摘要 |
One aspect relates to a method for testing the integrity of a bioreactor container, having the steps of: - providing a bioreactor container having a fluid-tight wall which is flexible at least in regions and having at least one container opening; - providing a test apparatus having a bioreactor container receptacle and a fluid-permeable and/or structured absorption layer which is replaceably arranged on the bioreactor container receptacle; - arranging the bioreactor container in the bioreactor container receptacle, wherein the wall of the bioreactor container makes contact, at least in regions, with the absorption layer in the bioreactor container receptacle; - connecting the at least one container opening of the bioreactor container to a fluid source; - filling the bioreactor container with a fluid from the fluid source in order to generate a predetermined overpressure P in the bioreactor container at a first time T; - discriminating whether the bioreactor container is sufficiently leakproof, and to a corresponding apparatus and a use. |
申请人 |
SARTORIUS STEDIM BIOTECH GMBH;DAHLBERG, MARTIN;GAY, ISABELLE;BOETTCHER, LARS;OBERMANN, STEFAN;SANDROCK, RAINER |
发明人 |
DAHLBERG, MARTIN;GAY, ISABELLE;BOETTCHER, LARS;OBERMANN, STEFAN;SANDROCK, RAINER |