Tissue Sterilization Process Exceeds Sterility Standards

A new patented process for tissue sterilization that meets or exceeds industry requirements is being used to process orthopedic, cardiovascular, and other allograft implants. The process was introduced at the annual meeting of the American Academy of Orthopedic Surgeons in New Orleans (LA, USA).

Current methods of sterilization and tissue processing, such as heat, irradiation, ethylene oxide, liquid chemical germicides, and aseptic processing may not provide complete removal of bacteria and viruses and/or have been recorded as compromising the biomechanical integrity or biocompatibility of allograft tissue.

The new process, called BioCleanse, is being used by Regeneration Technologies, Inc. (RTI, Alachua, FL, USA), which holds the patent on the process. Since March 2000, the company has processed about 300,000 allograft implants with no incidence of recipient infection, and expects to soon make its first shipment of sterile bone tissue.

"We are pursuing future innovations in BioCleanse to bring safe, high-quality tissue to a broader patient base,” said C. Randall Mills, Ph.D., vice president of operations and R&D at RTI.




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Regeneration Technologies, Inc.