Development and evaluation of a shipping system for platelet components.

Abstract

Platelet concentrates and apheresis platelets must be maintained at a temperature as close as possible to 20 to 24 degrees C during transport. To improve temperature control, ensure component quality, and meet handling and freight carrier needs, a new insulated shipping container system was developed and evaluated. Molded polyurethane-insulated shipping containers were loaded with different payloads of simulated platelet components, with or without gel-based temperature stabilizing packs (TSPs). The containers were subjected to constant ambient temperature of 37, 4 or -10 degrees C. Payload temperatures were continuously monitored, in situ, for 24 hours. Temperature data are reported as the mean number of hours needed for components to warm or cool by 1 degree C. The temperature of payloads exposed to a constant 37 degrees C ambient temperature increased by 1 degree C in 2.5 to 3.8 hours when no TSPs were included in the shipment and in 6.1 to 6.9 hours when TSPs were used. Exposure to a constant 4 degrees C ambient temperature resulted in a 1 degree C temperature decrease in 1.8 to 3.4 hours without TSPs and in 4.6 to 5.6 hours with TSPs. At a -10 degrees C ambient temperature, there was a 1 degree C drop within 1.0 to 1.6 hours without TSPs and within 2.7 to 2.9 hours with TSPs. The container and packing methods described moderate the rate of change in the temperature of platelet components during their exposure to challenging ambient conditions. The use of TSPs substantially improves the performance of the system. In addition, the system meets freight carrier requirements and is easy to use, environmentally friendly, and durable.