In a method of ventilating excised lungs, a ventilation gas is supplied to an airway of a lung and a vacuum is formed around the lung. A quality of the vacuum is varied between a lower level and a higher level to cause the lung to breathe, while the pressure of the ventilation gas supplied to the airway is regulated to maintain a positive airway pressure in the airway of the lung. The vacuum may be cyclically varied between the two vacuum levels. The levels may be maintained substantially constant over a period of time, or one or both of the lower and higher levels may be adjusted during ventilation. The lung may be placed in a sealed chamber, and a vacuum is formed in the chamber around the lung.

A continuous feed lyophilizer drying chamber that has an overall internal volume, a primly drying stage portion having a primary drying stage internal volume, a secondary drying stage portion having an internal volume, a frozen formulation feed inlet that provides frozen formulation droplets into the internal volume of the primary drying stage of the drying chamber and a dried particle outlet proximate an end of the continuous feed lyophilizer drying chamber configured to provide dried formulation droplet particles. The primary drying stage typically makes up from about 65-75% of the overall internal volume of the drying chamber and the secondary drying stage makes up from 25 to 35% of the overall internal volume of the drying chamber. The drying chamber dries frozen formulation droplets received into the primary drying stage internal volume via the frozen formulation feed inlet.

A lyophilization nest and method of using the same is described herein. In various embodiments, the lyophilization nest includes a base and first and second covers and is configured to support one or more receptacles each supporting one or more substances within interior spaces of the lyophilization nest. The interior spaces may be in fluid communication with the exterior of the lyophilization nest through one or more vent holes extending through the first and second covers. 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 spaces 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.

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 high pressure freezing cartridge (300, 400, 500) for use in vitrification of a biological sample (10) is provided, the cartridge (300, 400, 500) being adapted to fixedly hold a sample chamber (216, 218, 220) at a sample chamber position (320, 420, 520) in the cartridge (300, 400, 500), a refrigerant channel arrangement comprising at least one refrigerant channel (208, 308, 408, 462, 464, 466, 468, 508, 562, 564, 566, 569) being provided in the cartridge (300, 400, 500) and extending from a surface of the cartridge (300, 400, 500) to the sample chamber position, and the cartridge (300, 400, 500) comprising a baffle structure (350, 450, 550, 571) at a baffle position being adapted to interact with a refrigerant stream in the refrigerant channel arrangement before the refrigerant of the refrigerant stream reaches the sample chamber position in the cartridge (300, 400, 500). A corresponding method in which the high pressure freezing cartridge (300, 400, 500) is used is also part of the present disclosure.

Provided is a loading tray assembly for housing a lyophilization container and a related system and method. The loading tray assembly includes a chassis including a contact void configured to facilitate direct contact between the attached lyophilization container and a lyophilizer shelf. The method includes securing a multi-part lyophilization container including a peelable seal on a lyophilization loading tray assembly, inputting a liquid into a non-breathable section of the lyophilization container, loading the tray assembly into a lyophilizer, freezing the liquid, applying heat energy and a vacuum, the vacuum causing an opening of the peelable seal and occluding the lyophilization container to isolate the frozen liquid.

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.

Provided is a gas fill fixture for use in lyophilization, a related system and method. The gas fill fixture includes a chassis, fill indicator and a lid, such that the chassis and lid together form a cavity for receiving a flexible lyophilization container. The system includes a lyophilization container, a lyophilizer and a gas fill fixture incorporating a chassis, a fill indicator and a lid. The method includes process steps for using the system to lyophilize a fluid.

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.

Provided is a gas fill fixture for use in lyophilization, a related system and method. The gas fill fixture includes a chassis, fill indicator and a lid, such that the chassis and lid together form a cavity for receiving a flexible lyophilization container. The system includes a lyophilization container, a lyophilizer and a gas fill fixture incorporating a chassis, a fill indicator and a lid. The method includes process steps for using the system to lyophilize a fluid.