Resumen

ALVAREZ GONZALEZ, Marisol et al. Aseptic filling of diagnosticators in the Parenteral Products Plants at National Center for Bioproducts. RTQ [online]. 2019, vol.39, n.1, pp. 221-232. ISSN 2224-6185.

The HemoCen Aerobio is a general enrichment culture medium, destined to culture aerobics microorganisms in blood. Due to the importance of this product as a diagnosticator of microorganisms that affect human health, it is decided to implement the production of its three presentations in the Parenteral Products Plants at National Center for Bioproducts (BioCen). Therefore, this work is carried out with the objective of obtaining the production license from the Center for the State´s Control of Medical Medicaments and Equipments (CECMED) for the HemoCen Aerobio Neonatal, the HemoCen Aerobio Pediátrico and the HemoCen Aerobio. Productive results of three lots of each one of the presentations are presented, which showed satisfactory and consistent results that fulfill the quality requirements according to the stablished specifications, that allowed to obtain the production license for the three presentations in the Parenteral Products Plants.

Palabras clave : HemoCen Aerobio; culture media; aseptic filling.

        · resumen en Español     · texto en Español     · Español ( pdf )