A modification of methodology 6 Sigma for redesign evaluation of a rotary filter for a biological product

Abstract

The main subject of this research was to obtain an analysis methodology for a rotary filter redesign, in order to improve process reliability as an integral element of operational reliability. The method proposed by 6 Sigma methodology was adapted for the analysis of process reliability and mathematical models were implemented for the reliability and maintainability calculations. The methodology was implemented in a monoclonal product filtration process in a biopharmaceutical enterprise, obtaining that the problems that affected the operating parameters were associated with the reliability of the processes. Three alternatives were evaluated to verify the effectiveness of the redesign, describing in this order the current situation, the proposed changes, and the accepted proposal, as well as the behavior over time of the redesign modifications made. The data used was extracted from the SCADA software with an operating license, during the 2018-2019 period, which controls the operation of the rotary filter and the behavior of the variables analyzed. The application of this methodology allowed reducing the cleaning cycles of the rotary filter, selecting the appropriate mesh for the filtration process, increasing efficiency to 95% and proposing the rotation speed between 300-500 rpm to lengthen the clogging time.