Quality Assurance for Long Lasting Transports of Red Blood Cell Concentrates on Extreme Environmental Demand

Abstract

Summary Background: The blood center of the German Armed Forces in Koblenz provides not only military and civilian hospitals across Germany but also field hospitals of the German Armed Forces engaged in international peace-keeping missions worldwide with red blood cell concentrates (RBCs). Consequently, long lasting transport on extreme surrounding temperature has to be managed without any limitation in quality of the drugs as defined by standards of the German and European authorities. Material and Methods: Several commercially available transport box systems of different capacity with either efficient isolation technique or active electric refrigeration were investigated in a climatic chamber. A couple of packaging protocols were tested, and two approaches of temperature measurement (usual inter-product versus intra-product logger) were examined. The established combined transport by military van and aircraft over 2 days to Afghanistan was used to confirm the practicability and reliability of the evaluated performance. Results: Actively cooled boxes did not appear to be suitable since no permanent power supply could be ensured and supervised. The isolation box RCB 25 E (Elektrolux) containing up to 40 RBC units permitted loading and handling by a single person. A standardized packaging protocol from top to bottom was composed of distinct layers of ice packs (-30 °C, the number of which was dependent on the target country’s climatic zone), polystyrene, cold storage accumulators (+4 °C), knob film, RBCs, and identical components without ice packs in reverse order. Conventional temperature logger measuring every 10 min facilitated a sufficient monitoring compared with an in-product instrument. Conclusion: If the presented preparation protocol is followed, temperature stability can be ensured for at least 48/56 and 72/96 h provided that the environmental temperature does not decrease below -10 and exceed +40 °C, respectively. Additional parameters such as temperature increase by sun radiation, damage of the erythrocytes by air pressure change, effects of vibration or humidity on the cell stability, and the maximum carriage temperature of 10 versus 6 °C have to be validated to further optimize the transport conditions with regard to the therapeutic quality of the blood products.