When transporting temperature-controlled comparator drugs for clinical trials, it is important to maintain the integrity of the product so as to avoid any problematic temperature deviations. Although it is near impossible to avoid deviations entirely, trial sponsors can keep them to a minimum by choosing an appropriate shipping method for their transportation needs.
In a previous article, we looked at active shipping configurations as an option for trial sponsors. In this article, we will focus on passive shipping configurations.
Passive shipping configurations, as well as the media they use, can either be disposable or reusable. In either case, the containers use both insulated material and a range of temperature stabilizing technologies, including dry ice, gel packs, and phase change materials. When correctly configured, these materials work together to maintain a specified temperature range for a specified period of time, which is determined and logged before the package is released for transport. It can function like this without relying on any mechanical assistance, but only for the predefined transportation timeline.
There are a number of reasons a trial sponsor might benefit from using passive shipping configurations. Firstly, this type of container holds tighter temperatures than active shipping configurations, which means problematic temperature deviations are less likely to occur. Furthermore, they can be used all year round as they do not rely solely on batteries or dry ice, which can be affected by adverse summer or winter temperatures. Also, if a pre-qualified container design does not work for a specific product, most manufacturers can customize a unique design that better fits a trial sponsor’s needs.
However, using a passive shipping configuration can be problematic. Because these containers are designed with a predetermined transport life, product delivery must always occur within this specified period. This can make a trial sponsor less flexible to deal with unexpected problems or changes in the distribution processes. Also, because the trial sponsor has to buy the container, rather than lease it, storage can be an issue if a sponsor has limited warehousing space/availability.
As such, because there are both benefits and draw-backs associated with using passive shipping configurations, a trial sponsor will need to be well informed before deciding whether or not to choose such a transportation method. As every comparator drug and transportation process is unique, it is important to remember that, just because a passive shipping configuration works for one, does not mean it will work for all.