MONITORAMENTO MICROBIOLÓGICO AMBIENTAL EM ÁREAS GRAU A E B NA FABRICAÇÃO ASSÉPTICA DE MEDICAMENTOS ESTÉREIS: REVISÃO NORMATIVA

The aseptic production of sterile medicines requires strict control of environmental conditions, especially in Grade A and Grade B areas, due to the risk of microbiological contamination. This study aimed to analyze the main regulatory requirements for environmental microbiological monitoring in these areas, including sampling methods, microbiological limits, monitoring frequency, and microorganism identification. A narrative literature review with a descriptive and qualitative approach was conducted based on scientific articles, technical documents, standards, resolutions, and guidelines available in the SciELO, PubMed, Google Scholar, and ScienceDirect databases, as well as national and international regulatory documents. The analysis showed that environmental monitoring should include different methods for assessing air and surfaces, monitoring operators, and establishing alert and action limits. The results should also be evaluated in light of the risks involved in the process. The identification of recovered microorganisms may help investigate possible sources of contamination and understand deviations, contributing to the implementation of corrective and preventive actions. It is concluded that environmental microbiological monitoring is an important tool for preventing contamination and contributing to the quality and safety of sterile medicines.