Institution: | 1. Cellbiocontrol Laboratory, Department of Medical Engineering, Yonsei University College of Medicine, Seoul, Republic of Korea;2. Cellbiocontrol Laboratory, Department of Medical Engineering, Yonsei University College of Medicine, Seoul, Republic of Korea
Department of Medical Device Engineering and Management, Yonsei University College of Medicine, Seoul, Republic of Korea;3. Cellbiocontrol Laboratory, Department of Medical Engineering, Yonsei University College of Medicine, Seoul, Republic of Korea
Graduate School of Medical Science, Brain Korea 21 Project, Yonsei University College of Medicine, Seoul, Republic of Korea |
Abstract: | A terminal sterilization process for tissue engineering products, such as allografts and biomaterials is necessary to ensure complete removal of pathogenic microorganisms such as the bacteria, fungi, and viruses. However, it can be difficult to sterilize allografts and artificial tissue models packaged in wet conditions without deformation. In this study, we investigated the sterilization effects of electrical stimulation (ES) and assessed its suitability by evaluating sterility assurance levels in pouches at a constant current. Stability of polyvinylidene fluoride pouches was determined by a sterility test performed after exposure to five microorganisms (Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Escherichia coli, and Candida albicans) for 5 days; the sterility test was also performed with decellularized human dermal tissues inoculated with the five microorganisms. Sterilization using ES inactivated microorganisms both inside and outside of sealed pouches and caused no damage to the packaged tissue. Our results support the development of a novel system that involves ES sterilization for packaging of implantable biomaterials and human derived materials. |