Temperature regulation has seen major strides over the years thanks to scientific innovation. The industry has witnessed the ability to be much more targeted and effective in moving compliance regulations forward and we now have a much deeper understanding than ever before.
Modern techniques have evolved past the once rudimentary approaches with constraining capabilities, into more sophisticated methods of ensuring that all perishable products, such as pharmaceuticals, are held within the optimum temperature range.
And all the credit is due to phase change material.
Back in the Day
Shippers used expanded polystyrene with water-based gel paks, in the early days of temperature-controlled transport for pharmaceutical products. There were very few guarantees, the packaging would be validated for a specific time period and temperature range, but beyond that was nothing.
One solution that was implemented and is still in use today is styrofoam packaging. However, this often results in temperature excursions during shipping or storage, even with passive temperature control inserts.
While early solutions could be effective, they still had restricted temperature control and ranges. For example:
- Ice can keep things above freezing but can have “frozen spots” which kills or diminishes the efficacy of pharmaceutical product
- Dry ice can work, however, items must be and continue to be frozen.
On the other hand, phase change materials can be formulated to cover and help temperature ranges outside of other limitations.
Phase Change Materials
In addition to the shortcomings of the early solutions listed above, there were many other factors that drove innovators toward phase change materials (PCMs), The primary reasons are:
- Newly emerging markets with extreme temperatures
- More strict regulatory requirements internationally
- Increasing value of drugs such as biologics
- New temperature ranges created from customer demand
Phase Change Material (PCM) became the preferred packaging for many shippers, as more ranges for precise temperature became the norm. PCM’s emergence meant more emphasis on preconditioning to ensure packaging was ready to ship in-range. Comprised of paraffin and salt suspended in bricks, PCM gave shippers greater control over temperature ranges during transport.
The gold standard for temperature-controlled transport, currently, are boxes with Vacuum Insulated Panels (VIP) and PCM inserts. 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 values of drugs proceed to skyrocket and regulations become increasingly more stringent, reusable packaging (with PCMs) will become another viable option on the market.