Patent ID: 11898938
Assignee: SARTORIUS STEDIM FMT SAS
Field: Measurement (Instruments)
Classification: CPC G | IPC G

Claim 0:
1. A bag testing assembly, comprising:
a bag containing a biopharmaceutical fluid that is at least partly liquid and having a first wall and a second wall forming two opposite walls on both sides of a longitudinal axis of the bag, the bag being flexible and having a single interior volume delimited by the two opposite walls, the biopharmaceutical fluid being contained in the single interior volume, the bag being fluid-tight in a non-altered state, and of plastic material;
a receiving and controlling device for receiving and controlling the bag, the device comprising at least one pressure sensor, a control unit, two plates having facing surfaces between which is interposed the bag to be controlled, the control unit comprising or being associated to a pressurizing unit or pressure source, so that the control unit can actuate and hold a restrained configuration of the bag, in which the bag is sandwiched between the two plates with a controlled pressurizing effect;
an integrity/non-integrity indicator device comprising:
a pair of covering walls extending entirely outside the interior volume and externally covering the first wall and the second wall, in the restrained configuration of the bag, each covering wall of the pair of covering walls being configured to extend between at least one outer surface of the bag and an inner face of one of the two plates; and

a continuous colorimetric detection layer, integral with or included in the pair of covering walls, allowing visual detection of a biopharmaceutical fluid leak through the bag by a color change; and
wherein the control unit is linked to at least one pressure sensor and comprises the pressure source for controlling a positive pressure to be applied in the interior volume, the pressure source being controlled by the control unit that is configured to:
generate a set value of a positive pressure, correlated with liquid characteristics representative of the biopharmaceutical fluid; and
command a pressure adjustment device of the pressure source based on the set value, whereby the pressurizing effect is controlled; and

a human machine interface included in or connected to the control unit, the control unit being configured to:
receive at least one setting parameter representative of a test accuracy and/or of a liquid present in the biopharmaceutical fluid, the at least one setting parameter being input via the human machine interface.