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

SBIR 第一阶段：药品制造中粉末混合物代表性取样系统

• 批准号: 1621688
• 负责人: Barbara Alvarado-Hernandez
• 金额: $ 22.5万
• 依托单位: IBS Caribe, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1621688&HistoricalAwards=false
• 关键词: SBIR; Phase; System; Representative; Sampling

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.

该小企业创新研究 (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来制造片剂的制药行业中实现。这些片剂占利润最高的医药产品的 40%，以及商业产品的近 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。该采样器还适用于工业粉末混合物，例如维生素、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实现代表性采样，从而降低客户和患者的风险。当前方法中经常出现的抽样错误将会减少，从而提高工业生产率并避免生产延误。新的采样器将对许多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来设计粉末混合物采样装置。第一项工作将是将粉末混合物制成许多患者需要的药片。需要这些新的采样器是因为制药行业当前的做法是将矛插入 10 - 12 个预先选定的位置，这不会检测到这些位置之外的过强或弱效混合物。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有相同的被选为样品的可能性。新设备将基于最​​初在采矿业中建立的概念，该概念尚未适用于制药和粉末行业。实验和计算方法将用于设计新的采样器，这将使实施统计方法以确保代表性采样成为可能。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误，并帮助制药公司在更短的时间内获得新的收入。