Validación de la prueba de esterilidad mediante la técnica de filtración por membrana y determinación de pirógenos en el producto farmacéutico inyectable -Intravit 10.000 Blispack- de la empresa GINSBERG Ecuador S.A.

Abstract

The sterility test was validated by the membrane filtration technique and the presence or absence of pyrogens in the injectable drug product Intravit 10,000 Blispack from the Company GINSBERG Ecuador S.A. Of the city of Quito. In the validation process of the sterility test we developed tests that allowed to verify: the sterility of the culture media used and the promotion of growth, in which 6 strains of microorganisms Pseudomona aeruginosa, staphylococcus aureus, Clostridium sporogenes, Bacillus subtilis spizizenili, and aspergillus brasiliensis, a test carried out with the purpose of verifying that the culture media possess the necessary conditions for the growth of microorganisms. In addition, the fungistatic and bacteriostasis test was developed in which the bacteriostatic and fungistatic activity of the pharmaceutical product was determined and finally the membrane filtration method of the injectable was performed, a method that will be used as a routine test for the analysis of this drug. In pyrogen determination, depyrogenated material and reagents were used under strict storage conditions, ie, 2 ° C-8 ° C. Tests were performed such as the test Product dissolution without addition of bacterial endotoxin and test Dilutions of the product with addition of bacterial endotoxin and determination of the working dilution, which corresponds to the dilution at which the drug does not present any type of inhibition. According to the obtained results, it is concluded that the sterility test, specifically the membrane filtration technique was validity, allowing to use this methodology in later analyzes of the injectable, which will provide reliable results. In addition the medicine is free and pyrogens. Therefore the pharmaceutical product is suitable to be marketed and properly administered, will not cause any type of damage to the patient complying with the expected pharmacological effect.