Evaluación físico-química y microbiológica en el desempeño de las áreas de producción de productos naturales y cosméticos en el laboratorio NEOFÁRMACO del Ecuador Cía. Ltda.

Abstract

In this study, was evaluated the physicochemical and microbiological performance of the production areas of cosmetics and natural products at Laboratorio Neofármaco del Ecuador, located in the city of Ambato. Pharmaceutical laboratories require legal authorization to produce medicines in general, and they must comply with certain regulations such as good manufacturing practices (GMP) established by national and international health regulatory authorities, ensuring production processes and product quality. For performance evaluation, physicochemical tests were carried out to determine the temperature and humidity, the concentration of particles in the air with their respective process capability indexes (Cp), differential pressure, velocity air and exchange air rates. Then, a microbiological environmental monitoring of the air was carried out by means of different samplings such as active sampling in the area, active sampling of the diffuser, and passive sampling. On the other hand, for microbiological evaluation of surfaces, the swab sampling method was applied, where a microbiological count of total aerobes, molds-yeasts, and Salmonella spp was performed. To conclude, it was demonstrated that both areas comply with all the established specifications and maintain consistent results, which ensures the safety in manufacture of non-sterile pharmaceutical products.