Sterilization of sealed PVDF pouches containing decellularized scaffold by electrical stimulation

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.

The impact of pelvic floor electrical stimulation on vaginal microbiota and immunity

“…The effect of ES on various microorganisms such as Escherichia coli , Staphylococcus aureus , and Pseudomonas aeruginosa can be inhibitory, stimulatory, or none depending on the parameters and modes selected ( Caubet et al., 2004 ; Dusane et al., 2019 ; Lee et al., 2021 ). Studies showed that the mechanisms of ES for promoting wound healing might include increased angiogenesis and circulation as well as a direct antibacterial effect of ES ( Gentzkow, 1993 ; Asadi and Torkaman, 2014 ; Ashrafi et al., 2017 ).…”