Study of the Thermal Performance of a Medical Device Packaging System Using Phase Change Material

Abstract

Abstract Medical devices and biologics require to be maintained within specific temperature bands for the product to be safe and effective for treatment. It is a particular challenge during the distribution of products from manufacturing to healthcare facilities when active temperature control is not available. Phase change materials have greatly been used in medical packaging systems to keep the device within the specified thermal conditions. Determining the suitable phase change material as well as the related packaging components are highly important to provide an acceptable environment for medical devices encapsulated by packaging systems. In this study, the thermal performance of a medical device packaging system was investigated. A computational thermal analysis model for the packaging system was conducted. In addition, an experimental set-up was developed, and the packaging system was tested in the environmental chamber. Thermal properties of the PCM obtained by Differential Scanning Calorimetry (DSC) test was validated by in-house experiments as well as a 3D computational model. Furthermore, the full packaging system was tested at −18°C for 24 hours after it was preconditioned at 35°C. The experimental results were compared to the 3D computational analysis. Lastly, the influence of the outer insulation box material and its wall thickness on the thermal performance of the packaging system under the standardized temperature profile (ISTA 7D) which may represent the distribution path of the packaging system was investigated using a computational modeling approach. Through this optimization study, an environmentally friendly, cost-effective, and robust packaging system for medical devices was obtained.