A utilização da espectrometria de massa MALDI-TOF na identificação de microrganismos no controle de qualidade farmacêutico

Abstract

In drug manufacturing process is a requirement of the National Health Vigilance Agency (ANVISA) the quality of products to ensure their effectiveness and safety. The implementation of standards of good manufacturing practices (GMP) and quality control of products are required to maintain the integrity of the product and user protection. Fast reliable analytical methods, accurate and are important to ensure a safe outcome, meet demand for microbiological analysis and also the constant pressure to improve techniques that reduce costs and time to completion of stages of production of a pharmaceutical industry. Mass spectrometry has increasingly become an important analytical tool in microbiology. In recent years, this tool has been used to identify and classify of microorganisms, improving the process of monitoring the level of contamination and microbial diversity in the areas of production, raw material and final product. In this work , was demonstrated how mass spectrometry MALDI - TOF is applied in the identification of microorganisms in the pharmaceutical industry through the theoretical principles, methodology and the advantages and disadvantages of the technique, and also compared to results obtained with environmental and clinical isolates.