Examinando por Autor "Díaz Fernández, Martha María"

Seleccione resultados tecleando las primeras letras
Mostrando 1 - 1 de 1
  • Miniatura
    PublicaciónAcceso abierto
    Validación e implementación del método analítico del monitoreo de superficie por hisopado en la industria farmacéutica
    (Universidad Privada Norbert Wiener, 2018-10-10) Díaz Fernández, Martha María; Chávez Fernández, Ana María
    The present study was carried out with the purpose of evaluating the different methods of surface monitoring carried out in the pharmaceutical industry 2016 - 2017. A Field, Descriptive - Longitudinal, Qualitative and Applied study was carried out. To this end, the parameters were evaluated according to the United States Pharmacopoeia (USP 40 NF 35) Validation of alternative microbiological methods, microorganisms similar to those found were selected (biological standard) in the manufacturing processes of pharmaceutical products, it was evaluated that the working material, the levels of detection were defined and applied to the different methods of surface monitoring in evaluation. It is observed that although the methods do not present homogeneous results; It is considered the method that presents the highest percentage (%) of recovery, in more than one ATCC. It is the Regular Hyssop method of Plastic Soft Nylon Point Sterile Flocked + Shock absorber Solution Sodium Chloride - Peptone. ATCC 9027 (15.30%); ATCC 6538 (41%) and ATCC 8739 (17.4%). That is why this study us to know the importance of importance of identifying and evaluating the proposed methods for the pharmaceutical industry, which is always in constant improvement and innovating in methods to streamline results. The purpose is to avoid false positives or negatives and to guarantee the quality and safety of pharmaceutical products.