PFI:AIR-TT: Microscale Gas Sensor for Process Monitoring and Control in Bio/Pharmaceutical Lyophilization

这个PFI：空气技术转换项目的重点是转换一种气体传感器，该传感器能够在食品、生物和医药产品制造中使用的冷冻干燥过程的低压真空条件下同时测量压力和水分含量。这一点很重要，因为它将缩短生产时间，提高能源效率，并降低这些冷冻干燥产品的制造成本。该项目预计将产生一种基于努森热力驱动的微型面内克努森辐射致动器(MIKRA)气体传感器原型。这种气体传感器具有以下独特功能：在单个设备中同时进行热传递和压力测量，动态可调，允许传感器进行现场校准，并与标准微制造兼容。与市场上领先的竞争过程仪表技术相比，这些功能提供了紧凑、易于安装和节省成本的优势。该项目在从研究发现转化为商业应用的过程中解决了以下技术差距。传感器的设计将通过应用稀薄流动和传热学模拟来优化冷冻干燥/冷冻干燥条件下的操作压力、温度和气体组成。将开发一个原型传感器，将传感器设备与商用现成的信号调理和无线通信接口集成在一起。该样机将在实验室规模的冷冻干燥机中进行测试，测试条件为冷冻干燥生物/药物制造的典型条件。此外，参与该项目的人员，包括研究生研究员，将通过普渡铸造计划为对技术商业化感兴趣的学生提供创业和技术翻译体验。该项目与华盛顿州布鲁明顿的Baxter BioPharma和纽约州托纳万达的IMA Life合作，在商业冻干产品和制造设备的典型条件下测试原型传感器，努力将研究发现转化为商业现实。

This PFI: AIR Technology Translation project focuses on translating a gas sensor that is capable of simultaneously measuring pressure and moisture content in the low-pressure vacuum conditions of the freeze-drying process used in manufacturing of food, biologic and pharmaceutical products. This is important because it will allow shortened production times, improved energy efficiency and a decrease in the cost of manufacturing of these freeze-dried products. The project is expected to result in a prototype Microscale In-plane Knudsen Radiometric Actuator (MIKRA) gas sensor that is based on Knudsen thermal force actuation. This gas sensor has the following unique features: simultaneous heat transfer and pressure measurement in a single device, dynamic tunability allowing the sensor to be calibrated in-situ and compatibility with standard microfabrication. These features provide the advantages of compactness, ease of installation and cost savings when compared to the leading competing process instrumentation technologies in this market space. This project addresses the following technology gaps as it translates from research discovery toward commercial application. The sensor design will be optimized by application of rarefied flow and heat transfer simulations for conditions of lyophilization/freeze-drying in terms of operating pressures, temperatures and gas composition. A prototype sensor will be developed that integrates the sensor device with commercial-off-the-shelf signal conditioning and a wireless communication interface. The prototype will be tested in laboratory-scale freeze-dryer at conditions typical for lyophilized bio/pharmaceutical manufacturing. In addition, personnel involved in this project, including the graduate student researcher, will receive entrepreneurship and technology translation experiences through the Purdue Foundry program for students interested in technology commercialization. The project engages Baxter BioPharma in Bloomington, IN and IMA Life in Tonawanda, NY to test the prototype sensor at conditions typical for commercial lyophilized products and manufacturing equipment in this technology translation effort from research discovery toward commercial reality.