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Measuring Sub-23 Nanometer Real Driving Particle Number Emissions Using the Portable DownToTen Sampling System

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Justification and Impact of Reduced Sampling Flow Rates for Total Particle Counting in Grade A Environments.

Petra Merker¹, Didier Hélal¹, Svetlana Kiseleva¹

¹Plair SA, Route de Saint-Julien 275, 1258 Perly (Geneva), Switzerland.

PDA Journal of Pharmaceutical Science and Technology

|July 11, 2026

Summary

New Biofluorescent Particle Counters (BFPCs) at lower flow rates are suitable for Grade A environments. Studies show lower flow rates are non-inferior to standard rates for environmental monitoring, ensuring equivalent control.

Keywords:

Alternative and Rapid Microbiological Methods (ARMM)Biofluorescent Particle Counters (BFPC)EU GMP Annex 1 Environmental monitoring Non-viable Particle Counting

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Area of Science:

Pharmaceutical Manufacturing Technology
Cleanroom Environmental Monitoring
Particle Counting Science

Background:

Current EU GMP Annex 1 guidelines reference 28.3 L/min for total particle counting.
Newer Biofluorescent Particle Counters (BFPCs) operate at lower flow rates (e.g., 5 L/min) for simultaneous viable and total particle detection.
Lower flow rates offer potential advantages in viable particle detection efficiency and reduced particle losses.

Purpose of the Study:

To provide data supporting the use of lower flow rate particle counters in Grade A environments.
To compare the performance of particle counters at standard (28.3 L/min) and lower (2.83 L/min) flow rates.
To assess non-inferiority in detecting environmental quality deviations for 0.5 μm and 5 μm particles.

Main Methods:

Comparative performance analysis of two particle counters (28.3 L/min and 2.83 L/min) in two Grade A simulated environments.
Experimental setups included a laboratory-scale microbiological biosafety cabinet (BSC) and a full-scale Grade A chamber.
Identical contamination events were introduced to evaluate detection capabilities across different scales and airflow dynamics.

Main Results:

High concordance in alert thresholds was observed between the two particle counters under unidirectional airflow.
No consistent preference for alert precedence was found between the standard and lower flow rate instruments.
In the BSC setup, lag time between instruments was ≤1 minute in 96% of cases, indicating rapid detection.

Conclusions:

Particle counters operating at lower flow rates are non-inferior to standard flow rates for environmental monitoring in Grade A zones.
Lower flow rate particle counters maintain equivalent environmental control.
The findings support the suitability of lower flow rate BFPCs for Grade A applications.