Assuming a COVID-19 vaccine is on the horizon, the cold chain needs to be prepared for the onslaught of vaccines shipping around the world and the U.S.
It’s not an easy task, given the number of transfer points from manufacturing to administration sites. Vaccines often travel by truck and airplane, with stops and storage at the distributor before arrival at the terminal point, where they once again go into cold storage. The last mile to the healthcare provider could be a van delivery to a nearby town, or they could be transported via donkey, bike or camel.
Vaccines lose effectiveness the longer they are outside their target temperature range, whether too warm or too cold. They should be stored between -58 degrees Fahrenheit and 5 F if frozen, or 35 F to 46 F otherwise.
A quarter of vaccines are degraded by the time they arrive at their destination, due to incorrect shipping procedures, according to the International Air Transport Association's Center of Excellence for Independent Validators in Pharmaceutical Logistics. And 20% of temperature-sensitive biopharmaceutical products, including plasma, are damaged during cold chain transport. "These are very sensitive materials," said Mahesh Veerina, CEO of Cloudleaf, an IoT sensor and visibility company.
Losses from vaccines exposed to temperatures outside the recommended range, known as excursions, are estimated at $34.1 billion annually, including lost product cost, replacement cost and wasted logistics outlay.
"Considering the state of healthcare, that is almost unconscionable," said Joe Battoe, CEO of Varcode, a temperature monitoring technology company.
The characteristics, such as exact temperature range, of forthcoming COVID-19 vaccines are not yet known, but "every vaccine is a cold chain product," Veerina said. Vaccines used in clinical trials must be transported via the cold chain as well.
"Considering the state of healthcare, that is almost unconscionable."
As coronavirus cases tick up in many parts of the world, the stakes are high not only for manufacturers and suppliers, but the logistics providers tasked with safely transporting the vaccines across the world. With billions of doses needed, a 20% vaccine loss due to cold chain issues — or even lower loss percentages — is problematic.
Blockchain, cloud storage, and technology-enabled tracking and monitoring sensors provide real-time visibility into temperature changes — and an opportunity to intervene before damage is done. Without sensors, there's no understanding of what happens to the temperature once the pharmaceutical materials leave the labs or manufacturing facilities. Traditional data logger technology collects data, but by the time someone looks at it, it may be too late and the material must be discarded, Veerina said.
IoT sensors keep supply chains on alert
Digital technology can help manage distribution once the products leave the factory, with sensors placed on every pallet, case or unit on the production floor, tracked through their journey to the healthcare facility. Current vaccines aren’t tracked by dose, said Veerina, but that may change with higher value vaccines like the one for COVID-19.
Tracking will include IoT sensors in some cases, which are already in use in some biopharmaceutical logistics. They can help identify weak links along the supply chain, like if there’s a trend where temperatures change at a specific point in the route. More than 50% of the temperature excursions occur during airline and airport handling, according to IATA.
Cloudleaf uses Bluetooth radio technologies for continuous data transmission. Its data tracking system produces a digital twin that maps the product's transit history in real time. The sensors can read light, temperature and humidity, along with manufacturing details like serial or lot numbers. Along with that data, the manufacturer specifies business rules, including what temperature band or range to program into the sensors. The system sends alerts to stakeholders for any violations outside the band, noting temperature specifics and product location. A power unit could have broken, causing the materials to heat up, or the pallet might be sitting on an airport tarmac too long.
The sensors have cell memory to store information if cloud upload and wireless communication are not immediately available, said Veerina. When the healthcare organization receives the products, the organization would check the dashboard to review its history and chain of custody before signing off on the product. But even before the product got that far, the manufacturer would know if a batch of vaccines was out of the proper temperature range and unusable.
Cloudleaf is also combining its individual tracking data with outside contextual data, like weather and transportation information. The tech company can use artificial intelligence (AI) to predict anomalies, transit backups or estimated arrival times.
Another IoT method is using scannable barcodes which upload information to a cloud-based blockchain system. Varcode uses this approach to monitor time, temperature and location. The system can provide alerts after the barcodes are scanned. The Varcode tags, which can track cumulative time outside the designated temperature range, would return a message to the scanner within seconds, confirming the safety of the product or suggesting safety measures to preserve the product, like to chill it immediately or put it in cold storage, said Battoe.
"There are strict policies, but [the process is] mostly manual and not digitized."
Stakeholders in the vaccine supply chain can track and monitor individual vials or the entire pallet or tray. A bright orange parent tag at the pallet or tray level connects to other tags in the system, so individual tags inherit the parent’s history if handled in the same environment. "No one wants to scan thousands of vials as they take or relinquish custody," Battoe said.
Varcode and Cloudleaf use blockchain-based cloud systems, which provide an immutable record and can help identify counterfeit items. Using blockchain and tracking allows users to better recognize diversion of vaccines, those stolen or inadvertently sent to the wrong location, Veerina said. Traditional vaccines already have diversion problems domestically and internationally, he said, and certainly COVID-19 vaccines would be subject to the same concerns.
Tracking plasma to reduce waste
Temperature tracking is also helping to decrease waste of plasma, the liquid part of the blood. Convalescent plasma has antibodies from donors who have recovered from COVID-19, which could aid in treatment and research related to the illness.
Plasma is collected from donor centers where it’s kept in a freezer. The collection centers then send it in temperature-controlled trucks to facilities that process the plasma, separating out the components needed to create medicinal products. It’s stored at -4 F there, Veerina said.
"The processing is complex and a manual effort," he said. The processing happens in a room at 41 F. Bags of plasma have unique identification labels which include the source information. Temperature has to be monitored continuously, as it’s a violation if it’s left on the counter for more than 90 minutes. Also, labels can be lost, causing additional tracking problems.
"COVID-19 brought a completely different level of fragility to the supply chain."
"There are strict policies, but [the process is] mostly manual and not digitized," Veerina said, with alarm clocks monitoring the time outside the freezer.
"That’s where sensors come in," he said. They can detect location and temperature, and track how long the material is cumulatively outside of preservation to ensure the plasma doesn’t need to be discarded. Veerina said companies monitoring the plasma through the supply chain using real-time sensors have decreased spoilage and wastage.
"COVID-19 brought a completely different level of fragility to the supply chain," with billions of needed vaccine doses, said Veerina. Decreasing the waste of this biopharmaceutical product through the cold chain will have a direct impact on disease control.