Microbiología
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Browsing Microbiología by Author "Álzate González, Diego Alejandro"
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Item Validación de método microbiológico cilindro en placa para determinación de la potencia de neomicina en producto farmacéutico triconjugado crema (neomicina, clotrimazol y betametasona)(Universidad Santiago de Cali, 2023) Álzate González, Diego Alejandro; Rivera Sánchez, Sandra Patricia; Cruz Bolaños, Yimi WilliamThe finished product Betamethasone, clotrimazole, neomician cream, is manufactured for sale and export to the main countries of the world, such as: Mexico, the western part of South America, Ecuador, Peru and India. The determination of the potency of neomycin with the cylinder plate method allows demonstrating the effectiveness of the methodology, and can be used as a quality control method, in the plant located in the industrial zone of the city of Cali. The present work was carried out at the pharmaceutical company Lafrancol S.A.S plant Cali, where the challenge organism used in each stage of the process was evaluated, respectively the ATCC 12228 S. epidermidis strain. The stages of the process were: a) standardization of the inoculum, b) productivity tests of the culture media, c) development of the validation technique for the cylinder-in-plate microbiological method for the determination of neomycin potency. During the validation process, the comparison of the results obtained by two observers was included, demonstrating that the reproducibility complies, since the data shows that the coefficient of variation between each repetition with the different results of the standard and inoculum analyzed are less than 10 % being very homogeneous; Regarding accuracy, it was evidenced with the correlation coefficient of concordance between the counts of the observers, very consistent results were found. The effectiveness of the validation of the method was demonstrated, for the different stages of selectivity, which only evidenced the degradation of less than 70 % of the neomycin molecule in the acid condition