US 11,898,938 B2Granted

Method and system, using a colorimetric indicator, for detecting a possible loss of integrity of a flexible bag for biopharmaceutical product

AssigneeSartorius Stedim Fmt SAS

InventorsMarc Hogreve, Martin Dahlberg

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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.

Claims15

Dependent claims

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.

11 more elements

A test method for controlling the integrity of a bag containing a biopharmaceutical fluid and having a first wall and a second wall forming two opposite walls on both sides of a longitudinal axis of the bag, the method using a receiving and controlling 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 bag being flexible and already filled with a biopharmaceutical fluid that is at east partly liquid in a single interior volume of the bag, the bag being fluid-tight in a non-altered state, and made of plastic material, the method comprising:

providing an integrity/non-integrity indicator device that comprises a pair of covering walls extending entirely outside the single interior volume;
determining a positive pressure set value for a positive pressure to be applied in the interior volume, the determination step based on a predetermined defeat size threshold reflecting a minimal defect size for a leak to be detected by the test method;
associating the control unit to a pressurizing unit or pressure source, so as to actuate and hold, by the receiving and controlling device, a restrained configuration of the bag, in which the bag is sandwiched between the two plates with a controlled pressurizing effect;
externally covering the first wall and the second wall, at least in the restrained configuration of the bag, by the respective covering walls of the pair of covering walls that are configured to extend between at least one outer surface of the bag and an inner face of one of the two plates;
and
detecting a biopharmaceutical fluid leak through the bag, using a continuous colorimetric detection layer integral with or included in the pair of covering walls, the continuous colorimetric detection layer allowing visual detection of a biopharmaceutical fluid leak through the bag by a color change.

3 more elements

Dependencies are inferred from the claim text.