Abstract

DIAZ-ENRIQUEZ, Eidelys et al. Determination of the efficacy of the disinfectants employed in the aseptic areas at a biopharmaceuticals production center. Vaccimonitor [online]. 2017, vol.26, n.2, pp. 54-56. ISSN 1025-0298.

In the biopharmaceutical industry, disinfection has become a fundamental part of the activities to control the level of contaminants microorganisms that could compromise the quality of the final product. The objective of this work was to evaluate the efficacy of the disinfectants Anios Special DJP SF, Aniosurf Premium, Bacteranios SF, Aniospray 29, Aseptanios AD and Surfanios for the cleaning and disinfection of the aseptic area at the Parenterals Products Plant 2 (PPP2) at the National Center for Bioproducts (Mayabeque, Cuba). The efficacy was checked with challenge tests in surfaces, in practical usage conditions. The number of isolated microorganisms and the microbiota present before and after use was compared statistically. All the disinfectants complied with the established requirements. Therefore, the efficacy of the disinfectants was demonstrated to perform the cleaning and disinfection of the aseptic areas.

Keywords : disinfectants; contamination; clean rooms; biopharmaceutical industry.

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