ABSTRACT

This technical briefing provides information regarding the approach to the testing of cleanrooms, clean zones and separative devices (workstations such as isolators, RABS, glove boxes, etc.), the tests to be completed to measure the performance, an understanding of how these tests are undertaken, and the appropriate guidance standard. …..

KEYWORDS: Active air sampling, Aerodynamic segregation, Air movement, Air pressure difference test, Air supply, Air ventilation, Airborne, Airborne particle test, Airflow capture hood, Airflow direction test and visualization, Airflow test, Annex 1 of the European Union GGMP, Balometer, BS EN ISO 14644-2, Clean zones, Cleanliness levels, Cleanrooms, Containment leak test, Contamination concentration, Contamination control, Dew point sensors, Dielectric thin film capacitor humidity sensor, Due point, Electrostatic and ion generator tests, Healthcare applications, High efficiency air filters, Humidity measurement , Humidity test, Installed filter system leakage test, ISO 14644-3: 2019, Isolators, Light scattering airborne particle counter (LSAPC), Method principles, Microbe-carrying particles (MCPs), Microbes, Microbial concentration, Micro-organisms, Non-unidirectional airflow (non-UDAF), Particle deposition test, Passive air sampling, Photometer, Psychrometers, RABS, Recovery test, Relative humidity, Replicate organisms detection and counting (RODAC), Segregation test, Separative Devices, Surface Temperature test, Test apparatus, Test methods, Unidirectional airflow (UDAF), Volumetric air samplers.