Sterilization of Bioresorbable Polymers

Bioresorbable polymers for medical devices encompass a broad class of materials with two of the more common materials being poly(L-lactic acid) and poly(lactic-co-glycolic acid). Some terminal sterilization processes may result in changes in materials properties, thereby significantly impacting the functional behavior of bioresorbable implants. Matching a terminal sterilization method to a bioresorbable implant requires the materials properties of the device to be considered as part of the product development process. Currently, there are several types of terminal sterilization processes in use for these polymers, including gamma radiation, e-beam radiation, and ethylene oxide (EtO). Sterilization with nitrogen dioxide (NO2) gas provides a room-temperature alternative that should be considered for this class of materials.