Ima Life North America Inc.

The Boc Group, Inc.

Purdue Research Foundation

Ganguly, Arnab

Demarco, Francis W.

Renzi, Ernesto

Ernesto Renzi

Francis W Demarco

Arnab Ganguly

Paul Alan Stewart

Nicholas V Coppa

Joseph Brower

Michele Arduini

Dimitrios Peroulis

Nithin Raghunathan

Frans Damen

David Debo

Vaibhav Kshirsagar

Francis W DeMarco

Ivan H Lanaway

Johannes W Krikhaar

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.

Bulk freeze drying using spray freezing and agitated drying

Bulk freeze drying using spray freezing and stirred drying

Movement of a slot door of a freeze dryer is driven by a rack and pinion actuator. The actuator is easily sanitized and includes internal elements that are accessible to sanitizing sprays. The pinions are driven by pinion shafts that pass through a seal separating an aseptic area from a non-aseptic area where the drive train is positioned. Only rotary motion is transferred across the aseptic barrier, reducing the need for a bellows or sliding covers, which are difficult to sanitize.

Freeze dryer slot door actuator and method

A freeze dryer comprising a chamber having a rectangular slot through which vials are inserted into the chamber, and a slot door for forming a seal with the chamber to close the slot. To enable the vials to be subsequently removed from the chamber, the slot door is raised. As the door is raised, it is rotated to expose the rear surface of the door for cleaning purposes.

Freeze dryer

The present invention provides methods and apparatus for freeze drying in which a solution, which can be a radioactive salt dissolved within an acid, is frozen into a solid on vertical plates provided within a freeze drying chamber. The solid is sublimated into vapor and condensed in a cold condenser positioned above the freeze drying chamber and connected thereto by a conduit. The vertical positioning of the cold condenser relative to the freeze dryer helps to help prevent substances such as radioactive materials separated from the solution from contaminating the cold condenser. Additionally, the system can be charged with an inert gas to produce a down rush of gas into the freeze drying chamber to also help prevent such substances from contaminating the cold condenser.

Freeze drying apparatus

Freeze drying method

A transfer port system between two sterile environments having docked and undocked positions which is made up of two door frames connected to the environments and two doors connected to the two door frames. When the sterile environments are in the docked position the door frames of the two doors are juxtaposed and in close physical contact with one another and when the two sterile environments are in the undocked position the two door frames are spaced apart from one another and the two doors seal the sterile environments. The two door frames and the doors have a potentially non-sterile peripheral juncture located at the juncture between the doors and door frames when the doors are in a closed position sealing the sterile environments when the sterile environments are in their docked position. In order to sterilize this non-sterile peripheral junction, one or both of the door frames is provided with internal channels for circulation of a heat transfer fluid to heat the two door frames and the two doors and thereby sterilize said juncture. A vacuum sealing gasket is provided to allow a vacuum to be pulled between the two doors to hold the two doors together when the sterile environments are in the docked position. The two doors are then rotated as a unit between a closed position sealing the two sterile environments and an opened position away from the two door frames permitting transport through the two door frames and between the sterile environments.

Transfer port system between sterile environments

The present invention provides a shelf for a freeze dryer which includes a pair of first and second flat plates spaced apart from one another, and a plurality of ribs located between the first and second plates and spaced from one another so as to define flow channels for circulating a diathermic fluid. The ribs are preferably formed of hollow tubes that are brazed to the first and second plates and the hollow tubes and plates are stress relieved so that the first plate presents a flat surface at which heat is transferred from articles to be freeze dried and the diathermic fluid. A freeze dryer shelf constructed in such manner has less thermal mass than prior art design which have solid ribs and plates welded to the ribs with a thickness sufficient to prevent the formation of surface deformations that would interrupt the flat surface of the first plate. Additionally, the freeze dryer shelf of the present invention can have a diathermic fluid section on which the articles are supported and a refrigerant section in good thermal contact therewith. A diathermic fluid circulated through the diathermic fluid section cools the articles to the freezing point of water while the diathermic fluid is cooled by a refrigerant circulating through the refrigerant section. Such heat exchange provided for in the freeze dryer shelf helps eliminate heat leeks that are involved in prior art freeze driers using external heat exchangers.

Growing community of inventors

Youngstown, NY, United States of America

Ernesto Renzi