Effects of Sterilization on the Physical Properties of an Elastin Biomaterial

Abstract

The development of biomaterials for medical use requires the absolute sterility of the product as well as reliable product integrity and function. The development of biomaterials is a meticulous process in which the researchers attempt to limit the variables and carefully maintain a desired environment to optimize the product. A final product meets desired specifications but then must be removed from its ideal laboratory environment, sterilized and packaged without altering those specifications. With medical biomaterials the most common method of sterilization is the use of ionizing radiation that is able to penetrate the packaging and product. The radiation disrupts key bonds in the DNA of infectious agents that prevents their proliferation. The ionizing radiation also has the ability to disrupt other chemical bonds and can cause the denaturization of some proteins. Work in the past has shown that radiation can have adverse effects on the physical characteristics of collagen. The development of elastin based biomaterials at the Oregon Medical Laser Center has advanced in recent years and is nearly ready for clinical trials. Based on the similarities between elastin and collagen, concern about sterilization of the final product has arisen. The possible degradation of the elastin protein and subsequent loss of structural characteristics has prompted exploration into the effects of radiation as well as effects of other possible mechanisms for sterilization, such as heat. This requires measurement of the elastin biomaterial through tensile testing analysis, and confirmation of the complete sterility of the elastin biomaterial after processing.