Aseptic filling of diagnosticators in the Parenteral Products Plants at National Center for Bioproducts
Abstract
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.This work is licensed under the Creative Commons Attribution-NonCommercial.