Improving cold chain performance and reliability

The need to mitigate risks within global pharmaceutical supply chain logistics is driving innovation within the temperature-controlled packaging sector

To help eliminate temperature excursions in cold chain logistics, there is growing demand for reliable, high-performing packaging products to safeguard sensitive shipments. New technologies and advanced software systems are playing a pivotal role in the emergence of pioneering packaging that protects pharmaceutical payloads worldwide.

As temperature-sensitive pharmaceutical products are increasingly being shipped globally to more remote regions, the challenge the packaging and logistics industry faces is ensuring that evolutionary developments continue to provide sophisticated systems that are equipped to facilitate the worldwide transportation of high value pharma payloads. An impetus for the latest generation of high-performing packaging products is the advancements in drug developments, which includes an increase in more fragile and temperature-sensitive pharmaceutical products.

Various pharmaceutical compounds, utilised within the sector, are developed under certain controlled temperature conditions or designed to be stored at specific temperatures to maintain their stability. It is vital, therefore, when shipping pharmaceutical products between locations, that they remain at their storage condition temperatures to maintain their effectiveness at the point of use. Within the industry, there are certain typical temperature ranges, such as deep-frozen, frozen, refrigerated and room temperature.

The Crēdo Cube is a passive and reusable shipper qualified to hold chilled medical materials at a safe temperature for up to 5 days

With pharmaceutical companies developing ever more complex and temperature-sensitive drugs, there is a greater requirement in the cold chain industry to meet the growing market demand for supply… as well as improved packaging performance and efficiency. There is an enhanced emphasis on providing the global market with increasingly advanced packaging that does more than act as a vessel to transport high value payloads that need to navigate often complex shipping lanes while meeting ever-more stringent regulatory requirements.

The expertise of experienced engineers is a vital component in the latest developments within the packaging industry, with providers deploying increasingly sophisticated systems designed to mitigate supply chain risks and minimise temperature excursions. Any deviations or spikes in temperature, beyond the range specific pharmaceutical products are required to be stored and shipped at, could have a devastatingly detrimental effect on the payload, damaging the container’s contents and impacting the efficacy of the products being transported. As well as the financial repercussions, equating to losses of hundreds of thousands of pounds, any excursions could, more importantly, have catastrophic consequences for the patients/end users who are reliant on the designated drugs being delivered intact, with maximum efficacy. Acknowledgement within the industry of the need to provide adequate payload protection, throughout the supply chain, means there is growing recognition of the critical role advanced packaging plays in response to the stringent regulatory requirements that need to be adhered to.

Technical advances

Given that the quality of pharmaceutical products being transported has a direct effect on the efficacy of patient therapies and a direct effect on patient safety, the packaging industry continually strives to ensure new innovations are fit for purpose. Within the industry there’s an increase in the introduction of information-centric capabilities to assist with the safe shipping of pharmaceuticals around the globe. Advancements in recent years have seen the introduction of improved insulation by using vacuum insulated panels (VIPs), which reduce the bulk and mass of the insulation required while increasing performance.

The sector is also seeing the accelerated replacement of water-based systems with those using phase change materials (PCMs); through a combination of materials, the melting point of the coolants is customised to an ideal temperature, rather than water at approximately 0°C. These systems provide far more temperature stability inside the payload space and use much less material.

Increasingly, packaging companies are utilising advanced asset management software systems, which are in place specifically to ensure that pharmaceuticals are shipped to the right place, at the right time and, critically, that they arrive in the right condition. Companies deploying pharmaceutical shipments worldwide are benefiting from the introduction of new technological advancements such as web-based asset management software solutions, which are designed to track individual shipments around the globe. These systems offer a range of capabilities, including the option to set up automatic scheduled maintenance, next shipment alerts and produce customisable reports.

Cloud-based solutions

Whether a company is transporting clinical trial materials, delivering sample drugs or shipping finished products, the threat of any temperature excursions can mean the difference between success and failure, profit and loss. The sector is seeing a move to the utilisation of reusable systems coupled with asset management SaaS (software as a service) and reaping the associated benefits.

Integrating cloud-based systems supports and enhances the engineering expertise that is incorporated into the development and design of the increasingly sophisticated systems utilised by the life science industries. These systems provide a number of capabilities and can automatically collect and analyse data from company data logger outputs. The deployments of these monitoring devices are increasingly being used in cold chain as they are becoming more affordable and therefore more accessible to pharmaceutical companies. There is a rise in incorporating such data loggers to track temperature throughout the course of the shipment’s route via active bulk and passive systems. Risks rise if a container needs to be opened to access the temperature logger stored inside, so an alternative option is to use data devices that are attached to specialised containers that are utilised to ship a pallet of products. This option provides an isolated monitoring solution whereby data can be saved to the cloud via Bluetooth or Radio-Frequency Identification (RFID).

Within the current market is a range of SaaS products providing the collection and analysis of brand-agnostic sensor data, which is linked to a variety of smart packaging options that allow packaging vendors to track a diversity of data, including vibration, light, humidity and more. The increased use of these software platforms provides capabilities to capture and monitor information about the shipment throughout its journey.

At Peli BioThermal, we utilise our comprehensive asset management software — Crēdo ProEnvision — and global service centre solutions to help customers manage the entire lifecycle of their shipping inventory of Crēdo temperature controlled packaging. These technologies and services help life science industry clients reduce payload risk, distribution costs and their environmental impact, ensuring that temperature sensitive, critical and high value payloads reach their destination safely.

GPS is the latest development in response to ensuring the protection of high value pharma payloads. It is predicted that advancements in GPS tracking options via a SaaS system will be part of the industry in the near future. The benefits to pharma companies include knowing where their shipment is throughout its transportation trip. If payloads are lost or get delayed en route, the pharma company can take steps to intervene and recharge or replace coolants; as such, the package or the bulk system gets delivered before expected temperature duration is exhausted, which helps to avoid a temperature excursion caused by a delay.

What’s currently not in place in the temperature controlled space for smarter packaging is the capabilities to have data logger sensors and SaaS platforms communicate directly with each other, which is something that is expected to be introduced in the near future. Information is currently captured in the main by barcode, a process that requires human intervention to physically collect and then input the information into a SaaS system. The use of these smarter solutions, when it comes to packaging processes, allows pharmaceutical companies to discover when a system failed — and why — and help to avoid similar circumstances in future shipments.

Whether a company is transporting clinical trial materials, delivering sample drugs or shipping finished products, the threat of any temperature excursions can mean the difference between success and failure, profit and loss

Reverse logistics

Specialised software systems can also aid reverse logistics within the industry and can provide real-time tracking and trading through the entire end-to-end distribution cycle. These superior software systems help the global life sciences industry to manage its demanding and expanding cold chain logistics supply chain operations while critically meeting the stringent requirements of a highly regulated industry.

It’s not simply a case of vendors saying these packaging systems work; you have to prove they work consistently. Packaging qualification is crucial and makes sure the packaging systems perform as intended. It’s crucial that packaging performs and is fit for purpose; regulations have been changing in recent years to make them more encompassing, such as the GDP (Good Distribution Practice) guidelines.

This continues to set challenges to the industry as areas not previously covered now are. This has led to an increased requirement to ensure companies meet the latest regulatory requirements and ensure they’re getting the protection they need for their products in the market at the lowest cost. The industry is in mid-transition, with companies looking at how they can deploy more advanced VIP technology and PCMs to improve the efficiency of the supply chain.

In the short-term, we predict some interesting developments regarding the use of PCMs in different combinations and the increasing use of vacuum technology to maximise payload efficiencies and reduce handling and system preparation costs. We’ve recently released our Crēdo Universal system, which reduces customer costs and the controls required for pre-conditioning; it’s easy to use yet very reliable too, against both high and low temperature challenges. For the future, there’s an ongoing drive to look for the next generation of insulation to improve on costs and/or the payload efficiencies.

Innovators should be looking at more interesting ways of creating insulation and innovative ways of using PCMs to achieve optimal performance at a lower cost. Ultimately, the aim is to continue to reduce supply chain costs and improve performance and reliability.

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