The Federal Aviation Administration (FAA) has approved the PharmaPort 360 temperature-controlled shipping container for use in commercial and military air transport. The announcement was made by Lew Rosenblum, chief executive officer of Cool Containers LLC, and US Senator Sherrod Brown (D-OH) after 1½ years of formal testing and review.
“We are grateful to Senator Sherrod Brown and former Congressman Charlie Wilson for their help in navigating government procedures associated with the FAA regulations for air transport of active cargo,” said Rosenblum. “The process gave us a deeper understanding of the role the FAA plays in ensuring that our skies are safe for travel.”
Designed for shipment of high-value pharmaceuticals, the PharmaPort 360 is configured for standard NAS air cargo pallets. The container maintains internal temperature of 5° C in extreme ambient from 60° to –40° C in transport mode and a charge (ground) mode to assure safe movement of biologicals for optimum viability. It transitions easily through standard international logistic systems including air, sea, and highway for precision temperature-controlled service in a self-contained modular unit. The payload weight is 1,200 lbs (544 kg).
The PharmaPort 360 uses proprietary systems developed by Farrar Scientific LLC to exceed World Health Organization criteria for cold chain distribution. In flight, the PharmaPort 360 operates independently of the aircraft and requires no external system power. It generates no heat or hazardous vapors. A self-contained regenerative heat exchanger avoids hazardous materials costs associated with dry ice and eliminates the need for a refrigerated truck. Between uses, the container is recharged by a standard AC power supply before deployment in fixed-based storage, ground, sea, or air transport.
A data acquisition system operates during all modes. Control and monitoring technology supports proof-of-performance in compliance with FDA 21 CFR 11. GPS tracking permits retrieval and sharing of system performance en route. OQ/PQ documentation is available.
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