Method for filtering a large volume of a medium with a pre-sterilisable, at least semi-automated one-way filtration device

Abstract

A method of filtering a large volume of a medium using a pre-sterilizable, at least partially automated single-use filtration device which includes an unfiltrate inlet, a filtrate outlet, a main line running between the unfiltrate inlet and the filtrate outlet, filter elements arranged in the main line, a venting line and sensors for detecting specific process parameters and regulating means for adjusting specific process parameters, wherein the sensors and regulating means are connected to an external monitoring and control system which is adapted for evaluating and processing sensor data and for piloting the regulating means based on one or more control algorithms, comprises the following process steps: a) filling the single-use filtration device with medium with low flow; b) venting the single-use filtration device through the venting line; c) closing the venting line; d) rinsing the single-use filtration device, in particular the filter elements; e) filtering the medium by means of the filter elements; f) re-rinsing with high flow; and g) closing the main line; wherein the process steps f) and g) are optional.