Patent ID: 7988892

Claim:
A method of forming a sterilized implant comprising the steps of: (a) placing a charge of a moldable powder material in need of sterilization in a mold and locating the mold within a reactor, (b) regulating a pressurization rate of the mold in the reactor to bring the charge into contact with a sterilant fluid comprising CO 2 at or near its supercritical pressure and temperature conditions and a chemical sterilization additive, (c) maintaining said contact with the sterilant fluid under said temperature and pressure conditions for a time sufficient to achieve a 6-log reduction or greater in colony forming units (CFUs), and then (d) regulating a depressurization rate of the mold in the reactor until ambient operating conditions are reached, wherein by regulating the pressurization and depressurization rates, the moldable powder material is formed into a sterilized shaped article.