Big Pharma requires big help in protecting CRT products

An inside look at selection and implementation of passive thermal protection


Pallet Quilt QPharma

Fig. 1. Simulated environmental conditions for a pallet-size shipment covered with a palletquilt; through its temperature cycling, the payload maintained specified temperature for up to 72 hours. Credit: QProducts & Services

Meeting the challenges of ensuring product integrity, while keeping control of transportation costs, is a common responsibility for life sciences supply chain managers. This responsibility requires a finger on the pulse of both equipment cost and availability, combined with a true understanding of product stability and the shipping network it travels on. Where, when and how your shipment travels is the key to shipping with confidence. Quantifying risk versus costly equipment at a time when refrigerated capacity is causing rates to soar can be a real challenge. Compound this with products monitored for controlled room-temperature (CRT) specifications and maintaining the cold chain can get expensive quickly.

You can provide your supply chain with another viable option to increase flexibility and reduce transportation costs: employing passive thermal blanketing as an alternative to refrigeration equipment. Best practice is to understand the environmental conditions of a shipping lane, the stability characteristics of the payload, and predictive analytics for anticipating and preventing thermal excursions.

The savings are real, and believe it or not, Big Pharma has been using thermal blankets and covers to send pallets of temperature-sensitive freight on dry equipment for years. [1] One of the original players in the passive thermal protection industry, QProducts & Services (QPS), has been in the business for more than 20 years selling their CargoQuilt, PalletQuilt and other branded products to the food, beverage and chemical industries to protect their products from extreme heat and cold over land, air and ocean. “We didn’t know in the early years that all the time and effort put into product design, product testing and ambient temperature studies for the food & beverage industry would eventually play such a big part in protecting many of the healthcare products we use today,” says Jim O’Donnell, director of sales for the company’s life sciences market.

More recently, QPS has partnered with a UK firm, TP3 Global, to bring their SilverSkin reflective blanket covers to the US market, offering a wider range of technical options for the life sciences industry.

“As we all know now, the healthcare industry is required to follow Good Distribution Practices (GDPs) in many parts of the world. The cold-chain 2–8°C product always had to be protected, but now there is a newly required CRT temperature range, generally defined as 15–25°C. QPS has attended many healthcare conferences and joined healthcare groups that all have the same concern over there not being enough temperature-controlled equipment in the world to transport all this product that was never protected before. Even if the equipment was available, the cost would be unthinkable. Big Pharma required Big Help with this task,” O’Donnell adds.

Many questions need to be answered, such as: how hot or cold does it get in a trailer, in an overseas container or on an airport tarmac? And ultimately, could land, air and ocean CRT products be protected with thermal covers? The simple answer is yes, but with many important details to consider. “You have to be willing to work with an experienced supplier who will take the time to understand your specific challenges,” says O’Donnell. “Sometimes we learn with the shipper or manufacturer what is really happening before, during and after transit of their freight and how it’s actually affecting the product.” The recipe for success is to know your product, know your shipping environment and know your technology.

Know your product
Healthcare products are put through temperature stability testing determining the safe temperature range for a given product. Some products are labeled 15–25°C and cannot go above or below that temperature. Others may have the same label, but can have allowable temperature excursions for a specified time limit. When considering passive temperature protection, this information is essential for designing adequate protection.

Know your shipping environment
To understand passive temperature protection, you first must understand the effects weather has on the shipping environment. Know what temperatures your products are exposed to and for what length of time. For example, if the temperature outside is 85°F, how hot is it in a trailer that has been sitting in the sun for six hours in a parking lot? Does the temperature change if the truck is moving? Is there a difference between trailers and containers? Containers are shipped over land and sea, and for longer periods of time. How does this impact the internal shipping environment? Airfreight that sits outside waiting to be put on a plane is another set of environmental conditions to consider.

Make sure you work with a company that has years of experience in this area, are experts in passive thermal protection and have the answers to these questions, as well as the many others related to the mode and lane your shipment travels. “The idea is to avoid using a cover designed to protect for three hours in the sun on a shipment that requires three days of protection in a trailer. On the flip side, you don’t want to spend the money on a thermal cover designed to protect for days when your window for temperature excursion is only three hours on the tarmac,” says O’Donnell.

QPS has added to its consultative services by partnering with Riskpulse, a meteorological firm to analyze weather conditions regionally and nationally in predicting temperature conditions in trade lanes.

Price Performance

Fig. 2. The tradeoffs between the cost of temperature protection and the range of allowable product temperatures

Know your technology
Behold the price-performance continuum (fig. 2) portraying the cost and effectiveness of passive thermal protection products. With many shapes, sizes, benefits and features, it all comes down to what level of performance you need in order to validate and approve the protection you can count on. With a simple cover for starts and finishing with a hard-shelled, fully insulated shipping box, the cost variance is extreme. Passive thermal technology relies on some basic principles of thermal dynamics: radiant, convective and conductive heat, and inversely the loss thereof.  A proven solution for both convective and radiant heat can be found on the lower end of the continuum and include the popular reflective bubble covers. As the shipping environment becomes more demanding, moving up the continuum to a quilted solution provides more robust protection. The conclusion: know your product, know the risks throughout your transportation network and thus make an informed decision. Choose wisely!

As the US steadily moves towards stricter GDPs, and Europe and Canada lead the hunt for a tightly knit, overall turnkey solution to cold chain transportation, more than just one solution comes into play. Looking forward, the future of shipping protected product encompasses not only the physical tools we use every day, such as refrigerated equipment and passive thermal protection, but also a mix of less tangible services, such as historical/predictive weather data and lane analysis on the planning side, or the re-use and reclamation of thermal blankets and covers, utilizing asset tracking and reverse logistics in order to increase ROI and moderate capital expenditure.

For a more in-depth look at how passive thermal solutions can be a part of your successful supply chain management efforts, take a look at PDA (Parenteral Drug Association) Technical Report No. 72, Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance, co-authored by Peter Mirabella, vice president of technical services at QPS. [2]

References

1. Thermal blankets find a growing cold chain role Pharmaceutical Commerce, March/April 2017, p. 28. http://pharmaceuticalcommerce.com/supply-chain-logistics/thermal-blankets-find-growing-cold-chain-role/

2. PDA Technical Report No. 72, available for purchase at https://store.pda.org/

ABOUT THE AUTHOR
Tony Dellumo is sales and marketing coordinator, QProducts & Services, where he manages marketing efforts and inside sales support. He has a BA in marketing and media management from Columbia College Chicago.