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 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 Pi in the bioreactor container at a first time Ti 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: There is a bag (1) that has at least one lateral gusset (4) and at least one port (8), a source (10) of pressurized gas, elements (11) for measuring the pressure of the gas; —there are two restraining plates and spacer strips. The bag is placed flat between the two restraining plates (2a, 2b). At least one spacer strip (15a, 15b) is inserted between the two small walls of each gusset in order to prevent these walls from resting on one another. The port is connected to the gas source and the pressure measuring elements. The gas is sent under pressure into the bag, the expansion of the bag being limited by the restraining plates; then, the pressure drop in the bag is compared to a predefined threshold.

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.

Abstract: A mechanical interface for transferring a reciprocating movement from one element to another element releasably mountable thereto. The interface comprises at least three interface points, at least two of which being laterally spaced apart, and at least two of which being longitudinally spaced apart. A motion generator provides a reciprocating movement, which is transferred from the one element to the other element via at least one of the interface points. The interface point(s) transferring the movement includes contact portions having curved contact surfaces, such that the curved contact surfaces are in abutment with opposing contact surfaces of the interface point when the elements are mounted, thereby transferring the reciprocating movement.

Abstract: A data updating device with which the amount of time required to update data in a flash memory can be shortened and reductions in the life of the flash memory can be suppressed. The data updating device modifies a description content of record unit data that are described in a markup language and stored in a flash memory, and includes: a reserved word modifier for modifying a bit of a binary representation of character strings constituting the reserved words from 1 to 0 when a request is issued to update a description sandwiched between reserved words and corresponding to a record; and a data adder for additionally recording, in the flash memory, the record corresponding to the description sandwiched between the reserved words and including the part modified in accordance with the request.

Abstract: There is a bag (1) that has at least one lateral gusset (4) and at least one port (8), a source (10) of pressurized gas, elements (11) for measuring the pressure of the gas; —there are two restraining plates and spacer strips. The bag is placed flat between the two restraining plates (2a, 2b). At least one spacer strip (15a, 15b) is inserted between the two small walls of each gusset in order to prevent these walls from resting on one another. The port is connected to the gas source and the pressure measuring elements. The gas is sent under pressure into the bag, the expansion of the bag being limited by the restraining plates; then, the pressure drop in the bag is compared to a predefined threshold.

Abstract: A mechanical interface for transferring a reciprocating movement from one element to another element releasably mountable thereto. The interface comprises at least three interface points, at least two of which being laterally spaced apart, and at least two of which being longitudinally spaced apart. Motion means provides a reciprocating movement, which is transferred from the one element to the other element via at least one of the interface points. The interface point(s) transferring the movement comprises contact portions having curved contact surfaces, such that the curved contact surfaces are in abutment with opposing contact surfaces of the interface point when the elements are mounted, thereby transferring the reciprocating movement.