Validación del Método de Limpieza de la Envasadora de Cremas Comadis en la Empresa Ginsberg S.A. Mediante el Método del Toc Fusión

Abstract

The objective of this research is to validate the cleaning method used for washing the COMADIS cream packaging machine. The methodology used was based on establishing the 6 critical points to be sampled following the "Worst case" criterion, the cleaning was evaluated using visual and organoleptic inspection as first criteria, Swabbing was used as sampling technique and Total Organic Carbon Determination as analysis method, among the materials used were swabs with low level of carbon, water solvent with low conductivity and low level of carbon, vials for TOC use, and TOC FUSION Carbon Determination Equipment. The results were obtained as a general average for the 1st sampling 0.9615 ppmC, for the 2nd sampling 1.2485 ppmC and the 3rd sampling 0.5675 ppmC, a standard deviation of 0.6864, all data being within the acceptable limit of less than 10 ppm C. This shows that the method of analysis by Total Organic Carbon (TOC) is a valid and reliable method for the quantitative determination of any pollutant residue. After having fulfilled all the evaluation criteria, the cleaning process of the COMADIS cream packaging machine of the pharmaceutical company Ginsberg Ecuador is declared VALID. It is recommended that prior to the start of the validation, the personnel should be trained in the handling of the equipment and also verify that all the material used is clean and free of carbon to ensure reliable and reproducible results.