Validación de limpieza del reactor ACINDEC capacidad 15000 litros y cabina estéril, en Ginsberg S.A. Quito mediante el método TOC.

Abstract

The following investigation's objective was the validation of the cleaning of the Reactor ACINDEC capacity 15000 L and Sterile Cabin by means of the TOC method, in Ginsberg Ecuador SA., the study was of experimental character with quantitative data, in the first instance a validation protocol was elaborated as an instruction for the application of the method, the critical points of the equipment and the sterile cabinet were obtained by means of the superficial swab, established in the USP 38 with sampling area of 25 x 25 cm2, with criteria of acceptance of residues for detergent (EXTRAN 1%) lower 10 ppm and microbiological controls for fungi, yeasts less than or equal to 10UFC and aerobic bacteria less than or equal to 100 CFU. The results were analyzed using the univariate general linear model that evaluated the effect of the 26 criteria points and determined that there is variability in the concentrations of detergent residues present from one sample to another, that is, all the results obtained are different. In addition, the TUKEY test was carried out, which shows that there is no homogeneity in the results of each sample. The data obtained for the microbiological analyzes showed ZERO growths, therefore, it cannot generate statistical method due to not having significant comparison data. It is concluded that the TOC method is validated and is reproducible to determine the cleanliness of the reactor and a sterile cabinet. It presents residues of detergent Extran1% used in the cleaning, less than 5 ppm in the three samples taken, being within the parameters of established acceptance, which guarantees the safety and use until 8 hours after cleaning, after this time it is recommended to carry out a new analysis or cleaning process, this information is detailed in the approved report and delivered to the Headquarters of Validations, Quality Control and Technical Management, whose document rests in the Validations Department and Quality Assurance of the Ginsberg Pharmaceutical Industry SA; Quito.