Tightening Protective Transport

Active, passive, and hybrid designs are deployed as regulators bear down on quality.
Manufacturers of temperature-sensitive freight are adopting newer and improved shippers for ensuring cargo temperature maintenance over longer distances.
As countries have imposed stricter guidance and regulation for cold-chain shipments, auditors to an increasing extent are demanding proof that cargo temperatures are held within label or haven’t exceeded stability data parameters.
“One of the larger trends has been the infusion of controlled room temperature (CRT) shipments. A few years ago you had frozen and refrigerated and all else was treated as “ambient,” says Mark Davis, product manager, healthcare logistics, UPS.
“FDA is now looking at CRT as a new category for which companies have to provide documentation of temperature maintenance,” Davis adds.
Brazil is among countries auditing for CRT and ANVISA (Brazil’s FDA) auditors are requiring proof that CRT has been maintained, says John Howe, COO, CTO, Intelligent Thermal Solutions LLC (ITS; www.intelligentthermalsolutions.com).
“There are a tremendous number of products labeled for room temperature—products that have been on the market for years as well as newer biologics—that investigators have begun to scrutinize more closely. We are working feverishly right now to develop a CRT unit,” Howe says.
For refrigerated products, UPS has announced availability of the PharmaPort 360 pallet shipper from Cool Containers LLC (www.coolcontainersllc.com) as a solution in its Temperature True cold-chain service. Exclusively available from UPS, the unit will initially be available at the carrier’s primary gateways, says Davis.
“We are working with our fleet and our partner airlines to make sure they are capable of moving it, and plan to make them [the containers] available around the world as warranted by demand,” Davis says.
UPS has validated the unit per ISTA’s 7D in-transit monitoring standard for a hypothetical 72-hour shipment. Pharma firms will perform gap analyses comparing the test results with their own requirements, Davis says.
“Manufacturers at the very least will want to do a full analysis of our validation. For the most part we are hoping they can use our testing results with just some minor adjustments.
“Some manufacturers may want to test to absolute temperature extremes. We extended the ISTA test down to –20°C. The bulk of the manufacturers are running tests for 96 hours,” he adds.
Designed to maintain a tight 5°C internal temperature for refrigerated shipments through extremes of ambient temperatures, the PharmaPort 360 features heating and cooling capacity with a super-insulative R-70-plus value insulation.
FAA-approved for both narrow- and wide-body aircraft, the unit provides flexibility for flight options. It can be packed tight in a ULD or cargo compartment, on upper or lower aircraft deck positions, as no air is exchanged outside the container.
Davis calls the PharmaPort 360 a “hybrid active” system. In transit mode after charging, refrigeration and heating systems are idle. A regenerative heat exchanger heats or cools the compartment as air is blown over blocks of phase-change material—one frozen at –5.5°C the other chilled to 15°C—contained in eutectic plates.
“When it’s on the aircraft, it’s closer to a passive container. The only thing that runs is a small computer-driven, air-circulating fan that blows the internal air over the plates,” Davis says.
As a dry-ice-free system, the unit maintains in-transit refrigeration for up to 100 hours without recharging depending on ambient temperatures.
“In standard active systems, dry ice has to be replenished after 72 hours. Dry ice is unavailable or difficult to get in some parts of the world, which means you have to find a cold storage facility, assuming the manufacturer will allow you to open the box.
“If the performance of the PharmaPort 360 needs to be extended, you just plug it into a wall and it becomes a refrigerator,” he adds.
In proactive monitoring in the UPS Temperature True service, ground personnel physically check and document dry ice levels, internal temperatures, and battery voltages, as shipments are tracked for meeting itinerary milestones.
The PharmaPort 360 adds the dimension of “near-real time” remote monitoring. Its Elpro Libero data logger works with a GPS/GSM device to transmit, when the aircraft is on the ground, shipment conditions and location to UPS control towers in Atlanta, GA; Singapore; and Brussels.
“The device sends out prealerts on battery life, inside and outside temperatures, and the condition of the plates. This gives us far more visibility and many more opportunities for intervention,” Davis says.
For small-parcel consignments, Intelligent Thermal Solutions provides a hybrid passive/active solution in its EcoTherm containers. The shippers feature thermostatic temperature control, with a PCM material embedded in the lid, separated from the cargo area by a vacuum insulation panel (VIP) barrier. In the system, heat cannot move back and forth between the PCM and the payload area except through a thermal switch that starts and stops the cooling based on the internal temperature.
A key advantage is the container’s ability to protect cargo requiring 2 to 8°C temperature from freezing, Howe says.
“Many products can withstand excursions on the warm side. But others are ruined when frozen, which is more likely to happen if you ship in cold climates with standard passive systems.
“A standard foam box with gel packs is always cooling. The inside temperature will move to zero and the product will freeze if the outside temperature is too cold. In the EcoTherm, when the internal temperature drops below 4°C the thermal switch shuts the cooling off so the internal heat cannot be absorbed into the PCM,” Howe says.
EcoTherm’s technology supports shipping between cold and hot environments, as the PCM’s cooling capacity is regulated. “If you are loading up on frozen gel packs in Minnesota for shipping in traditional cold chain insulated packaging to Sydney, Australia in January, you’ll freeze the product before it leaves. If you go light on the gel packs, you won’t have enough cooling for Australia in the summer time. EcoTherm is an intelligent solution--it only cools when it needs to cool,” Howe says.
Recently enhanced with improved VIP insulation and a redesigned ATA-style case for ruggedness, EcoTherm shippers, offered in 11- and 36-liter payload sizes, are designed and tested to hold internal temperatures between 2-8C° for 120 hours at an average ambient temperature of 25°C.
Howe says ITS plans to expand its depot system that reduces the costs associated with leasing and renting the reusable container. A third depot planned for January 2012 in a high pharma traffic lane will join depots in North Brunswick, NJ, and Mainz, Germany, both opened in 2010.
In a rental program, units are shipped as ordered, charged, and ready to go. Customers return the shipped containers by cheap freight to the nearest depot avoiding the cost of shipping back to the point of origin. Customers inventory a quantity of units in ITS’s leasing program where they have the advantages of ownership—in addition to one way shipping. “When they ship, we see it in the system and dispatch a replacement container. The shipped unit is sent to the nearest depot, which costs a lot less than having to bring it back.”
ITS’s reusable shipper technology and the depot system were cited this year with two 2011 Greener Package Awards.
Customers with high volume can benefit from buying the units outright. EcoTherm boxes are designed to last to last for 100 trips. “The cost per trip becomes pretty low. So you are getting containers for less cost than the cost of a one-use throw away, with better protection technology. The market has been asking for a green cold-chain packaging solution that is less expensive than current disposable solutions--the EcoTherm product line delivers that result,” Howe says.
Cryopak, a divsion of TCP Reliable (www.cryopak.com) designs prequalified passive shipping solutions against accepted standards such as ISTA 7D and 7E. For the Canadian market, the company performed lane-mapping studies to develop prequalified shippers tailored for that region.
“We did the shipping studies ourselves because we found there was a total lack of profiles for this market. The ISTA profiles didn’t fit cleanly in the Canadian shipping lanes, which are quite diverse from region to region. And in, general, it is colder up there than in the United States,” says Anthony Alleva, Cryopak technical services manager.
“This will give customers in this market a much higher level of assurance. We are finding that the profiles—which are highly stressed—apply to other markets as well,” Alleva adds.
Cryopak collaborated with its ATP division for the lane mapping, partnering with large Canadian pharma distributors that ran the shipments. Profiles were developed from more than a year’s worth of accumulated data.
“There is more interest in using prequalified shippers in qualified shipping lanes. If you have not done any shipping studies and do not have a good handle on your profiles, a prequalified solution provides the assurance the packaging will work with supporting data behind it,” says Bill Hingle, director of marketing, TCP Reliable.
“The design criteria you use has to be able to stand up to challenges by the client’s internal quality group, and regulating authorities. It is critical the profile is well documented and supported,” Hingle adds.
TCP Reliable customers will often use a prequalified shipper as a stop-gap measure, while a parallel effort is under way to develop a custom solution optimized to their needs.
“These are customers that don’t have the time to develop a shipper that is fully tested and documented. They may be facing an immediate compliance issue and need to change what they are doing for the better. We have a lot of companies that use our boxes for the first year, then switch to a customized design where they can start to realize additional cost saving benefits,” Alleva says.
For companies shipping high-value products at low volume, a prequalified design—which may not fit the product exactly—will provide more robust performance. It’s worth the money because of the high value of the goods.
“Prequalified by their very nature tend to be an over-designed, more generalized packaging with costs associated with that. But if the number of shipments is low enough, a customer might use it indefinitely as their sole packaging,” Hingle says.
A biotech firm shipping high-value contents from Israel to the United States adopted the Cryopak urethane, 96-hour TimeSaver unit that leverages Cryopak’s 5°C phase-change material. The shipper provides extra assurance should custom delays or other obstacles interrupt the planned 14-hour transit.
As there is no universal temperature profile accepted on a worldwide scale that can be used in a design, prequalified containers from different manufacturers will be designed against different standards based on different assumptions, Alleva says.
Variables include the materials used, shipment destination, temperatures the shipment will be exposed to, shipment temperature profile, and the payload mass tested during the qualification.
“As an end-user, you have to look at those assumptions, evaluate how the prequalified system is designed and how applicable the design is to your own specific shipping lanes—comparing the parameters used in the prequalified system against those you would use in designing a project from scratch,” says Alleva. 
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