Purdue Research Foundation

Genentech, Inc.

Andrew Strongrich

Alina Alexeenko

Fredric John Lim

Lokesh Kumar

An environmental sensor system for monitoring nucleation in a lyophilization chamber is disclosed which includes a sensor unit, including a temperature sensor, a pressure sensor, and a reader circuit in electronic communication with the sensor unit; wherein the sensor unit is adapted to sealingly fit around a vial placed in a lyophilization chamber and further adapted to be energized by the reader circuit and provide signals associated with temperature and pressure within the vial in a non-invasive manner in which the sensors are configured to be positioned in a headspace within the vial but not in contact with product within the vial.

System and method for measuring rapid decompression ice nucleation in lyophilization

A lyophilization method for lyophilizing products inside one or more vials within a lyophilization chamber is disclosed which includes humidifying a charge gas to a predetermined relative humidity, cooling shelves in the lyophilization chamber to a predetermined temperature, pressurizing the chamber with the humidified charge gas to a pressurization threshold to thereby achieving a target relative humidity level within the lyophilization chamber, and suddenly releasing pressure within the lyophilization chamber until a depressurization threshold is reached in a short time interval up to about 4 seconds, during the depressurization, product inside one or more vials nucleate.

Rapid depressurization controlled ice nucleation in pharmaceutical freeze-drying

A system to monitor and control a lyophilization process using a wireless network is disclosed which includes one or more wireless pressure and gas temperature sensors adapted to provide pressure and gas temperature measurements of the ambient environment, a lyophilization chamber, wherein the one or more wireless pressure sensors are distributed in one or more lyophilization vial trays, a vacuum pump, adapted to change the pressure with the lyophilization chamber, a heat exchanger adapted to modify temperature within the lyophilization chamber, and a controller adapted to collect pressure and gas temperature data from the one or more wireless pressure and gas temperature sensors, calculate sublimation rate of a product to be lyophilized using the collected pressure and gas temperature data, and adjust one or both of pressure and temperature within the lyophilization chamber such that the calculated sublimation rate stays within a predetermined envelope.

Process monitoring and control for lyophilization using a wireless sensor network

A microelectromechanical (MEMS) gas sensor operating based on Knudsen thermal force is disclosed. The sensor includes a substrate, at least one stationary assembly that is fixedly coupled to the substrate, and at least one moveable assembly that is positioned above the substrate which is biased to move substantially according to a main axis and juxtaposed with the at least one stationary assembly.

Microelectromechanical gas sensor based on knudsen thermal force

A non-invasive method to monitor and control of lyophilization of a frozen product solution to remove solvents is disclosed which includes installing one or more wireless pressure sensors configured to fit into a lyophilization vial tray disposed in a lyophilization chamber having a plurality of product vials, wherein the wireless pressure are distributed among the product vials being lyophilized thereby providing spatial pressure variations, collecting the spatial pressure information from said wireless pressure sensors, calculating sublimation rate of the solution, and adjusting pressure and/or temperature within the lyophilization chamber such that the calculated sublimation rate stays within a predetermined envelope.

A system operating based on Knudsen thermal force includes a microelectromechanical (MEMS) gas sensor, the MEMS gas sensor includes a substrate. The sensor further includes at least one stationary assembly fixedly coupled to the substrate, the at least one stationary assembly terminating at corresponding pads configured to receive an electrical current for heating the at least one stationary assembly. Additionally, the sensor includes at least one moveable assembly disposed above the substrate and biased to move substantially according to a main axis and juxtaposed with the at least one stationary assembly.

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Saginaw, MI, United States of America

Andrew Strongrich