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 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 device (1; 2; 3; 4; 5) is provided for carrying out an integrity test on a sample of disposable components. The device has a medium chamber (10) with an inner chamber (11) that is bounded to the outside, for the purpose of receiving a culture medium. The device also has a sample holder (20) in which the sample (100) can be arranged in such a way that the sample (100) at least partially bounds the medium chamber (10) to the outside. The medium chamber (10) has a vent line (19) that is arranged on a side of the medium chamber (10) facing away from the sample holder (20).

Abstract: An ejector for jetting droplets of viscous media onto a substrate is disclosed. The ejector comprises a jetting nozzle having a nozzle space and a nozzle outlet, and an impacting device for impacting a volume of the viscous medium in the nozzle space such that droplets of viscous medium is jetted from the nozzle space through the nozzle outlet towards the substrate. The ejector also comprise a sensor arrangement arranged after the jetting nozzle in the jetting direction, wherein the sensor arrangement is adapted to detect a jetted droplet of viscous medium passing thereby.

Abstract: An ejector for jetting droplets of viscous media onto a substrate is disclosed. The ejector comprises a jetting nozzle having a nozzle space and a nozzle outlet, and an impacting device for impacting a volume of the viscous medium in the nozzle space such that droplets of viscous medium is jetted from the nozzle space through the nozzle outlet towards the substrate. The ejector also comprise a sensor arrangement arranged after the jetting nozzle in the jetting direction, wherein the sensor arrangement is adapted to detect a jetted droplet of viscous medium passing thereby.

Abstract: A mixing and thawing device (1) has a rocker drive (2) and a bag holder (3) for holding a bag (7). The bag holder (3) has a base part (8) and a lid part (9) that enclose a holding space (10) for the bag (7). A heating element (11) is arranged in the base part (8). Thus, the holding space (10) is designed as a heat-insulating closed chamber. Interconnected intermediate spaces (14, 15) are arranged between the bag (7) and the base part (8) and between the bag (7) and the lid part (9). One or more flow generators (16) are provided to generate a circulating fluid flow (17).

Abstract: A bioreactor container comprising has an at least locally flexible wall and at least one container opening. The wall of the bioreactor container has a fluid-tight inner sheet, and an at least locally fluid-permeable or structured outer sheet. A method for testing the integrity of the bioreactor container also is provided.

Abstract: A device (1; 2; 3; 4; 5) is provided for carrying out an integrity test on a sample of disposable components. The device has a medium chamber (10) with an inner chamber (11) that is bounded to the outside, for the purpose of receiving a culture medium. The device also has a sample holder (20) in which the sample (100) can be arranged in such a way that the sample (100) at least partially bounds the medium chamber (10) to the outside. The medium chamber (10) has a vent line (19) that is arranged on a side of the medium chamber (10) facing away from the sample holder (20).

Abstract: An ejector for jetting droplets of viscous media onto a substrate is disclosed. The ejector comprises a jetting nozzle having a nozzle space and a nozzle outlet, and an impacting device for impacting a volume of the viscous medium in the nozzle space such that droplets of viscous medium is jetted from the nozzle space through the nozzle outlet towards the substrate. The ejector also comprise a sensor arrangement arranged after the jetting nozzle in the jetting direction, wherein the sensor arrangement is adapted to detect a jetted droplet of viscous medium passing thereby.

Abstract: A bioreactor container comprising has an at least locally flexible wall and at least one container opening. The wall of the bioreactor container has a fluid-tight inner sheet, and an at least locally fluid-permeable or structured outer sheet. A method for testing the integrity of the bioreactor container also is provided.

Abstract: The present invention relates to a printer being capable of parsing, understanding and evaluating multiple target package files that include printing resources not only for a single printer or for a single type of printer, but for multiple printers or multiple types of printers. For this purpose, the package file is augmented with platform information that is separately associated with each printer resource included in the package file. Thereby, the parser of the printer can discriminate whether or not a particular resource is applicable to itself. Consequently, only the resources such as firmware are installed that are valid and applicable to the printer. In the same manner, the resources can also be augmented with individual printer information, so as to indicate different resources to be installed on different printers, even if they are of the same type.

Abstract: A mixing and thawing device (1) has a rocker drive (2) and a bag holder (3) for holding a bag (7). The bag holder (3) has a base part (8) and a lid part (9) that enclose a holding space (10) for the bag (7). A heating element (11) is arranged in the base part (8). Thus, the holding space (10) is designed as a heat-insulating closed chamber. Interconnected intermediate spaces (14, 15) are arranged between the bag (7) and the base part (8) and between the bag (7) and the lid part (9). One or more flow generators (16) are provided to generate a circulating fluid flow (17).

Abstract: A method for testing the integrity of a bioreactor container includes providing a bioreactor container having a fluid-tight, at least locally flexible wall and having at least one container opening and providing a test apparatus having a bioreactor container compartment and a fluid-permeable and/or structured reception sheet arranged replaceably on the bioreactor container compartment. The method continues by arranging the bioreactor container in the bioreactor container compartment so that the bioreactor container wall contacts the reception sheet in the bioreactor container compartment, connecting the container opening of the bioreactor container to a fluid source filling the bioreactor container with a fluid from the fluid source to generate a predetermined positive pressure P1 in the bioreactor container at a first time T1 and determining whether the bioreactor 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.

Abstract: A bioreactor container comprising has an at least locally flexible wall and at least one container opening. The wall of the bioreactor container has a fluid-tight inner sheet, and an at least locally fluid-permeable or structured outer sheet. A method for testing the integrity of the bioreactor container also is provided.

Abstract: An ejector for jetting droplets of viscous media onto a substrate is disclosed. The ejector comprises a jetting nozzle having a nozzle space and a nozzle outlet, and an impacting device for impacting a volume of the viscous medium in the nozzle space such that droplets of viscous medium is jetted from the nozzle space through the nozzle outlet towards the substrate. The ejector also comprise a sensor arrangement arranged after the jetting nozzle in the jetting direction, wherein the sensor arrangement is adapted to detect a jetted droplet of viscous medium passing thereby.

Abstract: A cleaning process is provided for a test apparatus that has a switch, external connections and internal volumes that can come into contact with a fluid from a filter to be tested or a container to be tested. The cleaning process includes selecting one or more internal volumes to be cleaned, cleaning the selected internal volumes with a cleaning fluid by a corresponding switching of the switch, at least partially draining the cleaning fluid left in the selected internal volumes after cleaning, and flushing the selected internal volumes with a flushing fluid different from the cleaning fluid. Also provided are a computer program product for performing the cleaning process, a cleaning apparatus, and a test apparatus for testing filters and containers.

Abstract: Disclosed is a device that changes a bit in a string of bits representing a character in a sting of characters defining a reserved word associated with a record containing pieces of information in response to a request for changing a piece of information in the record, and a printer configured to exclude from printing a record associated with a reserved word that has been changed by the device.

Abstract: A pouch (2) includes: a first, inner, envelope (1) which is closed, delimiting a first space (6) forming a pouch stricto sensu (1) intended for receiving a biopharmaceutical product or device; a second, outer, envelope (8) which is closed, delimiting a second space (9) in which is located the first envelope/pouch stricto sensu (1); a spacer element (11); at least one tracer gas located in the first space (6) or in the intermediate space (14) at a partial pressure different from that of the intermediate space or of the first space; and at least one colorimetric detection layer (12), responding to the concentration of tracer gas which reaches it by changing from a first color to a second color, and being an integral part of a wall (3, 4) of the first envelope/defined pouch (1) and/or of a wall (13) of the second envelope and/or of the spacer element.

Abstract: A cleaning process is provided for a test apparatus that has a switch, external connections and internal volumes that can come into contact with a fluid from a filter to be tested or a container to be tested. The cleaning process includes selecting one or more internal volumes to be cleaned, cleaning the selected internal volumes with a cleaning fluid by a corresponding switching of the switch, at least partially draining the cleaning fluid left in the selected internal volumes after cleaning, and flushing the selected internal volumes with a flushing fluid different from the cleaning fluid. Also provided are a computer program product for performing the cleaning process, a cleaning apparatus, and a test apparatus for testing filters and containers.