ABSTRACT

Further to the release of Annex 1, this technical briefing provides information regarding the different airborne concentrations for cleanrooms and clean zones, the functionality of particle counters used to measure these concentrations.

This technical briefing includes the requirements for sampling in zones of unidirectional airflow, and systems utilised for continuous monitoring of airborne cleanliness and classifications. It considers the technology and sampling requirements used to measure concentrations of airborne particles using LSAPC and real time reporting….

KEYWORDS:  Air Cleanliness, Airborne Particle Count, Anisokinetic, Aseptic Processing Guide, ASTM International: 2015, BSEN ISO 14644-1: 2015, Calibration, Clean Zone, Cleanroom, Contamination, Continuous Airborne Particle Monitoring, Continuous Monitoring, Controlled Environment, Critical Zone, Cumulative Count, Differential Count, Electrostatic Attraction, EU GGMP Annex 1, Fixed Automated Monitoring, Fixed Particle System, GGMP, GMP, Healthcare, ISO 14644-1, ISO 21501-4: 2018, Isokinetic, Isokinetic Sampling, Light Scattering Airborne Particle Counters, LSAPC, Macroparticles, Particle Counters, Particle Size, Pharmaceutical, Portable Particle Counter, Sampling Tube, Sampling Probe, Sterile Drug Products, Sterile Medicinal Products, UDAF, Unidirectional Air Flow, US FDA APG.

Further related information can be found in the following associated briefs:

1. Airborne particle counting using LSAPC – Technical Briefing (PDF)
2. Cleanroom Classification – Technical Briefing (PDF)
3. Cleanroom Testing – Technical Briefing (PDF)
4. High Efficiency Air Filters – Technical Briefing (PDF)
5. Cleanroom Airflow Visualisation – Technical Briefing (PDF)
6. Liquid and Gas Filtration – Technical Briefing (PDF)