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: 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 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).