Cold chain time- and temperature-controlled transport of vaccines: a simulated experimental study

PURPOSE: The objective of this research was to examine the cold chain temperature maintenance for the supply of vaccines and other biological products by pharmaceutical wholesaler. MATERIALS AND METHODS: In this study, six configurations using cold vaccine boxes or bags made with different materials, with and without insulation, of different sizes, and number of coolant-packs were used to simulate the configuration used by the pharmaceutical wholesalers for transportation of vaccine. Model vaccines (vial, n=10) were packed using these six configurations which then stored in an incubator at 38℃ and monitored for 24 hours. Each configuration was tested repeatedly for 5 times. RESULTS: In term of compliance to 2℃–8℃, four out of six tested configurations are effective in cold chain transportation. The effectiveness is highly dependent on the type of passive containers used, size of cold boxes, insulation, and number of coolant-packs. The configuration with a larger polystyrene foam box with five coolant-packs maintained the required temperature up to 23 hours. In contrast, configurations using a polystyrene foam box with four coolant-packs and a large vaccine cold box with two coolant-packs failed to reach below 8℃ throughout the 24 hours. CONCLUSION: Packaging method, the material and size of the container could have a direct impact on the effectiveness of cold chain temperature maintenance. Polystyrene foam box, cold box with polyethylene interior lining and polypropylene insulation, a cooler bag with proper number of ice packs could be effectively used for transportation of vaccines within their respective transportation duration allowance.