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

Abstract

Evidence has shown widespread failure to comply with standard recommendations for proper vaccine handling. The objective of this research is to examine the cold chain temperature maintenance for the supply of vaccines and other biological products by the pharmaceutical wholesaler. A study has shown that the packaging method and the material of the container are the most crucial part in the effectiveness of cold chain temperature maintenance. A total of ten vials of anti-tetanus vaccine were used as model vaccines in all six configurations. In this study, six different configurations using a container with different materials, insulation material, size, coolant-packs were used to simulate the configuration used by the pharmaceutical wholesaler and to study the impact of a number of coolant-pack. Each configuration was tested for five times over 24 hours using a large incubator set at 38°C. All four configurations are effective in cold chain transportation with a minimum of 13.5 hours of maintaining the desired temperature range of 2-8ºC, whereas both controlled experiments that were designed to study the impact on a number of coolant-pack used in Configuration 1 and 2 were not effective for cold chain transportation. This study has shown that Configuration 1 is the most effective configuration among 6 configurations in maintaining the desired temperature range during transportation, and correlation study has proven that no or very little correlation between internal and external temperature for all 6 configurations.