Browsing by Author "Orejuela Salcedo, Stefania"
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Item Validación de limpieza del área de volúmenes bajos 2 en una industria farmacéutica del Valle del Caucа(Universidad Santiago de Cali, 2024) Orejuela Salcedo, Stefania; Castro Narváez, Sandra Patricia (Directora)Ensuring the cleanliness of equipment in the veterinary pharmaceutical industry is a priority, since improper handling can generate incompatibilities between drugs. This study contributes to the cleaning validation activities in the low volume session of a pharmaceutical company. To this end, a risk analysis was initially carried out by the effect and failure methods (AMEF) using the 6M (Manpower, Measurement, Machinery, Method, Environment and Material). Subsequently, the compound categorized as the “worst case” was weighted to the active Meloxicam, giving an acceptable residue limit (ARL) of 1.5 ppm. High performance liquid chromatography (HPLC) allowed separation and quantification of meloxicam in a retention time of 5.3 min. Linearity was evaluated at 5 points from 40 to 140% obtaining a correlation coefficient of 0.9991, with a limit of detection (LOD) of 0.0602 ppm and limit of quantification (LOQ) of 0.182 ppm. Accuracy exhibited a %RSDp of 1.4%, accuracy with three different concentrations at 60%, 100% and 140%, allowed recovery percentages between 99.5 to 103.4%. Meloxicam exhibited greater stability at 4°C over a period of 84h. The implementation of the cleaning protocol in the low volume session established that no rejections or alerts were observed, consolidating the cleaning practices as an assertive method in the prevention of cross-contamination with other products.