What question did this study set out to answer?

The aim is to assess the operational performance of pharmaceutical clean rooms using experimental methods and simulations.

March 8, 2026Open Access

Evaluating Clean Room Performance in the Pharmaceutical Industry: A Numerical and Experimental Investigation Based on ISO 14644–3 Standards

Key Points

The aim is to assess the operational performance of pharmaceutical clean rooms using experimental methods and simulations.
Conducted experimental tests on airflow and particle distribution in clean rooms.
Utilized Computational Fluid Dynamics (CFD) for modeling airflow patterns and air quality.
Measured key parameters: airflow velocity, temperature, and relative humidity based on ISO 14644-3 standards.
Tested HEPA filters for leakages and filtration efficiency.
All environmental parameters met acceptable standards for clean rooms.
Out of 27 HEPA filters, 3 were found leaking, while 24 had 99.997% filtration efficiency.
Particle counting confirmed all clean rooms achieved the required cleanliness grade per ISO 14644-3, with airborne particles within standard limits.

Abstract

Abstract Nowadays, clean rooms have become an indispensable part of various industries for the production of sensitive products. This study evaluates the operational performance of a pharmaceutical clean room using a combined experimental approach and Computational Fluid Dynamics (CFD) simulations to model airflow distribution and particle transport. The evaluated parameters included airflow velocity and volume flow rate, differential pressure between clean rooms, temperature, relative humidity (RH), airflow patterns and inter-room airflow direction, high-efficiency particulate air (HEPA) filter leakage, and airborne particle concentration in accordance with the ISO 14644–3 method. The measured environmental parameters, including airflow rate and velocity, temperature (22 ± 2 °C), RH (45% ± 15%), and differential pressure (10–15 Pa between adjacent clean rooms), were all within acceptable standard ranges. The test results for 27 HEPA filters indicated that three filters had leaks in the filter media, while the remaining 24 filters showed acceptable performance with a filtration efficiency of 99.997%. Finally, the particle counting test indicated that all three clean rooms met the desired cleanliness grade based on the ISO 14644–3 method. The airborne particle concentrations (> 0.5 μm) were within the standard limits for Grade B clean rooms. This is due to adequate airflow rates (providing sufficient air changes per hour) and high-quality HEPA-filtered air in Grade B clean rooms. Graphical Abstract

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