Resumen

RODRIGUEZ-ZUNIGA, Wendy et al. Application of statistical control of process in the manufacture of topical OLEOZON^®. Rev. CENIC Cienc. Quím. [online]. 2022, vol.53, n.2, pp. 87-101.  Epub 15-Jul-2022. ISSN 2221-2442.

Topical OLEOZON® is a germicidal medicine whose proven effectiveness determined the scaling up of production and the transfer of technology to the current OLEOZON® Plant, with satisfactory design conditions for the expansion of the production process. The objective of the work was to apply statistical process control to the production process of topical OLEOZON®. The parameters of acidity index, peroxide, aldehyde content and viscosity of industrial batches produced between 2017 and 2019 were considered. Control charts were obtained, the process capacity indexes were determined and calculated, by the Bowker method, new limits for peroxide value and viscosity. Results and Discussion: it was shown that all batches complied with the limits of acidity index, peroxide, aldehyde content and viscosity and that the OLEOZON® production process was in a state of control, from the statistical point of view. The production process is out of control for the peroxide and viscosity index, being adequate for the aldehyde content and the acidity index, according to the Cp and Cpk values. New limits are proposed for the peroxide and viscosity index, estimated experimentally. The reproducibility of the process is demonstrated, fulfilling the quality specifications in the current production conditions. It will be necessary to evaluate the behavior of these parameters in industrial batches and monitor them, which will be favorable to analyze the stability of the finished product.

Palabras clave : environmental impact; environmental management; fuel analysis.