Forecast for the Cold Chain
As packagers focus on cold-chain compliance, new shippers support temperature uniformity and duration.
Continental Airlines Cargo plans to launch a new product next year for controlling ambient temperatures in aircraft cargo bins and during ground and warehouse handling. The carrier has signed a global contract with Envirotainer (Sweden) as a preferred partner in its ClimateSecure service.
Guidance and regulations for packagers and their airline carrier partners for the transport of temperature-sensitive medical products have advanced significantly in recent months.
In addressing the growing body of cold-chain global regulations with best-practices guidance, the Pharmaceutical Cold Chain Interest Group (previously named the Pharmaceutical Cold Chain Discussion Group), a working arm of the Parenteral Drug Association (PDA), has released a revision of Technical Report 39 (TR 39).
The revision harmonizes best supply-chain practices with EU regulations and perspectives, Robert Dana, vice president, quality and regulatory affairs, PDA, reported at the IQPC Pharma IQ 5th Annual Cold Chain Distribution for Pharmaceuticals conference in Philadelphia.
The revision includes expanded guidance on packaging components and design and transportation processes. A new Section 9 provides guidance to transport service providers. It includes the recommendation that a quality management system with a designated responsible individual should be established.
Dana said that PDA’s training and resource institute will provide training programs on TR 39 this year in Europe, and next year at domestic locations.
The International Air Transport Association (IATA) in March issued Perishable Cargo Regulations, replacing a Perishable Cargo Manual that served as guidance for its airline members. The regulations include a new Chapter 17 that establishes best practices for handling healthcare products. “Air Transport Logistics for Temperature-Sensitive Healthcare Products” was developed by a cross-industry committee chaired by Kevin O’Donnell, director and chief technical advisor to industry, Tegrant Corp., ThermoSafe Brands.
Representatives from IATA’s Live Animals and Perishables Board (LAPB) reported at the cold-chain event on the new rules and noted some of challenges and issues of concern facing airlines. “High-value cargo requires an SOP. All members now have to follow these perishable-cargo regulations,” said Gregg Pittelkow, LAPB chairman, and senior specialist, operations, Northwest Airlines.
Pittelkow said that a perishables cargo panel will convene this year to address regulation implementation. One consideration will be standard labeling and marking for transport containers, he noted.
“The pharmaceutical industry has not wanted to put labels on the containers [as a theft deterrent]. We need to know what is in the containers,” said Carl Kole, LAPB vice chair, and administrator corporate compliance, special operations, United Airlines.
Kole noted that while in-flight humidity is extremely low, “We don’t have a lot of control over the temperature in the cargo compartment. We depend on the shipper to make sure [the packaging is adequate]. Environmental control systems are expensive and burn more fuel. Airlines will have to decide if the investment is worth it,” he said.
Continental Airlines Cargo (Houston, TX) is developing a new product for monitoring and controlling ambient temperatures in aircraft cargo bins and during ground and warehouse handling. Slated for a 2008 launch, the solution encompasses new handling processes and equipment. Temperature sensors will be fixed to the exterior of containers for tracking ground and in-flight temperatures, says Mark Mohr, manager, product development and specialty sales, Continental Airlines Cargo.
“We are working on maintaining a controlled-temperature scenario for the aircraft, ground, and ramp conditions. The weakest links are the ground and the warehouse handling. The program is designed to maintain room temperatures through hot and cold extremes from shipment tender all the way through to customer recovery,” Mohr says.
Mohr says the ambient-temperature-control product is primarily geared for protection of passive packouts. Unit-load devices (ULDs) employing active temperature-control components are used in the carrier’s ClimateSecure service, which provides high-priority shipment-monitoring and management.
“Cargo-bin temperature variances are less extreme in the wide-body-type aircraft where we use a ULD solution,” says Mohr.
Mohr says the carrier is performing studies monitoring cargo-compartment temperature variances in flight and on the ground. “Our current fleet has capabilities that provide a level of temperature modification in the cargo bin. In aircraft where there has been an opportunity to provide an air conditioning or heat/cool–type system, we have made those investments. We continue to conduct research on ambient-temperature-control capabilities by aircraft type. In addition, we are finalizing temperature-control elements for the 25 Boeing 787 Dreamliner aircraft we have on order,” says Mohr.
Continental Airlines Cargo has signed a global contract with Envirotainer (Sweden) for expanded use of the company’s active temperature-controlled pallet shippers. As part of the agreement, Continental employees and contracted ground handlers will be trained in Envirotainer’s container service training program for Qualified/Certified Envirotainer Partner (QEP-CEP) certification by Envirotainer.
For packagers, understanding the capabilities of the distribution chain, including airline partners, is a key element in the process of qualifying packaging using realistic temperature profiles. (For more details, see the Supply Chain Management Supplement to the September issue of Pharmaceutical & Medical Packaging News.)
Longer routes, where packaging that crosses international borders might encounter multiple handoffs or delays, are driving innovation by packaging suppliers that are providing prequalified solutions. New shippers hold cargo temperatures for up to five days.
Cold Chain Technologies (CCT; Holliston, MA) has extended its Kooltemp GTS (global transport system) line of prequalified shippers with the Kooltemp GTS Pallet Shipper. Featuring an interlocking-panel design, the unit holds temperatures for 120 hours, in summer and winter conditions.
“Our customers asked for a longerduration solution for shipments. We have prequalified this to five days, with field data supporting longer use,” says Larry Gordon, president of Cold Chain Technologies.
Constructed of 5-in.-thick rigid molded polyurethane, the panels are molded to hold sleeves of CCT’s Koolit Brick refrigerants flush with the container walls. The user interlocks the walls around the product after it is placed on the base, then secures the refrigerant sleeves and interlocking lid.
“Temperature gradients are minimized by the thermal mass and refrigerant placement that allow convective flow of energy between the external heat loads and internal components. Thus, product temperature uniformity is maintained,” says Gordon.
The water-based refrigerants used in the Koolit Bricks address cost and performance. “Water-based gels hold temperatures longer than phase-change materials made of either organic paraffins or inorganic salt solutions, because, pound for pound, they have significantly greater capacity for heat storage,” he says.
Cold Chain Technologies’ KoolTemp GTS Pallet Shipper accommodates a universal (hot or cold) shipping environment. Prequalified to 120 hours for maintaining product at 2C- 8C, it accepts full pallet sized payloads (up to 48” L x 40” W x 35.25” H).
Addressing longer-duration shipment protection, TCP Reliable Inc. (Edison, NJ) is offering a 120-hour shipper for 2°-to-8°C parcel-sized payloads in its TimeSaver line of prequalified shippers. The unit is being qualified for summer and winter environments, says William Hingle, marketing manager.
The TimeSaver 120-hour shipper incorporates more volume of TCP Reliable’s Phase 5 phase-change refrigerant than is used in the TimeSaver 96-hour shipper. Thermal-control panels are supplemented by a flex-sized blanket with additional refrigerant. Urethane insulation replaces EPS, promoting a sturdier packout and reusability.
“The 120-hour unit responds to customers needs for more reach and more shipping–lane options. Customers are concerned about network delays and the need for longer provisional holding times. They will often go with a longer duration shipper to account for potential delays,” he says.
Thermal shipper solutions from AcuTemp Thermal Systems (Dayton, OH) include reusable pallet-sized shippers featuring active cooling and heating. Payload cooling is accomplished without the use of dry ice.
The company’s newest LD3 containers include the AcuTemp AX2100LG for ground transport and the AcuTemp AX2100L for air transport. Both units provide temperature control at user-selected temperatures between 4° and 25°C for more than 100 hours on battery power at ambient temperatures of 25°C. A data-logging system reports on internal and ambient temperatures, door openings, and changes from ac to battery-power modes.
Featuring a safety system to conform to air-transport requirements, the AcuTemp AX2100L is undergoing certification for use on domestic air carriers, says Brian Kohr, president and COO.
“With our partner AmSafe, we have passed the most stringent pieces of the FAA certification process, and we are awaiting agency approval of the AX2100L,” says Kohr.
The shippers feature a proprietary wall construction technology that adds resistance to rough handling. ThermoCor high-performance insulation with an R value of 45 supports internal temperature consistency and extended hold time should batteries expire.
Active and passive shippers each have their advantages. Some suppliers predict a trend toward increased use of active containers, driven by customer outsourcing.
Don Pagel, CEO of Kodiak Thermal Technologies Inc. (Houston), foresees increasing demand for reusable solutions that protect payloads for extended periods and reduce packaging waste. Logistics providers will favor reusable containers for closed-loop transportation networks, he says.
Outsourcing of transportation packaging, and delivery by companies for which transportation is not a core competency, will increase. “The biotech segment is growing at three to five times the pace of the overall pharmaceutical industry. Biotechnology companies have already made the decision that they are going to outsource most if not all of their temperature-critical transportation,” Pagel says.
“Disposal of styrene in landfills is becoming a serious issue with many countries. Germany is forcing shippers to take disposable packaging back. Kodiak shippers are designed for worldwide shipping and repeated use in third-party logistics networks,” he adds.
Kodiak has redesigned 11-liter and 36-liter parcel-sized shippers to increase thermal efficiency and ruggedness. The R11 and R36 units hold payload temperatures in average ambient environments of 25°C for more than five days.
Kodiak segregates phase-change material in a thermal-regulating unit (TRU). In the first-generation design, the TRU is located in the container lid. When a set temperature is exceeded in the payload area, a TRU switch engages with a convection plate to enable heat transfer from the payload area to the TRU coolant manifold. Vacuum Insulation Panels (VIPs) surround and separate the TRU and payload compartment, allowing heat transfer only through the switch.
In the redesign, the TRU is situated in the body of the container, eliminating a break in the VIPs between the container and lid. “The break point was causing more heat leak than we were comfortable with. The VIP now completely surrounds the TRU and payload, increasing the thermal efficiency and decreasing the time required before recharging,” says Pagel.
The units have been refitted with rugged Air Transport Association standard fabricated exteriors to add to their reusable life.
“The new design significantly improves longevity of use. The new ATA R36 was designed specifically for logistics companies requiring a container that can stand up to reuse and can provide a value-added solution for their customers,” says Pagel.
Kohr says AcuTemp’s AX2100LG ground-transport container is suitable for sale or lease to pharma companies shipping between plants or to distribution partners in closed-loop scenarios, as well as for over-the-road companies that might be taking product to end-users.
“One-time shippers are very much the prevalent mode of shipping in the United States when wholesalers break down pallet loads to parcel-sized shipments to end-users. However, there is growing interest in reusable containers as a way to reduce packaging waste and lower total shipping costs,” says Kohr.
Vince Reidy, vice president, sales and marketing for AcuTemp, says customers can realize major trucking-cost savings by using the AX2100LG shipper with dry instead of refrigerated trucks, such as for less-than-truck-load shipments. “Customers are generally only shipping a pallet at a time. You can use our fully validated unit with a dry truck from any ground carrier and add dry products to fill out the shipment,” he says.
New configurations for passive-style packouts support reuse when networks are in place for inspection and reconditioning. Passive shippers from TCP Reliable incorporate reusable components that reduce packaging waste and material and shipping costs. “Customers are much more critically attuned to environmentally friendly solutions. We get the same thermal performance with less refrigerant with reusable phase-change material, such as Phase 5 packs. Since insulating material isn’t required to buffer frozen gel packs, we can achieve a smaller package, reducing shipping costs,” Hingle says.
Gordon says that industry needs to focus on closed-loop processes for the recycling of traditional systems. The Kooltemp GTS pallet shipper’s simplified construction and physically rugged interlocking design supports disassembly for storage and reuse.
“Our systems can be reused providing they are not damaged and are properly inspected. The Kooltemp GTS is a passive system offering dependability of operation without the assistance of outside sources of energy or dependence on logistical handoffs.
Drug companies, logistics providers, and product suppliers need to work together to promote the recycling of containers. We have taken steps in this direction both domestically and internationally with our Topa Verpakking V.P. (The Netherlands) partnership,” he says.
Topa Verpakking has begun manufacturing CCT containers and refrigerants for European distribution.