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

Claim 12:
13. The test method as claimed in claim 11, comprising:
in a preparation phase:
determining, at the determination step, the positive pressure set value, which is correlated with liquid characteristics representative of the biopharmaceutical fluid, as a function of correlation data that are selected amongst correlation data representative of liquid properties of a plurality of liquids; and
generating a test time set value;
and in a test phase:
controlling the two plates and/or injection of a gaseous content in the interior volume of the bag, by the control unit, in order to rise pressure in the interior volume until positive pressure applied in the interior volume of the bag reaches said positive pressure set value, the bag being in said restrained configuration before reaching the positive pressure set value;
then maintaining same positive pressure; and
if no change of color is obtained on the integrity/non-integrity indicator device, after a time period at least equal to the test time set value, determining that the flexible bag is without any defect having size superior or equal to the size threshold and can be considered to have passed an integrity verification.