Virus Filtration: Minimizing hold-up volume of EPO intermediates product by optimizing assembly design

Abstract

Kalbio Global Medika (KGM) are drug manufacturing companies who serve society by providing high quality and qualified products, such as Hemapo and Efesa. The production goes through several processes of purification to ensure the safety and quality of the drug. The author was placed in KGM downstream team and work on one of purification process, virus filtration. Virus filtration process aim to remove contaminant from the drug by transferring the liquid past the virus filter with certain arrangement. However, the some arrangement made for virus filter are insufficient due to high hold-up volume in the assembly. In order to maximize the performance of virus filtration, hold-up volume study was conducted to identify the most efficient arrangement with the lowest hold-up volume. The hold-up volume area measured are pressure vessel, post-filter arrangement, and tubing volume. Hence, the other type of assembly with horizontal virus filter placement is not applicable since it produces higher hold-up volume present in the virus filter. Therefore, comparison between arrangement 1 (figure 2) and arrangement 4 (figure 4) was conducted with arrangement 4 as expected as the most efficient arrangement. However, the main problem during the experiment is that a lot of bubbles were found in the pressure vessel. The air bubble created from collision between protein liquids traps the bulk protein by adsorption towards the bubble surfaces. During the experiment, several improvements were found to solve the bubble formation problem and result in low hold-up volume. The project was successfully done and brought high profit to the company.