Beyond 2-8°C – temperature-controlled logistics for pharma

Thomas Heller Strategic Account Manager
thomas.heller@envirotainer.com

With the rapid development of medical science, drugs are more sensitive than ever before. Here are the main challenges of temperature-controlled logistics.

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Temperature-controlled transport by air only makes up a small – but critical – part of the end-to-end supply chain for sensitive pharmaceuticals. Though high-end products and products with a short shelf life must be sent by air, airfreight also exposes the products to a certain amount of risk. According to IATA, the International Air Transport Association, as much as 30 percent of scrapped pharmaceuticals can be attributed to logistics issues. The primary causes of damaged products, according to IATA, are a lack of standardization and transparence throughout the logistics chaini. With the increase of large molecule biologics, gene therapy, and other sensitive pharmaceuticals, the logistics issues will only be exacerbated. Here we discuss challenges of temperature-controlled logistics and strategies to overcome them.

as much as 30 percent of scrapped pharmaceuticals can be attributed to logistics issues...

Temperature-controlled transport more than just cold chain

With the rapid development of medical science and medical technology, drugs are more sensitive than ever before. Large molecule biologics and specialized pharmaceuticals such as gene therapy need accurate handling throughout the transport. Any deviations from protocol might render the products worthless or even harmful for patients. It can also lead to significant costs for the business. This puts extra pressure on pharmaceutical companies to ensure efficient temperature-controlled logistics of these sensitive products from start to end.

The term temperature-controlled has also moved beyond the traditional notion of cold transport between 2-8°C, to encompass a range of different temperature intervals. More products have to be shipped at controlled room temperature, some products are not allowed to freeze in order to avoid agglomeration of particles, and other products must be kept frozen at cryogenic temperatures. In addition, products can be sensitive to humidity, shock and vibration, and light, as well as to fast temperature fluctuations.

Balancing quality and cost for temperature-controlled transport

Finding the right temperature-controlled transport always comes down to the product. What are you willing to pay and what is the risk profile of the product? Is it a low risk launch or shipment, for example a regular shipment with not that many challenges, or is it a NPI (New Product Introduction)?

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Temperature-controlled logistics is also a balancing act that depends on quality and price pressures. The pharmaceutical industry constantly tries to do things better in terms of quality, but how can you justify a specific level of service if it comes with a high price tag? This is a challenge where there is a certain overlap between procurement and logistics, but the two departments are not always on the same page. Sometimes logistics managers have very strict dictates from headquarters on which packaging and logistics solutions they have to choose. At other times, logistics managers can choose more freely and are able to build trust and long-term relationships with local logistics providers. In either case, building long-term partnerships will always be beneficial for the business.

Visualizing the logistics chain

A good strategy to prevent logistics issues when transporting sensitive pharmaceuticals is to bring together all stakeholders who will handle the packaging or containers, some months before the actual shipment. By visualizing, or mapping, the logistics chain – loading, warehousing, ground handling – there will be a better transparency and understanding of where things can go wrong. It also helps to prevent from “assuming” the responsibilities of another involved stakeholder.

By visualizing the delivery from end to end, you have the possibility to go through roles and responsibilities beforehand, and to tweak procedures if needed. Perhaps you will discover that there are too many people handling the shipments, which leaves room for human error, or other factors that could threaten the execution of the delivery. In this way, it will be easier to identify areas of risk, to understand the touch points better, and to develop contingency plans.

Active or passive containers for temperature-controlled logistics

No matter how good your preparations are or how strictly you control your service providers, there are many things that can go wrong in the cold chain. There will be customs delays, strikes, hurricanes, and an endless number of other circumstances that could have a detrimental effect on product quality and functionality. Whatever the solution for temperature-controlled transport, you need to be prepared for unforeseen events. There’s no solution that needs no process, or can cover all unforeseen aspects.

Whatever the solution for temperature-controlled transport, you need to be prepared for unforeseen events.

In general, there are two types of temperature-controlled solutions to choose between – active or passive containers/packaging. There are differing views on what constitutes an active vs. a passive container. The most intuitive explanation, and the predominant view, is that active containers have an active temperature control that can measure and adjust the temperature inside the container. Active, temperature-controlled containers can have electrical cooling and heating systems or just cooling via dry ice. Passive solutions are insulated boxes or containers that have no active temperature control. The packaging therefore makes no adjustments according to ambient temperatures, even if the box go from +50°C on the tarmac in Dubai to -10°C in Alaska.

The preferred choice of container is dependent on the risk profile of the product and what you are willing to pay for a seamless distribution. Active containers are by far the safest alternative. The costs are usually higher at face value with active containers but they take up much less volume and may require less handling. A thorough cost analysis (Total Landed Cost end-to-end) may show that the price difference is not that large or existent at all when all costs are considered.

Summary

According to IATA, a high percentage of temperature-sensitive pharmaceuticals are damaged during transport. The growing amount of specialized and temperature-sensitive products will further exacerbate the problem with scrapped pharmaceuticals. There are, however, a number of preventive actions for logistics managers that can reduce the risk of transport. One such strategy is to fully understand the product requirements and the risk profile of the product. Another strategy is to map all the touch points of the transport beforehand, in order to identify the weak parts of the chain and from there develop better contingency plans. To choose the right packaging or container is likely the most important strategy to reduce risks and to guarantee a seamless delivery to the destination. And over all: communicate & collaborate among the stakeholders to prevent from misunderstandings.

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