To ensure that the temperature control of the pharmaceutical goods is properly cared for, there is a level of qualification and monitoring that must be met. Depending on the country, industry, or drug itself, there are many levels of regulation to consider.
The warehouse, cooler, and trailer all need to be closely monitored to determine if there are any risks of the drugs being exposed to outside temperatures. To approve for temperature qualification, a test is done when the warehouse is empty, again once it is stocked with products, and at several other touchpoints.
There are many factors that go into how we used 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 play a huge role in how we protect pharmaceuticals because outside factors like these can mess with temperatures big time if we’re not prepared. Obviously, if a package is left out baking in the sun on a hot day or left unattended in a freezer when it shouldn’t be, the integrity of the pharmaceuticals can be compromised. And, it gets even trickier if you’re shipping from one climate to another, which is becoming much more common. Control methods also change depending on the time of year the products are being shipped.
Today, manufacturers need to ship increased volumes of material over longer distances, thanks to worldwide demand for new medications and widely-dispersed patient populations. What’s more, these goods are often more valuable, in larger quantities, or more temperature-sensitive than they’ve been in the past.
The greater range of shipping temperatures required by manufacturers increases the demand on both the packaging and on the integrity of the entire temperature-controlled supply chain.
To reach these regions and more distant patient communities, longer shipping routes are inevitable. Conditions along the route are often more difficult and unpredictable, the shipment is more likely to pass through widely varying climate zones and the transport/storage infrastructure may be less well-developed.
Under these challenging circumstances, successful shipments rely on the right choice of packaging for the type of material and the conditions that will be encountered during transit.
Finding the right packaging is just one component of secure temperature-controlled shipping, but it’s a critical one. Packaging is much more sophisticated than simply using styrofoam to insulate the products.
With PCMs, rudimentary approaches with limited capabilities have evolved into more sophisticated methods of ensuring that all pharmaceuticals are kept within the optimum temperature range.