The U.S alone holds over 45% of the global pharmaceutical market. Our nation is responsible for guaranteeing the quality and efficacy of these vital products, from vaccines to diabetes medications. Unfortunately, many pharmaceuticals are dependent on strict temperature controls in order to remain effective, and not all cities and towns are nearby the manufacturing locations; this means that certain procedures must be followed and certain equipment must be used to ensure that these important medicines don’t fall out of their ideal temperature range.
Understanding The Cold Chain
Approximately seven out of every 10 pharmaceutical products require temperature-controlled transportation; this temperature-controlled supply chain is often referred to as the cold chain because many medications and pharmaceuticals must be either refrigerated (kept at between two and eight degrees Celsius) or frozen (kept at -50 and -15 degrees Celsius). As a result, all aspects of transportation — from storage to handling — must be carefully monitored, usually with the following devices.
- Temperature Monitoring Device (TMD): Temperature monitoring devices track and record any changes in temperature throughout the product’s storage life. They record when refrigerator or freezer doors are opened, and can tell technicians of any major changes that occurred throughout the day; this is precisely why they should be checked at the start and end of the workday, and at any point when the door is opened.
- Temperature Sensor Alarm: If the pharmaceuticals being moved are extremely sensitive or rare, the storage units may be outfitted with temperature sensor alarms, which allow technicians to set maximum and minimum temperatures. If the unit falls out of that safe range, the device will sound an alarm, alerting nearby techs. They can then correct the temperature problem before any products begin to degrade or lose efficacy.
Maintaining the cold chain can be exceptionally difficult, especially during cargo exchanges (such as from truck to boat) and in hot climates. Let’s find out how businesses mitigate the risks associated with fluctuating temperatures.
Cold Chain Packaging Systems
There are two kinds of systems that cold chain users rely on, each with their own benefits and drawbacks.
- Active Thermal System: Active thermal systems use mechanical or electrical systems powered by an energy source to keep the entire containment area cooled to specific temperatures. As a result, they are much more precise and easy to manage, making them extremely reliable in terms of temperature accuracy. However, they are also more expensive because they need to be constantly connected to a power supply.
- Passive Thermal System: If you’ve ever packed refrigerated foods in a cooler for a road trip, you’ve used a passive thermal system. They use phase change materials (PCM) such as water or dry ice to keep temperatures low. Unfortunately, this exceedingly basic form of temperature control is almost impossible to maintain with any consistency; if you’re transporting vaccines that need to be held at five degrees Celsius, you won’t be able to guarantee the exact temperature.
The type of cold chain transportation system you use depends on the product you’re moving. With delicate and fragile pharmaceuticals, you’ll want to choose the system that ensures their efficacy upon arrival. Vaccines prevent an average of 2.5 million unnecessary deaths in the U.S. every year, but if they were not stored in a meticulously controlled temperature environment, they would break down and essentially become useless. The better we are able to guarantee this control, the more illnesses we can treat and the more lives we can save.