Continuous airborne particle count in the pharmaceutical industrial environment: a fundamentals theoretical review
DOI:
https://doi.org/10.1590/s2175-97902025e24077Keywords:
Particle count, Definition of sampling points, Quality control, Risk assessment, environmental monitoringAbstract
In a pharmaceutical industrial environment, air quality control aims to find contaminations in the environment, which are used as an indicator of possible contamination of the product. Variables can be common quantities such as pressure differential, temperature, and humidity; or more complex quantities such as the number of particles suspended in the air and microbiological contamination. This set of controls in classified areas is called Environmental Monitoring. Monitoring the concentration of suspended particles in the air is detailed in the ISO 14644-2:2015 standard. This standard makes it mandatory for companies that have clean areas to control the number of particles suspended in the air as part of their environmental monitoring program and serves as a guide regarding the amount of concentration accepted for each type of clean area, as well as the classification of the clean room itself (ISO 14644-1). However, many features are not detailed in the ISO standard. The objective of this article was to review the main fundamentals related to particle counting in a pharmaceutical environment and to be used as a start point for professionals and academics starting studies in this area.
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