SBIR Phase I: Mass Flux Sensor for Pharmaceutical Manufacturing

这个小企业创新研究（SBIR）第一阶段项目解决了制药和生物技术制造业对实时测量汽相水质量通量的迫切需求。具体的创新是低压汽相水浓度和气体速度测量的组合，以提供汽相质量通量率的确定。在第一阶段的工作中，关键的传感器硬件将在商用制造设备上设计、制造和测试。传感器的开发目标是美国食品和药物管理局和制药行业的一项新举措，即使用过程分析技术进行在线过程控制，以提高药物制造质量，药物可用性，行业竞争力和处方药成本。第一阶段计划将验证质量通量监测器的技术和商业可行性。该项目的商业应用是为了提高制药行业的质量控制。气相质量通量监测器将为制药和生物技术行业提供用于实时质量通量测量的传感器，从而提高药物制造过程的效率和质量。该项目通过与康涅狄格大学和普渡大学的制药科学家合作推进研究和教育。

This Small Business Innovation Research (SBIR) Phase I project addresses an immediate need for a real-time means for measuring vapor phase water mass flux in pharmaceutical and biotechnology manufacturing. The specific innovation is the combination of low-pressure vapor phase water concentration and gas velocity measurements to provide a determination of vapor phase mass flux rates. During the Phase I effort critical sensor hardware will be designed, fabricated and tested on commercially available manufacturing equipment. The sensor development targets a new initiative by the Food and Drug Administration and the pharmaceutical industry to use process analytical technology for on-line process control to improve drug manufacturing quality, drug availability, industry competitiveness, and prescription drug costs. The Phase I program will verify the technical and commercial feasibility of the mass flux monitor.The commercial application of this project is to improve quality control in the pharmaceutical manufacturing industry. The vapor phase mass flux monitor will provide the pharmaceutical and biotechnology industries with a sensor for real-time mass flux measurements, enabling improved drug manufacturing process efficiency and quality. The project advances research and education via collaborations with pharmaceutical scientists at the University of Connecticut and Purdue University.