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.

A process for freeze drying a material. The process has the steps of (a) placing material to be freeze-dried in a vessel, the vessel comprising a container having a base, and at least one wall defining an opening at one end; (b) applying a membrane to the at least one wall to thereby cover the opening, wherein the membrane comprises an aperture which, in use, is aligned with the opening; and (c) subjecting the vessel to a lyophilisation procedure, wherein the membrane is in place on the container during the lyophilisation procedure.

A process for freeze drying a material. The process has the steps of (a) placing material to be freeze-dried in a vessel, the vessel comprising a container having a base, and at least one wall defining an opening at one end; (b) applying a membrane to the at least one wall to thereby cover the opening, wherein the membrane comprises an aperture which, in use, is aligned with the opening; and (c) subjecting the vessel to a lyophilisation procedure, wherein the membrane is in place on the container during the lyophilisation procedure.

An apparatus and method for lyophilization, the apparatus includes a block made from a conductive material. The block has multiple wells dimensioned to receive containers wherein the depth of the wells is proportional to the length of the containers. A silicone pad covers the well and can secure the containers in the well. A metal plate can secure the silicone pad by fastening it to the block. The silicone plate and the metal plate can have vents to allow vapors from the containers to escape. The apparatus can be turned up to 90 degrees resulting in the turning of the containers from an upright position to a horizontal position. The container can be a syringe.

An apparatus and method for lyophilization, the apparatus includes a block made from a conductive material. The block has multiple wells dimensioned to receive containers wherein the depth of the wells is proportional to the length of the containers. A silicone pad covers the well and can secure the containers in the well. A metal plate can secure the silicone pad by fastening it to the block. The silicone plate and the metal plate can have vents to allow vapors from the containers to escape. The apparatus can be turned up to 90 degrees resulting in the turning of the containers from an upright position to a horizontal position. The container can be a syringe.

A lyophilization method for lyophilizing products inside one or more vials within a lyophilization chamber is disclosed which includes humidifying a charge gas to a predetermined relative humidity, cooling shelves in the lyophilization chamber to a predetermined temperature, pressurizing the chamber with the humidified charge gas to a pressurization threshold to thereby achieving a target relative humidity level within the lyophilization chamber, and suddenly releasing pressure within the lyophilization chamber until a depressurization threshold is reached in a short time interval up to about 4 seconds, during the depressurization, product inside one or more vials nucleate.

A lyophilization method for lyophilizing products inside one or more vials within a lyophilization chamber is disclosed which includes humidifying a charge gas to a predetermined relative humidity, cooling shelves in the lyophilization chamber to a predetermined temperature, pressurizing the chamber with the humidified charge gas to a pressurization threshold to thereby achieving a target relative humidity level within the lyophilization chamber, and suddenly releasing pressure within the lyophilization chamber until a depressurization threshold is reached in a short time interval up to about 4 seconds, during the depressurization, product inside one or more vials nucleate.

Apparatus and methods for lyophilizing and sealing a medicament within a medical delivery device having an opening. The apparatus may include a stopper for sealing the opening. The stopper may have one or more elongated members extending from a base, in a direction that is parallel to a central axis of the base. One or more of the members may be set radially away from the axis and define a coaxial central well. The member or members may define a void. The elongated member or members may engage a device inner wall and support the base away from the opening. The void may provide gas exchange between a device interior and a device exterior. The gas may be a lyophilization byproduct that escapes from the device interior between the inner wall, the base and the member or members. The stopper may be advanced into the device to seal the opening.

Apparatus and methods for lyophilizing and sealing a medicament within a medical delivery device having an opening. The apparatus may include a stopper for sealing the opening. The stopper may have one or more elongated members extending from a base, in a direction that is parallel to a central axis of the base. One or more of the members may be set radially away from the axis and define a coaxial central well. The member or members may define a void. The elongated member or members may engage a device inner wall and support the base away from the opening. The void may provide gas exchange between a device interior and a device exterior. The gas may be a lyophilization byproduct that escapes from the device interior between the inner wall, the base and the member or members. The stopper may be advanced into the device to seal the opening.

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.