Validación del método de limpieza y trazas de corticoides después de la elaboración del producto CORTIPAN (betametasona sodio fosfato+betametasona dipropionato) en el Reactor OLSA PCBF50 en GINSBERG Ecuador S.A

Abstract

The cleaning method used after the elaboration of the product Cortipan (Betamethasone sodium phosphate + Betamethasone dipropionate) was validated in the OLSA PCBF50 reactor at Ginsberg Ecuador S.A., in the Quito canton, province of Pichincha; to verify if the method used reduces to the maximum the traces of the product after its elaboration. Initially, the validation of the method of valuation of the active principles of the Cortipan product was carried out, to determine traces of active principles by means of the HPLC method (High Performance Liquid Chromatography), according to the analysis and results obtained, the HPLC method was discarded for the validation of the cleaning method; applying the TOC (Total Organic Carbon) method, Swab was used as sampling technique, TOC determination analysis method, polyester swabs, vials for TOC use, reagent type water as solvent, and TOC FUSION carbon determination equipment. After the pertinent analyses and studies, it was determined that the cleaning method used in both the OLSA 1 and OLSA2 reactors reduces the traces of active principles to the maximum, being found under 10 ppmC (parts per million of carbon), In the analysis of variance, the f (distribution factor) calculated for the OLSA1 (f=0.09348) and OLSA2 (f=2.70628) reactors are lower than the critical f (fcritical OLSA1= 3.4668 and fcritical OLSA2 =4.2565), demonstrating that the cleaning method is appropriate. It is recommended that the cleaning method be applied permanently, guaranteeing the cleanliness of the equipment.