A New Soluble Powder for Sterilization of Medical/Dental Instruments

"The standard method of sterilizing medical/dental instruments, by high temperature steam autoclave, is impractical for many field uses due to size, weight, and power constraints. Liquid sterilization methods can be used to sterilize medical/dentalinstruments when autoclaving is impractical. However, many liquid sterilants are stored as highly-concentrated, hazardous, unstable solutions that are costly to transport.This Phase II SBIR proposal describes a novel formulation consisting of a solid powder that when dissolved in water can sterilize dental instruments in 10 minutes at room temperature. In Phase I, six novel peroxygen compounds were synthesized andisolated. The capability of dilute solutions of these compounds to sterilize dental instruments contaminated with spores, bacteria, or fungi was demonstrated. Also, dental instruments exposed to 1,000 equivalent sterilization cycles showed no significantdamage.In the Phase II research, the novel compounds will be fully characterized in accordance with the requirements of a 510(k) submission to the FDA. This characterization includes antimicrobial efficacy, simulated use testing, shelf-life stability, and invivo and in vitro toxicity testing. The proposal also describes the design and assembly of a field-deployable sterilization package to be delivery to the Army at the conclusion of the Phase II research."