Packaging solutions for biodegradable tissue engineering products
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Tissue engineering is a multidisciplinary field that develops biological substitutes to restore, maintain, or improve damaged tissues. Biodegradable tissue engineering applications are often complex composite structures that combine a biodegradable medical device with biological factors. Materials used in tissue engineering applications are sensitive and cannot withstand high temperatures, humidity, irradiation, and/or chemicals. These qualities pose special challenges to sterilization process and packaging design. The heavy regulations that apply to tissue engineering products affect the packaging solution from choosing the sterilization method to the design and testing of the final package. This thesis is a literature review. The scope of this thesis was to examine suitable packaging solutions for biodegradable tissue engineering products. For background, the current relevant legislation and regulations in the European Union and in the United States were reviewed, and different aspects of packaging of medical devices were discussed. Also several sterilization methods, as well as aseptic processing were reviewed, and multiple packaging solutions that are or could be suitable for sterile biodegradable implantable medical devices were presented. Due to the diverse nature of biodegradable tissue engineering products, it is impossible to suggest one universal packaging solution. Some general guidelines, however, can be suggested based on the common features of biodegradable tissue engineering products, usability studies, and sustainability considerations. An ideal packaging would be a double sterile barrier system consisting of a rigid tray in a flexible, clear pouch that would also serve as a moisture barrier. All the packaging components should be easy to open quickly in an operating room environment. The outer carton should be as small as possible, while still providing sufficient protection and information. The final materials for the packaging should be chosen based on whether the product will be sterilized in the final package or whether it will be aseptically processed.