Validación del proceso de limpieza y manufactura de una jalea multivitamínica, en el Laboratorio Neofármaco del Ecuador

Abstract

The objective of this research was to validate the cleaning and manufacturing process of multivitamin jelly, elaborated in the Neodrug laboratory. In the cleaning validation, the equipment and materials involved in the manufacturing train were taken into consideration, in which 78 critical sampling points were identified, as well as two worst cases: vitamin B2 (riboflavin) and vitamin E (tocopherol); for water-soluble and fat-soluble vitamins respectively. The cleanlinessanalysis was carried out using high- performance liquid chromatography (HPLC), the water from the last rinse of the equipment and materials was analyzed by conductimetry and pH, as well as the microbiological analysis of the critical sampling points in which no microbial growth was observed. In the manufacturing validation, different critical control points were identified in the multivitamin jelly elaboration process, which were sampled at different times, from the three points: background, middle and end; which were analyzed by HPLC and volumetry, of these results a process capacity analysis was carried out, which showed that the final mixing time of the multivitamin jelly established by the laboratory is adequate. In the final mixture, all the quality control tests were carried out, including the microbiological analysis, finding this product within the parameters established by the Neodrug laboratory. In conclusion, the cleaning and manufacturing process of multivitamin jelly meets the criteria established for its validation, it is necessary to carry out the study of subsequent batches to ensure a reproducible cleaning and manufacturing process over time.