Seamless cold chains
Transportation of temperature-sensitive pharmaceutical products poses a crucial challenge. One way to overcome it is to utilise the technology of active temperature control.
Today people are living longer, healthier lives. There is no doubt that this is mainly thanks to better living conditions in terms of nutrition, shelter, and lifestyle. However, much of the improvement is also owing to better medical care, and that includes the contribution made by the pharmaceuticals industry. Its products are not only increasingly expensive – an important issue in many societies – but are also becoming more effective, sophisticated and thus more fragile.
More and more pills and other formulations contain perishable, temperature-sensitive ingredients. These include vaccines, bioengineered drugs, intermediate products, and substances for testing and research, all of which may contain living cells or organisms. Materials obtained from the human body itself, such as blood plasma, also come into this category.
In some cases such substances need to be forwarded over great distances because of global outsourcing. If these items, most of which are expensive, are not kept at a precise temperature during transportation, their shelflife may be shortened, or their efficacy reduced or completely destroyed. This could jeopardise the success of scientific studies, or in the worst case even endanger human lives.
Demand for forwarding such temperaturesensitive pharmaceutical products is soaring. The correct technology and infrastructure is a decisive factor in ensuring that the shipment survives its journey from the manufacturer’s laboratory to the recipient – whether this is a doctor, hospital or patient – unharmed. Freight carriers, airports and their handling companies as well as airlines must all master this technology if they want to succeed in the pharmaceuticals forwarding business.
It probably goes without saying that air transport is the only option worth considering when forwarding such products. However, aircraft may move through temperature zones ranging from 50 degrees Celsius above zero on the airport tarmac to minus 60 when cruising at 30,000 feet. Passengers are protected from these extremes, thanks to the powerful air-conditioning systems used in airports, transfer vehicles and the pressurised cabins of the aircraft themselves. Furthermore, passengers are a fairly temperaturetolerant type of “cargoâ€: they may perhaps shiver or perspire in the zone between plus 10 and plus 30 degrees, but they will not suffer any permanent harm.
This is not the case for the pharmaceuticals products mentioned above. Vaccines and many other substances need to be kept within quite a narrow temperature range, such as between +2 and +8 degrees according to one EU directive. It is crucial not to let the temperature go above or below this range at any time in the whole journey, from the sender to the consignee’s address – a journey that may take up to 72 hours. The goods therefore require an accurately controlled temperature environment, usually involving refrigeration.
Passive and active temperature control
First of all, a decision has to be made regarding whether passive or active temperature regulation is appropriate. The passive type involves packing the goods in insulating material, which often contains a cooling element. The packaging may consist of many thick layers, depending on the length of the journey, so it could be very voluminous. Typically, the goods and cooling elements are placed in a cardboard box lined with polystyrene. Several boxes are stacked in a wellinsulated air freight container, which may in turn be protected by an insulating sheet. However, if this kind of shipment is in transit for longer than expected – perhaps because of a strike or for technical reasons, or if weather conditions should change – there is a greater risk that its temperature will exceed the tolerance boundaries.
Active temperature control, which was developed in the mid- 1990s, operates differently. Here, the shipment is protected by an integral air-conditioning system throughout the entire journey. Inside the air freight container, which is of course well insulated, a precisely controllable thermostat keeps the temperature stable. Dry ice is the most commonly used means of cooling. If the temperature of the goods rises, even only slightly, the thermostat switches on a fan which blows the air inside the container over the dry ice, thus cooling it.
The latest generation of air freight containers for temperaturesensitive goods does not use dry ice. Instead, they have their own cooling units, similar to the compressors used in refrigerators. The electricity to power the cooling unit comes from batteries that are included; the containers also have mains leads attached.
Probably the best-known supplier of these containers is Envirotainer, which is based in Knivsta, near Stockholm-Arlanda airport. This company developed its first actively temperaturecontrolled container in 1995 and now has over 3,500 available in various sizes, cooled by either a compressor or dry ice. Its branch network covers about 50 sites in two dozen countries throughout the world.
Envirotainer does not simply rent out its containers, it also offers customers training plus technical and organisational support. The latter is particularly important: in order to prevent a handling error interrupting the cool chain, the organisational procedures must be the same at all points along the chain, and the staff responsible need to be properly trained. Customers – that is, forwarders and airlines – that meet its requirements are accredited by Envirotainer as “Quality Envirotainer Providers†(QEP). Panalpina is one of six logistics companies to have been awarded QEP accreditation.
The US company CSafe also offers actively temperaturecontrolled containers. It was founded in 2008 as a joint venture between AmSafe, a company active in the security sector, and AcuTemp Thermal Systems, a manufacturer of insulated packaging and materials. The German firm DoKaSch has already made a name for itself as a manufacturer of traditional air freight containers and pallets. Based in Staudt, near Frankfurt airport, this company went into the temperature-controlled container business several years ago. Its LD3 and LD9 models, which have a usable inside volume of 1.3 m3 and 6.8 m3 respectively, may be used for cooling only or for both cooling and heating as required.
Multilayer protection
The more layers in which temperature-sensitive freight is packed, the better it will be protected. The usual practice adopted when forwarding such cargoes demonstrates this. The first layer of packaging consists of insulating material, which offers passive protection. The manufacturer stores perishable substances in a second, active layer: that is, a cold storage room, where the air freight container (third layer) is loaded. This is then taken to the airport in a refrigerated truck. At the airport, the container is unloaded by the ground handling firm and immediately placed in cold storage again. The handling firm removes it from cold storage at the last possible moment before driving it across the apron and loading it onto the aircraft. Inside the aircraft, the temperature in the relevant area of the hold is optimally adjusted to the requirements of the refrigerated cargo, with due consideration given to the other goods also loaded. When the cargo reaches its destination, the same process is carried out in reverse. The above describes what ought to happen in an ideal case.
There is a conspicuously large number of points at which the goods have to be transferred: from the manufacturer to the truck, from the truck to the airport cold store, and thence over the apron to the aircraft, which may be a considerable distance. For this last transfer, Dubai-based airline Emirates has developed what are known as “Cool Dolliesâ€.
These are trailers with an insulated container and integral diesel-powered refrigeration unit for transporting freight across the airport tarmac. Temperatures of 50 degrees Celsius are not unusual in Dubai.
Challenge at the interface
These transfer points are critical, as the shipments are handed over to a new “custodian†here. They are interfaces between very different kinds of company-manufacturers, road haulage firms, airport/handling companies and airlines. They therefore present a particular organisational challenge.
These interfaces are also the points in the supply chain at which a shipment can be physically accessed. Opportunities for such access are very limited on board a truck or aircraft. It is only at transfer points that dry ice can be topped up, for example, or the batteries in a container changed.
Someone with overall responsibility must coordinate all this and retain an overview of the entire supply chain. Forwarding and logistics companies such as Panalpina, specialise in this activity. They have experience of training the staff who deal with these cold chains, and bringing their branches up to QEP standard (see above), for example.
A single source is best
The smaller the number of interfaces needing to be coordinated, the simpler and more reliable a supply chain will be. The ideal situation would be to provide every stage of the service from a single source: the firm’s own refrigerated truck takes the shipment to its own cold storage facility at the airport, where it is handled by the firm’s own staff and flown to the destination in the firm’s own aircraft… and so on. Panalpina comes very close to achieving this ideal, thanks to its Dixie Jet.
For more than 15 years, a Boeing B747 freighter has been flying back and forth between Luxembourg and Huntsville, Alabama. The aircraft is provided and crewed by Atlas Air, but is operated by Panalpina as if it was its own property under the terms of its “own-controlled capacity†scheme. Originally introduced for the car industry, this service, known as the Dixie Jet, now also transports goods for the oil industry as well as all kinds of different cargo, including temperaturecontrolled pharmaceutical products. It has been so successful that Panalpina and Atlas Air recently extended their agreement.
To begin with, the Dixie Jet was an older generation Boeing B747-200F, but for some time now the service has been provided by a modern B747-400F which operates five flights a week. Two of these depart from Huntsville for Mexico City before returning via Prestwick (Scotland), and the others go back and forth between Luxembourg and Huntsville.
The B747-400F has three separate holds – one on the main deck and the others on the lower deck aft and the lower deck forward. They have individually controlled air-conditioning systems. These can be set very accurately to the requirements of temperature-controlled pharmaceutical products in transit. In addition, Panalpina has had special cold stores built in Luxembourg and Huntsville, so that cargoes can remain continuously chilled even in the transit warehouses.
Volumes
Just how high are the volumes of temperature-controlled pharmaceutical products shipped by air? Estimates range between two and three per cent of all perishable items, although it is not always clear where the dividing line between forwarding by air or sea actually lies. What is clear, however, is that this segment is growing strongly; Envirotainer says it is increasing by 10 per cent a year. The simplest way to find out would be to ask the airline companies, but most of them guard such information jealously.
Air France/KLM Cargo is the only one that publishes its figures: the Franco-Dutch carrier forwards about 10,000t of such shipments per year, representing about 24 per cent of its total volume of perishable goods. According to AF/KLM Cargo, this figure is made up mainly of regular shipments, often sent by large clients, as part of a supply chain. The company says that for years now it has deliberately been pursuing a strategy of massive global investment in the necessary technical infrastructure and staff training. The company now has pharmaceuticals specialists throughout the world. However, AF/KLM Cargo, which uses refrigerated containers leased from Envirotainer, estimates that global growth in these shipments is running at two to three per cent – lower than the figure quoted by Envirotainer.
Lufthansa Cargo, on the other hand, does not specify any figures, but it says that pharmaceutical shipments are growing strongly as a proportion of perishable items overall. Many of these shipments occur regularly as part of a supply chain; the carrier says its sales department therefore receives daily ad hoc enquiries from forwarding companies, which have in turn just been approached by shipping agents.
LH Cargo also reveals that most of the refrigerated units it uses are from Envirotainer. However, it does not wish to depend on a single supplier, and it is adding high-value container technologies to its portfolio, such as the DoKaSch “Unicoolerâ€, which can heat as well as cool the contents. This model is very much in demand and is used when products need to be kept at a precise temperature. The company has stated that at the end of November it had more than 120 of its own Unicooler RAP (LD9) containers available, and was able to handle temperaturecontrolled shipments at 88 sites throughout the world.
Envirotainer has accredited Panalpina as a QEP. To receive such accreditation, a company has to meet stringent standards in the storage, handling and shipping of temperature-sensitive pharmaceutical products.
Envirotainer launched its QEP program at the suggestion of shippers of pharmaceutical products who are themselves bound by industry specifications. In this program, companies receive accreditation if they fulfil the clearly defined requirements for the professional handling of goods shipped in Envirotainer containers. Panalpina and Envirotainer signed a global partnership agreement in 2008 that features this certification process. Following a comprehensive audit, Panalpina has now been accredited at 23 sites around the world.
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