PHARMACEUTICALS\\\


With January 2012’s expected opening of Lufthansa new Cargo Cool Center for sensitive temperature controlled goods at Frankfurt, the German flag carrier’s


service for


pharmaceutical products is stepping up a gear, says the carrier’s senior manager for the Temperature Control competence centre, Christopher Dehio. Testing of the equipment and training of staff was expected to be complete early in the new year, in time for opening of the new facility on 9 January. It


will be highly automated,


more so than most ‘dry’ freight facilities with automatic handling and stacking of units for example and it also includes a separate idea for carrying out dangerous goods checks. It is envisaged that the facility will be used almost exclusively for pharmaceutical goods, along with perhaps small volumes of semiconductors and optical equipment – what it will definitely not be used for are perishable foodstuffs. While mixing of fruit and veg and pharmaceuticals is not impossible – indeed this is regularly the case at most other airport facilities around the world – there are great advantages in having a separate facility, explains Dehio: “As well as the advantage of having a dedicated dangerous goods facility, an independent set- up is useful because of the high value of the shipments, the need for special training and the need for high precision in the supply chain. In pharmaceuticals, you can destroy the entire value of a shipment with a slight deviation in temperature.” A temperature fluctuation that is


impossible to feel or sense is enough to cause damage to these ultra- sensitive shipments and, whereas


Lufthansa’s right- temperature record is close to 100%, says Christopher Dehio


Issue 1 2012


German carrier opens a new comfort zone


it may be possible to tell by smell or appearance that fish or fruit has been damaged, pharmaceuticals may show no outward ill-effects from incorrect temperatures. Lufthansa can, in its new cool


centre and, throughout the entire cool/td


supply chain, provide


a complete temperature log of all shipments, thanks to the sophisticated technology used in its specialist temperature controlled airfreight Unicooler, Opticooller and Envirotainer containers. “We think the Cool Center is


unique in the airline industry as we’re the only airline with a facility of its own,” continues Dehio. Most airport perishable centres are provided by handlers and other third parties. Lufthansa decided to go it alone,


partly because space at the Frankfurt perishables centre was at a premium and had become very expensive. But there are other great advantages in being able to keep the operation under its own control. The carrier hasn’t yet decided whether to eventually allow other


airlines to use the facility (other than fellow group members Swiss and Austrian) – a lot depends on the level of usage. If traffic turns out as hoped, then it will remain an exclusively Lufthansa facility, but the option remains to allow other airlines in if market conditions allow it. Lufthansa does have one other


dedicated Cool t/d terminal in its network, at Hyderabad in India. The terminal there was developed partly in response to demands from the city’s burgeoning pharmaceutical manufacturing industry and also because Indian customs regulations do not allow airline ULDs to be moved off-airport unless a bond is paid which, given the numbers of units that would be involved, would have be a significant cash-flow item. That means that rather than relying on the temperature-controlled container’s ability to monitor temperature for the land journey, containers of pharmaceuticals have be broken down on arrival in India and transferred to temperature-controlled road transport (or vice-versa) and


being able to do this inside a Cool t/d facility allows the integrity of the entire supply chain to be maintained. The two facilities will be joined in


due course by others in the Lufthansa Cargo world network. That in Seoul, Korea has just been certified and another is expected to open at Chicago during the first quarter of 2012. Other strong candidates include either Montevideo or Rio de Janeiro in South America, Johannesburg and possibly somewhere in China. “We are thinking about Cool t/d stations wherever customers expect a high level of integrity,” Dehio says. In many cases, most of the work


involved is not so much physical construction as certification and training of existing terminals with, perhaps fitting of additional temperature monitoring


controls.


But the amount of work involved in certification should not be under- estimated; there is a 150-point check list based on a series of audits developed by the pharmaceutical industry itself. One problem is the multiplication


of different standards, including the EU, the World Health Organisation and also the airline industry’s own IATA’s Chapter 17 rules, some of which can conflict with each other. The pharmaceutical industry itself, which takes the lead in setting standards, tends to set the bar extremely high, often seeking similar levels of control that would be used in the production facilities themselves. The airline industry sometimes has to gently remind them that what might be necessary in a factory where exposed, unpackaged products are in the process of being created may not always be practical in a transit facility with people and vehicles constantly coming and going or doors being opened and closed. But on the whole, the two sides do have a good understanding of each other, says Dehio. Lufthansa Cargo can itself point to


its own 99.8% record in maintaining correct temperatures. Generally speaking, where problems do occur, they are due to factors outside its control – failure to pre-condition a container or road journey to or from the airport taking longer than expected. Frankfurt will continue to be


the sole point in Europe, at least for the foreseeable future, despite the recent ban on night flights. The pharmaceutical industry has, along with many others, been affected by the longer journey times and the need to hold flights at other airports in order to comply with the ban imposed by the Hesse regional court. (A final ruling on the issue by the Federal Court was still awaited at the time of writing.) “Yes, the pharmaceutical industry is concerned by this; unfortunately,


37


when the decision was taken to develop the Cool Centre, none of us knew that this would happen,” says Dehio. (Not that there is really any realistic alternative to Frankfurt as a European hub.) Lufthansa cargo now reckons


that it has a ten-year lead over other carriers in Europe in developing its pharmaceutical supply chain. It is an excellent business for an airline to be in, Dehio considers. Despite the recession, annual global growth in pharmaceutical manufacturing is expected to remain in double- digit percentages, though quite how much of that will translate into transport by air is trickier to judge. Transported volumes could be affected by development of more production capacity in other parts of the world; on the other hand, new pharma manufacturing countries such as India are developing large export markets. “But at the same time,


the pharma industry is


globalising and the level of expertise in both manufacturing and research in countries such as India and China is growing. And at the same time the vaccines and molecules that are being developed are ever more complex and that will lead in turn to more complex transport requirements.” In time it is possible that


transporters will be expected to monitor pharmaceutical shipments not just for temperature but other factions such as radiation or vibration. Fitting additional sensors into the controlled environment containers that Lufthansa uses would not be a problem – such is their sophistication that less than a tenth of the available circuitry is currently used.


Packaging solution applies cold logic to transport problem


The need to store certain drugs in refrigerated conditions is widely accepted. In the UK, failure to comply with the guidelines imposed by the Medicines and Healthcare Produces Regulatory Agency (MHRA) can result in wastage of affected drugs, expensive product recalls and most importantly, a risk to patients’ health, writes IMC Group managing director, Ian Robinson. The IMC Group was formed


in 2007 by the amalgamation of Lamerholm Electronics, Hanwell Instruments and Jekyll Electronic Technology and recently announced the acquisition of Silvertree Engineering. The group offers a range of instrumentation and communication systems.


While many drugs are unaffected by fluctuations in temperature, several categories of medicine must be maintained at between 2C and 8C to safeguard their quality and effectiveness. The problem is that pharmaceuticals rarely stay in one place, so although the hospital refrigerator might be ideally configured, the conditions encountered during transit can vary wildly. Measures should be taken


during the packaging and storage of pharmaceutical drugs and equally whilst transporting products to suppliers. Exposure to inappropriate conditions can not only impinge on the effectiveness of certain drugs but can be highly


detrimental to a distributor’s reputation, oſten costing them vital customers. One issue is that while


manufacturers are acutely aware of the ideal conditions in which their drugs should be stored, this information is not always relayed fully to transport staff who are moving them from place to place. This should not be leſt to chance. The IMC Group has revolutionised the packaging industry by creating a device designed to record up to eight conditions of


temperature


during packing, storage and transportation. The small, single-use device has


an adhesive back cover for easy fixing onto packages. The review


Temperature- monitoring outside the lab can be tricky


For pharmaceutical manufacturers, and the packaging and logistics suppliers who serve them, the TempMark8 is a highly cost- effective assurance that the items being delivered have been stored at an appropriate temperature throughout, says IMC. Attaching such a device to


button allows the user to cycle through alarm level, number of times the predetermined limit was exceeded, consecutive samples over the limit and cumulative samples over the limit. The eight alarm triggers combine three descending (-1C, 0C and 2C) and


five ascending (8C, 10C, 15C, 20C and 25C). To help allow for international logistics and extended periods of storage, the device has a battery life of 90 days and then switches into low-battery mode in order to retain the data until the battery is completely depleted.


pharmaceutical packages not only provides assurance but can also be a visual deterrent against improper handling, making logistics staff aware of the need to maintain appropriate temperatures. With emerging technologies


like these, there is no longer any excuse for manufacturers and carriers to take risks with adverse temperatures.


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