In 2026, HEPA Filter Scanning and Validation has become the cornerstone of facility certification under the DOSH ICOP IAQ 2026, ISO 14644-3, and the newly enforced PIC/S standards for hospital pharmacies (effective Jan 1, 2026). Validation is no longer just a "spot check"; it is a mandatory, documented proof that your filtration system—including the media, frame, and housing—is free of bypass leakage that could compromise sterile zones.
At EKG M&E, we leverage 34 years of engineering depth to provide independent, accredited validation for the Klang Valley’s most sensitive pharmaceutical and industrial environments.
Scanning is the process of physically moving a probe across the filter face to detect localized "hot spots" of particulate penetration.
The Aerosol Challenge: We inject a certified PAO (Polyalphaolefin) aerosol upstream at a concentration of 10–100 µg/L. This creates a measurable "stress" on the filter media.
Overlapping Strokes: Our technicians move the photometer probe in overlapping strokes at a maximum velocity of 5 cm/sec (approx. 10 linear feet per minute). This speed is critical; moving too fast risks missing a pinhole leak.
Probe Distance: We maintain the probe exactly 25 mm (1 inch) from the filter face. This distance is calibrated to capture the air stream before it disperses, ensuring the most accurate leak detection.
To satisfy DOSH 2026 and NPRA auditors, the validation must meet specific pass/fail benchmarks:
H13/H14 HEPA Limits: Any localized penetration exceeding 0.01% of the upstream challenge is a failure. For ULPA (U15) filters used in microelectronics, this threshold drops even lower.
Zero-Bypass Mandate: We validate not just the media, but the "Grid Integrity." Any leak detected at the gasket or gel-seal interface is categorized as an "Installation Failure," requiring immediate reseating or frame repair.
Fill Repair Limitations: Under current standards, a single repair (patch) cannot exceed 3.8 cm (1.5 in) in any dimension, and the total area of all repairs must not block more than 3% of the filter face.
Under the Energy Efficiency and Conservation Act (EECA) 2026, validation now includes an energy audit of the filtration system:
VFD Airflow Stabilization: During the scanning process, we use the Variable Frequency Drive (VFD) to lock the fan speed, ensuring a steady face velocity of 0.45 m/s ± 20%.
The Cube Law Advantage: A validated, leak-free system allows the VFD to operate at its lowest possible RPM. Following the Cube Law, if we can maintain the room's ISO class at a 20% lower fan speed, your ventilation energy costs drop by nearly 50%.
Pressure Drop Baseline: We record the "Clean" differential pressure ($\Delta P$) to set the energy-efficiency baseline for the remainder of the filter's lifecycle.
Starting in 2026, the Malaysian Ministry of Health and DOSH have tightened the validation schedule:
ISO Class 5 (Grade A/B): Mandatory validation every 6 months.
ISO Class 7/8 (Grade C/D): Mandatory validation every 12 months.
Hospital Pharmacies (PIC/S 2026): All compounding cleanrooms must be re-validated annually by an independent third-party agent to maintain their "Approval Letter for Use."
34 Years of Engineering Depth: Based in KL, we are experts in the unique humidity and thermal challenges of the Malaysian climate.
Accredited Independent Testing: We provide the "IQ/OQ/PQ" documentation required for Ministry of Health (MOH) and DOSH 2026 audits.
Turnkey Solutions: If a scan fails, we don't just leave a report; we provide Certified Remediation and re-testing on the same day.
Malaysia
