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

Abstract

SummaryBackground: The blood center of the German Armed Forces inKoblenz provides not only military and civilian hospitals across Germanybut also field hospitals of the German Armed Forces engagedin international peace-keeping missions worldwide with red bloodcell concentrates (RBCs). Consequently, long lasting transport onextreme surrounding temperature has to be managed without anylimitation in quality of the drugs as defined by standards of the Germanand European authorities. Material and Methods: Severalcommercially available transport box systems of different capacitywith either efficient isolation technique or active electric refrigerationwere investigated in a climatic chamber. A couple of packagingprotocols were tested, and two approaches of temperature measurement(usual inter-product versus intra-product logger) were examined.The established combined transport by military van andaircraft over 2 days to Afghanistan was used to confirm the practicabilityand reliability of the evaluated performance. Results: Activelycooled boxes did not appear to be suitable since no permanentpower supply could be ensured and supervised. The isolationbox RCB 25 E (Elektrolux) containing up to 40 RBC units permittedloading and handling by a single person. A standardized packagingprotocol from top to bottom was composed of distinct layers of icepacks (-30 °C, the number of which was dependent on the targetcountry’s climatic zone), polystyrene, cold storage accumulators (+4°C), knob film, RBCs, and identical components without ice packs inreverse order. Conventional temperature logger measuring every10 min facilitated a sufficient monitoring compared with an in-productinstrument. Conclusion: If the presented preparation protocol isfollowed, temperature stability can be ensured for at least 48/56 and72/96 h provided that the environmental temperature does not decreasebelow -10 and exceed +40 °C, respectively. Additional parameterssuch as temperature increase by sun radiation, damage ofthe erythrocytes by air pressure change, effects of vibration or humidityon the cell stability, and the maximum carriage temperatureof 10 versus 6 °C have to be validated to further optimize the transportconditions with regard to the therapeutic quality of the bloodproducts.