Ima Life North America Inc.

Purdue Research Foundation

Ganguly, Arnab

Demarco, Francis W.

Renzi, Ernesto

Arnab Ganguly

Ernesto Renzi

Francis W Demarco

Joseph Brower

Michele Arduini

Dimitrios Peroulis

Nithin Raghunathan

David Debo

Vaibhav Kshirsagar

Francis W DeMarco

Ivan H Lanaway

A freeze drying system () having a nozzle () operated at a setpoint pressure to generate fluid product drops () for freezing in a freezing chamber () of a freezing vessel (). The freezing chamber includes an inner wall () that defines a cavity () and an outer wall () having an inlet () that extends from a location on the outer wall that is lower than an outlet (). A cooling fluid flows through the inlet, cavity and outlet to form a freezing zone (). A drying chamber () having sloped shelves () receives frozen particles () from the freezing chamber. A heating element () is associated with each shelf that heats the frozen particles to promote sublimation. Vibration elements () located outside the drying chamber vibrate the shelves causing the frozen particles to move from shelf to shelf to form freeze dried product ().

Bulk freeze drying system

An arrangement for monitoring an aseptic manufacturing process includes product condition sensors capable of making closely spaced measurements of a product condition such as temperature or humidity. The measurements are made using closely spaced sensors arranged in a linear array on a single probe, which may be used to take measurements at multiple levels within the product. Data from the sensors is transmitted to a data collection point via short range wireless digital communications. The sensors may be used to measure temperature and humidity at a single point. For example, when the sensors are used in pharmaceutical freeze drying, the location of a sublimation front may be calculated for each vial, and the freeze drying process may be controlled using the data.

Process monitoring and control using battery-free multipoint wireless product condition sensing

A freeze drying vessel () having a freeze drying chamber () that includes sloped horizontal shelves () that receive frozen particles (). Each shelf is sloped relative to a horizontal axis () and arranged such that a downward slope between successive shelves alternates between first () and second () directions. At least one connecting member () is attached between pairs of shelves. At least one connecting member is attached to an associated vibration element () located outside the drying chamber. Each vibration element vibrates a pair of shelves to cause the frozen particles to advance relative to an associated shelf and drop downward from shelf to shelf wherein the shelves heat the frozen particles to promote sublimation to form freeze dried product ().

Freeze drying chamber for a bulk freeze drying system

In a system and method for controlling a freeze drying process, a diagnostics server () is connected for receiving time series data from a freeze drying system (). The diagnostics server uses a tuned freeze drying system mathematical model to analyze the time series data to predict a system event, and alter the freeze drying process. An analytics server () is connected for secure communication with the diagnostics server, and creates and tunes the freeze drying system mathematical model. An equipment provider service and diagnostic cloud () may apply learning algorithms to the time series data to enhance diagnostic tools and provide predictive maintenance and diagnostic services to the operator of the first production sites using the diagnostic tools.

Freeze drying process and equipment health monitoring

An arrangement for monitoring a freeze drying process includes product condition sensors for product condition measurement within product vials. The product condition sensors are bimetal junctions deposited on a substrate using an ink jet printing process. The substrate may be a flexible film applied to an interior surface of the product vial, or may be the vial surface itself. The bimetal junction may be printed using a roll-roll inkjet printing process with metallic nanoparticle inks. Multiple closely-spaced bi-metal junctions are provided in each measurement vial. Data from the sensors is transmitted to a data collection point via short range wireless digital communications. The location of a sublimation front may be calculated for each measured vial, and the freeze drying process may be controlled using the data.

Process control using non-invasive printed product sensors

A freeze dryer processes aseptic bulk powder products. The freeze dryer freezes the product by mixing an atomized spray of product with sterile liquid nitrogen to produce a frozen powder. The frozen powder is freeze dried in a vessel by dielectrically heating the frozen powder using electromagnetic radiation such as microwave radiation or infrared radiation, and the frozen powder is continuously agitated using a sterilizable apparatus such as a series of vibrating shelves to maintain even heating and to prevent agglomeration.

Bulk freeze drying using spray freezing and agitated drying with dielectric heating

A freeze dryer processes bulk powder products. The freeze dryer freezes the product by mixing an atomized spray of product with sterile liquid nitrogen. The resultant powder is freeze dried in a vessel, and the vessel contents is agitated to maintain product contact with heated vessel wall and to prevent agglomeration.

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Williamsville, NY, United States of America

Arnab Ganguly