Introduction: Terminal sterilization is important for the clinical applicability of decellularized xenografts. High hydrostatic pressurization (HHP) process is a potential strategy for decellularization and decontamination of xenografts; however, its disinfection efficiency remains poorly elucidated. This study investigated the disinfection efficacy of the HHP process at physiologically relevant 36 °C against difficult-to-kill spore-forming bacteria.
Methods: Bacillus atrophaeus and Geobacillus stearothermophilus were suspended in a pressurization medium with or without antibiotic agents and pressurized under two different HHP procedures: repeated and sustained pressurization.
Results: The sustained pressurizing conditions, exploited for the conventional tissue decellularization, did not effectively eliminate the bacteria; however, repeated pressurization greatly increased the disinfection effect. Moreover, the antibiotic-containing pressurization medium further increased the disinfection efficiency to the level required for sterilization.
Conclusions: The optimized high hydrostatic pressurization can be used to sterilize biological tissues during the decellularization process and is a promising strategy for manufacturing tissue-derived healthcare products.
Keywords: Biomaterials; Decellularization; High hydrostatic pressure; Sterilization; Xenografts.
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