There is a degree of qualification and monitoring that must be met in order to ensure that the temperature control of the pharmaceutical goods is properly handled. Contingent upon the nation, business, or medication itself, there are numerous factors of regulation to consider.
If there is any potential for the drugs to be exposed to outside temperatures, the warehouse, cooler, and trailer all must be closely monitored. For temperature qualification approval, a test takes place when the warehouse is vacant, again once it is fully stocked, and at several other touchpoints.
There are a multitude of components that go into how we employ phase change materials (PCMs) to maintain temperature-sensitive pharmaceuticals during the shipping and storage process. Here are 3 of the most important:
Climate and Season
Climate and season both assume a massive role in how we protect pharmaceuticals. If you're not prepared, outside conditions like these can impact with temperature. Obviously, the safety of the pharmaceuticals can be undermined when a package is left sitting out in the sun on a hot day or left unattended in a freezer when it shouldn’t be. And, it gets considerably trickier if you’re shipping from one place to another with a different climate, which is becoming much more common. The time of the year that the products are being shipped can also effect control methods.
Thanks to a greater worldwide demand for new medications and widely-dispersed patient populations, manufacturers need to ship increased volumes of material over longer distances. Likewise, in bigger amounts, these products are becoming progressively significant, or more temperature-delicate than they've been the past.
Increased demand on both the packaging and on the integrity of the entire temperature-controlled supply chain has been impacted by the greater range of shipping temperatures required by manufacturers.
Longer shipping routes have become unavoidable in order to reach these regions and more distant patient communities. The shipment is more likely to pass through broadly varying climate zones, conditions along the route are regularly more difficult and unpredictable, and the transport/storage infrastructure may be less well-developed.
In order to be successful under these challenging circumstances, shipments rely on the correct choice of packaging for the conditions and type of material that will be encountered during transit.
Packaging has become much more sophisticated than simply using styrofoam to insulate products. Finding and using the right packaging is just one component of secure temperature-controlled shipping, but it’s a critical one.
With PCMs, basic approaches with restricted capabilities have progressed into much more sophisticated methods of guaranteeing that all pharmaceuticals are kept within the optimum temperature range.