Throughout any supply chain, whether that be clinical or commercial, the threat of temperature excursions is a pressing one to any supply chain professional. Take for instance, a pallet containing a supply of drugs left on an airport tarmac. With an ambient temperature rising just above 70°F (21°C), temperatures could soar past 130°F (50°C) on a given day. Even a controlled room temperature (CRT) product, such as an over the counter (OTC) drug, which must remain at room temperature at times, is just as much at risk to an excursion as a cold chain product that must remain between 2°C and 8°C (35º–46ºF). What this showcases is the scale of the problem that can occur if a shipment isn’t monitored carefully.
Temperature excursions can have costly ramifications…
In a recent survey carried out by Cold Chain IQ, it was found that 10 percent of participants discovered temperature deviations in over 15 percent of their temperature sensitive shipments. However, 20 percent were unsure whether their shipments had encountered any excursions. It’s always important to remember room temperature products do have temperature limits (naturally) – the standard being 68-77°F (or 20-25°C). Such products in general should not exceed temperatures above 104°F (40°C). Also keep them stored away from heat, moisture, and light.
According to Craig Montgomery, Cargo Sense, temperature excursions cost the pharmaceutical industry over $15 billion on average a year. What’s more, over $35 billion is lost year on year, and that accounts for the outlay spent replacing those products, as well as the associated costs spent on labor, root cause analyses and so forth.
A failed Cold Chain can lead to 4 Key Risks:
While the ramifications of temperature excursions might not be lost on supply professionals, it can be easy to take the eye off the ball. What’s more, it’s worth placing things into context by showing how even OTC drugs stored at room temperature are just as vulnerable to excursions as cold chain products. Therefore, it’s important to acknowledge the implications of a failed cold chain:
- The patient could be administered an unsafe product
- A lack of compliance with global regulatory and standards-based requirements can increase liability
- Thermal variability can lead to inconsistency of results between and within batches
- The shipment can be rejected by the Quality department therefore leading to costly delays – increasing the complexity of trial management
Source: Rafik H. Bishara, Ph.D., Good Cold Chain Management Practices for Clinical Trial Materials/Investigational Medicinal Products
Safeguarding the Cold Chain
Therefore, in cold chain logistics, two factors need to be considered to successfully transport supplies. There’s the container (passive or active shipping systems) and the monitor (downloadable devices or Real Time with GPS).
For containers with passive shipping systems, the configurations in place are manufactured systems that:
- Are typically insulated with polystyrene, polyurethane or vacuum insulated panels
- Maintain temperature by using Dry Ice, Gel or Phase Change Materials (PCM)
- Have been pre-qualified to hold a particular temperature for a certain amount of payload capacity for a specified period of time: 24, 72 or 96 hours, and more
Source: Frank Leu, CEO, Novapeutics
For all the advantages of passive shipping, active shipping configurations are generally considered more secure. In the event the temperature falls outside the desired range, batteries can be refilled. Alternatively, a system can be put in place that allows the batteries to be plugged in if there’s a delay to the shipment. Such a design can help lower the threat of theft while aiding compliance to regulations.
Furthermore, the monitors used in the shipments ideally should have web-based access. It’s important supply professionals have the capacity to track and report on all moving shipments online around the clock. With technologies, such as real-time monitors that offer GPS locations, it’s always to the benefit of the trial in question that supply professionals have a handle on where shipments are at any given time. By using the right shipping container and the right monitor, the risk of temperature excursions are greatly reduced, and safeguard not only the integrity of the product, but the patients themselves.
*Based on Frank Lew’s presentation, Temperature Maintenance through the adoption and utilization of the latest technology delivered at the Clinical Trial Supply East conference in October 2016