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Ask the expert, Pharmaceuticals, Cold chain management
Controlant CEO and Co-founder, Gisli Herjolfsson, offers his thoughts on challenges that companies face while trying to navigate the temperature-controlled supply chain in this recent article with Pharmaceutical Manufacturing and Packing Sourcer (PMPS).
PMPS: Location tracking remains integral in temperature-controlled logistics, but what improvements need to be made to better inform distributors and reassure clients?
Gisli Herjolfsson: Many pharmaceutical supply chains are not equipped with real-time data that would help them prevent issues; often, they can only see the issues once the product has been received. This leads to companies not being able to alert their carriers and logistics providers that a problem has arisen so that proactive action may be taken to prevent in-transit product waste. Real-time data monitored and tracked by IoT devices can be used to send escalation notifications based on product integrity, location, and other risks, like pallets being split up, longer than usual dwell times, or other incidents that can compromise quality conditions.
The COVID-19 vaccine distribution efforts have demonstrated how technology can be used to effectively connect stakeholders and align goals across the supply chain. Integrations of various systems and platforms made it possible for manufacturers to aggregate data into insights using multiple control towers. Technology improves communication and collaboration with their carriers while also automating workflows and processes. Integrating cold chain control towers will enable greater visibility, agility, and responsiveness moving forward, connecting stakeholders across the value chain, reducing waste, improving delivery time, and ultimately increasing patient safety.
How are risks mitigated throughout a cold chain shipment’s journey?
Within the cold chain, problems typically happen at multiple handoff points. Temperature excursions account for nearly 80 percent of supply chain problems, damaging products and diminishing consumer confidence in trusted brands. Each lane of travel—air, road, or sea—requires different handoff points, and each one poses unique risks. Losses of temperature-controlled products often occur because cold chains have historically lacked real-time access to actionable data that enables accurate decision-making and documents the integrity of delivered cargo.
Real-time data logger technology can be used to measure various scenarios that would require escalation, like products being delayed, pallets being split up or arriving at the wrong location, a potential security issue, or issues at borders. This level of insight allows companies to see into their business operations, supply chain operations, suppliers, and partners and then make decisions that maximize improvements.
How do data help to understand issues that have arisen to improve future performance?
Real-time visibility and monitoring have made previous, retrospective processes and minimal data logging irrelevant. We can answer, ‘What is happening right now?’ so parties can act on critical information, fast. Moving forward, supply chain stakeholders can leverage gathered business intelligence and data to predictively answer, “What will happen?” This data will enable businesses to execute planning in an entirely new way. For instance, if a product is shipped using a particular lane or packaging type, during a specific time of year, prescriptive analytics can help people understand scenarios that are likely to occur. Information like this is crucial to prevent product waste and stock outages, as well as determine the best route or packaging material. These technologies include integration of multiple systems and connect the physical and digital supply chains together to enable stronger collaboration, decision-making, and responsiveness.
The last mile is often the trickiest area of temperature control – what are the main challenges of completing the supply chain?
Traditionally, visibility has been limited within the last mile, but we are seeing the opportunities that real-time technology provides, like automating processes and workflows. Automation has been a key component of successful COVID-19 vaccine distribution and delivery. The automated services and processes put into place can apply to other scenarios moving forward to positively impact the pharmaceutical industry, such as automatic triggering of events according to predefined business rules set by the customer.
For example, orders are entered into an ERP (enterprise resource planning) system, and a shipment is created to the designated customer and site. When a shipment arrives, a detailed report is automatically created and emailed to designated onsite stakeholders, including the internal quality team, for sign off. Recipients know automatically if the vaccine, medicines, and other pharma products should be placed on hold pending further review or if it may be released and administered to patients.
The implications for the last mile and direct-to-patient (D2P) delivery models are now evident. We can send smaller quantities of shipments directly to patients, clinics, and other sites, bypassing the traditional wholesaler/distributor network model. The D2P approach can now be automated to support the last mile and clinical trial logistics process.
What part can temperature-controlled logistics play in sustainability, and how can it improve?
The biopharma industry loses approximately $35 billion annually due to failures in temperature-controlled logistics. These unusable products are destroyed and end up in landfills. There is an environmental cost associated with the manufacture, transport, and distribution of the replacement products, including water consumption, plastics produced (and discarded), CO2 emissions, and fuel. If companies are to reach their corporate sustainability goals, they will need to vastly improve the supply chain to minimize waste.
Historically, most enterprises have utilized single-use USB data loggers for their temperature monitoring programs. At the end of the supply chain journey, loggers are removed from a shipping container, data is retrieved from the logger, and the device is subsequently discarded. However, we are seeing an increasing trend in the use of reusable packaging and IoT devices.
For many pharmaceutical manufacturers, this might add up to tens of thousands of data loggers that are discarded every year. To visualize the magnitude of the waste involved, below is an image that shows how much e-waste is created by single-use loggers.
A typical data logger measures approximately 11 cm in length. If a company uses 150,000 loggers in one year, it would measure 10 miles, or more than 16 km, equivalent to Mount Everest’s height. When you consider the long-term implications of single-use logger programs over many companies each year, the amount of wasted plastic is staggering.
If we calculate the number of IoT devices used in the COVID-19 vaccine distribution over three years, the number of single-use or limited-use devices would reach the space station.
Over time, utilizing reusable IoT devices and packaging materials translates to a substantial reduction in plastics waste and can help companies achieve their corporate sustainability efforts.
What needs to change for more companies to invest in and use multi-use loggers for their shipments?
Companies need to see clear value up front. Historically, pharma enterprises were hesitant to adopt real-time visibility technology, as they didn’t have the resources to respond to issues that escalated in their supply chains. Now, they have access to solution providers that offer 24/7 monitoring and response services to facilitate proactive corrective action with carriers and logistics providers on behalf of their customers.
Similarly, now we are seeing solution providers offering reusable technology in tandem with reverse logistics programs that collect loggers from receiving sites and, after sanitizing, charging, and calibration, replenish them at designated shipping sites. More commonly, we are seeing an increase in the number of partnerships among reusable IoT data logger providers and reusable packaging providers to deliver these automated services together.
We’ve seen pharmaceutical and logistics companies find success by starting with a pilot program which shows them just how much more efficient a multi-use logger program can be. Businesses should not overlook the benefits of adopting innovative solutions as part of their sustainability efforts. Enterprises looking to save money in the long-term by utilizing sustainable solutions and improving supply chain efficiency in the cold chain are realizing resources and cost savings, which, in turn, can be allocated elsewhere.
After shifting from a single-use temperature monitoring data logger program for its supply chain operations, one of our customers saw the number of loggers used annually changed from approximately 150,000 disposable loggers to 35,000 reusable data loggers offering a multi-year shelf life. When considered along with the broader opportunities for supply chain sustainability improvements that reusable, real-time IoT technology offers, the savings add up.
What have been the main obstacles to the cold supply chain during the pandemic?
There are several risk factors in the cold and ultra-cold chain of COVID-19 vaccine distribution, and really most vaccines in general. First, the vaccines must be stored at low and ultra-low temperatures, some much lower than the usual cold-chain standard of 2–8 °C. Any deviations in temperature during transport or storage can render the vaccine ineffective or even unsafe. Additionally, there are multiple hand-off points along the supply chain, and each one poses risks of temperature deviations, pallets being split, or other incidents that can compromise the products’ quality condition. Likewise, the receiving facility staff must review and understand all handling and storage instructions for each vaccine.
Many suppliers from all parts of the distribution chain—from makers of thermal packaging, sensors, data loggers, and supply-chain visibility systems to dry ice suppliers and airlines—stepped up to prioritize vaccine distribution, and in some cases modified existing technologies to meet the requirements. We have seen tremendous efforts across the COVID-19 vaccine distribution channel, with parties coming together to help solve a common goal for humanity.
Real-time data logger technology was designed to measure various scenarios that would require escalation, like products being delayed, pallets being split up or arriving at the wrong location, a potential security issue, or issues at borders. Our 24/7 Monitor and Response Service (MARS) team was also available in the background to facilitate corrective action if escalations occurred. In tandem, Controlant worked extensively with stakeholders and designated sites to create an onsite monitoring control tower, providing centralized services to facilitate responsiveness and corrective action, per the vaccine manufacturer’s instructions and according to specific business rules and regulations. Multiple parties involved with the distribution and onsite process are provided with pertinent information and alerts, as they happen, so that the vaccines can be protected, helping to ensure public safety, mitigate financial losses, and expedite vaccine administration.
COVID-19 has driven up the need for the cold chain, but how do you see the next five years evolving as we move out of the pandemic and beyond?
A new pharmaceutical distribution model was established globally in a matter of months due to the COVID-19 pandemic. This included the integration of multiple control towers, sharing of data, collaboration on processes, and technology enabling responsiveness on a level never witnessed previously. We can now aggregate and automate data that tell us: What has happened, what is happening as it happens, and what will happen?
Most supply chain technology provides descriptive information only. It tells us what has happened after the fact. In the supply chain, this is problematic because we are no longer able to act on the information. This data is of limited use to us as supply chain leaders. We might be lucky if we have complete data, if at all, to understand what happened and to mitigate risk moving ahead.
Now that supply chains are moving towards real-time visibility, they can answer the second question: “What is happening?” so they can act. They can also answer, “What will happen?” which will is enabling businesses to execute planning in an entirely new way.
Technology, including the integration of multiple systems, will continue to play a large part in the coming years. It will connect the physical and digital supply chains together for a single source of truth and create a true control tower. The new cold chain control tower can now involve multiple enterprises and participants in the supply chain. This will enable stronger collaboration, decision-making, and responsiveness. This modern enterprise architecture provides a lot of opportunities to build patient and customer-centric business models and expand on current models. Artificial intelligence, machine learning, and automation will continue to drive the industry forward, vertically integrating value chain activities, and enabling companies to process data in new ways.
This article is taken from Pharmaceutical Manufacturing and Packing Sourcer May 2021, pages 16-18. © Samedan Ltd
Interested in learning more about real-time temperature monitoring or getting started with a pilot? Get in touch. We would be happy to help you solve your cold chain challenges.