sterilization technology

sterilization challenges

Sterilization methods for biologic materials constantly face the challenge of removing/inactivating harmful pathogens while maintaining the integrity and compatibility of the sterilized tissues. Irradiation is an acknowledged method of achieving terminal sterility of biomaterials, but the exposure levels required to accomplish these safety parameters also result in compromise of the original bioimplant integrity.(5) Pathogen inactivation has also been accomplished employing a variety of chemicals. However, biomaterials sterilized via this method have demonstrated inflammatory host reactions resulting from the inability to remove harmful chemical residues.(6) On the other hand, tissues that are screened and processed via aseptic methods, such as allografts, have been documented to support the risk of pathogen related adverse events.(7)

sterilization technology

Synovis Orthopedic and Woundcare’s liquid sterilization technology delivers biocompatible collagen bioimplants without exposure to irradiation or chemicals with potentially harmful residues. Bioimplants exposed to this technology are able to pass stringent USP sterility testing without compromise to the biomaterial properties. Similar to the patented crosslinking technology, this proprietary sterilization process has been optimized with EDC [1-ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride] to reliably result in robust pathogen inactivation with water soluble derivatives. Bioimplants processed with our proprietary technology have passed stringent biocompatibility and international safety standards. Bioimplant architecture and biomechanical properties are preserved including any induced crosslinking.