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Pharmaceutical Manufacturing and Packing Sourcer

Air Freight Innovation

Shippers and forwarders stress the importance of time- and temperature-sensitive pharmaceutical products, as well as their trend to grow in the short term. As more countries are enforcing Good Distribution Practice (GDP) type guidelines, this will likely lead to a rise in medicines shipped via air, due to stricter requirements. The consensus and understanding in the air cargo logistics community is that shippers will increasingly look for reliable and transparent temperature-controlled solutions.

The global sourcing and distribution model of the pharma industry favours air cargo. The current major production locations in Europe and the US are expected to grow, with new sites being developed in India and Latin America.

This explains the big differences in pharma volumes between regions. For example, looking at the European average, healthcare products comprise 3.3% of air cargo volumes. If we consider Belgium in particular, located in the middle of one of the European pharma clusters, the industry represents 5.7% of total air cargo volumes in the country.

Specialist Services

Since the average market share of the healthcare segment in the total air cargo volume is limited, specialisation is only possible in an exclusive number of international logistical platforms. A clear trend is emerging where airports close to pharma clusters are offering dedicated temperature-controlled infrastructure and specific pharma handling know-how.

This evolution also sees local logistical suppliers taking steps to increase the quality of their services in the air freight supply chain for pharmaceutical products. These consist of a diverse range of commodities with different handling and storage requirements, driving the development of a wide range of niche services.

Based on pharma volumes handled at Brussels Airport, estimates indicate that about 75% of products require passive cooling solutions, and about 25% require active temperature control. Due to their complex supply chain requirements, active solutions demand premium handling. Passive options, on the other hand, are less costly to implement, and drive the biggest part of the pharma volumes in air freight.

It is predicted that the global pharma industry will spend $8.36 billion on cold chain logistics in 2014, and is expected to expand to more than $10 billion by 2018 (1).

Mode Shift

A recent International Air Transport Association (IATA) study has shown that a mode shift from air to ocean is in process, including for pharmaceutical shipments (2). However, if we take a closer look, differences exist based on the value density of the products. The more valuable the commodity, the more likely it is to fly by air. Air freight transport has seen larger growth rates for the pharma sector in comparison with other industries, most likely as a result of its high product costs.

A good example of this trend is biopharmaceutical products, which are often extremely highly valued. Protecting and certifying the integrity of these costly shipments requires a substantial additional investment in cold chain services. Close and careful temperature and humidity management during transport is essential, but has significant supply chain implications. Effective cold chain management with a risk-based approach has to be introduced by logistics managers, in order to handle these products within very specific parameters.

This carries great specialist storage and transportation capabilities that are not limited to pharmaceuticals; some medical devices and diagnostics products are also condition-sensitive.

Work in Progress

The pharma industry relies on air transport for its speed, reliability and efficiency in delivering high-value, time-sensitive, temperature-controlled cargo. However, while air carriers, freight forwarders, ground handlers and airports all strive to provide quality services, many challenges remain. Regulations are increasing around the world; processes and specialised equipment are becoming more complex; specific training is required to ensure staff handling products have good pharma awareness; and multiple audits are being imposed by companies and regulators.

Historically, there have been a huge number of different regionally based regulations for the industry to comply with. More recently, the EU and various other countries have introduced GDP guidelines to ensure product integrity is maintained throughout the supply chain. However, there is currently no global certification standard for handling of pharmaceutical cargo, in line with existing regulations and standards, that is internationally recognised and implemented.

As a result, in many cases, a mismatch remains between expectations and the services offered. There is a lack of uniform implementation at airports throughout the entire global supply chain. Not all stakeholders – whether at the origin or the destination of the cold chain route – will be properly equipped to handle temperature-controlled products.

In addition, a common audit format is lacking, leading to lower audit effectiveness: ground handlers and airlines are being subjected to multiple audits by various pharma companies and freight forwarders, with different sets of standards. This is not contributing to a smooth, effective transition through the supply chain.

Service Optimisation

Logistical service providers must adopt a more aligned model. This means working collectively with all business partners and service providers to craft supply chains for optimal end-to-end visibility and reliability.

Infrastructure Investment

So what exactly constitutes an ideal cold supply chain? Firstly, from an infrastructure perspective, any operator participating in the cold chain – be it a trucker, forwarder, handling agent or airline – must have the right temperature control technology and process in place to keep the pharma products at the correct coldness.

This often requires investments in temperature-controlled warehouses with a variety of temperature zones. Zones of 15-25°C, 2-8°C and cold storage at -20°C are most commonly used as standards in pharma air freight.

As an alternative, high-level passive solutions or active containers can be used to protect the temperature-sensitive cargo during transport on the ground and in the air.

Pharma Awareness

Regardless of the type of packaging or cool room, handling quality is primarily impacted by the expertise of staff. Rigorous training has to be put in place in order to make the people handling the shipments understand the specific transport and storage requirements. Staff need to develop pharma awareness.

Every operator should select its suppliers based on their understanding of the industry, ensuring correct handling at each step of the supply chain. Training of every person involved in the handling, supervision or processing of products is key, in order to make them aware of the impact of their job in maintaining GDP guidelines.

Managing Complexity

The biggest challenge, however, lies in the complexity and number of handovers from the moment the goods are transported to the airport, to the point at which they are handed over to the customer at the destination. If just one single step in the logistical process is not up to standard, the integrity of the product cannot be maintained.

Aligning and standardising the pharma handling processes between supply chain partners, as well as training all industry stakeholders on and around the airport, is the only effective way to guarantee the correct handling of pharmaceutical cargo.

Global Standard

Instead of local regulations and procedures, it should be possible to lay down a global standard. This will lead to an end-to-end integrated cool chain. Rather than one individual service provider upgrading their operations to a top-level performance, the focus should be on a community approach where all partners within the supply chain apply the same high standards to attain true temperature control.

IATA is best-placed to take the initiative to develop a global air cargo industry certification standard. Brussels Airport has worked collaboratively with IATA, in order to develop and implement such a standard in the framework of the IATA Center of Excellence for Independent Validators in Pharmaceutical Handling programme (CEIV Pharma).

The CEIV Pharma certification programme provides participants in the air cargo value chain with the tools to ensure that they are operating to the highest standards for the transport of what, in many cases, are life-saving drugs and medicines. It is hoped that this will give pharma companies the confidence and assurance that their cold chain logistics requirements are being met through an independent certification process.

IATA and Brussels Airport have started a pilot project to develop the programme and certify every supplier involved with the cold chain. This community approach covers every logistical element throughout the airport. The Belgian regulator, Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten, and Belgian customs – as well as the pharma shipper community – are actively involved in the project. This highlights the intention to build a broad consensus on the subject by bringing together all relevant parties.

Brussels Airport has been working with a group of 11 local stakeholders (ground handlers, freight forwarders, truckers and airlines) to undergo the CEIV Pharma training – bringing the cargo community together with the common goal of becoming certified. The aim is that these businesses will be able to offer pharma companies the competitive advantage of assuring cold chain integrity to their clients.

For the Future

The project’s hope is that more airports, and other supply chain providers, will also be persuaded to undergo such training and on-site assessments. Step-by-step routes will become certified when air cargo communities at both origin and destination begin to align to the clear set of guidelines created by IATA, ultimately ensuring that cold chain pharmaceutical products can be transported in a standardised, sanitary and secure way throughout the world.

1. Pharmaceutical Commerce, 29 April 2014
2. IATA World Cargo Symposium, 11 March 2014

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Nathan De Valck is Cargo Account Manager at Brussels Airport Company, and a cargo resident pharma and life science logistics expert in charge of the pharma and perishables projects at Brussels Airport. He is also a member of the IATA Time and Temperature Taskforce.

Nathan De Valck
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