ABSTRACT
The new sterilization technologies eliminate the safety and environmental concerns associated with ethylene oxide (EO) and provide benefits in the area of material compatibility for some products as compared to gamma irradiation. Plasma technology by itself had very limited application for the sterilization of medical devices due to the limited penetrating capability of the plasma species. Peroxygen plasma sterilization systems, compared to EO or gamma irradiation, have demonstrated significant benefits for the sterilization of some medical devices. “Plasma” refers to a gas in which negatively charged electrons exist, and in which some of the atoms, molecules or molecular fragments are electrically charged. Items that are placed in the plasma field, or the primary plasma, are exposed to bombardment by ions, electrons and charged particles that may cause physical damage to the item being sterilized. Plasma systems are being evaluated by more than 75 manufacturers of sterile devices; the companies are in various stages of the evaluation or validation processes.
