Herein described are an assembly, apparatus, and method for lyophilization that utilizes a thermal block made from a conductive material, the block having multiple wells designed and dimensioned to receive containers carrying material to be lyophilized in situ. In preferred embodiments, a vented silicone pad covers the wells and secures the containers therein, and a similarly vented rigid plate in turn secures the silicone pad by fastening it to the thermal block. The assembly can be turned up to 90 degrees resulting in the turning of the containers from an upright position to a horizontal position, a position in which the distance through which sublimation must progress is drastically reduced so as to greatly enhance the efficiency of the lyophilization process.

A method of preparing a pharmaceutical product in a single multiple chamber flexible bag. A pharmaceutical product is introduced in a liquid state into a first chamber of the flexible bag through a first port. The pharmaceutical product is lyophilized within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product. The flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal. The second chamber further includes a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution to order to administer the pharmaceutical product to a patient.

A freeze-drying system includes a vented cart for operation in a pressure-controlled chamber, and a plurality of heated shelves disposed in the vented cart. Each heated shelf includes a planar sheet made from a thermally conductive material. The planar sheet is folded to provide a top portion configured to conduct heat to a tray resting on the top portion, a bottom portion disposed opposite the top portion, and a folded leading edge. A heating element is secured between the top portion and the bottom portion so as to be disposed in thermally conductive contact with either the top portion or the bottom portion. The top portion is configured to conduct heat to a tray resting on the top portion. The leading folded edge permits food items to slide out of the freeze-drying system, even though pressing along the bottom portion of the heated shelf, without catching on the food.

A process for the production of a device for dispensing eye drops. The process includes the steps of providing a first container and a second container configured to be engaged in a fluid-tight manner, providing a spacer, introducing a water-based solution inside the first container, introducing a solution or dispersion comprising a drug inside the second container, arranging the spacer between the first and second containers, engaging in a fluid-tight manner the second container and the first container, and freeze-drying the solution or dispersion comprising the drug.

A lyophilization nest and method of using the same is described herein. In various embodiments, the lyophilization nest is configured to support one or more receptacles each supporting one or more substances within an interior space of the lyophilization nest. The interior space may be in fluid communication with the exterior of the lyophilization nest through one or more vent holes extending through a surface of the lyophilization nest. Each of the one or more vent holes have a corresponding sealing element configured to selectively form an air-tight seal within the vent holes, such that a controlled environment may be maintained within the interior space when the ambient conditions surrounding the lyophilization nest are not lyophilization conditions. The one or more sealing elements may be operable while the lyophilization nest is positioned within a sealed lyophilizer by depressing the sealing elements into corresponding vent holes to form the air-tight seal.

A method of preparing a pharmaceutical product in a single multiple chamber flexible bag. A pharmaceutical product is introduced in a liquid state into a first chamber of the flexible bag through a first port. The pharmaceutical product is lyophilized within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product. The flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal. The second chamber further includes a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution to order to administer the pharmaceutical product to a patient.

Provided is a multi-part lyophilization container for lyophilizing a fluid, storing the lyophilizate, reconstituting the lyophilizate, and infusing the reconstituted lyophilizate into a patient, including a method of using same. The container includes a front surface, a back surface, a non-breathable section including a port region, a breathable section including a breathable membrane, and a peelable region including a peelable seal encompassing a boundary between the non-breathable section and the breathable section. The method includes inputting a fluid into a non-breathable section of the container, freezing the fluid, applying, in a lyophilization chamber, vacuum pressure, opening the peelable seal using a pressure differential, applying heat energy, sublimating the fluid and creating a temporary occlusion in a peelable region of the container.

A method of preparing a pharmaceutical product in a single multiple chamber flexible bag. A pharmaceutical product is introduced in a liquid state into a first chamber of the flexible bag through a first port. The pharmaceutical product is lyophilized within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product. The flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal. The second chamber further includes a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution to order to administer the pharmaceutical product to a patient.

A device for drying foam pieces is provided. The device uses a combination of heating and air convection to drive moisture or other solvents and volatile compounds from the adhesive, causing it to rapidly dry. The device for drying foam pieces has a frame that defines a cavity. Foam pieces may be placed in the cavity to be dried. A heater is positioned to direct heat to an item within the cavity. An air blower is configured to draw air into the cavity and expel it from an outlet.

Assemblies, systems, and methods for preventing contamination and alteration of a biological material during and after freeze-drying processes are disclosed. Tray assemblies configured to hold the biological material in a container during a freeze-drying process include a tray and complementary lid. The lid can include compressible leg members configured to transition from an extended configuration to a compressed configuration in response to a downward force applied against the lid when the lid is positioned above the tray. A gap exists between an upper edge of the tray and an underside of the lid when the leg members are extended. With the legs extended and the tray assembly open, the tray assembly is freeze-dried. After freeze-drying is complete, the legs can be compressed and the lid sealed against the tray, enclosing the biological material within the assembly, and protecting it from contamination and ambient air exposure within and outside the chamber.