Bacteriostatic filter system for antibody drugs production process, and method of operating same

A sterilization filter system for a process of manufacturing an antibody pharmaceutical, comprising:

• a preparation tank for preparing one selected from a medium and a buffer;
• a storage tank for storing the medium or buffer received from the preparation tank;
• a transfer pipeline configured to flow the medium or buffer stream discharged from the preparation tank into the storage tank;
• a process liquid storage tank for storing a process liquid in the intermediate stage of purification and culture processes;
• a process liquid transfer pipeline configured to flow the process liquid into the process liquid storage tank;
• a sterilization filter cartridge disposed on one or more selected from the transfer pipeline and the process liquid transfer pipeline;
• and
• a control unit,
• wherein the sterilization filter cartridge comprises, for a washing and filter test process including one or more selected from filter sterilization, filter wetting, flushing, filter integrity test, air ballasting and barrier integrity testing, a first pipeline entering the sterilization filter cartridge, and a second pipeline exiting the sterilization filter cartridge,
• wherein the first pipeline and the second pipeline are separate from the transfer pipeline and the process liquid transfer pipeline,
• wherein the first pipeline and the second pipeline are configured to supply and discharge a test fluid for performing the washing and filter test process, and
• wherein the washing and filter test process is performed while the sterilization filter cartridge remains disposed on the transfer pipeline or the process liquid transfer pipeline.