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水平消毒/灭菌技术，该技术在使用前几分钟通过在水中混合即可工作。这两种组分分别是活性高水平消毒剂的非活性稳定衍生物，具有良好的保质期，与二醛相比易于处理限制，确保了成本效益。在使用前将两种组分在水中混合后，混合物将产生两种单独消毒剂的活性成分的混合物，以获得更广泛的生物活性。这将（1）将人员暴露于醛蒸气限制到最低限度，（2）在温和的溶液温度下短时间接触有效，（3）表现出更广谱的消毒能力，（4）没有储存和运输危害，并且在长期储存时相当稳定，（5）甚至适用于严酷的条件，例如在战争和其他灾区，除了使用饮用水之外，没有正常的消毒条件。我们的研究将包括非活性制剂的两个部分的合成、纯化、表征和包装，在对B进行FDA要求的杀孢子试验之前，将其加入水中形成活性消毒剂溶液。subtilis和C.生孢子菌和AOAC定量TB测试。还将对上述实验制剂进行生物负载强制降解处理试验，并与对照市售消毒剂溶液进行比较。长期目标是在第II阶段的高级研究中获得与高水平消毒剂和灭菌相关的必要数据并提交上市前通知[510（k）]后，将该产品商业化，其中包括优化配方以获得最佳消毒剂、有效期稳定性、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、外科和牙科设备的医院感染爆发的报道，包括最近来自全国最负盛名的医院的报道。不幸的是，没有理想的高水平消毒剂（HLD）存在，因为市场上的所有产品都有局限性。二醛对某些重要微生物和某些孢子的潜在无活性现在已经得到了很好的证实。唯一能杀死这些微生物的高水平消毒剂是过氧化物。此外，液体二醛存在人员暴露的问题，包括其在运输和储存中的特殊需要。因此，需要努力开发一种HLD /灭菌剂，其可以作为消毒剂的非活性固体衍生物储存和运输，以消除暴露风险，降低储存/运输成本并提高稳定性;该产品可以在使用前通过将该组分与另一种固体稳定消毒剂溶解在水中来配制合适的量用于更广谱的生物活性。与目前的二醛相比，预期两种组分分别具有良好的有效期和易于处理的限制。该产品将（1）将人员暴露于醛蒸气的风险降至最低，（2）在温和的溶液温度下短时间接触有效，（3）表现出更广泛的消毒能力，（4）没有储存和运输危害，长期储存相当稳定，（5）即使在严酷的条件下也适用，例如在战争和其他灾区，除了使用饮用水之外，没有正常的消毒条件。

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.