A Better and Stable Cold High-Level Disinfectant Formulation for Medical Equipments

DESCRIPTION (provided by applicant): We are developing a novel two-part cold high-level disinfecting/sterilization technology that will be ready to work by mixing in water, just minutes before use. Both components separately are inactive stable derivatives of active high level disinfectant agents, have good shelf life, and easy handling restriction compared to dialdehydes, ensuring the cost-effectiveness. After mixing the two components in water just before use, the mixture would generate a mixture of active ingredients of two separate disinfectant agents for a wider scope of bioactivity. This will (1) limit personnel exposure to aldehyde vapors to a minimum, (2) be effective with short contact times at mild solution temperatures, (3) exhibit a wider spectrum of disinfection capabilities, (4) have no storage and transportation hazards and be quite stable on long term storage, (5) be suitable even for austere conditions, like in war and other disaster areas where normal sterilization conditions are not available, except the use of potable water. Our research will include the synthesis, purification, characterization, and packaging of the two parts of inactive formulation, which will be added to water to form an active disinfectant solution just before testing on FDA required sporicidal test on B. subtilis and C. sporogenes, and the AOAC Quantitative TB Test. The above experimental formulations will also be tested for handling the bioburden stress compared to that handled by control commercial disinfectant solutions. The long term objective is to commercialize this product, after an advanced research in the phase-II leading to acquiring the necessary data related to high- level disinfectant and sterilization and submission of pre-market notification [510(k)], which will include optimization of formulation for the best disinfectant, shelf life stability, instrument and human safety, and biocompatibility properties. PUBLIC HEALTH RELEVANCE: There have been many reports of outbreaks of nosocomial infections from diagnostic, medical, surgical and dental equipments, including the recent ones from nation's most prestigious hospitals. Unfortunately, no ideal high-level disinfectants (HLDs) exist, as all products in market have limitations. Potential inactivity of dialdehydes against certain important microbes and some spores is well established now. The only high-level disinfectants to kill such microbes are peroxides. Also, liquid dialdehydes have the problem of exposure of personnel, including their special needs in transportation and storage. Therefore, an effort is required to develop a HLD / sterilant, which could be stored and transported as inactive solid derivative of the disinfectant to eliminate the risk of exposure, reduce the storage / transportation costs and enhance the stability; the product could be formulated just before use by solubilizing this component with another solid stable disinfectant in water that would allow release of the two disinfectant components in appropriate amounts for a more wide spectrum bioactivity. It is expected that both components separately have good shelf life, and easy handling restriction compared to current dialdehydes. The product will (1) limit personnel exposure to aldehyde vapors to a minimum, (2) be effective with short contact times at mild solution temperatures, (3) exhibit a wider spectrum of disinfection capabilities, (4) have no storage and transportation hazards and be quite stable on long term storage, (5) be suitable even for austere conditions, like in war and other disaster areas where normal sterilization conditions are not available, except the use of potable water.