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

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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.