Abstract: A method for the sterile filling of at least one final basic container, includes: providing at least one sterile chamber having at least one sterile entrance port and providing a source container containing the content, located outside the chamber; providing a communication element, a dispensing element and at least one filling member, to form when all are assembled, a sterile fluid filling and transfer line; inserting at least one final container into the chamber; structurally combining at least one final container with at least one filling member; providing inner members and elements in sterile condition for a single-use; inserting the inner element and members which were previously outside the chamber in the chamber in a sterile manner, such that after filling, a new filling process can be performed without sterilizing the inside of the chamber; transferring in a filling step content from the source container into the final container.

Abstract: The invention relates to a housing (1) that is especially designed to be associated with a device for a tight connection to a second housing (2), said first housing comprising a structure including a wall (3) defining a space (1a), an opening (4) defined by a flange (5) that can be hermetically applied to a second flange (9) of the second housing (2), holding means that can keep the first flange and the second flange (9) applied to each other, a door (6) supported by carrying means (11a), the door leaf (6v) being mobile in such a way as to be closed or open and having an outer face (6a) that can ensure the hermetic application of a second door (10) of the second housing (2), fixing means for holding the leaves (6v, 1 Ov) against each other, displacement manoeuvring means (11b), and means for controlling the displacement manoeuvring means (11b), and, when the leaf (6v) is open, an inlet/outlet space (13a) in/of the inner space (1a) forming part of a communication space (13) between the two housings (1, 2), whe

Abstract: A device for a tight connection between a first housing (1) having a wall (3), an opening (4), a flange (5) and a door (6), and a second housing (2) having a wall (7), an opening (8), a flange (9) and a door (10). The flanges are complementary, and elements are used to displace the door (6). Elements are used to hold the two doors against each other, and the housings communicate between each other via a communication space (13). There is an inner annular critical line on the door (6) and an outer annular critical line of risk of contamination on the flange (9). The device includes elements (25 and/or 26) that are structurally integrated into the door (6) and/or the flange (9) and can form a separation between the communication space and the inner annular critical line and/or the outer annular critical line, when the doors are open.

Abstract: A system for use in storing biopharmaceutical materials includes a holder and a container for holding biopharmaceutical materials therein. The container includes a storage portion and a sampling portion connected to each other by a connecting portion. The holder has a storage cavity receiving the storage portion and a sampling cavity receiving the sampling portion. 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 storage cradle bounding the storage cavity of the holder. The holder includes an interior sampling cradle bounding the sampling cavity. The sampling cradle is separated from the storage cradle and connected to the storage cradle by a passage receiving the connecting portion connecting the storage portion to the sampling portion. An outer rim of the holder is connected to the cradle and separated from the cavity.

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 system for use in freezing, thawing, transporting or storing biopharmaceutical materials which includes a container, a holder and plurality of heat transfer members. The container is configured to hold biopharmaceutical materials therein. The holder has a cavity for receiving the container and includes an interior surface bounding the cavity. A plurality of pockets contact outer surfaces of the container and is received in the cavity. Each pocket of the plurality of pockets includes a pocket cavity. A heat transfer member actively controls the temperature of biopharmaceutical materials held in the container and is received in the pocket cavity.

Abstract: A system for use in freezing, thawing, transporting or storing biopharmaceutical materials which includes a container, a holder and plurality of heat transfer members. The container is configured to hold biopharmaceutical materials therein. The holder has a cavity for receiving the container and includes an interior surface bounding the cavity. A plurality of pockets contact outer surfaces of the container and is received in the cavity. Each pocket of the plurality of pockets includes a pocket cavity. A heat transfer member actively controls the temperature of biopharmaceutical materials held in the container and is received in the pocket cavity.

Abstract: A method of mixing including providing a flexible container which comprises at least two components, assembling the components from outside the flexible container to form a centrally disposed magnetic driven shaft with at least one impeller, whereby the integrity of the flexible container is maintained, filling the flexible container having the centrally disposed magnetic driven shaft with one or more ingredients of the contents to be mixed; engaging a magnetic element of the centrally disposed magnetic driven shaft with an external magnetic drive element; analyzing the contents of the flexible container using at least one sensor or a sampling line on the flexible container; and draining the contents of the flexible container through a drain port at the bottom of the flexible container.

Abstract: A disposable mixing vessel comprising a flexible container, a centrally disposed shaft having first and second ends with one or more impellers thereon and a magnetic element associated with a first shaft end, a first flange adapted to rotatably engage the first shaft end and a second flange adapted to rotatably engage the second shaft end.

Abstract: A presterilizable filtration system is provided and is to be disposed of after a single use. The system has a recirculation tank and a filtration module that are connected to each other in a circuit via a hose system that can be regulated by at least one valve. The valve has a disposable separate valve part that can be integrated in the hose system and a reusable actuator.

Abstract: A system for use in storing biopharmaceutical materials includes a holder and a container for holding biopharmaceutical materials therein. The container includes a storage portion and a sampling portion connected to each other by a connecting portion. The holder has a storage cavity receiving the storage portion and a sampling cavity receiving the sampling portion. 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 storage cradle bounding the storage cavity of the holder. The holder includes an interior sampling cradle bounding the sampling cavity. The sampling cradle is separated from the storage cradle and connected to the storage cradle by a passage receiving the connecting portion connecting the storage portion to the sampling portion. An outer rim of the holder is connected to the cradle and separated from the cavity.

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.