Validation of an analytical method for the determination of traces detergent in the cleaning process of a fractionation chamber of sodium iodide 131I oral solution

Abstract

The validation of the cleaning process of a ¹³¹I fractionation chamber was carried out in order to demonstrate that the process efficiently reduces detergent residues below the acceptance level. For this purpose, an analytical method was developed and validated to determine traces of detergent. The study was experimental and the sampling method was by rinsing. Tego at 2 % was used as a detergent and rinsing water samples were taken. The determination of traces was carried out by means of the conductivity and pH analysis, evaluating the concentration of the detergent present in the rinsing solution. For the development and validation of the analytical method, the parameters of linearity, limit of detection, limit of quantification and working interval were considered. Under the experimental conditions, the linearity of the detergent was statistically demonstrated from 0.02 to 0.06 mg/mL, the limit of detection gave us a value of 2.82 μg/mL, limit of quantification of 9.45 μg/mL of detergent concentration and a consistent work interval according to the results. The analysis of the water samples of the last rinse determined the absence of traces of detergent used in the cleaning process of the ¹³¹I enclosure, demonstrating compliance with the established acceptance criteria. In conclusion, the ess is adequate and the analytical method is validated in the established lytical conditions.