ABSTRACT

This technical briefing provides information regarding the approach to the classification of cleanrooms, clean zones & separative devices (workstations such as isolators, RABS, glove boxes), by measuring 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.