Entwicklung und Validierung eines modularen Verpackungskonzeptes für den Transport von Arzneimitteln im Temperaturbereich von 2 bis 8 Grad Celsius

Some drugs, especially biopharmaceuticals, often have to be stored at temperatures between 2-8 °C. Therefore their transport validation is challenging. The following paper describes the development of a new, modular system, which consists of a disposable container for the transport with a maximum cost of € 20. The temperature during transportation should be within the range of 2 - 8 °C not to exceed a 48-h period. The volume of the container is sufficient for 10 bottles of a 100 ml volume. As a result, the transport validation would be valid within Europe. The tool, Design of Experiments, was used to render a maximum span of tests using a minimum amount of experiments.