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

Bernd Ibscher¹, Sonja Knittel¹, Gunther Hesse¹, Roland Liebisch¹, Ingrid Müller²

¹ ratiopharm GmbH, Ulm
² Hochschule Albstadt-Sigmaringen, Fachbereich Life Sciences, Studiengang Pharmatechnik, Sigmaringen

Korrespondenz: Dr. Bernd Ibscher, Ludwig-Merckle-Str. 3, 89143 Blaubeuren (Germany), e-mail: bernd.ibscher@ratiopharm.de

Development and Evaluation of a Modular Packaging Concept for the Shipping of Drugs at Temperatures of 2–8 Degrees Centigrade

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.

Key words Biopharmazeutika • Design of Experiments • Kühltransporte • Mean Kinetic Temperature • Stabilitätsstudien • Transportvalidierung