Modelamiento espacial de la temperatura y humedad como parámetros de producción en el control de almacenaje del área de bodega en una industria farmacéutica para la identificación de puntos críticos

Abstract

Spatial modeling of temperature and relative humidity is the technique used to ensure effective control of these parameters. Compliance with Good Manufacturing Practices (GMP) for medicines, transportation, storage, and their subsequent distribution, prevents their physical, chemical and biological degradation. In this sense, in the present work, the investigation of the behavior of temperature and relative humidity in a warehouse of a company in the city of Quito was carried out. The variations of these magnitudes over time were mapped and monitored in two sectors where pharmaceutical products are stored. For this, duly calibrated integrated sensors from the firm Embedded Data Systems were used, distributed throughout the area of the enclosure and in three vertical positions. The foregoing made it possible to locate critical points of abnormal variations of the parameters, where the values established by national and international standards are exceeded. The final result was reflected in graphs of the average temperature, 2D maps covering the entire area of both sectors and for each of the vertical sections. Likewise, the graphs for each sensor were exposed. The forecast of both temperature and relative humidity was based on the application of the ARIMA model (Autoregressive Integrated Moving Average model of order p, d, q), which allowed a satisfactory adjustment of the experimental data with the simulated curve, prior to prediction. As a summary, the conclusions and recommendations are provided and a contingency plan that concentrates all the incidents observed during the study and the measures for their remediation was also proposed.