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 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: 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: 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: 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: 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 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 method, a device and a use of the device are provided for carrying out an integrity test on a test container (1) that has at least one flexible casing material. The method includes the steps of: filling a test fluid into the test container (1); and detecting the presence of test fluid directly outside the test container (1). The test fluid is designed in such a way that the permeation rate of test fluid through undamaged casing material of the test container (1) is not greater than 1·10?6 mbar·m/(s·bar).

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: 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 method for conducting an integrity test on a flexible test container (1) includes arranging the test container (1) in an examination container (5) that is sealable in a fluid-tight manner, providing negative pressure in the interior of the sealed examination container (5), filling examination fluid into the test container (1) arranged in the examination container (5), detecting examination fluid present in the interior of the examination container (5), and providing negative pressure in the test container (1) arranged in the examination container (5) prior to filling the examination fluid. Prior to filling the examination fluid, the negative pressure in the test container (1) is lower than the negative pressure in the interior of the examination container (5), and the pressure difference between the negative pressure in the test container (1) and the negative pressure in the interior of the sealed examination container (5) is more than 0 mbar and a maximum of 100 mbar.

Abstract: A method, a device and a use of the device are provided for carrying out an integrity test on a test container (1) that has at least one flexible casing material. The method includes the steps of: filling a test fluid into the test container (1); and detecting the presence of test fluid directly outside the test container (1). The test fluid is designed in such a way that the permeation rate of test fluid through undamaged casing material of the test container (1) is not greater than 1·10?6 mbar·m/(s·bar).

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 method for conducting an integrity test on a flexible test container (1) includes arranging the test container (1) in an examination container (5) that is sealable in a fluid-tight manner, providing negative pressure in the interior of the sealed examination container (5), filling examination fluid into the test container (1) arranged in the examination container (5), detecting examination fluid present in the interior of the examination container (5), and providing negative pressure in the test container (1) arranged in the examination container (5) prior to filling examination fluid being. The negative pressure in the test container (1) is lower than the negative pressure in the interior of the examination container (5), and the pressure difference between the negative pressure in the test container (1) and the negative pressure in the interior of the sealed examination container (5) is more than 0 mbar and a maximum of 100 mbar.

Abstract: A method for testing a flexible container includes arranging the flexible container on a winding core that can be rotated about a winding axis W and forms an internal support. The method continues by winding the flexible container around the winding axis W arranging an external support around the wound container and connecting at least one container opening of the container to a fluid source. The method proceeds by filling the container with a fluid from the fluid source to generate a predetermined positive pressure P1 in the flexible container at a first time T1 and determining whether the container is sufficiently leaktight.

Abstract: A method for testing a flexible container includes arranging the flexible container on a winding core that can be rotated about a winding axis W and forms an internal support. The method continues by winding the flexible container around the winding axis W arranging an external support around the wound container and connecting at least one container opening of the container to a fluid source. The method proceeds by filling the container with a fluid from the fluid source to generate a predetermined positive pressure P1 in the flexible container at a first time T1 and determining whether the container is sufficiently leaktight.