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 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 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 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: 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: 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: 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: 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: 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.

Abstract: A support device (20), mounted on an upper edge of a container (3), includes lifting elements that define a support surface (22) which extends transversely outwards from an inner edge (55). The upper end (2b) of a flexible pouch for biopharmaceutical product can rest on this support surface, the rest of the 3D-type pouch extending into the container. The slot (23) which separates the support surface into two portions defines a guide path for a flexible supply line (9a, 9b) for the pouch (2) that is connected at its bottom to the end (2b). A convex surface is formed at the rear end of the slot and above the edge of the container, so as to guide and facilitate the passage of the line (9a) into the housing, when the filling state is sufficiently advanced. The causes of poor deployment of the pouch are thus minimized, without human intervention.

Abstract: Disclosed is a device for transporting a biopharmaceutical fluid, including an inner bag forming an inner chamber adapted and intended for receiving a biopharmaceutical fluid, an outer container including an outer receptacle, the outer receptacle including a wall forming an outer chamber, an expandable protective element arranged at least partially between the outer receptacle and the inner bag and adapted to receive the inner bag, the expandable protective element being adapted to expand in volume to an expanded state so as to be interposed between the outer receptacle and the inner bag, the expandable protective element in the expanded state surrounding the inner bag and filling the space between the wall of the outer receptacle and the inner bag.

Abstract: Disclosed is a fluid-connection device for connecting a first wall defining a first fluid space, for example a flexible pipe, to a second wall defining a second fluid space, in the form of a flexible pipe or enclosure, including a first male connector, the first connector including a seal and a snap-fitting collar, the seal extending radially prior to coupling from the axis until a first radial distance R1, a second female connector capable of receiving the first connector, the second connector including at least one flexible tab with one end against which the locking collar abuts in coupling position, in order to prevent retraction from the coupling position, the flexible tab being defined relative to the axis between a second radial distance R2 and a third radial distance R3, which is greater than the second radial distance R2, wherein R2>R1.

Abstract: Female connector for accepting a male connector having a retaining external annular rim, a slot including two parallel lateral grooves and the slot opening at least at one of its ends forming a mouth of the housing, the female connector including a locking slide distinct from the body, movable between a locking position and an unlocking position, the locking slide including a locking plate and an actuating knob formed integrally with the plate, with a retaining portion belonging to the locking plate to come into abutment against the retaining outer annular rim, the locking slide including at least one flexible tab formed integrally, returning the slide toward the first position, the flexible tab pressing on each side of the mouth in the axial direction X so that the return force is balanced about X and creates no torque that could have a tendency to cause the locking plate to jam.

Abstract: A method for assembling a mixer-container intended for receiving a biopharmaceutical fluid includes providing a container with a mixing device including at least one shaft having an adjustable length, and at least one first bearing attached to a wall of the container, the shaft extending at least into the inner space from the first bearing; a rigid outer device that compresses the container; and a drive motor located outside the container, the first bearing of the container is placed so as to be spaced apart from the motor, and the length of the shaft is adjusted along the main axis by arranging the shaft opposite the motor to enable the motor to rotate the shaft.