Kanomax High-Pressure Diffuser for Particle Counters – Model 50/100 LPM
| Brand | Kanomax |
|---|---|
| Flow Rates | 50 L/min & 100 L/min |
| Operating Pressure Range | 18–125 psi (50 LPM), 21–125 psi (100 LPM) |
| Material | Stainless Steel |
| Inlet Connection | Stainless steel tubing, OD Φ12.7 mm with Φ25 mm clamp |
| Outlet Connection | Internal diameter Φ1/2 inch |
| Dimensions (Body) | Φ30 mm × 185 mm |
| Weight | ~1.0 kg |
| Ambient Operating Conditions | 10–35 °C, 0–85% RH (non-condensing) |
| Compatible Gases | Clean, dry air and non-toxic inert gases |
Overview
The Kanomax High-Pressure Diffuser (Model 50/100 LPM) is an engineered flow-conditioning device designed specifically for integration with high-flow airborne particle counters and microbial samplers in regulated cleanroom and controlled environment applications. It operates on the principle of pressure reduction and laminar flow stabilization—converting turbulent, high-pressure gas streams into uniform, low-velocity, isokinetic output flows suitable for precise aerosol sampling. This diffuser addresses a critical gap in ISO 14644-1, EU Annex 1 (2022), and FDA Guidance for Industry: Sterile Drug Products Manufactured by Aseptic Processing—where compressed air used in cleanrooms must be validated for particulate and microbial content. By maintaining consistent mass flow delivery across variable upstream pressure conditions (18–125 psi), it ensures measurement integrity for instruments such as the Kanomax LPC-3910 (50 L/min) and LPC-3920 (100 L/min), minimizing flow-induced sampling bias and sensor overloading.
Key Features
- Stainless steel construction (316L-grade compatible per ASME BPE specifications) for corrosion resistance, cleanability, and compliance with GMP cleaning validation protocols.
- Dual-mode calibrated design supporting two discrete volumetric flow rates: 50 L/min and 100 L/min—each optimized via dedicated inlet geometry to preserve flow profile fidelity and minimize pressure drop hysteresis.
- Integrated diffusion chamber with precision-machined orifice and flow-straightening elements to suppress turbulence and achieve <5% velocity profile deviation (per ISO 21501-4 Annex C).
- Robust mechanical interface: standardized Φ12.7 mm stainless steel tube inlet with Φ25 mm sanitary clamp; outlet configured for 1/2-inch ID flexible tubing (e.g., PTFE or silicone) compatible with common particle counter manifolds.
- Compact cylindrical form factor (Φ30 mm × 185 mm, ~1.0 kg) enabling direct mounting on mobile sampling carts or fixed wall brackets without structural reinforcement.
Sample Compatibility & Compliance
The diffuser is qualified for use with clean, dry compressed air and non-toxic inert gases (e.g., nitrogen, argon) meeting ISO 8573-1 Class 2:2:2 or better for particulate, moisture, and oil content. It supports validation workflows aligned with ISO 14644-3 (test methods), ISO 14644-2 (monitoring), and USP / environmental control requirements. Its pressure tolerance range (18–125 psi for 50 LPM; 21–125 psi for 100 LPM) accommodates typical pharmaceutical plant header pressures while remaining compatible with point-of-use regulators. The unit itself does not require calibration certification but must be included in instrument system qualification (IQ/OQ/PQ) documentation when deployed in FDA 21 CFR Part 11 or EU GMP Annex 1 environments.
Software & Data Management
As a passive pneumatic component, the Kanomax High-Pressure Diffuser does not incorporate embedded electronics, firmware, or software interfaces. Its performance is verified through physical flow mapping and pressure-drop characterization during system commissioning. When integrated with Kanomax LPC-3910 or LPC-3920 particle counters, it contributes to full audit trails generated by the host instrument’s data acquisition software—supporting GLP/GMP-compliant record retention, electronic signatures, and 21 CFR Part 11–enabled user access controls. Documentation packages include material traceability certificates (MTRs), surface finish reports (Ra ≤ 0.8 µm), and dimensional inspection records compliant with ASME Y14.5.
Applications
- Aseptic processing line compressed air monitoring per EU Annex 1 §8.112–8.115.
- Isolator and RABS environmental qualification per ISO 14644-3 Clause 6.3.3.
- Pharmaceutical facility compressed gas system validation (IQ/OQ/PQ).
- Microbial air sampling using impactor-based systems (e.g., MAS-100, BioTrak) requiring stable 100 L/min flow.
- HEPA filter leak testing with photometer-based challenge agents where flow consistency directly affects sensitivity.
- Research-grade cleanroom commissioning in semiconductor and biotech pilot plants.
FAQ
Does this diffuser require periodic recalibration?
No—this is a passive mechanical flow conditioner with no moving parts or sensors. Verification is performed during system-level flow profiling and documented in the instrument’s OQ report.
Can it be used with oil-lubricated compressors?
Only if downstream filtration achieves ISO 8573-1 Class 2 oil contamination limits; direct connection to oil-flooded lines without coalescing filters is not recommended.
Is sterilization-compatible?
Yes—the stainless steel body withstands autoclaving (121°C, 20 min) and VHP (vaporized hydrogen peroxide) exposure; however, elastomeric seals (if added externally) must be verified separately.
What is the maximum allowable backpressure at the outlet?
The device is rated for zero differential backpressure; outlet piping must remain unobstructed and ≥1/2-inch ID throughout its length to avoid flow restriction and measurement drift.
Is it suitable for hazardous area installations?
No—it lacks ATEX, IECEx, or UL Class I Div 1 certification; use only in non-classified environments per NEC Article 500.
