Rigorous Quality Controls for Cold-Chain Drug Shipments

Life science organizations invest heavily in quality and product integrity within the confines of their own facilities and the facilities of their contract manufacturing organizations (CMOs) and contract packaging organizations (CPOs). However, those investments are for naught if drug makers fail to
apply similar standards to the soft underbelly of their supply chain — transportation and logistics.

Need for Rigorous Quality Controls

It has been estimated that 20% of drug products and more than 33% of vaccines experience temperature excursions en route to their final destinations,1 at enormous monetary cost and — more importantly — at the risk of patient adverse reaction or reduced efficacy. This issue is particularly stark for vaccines, as patients who believe that they have been vaccinated with a compromised vaccine may be at greater risk of contracting the relevant disease than patients who know that they have not been immunized.

Whereas the European Union promulgates regulations for transportation quality in the form of “Good Distribution Practices,” no such prescriptive regulation exists in North America. Rather, a combination of government and industry groups establishes and disseminates recommended standards and best practices, such as USP <1079>.2 Therefore, it is incumbent upon life science organizations to ensure that service providers apply rigorous quality controls when transporting their products.
The layperson is often shocked when he or she peels back the onion of logistics. Many North American providers use business models with labels like “non-asset/asset light/intermediary/3PL/4PL.” There has been an explosion of entities that happily insert themselves between you and the actual transporter of your product. The intermediary provider brokers the shipment to a carrier, who, in turn, may subcontract to an independent truck owner, who may then hire drivers to accomplish the delivery. This model works well for e-commerce and lower-value commodities that do not require much in the way of quality, safety or security. However, this multi-tiered “game of telephone” is typically not a good fit for pharmaceutical and biologic shipping, where accountability and execution of protocols are paramount.

Given the value of pharmaceutical and biologic shipments, it is imperative that life science organizations have representation from their quality, security and logistics groups when engaging a transportation provider. Shipping can either pose a huge risk or it can serve as an extension of the quality management practices found within the shipper’s walls. Pharmaceutical logisticians charged only with cost control often bemoan this dynamic. A common complaint goes something like this: “We spend billions making this drug, and now we’re supposed to hand it over to the cheapest carrier?” The risk of forfeiting control over a drug is an obvious concern.

In contrast to the multi-tiered subcontracting model described above, our company operates a closed-loop system — our fleet of vehicles is company-owned, and our professional drivers are highly qualified, vetted, trained and uniformed employees (not independent subcontractors). There are no handoffs to a third party. As a result, we are able to apply rigorous quality, safety and security protocols. Our history is rooted in the transportation of sensitive cargo for the U.S. military, so we have applied that disciplined expertise to life science commodities for the past 12 years.

Given the value of pharmaceutical and biologic shipments, it is imperative that life science organizations have representation from their quality, security and logistics groups when engaging a transportation provider.

Think Inside the Box

We use tractor-trailers to transport pharmaceuticals and biologics within the United States and into/out of Canada. One might think that, after buying a $95,000 temperature-controlled trailer outfitted with premium specifications and technologies, we’d be able to start transporting such products, right? Though this would seem reasonable, several steps are still required. Before ever putting such equipment into service at Boyle Transportation, we perform both validation and calibration, all in accordance with USP <1079>.

The thermal mapping/validation study follows a comprehensive protocol established in cooperation with our partners at Sensitech. Thirty data loggers are placed throughout the trailer to record temperature performance for more than 24 hours at the prescribed set point. An exhaustive analysis (and a 30-page report) reveals whether all cargo spaces in the trailer are conditioned within the established tolerance. When we began this process more than 10 years ago, one study resulted in a failure. Embracing the credo that “failure is an opportunity to improve,” we adjusted the specification of our trailers to increase thermal performance. In essence, the validation process proves the efficacy of the trailer’s temperature control.

The calibration process involves proving that the temperature sensors within a trailer are accurate. Our protocol mandates that we use a reference thermometer that itself must be calibrated to National Institute of Standards and Technology (NIST) standards annually. By comparing the reference thermometer to the trailer’s sensors, we can document that the temperature we report to shippers is accurate.

Some transportation service providers perform mapping and calibration on only a portion or “representative sample” of their fleet. As someone who has witnessed the extremely manual job shop of a trailer manufacturing process, I would not be comfortable representing to a pharmaceutical shipper that 10% of a batch of trailers accurately depicts the temperature performance of an entire lot. As one of our valued customers experienced during a recall, the U.S. Food and Drug Administration (FDA) does not want to hear that “the particular trailer that’s bringing the product back for analysis has not been validated, but there’s a similar one that has.”

Our company chooses to perform both thermal mapping/validation and calibration before even putting a trailer into service, and we revalidate and recalibrate at regularly scheduled intervals thereafter, for 100% of our fleet. By proving the temperature efficacy of all of our containers, to use a football analogy we can say, “they are who we thought they were.”

In-Transit Visibility

Some transporters may furnish a printed temperature history receipt at the end of a trip, or the receiver may download a temperature data logger that had accompanied the product on its voyage. While such methods are nice to have, they serve as an ex post facto record. If a temperature malfunction had occurred in transit, it is now too late to do anything about it. You won’t ever hear: “Your product suffered an excursion. Here’s your receipt. Have a nice day.”

Instead, we apply real-time communication technology to view a vehicle’s location, route and estimated time of arrival (ETA), as well as its temperature throughout transportation. If we incur a mechanical issue, or if the temperature veers outside the predetermined tolerance, an alert is communicated both to the professional drivers and our 24/7 operations center. That way, we can take action immediately and mitigate the risk of any effect on the product.

We also provide complete visibility to customers, via a web or email interface that allows them to see their shipment moving across a map, along with the temperature and ETA to destination. The temperature and location history is downloadable as a PDF in case the customer needs to retain it for quality or security purposes. It also remains accessible at any later date from our system.

Our company chooses to perform both thermal mapping/validation and calibration before even putting a trailer into service, and we revalidate and recalibrate at regularly scheduled intervals thereafter, for 100% of our fleet.

Advanced Safety and Risk Management

Your product is subject to substantial risk once it leaves your facility — in the form of temperature, product integrity or motor vehicle accidents. While that will never get to zero, it is crucially important to have a partner that manages that risk as close to zero as possible.

We have always been an early adopter of onboard safety technologies. All of the trucks in the Boyle Transportation fleet are equipped with radar-based automatic emergency braking and adaptive cruise control, speed limiters, roll-stability control, and lane-departure warning. These systems were designed and implemented to arm our people with the tools necessary to do their job as safely as possible.

Furthermore, our fleet is outfitted with video cameras. The purpose of the camera system is twofold: to exonerate us from false claims and to continuously improve driving habits. The system generates weekly safety scores for each professional driver and helps to determine whether anyone is exhibiting unsafe or suboptimal habits. If so, we can proactively train the drivers. A significant portion of their incentive compensation is linked to this score, and we have achieved substantial improvement. Through such advanced management, we reduce risk for customers. This commitment to managing and reducing risk was validated as evidenced by our being awarded the Grand Prize in the National Fleet Safety Awards.

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People — Our Most Important Assets

We invest heavily in our most important assets — our people. Most North American carriers compensate drivers on a “per mile” basis, which incentivizes people to go over on their allowable hours or drive fast and erratically in order to make a decent paycheck. Our clients entrust us with precious cargo, so our salary-based package is predicated on drivers executing quality, safety, and security protocols — thereby aligning the incentives of our professional drivers with the goals of our customers. By ensuring predictable earnings and predictable schedules, we achieve significant retention of the drivers in our fleet, with a turnover rate of 18%, while the industry averages ~90% turnover. Furthermore, 37% of our professional drivers are women. Each truck is staffed by a team of two professional drivers, which ensures continuous movement and attendance to the loaded vehicle.

Our drivers undergo a robust training and credentialing process, including an extensive background check, a hazardous materials handling course and certification, Transportation Worker Identification Credential (TWIC), Smith System defensive driving course, pharmaceutical protocol training, security awareness training, quarterly safety training and Truckers Against Trafficking instruction. At Boyle Transportation, we view our operation as a “virtuous circle” — the company invests in its people, the people, in turn, take care of the customer, and, therefore, the customer wants to continue doing business with the company. By focusing on a high touch customer experience, Boyle Transportation has achieved a Net Promoter Score of 85.7 for 1H2019 (i.e. 92% of customers rated us either 9 or 10 out of 10). We’re delighted to say that we’ve been named one of the “20 Best Fleets to Drive For” in North America for 5 years running!

If a product’s quality and temperature has been controlled throughout the entire supply, manufacturing, and distribution chain, it can almost be considered to be a small miracle. But given the amount of risk that exists in the transportation and logistics component of that chain, life science organizations are wise to engage service providers as strategic partners rather than counting on divine intervention. Mitigating those risks requires a comprehensive approach that includes processes, technology, and most importantly — people.

About Boyle Transportation

Boyle Transportation is a specialized trucking firm providing exceptional quality, safety, and security to select clients in life sciences and defense. By combining expertise in highly regulated and valuable military cargo with rigorous quality and temperature protocols, Boyle Transportation is now widely regarded as the premier provider of end-to-end, secure cool and cold chain truckload services for pharmaceutical shippers in the U.S. and into/out of Canada.

References

  1. Hanson, Celina M. et al. “Is Freezing in the vaccine cold chain an ongoing issue? A literature review.” Vaccine. 17: 2127–2133 (2017).
  2. <1079> Good Storage and Distribution Practices for Drug Products. U.S. Pharmacopeia. 2019. Web.

Andrew Boyle

Andrew T. Boyle was an investment banker with J.P. Morgan, before returning to the company in 2003. He earned an MBA from Northwestern University’s Kellogg School of Management and an AB from Bowdoin College. Andrew is vice chairman of the American Trucking Associations, and a director of the American Transportation Research Institute (ATRI). He is a member of the Business Advisory Committee of the Northwestern University Transportation Center, a director of the (Lowell, MA) House of Hope, and a trustee of Eastern Bank.