SBIR Phase I: A System for Representative Sampling of Powder Blends in Pharmaceutical Manufacturing

这一小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力将首先在需要粉末混合物制造片剂的制药行业实现。这些片剂占最有利可图的医药产品的40%，占商业产品的近80%。拟议的设备（采样器）将保护制药厂的员工免受潜在有毒药物的影响。该采样器也将适用于工业粉末混合物，如维生素，营养保健品，奶粉和其他食品。采样器将改善这些公司的质量控制，并导致代表性采样，从而降低客户和患者的风险。目前的方法经常出现的抽样误差将减少，从而提高工业生产率并避免生产延误。新的采样器将在一些粉末加工行业产生积极的财务影响，同时提高产品质量。拟议的项目将提供资金，用于设计粉末混合物取样装置。第一项工作将是粉末混合物，成为许多患者需要的片剂。需要这些新的采样器，因为制药行业目前的做法包括将矛插入10 - 12个预先选择的位置，这将无法检测这些位置之外的过量或次有效混合物。相比之下，新的采样器将获得流动粉末的横截面，并且混合物的所有部分都具有被选为样品的相同可能性。新设备将基于采矿业首次建立的概念，这些概念尚未适应制药和粉末工业。将使用实验和计算方法来设计新的采样器，这将使实施统计方法以确保具有代表性的采样成为可能。该研究团队将致力于提供商业采样器和支持服务，以避免新产品推出的延迟，并帮助制药公司在更短的时间内获得新的收入。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be realized first in pharmaceutical manufacturing where powder blends are needed to make tablets. These tablets constitute 40% of the most profitable pharmaceutical products, and nearly 80% of commercial products. The proposed device (sampler) will protect employees in pharmaceutical plants from exposure to potentially toxic drugs. The sampler will also be suitable for industrial powder blends such as vitamins, nutraceuticals, powdered milk, and other food products. The sampler will improve quality control in these companies and lead to representative sampling, thereby reducing risk to customers and patients. Sampling errors, which are frequent with the current approaches, will be reduced, increasing industrial productivity and avoiding production delays. The new sampler will have a positive financial impact in a number of powder processing industries and at the same time improve product quality. The proposed project will provide funding to design devices to sample powder mixtures. The first work will be with the powder blends that become the tablets that many patients require. These new samplers are needed because the current practice in the pharmaceutical industry consists in inserting a spear into 10 - 12 pre-selected locations, which will not detect over or sub-potent blends outside of these locations. In contrast the new sampler will obtain a cross-section of a flowing powder, and all parts of the blend have the same possibility of being selected as a sample. The new device will be based on concepts first established within the mining industry, which have not been adapted to the pharmaceutical and powder industries. Experimental and computational methods will be used to design the new sampler, which will make it possible to implement statistical methods to assure representative sampling. The research team will work to provide a commercial sampler and support services to avoid delays in the introduction of new products and help pharmaceutical companies grow to obtain new revenues in less time.