Temperature regulation, just like any other product or technology, has seen major strides over the years. Scientific innovation has driven these changes and we have a much deeper understanding than ever before, which enables us to be more targeted and effective in our approach.
What were once rudimentary approaches with limited capabilities have evolved into more sophisticated methods of ensuring that all perishable products, like pharmaceuticals, are kept within the optimum temperature range.
And it’s all because of phase change materials.
A Brief History Lesson
In the early days of temperature-controlled transport for pharmaceutical products, shippers used expanded polystyrene with water-based gel paks. This packaging would be validated for a specific time period and temperature range, but beyond that there were no guarantees.
Styrofoam packaging is another solution that was introduced and is still used today. However, even with passive temperature control inserts, this often results in temperature excursions during shipping or storage.
These early solutions could be effective, but they had limited temperature control and ranges. Fr example:
Ice keeps things above freezing, but can have “frozen spots” which kills or reduces efficacy of pharma
Dry ice works, but items must be frozen and continue to be that way
Phase change materials, on the other hand, can be formulated to cover and help temperature ranges outside of other limitations.
Introducing Phase Change Materials
There were many factors that drove innovators toward phase change materials (PCMs), in addition to the shortcomings of the early solutions listed above. These are the primary reasons:
More stringent regulatory requirements across the globe
Growing value of drugs like biologics
Customer demand for new temperature ranges
Emerging markets with extreme temperatures
As more precise temperature ranges became the norm, Phase Change Material (PCM) became the preferred packaging for many shippers. Comprised of materials such as salt and paraffin suspended in bricks, PCM gave shippers greater control over temperature ranges during transport. PCM’s emergence also meant more emphasis on preconditioning to ensure packaging was ready to ship in-range.
Boxes with Vacuum Insulated Panels (VIP) and PCM inserts are the current gold standard for temperature-controlled transport. And while these packaging innovations may require more up-front preconditioning and planning to mitigate excursions, shippers who use them experience fewer quarantines and shipments clearing quickly to investigator sites.
As drug values continue to soar and regulations become more and more stringent reusable packaging (with PCMs) will become another viable option on the market.