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European Pharmaceutical Contractor

Sun Screen

In recent months, the world has witnessed a succession of temperature extremes generally attributed to global warming, and believed to be part of a long-term pattern of greater weather severity and uncertainty. This trend has implications for the safe distribution of temperature-sensitive pharmaceutical products.

Reports are being received that some distributors have suffered sizeable losses as a result of being inadequately prepared for sudden temperature events, such as the recent record-breaking heatwave in parts of South America.

Unfortunately, this is not set to improve any time soon. As global warming continues to exert its upward influence on world temperatures, experts are predicting even more heat extremes. According to the Intergovernmental Panel on Climate Change (IPCC) (1) and The European Centre for Medium-Range Weather Forecasts (2), heatwaves and droughts will become more common and severe in the future. The latest cause for alarm is predicted to be the imminent arrival of ‘El Niño’ – the cyclical warming/cooling cycle in the Pacific that can spark momentous weather events and is historically associated with global temperature records (3).

The significance of these extremes is not lost on the pharma industry, which is having to meet ever-more stringent regulations relating to the temperature control of its products during storage and distribution. Ultimately, it is all about patient safety, and the temperature control issue in particular has been pushed to the fore by the recent extension of the European Good Distribution Practices (GDP) to cover finished pharma products requiring continuously controlled room temperature (CRT) freight conditions. One recent industry study suggests that around 87% of pharma companies manufacture products in this CRT category and, for the majority of these producers, it is the main part of their overall production (4).

With over 90% of all new FDA-approved pharmaceutical products demonstrating temperature sensitivity, the industry is being forced to take a long, hard, collective look at its distribution practices – all the way from factory to pharmacy. “As the frequency and intensity of extreme weather events accelerates, so does the need for improved temperature control of pharmaceutical products during their transportation to market”, says Tony Wright, Chief Executive Officer of Exelsius Ltd – an independent cool chain consultancy.

The Weakest Link

Although enormous strides have been made in recent years to improve the integrity of the pharma cool chain, there still remain a number of acknowledged weak points. Undoubtedly, the most intractable of these weaknesses relates to the issue of ‘tarmac standing time’ during air freight ramp handling procedures. This involves shipments of temperaturesensitive goods being left standing in fluctuating ambient conditions on the airside apron during the loading, unloading and transfer phases.

According to the International Air Transport Association, 57% of temperature excursions occur during these ‘uncontrolled’ air cargo stages of the distribution process. Throughout such intervals, pharmaceutical merchandise can be exposed to exceptional temperature extremes as a result of the ‘greenhouse’ effect of solar radiation – the very same heating phenomenon associated with global warming. Moreover, the resulting temperature excursions are not rare occurrences – it has been estimated that up to 5% of all transport events involve a deviation from the planned temperature (5).

Airport apron handling is, of course, not the only point of risk; there are a number of other possible hotspots and bottlenecks during the distribution phase when shipments can be subject to unforeseen temperature events. Having said this, any system that can succeed in closing the ‘tarmac gap’ will simultaneously address many of the other potentially vulnerable points in the air cargo stage, securing overall GDP compliance.

However, finding an answer to this problem is made more difficult by the fact that airlines and their logistics providers do not generally exercise much direct control or influence over some of the third-party factors which contribute to these extrinsic temperature incidents. For example, some airports are not equipped with modern facilities, others have their freight storage and consolidation areas situated a long way from the aircraft stands and, in many cases, there is a serious lack of both operator-level and managerial cool chain education and training.

These obstacles, together with the latest GDP requirements, have necessitated the escalation of logistical quality issues – especially improved temperature control – to priority status in many pharma companies. Indeed, in the aforementioned study, 94% of respondents indicated that the identification of cost-effective temperature control services and solutions is their biggest challenge in this area (4).

Quality Issues

A high incidence of costly temperature excursions could explain why some pharma shippers are switching from fast and efficient air carriage to the considerably slower mode of containerised sea freight – an option offering relatively poor traceability and flexibility, but which is perceived as providing more thermal controllability.

“Solar radiation is a prime cause of airfreight temperature excursions”, adds Wright. “This is a huge concern for major pharma companies who, at any given point in time, will have millions of pounds worth of merchandise in transit across the globe. A single temperature excursion can wipe out the entire value of a shipment, causing enormous commercial, logistical and reputational loss.”

A Problem Reflected

This is the challenge which some companies are addressing with a new range of air cargo covers. Lightweight, low-bulk thermal covers provide vital sun protection to pharmaceutical pallets and unit load devices used for air freight, which might otherwise be exposed to potentially damaging solar radiation and ambient heat during their journey to market.

These covers can be designed to provide a reliable and affordable means of protecting pharmaceutical shipments that must be kept within the different desirable CRT temperature bands – such as 2°C to 30°C or 15°C to 25°C – in accordance with the revised EU GDP. ‘Passive’ solutions such as this can employ a unique triple-action approach to temperature control, rendering them very effective and cost-efficient in CRT control and product stability. This triple-action can specifically address the heat flow mechanisms that are at work in the temperature swings and movements typically found in global air cargo distribution.

For example, in DuPont’s Tyvek® air cargo covers, the first tier of protection comprises a white micro-fibre exterior surface that provides a natural reflective barrier against the highly detrimental effects of solar radiation. The second tier of protection comes from a shiny, low emissivity, metallic layer on the internal surface of the cover, presenting a radiant heat barrier to help maintain core package temperatures. Finally, the third protective tier relates to the proprietary porous structure of the cover material which, being vapourand gas-permeable, permits the escape of damaging condensation that can form during hot-cold thermal cycles. This ‘breathability’ is also of importance where goods must be protected from freezing, since excess moisture can exacerbate cooling effects.

Greenhouse Effect

During preliminary validation tests of these covers, the damaging, but often ignored, effects of solar radiation on palletised pharmaceutical products was very apparent. Direct sunlight can cause exposed surfaces to rise as high as 70°C or more, and these temperatures can be further magnified by local conditions such as the ‘mirror’ effect of nearby glassand metal-clad buildings, and the ‘heat island’ effect of the surrounding asphalt pavement of the tarmac.

However, the sunlight problem does not stop there: the use of clear or black cargo coverings results in a very powerful degree of heat entrapment, as the sun’s rays are absorbed and unable to escape. This is because common packaging materials, such as stretch wrap and bubble wrap, can provide a significant ‘greenhouse effect’ by trapping heat and increasing the surface temperature of the pharmaceutical merchandise far beyond the surrounding ambient air temperature. Triple-action air cargo covers, on the other hand, can restrict this solar heat gain because of their reflective properties of both the visible and infrared radiation wavelengths.

Recent trials in India have showed temperature differences of as much as 25°C between standard shrink-wrapped pallets and identical pallets with tripleaction covers when both were subjected to solar radiation over a three-day period. In fact, in tests conducted throughout a six-and-a-half-day door-to-door shipment from Brazil to France, some temperature sensors positioned within shrink-wrap pallets indicated, alarmingly, ‘out of limit’ temperatures for periods exceeding 24 hours.

Manufacturers Exposed

Aynur Rasulova-Rzepa is a Special Products Consultant and Manager at one of Dubai’s top cargo agencies, International Transport Services FZCO. In this Gulf city, summer temperatures in the shade are routinely around 45°C, but can easily be several degrees higher during particularly hot spells. If these are the temperatures in the shade, it is clear that, when exposed to direct sunlight, the pharmaceutical shipment’s packaging surface temperature is likely to reach dangerous levels.

“Many route qualification programmes rely on data derived from average ambient temperature conditions, and fail to take into account the huge solar exposure effects that can be encountered during loading and offloading operations, often the result of unplanned delays or disruptions”, says Rasulova-Rzepa. “Even brief solar exposures and occasional sunny intervals can cause huge and surprisingly fast temperature spikes.” For this reason, choosing the right cargo cover is crucial to providing shipments with a further, potentially vital, line of defence against temperature excursions.

Marina Valente, Marketing Manager for Tyvek Air Cargo Covers, agrees. According to Valente, solar gain is a serious problem that, unless countered, will serve to undermine the validity of many qualified logistics arrangements. Valente is located in the São Paulo area of Brazil where ambient temperatures this summer peaked close to 50°C, so she is well-acquainted with the issue. “One of the problems lies in the fact that many operators are continuing to use standard packaging materials or ineffective cargo covers based on commercial bubble wrap and similar materials”, she says. “In many cases, these products dramatically exaggerate the solar gain effect, making a serious problem even worse. Being unprepared for the level of temperature surges that we have been experiencing here in Brazil – and, in particular, by using the wrong type of cover materials – can leave pharma manufacturers exposed to potentially huge losses.”

High Stakes

With the increasing frequency of global temperatures exacerbating the already high incidence of unacceptable temperature excursions in pharmaceutical shipments, the message is clear: manufacturers and their logistics providers must not only be prepared for excessive ambient heat levels during the different phases of transport; they must also factor in a growing risk of unforeseen or accidental exposure to high levels of solar radiation. For these eventualities, it is becoming more and more essential to select high-performance air cargo covers that provide a reliable solution.

References
1. Visit: www.ipcc.ch
2. Visit: www.ecmwf.int
3. Visit: www.motherjones.com/environment/2014/06/2014-temperature-record-el-nino
4. Pharma IQ, Storage and distribution of CRT and ambient products survey, conducted December 2011-February 2012
5. Ammann C, Handling temperature excursions and the role of stability data, September 2013
6. Visit: www.ipcc.ch/publications_and_data/ar4/wg1/en/ch10s10-es-2-temperature-extremes.html
7. WMO, The global climate 2001-2010: A decade of climate extremes summary report, 2013


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Malik Zeniti is Manager of Business Development at DuPont Europe, Middle East and Africa, where his focus is on developing and promoting new protective applications to improve the perishable and cool chain market. He is a member of the Board of Directors at the Cool Chain Association – the leading global community for temperature-sensitive supply chain professionals – and is a qualified Chemical Engineer from the University of Karlsruhe in Germany.
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