Collaborating to Meet The Challenge of Air Cargo Cold Chain Regulations

The number of temperature-sensitive pharmaceutical products is growing, as is the worldwide demand for these highly sensitive goods. Patients in developing as well as emerging markets rely on the fast, safe delivery of life-saving drugs and vaccines, and this is driving an ever-more valuable market for cold chain logistics, estimated to reach $9.3 billion by 2017, according to the Biopharma Cold Chain Sourcebook .

Advances in technology, packaging, and supply chain management allow temperature-sensitive pharmaceuticals to be moved farther and in greater quantity than ever before. This emergence of a truly globalized cold chain has been matched with a growing body of regulatory guidance. Meeting new and changing regulatory requirements demands close collaboration between cold chain logistics providers and the manufacturers of the delicate products. By this, industry can continually improve the temperature-sensitive shipping to consistently maintain product integrity and by consequence, patient safety.

There are myriad regulations and good distribution practices (GDP) from national, regional and country-specific organizations. New European Union GDP guidance was published in March 2013. This comes in addition to guidance from: the Parenteral Drug Association’s Technical Report No. 39 , "Guidance for Temperature-Controlled Medicinal Products;" the U.S. Pharmacopeia, Section 1079 , "Good Storage and Shipping Practices;" IATA’s Perishable Cargo Regulations Chapter 17 ; and many other groups.

At the same time, customs agencies around the world are tightening their requirements for customs clearance of temperature-sensitive cargo. Increasingly, customs regulations demand documentation that proves cargo has remained within viable temperature parameters throughout its journey. What is more, customs requirements often differ between countries, making cold chain logistics that much more complex.

In response to the growing demand, product volume, and regulatory oversight, many freight forwarders and air carriers are making substantial investments in services and infrastructure that enhance and improve the cold chain. Over the last several years, the logistics and pharmaceutical industries have enjoyed a significant increase in the capabilities for moving temperature-sensitive products by air cargo. Some airport infrastructure now includes validated temperature-controlled facilities, which help preserve the product between transfer to another flight or mode of transportation. American Airlines Cargo, for example, has been building Controlled Room Temperature (CRT) facilities in strategic locations around the world, which help thermal packaging better protect the product.

Employee training is also essential, as operations crews must follow rapid processes for monitoring and moving temperature-sensitive cargo. Ground crews need to understand cargo requirements and quickly usher shipments through the supply chain. Just as important is documenting cargo location and temperature throughout every leg of the journey. This is done in part through cargo tracking and monitoring technology, which offers auditable proof that a product has remained within a viable temperature range.

Pharmaceutical and other healthcare product providers have long-known these kinds of investments are critical. Yet, to best put these capabilities to work, all cold chain stakeholders need to understand the specific pharmaceutical cargo requirements and the ideal cold chain solution that will support the integrity of that product. Managing temperature-sensitive cargo in the international supply chain means forwarders and carriers must be aware of a product’s precise time and temperature constraints, knowledge best learned from the pharmaceutical manufacturer. This product understanding informs operations and contingency planning and requires each of these participants to work together in a collaborative, tripartite approach.

Meanwhile, air carriers and forwarders hold the expertise needed to pair product requirements with the best cold chain solution. With product knowledge, logistics providers can help the manufacturer to weigh passive and active shipping, consider transfer points, and develop movement and contingency plans. Through collaboration and conversations, cold chain partners can establish and share the critical knowledge that supports temperature-sensitive product integrity. In the cold chain, the highest priority is ensuring that life-saving pharmaceuticals arrive on time and unharmed. As logistics providers continue to make important investments in training, infrastructure and operations, focused knowledge sharing can help all stakeholders achieve a consistently safe supply chain. Continued dialog about new regulatory requirements and product demands will yield the understanding that enhances cold chain logistics. Patients around the world are counting on it.

Collaborating to Meet The Challenge of Air Cargo Cold Chain Regulations

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