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Pharmaceutical Manufacturing and Packing Sourcer

Jet Set


The transportation of temperature-controlled pharmaceutical products has always been a challenge, even for the most experienced service providers; not least due to the myriad factors that can affect the process, as well as the limitations present with all types of supporting technology. Even though transporting temperaturesensitive air cargo is no rocket science, it does present challenges that need to be overcome in order to close yet another gap in cool chain logistics. Of course, everyone handling temperature-sensitive goods accepts great responsibility, as well as a considerable risk; after all, the values of the goods that are transported often rates as much as 300 to 400 times the shipment revenues that can be obtained. Were it not for the various international legal tools available to the airlines to limit their liability, it is doubtful that any carrier would accept shipments of which they know neither the value nor the sensitivity of the contents, and where a total loss could be incurred by a temperature deviation of a mere few degrees from a given set point. But airlines do know that a shipment of pharmaceuticals is the result of an expensive and complicated production process and that in the end it will somehow enter the human body to produce the effect for which it was designed.

So, avoiding temperature deviations in the fi rst place is the top priority. This is the case not only because those involved in the logistics chain have contracts to fulfi l or would like to avoid fi nancial complications, but also because we all have a moral obligation to see that nothing goes into a human body that might have deteriorated due to a temperature variation during the transit period from production to consumption.

In that context, understanding what an air carrier can do and what it cannot is an important step to avoiding temperature deviations. The answer to the question: “what can we do to improve the effi ciency of the air transportation element?” might well be: “understand where the limitations are and appropriately adjust your packaging solution.”

Ever since the old DC3 plied the South Pacifi c, temperature-controlled transportation was the challenge for airfreight and one might expect that the airlines have temperature control under control. After all, aviation is – and always will be – at the forefront of technological development. It is a process-driven industry with a high level of built-in, redundant safety measures. Above all, it is fast and reliable. In flight, airlines don’t differ from each other in terms of cargo; they all fly at the same speed, and all use the same or similar equipment. A 747 jumbo of one airline doesn’t differ much from a 747 of the next airline – at least not technically. What happens on the ground before and after the flight is always a decisive factor. How good are an airline’s processes on the ground and how well do they control those processes? Can they provide the same level of protection at destinations in all four corners of the world?

The View from the Ground

In the early days, the transportation of pharmaceuticals consisted mostly of simple medicines, such as aspirin, that were insensitive to temperature fluctuations. If temperature-sensitive transportation of pharmaceuticals was required, it usually involved small amounts that were dispatched using hand-carried thermo containers. Then a number of changes began to happen. As scientific research began to find remedies for an increasing number of diseases, components and active ingredients became more complex and thus more sensitive to temperature changes. Shipment sizes began to increase dramatically as humanitarian aid activities around the world grew, while globalisation of the pharmaceutical industry greatly increased traffic of semifinished as well as finished products.

As the necessity for temperaturecontrolled air transportation became more apparent, so did the complexity of the packaging material development. Just putting a box on a plane, along with other general cargo, would no longer suffice (see Figure 1).

The Process Evolves

The new era began with simple cardboard boxes and dry ice for the transportation of deep-frozen products. As requirements for transportation grew to include other temperature ranges, insulation and gelpacks were added to the packaging. In more advanced packaging examples, simple battery-operated fans were added to circulate air. More sophisticated chemicals were used to fill gelpacks in order to achieve defined temperature ranges. As none of these packaging systems had any form of feedback loop to actively control the temperature, the term ‘passive packaging’ quickly established itself.

Around the mid 1990s, the first containers appeared on the market that had integrated electronic feedback loops that could actively control the temperature, using dry ice as a cooling agent. These then evolved to include heating capabilities and finally compressors.

As in other industries, new developments were always an improvement on the last step. But contrary to other products, where the use of older models declines until the product vanishes from the market, all varieties of temperature-controlled packaging continue to be used. It is easy to see that an air carrier cannot possibly know the operational details of all passive and active packaging solutions available. An airline must make choices as to how many different types of containers they can handle before the added complexity makes handling errors more likely.

While passive packaging can be more affordable depending on the business case, temperature variations can and do occur. Passive packaging is subject to ambient temperatures, just as active containers are. Unlike active containers, however, passive packaging has no technical components that control the temperature through a signal feedback loop. While insulation and gel-packs help mitigate the risk of temperature deviations, they don’t eliminate them. And though aircraft cargo holds are pressurised and heated, temperature control in the sense that the pharmaceutical industry is used to does not exist. Since the air carrier has no knowledge of how sensitive the contents really are, it is usually left up to the shipper to determine which packaging type would be appropriate for the sensitivity of the contents and the intended transportation profile.

Potential Problems

Air carriers can implement procedures that support temperature sensitive passive shipments on the ground, but they have little control over the duration of ambient temperature exposures. Shipments must be taken from the aircraft and moved to warehouses. At busy hubs that can take quite a while and tarmac exposure can be extreme.

Warehouses themselves are designed for transit, not for long-term storage. They are designed for a high throughput, so doors open and close frequently. Hot or cold shipments come in off the tarmac and are put into a temperature-controlled environment, where they either absorb or release energy, depending on how long they have been exposed to outside temperatures. That makes precise temperature control of an air cargo warehouse a challenging task.

Factors including the weather and geophysical incidents (volcanic eruptions, earthquakes), but also interruptions by labour disputes, traffic congestion and technical deficiencies at airports, or with the aircraft itself, can make deviations from standard procedures likely, and can have an impact on the stability of the temperature range of a given packaging solution. It is precisely for these reasons that many countries have mutually agreed to limit the liability of a carrier.

Ideas Abound

It is not that airlines do not have more reliable solutions available; as far as active temperature control is concerned, the solutions are quite sophisticated and rarely fail expectations. Obviously, high-end compressor technologies are more reliable, but they also require larger investment and must therefore achieve higher rates in the market. The future of precise temperaturecontrolled transportation most likely lies with further innovations in active temperature-controlled packaging solutions. Passive packaging solutions have probably reached the pinnacle of their development.

Groundbreaking, revolutionary ideas seem more likely to develop in the area of active temperature-controlled containers. Here, the number of sensors will surely be increased in the near future to record other potential threats to the molecular integrity of the pharmaceuticals. Factors like shock, vibration, X-rays, altitude radiation and so on may have an impact and might have to be measured and recorded. The availability of GPS/GSM technology will make realtime data logging available and help airlines to pro-actively intervene before things go wrong. The development of an airworthy hydrogen fuel cell will give active containers vastly improved independence from external power sources. New lightweight composite materials will make containers lighter and better insulated.

Conclusion

Ultimately, there are a few simple steps that can be taken before sending a temperature-sensitive shipment on its way:

  •  Anticipate signifi cantly varying temperatures and choose appropriate packaging
  •  Deliver and pick up as close to the times agreed with the carrier as possible
  •  Put temperature recorders inside the packaging and ensure it is not exposed to sunlight
  •  Clearly label all packaging units in an unambiguous manner
  •  Avoid long storage periods at airports
  •  Ensure that import and export documentation fulfils all country regulations

But until the ultimate, failproof packaging technology has been developed – one that you can pack, turn on and forget – the best plan to avoid temperature excursions is for the shipper, the forwarder and the carrier to come together and openly discuss the needs and capabilities of all parties involved. Without this tripartite exchange, too many elements of the supply chain will be left open to guesswork and assumptions in a complex logistical challenge that leaves very little room for error.


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Christopher Dehio is Senior Manager, Global Key Accounts for temperature controlled airfreight at Lufthansa Cargo AG, and holds a degree in Mechanical Engineering from the University of Koblenz, Germany. After his education he started his career at the engine overhaul and repair facility of Lufthansa Technik undertaking damage and failure analysis of jet engines. He later moved to Singapore to develop the AsPac sales organisation for Lufthansa Technik, and to negotiate a second aeronautical overhaul facility as a joint venture in Asia for Lufthansa Technik. In 2003 Chris returned to Germany and undertook an organisational development project to implement key account management at Lufthansa Systems. His current business focus lies with driving Lufthansa Cargo’s temperaturecontrolled airfreight business on a global scale.
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