Abstract: 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.

Abstract: 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.

Abstract: A freeze drying vessel (302) having a freeze drying chamber (304) that includes sloped horizontal shelves (352) that receive frozen particles (282). Each shelf is sloped relative to a horizontal axis (390) and arranged such that a downward slope between successive shelves alternates between first (392) and second (394) directions. At least one connecting member (374, 376, 378, 380, 382, 384, 386, 386, 388) is attached between pairs of shelves. At least one connecting member is attached to an associated vibration element (396, 398, 400, 402) 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 (284).

Abstract: In a system and method for controlling a freeze drying process, a diagnostics server (718) is connected for receiving time series data from a freeze drying system (710, 711). 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 (730) 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 (735) 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: Parameters of a freeze drying process are monitored by measuring trace materials in the vacuum pump exhaust. The measurements are made using techniques such as acousto-optic spectrometry, multipass cavity-enhanced absorption spectrometry (CEAS) and cavity ring-down spectrometry (CRDS). The technique may be used to diagnose problems such as leakage in the freeze drying shelves, leakage in the condensation coils, leaks from atmosphere in the chambers and the presence of residual cleaning materials. The technique may also be used to monitor the presence of water vapor in the exhaust of a secondary drying process.

Abstract: 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.

Abstract: 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.

Abstract: 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.