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.

Lyophilization methods for preparing protein formulations for long-term storage at room temperature or improved stability at refrigeration storage are provided. Specifically, the present application provides lyophilization methods to obtain a target percentage of residual moisture of a lyophilized product, such as 3-5% residual moisture. The secondary drying of the lyophilization can be conducted under controlling rate of desorption under a temperature which is similar to the shelf temperature of the primary drying. Alternatively, the lyophilization can be conducted without a distinguished secondary drying step.

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.

Lyophilization methods for preparing protein formulations for long-term storage at room temperature or improved stability at refrigeration storage are provided. Specifically, the present application provides lyophilization methods to obtain a target percentage of residual moisture of a lyophilized product, such as 3-5% residual moisture. The secondary drying of the lyophilization can be conducted under controlling rate of desorption under a temperature which is similar to the shelf temperature of the primary drying. Alternatively, the lyophilization can be conducted without a distinguished secondary drying step.

A device for holding and monitoring a predetermined dose of a product during a freezing, drying and/or lyophilization process, includes a mold having a receptacle part for containing the predetermined dose of the product in direct contact with the receptacle part, a sensor, contacting the mold or integrated in the mold, for measuring a physical characteristic and/or quantity, and a transmitter for transmitting the measured characteristic and/or quantity in the form of a sensor signal to a control unit for controlling a heating and/or cooling element, integrated in the device, for heating and/or cooling a predetermined dose of product during a freezing, drying and/or lyophilization process, in the lyophilization process. The device relates in further aspects to a system and a method.

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 freeze-drying device includes a controller configured to control depressurization of containers filled with a liquid including a raw material and a medium to freeze the liquid from a liquid surface. The freeze-drying device also includes a gas capture pump configured to exhaust a freeze-drying chamber accommodating the containers, and a positive-displacement pump configured to discharge gas from a space accommodating the gas capture pump. The controller executes an exhaust mitigation process that performs the depressurization at an exhaust capability that is less than a rated exhaust capability of the freeze-drying device. The controller uses a partial pressure value of the medium to determine when the exhaust mitigation process ends. The controller maintains an exhaust speed of the gas capture pump and decreases an exhaust speed of the positive-displacement pump in the exhaust mitigation process.

A freeze-drying device includes a controller configured to control depressurization of containers filled with a liquid including a raw material and a medium to freeze the liquid from a liquid surface. The freeze-drying device also includes a gas capture pump configured to exhaust a freeze-drying chamber accommodating the containers, and a positive-displacement pump configured to discharge gas from a space accommodating the gas capture pump. The controller executes an exhaust mitigation process that performs the depressurization at an exhaust capability that is less than a rated exhaust capability of the freeze-drying device. The controller uses a partial pressure value of the medium to determine when the exhaust mitigation process ends. The controller maintains an exhaust speed of the gas capture pump and decreases an exhaust speed of the positive-displacement pump in the exhaust mitigation process.

A freeze-drying device includes a controller configured to control depressurization of containers filled with a liquid including a raw material and a medium to freeze the liquid from a liquid surface. The freeze-drying device also includes a gas capture pump configured to exhaust a freeze-drying chamber accommodating the containers, and a positive-displacement pump configured to discharge gas from a space accommodating the gas capture pump. The controller executes an exhaust mitigation process that performs the depressurization at an exhaust capability that is less than a rated exhaust capability of the freeze-drying device. The controller uses a partial pressure value of the medium to determine when the exhaust mitigation process ends. The controller maintains an exhaust speed of the gas capture pump and decreases an exhaust speed of the positive-displacement pump in the exhaust mitigation process.

Freeze-drying methods and systems include performing a constant-pressure drying phase in a chamber, where a temperature of a heating tray increases. A constant-temperature drying phase is performed in the chamber, where a pressure in the chamber decreases. Additional phases alternate between constant-pressure drying phases and constant-temperature drying phases. The alternating drying phases are halted, responsive to a determination that the temperature of the heating tray has reached a maximum temperature.