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.

Modular blood product storage system for temperature-regulated storage of blood products with a temperature regulation unit for temperature regulation of the blood product storage system, a base unit and at least one agitator unit with an upper connection side, a lower connection side, a movable compartment to receive the blood products and a drive for movement of the compartment, wherein the compartment is arranged between the upper connection side and the lower connection side, wherein the upper connection side of the agitator unit is selectively connectable to the temperature regulation unit or a further agitator unit, and wherein the lower connection side of the agitator unit is selectively connectable to the base unit or a further agitator unit.

A freeze/thaw containment system is provided, having a protecting body and a flexible pouch protected by two plates of the protecting body. The two plates are attached together at a peripheral margin and form a rectangular protecting body. The peripheral margin is mounted in supporting parts of a stationary frame and sliding positioning members are secured to the peripheral margin, so that the peripheral margin is guided and allowed to be displaced inwardly during filling of the pouch, while the protecting body extends generally planar to sandwich and constrain the pouch in empty state of the pouch. This way of holding and retaining the protecting body allows for progressive conformational change of the protecting body due to the change in volume of the pouch when filled with a biopharmaceutical product, while facilitating reverse displacement of the peripheral margin during draining operations.

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.

A freeze/thaw containment system is provided, having a protecting body and a flexible pouch protected by two plates of the protecting body. The two plates are attached together at a peripheral margin and form a rectangular protecting body. The peripheral margin is mounted in supporting parts of a stationary frame and sliding positioning members are secured to the peripheral margin, so that the peripheral margin is guided and allowed to be displaced inwardly during filling of the pouch, while the protecting body extends generally planar to sandwich and constrain the pouch in empty state of the pouch. This way of holding and retaining the protecting body allows for progressive conformational change of the protecting body due to the change in volume of the pouch when filled with a biopharmaceutical product, while facilitating reverse displacement of the peripheral margin during draining operations.

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.

A tube winding bobbin is accommodated in a segment pocket of a centrifugation transfer device in which a blood bag system is set. The blood bag system is provided with a plurality of sealed tubes which extend for a predetermined length and which have an occluded lumen therein. The tube winding bobbin has a winding part around which the plurality of sealed tubes are wound, a pair of side parts connected to both ends of the winding part, and an engagement part engageable with a wall part constituting the segment pocket.

This disclosure relates to a system and method to improve the uniformity of the heat transfer coefficient of containers filled with biological materials during the freezing and thawing process, in particular a system that is easily transported and incremented to other conventional freeze-thaw methods and equipment. The system includes a portable air blast system configured to receive a container filled with biological materials and to be placed in a cooling or heating chamber, for homogeneous and reproducible freezing and thawing of biological materials. This disclosure also relates to a method of freezing and thawing biological solution inside a container by using the portable air blast system according to any of the previous claims 1-12, comprising: obtaining a container filled with biological solution; placing the container into the vent enclosure and on the stand of the air blast system; placing the air blast system with the container into a heating or cooling chamber; activating the air blast system by activating the fan in the air blast system.

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 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.