Abstract

System and process reliability is a key element in the Operational Reliability analysis. The objective of this research was to analyze the reliability of the vial filling system in a biopharmaceutical industry based on a new mathematical model. The published models to evaluate process reliability do not take into account the integration of the elements: logistics, quality and organization, this inadequacy in the new model are overcome. The main methods applied were mathematical modeling for the assessment of reliability and its components and the statistic for obtaining data. The research was carried out between the years 2017 and 2019. The main result is that the variable Use of the Installation had the greatest impact on the results, being the proposal to implement better use of the installed capacity. Results demonstrate that capacity utilization had the most important impact on the outcomes. The findings support the proposal to improve the capacity utilization of the installed facilities.