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

A method of filtering a large volume of a medium in a pre-sterilizable, at least partially automated single-use filtration device, comprising the following process steps:

• a) filling the at least partially automated single-use filtration device with the medium using low flow, the at least partially automated single-use filtration device including 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 relevant to a filtration process and regulating means for adjusting the specific process parameters, wherein the sensors and the regulating means are connected to an external monitoring and control system which is adapted for evaluating and processing sensor data from the sensors and for controlling the regulating means based on one or more control algorithms;
• b) venting the at least partially automated single-use filtration device through the venting line;
• c) closing the venting line;
• d) rinsing the at least partially automated single-use filtration device including the filter elements;
• e) filtering the medium using the filter elements;
• f) re-rinsing the at least partially automated single-use filtration device with high flow;
• and
• g) closing the main line;
• wherein the process steps f) and g) are optional,
• wherein at least process steps d) and e) are controlled by the external monitoring and control system for evaluating and processing the sensor data from the sensors and for controlling the regulating means based on the one or more control algorithms,
• wherein the sensors include a flow sensor provided at the unfiltrate inlet, an outlet liquid detector provided at the filtrate outlet, and an outlet pressure sensor provided at the filtrate outlet, and
• wherein the regulating means include an inlet regulating valve provided at the unfiltrate inlet and an outlet regulating valve provided at the filtrate outlet.