Facultad de Ciencias Básicas

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Validación de la prueba de retención bacteriana para el producto inyectable Medroxiprogesterona acetato 150mg bajo los criterios del informe técnico N.26 de la PDA y la norma ASTM F838-15A.
(Universidad Santiago de Cali, 2022) Bastidas Basante, Jhosed Yamid; González Vargas, Iván Andrés; Acevedo Estupiñán, José Nicolas
The validation of the bacterial retention test is a test required by Colombian resolution 1160 of 2016, in order to demonstrate that the filters used in the sterilization of products are capable of retaining microbial contamination. For this reason, the described report 26 of the association of parenteral drugs and the ASTM F838-15A standard were used as a reference to validate the filters used in the sterilization of the product medroxyprogesterone acetate 150mg, in this way, the design of the bacterial retention system was carried out, followed by the standardization of the inoculum, continuing with the evaluation of the viability of the microorganism with respect to the product by direct inoculation and subsequently proceeded with the bacterial retention test. The microorganism proved to be viable in only one of the two solutions of the product and the evaluation of the retention resulted in obtaining a sterile effluent. Finally, it was shown that the filters have the ability to retain a concentration > to 1x107 CFU/cm2 of effective filtration area