thermal Technologies Inc. (Houston) has developed new versions of its R11TC and R36 containers for cold-chain shipping.

The new 36-liter R36C uses an industry-standard ATA (Air Transport Association) fabricated exterior to offer an even longer life. The ATA R36C can accurately hold temperatures for refrigerated shipments between 2° and 8°C with an average ambient of 25°C for more than 5 days. Donald Pagel, president and CEO, says, “This new design significantly improves the longevity of use of the customers’ investment as well gives unparalleled physical protection for valuable payloads. This unit was designed specifically with the logistics company in mind that can now offer these robust capabilities to their customers.”

The new 11-liter R11TC container uses the same rugged ATA fabricated exterior like its big brother ATAR36C. The R11TC can also hold temperatures for refrigerated shipments between 2° and 8°C with an average ambient of 25°C for more than 5 days.

“This new design is lighter and more thermally efficient than its predecessor,” says Pagel. “The primary difference is that the TRU (Thermal Regulating Unit) now slips down inside the container, increasing the thermal efficiency while decreasing the charge time needed for the next shipment. Additionally, the position of the container during shipment is of little consequence now.”

The AcuTemp AX2100LG accepts standard GMA pallets in any orientation and is equipped with a base that can be lifted by forklift.

The units have been tested against upper and lower extremes as well as winter and summer prequalified profiles. Both have an Escort onboard data logger to monitor internal and ambient temperatures with a digital readout as well as data download abilities. Temperature regulation is accomplished using Kodiak’s patented Thermal Switch and Thermal Shield technologies, which do not require any gel packs in the payload area. A frozen version is also close to release.

Reusable watertight cases from Pelican Products (Torrance, CA) employ an open-cell core and solid-wall construction for durability. An automatic pressure-equalization valve protects contents during air or high-altitude shipping. According to the company, reusable containers result in lower per-trip costs than do disposable containers. “Companies not only save money by not having to replace expendable packaging, but also reduce non-value-added labor costs, as there is no longer a need to set up and break down packaging,” the firm reports.

Envirotainer (Stockholm) has signed an agreement with Continental Airlines Cargo to increase use of Envirotainer’s active temperature-controlled air cargo containers for customers using Continental Airlines Cargo’s ClimateSecure service. ClimateSecure provides a door-to-door cool chain for up to 72 hours or longer when dry ice and batteries are replenished in transit. The service is designed for customers shipping high-value and sensitive goods including pharmaceuticals and other perishables.

“Our new agreement with Envirotainer demonstrates Continental Cargo’s commitment to expand our position as the only U.S. airline with a comprehensive temperature-controlled shipping program,” says Mark Mohr, Continental Cargo’s manager of product development and specialty sales. The airline says using these advanced unit-load devices provides its customers with a “superior alternative to traditional cooling means such as foam, gel packs, or insulating blankets, which add expense to shipments and waste space.”

As part of the agreement, Continental Airlines will participate in Envirotainer’s training program with the goal to become a QEP-CEP (Qualified/Certified Envirotainer Partner) accredited airline. The program was developed in consultation with the pharmaceutical industry to identify service providers capable of using the Envirotainer solution to ensure the integrity of temperature-sensitive shipments. Continental will start training in Newark, NJ, and in Houston, followed by locations in Western Europe.

Martin Peter, vice president, sales, for Envirotainer, says: “This is an important milestone for Envirotainer. Rolling out the product within Continental Airlines alongside with the QEP-CEP program will help to grow the business at a high quality.”

Cold Chain Technologies (Holliston, MA) has partnered with Topa Verpakking B.V. (The Netherlands), a provider of cold-chain solutions throughout Europe. Topa Verpakking will supply KoolTemp containers (EPS, PUR) and Koolit refrigerants (bricks, gels, mats) to the European market. Working together, the labs of these firms will provide equivalent design and qualification testing on both sides of the Atlantic. Robert Willemse, Manager of Thermal Packaging and Special Projects, of Topa. “Thanks to our collaboration, we can exchange scientific knowledge and innovate in thermal packaging concepts. For our customers, this means that they can get client-specific, optimal, fully compliant insulated packaging that meets the applicable specifications, at any time and anywhere in the world. Reproducibility is the keyword for the USA, Europe and Asian markets.”

TCP Reliable has qualified its TimeSaver96 PUR under ISTA 7D Performance Test Procedures as a 96-hour prequalified shipper. Offering low heat conductivity, the system is designed to be rugged and lightweight. The corrugate components can be easily replaced for reuse. Featuring the same packaging configuration for both winter and summer cycles, the system eases packout and inventory. Each shipper has an inner box for housing payloads up to 0.07 cu ft. The overall dimensions of the TimeSaver96 PUR are 16.25 x 18.5 x 20.25 in. Included with the prequalified shipper are Phase 5 thermal-control panels and a certificate of qualification.

Four new Medical Transporter totes are available from ThermoSafe Brands (Arlington Heights, IL), a division of Tegrant Corp. Model 930 is a durable unit insulated with stain- and impact-resistant expanded polypropylene for storing and transporting blood, sensitive specimens, medications, and organs. The lightweight container features wheels and an adjustable handle for mobility and disposable plastic liners to ease clean up. It is qualified by ISC Labs for the temporary storage and transport of packed red blood cells using Polar Pack refrigerants. Coming soon is Model 960.

ThermoSafe Medical Transporter models 931 and 932 nonqualified nylon totes are designed for specimen and sample transport. Both units include rigid removable liners for easy clean up and added durability. The exterior is constructed of washable, weather- resistant nylon with an adjustable carrying strap and is printed with the standard biohazard symbol. The totes are insulated with high-density polyethylene foam.


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