title: Inactivation of bacterial spores and viruses in biological material using supercritical carbon dioxide with sterilant.
abstract: The purpose of this study was to validate supercritical carbon dioxide (SC-CO(2)) as a terminal sterilization method for biological materials, specifically acellular dermal matrix. In this study, bacterial spores, Bacillus atrophaeus, were inoculated onto porcine acellular dermal matrix to serve as a "worst case" challenge device. The inactivation of the spores by SC-CO(2) with peracetic acid (PAA) sterilant was analyzed as a function of exposure times ranging from 1 to 30 min. A linear inactivation profile for the Bacillus atrophaeus spores was observed, and a SC-CO(2) exposure time of 27 min was determined to achieve a sterility assurance level of 10(-6). The inactivation of viruses was also studied using Encephalomyocarditis (EMC) viruses. After 15 min of exposure to SC-CO(2) with PAA sterilant, more than a 6 log(10) reduction was observed for EMC viruses. Biochemical and biomechanical evaluations showed that the SC-CO(2) treatment with PAA sterilant did not cause significant changes in porcine acellular matrix's susceptibility to collagenase digestion, tensile or tear strength, indicating limited alteration of the tissue structure following SC-CO(2) sterilization.
authors: Department of Research, LifeCell Corporation, Branchburg, New Jersey 08876.
authors: Qing-Qing
authors: QQ
authors: Qiu
authors: Department of Research, LifeCell Corporation, Branchburg, New Jersey 08876.
authors: Patrick
authors: P
authors: Leamy
authors: Department of Research, LifeCell Corporation, Branchburg, New Jersey 08876.
authors: Jennie
authors: J
authors: Brittingham
authors: Department of Research, LifeCell Corporation, Branchburg, New Jersey 08876.
authors: Jason
authors: J
authors: Pomerleau
authors: Department of Research, LifeCell Corporation, Branchburg, New Jersey 08876.
authors: Nimesh
authors: N
authors: Kabaria
authors: Department of Research, LifeCell Corporation, Branchburg, New Jersey 08876.
authors: Jerome
authors: J
authors: Connor
mesh_terms: D000465:Algorithms; D000818:Animals; D001672:Biocompatible Materials; D002245:Carbon Dioxide / Q000737:chemistry / Q000494:pharmacology*; D004202:Disinfectants; D007700:Kinetics; D008422:Materials Testing; D050296:Microbial Viability; D017768:Skin, Artificial; D013171:Spores, Bacterial / Q000187:drug effects*; D013242:Sterilization / Q000379:methods*; D013552:Swine; D013718:Tensile Strength; D014780:Viruses / Q000187:drug effects*
chemical_list: D001672:Biocompatible Materials; D004202:Disinfectants; D002245:Carbon Dioxide