Otimização do processo de revestimento de comprimidos: aplicação da metodologia SMED e avaliação de perdas de suspensão

Abstract

The pharmaceutical industry, particularly the generic drug sector, operates in a highly competitive market in which operational efficiency and waste reduction are essential to maintaining competitiveness. In this context, this study evaluated the film coating process of a generic pharmaceutical product in two different dosage strengths through two sensitivity analisys: the influence of inlet airflow rate on coating suspension losses and the rationalization of the coating machine setup process using the Single-Minute Exchange of Die (SMED) methodology. In the first approach, a methodology was developed to estimate the amount of coating suspension applied and subsequently assess the influence of the inlet airflow rate on polymer coating suspension losses using data from 168 production batches manufactured during the first half of 2024 and 2025. A 10% reduction in the inlet airflow rate, from 5,000 to 4,500 m³/h, was accompanied by a trend toward increased average coating efficiency, from 66.54% to 68.74% for Dosage A and from 73.87% to 77.38% for Dosage B. In addition, a lower frequency of exhaust filter saturation was observed, suggesting reduced solid particle carryover. The projected potential savings reached up to 120.66 kg of solid coating materials per semester. However, statistical analysis did not reveal significant differences between the operating conditions (p > 0.05), indicating that the observed trend could not be statistically confirmed due to limitations in the available process data. In the second approach, time studies, the conversion of internal setup activities into external ones, and the simplification of the coating machine unloading process eliminated redundant operational steps. The implementation of the new standardized procedure resulted in substantial improvements, with preliminary data indicating a reduction in the average setup time from 147.8 to 90.0 minutes (39.1% reduction), increasing equipment availability for production and reducing process variability by 37.6%. It is concluded that the evaluation of inlet airflow rate provides a basis for future studies and potential improvements in the film coating process, while the application of the SMED methodology reduced time-related waste, increased the plant's productive capacity, and established the foundation for continuous performance monitoring through the OEE indicator.