Abstract: Integrity of a flexible bag is verified by a testing system, using helium to detect existence of a possible hole. The flexible bag is preliminary placed in vacuum chamber of a fluid-tightly isolated enclosure. After connecting a port of the bag to a helium feeding pipe, vacuum suction is performed to obtain vacuum outside the bag in the enclosure. Then, a first amount of helium is diffused in the internal volume of the enclosure through a gas permeable wall, to increase helium partial pressure outside the flexible bag. After, in a test phase while said vacuum suction is still performed, the bag is filled with a second amount of helium. A detector detects information representative of helium partial pressure in the internal volume, to allow detection of helium escaping from the bag, by analysis of a helium partial pressure drop.

Abstract: A biopharmaceutical liquid reservoir, includes a bag forming an inner storage space for storing a biopharmaceutical liquid, a mechanical member located at a wall of the bag, having: a stationary set of parts that is stationary with respect to the wall of the bag, a rotating set of parts rotating about an axis of rotation with respect to the stationary set, a bearing located between the two sets and, inside the bag, a communication passage: separating the bearing from the inner storage space, including one or more changes of direction, being formed by a portion of the parts of the rotating set located opposite a portion of the parts of the stationary set.

Abstract: A device for emptying a flexible bag comprising a fluid product, comprising a tray including a base having at least a top flat surface and two side members rigidly mounted on the base, perpendicularly to the base, the base being arranged substantially horizontally, namely along a front-rear direction and a left-right direction, a pressure element having at least a flat bottom face, for pressing downwards on a flexible bag under the influence of gravity. The tray includes guiding means for guiding the pressure element, as it goes downwards when the bag is emptying. The pressure element exhibits a gravity center and a geometric center, the gravity center being away from the geometric center.

Abstract: The invention relates to a 3D flexible pouch to be filled with a biopharmaceutical product, produced by assembling two wall elements and two gussets. At least one connection port can be provided for filling and/or emptying. A substantially parallelepipedic configuration is obtained in a filled state by unfolding the gussets and folding the flaps of the two wall elements. A welded seam is produced in a join portion formed at one end and cut out in a V shape, so as to directly connect the two wall elements. In a substantially flat configuration of the empty flexible pouch, the join portion projects axially outwards in relation to the gussets and is defined by two edges which are oblique in relation to a longitudinal axis of said pouch.

Abstract: Disclosed is a container for transporting a biopharmaceutical fluid, the container including a leak-tight wall having an outer portion and an inner portion, the outer portion and the inner portion delimiting between them an intermediate space that may be inflated under pressure with an inflation gas, the container being adapted to be alternately in: a non-inflated state in which the container is empty of pressurized inflation gas; an inflated state in which the wall of the container is inflated and delimits an internal cavity adapted to contain the biopharmaceutical fluid. The wall includes a peripheral lateral wall around the internal cavity, the peripheral lateral wall being completely rigid or semi-rigid when the container is in the inflated state so as to ensure a protection of the biopharmaceutical fluid.

Abstract: A 3-D flexible bag to be filled with a biopharmaceutical product is formed by assembling of two wall elements and two gussets. At least one connection port is provided, for filling and/or emptying. A substantially parallelepipedal configuration is obtained in a filled state thanks to the unfolding of the gussets combined with the folding of flaps of the two wall elements. A transverse weld, formed at one end, connects the two wall elements of the bag and extends continuously, keeping in a folded-flat state:—an elongate edge portion of one gusset;—an elongate edge portion of the other gusset. This transverse weld has a length corresponding to a determined dimension of the flexible bag in the parallelepipedal configuration.

Abstract: A 3-D flexible bag to be filled with a biopharmaceutical product is formed by assembling of two wall elements and two gussets. At least one connection port is provided, for filling and/or emptying. A substantially parallelepipedal configuration is obtained in a filled state thanks to the unfolding of the gussets combined with the folding of flaps of the two wall elements. A transverse weld, formed at one end, connects the two wall elements of the bag and extends continuously, keeping in a folded-flat state: an elongate edge portion of one gusset; an elongate edge portion of the other gusset. This transverse weld has a length corresponding to a determined dimension of the flexible bag in the parallelepipedal configuration.

Abstract: Disclosed is a fluid connection system including a sleeve, a pipe and a fluid connector, the fluid connector including at least one rigid body made from a sterilizable biocompatible material, and the pipe including a flexible connection portion made from a sterilizable biocompatible material that is at least partially elastomeric. The fluid connector and the flexible connection portion of the pipe are assembled to one another, with the flexible connection portion of the pipe surrounding the rigid body, and the sleeve being shrunk tightly, but with free movement, on the pipe.

Abstract: A fluid-connection device capable of and intended for connecting a flexible pipe to a flexible or rigid pipe or enclosure in a biopharmaceutical assembly such as to provide fluid communication between two fluid spaces, including a first connector in fluid communication with the first fluid space, a second connector in fluid communication with the second fluid space, the first connector and the second connector optionally being coupled together in a coupling position, the first connector including a tubular nozzle which can be inserted in one end of the pipe, a pipe clamp being arranged around the end of the tube in order to clamp the pipe onto the tubular nozzle of the first connector, the second connector including protection elements which, in the coupling position, are positioned radially at least partially opposite the pipe clamp, whereby the pipe clamp cannot come into direct contact with external elements.

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: A method for characterization of a calibrated defect of a film of a bag for biopharmaceutical fluid comprises a bag film sample (3) with a calibrated defect is installed in a test device (1), a leak test is applied to the bag film sample (3) provided with a calibrated defect, in the test device (1), by applying controlled fluid stresses to the bag film sample (3) provided with a calibrated defect, a result of the leak test is measured, and characteristics of the bag film sample (3) provided with a calibrated defect, characteristics of the controlled fluid stresses, and the result of the leak test are recorded in a database (16).

Abstract: A tight connection device for the aseptic transfer of a biopharmaceutical product includes: a stationary temporary clamping means keeping the container hermetically clamped against the chamber; a stationary unlocking means capable of switching the container from an initial locked position to an intermediate unlocked position; a stationary locking means; and an annular functional crown capable of being rotated to actuate the stationary unlocking means and the stationary locking means of the container. The stationary unlocking means and the stationary locking means are mechanically linked to the annular functional crown and arranged such that the rotation of the annular functional crown and the end locked position. The device further includes stationary immobilising/release means capable of allowing and preventing the annular functional crown to rotate.

Abstract: A protective container for a biopharmaceutical liquid bag comprises: a lower shell comprising a bottom and side walls; and an upper shell, said upper shell comprising a reinforcement capable of covering the bag and being insertable in the lower shell, so that the upper shell is retained in the upper part of the side walls of the lower shell by resting on support elements located in the lower shell.

Abstract: A bag for containing a biopharmaceutical product includes at least one fluid input/output port and a measurement opening remote from the fluid port. A probe holder port has a body with an axial through-bore and a peripheral collar with a second fastening zone and defining a fastening plane. A contact probe, extending in the axial through-bore, is assembled on the probe holder port, has an active measurement end portion in contact with the product, and has an end portion opposite the end portion. The probe holder port includes a transition portion between the body and the collar, which extends between a radially central end portion of the collar and a first axial end portion of the body. The first axial end portion is the axial end portion closest to the radially central end portion of the collar. The first axial end portion is disposed on the outer side relative to the fastening plane, and the active measurement end portion is axially disposed on the outer side relative to the fastening plane.

Abstract: A fluid connection set includes a connector (1), a flexible hose (2), and a crimping collar (5) for fixing the front end of the flexible hose to the connector, the connector including a connector body (10), a tubular nozzle (3), the tubular nozzle including retaining radial projections (31) of the hose as well as a clamping area (30) of the hose, and a temporary accommodation space (4), arranged between the tubular nozzle (3) and the connector body (10), for housing the collar during the operation of inserting the flexible tube, after which the collar is moved with respect to the clamping area and then crimped.

Abstract: The container includes a lower wall and an erect side wall limiting an upper opening of a housing for accommodating a flexible pouch containing a fluid; containment elements including a containment wall, the gap between its peripheral edge and the side wall being limited; the containment wall adapted to be applied against the pouch and held fixed in this position by holding elements arranged in the container and borne by the containment elements by a structural and functional combination, and being movable between an inactive retracted state and an active expanded state, in which a distal end part is either moved away from the side wall or applied there against without any chance of sliding; and adapted to be applied at any desired location of a zone of the side wall such that the containment wall can be applied and held against the pouch regardless of how full the latter is.

Abstract: Disclosed is a bag including: a first envelope having at least one fill and/or discharge orifice for a biopharmaceutical fluid and a fill and/or discharge tube associated in a fluidtight manner with the fill and/or discharge orifice, a second envelope within which the first envelope is located, and a spacer element. The first envelope, the second envelope, and the spacer element form a coherent whole, in particular during use of the bag, and the fill and/or discharge tube traverses the second envelope by a fluidtight connection, the fill and/or discharge inlet being located outside the second envelope.

Abstract: Disclosed is a fluid-connection device for connecting a first wall defining a first fluid space, in the form of a flexible pipe, to a second wall defining a second fluid space, in the form of a flexible or rigid disposable pipe or enclosure, in a biopharmaceutical assembly, including a first connector in fluid communication with the first space, the first connector including a tubular nozzle for receiving the pipe by insertion along the axis A, a pipe clamp arranged around the end of the pipe in order to clamp the pipe onto the tubular nozzle of the first connector, a protective cover forming a separate part, capable of being snap-fit in an operative position in which the cover is at least partially surrounding the first connector and the pipe clamp thereof, by way of which the pipe clamp cannot come into direct contact with external elements.

Abstract: A fluid connection device (10) for connecting two fluid conduits (11, 12), includes a female plug (1), a male plug (2), intended to be inserted into the female plug into a final coupling position, a movable primary locking device (3), having a locked position (30) in which it prevents the male and female plugs from being released from the final coupling position, and a movable secondary latch (4) having an active position (40) designed to prevent the primary locking device (3) from being moved out of the locked position of same, whereby the fluid connection device can establish a permanent connection of the first and second conduits.

Abstract: The invention relates to a protective housing for a biopharmaceutical liquid bag having a lower shell with a bottom and side walls, and an upper shell. The upper shell includes a housing for receiving the bag, and can be inserted into the lower shell, in such a way that the opening of the housing is adjacent to and facing the bottom of the lower shell, and in such a way that the upper shell is laterally held in place between the side walls of the lower shell.