Biologics Sterilization Challenges
Sterilization methods for biologic materials constantly face the challenge of inactivating all harmful microorganisms 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 compromise the original bioimplant integrity.1 Pathogen inactivation has also been accomplished by employing a variety of chemicals. However, biomaterials sterilized via this method have demonstrated inflammatory host reactions resulting from harmful chemical residues.2 Additionally, tissues that are screened and processed via aseptic methods, such as non-sterile allografts, are subject to the risk of pathogen-related adverse events.3
Proprietary Sterilization Technology
Synovis Orthopedic and Woundcare’s liquid chemical 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.
- Schwartz HE, et al. The effect of gamma irradiation on anterior cruciate ligament allograft biomechanical and biochemical properties in the caprine model at time zero and at 6 months after surgery. Am J Sports Med. 2006; 34(11):1747-55.
- Lucas AD, Residual ethylene oxide in medical devices and device material. J Biomed Mater Res B Appl Biomater. 2003; 66(2):548-52.
- Mroz et al. Musculoskeletal Allograft Risks and Recalls in the United States. J Am Acad Orthop Surg. 2008; 16:559-565.