With increasing regulatory requirements for the safe transportation of pharmaceuticals and biologics, innovation in temperature-controlled packaging is increasingly vital. With the rise of biologics and biosimilars, any minor ‘temperature excursion’ during the cold chain journey can have costly consequences for patients and pharmaceutical companies alike.
The industry faces many challenges, not least from ever more complex distribution lanes, remote region locations and compliance conditions. While the cold chain infrastructure in Europe, the US and some parts of Asia is proficient, emerging markets such as Russia, China, India and Brazil pose greater challenges. A growing need for ‘last-mile’ pharmaceutical transportation requires stringent end-to-end compliance to protect high-value, temperature-sensitive pharma payloads, while a trend towards the use of bespoke drug shipments raises unique issues around thermal stability for smaller sample shipments. Industry innovation is also required in response to the rise of in-country guidelines and regulations.
Responding to these challenges, temperature-controlled packaging (TCP) manufacturers are creating ever more pioneering passive packaging systems, as well as demonstrating their compliance from region to region. Such technologies include advanced phase-change materials (PCM) and vacuum insulated panels (VIPs) that are instrumental in maintaining a consistent temperature and avoiding temperature excursions that could render the drugs unstable and cause them to lose efficacy.
Other notable innovations include next-generation packaging systems that create ‘hibernation’ capabilities so that, should a customs delay occur, for example, they can be placed in a refrigerated area and remain protected for extended periods of time.
Easy does it
Emerging technologies are also reducing the complexity of the packaging process and changing the coolants used in thermal packaging. Simplified packaging processes have several benefits not least that they allow companies to use the same protocols year-round rather than adapting them season-to-season. They can help avoid the main cause of temperature excursions – human error during the packaging process – by maintaining temperature in the payload area.
The TCP industry is moving away from older water-based coolant systems towards advanced VIPs and PCMs, which remove the need for seasonal packaging components and additional seasonal training for warehouse personnel, resulting in performance improvements and cost savings. The industry is also embracing pioneering technical tools to aid performance modelling, allowing companies to develop a temperature profile easily and test it against a specific shipping lane. Another innovation is the use of indicators on PCM coolant panels that show when they are ready for use.
Looking forwards, the use of reusable packaging will increase. While single-use packaging will continue to serve a purpose – particularly with more difficult-to-control or challenging lanes – reusable packaging can prove a more cost-effective option, when the retrievable infrastructure is in place.
The packaging industry is working hard to change perceptions about reuse and its reliability, with a focus on industry standards to demonstrate how such packages remain fit for purpose after multiple uses.
Finally, ensuring stability in the supply chain is critical within the pharmaceuticals industry where patient safety and efficacy are an absolute priority. However, convincing pharmaceutical firms of the importance of fit-for-purpose cold chain shipping systems is an ongoing challenge. Ultimately, this comes down to a better understanding of the cost of moving to newer technologies and the impact they can have on operations.
Kevin Lawler is vice-president of sales at Pelican BioThermal. He can be contacted at kevin.lawler@pelican.com
