Article: The evolution of temperature control
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. Though inexpensive, Styrofoam packaging — even with passive temperature control inserts — often resulted in temperature excursions during shipping or storage. Logistics providers had to make a lot of assumptions about whether or not a product or sample stayed in temperature range during transport, and manufacturers and trial sponsors experienced delays due to damaged product.
Drivers of innovation in temperature control include:
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.
In the early days of PCM, World Courier teams placed various packaging configurations on the roof of our London office to test the materials’ endurance at absolute external ambient temperatures.
Over the last decade, temperature monitoring during transport via high-tech loggers has become more and more prevalent. And while real-time monitoring has a long way to go, shippers are now able to prove packaging performance for customs clearance. In Saudi Arabia, for example, customs officials remove temperature monitors from packaging to check for excursions — and shipments with temperature deviations are not allowed into the country.
Packaging evolution has resulted in a value exchange for the logistics market, as shippers are willing to invest more in technology up-front to avoid excursions, trial delays and patient losses down the line.
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.
Experts say a shipper’s best bet is to invest in packaging that is independent of the supply chain and can keep shipments on-temperature even when storage conditions deviate.
As drug values continue to soar and regulations become more and more stringent, what does the future hold for temperature-controlled transport? Our experts predict a few ongoing innovations:
Real-time data on temperature will drive even more advances
Reusable packaging will become more realistic