Browsing by Author "Reyes Moctezuma, Nataly Alexandra"
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Item Validación secundaria para la prueba de recuento microbiano y la prueba de microorganismos específicos para nitazoxanida por 500 mg(Universidad Santiago de Cali, 2020) Reyes Moctezuma, Nataly Alexandra; Rivera Sánchez, Sandra Patricia (Directora)The drug Nitazoxanide tablet, coated with 500 mg, is manufactured for certification and export to the main risk areas with protozoal infections, such as: Mexico, western South America, western Africa, South Africa and parts of the Middle East and India. The deep plate microbial count test and the test for specific microorganisms, allow to demonstrate the methodology 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 Sanofi, Cali plant, where the challenge organisms used in each stage of the process were evaluated, respectively the strains ATCC (American Type Culture Collection) Escherichia coli ATCC 8739, Staphylococcus aureus ATCC 65538, Pseudomonas aeruginosa ATCC 9027, Bacillus subtillis ATCC 6633, Aspergillus niger ATCC 16404 and Candida albicans ATCC 10231. The stages of the process were: a) standardization of inoculum, b) productivity and selectivity tests of the culture media, c) development of the technique of Secondary validation for the plate microbial count test and specific microorganism test. During the validation process, the comparison of the results evaluated by three observers is included, demonstrating that the reproducibility complies, since the data shows that the coefficient of variation between each repetition with the different microorganisms analyzed is less than 30%, being very homogeneous; Regarding the accuracy, it is evidenced with the correlation coefficient of agreement between the observer counts, it is very good, it shows results over 80% and a recovery greater than 70% of all the study microorganisms, when compared with the controls. positive, and used in the 1: 1000 dilution in the total count of aerobic bacteria and in the total count of molds and yeasts. The recovery of the validation of the method was demonstrated, for the count of microorganisms and the recovery of the specific microorganism (Escherichia coli).