Test method and apparatus for bioreactor containers having reception sheet clamped between bioreactor container and bioreactor container compartment

摘要

A method for testing the integrity of a bioreactor container includes providing a bioreactor container having a fluid-tight, at least locally flexible wall and having at least one container opening and providing a test apparatus having a bioreactor container compartment and a fluid-permeable and/or structured reception sheet arranged replaceably on the bioreactor container compartment. The method continues by arranging the bioreactor container in the bioreactor container compartment so that the bioreactor container wall contacts the reception sheet in the bioreactor container compartment, connecting the container opening of the bioreactor container to a fluid source filling the bioreactor container with a fluid from the fluid source to generate a predetermined positive pressure P1 in the bioreactor container at a first time T1 and determining whether the bioreactor container is sufficiently leaktight.

主权项

1. A method for testing the integrity of a bioreactor container (1), having the steps of:
providing a bioreactor container (1) having a fluid-tight, at least locally flexible wall (3) and having at least one container opening (9a, 9b, 9c, 9d); providing a test apparatus having a bioreactor container compartment (25) and a fluid-permeable and/or structured reception sheet (7) that is arranged replaceably on the bioreactor container compartment (25); arranging the bioreactor container (1) at least partially in the bioreactor container compartment (25), the bioreactor container (1) coming in contact by its wall (3) at least locally with the reception sheet (7) in the bioreactor container compartment (25); connecting the at least one container opening (9a, 9b, 9c, 9d) of the bioreactor container to a fluid source (27); filling the bioreactor container (1) with a fluid from the fluid source (27) and thereby clamping the reception sheet (7) between the bioreactor container (1) and the bioreactor container compartment (25) and generating a predetermined positive pressure P1 in the bioreactor container (1) at a first time T1; and determining whether the bioreactor container (1) is sufficiently leaktight.