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

描述（由申请人提供）：我们正在开发一种新型的两部分冷高级消毒/灭菌技术，只需在使用前几分钟将其与水混合即可。两种成分分别为活性高级消毒剂的非活性稳定衍生物，与二醛相比，具有良好的保质期，易于处理限制，确保了成本效益。在使用前将两种成分在水中混合后，会产生两种不同消毒剂的有效成分的混合物，具有更广泛的生物活性。这将(1)将人员接触乙醛蒸气的时间限制在最低限度，(2)在温和的溶液温度下，在短时间内有效，(3)表现出更广泛的消毒能力，(4)没有储存和运输危险，并且在长期储存中相当稳定，(5)甚至适用于恶劣条件，如战争和其他灾区，除了使用饮用水之外，没有正常的灭菌条件。我们的研究将包括两部分非活性制剂的合成、纯化、表征和包装，在FDA要求的枯草芽孢杆菌和芽孢杆菌的杀孢试验和AOAC定量结核病试验之前，将其加入水中形成活性消毒剂溶液。还将对上述实验配方进行处理生物负荷压力的测试，并与对照商业消毒剂溶液进行比较。长期目标是将该产品商业化，在ii期的高级研究之后，获得与高级消毒剂和灭菌相关的必要数据，并提交上市前通知[510(k)]，其中包括最佳消毒剂配方的优化，保质期稳定性，仪器和人体安全性以及生物相容性。公共卫生相关性：有许多关于诊断、医疗、外科和牙科设备爆发医院感染的报告，包括最近来自国家最负盛名的医院的感染。不幸的是，没有理想的高级消毒剂（hld）存在，因为市场上所有的产品都有局限性。二醛对某些重要微生物和一些孢子的潜在无活性现已得到充分证实。唯一能杀死这类微生物的高级消毒剂是过氧化物。此外，液体二醛存在人员接触的问题，包括在运输和储存方面的特殊需要。因此，需要努力开发一种HLD /消毒剂，它可以作为消毒剂的非活性固体衍生物储存和运输，以消除接触风险，降低储存/运输成本，提高稳定性；该产品可以在使用前通过将该成分与另一种固体稳定消毒剂在水中溶解来配制，这将允许释放适量的两种消毒剂成分，以获得更广泛的生物活性。与目前的二醛相比，这两种成分分别具有良好的保质期和易于处理的限制。该产品将(1)将人员接触乙醛蒸气的时间限制在最低限度，(2)在温和的溶液温度下，在短时间内有效，(3)表现出更广泛的消毒能力，(4)没有储存和运输危险，并且在长期储存中相当稳定，(5)甚至适用于恶劣条件，如战争和其他灾区，这些地区没有正常的灭菌条件，除了使用饮用水。

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.