Medical Device Link.

Originally Published PMPN October 2004

Transportation Packaging

Scaling Up Controlled-Temperature Shippers

Pallet-sized insulated shippers, ranging from passive systems to active systems with sophisticated monitors, protect and deliver big pharma’s—and little pharma’s—big payloads.

by Jenevieve Blair Polin

Contributing Editor

Many pharmaceutical manufacturers in the United States now ship active pharmaceutical ingredients (APIs) in bulk to other countries where subsidiaries may complete the form and fill, then ship the finished product back to the United States for distribution. These shipments are large and extremely valuable. If the product is temperature sensitive, it requires thermal protection in both directions. Transportation packaging materials offer manufacturers an expanding armada of pallet-sized shippers to ferry these big, sensitive payloads.

AVOIDING MIGRATION

Cold Chain Technologies’ KoolGuard has 3-in.-thick walls of extruded polystyrene and can be further protected with refrigerant bricks.

There is no way to ensure that a package will always remain “this end up” as it travels through the distribution chain. Therefore, many packaging experts recommend surrounding the temperature-sensitive payload equally on all sides with thermal protection.

TCP Reliable Inc. (Edison, NJ) recently introduced thermal control panels (TCPs) as a shiftproof option. The thermal control panels are a hard-shell modular system with interlocking features. The panels interlock to form a continuous cube around the payload. Each contains a phase-change material. “That gives you extremely precise temperature control, because you’ve completely surrounded the product,” explains Maurice Barakat, president and CEO of TCP Reliable.

“By using temperature-specific phase-change materials in TCPs, we very often reduce the volume and the weight by about half. It’s the direction that many people want to go. They want to save money on the freight, which is usually many times more than the packaging, and have a more reliable, rugged temperature control,” Barakat adds.

A multilayered approach to controlled-temperature pallet shipper construction facilitates recycling, particularly important in shippers destined for Europe. In this scheme, a hard outer shell, sometimes corrugated, covers a completely separate layer of insulation. In some cases a third layer, a thin inner shell, surrounds the payload. Each layer can be disposed of or recycled individually. The user can replace each layer, if necessary because of damage during transit, without discarding all layers. The Repak from TCP Reliable is an EPS-insulated pallet shipper with a separate corrugated shell. “We have customers that have used the Repak for 100 cycles, and their products are still working,” Barakat says.

Cold Chain Technologies Inc. (Holliston, MA) employs a similar approach to avoiding migration of cold packs in its KoolGuard insulated pallet shippers. Corrugated sleeves, which hold Koolit refrigerant bricks in place, line the inside of the shipper. Cold Chain Technologies offers three sizes of KoolGuard pallet shippers, ranging from 23 cu ft to a 45-cu-ft unit introduced in 2003.

Larry Gordon, president of Cold Chain Technologies Inc., says the largest—the 4500—can be used as a stand-alone but was designed specifically to fit inside the LD3-size RKN container made by Envirotainer (Lagga Marma, Sweden). The 4500 is called an I-Box when sold or leased through the company Envirotainer.

Vacuum insulation technology, used in Energy Storage Technologies’ AcuTemp shipping boxes, protects temperature-sensitive products.

“It is naturally the shipper’s choice if they’re looking to extend the specifications to even-more-demanding criteria, which can be met by varying how they use our containers. One example is the two-step solution, or I-Box, that was developed with Cold Chain Technologies,” explains Magnus Welander, CEO and president, Envirotainer. “The box inside the Envirotainer RKN container improves the passive insulation properties of the system.”

Laminar Medica (Tring, Hertfordshire, UK), a leading European manufacturer of insulated shippers, debuted a similarly jumbo-sized pallet shipper, the 48 ¥ 42-in. Meditherm M14.0, at EastPack in New York City in June 2004. The company claims the product can maintain internal temperature in the 2°–8°C range for up to seven days.

Joseph Villa and Sandy Cook of Thermal Packaging Solutions LLC (Ocean, NJ) designed, validated, patented, and successfully marketed the first reusable temperature-controlled pallet shipper in the late 1990s to major global pharmaceutical companies for domestic and long-duration (up to five days) international shipments. “We also worked with global European airlines to develop systems that will hold appropriate temperatures for pharma products from the manufacturers throughout their distribution worldwide,” says Cook.

Not all manufacturers of temperature-sensitive shipping systems have entered the pallet-shipper arena. “We are not making a pallet shipper,” says Don Santeler, president of Polartech (Genoa, IL). “I think a lot of people jumped into that too quickly. I believe there is a component missing that would provide better protection. That’s something we may come up with later.” Polartech manufactures Thermo Chill EPS shippers and Ice Brix refrigerant packs.

RUGGED ALTERNATIVES

“We have seen a large increase in demand for bulk transport of temperature-sensitive goods,” says Kevin Grogan, director of marketing and business development, SCA Packaging North America, ThermoSafe Brands (Arlington Heights, IL). “The drug companies were coming to us looking for things that were larger and larger—types of batch productions that they needed to keep cold, oftentimes between their facilities or from one production site to another. Many of these shipments are moving from Puerto Rico or even Europe, back to somewhere in North America. The traditional molded EPS or polyurethane box just wasn’t big enough or rugged enough to hold up to a 50-L payload.”

To meet this demand, SCA recently acquired HR Industries, a leading manufacturer of rotationally molded insulated shippers. The walls of these shippers contain 3 to 3.5 in. of foamed polyurethane insulation. SCA relaunched the shippers under the ThermoSafe brand, now called ThermoSafe Durable Goods, in October 2003. These reusable passive shippers have capacities of up to 69 cu ft or more. “They’ll hold up for 6–8 years in heavy freight use,” Grogan says. Most customers, he says, prefer to buy the shippers, although leasing is also an option.

Some of these units, Grogan says, “are built specifically for daily deliveries. You put it on the back of a warm truck that goes out on its route. The truck might make four or five stops, and the shipper will keep the payload cold all day, with many openings.” Other ThermoSafe Durable Goods transporters, which are loaded and sealed and not opened until they reach their destination, can hold frozen and refrigerated temperatures for 3–5 days, he adds.

TCP Reliable Inc.’s thermal control panels won a 2004 AmeriStar Award.

At the time this issue went to press, Cold Chain Technologies was scheduled to introduce a rigid, molded vacuum-insulated-panel pallet shipper, the Vac-Q-tainer, at the Cold Chain Management for Pharmaceutical and Biotech Manufacturers conference in Philadelphia, October 14–15. The conference is organized by the Center for Business Intelligence. This passive system, Gordon says, will hold 2°–8°C for more than 90 hours. The coolant is a proprietary blend of phase-change materials. Cold Chain Technologies has tested the system in a chamber at 40°C for 90 hours. “It remained 2°–8°C throughout the pallet cavity,” Gordon says. In a chamber at –20°C, the unit maintained the target temperature range (2°–8°C) for 24 hours. Gordon expects customers to purchase the Vac-Q-tainer for closed-loop distribution systems (APIs out, finished goods returning).

Envirotainer is a pioneer in the manufacture of rugged reusable temperature-controlled bulk shippers. The company has for many years leased out its active thermostat-controlled units, which are cooled by a bunker of dry ice and a battery-operated fan for air exchange and active temperature control. The t2 series introduced in 2002 consists of three sizes, ranging from the CLD (5.7-cu-ft payload) to the RAP (290-cu-ft payload, up to four pallets).

“We have also seen interest from some pharmaceutical customers in using the 20-ft Envirotainer RGX container (980-cu-ft payload), which was specifically developed for the high-tech equipment market for pharmaceutical shipments,” Envirotainer’s Welander says.

The next step in the evolution of active temperature control is a system that both cools and heats, if necessary. In the first quarter of this year, Energy Storage Technologies (EST; Dayton, OH) introduced such a unit, the AcuTemp RKN thermal pallet shipping container. This unit used a CFC-free refrigeration system and electrical heating elements to provide temperature control in a wide range of ambient temperatures. The shipper is constructed of VacuPanel vacuum insulated panels. It can use ac or dc power or run on internal batteries for up to 72 hours. The unit will enter full production in early 2005.

Envirotainer also has a unit with active heating and cooling capabilities in development. It is currently in the field test phase.

TEMPERATURE MONITORING

Given the high value of a pallet of pharmaceutical product, many pharmaceutical manufacturers opt for temperature monitoring. Monitors range from inexpensive disposable units to sophisticated units that “phone home” if they run into trouble.

The Cryogenic shipper, Model LN2DS, from SCA Packaging North America, ThermoSafe Brands, is used for shipping diagnostic specimens at temperatures of –150ºC or below.

Envirotainer containers, Welander says, already log the ambient temperature and the internal container temperature throughout the shipment. In 2003, to expand its fleet’s data-logging capabilities, Envirotainer forged a strategic alliance with Sensitech (Beverly, MA), which sells the TempTale temperature-monitoring system. The two companies plan jointly to launch enhanced temperature monitoring solutions within months.

Envirotainer also has in development a tracking and tracing service for the Envirotainer containers. This service, which the company does not expect to be available on the market in the next 12 months, will include tracking and tracing, temperature monitoring, and a “call home” feature. The latter will be an alert produced by the control unit and transmitted via the mobile phone system network.

The goal, Welander says, is to obtain information in time to take effective countermeasures. “The most interesting part for a pharmaceutical company is not to receive information that something is going wrong; it is for them to have somebody proactively act on information with measures to preserve and ensure the quality of the product being shipped,” he stresses. “The key is therefore not the introduction of a reporting system, but the complex task of setting up the system that can act upon the information, something that has to be done in partnership with all the service providers along the supply chain.” (See sidebar “Going Beyond Temperature,” page 38.)

EST’s AcuTemp thermal pallet shipper has eight onboard sensors, says Mike Sieron, vice president of sales and marketing. “They sample not only four points in the payload area but also the ambient temperature so that we can assure the customer that, of course, the payload is in good shape throughout the transport cycle, but the information is also diagnostic.” The unit also has an extra thermocouple that can be inserted into the payload for special situations.

The EST logger has a redundant power supply. If the main power supply goes dead, the logger remains powered to monitor the duration of the power failure. The unit can download the data at any time via an infrared device or via a serial port for a laptop.

Even a relatively simple data logger can provide information that saves millions of dollars worth of product. In November 2003, TCP Reliable launched a 21 CFR Part 11–compliant data logger, the XI3, a one-way monitor that can be incorporated within a package. “Probably not every package but every high-value package” might benefit from one, Barakat explains.

In trials conducted before the launch of its Meditherm 14.0 this year, Laminar Medica made 450 air freight shipments in the units, all bearing data loggers. These loggers documented that these shipments occurred without a single temperature excursion.

Laminar Medica’s sales manager, Tim Jennings, tells a story demonstrating the value of data loggers. “One pallet shipper got lost at Tokyo airport on the way to Australia, and it was lost for two days. The clients had data loggers in all the shippers, and they downloaded the data simply with the intention of writing the goods off. To their surprise, the temperature had only just cleared 8°C. They had the ability to handle a 2° excursion within their specifications. In that case, quite a substantial value of product was not lost.”

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