R O B E R T P. TO M A S E L L I , C O N S U LTA N T
ISO 21501-4, Determination of particle size distribution - Single particle light interaction
methods - Part 4: Light scattering airborne particle counter for clean spaces
At-rest and operational classification should performed periodically based upon risk
assessment of the cleanroom and clean zone operations, typically on an annual basis
Where the cleanroom and clean zone is equipped with instrumentation for continuous or
frequent monitoring of air cleanliness (airborne particles, room pressure differentials), the
time intervals between classification may be extended provided that the results of the
monitoring remain within the specified limits. However, in the pharmaceutical and related
industries formal classification / re-qualification must be undertaken at least annually.
Annex B (informative**)
• Six examples of classification calculations
Annex D (informative)
• Sequential sampling procedure (for environments with very low particle concentrations, i.e., a
count of <20 for the largest particle size)
Annex E (informative)
• Specification of intermediate decimal cleanliness classes and particle size thresholds
Annex F (informative)
• Test instrument specifications
NOTE: similar guidance is given for real-time room pressure differential monitoring
systems and airflow velocity and volume monitoring
New guidance in Annex B (informative) – lists considerations for setting alert and action
levels for airborne particle counts and pressure differential monitoring – references ISO
14644-3 for ancillary tests
NOTES
• For ISO 14644-2, the parameter in question is the concentration of airborne particles (only)
• Ensure internal procedures are consistent with these definitions