Abstract: A film for manufacturing a pouch includes a contact layer including (A) a copolymer of ethylene and ?-olefin having a density in the range of 0.870 g/cm3 to 0.910 g/cm3, alone or in mixture with (B) a polyolefin having a density in the range of 0.910 g/cm3 to 0.940 g/cm3, the contact layer including less than 0.10 wt %, preferably less than 0.07 wt %, of additives able to release a degradation compound further to gamma irradiation in the range of 25 kGy-50 kGy that can slow down or delay cellular growth. The process for manufacturing such a film, as well as the single-use pouch manufactured from that film are also described.

Abstract: The sealing arrangement includes a connecting device and one or more housing parts of a housing unit for enclosing of a component, typically an attachment component forming a head of the connecting device. The gas permeable end formed in such component can be isolated, so that the sealing arrangement is adapted for use in detecting a detectable gas in a hermetically sealed detection chamber. Thanks to a sealing structure configured at a passageway for the fastening of the connecting device, a housing unit is obtained with a tight radial contact around an intermediate portion of the connecting device. The device is fitted with a flexible hose end, preferably at a barbed nozzle forming the end at the opposite from the gas permeable end. With such arrangement, the hose mounting can be tested for its integrity.

Abstract: Integrity of a flexible bag is verified by a testing system, using helium to detect existence of a possible hole. The 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 and after pre-pressurizing the bag with nitrogen, a test is performed in a vacuum suction mode for a detection area outside the bag in the enclosure. Before starting the test phase, the bag is additionally filled with an amount of helium. A detection 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. A small amount of nitrogen is sufficient to decrease leak rate mean value, so that uncertainty regarding integrity of some bags decreases.

Abstract: The sealing arrangement includes a connecting device and one or more housing parts of a housing unit for enclosing of a component, typically an attachment component forming a head of the connecting device. The gas permeable end formed in such component can be isolated, so that the sealing arrangement is adapted for use in detecting a detectable gas in a hermetically sealed detection chamber. Thanks to a sealing structure configured at a passageway for the fastening of the connecting device, a housing unit is obtained with a tight radial contact around an intermediate portion of the connecting device. The device is fitted with a flexible hose end, preferably at a barbed nozzle forming the end at the opposite from the gas permeable end. With such arrangement, the hose mounting can be tested for its integrity.

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 recess 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 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: A container for transporting and/or processing a biopharmaceutical fluid, the container comprising a wall, the wall comprising a shape memory material being adapted to change shape when induced by an external stimulus, so that the container can be alternately in a collapsed state and in an unfolded state, the wall of the container in the unfolded state delimiting an internal cavity adapted to contain the biopharmaceutical fluid.

Abstract: Integrity of a flexible bag already filled with a biopharmaceutical fluid is verified by a receiving and controlling device. The first wall and a second wall, forming two opposite walls on both sides of a longitudinal axis of the bag, are in contact with the fluid and with two parallel restraining plates of the device, while test pressure is controlled. Additionally, an integrity/non-integrity indicator device that comprises a pair of covering walls is provided to be interposed between the bag walls and the restraining plates. A leak through the bag walls can be detected by a color change of at least one continuous colorimetric detection layer, integral with or included in the pair of covering walls. Such continuous colorimetric detection layer is included in a permeable or impregnable layer.

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: 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: The invention relates to a biopharmaceutical container comprising: a connector to be secured to a chamber connector; a bag serving as a receptacle, one part of which is secured to the connector; and a flexible tube tucked inside the bag, which tube can extend out from the bag through the connector. The biopharmaceutical container, wherein: the tube forms part of the bag, the tube is a neck of reduced size extending from the body of the bag, and the aforementioned part of the bag that is secured to the connector is a fold in the wall of the bag, said wall of the bag forming the body of the bag on one side of the fold and the tube on the other side of the fold.

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 pouch for transporting and/or processing a biopharmaceutical fluid, the pouch comprising a flexible wall, the flexible wall comprising a shape memory material being adapted to change shape when induced by an external stimulus, so that the pouch can be alternately in a collapsed state and in an unfolded state, the wall of the pouch in the unfolded state delimiting a closed internal cavity adapted to contain the biopharmaceutical fluid.

Abstract: A sterile filling unit, of a basic container with contents that can be distributed in a fluid form and that is originally located in a source container in a sterile manner, includes a sterile chamber with at least one sterile entry port and/or outlet; a sterile fluid transfer and filling line with an intake and an outlet, such that for a filling stage the line passes through the wall of the sterile chamber in a sterile manner, with the intake located outside of the sterile chamber in sterile fluid communication with the source container, with the filling element at the outlet located inside the sterile chamber and positioned to be operating; and a unit that can introduce the disposable internal elements that, in a stage prior to the filling stage, were located outside of the sterile chamber, into the interior of the sterile chamber in a sterile manner.

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 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: The stirring device, in particular for a fluid-mixing bioreactor, comprises a drive shaft including a rod, an agitating element and a sleeve of tubular shape. The sleeve forms a coupling sleeve receiving the shaft therethrough and is directly rotationally coupled to the rod. The agitating element, which has a hub with an annular side wall delimiting an inner space and an impeller assembly comprising blades, is indirectly rotationally coupled to the rod via the sleeve that is engaged in the inner space. One of an inner surface of the wall and an outer surface of the sleeve is a guiding surface with progressively reduced cross section. Axial movement between the hub and the sleeve is prevented in a locked configuration of a sleeve fastening arrangement. Hub-sleeve contact areas can be axially distributed.

Abstract: Integrity of a flexible bag is verified by a testing system, using helium to detect existence of a possible hole. The 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 and after pre-pressurizing the bag with nitrogen, a test is performed in a vacuum suction mode for a detection area outside the bag in the enclosure. Before starting the test phase, the bag is additionally filled with an amount of helium. A detection 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. A small amount of nitrogen is sufficient to decrease leak rate mean value, so that uncertainty regarding integrity of some bags decreases.

Abstract: Integrity of a flexible bag already filled with a biopharmaceutical fluid is verified by a receiving and controlling device. The first wall and a second wall, forming two opposite walls on both sides of a longitudinal axis of the bag, are in contact with the fluid and with two parallel restraining plates of the device, while test pressure is controlled. Additionally, an integrity/non-integrity indicator device that comprises a pair of covering walls is provided to be interposed between the bag walls and the restraining plates. A leak through the bag walls can be detected by a color change of at least one continuous colorimetric detection layer, integral with or included in the pair of covering walls. Such continuous colorimetric detection layer is included in a permeable or impregnable layer.

Abstract: A stopper configured to hermetically close a nozzle intended to contain a biopharmaceutical fluid with a cylindrical bore of diameter (D1) and a flange having a groove. The stopper has a body with a front part with a cylindrical outer wall about an axis A, with a diameter at rest greater than (D1), intended to be received under stress in the cylindrical bore of the nozzle, a stop disc extending a rear part of the body radially towards the outside and extending in a plane transverse to the axis. The body and the stop disc are rotationally symmetric about the axis A. The stop disc includes an annular bulge, interposed radially between a first annular shoulder and a second annular shoulder, the bulge extending forward from the stop disc and being intended to be received in the groove in the flange of the nozzle.