M19 Filtration Efficiency Analyzer (FEA-50) for pharmaceutical — AI-based, ultra-high-precision testing. Standards: EN 1822, ISO 29463.
Model: FEA-50 · Industry: Pharma
The M19 Filtration Efficiency Analyzer (FEA-50) evaluates how effectively HEPA and cleanroom filter media capture and retain particulate matter, the core determinant of clean-environment integrity in pharmaceutical manufacturing. An automated aerosol control system challenges one side of the media with mono- or poly-dispersed particles while synchronised upstream and downstream particle counters, together with differential-pressure measurement, resolve efficiency across the penetrating particle size range. Purpose-built for pharma air-quality validation, the FEA-50 simulates in-use conditions to confirm that filtration systems meet EN 1822 / ISO 29463 (HEPA/ULPA) and ISO 14644 cleanroom classifications. Real-time feedback supports both media development and routine QA/QC, so manufacturers can demonstrate consistent air-quality performance for aseptic and sterile production areas.
| Specification | Value |
|---|---|
| Particles | Configurable ranges |
| Flow | Stable & repeatable |
| Use cases | Media & PPE |
| Compliance | Audit-ready |
The FEA-50 quantifies particulate filtration efficiency of pharma air-filter media, including: Fractional and overall capture efficiency across particle sizes Most Penetrating Particle Size (MPPS) behavior for HEPA/ULPA Differential pressure (resistance) at rated flow Efficiency against mono- and poly-dispersed challenge aerosols
Automated aerosol generation, synchronised upstream/downstream counting and integrated differential-pressure logging remove operator variability, shorten test time and produce validation-ready reports — a step change over manual scan-and-count methods.
A closed-loop aerosol control system: Delivers a stable, characterized challenge concentration Supports mono- or poly-dispersed particles for standard-specific tests Correlates counts with differential pressure for true efficiency Minimises drift for reproducible EN 1822 / ISO 29463 results
Made-in-India/USA build delivers: Faster service response and local support Reduced lead times and spare-parts availability Lower shipping and import cost 2-year warranty with on-site support
Yes — USB, Ethernet and SCADA/PLC connectivity, PDF/CSV reporting and 21 CFR Part 11 electronic records let the FEA-50 slot into cleanroom qualification (IQ/OQ/PQ), routine media QC and batch-release documentation.
Results align with EN 1822, ISO 29463, ISO 16890 and ISO 14644, and the 21 CFR Part 11-ready software (electronic signatures, tamper-proof audit trails, validation documentation) keeps cleanroom filtration data audit-ready for US FDA, EU GMP and WHO GMP inspections.