The cold chain is a dynamic process, and ensuring an effective cold chain supply from manufacturer to patient is no easy task. Temperaturecontrolled logistics presents a variety of complex challenges from regulatory compliance to entering emerging markets; today’s pharmaceutical manufacturers and their logistics providers must keep abreast of the latest solutions and technologies to guarantee their supply chains. In addition, in a post-recession world there are still great pressures around cost—containment manufacturers face tough decisions when choosing the right solutions for their supply chain.
Patient Safety First
Protecting the efficacy of pharmaceutical products is about much more than commerce. Patients around the world depend on a reliable supply of life-saving medicines. Maintaining supply chain integrity and patient safety remains the number one priority for manufacturers, and as such they rely on technology to ensure a compliant temperature-controlled supply chain.
The Maturing Market
As the market for cold chain solutions has matured, the end-users have become more knowledgeable about challenges of temperaturecontrolled supply. As a result, end-users have become more shrewd and savvy about their choices.
In a recent interview with Cold Chain IQ, Jean-Pierre Emond, PhD, Director of Cold Chain Research at Georgia Tech Research Institute, highlighted the shift in industry discussions—from packaging solutions to taking a global approach to cold chain handling:
“Before, when we were talking about packaging, it was little packages. Now we’re talking about a global approach to cold chain handling, which is great. Process, temperature monitoring, qualification, validation of solution, and control improvement are an integral part of the cold chain management program.”
“This increase in knowledge is causing the users to become more savvy shoppers for packaging, handling and logistic services, because you realize that packaging is only a small part of the cold chain. When we talk about cold chain, people usually think about a Styrofoam box, but we are far from that now. People have moved on and are so much more knowledgeable,” Emond continued.
Taking a Global Approach
Globalization is placing increasing trends on temperature-controlled supply chains. Manufacturers now need to have solutions that work effectively in different regions of the world. This means they must address differences in environmental conditions and customs regulations, which can have a huge impact on shipping times and packaging requirements.
“The big shift that we see is that now we have a global approach, everybody is trying to harmonize their solutions around the world, because now we ship everywhere. Being conscious of the environmental impact should also be considered. Many countries are pushing for more reusable packaging components. Some are even banned. Some components that they want to make sure that you recycle this product, and you know where it’s going to go,” said Emond.
Going Green
Like many other industries, there are also pressures from government and other public bodies to reduce the carbon footprint of the cold chain and increase environmental accountability. As focus shifts towards using greener packaging solutions, reducing carbon emissions and energy costs, the pharmaceutical industry must grapple with maintaining costs and standards whilst improving its environmental impact.
In the Cold Chain IQ article “Cutting Waste in the Cold Chain,” Geraint Thomas, Technical Director at Laminar Medica, wrote: “The suppliers and users of temperature-controlled packaging systems are under increasing pressure to reduce the environmental impact of cold chain shipping. The widespread introduction of formal corporate social responsibility policies, together with new customer expectations and more strict regulations, mean that developing a suitable packaging system is more challenging than ever.”
Striking a balancing act between reducing the environmental impact of temperature-controlled supply chain whilst reducing cost is growing in importance among stakeholders in the cold chain. Building a robust green pharmaceutical cold chain is not just about the packaging. Installation of renewable energy technology at the warehouse and utilizing alternative fuels during distribution are also avenues being explored for reducing the supply chain's carbon footprint.
Controlled Room Temperature Shipments
Historically, the big challenge has been maintaining temperature during distribution of products requiring refrigerated conditions (35.6°F to 46.4°F; 2°C to 8°C). The “cold chain” landscape has also changed in recent years. Due to an increase in biological products, controlled room temperature products (CRT) now make up nearly 90% of all shipments. With some regulations now covering a much wider temperature range, we are seeing changes in packaging requirements and new solutions entering the market for products between 59°F to 68°F (15°C to 20°C) and 59°F to 86°F (15°C to 30°C).
“With the recent increase in the number of products requiring CRT and frozen temperature conditions, the industry has been faced with adopting specific protocols to ensure these products are protected throughout distribution. The temperature requirements of the various products that are now being introduced to the market have posed unique challenges which have forced manufacturers to conduct the necessary risk assessment required to identify and understand all of the exposures that exist (not just temperature-related) along a given shipping lane. Only after conducting a proper and thorough risk assessment of a shipping lane can a manufacturer implement appropriate measures to ensure that the quality and integrity of their products are adequately protected throughout distribution,” said Eric Newman, Vice-President for Loss Prevention at ProTecht Risk Solutions to Cold Chain IQ.
So What Is The Solution?
There are many technological solutions available for manufacturers and logistics providers to use in their temperature-controlled supply chain.
Some of the core products available are outlined in Table 1.
Table 1.
The pharmaceutical supply chain has gone through a dramatic transformation over the past few decades, with an ever-increasing number of players involved in developing, manufacturing, marketing, and distributing drugs.
Andrea Charles is the Senior Editor of both Pharma IQ and Cold Chain IQ and has worked at IQPC since 2010. In her role she is responsible for delivering the online content strategy and optimising digital content, whilst understanding global communities and delivering a great member experience over multiple brand sites. Prior to her current position, Andrea was Head of Conferences for an independent business information provider to the Telecom and Pharmaceutical industries, responsible for all areas of international event production and operations, and was the Senior Product Development Executive at international B2B publisher Touch Briefings. In her role at Touch she was responsible for the development of over 30 healthcare and pharmaceutical digital and print publications and their associated online portals. Andrea graduated from the University of Sussex with a BSc (Hons) in Computer Science and Artificial Intelligence.