Cool-chain challenge

In the pharmaceutical sector, medical products are often stored within a prescribed temperature range. As the products go through the distribution line, maintaining a stable temperature is a fine balancing act. Movianto, a healthcare service provider, has developed the logistical technology to meet the cool-chain challenge.

The cool chain is where transported goods are maintained within a specific temperature range, usually 2ºC to 8ºC, the range stipulated by EU directives for Good Distribution Practice for medical products for human use. Most vaccines, and many other biotech products, must be kept within this temperature range.

The requirement for a continuous cool chain, with no break at any point – even during storage or distribution to the customer – is growing. Factors driving demand include: growth in the biotech market, a stronger regulatory environment and a desire to reduce the manufacturer’s product liability risk.

‘Breaking the cool chain usually results in products losing their efficacy for the patient,’ explains Franz Bockhorni, head of European key account management at Movianto. ‘These products are often part of a treatment course, to be taken within a prescribed period. Break the chain, and the entire treatment becomes ineffective.’ 

Consequently, the manufacturer requires consistent proof of the chain, to prove that there is no break in chain in the event of third-party claims. The temperature range is dictated by the US FDA or by EU regulations. It is also specified by the manufacturer’s product specification and standard operating procedures.

Logistical problems
Warehousing of goods presents challenges, but these are easier to deal with than maintaining the chain in transit. In warehousing, for example, there is constant monitoring of temperature, alarms triggered in the event of a system failure, and 24-hour maintenance on hand to fix problems should they arise.

Transporting goods represents a greater challenge. ‘Historically, passive cool transport using validated packaging material was the popular option,’ says Bockhorni. ‘The problem is the different transport situations. In the winter it might be -30ºC in a truck, while in the summer it can reach over 45ºC, requiring a special operating procedure for packing, depending on external temperatures. The packaging material may include sensors, indicating whether the temperature has extended beyond the cool range, but you only find out after delivery. By which time the damage is done.’

Tracking solution
Temperature-controlled transport, also known as active cool transport, is an alternative, but faces similar problems as temperature variation beyond the regulated range is revealed on delivery, for example, at the patient premises or the pharmacy. Movianto, however, is using the internet-based Masternaut system, an innovative solution to the challenge of maintaining the cool chain.

‘We monitor temperature during transport via GPS satellite,’ says Bockhorni. ‘At a time interval ranging from 30 seconds to ten minutes, information about temperature and geographical location is transferred via GPS to a central monitoring centre, allowing us to address any issues as they arise in transit.’

The Masternaut satellite tracking system also tracks the vehicle location in real time.

UK, Ireland and beyond
Movianto has rolled out its new technology in the UK and Ireland. As part of a 24-hour delivery service with Healthcare Logistics, part of the Movianto Group, and its fleet of 90 GPRS satellite-tracked chilled vehicles, it reaches over 500,000 deliveries each year. It is used in the company’s vaccine and home-delivery service in the UK. The intention is to extend the active monitoring service throughout Europe.

It seems likely that most cool-chain distribution will use this type of active tracking technology in the future. ‘Until then, Movianto is well placed to capture a significant share of the market,’ says Bockhorni. ‘When we implement a cool-chain solution we must prove the product is kept within the temperature range, and demonstrate monitoring of the temperature while in the distribution chain. This system allows us to do that with complete confidence.’

Company profile
Movianto Group is based in Germany with subsidiaries operating in Austria, Czech Republic, Denmark, France, Ireland, Norway, Spain and the UK. It offers warehousing, transportation, cold-chain logistics, as well as administrative and customer-specific services such as repackaging and relabelling to the healthcare industry.

For more information, visit www.movianto.com.

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