When a temperature excursion occurs during transit, companies lose hundreds of thousands of dollars in lost product and time. An excursion occurs when the temperature of the shipment deviates from the required temperature range during transit. Often, when a temperature excursion occurs, specimens or pharmaceutical compounds are no longer viable. This can lead to wasted clinical trials, delaying the launch or distribution of new pharmaceutical drugs, creating situations where patients have to go through tough procedures again, or create false positives.
How does a temperature excursion occur?
While there are many reasons an excursion can occur, the root cause of temperature excursions stems from a lack of control or visibility. These are often fixable errors. An excursion can be tied to faulty packaging, improper pre-conditioning, human error, failure to correctly handle or store the package(s), or a lack of information regarding the temperature and location in real-time. Working alongside a Cold Chain logistics company that specializes in visibility and service will provide a safer, more reliable transportation process.
While Covid has already decreased available routing options, biopharma companies must be overly cautious when shipping specimens within dry ice. As the supply of carbon dioxide (C02), the main ingredient in dry ice, tightens, many large distributors of dry ice and C02 have experienced supply shortages. This shortage of dry ice means many cold chain logistics companies will look to either skip replenishing dry ice between longer transit legs altogether or replenish it with less dry ice than optimal.
Supply is being impacted by multiple plant maintenance and temporary shutdowns, which are impacting independent gas distributors and customers in the food and drink industry. CO2 demand in northern California has outpaced production so the product is being brought into the area via rail cars and roads, which adds to distribution costs and is driving up CO2 prices, according to sources close to the situation.
However, the lack of dry ice isn’t the only cause of temperature excursions. Improper processing of pre-conditioning and packaging means a payload can be packaged within a faulty box, creating opportunities for temperature excursions to occur even before the shipment has left the lab. The cause of this error could be due to improperly placing the payload within the dry shipper or faulty packaging. While cold chain logistics companies typically will pre-condition and send their temperature-sensitive packaging to the shipper, mistakes can occur due to improper handling, training, or human error. This improper handling can lead to deviations during transit.
Pre-conditioning is the process of setting the internal temperature of the package to be within the required temperature range of the payload. Depending on the temperature range required, the pre-conditioning process can change. Within the pharmaceutical industry, temperature-controlled shipments are often transported within one of the following temperature ranges: controlled room temperature (+15C - +25C), refrigerated (+2C - +8C), frozen (-20C), dry ice (-80C), and liquid nitrogen (-150C). If the package is not pre-conditioned to the correct temperature range or if it is faulty then an excursion will occur, and the payload will be damaged due to temperature integrity.
During pre-conditioning and packaging, a lot of the error can be associated back to a human failing to follow protocols or training in place. While managing training is crucial, it is important to remember that humans make mistakes and setting up stop gaps to catch human error is required. The challenge is that most temperature sensitive shipments are transported with traditional USB data loggers. While effective at capturing the temperature range within the payload, a USB data logger does not allow that information to be used or seen until after the shipment has been delivered and the data logger has been plugged into a computer.
How to eliminate temperature excursions?
Without visibility into your pharma shipment’s location and live temperature updates, you are risking costly failures in your supply chain. By increasing the visibility of a shipment, shippers and transportation companies have more control over temperature integrity, location, and delivery. When packaging a shipment, using a GPS and temperature tracker alongside the traditional data logger enables the logistics company, shipper, and consignee to all receive live updates regarding the payload’s location, temperature, light, and shake no matter where the shipment is currently located.
This advanced technology enables the logistics company to pro-actively monitor the shipment and make decisions to eliminate temperature excursions. Live monitoring means logistics experts can be alerted as soon as the temperature range starts creeping up or down towards an excursion and work to fix the issue. Areas where most temperature excursions occur are 3rd party warehouses or cargo facilities like the airlines or customs. Shippers and the operations team handling the transportation aspect often do not have access or control into these environments and have to rely on relationships to ensure proper handling. However, with live tracking, you can always see the location and temperature of the shipment and request changes to the storage area to increase or decrease the temperature of the package.
Real-time condition tracking also enables transportation companies to pinpoint exactly when and where temperature excursions would have occurred and solve the problem before the product is damaged and find alternative modes of transport to ensure future shipments don’t have the same issue.
Optimize believes every biopharma company should have a solution that is custom built for them, not a list of system driven options. By combining a personalized service with over 40 years of cold chain logistics experience and advanced tracking technology, Optimize provides a unique logistics experience and has set a new standard within the specialty courier industry.
