ABSTRACT

This technical briefing provides information regarding the approach to the classification of cleanrooms, clean zones and separative devices (workstations such as isolators, RABS, glove boxes, etc.), by the measurement of airborne particles, the guidance documents to be utilised for classification and the specific requirements for the classification of a healthcare cleanroom and the specific requirements for the classification of a healthcare cleanroom…..

KEYWORDS: Airborne Particle Concentration, Annex 1 European Union GGMP (2022), Clean Zones, Cleanroom Classification, Cleanroom Re-classification, Cleanrooms, Control Airborne Contamination, Equation, Formula, Healthcare, ISO Standard 14644-1, Isolators, Light Scattering Airborne Particle Counter, LSAPC, Macroparticle Classification, Manufacture of Sterile Medicinal Products, Occupancy States, Particle Concentration Limits, Qualification, RABS, Sampling, Separative Devices.