Adapting to Any Shipping Scenario

New passive systems aim to protect payloads against the unexpected, and even offer reuse possibilities.

Demand for pallet-sized shippers for temperature-sensitive pharmaceuticals is on the rise, report suppliers to the industry. But their size doesn’t make them immune to the hazards of a complex supply chain, the challenges of securing global support, and the push to contain costs and reduce waste. Sophisticated solutions are now available, but drug shippers need to fully understand their supply chains and carefully examine all options.

“We are seeing an increasing need for pallet load–sized insulated shippers for bulk products and other needs,” reports Bill Hingle of TCP Reliable (Edison, NJ). “Companies are looking for large-volume capacity.”

The BulkpakPIR is available in full and half sizes.

Active and passive systems for maintaining specific temperature ranges are now available in various sizes, at various price points, and with varying degrees of necessary assembly and support. Two passive solutions from TCP Reliable, for instance, include the BulkpakPIR and RePak120 bulk shippers. They are available in single-use or reusable versions and can be assembled by one person. The company also has eight other models with varying sizes and temperature ranges under development. One system in the works is a full pallet transporter in which the pallet itself—complete with its load—could be placed inside a shipper.

On their journey, temperature-sensitive drugs and biologics may end up waiting during loading and unloading times. Chances are that some of that time may be spent left out on airport tarmacs or other holding areas, where they could see extreme temperatures. In addition, “when companies are transporting along global lanes, their shipments could get caught in customs,” notes Hingle. “They also may not get optimal placement in cargo areas.”

Shippers that maintain tight temperature control for long durations can help drug companies protect their payloads. The RePak120, for instance, is a passive system designed to maintain 2–8°C for up to 120 hours. Utilizing Cryopak refrigerants in either gel packs, Flex Ice Blankets, or H-Type engineered phase-change bottles, the RePak line has been tested against robust summer and winter profiles.

Hingle says that long-duration passive systems may be able to address the unexpected delays often experienced throughout the supply chain. “Active systems often require tightly maintained shipping lanes with a well-supported network to transport and service the containers throughout shipment,” observes Hingle. “Because they utilize a highly traceable network, they are often very attractive to pharmaceutical companies.

“But if that network isn’t in place throughout the entire shipping route, and the container experiences a wild card as it moves in and out of countries without such infrastructure, the payload could be vulnerable. Passive systems, on the other hand, are designed to perform without such active support.”

In addition, required shipping capacity may vary from lot to lot, which could be problematic if a company has committed to a long-term rental of an active container. “Passive systems can easily be scaled up or down to meet varying needs in temperature, size, and weight,” says Hingle.

Using lightweight insulated panels, the RePak120 can maintain 2-8 degrees C for up to 120 hours.

For instance, one current customer asked TCP Reliable to maximize the cube space on unit-load devices, the aluminum sheets often called cookie sheets. “The company wanted two shippers that could sit four to one sheet or two to one half-sheet. We built passive insulated systems that could be easily adapted to any shipping scenario,” Hingle reports.

Given the ruggedness of passive designs like RePak and BulkpakPIR, reusability is a definite possibility. Reuse scenarios, however, require the development of SOPs for inspection, refurbishment, replacement, and cleaning or sterilization processes as needed.

For instance, Hingle outlines three possible reuse scenarios once a shipper has arrived at its destination:

• It could be processed, refilled, and placed into a different shipping lane.
• It could be shipped back empty to its point of origin for reprocessing.
• It could be broken down into a flattened state and shipped elsewhere for reconstruction.

TCP Reliable’s subsidiary company, DDL Inc. (Eden Prairie, MN), tests reusable designs for clients to determine how many turns a shipper can take while maintaining thermal performance equivalence, with no physical damage. “DDL provides data to customers based on their custom protocols,” says Hingle.

The number of cycles as well as the cost of refurbishing can demonstrate the viability of a reuse program. “In some scenarios, companies can cost effectively get the shippers back, and they have the performance data to support reuse,” says Hingle. “It is important to be able to ensure no performance degradation.”

For such programs, TCP Reliable and DDL help customers develop custom protocols. “In these cases, everything is client specific,” he continues. “We have to be able to validate custom cycles and protocols and then write custom SOPs.” TCP Reliable helps support that client protocol with factory refurbishment as specified by the custom SOPs. “We support it directly. We do not contract out that support.”

Hingle says that more and more pharmaceutical companies are taking this route. “They are driven by two things: straight economics and the heavy push—and maybe even mandates—toward greener solutions.”

But reuse may not always be the greenest alternative. “If you are returning an empty box, you are expending energy and money for shipping air. To minimize environmental impact, companies should be looking at the total solution,” advises Hingle. “The most successful project will combine both environmental and economical benefits.”

In the meantime, Hingle says that companies are most interested in fully tested and qualified cost-effective shipping solutions. “They also want variety in size and temperature ranges and easy assembly. Keeping these needs in mind, there can be a clear economic benefit to a large passive system.”

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