In an edited extract from its latest white paper, Passive vs. Active Systems in a globally disrupted age, Tower Cold Chain explores the challenges involved in the transportation of pharmaceuticals into developing nations.
As pharmaceutical supply chains become far more complex and truly global in nature, the management of risk becomes far more critical. Choosing the right robust, reliable, reusable packaging is therefore a vital factor to consider when building a secure and compliant supply chain.
The baseline requirement for pharmaceutical logistics is that products should arrive on time, undamaged and with no temperature excursions. With the added challenges when delivering pharmaceuticals in developing countries, it is essential that pharmaceutical manufacturers partner with a reliable cold storage provider to transport temperature-sensitive products, ensuring product integrity regardless of transport type or environment.
The increasingly complicated requirements put in place to ensure product integrity is maintained throughout the entire supply chain, has led to the development of strategic hubs and ‘pharma corridors’, in which groups of GDP compliant companies work together to offer customers assurance that their product will be handled with compliance and consistency from start to finish.
However, the pandemic and vaccine rollout has called to attention this defined ‘start to finish’ process. Multiple exposés of the vast quantities of unused vaccines in western countries point towards a need to re-evaluate the logistical ease and efficiency with which vaccines can be redirected to less vaccinated populations. Mike Meakin, Vice President of Global Quality Regulatory & Compliance at DHL Supply Chain, highlights the need for the industry to collaborate in order to react to this necessary ‘surplus transportation’, both in the current COVID-19 vaccine climate and beyond.
The challenge for the pharmaceutical logistics industry here is to further broaden these corridors globally into, say, parts of Africa where the ascendency of perishables in national imports and exports means that cold chain infrastructures have a more limited portfolio. Roger Chew of SFS Pharma Logistics and a leading figure in the Asian pharmaceutical logistics sector, expressed similar cautionary words given the still gradual transferral of cold chain ‘know-how’ in the East.
Regardless of geography, the environmental conditions of the shipped product need to be managed to prevent any excursion during transportation. This is accomplished using active, hybrid, or passive thermal packaging, which has been qualified from origin to destination – for the time and temperature of the specific shipping lane. Details of the temperature monitoring should be justified using the proper loggers and/or qualification data. Realtime data loggers should be considered – which could allow for real time corrections over the entire shipment process.
The COVID pandemic highlighted the importance of the pharmaceutical supply chain. Perhaps up until this point, how medicines for human use were delivered to patients was relatively unknown. Certainly, within the logistics industry, not only was working remotely a significant challenge but also the lack of freight capacity compounded a very difficult situation.
The pandemic has highlighted the challenge to get medicines delivered to both developed and developing countries in a secure and efficient way. Despite the challenge, many opportunities have arisen and none more so that in the Temperature Controlled Packaging sector.
Several factors influence the choice of packaging solution: risk, cost, mode etc., but perhaps one of the most important influences is location and route.
According to Maik Slijpen, Value Stream Management at Janssen Pharmaceuticals, “Destination is a critical decision factor in concerning packaging. Packaging solutions can be different depending on the destination country.” Don Riach, from Biocair, echoes the opinion of Janssen Pharmaceuticals and emphasises that “it is not only the destination of the shipment but also the airline’s capabilities to that destination that influence the choice.”
With the demand for medicines increasing globally, particularly from developing countries, the reliability and availability of temperature-controlled packaging solutions is a very important consideration. There can be significant global variations in the type and availability of airport infrastructure, as highlighted by Mike Meakin, DHL Supply Chain, at the recent Tower roundtable discussion.
Temperature Controlled Packaging is used to reduce the risk of temperature deviations and excursions in the supply chain. Packaging is typically used to provide control to an uncontrolled process. The challenges faced by the pharmaceutical supply chain in delivering products in a controlled way can be further compounded when delivering products to remote locations.
Sanofi’s distribution specialists Jeff Beck and Lisa Barbieri at believe that a passive packaging solution may well be the only option. “Some developing countries are already there, as they cannot accommodate active solutions, or, due to plane size, they cannot accommodate active solutions. For sure, especially when we consider how fast technology is moving forward (i.e. drone delivery).” Maik Slijpen from Janssen Pharmaceuticals shares the same opinion. “Definitely passive. Passive containers do the job, it works. They are much easier to handle at distribution centres.”
Interestingly, many of the other key players in the pharmaceutical supply chain have the same opinion. When deliveries need to be made to remote locations where infrastructure is not available to support a compliant supply chain, the use of a passive packaging system wins out. Certainly, within the freight forwarding and specialist courier market, the use of a passive packaging system provides greater reliability and performance.
It is very much the responsibility of all stakeholders in the pharmaceutical cold chain to ensure patient safety. In a supply chain increasingly global in nature, we must make the right decisions to ensure product quality, safety, efficacy, and integrity. With demand for advanced pharmaceuticals in middle to low-income countries set to increase, logistics providers must ensure they are operating lean supply chains, with extended capabilities to transport products quickly and effectively in all four corners of the globe.
Tower Cold Chain collaborated with industry experts from the airline, pharmaceutical and logistic sectors to discuss the changing face of the industry.