A cool way to travel

Leaving aside the argument about the cause, there is little doubt that the world's climate is becoming increasingly extreme. Heat and cold, drought and flood are making many populations reassess their strategies for coping with climate change.

The vagaries of the weather are something that the pharmaceutical industry has had to learn to deal with over the years to make sure its products arrive at their destination in the same condition as they left the manufacturing facility – no mean feat when the product in question is a live vaccine being produced in Canada in the depths of winter and being exported to Australia in the height of summer, for instance.

With a growing proportion of drugs and other medical products sensitive to even relatively small variations in temperature, managing the cold chain distribution network has never been more crucial.

Swedish company Envirotainer, which is headquartered in Lagga Marma near Stockholm, pioneered the first active temperature-controlled air transportation solution 10 years ago. The company started out by manufacturing insulated panels for truck walls for the transportation of foodstuffs, principally seafood, around Europe. From there it moved into insulated containers for shipping perishable foods by air, and today is a leader in cold-chain, cargo-based distribution systems.

In recent times its focus has moved from the food to the pharmaceutical sector, which now accounts for 75% of its customer base, compared with food at 20% and other sectors 5%. Insulin is the single biggest commodity shipped in the containers today, with other items in the pharma sector including vaccines, blood and plasma, drugs for clinical trials and biotech products.

"There has been a shift in the customer base and it has become much more demanding, more quality orientated and more process orientated," says Envirotainer ceo Magnus Welander.

The company's original pioneering concept for a container with an active cooling mechanism is still in use. It consists of a discreet compartment containing dry ice with a series of channels and fans to circulate the cooled air around the product in such a way that the temperature profile remains constant throughout the container. The basic technology used was relatively simple but the containers had the virtue of meeting the demands of airworthiness certification.

Interest in using the system was high but neither the logistics industry nor the end-users in the food and pharma sectors wanted to take ownership of the containers themselves. Envirotainer, therefore, decided that it should become a rental company, taking on all the tracking and tracing, cleaning, storage and maintenance liabilities itself. This move resulted in partnerships with all the world's leading cargo airlines, keen to add cold chain shipments to their value added services.

Management services

Last year Envirotainer launched a range of cold chain management services and now operates a fleet of 3,500 containers ranging in size from 60 litres up to 20ft air cargo containers. It has a turnover in the region of US$27M and its services are used by many of the big pharma companies. "We raised the quality bar significantly – how our containers looked, how they were serviced, the way we repaired them, how quickly we responded, how many stations we opened up. This changed rapidly over a 12-month period," says Welander.

Priority was given to understanding the requirements of the end users – not the airlines but the pharmaceutical companies. "We identified six different services we could offer to help customers manage their cold chain," explains Welander. These included setting up and evaluating the cold chain; assisting the company with test shipments and analysis of the resulting data; assessing and optimising an existing cold chain; laboratory testing of the shipping solution by simulating the climatic conditions the shipment is likely to encounter; setting up training programmes "to teach people to have a cold chain mindset"; and carrying out a real test shipment to prove that the solution works correctly when encountering real-life logistical challenges.

Three pieces of information are considered key – the product temperature, the ambient temperatures it has been exposed to and the logistics challenges it has encountered. Envirotainer believes that it is just as important to determine what went right with a particular shipment as what went wrong. "Small things, such as the temperature of the product when it enters the cold chain container, for example, can make a significant difference if there is a problem elsewhere in the distribution chain. If it is too cold, you could end up freezing the product," Welander explains.

Cleanliness is obviously a major requirement for the pharma industry, and Envirotainer therefore maintains a segregated fleet of containers to avoid the risk of cross-contamination from the food sector. Two new services have also recently been introduced: damage waiver is available to protect the lessees from repair costs caused by damages during the lease, and End-of-Lease Assistance is an add-on service to assist the lessee in closing the lease at destination.

Flexibility is another critical factor. Most leasings are on a single trip basis and the company has a worldwide network of hubs and stations where containers can be collected and dropped off by customers. They can also be delivered to the point of use for an additional fee.

"We budget our container flows at the beginning of the year based on experience and market knowledge, then we update those on a 3-month rolling forecast," says Welander. "On that basis we can plan where we will need which containers to be. We need four days' notice to supply containers, although we can offer an express service for an additional fee."

The network is constantly expanding. In the past six months facilities in Taiwan, Malaysia, Singapore, South Africa/Namibia and Mexico have been added, while two more new stations – Luxembourg and Kuala Lumpur – have just come on-stream. The company has also just expanded its operations into the Japanese market and the service is now available in Tokyo, Nagoya and Osaka. "Pharmaceutical manufacturers in Japan have extreme quality demands, so we have had to apply slightly different and even more stringent checks," says Welander.

For pharmaceutical companies, at least, climate change need not be a problem any longer.

New container turns up the heat

The latest development in the Envirotainer range is the RKN e1, designed to ensure pharmaceutical products remain within tightly specified temperature parameters even during extreme fluctuations in ambient conditions. Rather than using dry ice as the cooling source, the new container works by using electrical energy supplied from a large rechargeable battery pack in a separate compartment to power heating elements and a compressor for cooling.

The batteries were developed for the electric car industry and were chosen for their intrinsically safe design. They can be recharged from a standard power supply up to 1,000 times with no loss of capacity and take a maximum of eight hours to charge. The container is equipped with a 12m cable and six different adapters that cover virtually all countries worldwide. A pro-active alert signal is given if the container is low on power.

Running autonomously on batteries and exposed to an external temperature of a constant 30°C, the system could maintain an internal temperature of 5°C for 40 hours. On a typical journey, the autonomous range would be around 60 hours, but plugging the batteries into the mains supply for one hour would increase the range by some 15 hours, according to Welander.

"The specification of requirements by healthcare customers for this product states that the unit should operate for a minimum of 30 hours in extreme temperatures from -10 to +30°C without recharging. Our tests have established autonomy for the RKN e1 without recharging of 38 hours at -10 °C and 38 hours at +30°C."

The RKN e1 is the result of a three-year product research, development and testing programme, and was recently awarded air worthiness certification by the European Aviation Safety Agency (EASA). It has external dimensions of 2000x1530x1620mm, measures 1340x1319x1315mm internally and has a loadable volume of 2.3m³

The RKN e1 is the most thoroughly tested container Envirotainer has ever produced. Its development has included safety tests to show compliance with avionics regulations, extensive vibration and shock testing, tests at different pressures, tests at severe humidity, Electro Magnetic Capability testing, shell stability testing and functionality testing of the control unit and battery charging in a wide array of electricity conditions.

Envirotainer has also conducted a thorough analysis of cargo and container loading, physical damage and repair techniques, cleaning, real shipment simulations, autonomy at extreme conditions and air velocity performance testing.