ABSTRACT
Electron beam (E-beam) sterilization is a validated, reliable sterilization technology rapidly growing in use for medical device and healthcare applications. Both medical device manufacturers and healthcare facility managers face a set of tough, interlocked challenges. E-beam systems sterilize by sweeping an intense beam of high-energy electrons across the target material in a shielded chamber. Electrons from the beam ionize the atoms of this material, breaking the chemical bonds of organic compounds to produce highly reactive ions and free radicals. Radiation dose is the parameter that determines the effectiveness of microbial inactivation and is defined as the quantity of energy deposited by the electron beam per unit mass of the treated material. Radiation distribution emanating from the E-beam exit window should be as uniform as possible to maximize sterilization efficiency. Contract beam sterilization facilities have mastered the Good Manufacturing Practice qualification process to incorporate E-beam sterilization into the manufacturing process and have established a transferable precedent for on-site sterilization.
