Temperature check for pharmaceutical supply chains

Temperature monitors in drug shipments are often misconceived as little more than safety measures. Niclas Ohlsson, CEO of TSS, explains how they can be used to save pharmaceutical companies money and considers the future applications for this developing technology.

As the number of biological drugs rises, temperature monitoring is becoming an increasingly important part of pharmaceutical supply chains. As well as allowing recipients to ensure that products have stayed within safety parameters and to adhere to stringent Food and Drug Administration (FDA) regulations, they can be used to highlight weaknesses in shipping processes which, when fixed, will save companies money.

But before these benefits can be fully realised, temperature monitor manufacturers have had to deal with an entirely separate challenge: inexperienced, and at the time of shipping unknown, recipients of pharmaceutical supplies in areas such as South-East Asia and South America, where more clinical trials are taking place.

"You have a lot of shipments to new sites," says Niclas Ohlsson, CEO of TSS, a temperature-monitoring solutions company. "And that means you have a lot of recipients who've only dealt with a temperature logger once or twice in their lives. You often won't know exactly who is receiving the product, so you can't offer them training either."

TSS's solution to the problem has been to create a product that even those who are unfamiliar with temperature-monitoring technology can operate easily. The Temp Tracer is the size of a credit card, can be easily slipped into a shipment package, is accurate to within 0.5 °C and has a sample rate of 1.255 minutes.

A platform-independent solution
"We've worked hard with GlaxoSmithKline's (GSK's) R&D department to create a platform-independent solution that's extremely easy to use," says Ohlsson. "We offer a USB cradle attached to the Temp Tracer, which the recipient can use to upload data directly onto the TSS global web database in three simple steps, without having to install any new software."

Not only does this approach have the advantage of simplicity, the web-based format also means the package's full temperature history is available to all parties involved with the shipment.

"As the recipient is known by the system, we can instantly communicate with them if there's been an alarm, and send them advice or instructions on how to handle the problem," says Ohlsson. "We can also take immediate action, such as sending new products if data shows the initial products cannot be used. That's not possible with monitors that only tell recipients whether or not the temperature requirements have been maintained (usually with a small red/green light or display). When that happens, the recipient will need to learn whom to contact and how to communicate the result urgently. This is time-consuming, problematic to ensure adherence and may delay the study. Without a central repository of all shipments, both within and out of temperature range, it is more or less impossible to assess the process coherence and general performance."

Temperature monitoring at every stage
In addition to the web database benefits, the Temp Tracer has broader implications for pharmaceutical supply chain management: by allowing companies to pinpoint precisely where problems occurred during shipment, they can start to improve transportation efficiency.

"You can see what the temperature was at every stage," Ohlsson explains. "It's only through this kind of monitoring that firms can isolate weaknesses in their transportation processes. It's a bit like having an onboard auditor during the shipping process."

Furthermore, with state-of-the-art and lean web solutions, you can gather high-quality data related to the shipment that allows you to assess the impact on quality. For example, the service provider's performance, different packaging solutions, mode of transport and temperature protection methods can be evaluated, assessed and compared in field. As such, the shipping design can be improved, and ensured that it is not over engineered.

Companies should, however, be careful of cutting corners for extra savings, as low-quality monitors will not only fail more often, you may not even be aware that it recorded an incorrect temperature. The consequence is critical as products that should not be released without further investigation are slipping through. The potential patient ramifications for a failure rate of even just 0.1%, when so many drugs are highly sensitive biologics, far exceed any initial financial savings. At the end of the day, patient safety always comes first.

As the number of biological drugs continues to rise, technologies used for temperature monitoring will no doubt become more sophisticated and it will be important for supply chain managers not to get carried away with new developments. "Temperature-monitoring technology itself is not the challenge," says Ohlsson. "What really matters is how you apply it to your organisation, and what benefits it brings to you, be that in terms of time, money, quality - or all three."