Abstract: An analysis container includes an outer tube and a plurality of inner tubes. The outer tube defines a buffer volume that is configured to receive a buffer material. The plurality of inner tubes is disposed within the buffer volume. Each inner tube has an inner diameter equal to or less than 6 mm and is configured to receive a biopharmaceutical composition therein. The outer tube is configured such that the buffer material and the biopharmaceutical composition are axially frozen.

Abstract: A carrier for receiving a vessel includes a body that defines a well. The well is sized and dimensioned to receive a vessel including media. The body is configured to urge the vessel received in the well towards an external wall of the body to enhance thermal energy transfer into or out of the media within the vessel. A box assembly for supporting media during thermal changes includes a box, a vessel, and a carrier is also disclosed.

Abstract: A thermal capacitor includes a shell and a PCM. The shell includes a first major surface that is configured to contact a container including media to be frozen. The shell defines a cavity in which the PCM is disposed. The PCM has a transition temperature in a range of ?80 degrees Celsius to ?50 degrees Celsius and is configured to rapidly freeze media from room temperature to ?60 degrees Celsius with the container including the media in contact with the shell in an enclosed space.

Abstract: Disclosed is a system for freezing, storing, transporting, and thawing biopharmaceutical product, comprising a stationary equipment and one or more movable pallets, each pallet configured to carry one or more container units, each containing biopharmaceutical product, the stationary equipment comprising a gas circulating unit configured to cause a circulation of cold gas and/or warm gas, from a pull inlet toward a blow outlet, wherein there is provided at least a first side plenum having one or more gas conveying channel therein, configured to be fluidly coupled to the blow outlet of the gas circulating unit, the first side plenum having a plurality of outlet ports directed toward an interior volume of the pallet, wherein the gas circulates substantially in a horizontal direction in the interior volume of the pallet, and wherein a shaking arrangement is provided.

Abstract: The protecting package for a flexible pouch specially designed to contain a biopharmaceutical fluid, includes two frames which respectively form a lower frame and an upper frame and which have a peripheral area, respectively to a main plane of the frames, each frame has an opening on a central area, the two frames are fixed to each other such that they are able to respectively surround two plates which sandwich the flexible pouch.

Abstract: A system for freezing, storing, transporting, and thawing biopharmaceutical product, the system including a stationary equipment and one or more movable pallet, each pallet being configured to carry one or more container units, each containing biopharmaceutical product, the stationary equipment including a gas circulating unit configured to cause a circulation of cold gas and/or warm gas, from a pull inlet toward a blow outlet, wherein there is provided at least a first side plenum having one or more gas conveying channel therein, configured to be fluidly coupled to the blow outlet of the gas circulating unit, the first side plenum having a plurality of outlet ports directed toward an interior volume of the pallet, wherein the gas circulates substantially in a horizontal direction in the interior volume of the pallet.

Abstract: Disclosed is a method and system for freezing a biopharmaceutical fluid which is hold in a disposable container. The method includes the steps of arranging the container on the heat transfer surface area, cooling the heat transfer surface area to cool the bottom surface of the container until freezing and forming a layer of ice or an ice block of biopharmaceutical fluid inside the container; dislodging the ice layer or ice block frozen to the container. The steps of cooling the heat transfer surface area and dislodging the ice layer or ice block are repeated until the container is filled with a matrix of frozen biopharmaceutical fluid and liquid biopharmaceutical fluid, the liquid biopharmaceutical fluid occupying interstitial passages between ice layers or ice blocks of biopharmaceutical fluid. The cooling is then maintained until the freezing of the entire biopharmaceutical fluid held in the container.

Abstract: The protecting body for a flexible pouch is specially designed to contain a biopharmaceutical fluid. It includes two substantially planar plates which respectively form a lower surface and an upper surface and which are fixed to each other. The two plates are able to sandwich the flexible pouch for constraining the flexible pouch such that the protecting body is substantially planar, and includes, on a peripheral side, at least one opening able to receive at least one port of the flexible pouch.

Abstract: A system for freezing, storing, transporting, and thawing biopharmaceutical product, the system including a stationary equipment and one or more movable pallet, each pallet being configured to carry one or more container units, each containing biopharmaceutical product, the stationary equipment including a gas circulating unit configured to cause a circulation of cold gas and/or warm gas, from a pull inlet toward a blow outlet, wherein there is provided at least a first side plenum having one or more gas conveying channel therein, configured to be fluidly coupled to the blow outlet of the gas circulating unit, the first side plenum having a plurality of outlet ports directed toward an interior volume of the pallet, wherein the gas circulates substantially in a horizontal direction in the interior volume of the pallet.

Abstract: A system for receiving a single-use vessel containing a mixing device has a support structure adapted to receive the single-use vessel and a drive-unit adapted to power, to control, or to power and control a mixing of contents of the single-use vessel when the single-use vessel is arranged in the support structure. The support structure and the drive-unit are provided as separate components that may be arranged both in an operating position, where the drive-unit is connectable to the mixing device of the single-use bag in the support structure, and in a separated position, where the drive-unit is separated from the support structure. The drive-unit comprises a tag reader that, in the operating position, is arranged to read a vessel tag of the single-use vessel arranged in the support structure.

Abstract: The leak test for a flexible pouch specifically designed to contain a biopharmaceutical fluid includes the following steps: the flexible pouch is sandwiched between two plates which have an internal surface able to allow gas which escape from a hole on the flexible pouch flowing out of an external surface of the flexible pouch, a gas is introduced within the flexible pouch, and the pressure within the flexible pouch is measured.

Abstract: Disclosed is a method and system for freezing a biopharmaceutical fluid which is hold in a disposable container. The method includes the steps of arranging the container on the heat transfer surface area, cooling the heat transfer surface area to cool the bottom surface of the container until freezing and forming a layer of ice or an ice block of biopharmaceutical fluid inside the container; dislodging the ice layer or ice block frozen to the container. The steps of cooling the heat transfer surface area and dislodging the ice layer or ice block are repeated until the container is filled with a matrix of frozen biopharmaceutical fluid and liquid biopharmaceutical fluid, the liquid biopharmaceutical fluid occupying interstitial passages between ice layers or ice blocks of biopharmaceutical fluid. The cooling is then maintained until the freezing of the entire biopharmaceutical fluid held in the container.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A device for monitoring the freezing state of a biopharmaceutical fluid in a container intended to receive a biopharmaceutical fluid that must pass between the liquid state and the frozen state, includes a peripheral envelope (25) made of plastic, to be connected to a heat treatment receptacle (5), a sensor (19) suitable for detecting a control parameter which is a macroscopic parameter of the container, and an analysis system (62) suitable for determining a freezing state of the biopharmaceutical fluid on the basis of the macroscopic parameter of the container.

Abstract: A system for receiving a single-use vessel containing a mixing device has a support structure adapted to receive the single-use vessel and a drive-unit adapted to power, to control, or to power and control a mixing of contents of the single-use vessel when the single-use vessel is arranged in the support structure. The support structure and the drive-unit are provided as separate components that may be arranged both in an operating position, where the drive-unit is connectable to the mixing device of the single-use bag in the support structure, and in a separated position, where the drive-unit is separated from the support structure. The drive-unit comprises a tag reader that, in the operating position, is arranged to read a vessel tag of the single-use vessel arranged in the support structure.

Abstract: A facility (1) for producing a container loaded with a biopharmaceutical fluid, includes: a container (2) wherein a biopharmaceutical fluid is placed (B); a control module (9) for controlling the filling of gas into the container (2); and an analysis module (10) for estimating a parameter for controlling the gas filling; and a pumping device (40) for generating a depression in the inner filling space (Vg).

Abstract: The protecting body for a flexible pouch is specially designed to contain a biopharmaceutical fluid. It includes two substantially planar plates which respectively form a lower surface and an upper surface and which are fixed to each other. The two plates are able to sandwich the flexible pouch for constraining the flexible pouch such that the protecting body is substantially planar, and includes, on a peripheral side, at least one opening able to receive at least one port of the flexible pouch.

Abstract: The leak test for a flexible pouch specifically designed to contain a biopharmaceutical fluid includes the following steps: the flexible pouch is sandwiched between two plates which have an internal surface able to allow gas which escape from a hole on the flexible pouch flowing out of an external surface of the flexible pouch, a gas is introduced within the flexible pouch, and the pressure within the flexible pouch is measured.

Abstract: The protecting package for a flexible pouch specially designed to contain a biopharmaceutical fluid, includes two frames which respectively form a lower frame and an upper frame and which have a peripheral area, respectively to a main plane of the frames, each frame has an opening on a central area, the two frames are fixed to each other such that they are able to respectively surround two plates which sandwich the flexible pouch.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.