NovaSterilis, specialist in the development of commercial applications for supercritical carbon dioxide (SCCO2) has been granted US patent 8658091 for the removal of toxic ethylene oxide (EO) residuals.
This patent describes a process utilising nontoxic CO2 at or near its supercritical pressure to remove the toxic EO residual from absorbable sutures following sterilisation. Currently used for sterilising absorbable sutures, EO is a toxic, carcinogenic and explosive gas that is difficult to remove from many biomaterials. NovaSterilis says it successfully removed toxic levels of EO from sutures while maintaining all the vital physical and mechanical characteristics of the suture.
Through additional work the company was also able to eliminate the need for EO sterilisation altogether, achieving a Sterility Assurance Level of 10-6 with supercritical CO2 while maintaining the integrity of the product. Sutures are the number one wound closure device, and the market is dominated by Johnson & Johnson and Covidien, says NovaSterilis.
David Burns, president of NovaSterilis noted: “This new application is extremely exciting and can be applied across many classes of products that are sterilized with EO, potentially improving the performance of the product and outcomes of procedures utilizing these devices. We are confident that this process can be expanded to a broad range of products and chemicals including, for example the removal of residual solvents from pharmaceuticals.”