In the 2026 Malaysian high-tech manufacturing and pharmaceutical landscape, Particle Count Testing for Cleanroom Grade AHUs is the ultimate validation of environmental sterility. Governed by ISO 14644-1:2015 and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), this testing is a statutory requirement for facilities overseen by the Medical Device Authority (MDA) and the National Pharmaceutical Regulatory Agency (NPRA).
At EKG (Malaysia) SDN BHD, our mechanical specialists perform these tests to ensure your AHU system is Sterile, Secure, and Statutory-Compliant, maintaining the integrity of your controlled environment.
For Cleanrooms in KL and Selangor, particle count limits are strictly defined by the "Grade" of the room (Grade A through D) or the ISO Class (Class 1 through 9).
| ISO Class | Particle Size ≥ 0.5 μm (max/m³) | Typical Application |
| ISO Class 5 (Grade A) | 3,520 | Sterile Filling / Aseptic Processing |
| ISO Class 7 (Grade C) | 352,000 | Preparation of solutions for filtration |
| ISO Class 8 (Grade D) | 3,520,000 | Cleaning of components / Less critical stages |
Under the Energy Efficiency and Conservation Act (EECA) 2024, Cleanroom AHUs must achieve these counts while maintaining a Specific Fan Power (SFP) that balances high-efficiency filtration (HEPA/ULPA) with energy intensity targets.
We utilize NATA-traceable discrete particle counters to perform "At-Rest" and "Operational" validations.
Before counting particles in the room, we perform a Dispersed Oil Particulate (DOP) or Polyalphaolefin (PAO) leak test. This ensures that the AHU Ducting Service and filter housings are 100% sealed, preventing any "unfiltered" air from bypassing the media.
We calculate the number of sampling locations based on the square root of the cleanroom area ($N = \sqrt$). At each point, we sample a specific volume of air (typically 1 cubic foot or 28.3 liters) to verify the concentration of particles at sizes 0.5 $\mu$m and 5.0 $\mu$m.
We simulate a "contamination event" and measure how long the AHU takes to return the room to its specified ISO Class. A slow recovery indicates insufficient Air Changes Per Hour (ACPH) or poor AC System Balancing.
The success of a particle count test depends entirely on the Terminal Connection Setup and airflow patterns.
Laminar Flow Verification: We use smoke generators to visualize the air path. In Grade A zones, air must move in a unidirectional, downward "piston" motion to sweep particles away from the work surface.
Pressure Cascade Audit: We verify that the AHU maintains a Positive Pressure (+12 to +15 Pa) relative to adjacent lower-grade rooms. This prevents "Infiltration Contamination" from entering the sterile zone.
VFD Modulation Check: We ensure the VFD-driven AHU maintains constant airflow even as HEPA filters become "loaded" with dust, preventing a drop in ACPH that would lead to a failed particle count.
Cleanroom AHUs have unique safety requirements under BOMBA (JBPM) 2026 to protect both personnel and high-value inventory.
Automatic Fire Signal AHU Shut-off: Upon a fire signal, the AHU must shut down immediately to prevent the spread of smoke through the HEPA highway.
Containment Isolation: Motorized dampers must seal the cleanroom to prevent fire suppressant gases (like FM-200 or Novec 1230) from escaping, ensuring the gas reaches the required concentration to extinguish the fire.
BOMBA Audit: JBPM officers verify the "Fire-Tight" integrity of the cleanroom envelope and AHU dampers during the annual Fire Certificate (FC) audit.
Technical Integrity: We are Cleanroom T&C specialists, not just installers. We provide full validation protocols (IQ/OQ/PQ) required for NPRA and MDA submissions.
Sterility Excellence: We understand that a single failed particle count can halt an entire production line. We identify the root cause—whether it's a Duct Leak or a Trap Prime Failure—and fix it.
Audit-Ready Reports: We provide a comprehensive Particle Count Certification Report including localized maps of every sampling point and statistical pass/fail analysis.
Is your Cleanroom AHU due for its annual ISO 14644 validation?
Contact EKG (Malaysia) SDN BHD today for a professional Cleanroom Grade AHU Particle Count Test & Compliance Audit.
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