Method for sterilizing bioactive materials
A method is provided for sterilizing a bioactive material which comprises contacting the bioactive material with hydrogen gas and while the bioactive material is in contact with hydrogen gas, irradiating the bioactive material with ionizing radiation to sterilize the material.
1. A method for sterilizing an osteogenic and/or osteoinductive bioactive material for implantation within a human body which comprises contacting the bioactive material with hydrogen gas in a sealed package, and while the bioactive material is in contact with the hydrogen gas, irradiating the bioactive material with ionizing radiation to sterilize the bioactive material, wherein contacting the bioactive material with the hydrogen gas comprises contacting the bioactive material with a gaseous atmosphere of about 100% hydrogen gas by volume.
2. The method of claim 1 , wherein the bioactive material comprises at least one osteogenic and/or osteoinductive material selected from the group consisting of fully mineralized autograft bone, partially demineralized autograft bone, allograft bone, xenograft bone, cortical bone, cancellous bone, corticocancellous bone, and combinations thereof.
3. A method for sterilizing an osteogenic and/or osteoinductive bioactive material for implantation within a human body which comprises contacting the bioactive material with hydrogen gas in a sealed package, and while the bioactive material is in contact with the hydrogen gas, irradiating the bioactive material with ionizing radiation to sterilize the bioactive material, wherein contacting the bloactive material with the hydrogen gas comprises contacting the bioactive material with a gaseous atmosphere containing from about 5% to about 80% hydrogen gas by volume, the balance of the gaseous atmosphere being made up of one or more diluent gases or inert gases.
4. The method of claim 3 , wherein the bioactive material comprises at least one osteogenic and/or osteoinductive material selected from the group consisting of fully mineralized autograft bone, partially demineralized autograft bone, allograft bone, xenograft bone, cortical bone, cancellous bone, corticocancellous bone, and combinations thereof.
5. The method of claim 3 , wherein contacting the bioactive material with the hydrogen gas comprises contacting the bioactive material with a gaseous atmosphere containing from about 30% to about 70% hydrogen gas by volume, the balance of the gaseous atmosphere being made up of one or more diluent gases or inert gases.
6. The method of claim 5 , wherein the diluent gas or inert gas is at least one of nitrogen or argon.
7. The method of claim 3 , wherein the diluent gas or inert gas is at least one of nitrogen or argon.