A cool way to travel

An increasing number of pharma products are vulnerable to even slight temperature variations during shipping. Hilary Ayshford visited Envirotainer in Sweden to see the latest innovations in cold chain distribution systems.

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 ensure 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 being produced in Canada in the depths of winter and being exported to Australia in the height of summer, for instance.

temperature sensitivity

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 Eurotainer, 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, mainly seafood, around Europe. From there it moved into insulated containers for shipping perishable goods 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 Envirotainer's containers today; other temperature-sensitive items in the pharma sector include 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 discrete 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 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.

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.

cold chain mindset

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 (Envirotainer has one of Europe's biggest climate chambers purpose-built for logistical testing); 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,' Welander explains.

data logging

'We have seen a shift, especially in the pharmaceutical industry in the last couple of years, away from using validated shipping lanes towards more qualified shipping lanes. For some time now we have recommended that they should use a data logger to record information on the temperature from every single shipment.'

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 recently been introduced: damage waiver is available to protect the lessees from repair cost caused by damages during the lease, and End-of-Lease Assistance 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.

'We budget our container flows at the beginning of the year based on experience and market knowledge, then we update those on a three-month rolling forecast,' says Welander. 'On that basis we can plan where we will need the 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 last six months facilities in Taiwan, Malaysia, Singapore, South Africa/Namibia and Mexico have been added, while Luxembourg and Kuala Lumpur have also come on stream. The company has also just expanded its operations into the Japanese market using a trained ground handler. '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.