Abstract: A method and apparatus for eliminating or minimizing the non-uniformity of edge vials compared to center vials during freezing or primary drying of product therein in a freeze dryer. A temperature controlled surface is positioned in close proximity to or in contact with the edge vials to control the temperature thereof. The method and apparatus may be used to simulate in a development freeze dryer the conditions of the center and edge vials in a larger batch target freeze dryer.

Abstract: A method of monitoring and controlling a freeze drying process in a freeze drying apparatus having walls, shelves and a number of vials or trays positioned on different areas of the shelves and containing product to be freeze dried. One or more vials or trays are selected that are representative of the positions of all of the vials or trays in different areas of the shelves. One or more heat flux sensors are positioned between the selected vials or trays and adjacent portions of the walls and/or shelves. The heat transfer between the selected vials or trays and the adjacent wall or shelf portions is measured during the freezing and drying stages of the freeze drying process.

Abstract: A method and apparatus for eliminating or minimizing the non-uniformity of edge vials compared to center vials during freezing or primary drying of product therein in a freeze dryer. A temperature controlled surface is positioned in close proximity to or in contact with the edge vials to control the temperature thereof. The method and apparatus may be used to simulate in a development freeze dryer the conditions of the center and edge vials in a larger batch target freeze dryer.

Abstract: A method and apparatus for eliminating or minimizing the non-uniformity of edge vials compared to center vials during freezing or primary drying of product therein in a freeze dryer. A temperature controlled surface is positioned in close proximity to or in contact with the edge vials to control the temperature thereof. The method and apparatus may be used to simulate in a development freeze dryer the conditions of the center and edge vials in a larger batch target freeze dryer.

Abstract: A method of controlling and enhancing the nucleation of product in a freeze dryer wherein a product is maintained at a predetermined temperature and pressure. A mixture of water vapor and CO2 gas is introduced into a condenser chamber separate from the product chamber to create a predetermined volume of condensed frost, ice and dry ice crystals on an inner surface of the condenser chamber. The condenser chamber is connected to the product chamber and has a predetermined pressure that is greater than that of the product chamber. Upon the opening of the condenser chamber into the product chamber, gas turbulence is created that causes the condensed frost in the form of an ice fog and accompanying ice and dry ice crystals to rapidly enter the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber.

Abstract: A method of controlling and enhancing the nucleation of product in a freeze dryer, wherein the product is maintained at a predetermined temperature and pressure in a chamber of the freeze dryer, and a predetermined volume of condensed frost is created on an inner surface of a condenser chamber separate from the product chamber and connected thereto by a vapor port. The opening of the vapor port into the product chamber when the condenser chamber has a pressure that is greater than that of the product chamber creates gas turbulence that breaks down the condensed frost into ice crystals that rapidly enter the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber.

Abstract: A method of monitoring and controlling a freeze drying process in a freeze drying apparatus having walls, shelves and a number of vials or trays positioned on different areas of the shelves and containing product to be freeze dried. One or more vials or trays are selected that are representative of the positions of all of the vials or trays in different areas of the shelves. One or more heat flux sensors are positioned between the selected vials or trays and adjacent portions of the walls and/or shelves. The heat transfer between the selected vials or trays and the adjacent wall or shelf portions is measured during the freezing and drying stages of the freeze drying process.

Abstract: A method of controlling and enhancing the nucleation of product in a freeze dryer wherein a product is maintained at a predetermined temperature and pressure. A mixture of water vapor and CO2 gas is introduced into a condenser chamber separate from the product chamber to create a predetermined volume of condensed frost, ice and dry ice crystals on an inner surface of the condenser chamber. The condenser chamber is connected to the product chamber and has a predetermined pressure that is greater than that of the product chamber. Upon the opening of the condenser chamber into the product chamber, gas turbulence is created that causes the condensed frost in the form of an ice fog and accompanying ice and dry ice crystals to rapidly enter the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber.

Abstract: A method of controlling and enhancing the nucleation of product in a freeze dryer, wherein the product is maintained at a predetermined temperature and pressure in a chamber of the freeze dryer, and a predetermined volume of condensed frost is created on an inner surface of a condenser chamber separate from the product chamber and connected thereto by a vapor port. The condenser chamber has a predetermined pressure that is greater than that of the product chamber. The opening of the vapor port into the product chamber creates gas turbulence that breaks down the condensed frost into ice crystals that rapidly enter the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber.

Abstract: A method of controlling and enhancing the nucleation of product in a freeze dryer, wherein the product is maintained at a predetermined temperature and pressure in a chamber of the freeze dryer, and a predetermined volume of ice fog is created in a condenser chamber separate from the product chamber and connected thereto by a vapor port. The ice fog has a predetermined pressure that is greater than that of the product chamber, and is rapidly conveyed through the vapor port into the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber.

Abstract: A method of controlling and enhancing the nucleation of product in a freeze dryer, wherein the product is maintained at a predetermined temperature and pressure in a chamber of the freeze dryer, and a predetermined volume of condensed frost is created on an inner surface of a condenser chamber separate from the product chamber and connected thereto by a vapor port. The opening of the vapor port into the product chamber when the condenser chamber has a pressure that is greater than that of the product chamber creates gas turbulence that breaks down the condensed frost into ice crystals that rapidly enter the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber.

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 and enhancing the nucleation of product in a freeze dryer, wherein the product is maintained at a predetermined temperature and pressure in a chamber of the freeze dryer, and a predetermined volume of ice fog is created in a condenser chamber separate from the product chamber and connected thereto by a vapor port. The ice fog has a predetermined pressure that is greater than that of the product chamber, and is rapidly conveyed through the vapor port into the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber.

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.