Validación de limpieza se equipos utilizados en la producción de Ácido Ascórbico y Ácido Fólico–forma farmacéutica polvo para la suspensión oral en Ginsberg Ecuador S. A. mediante análisis de trazas.

Abstract

The cleaning of ascorbic acid and folic acid manufacturing equipment was verified - pharmaceutical dosage form powder for oral suspension by analyzing traces of these components, after regular production, in Ginsberg Ecuador S.A in Quito, to avoid cross contamination problems by presence on acceptable residue limits of API ̓ s unrelated to a particular product. Critical sampling points for each of the equipment (swabbing) were established, three acceptance criteria of waste (FDA) used in the company were applied, and as a method of High-perfomance liquid chromatography (HPLC) for trace determinations, and in conjunction with the validate analytical method for determining ascorbic acid and folic acid performed preliminarily. The obtained results of each critical point of sampled equipment of three sets reflect that they can not be quantified by the equipment due to these retention time correspond to a negative polarity, so it is assumed that the concentrations of ascorbic acid and folic acid are lower than theoretical limits of quantification for ascorbic acid 1.2x10 -6 mg/mL and folic acid 5x10 -8 mg/mL. In order to know the waste acceptance limit. It was applied three acceptance criteria from these the most demanding, the first criterion to folic acid 0.001 mg and the third criterion to ascorbic acid 0.4 mg. In conclusion, trace concentrations are below the limit of waste acceptance. We conclude that the equipment are completely clean and they are safe to produce a different product or a subsequent set.