In normal everyday shipping methods, ambient temperatures can swing to extremes, as airplanes sitting on the tarmac heat up on hot summer days, and then flying at altitude where temperatures drop below freezing. These temperature swings can be harmful to pharmaceutical products of all kinds, so there are many ways packagers and shippers use to moderate the temperature. There are also ways to test how effective packaging is at keeping internal and product temperatures within tolerances.
In the last 10 to 15 years there has been a proliferation of companies that manufacture containers and devices that protect temperature-sensitive products. The transport of biopharmaceutical goods is regulated by the FDA, and the government requires data to validate that shipping methods and storage materials are adequate to maintain safe interior environments. The methods and tools that the pharmaceutical industry has been using for this protection and validation are now making their way into consumer goods protection and monitoring.
Moderating temperature
Available shipping technologies include expanded polystyrene, urethane, advanced plastic foams, capturedair-in-bags, vacuum panels, and even refrigerated freight containers. Phase-change materials (PCMs) beyond merely a water/ice substitute are now used as an interior temperature stabilizer, changing phase to absorb temperature extremes. With PCMs and the proper design or coordination of insulation, packaging can now control internal temperatures within a narrow range for up to five days as the external temperatures swing from -22° F (-30° C) to as high as 104° F (40° C).
Today’s pharmaceutical packagers, such as the Emballasjen AS in Norway, mix and match existing product technologies to best regulate temperatures for each application. Education about these products and the knowledge to skillfully use them efficiently has also morphed into an essential industry of its own. Being the lowest cost producer providing the lowest prices at the highest quality and delivery, plus creative marketing and service programs, has become the formula for success in the maturing packaging supplier industry.
Also developing at a rapid rate has been the accurate low cost monitoring of temperatures to provide assurance that products have not been exposed to unsafe conditions. As technology in these areas matures, the result will be new devices that can merge all of this knowledge into low cost, easy-to-use products. As the costs come down, more consumer goods companies will see the benefit of carefully monitoring their products during shipment.
For example, electronic temperature data loggers have been on the market for at least 15 years. The newer ones are very small—the size of a quarter or a credit card—and can record extremely accurate information. These devices will keep track of the information for various durations and will encrypt the data to conform to FDA’s regulatory requirements. The newest data logging units are capable of transmitting temperature data remotely at any point during shipping or downloading directly to a computer
after shipping.