Abstract: The present technology is directed to an apparatus for freeze-drying various items. The apparatus described herein includes a reusable sealable container enabling aseptic handling of bulk processed materials. The multi-use tray enables a sterile sealable enclosure for use throughout the freeze-drying process, including: pre-freeze-drying (e.g., filling, handling, storage, transfer), freeze-drying processing, and/or post-freeze-drying (e.g., handling and storage).

Abstract: A method of monitoring and controlling the freezing and thawing of a drug substance partially or fully surrounded by a temperature control medium. The heat flow between the drug substance and the temperature control medium is measured and controlled to create a uniform ice crystal structure to minimize any degradation of the drug substance being frozen and thawed.

Abstract: A method of controlling the primary drying stage in a freeze drying apparatus having a shelf and bulk product or a number of vials in different areas on the shelf which contain product to be freeze dried. Temperature sensors are positioned in selected locations or vials which are representative of the different bulk product areas or the positions of all of the vials in different areas of the shelf. The temperature sensors are monitored and compared to determine the selected location or vial having the highest temperature while the temperature sensor therein is still in ice. The shelf temperature is controlled based on the selected location or vial with the highest temperature so long as the temperature sensor therein is still in ice. When the temperature sensor in the highest temperature selected location or vial is no longer in ice, another selected location or vial with the highest temperature and a temperature sensor therein that is still in ice is then used to control the shelf temperature.

Abstract: A method of controlling the primary drying stage in a freeze drying apparatus having a shelf and bulk product or a number of vials in different areas on the shelf which contain product to be freeze dried. Temperature sensors are positioned in selected locations or vials which are representative of the different bulk product areas or the positions of all of the vials in different areas of the shelf. The temperature sensors are monitored and compared to determine the selected location or vial having the highest temperature while the temperature sensor therein is still in ice. The shelf temperature is controlled based on the selected location or vial with the highest temperature so long as the temperature sensor therein is still in ice. When the temperature sensor in the highest temperature selected location or vial is no longer in ice, another selected location or vial with the highest temperature and a temperature sensor therein that is still in ice is then used to control the shelf temperature.

Abstract: A temperature conditioning device acheives a fast rate of temperature change in air or gas applied to stress thermally an electronic component by establishing separate cold and hot gas paths from a two-way directing valve interior the device cabinet to a nozzle assembly retaining the gas of selected temperature around the electronic component. An evaporation coil of a mechanical refrigeration system chills the air or gas in the cold gas path interior the cabinet and a tube heater adjusts the air or gas temperature in the cold gas path to that selected. A quartz enveloped nickel-chrome filament heater adjacent the nozzle assembly heats the air or gas in the hot gas path to the temperature selected.