Kanomax KA25 Thermal Anemometer for Pharmaceutical Cleanroom Monitoring

Overview

The Kanomax KA25 Thermal Anemometer is a precision-engineered instrument designed specifically for airflow validation and routine monitoring in pharmaceutical cleanrooms compliant with ISO 14644-1, EU GMP Annex 1, and FDA guidance on environmental control. It operates on constant-temperature anemometry (CTA) principle—where a heated sensor element dissipates heat proportional to local air velocity—and delivers real-time, traceable measurements of air velocity (0.01–20.0 m/s) and ambient temperature (−20–70 °C) under controlled laminar or turbulent flow conditions. Its calibrated thermal sensor ensures high reproducibility across low-velocity regimes critical for ISO Class 5–8 environments, where face velocities at HEPA/ULPA filters and supply diffusers must remain within tight tolerances (e.g., 0.36–0.54 m/s per ISO 14644-3). The device meets the functional requirements for periodic qualification (IQ/OQ/PQ), routine operational checks, and corrective action verification in sterile manufacturing facilities.

Key Features

• Simultaneous dual-parameter measurement: air velocity and temperature, both displayed concurrently with unit consistency (m/s and °C)
• Telescoping and bendable probe (Ø6 mm sensing tip, 294–1060 mm adjustable length) enables access to confined ducts, glovebox ports, and high-mounted supply grilles without disassembly
• On-device air volume calculation: user inputs duct geometry (rectangular or circular) and dimensions (0.1–255.0 cm); instrument computes volumetric flow rate (m³/h) using integrated cross-sectional area algorithms
• Configurable time constant (1 s / 5 s / 10 s / 20 s) allows optimization for transient vs. steady-state airflow evaluation—essential for mapping dynamic HVAC responses during pressure cascade tests
• Smart statistical functions: real-time min/avg/max tracking over user-defined intervals, supporting ISO 14644-3 sampling protocols requiring ≥30 seconds per point
• Three-level backlight LCD with intuitive icon-based navigation; supports data hold, auto power-off (3/5/10 min), and battery-level indication
• Rugged, lightweight design (220 g) with IP54-rated probe housing and chemical-resistant casing suitable for frequent use in ISO 7/8 gowning rooms and buffer zones

Sample Compatibility & Compliance

The KA25 is validated for use with clean, dry, non-corrosive air—typical of HEPA-filtered supply air in Grade A/B/C/D environments. It is not intended for particulate-laden, humid (>80% RH), or chemically aggressive airstreams. While the instrument itself does not carry formal ISO/IEC 17025 calibration certification, its factory calibration traceability aligns with NIST-traceable standards, and documented calibration records satisfy GLP/GMP audit requirements when performed annually by an accredited lab. The device supports compliance with key regulatory references including EU GMP Annex 1 (2022), USP , and ISO 14644-3:2019 Annex B for cleanroom airflow characterization. Probe interchangeability ensures consistent metrology across multiple units within a facility’s QC fleet.

Software & Data Management

The KA25 operates as a standalone field instrument with no proprietary software dependency—data are recorded manually or via external logging systems. All measured values (velocity, temperature, computed volume, timestamps, and statistical outputs) can be transcribed into electronic batch records (EBRs) or LIMS-compatible spreadsheets. For facilities requiring 21 CFR Part 11 compliance, the instrument supports integration with validated third-party data acquisition platforms that provide audit trails, electronic signatures, and secure export functionality. Its deterministic response behavior (±3% + 0.03 m/s accuracy, 1 s velocity response) enables reliable correlation with computational fluid dynamics (CFD) model validation points during cleanroom commissioning.

Applications

• HEPA filter face velocity mapping per ISO 14644-3 Section B.4.2
• Supply air diffuser uniformity testing in Grade A laminar flow hoods and isolators
• Room air change rate verification (ACH) in Grade B/C background areas
• Pressure differential airflow balancing across anterooms and transfer hatches
• Post-maintenance HVAC performance requalification after filter replacement or duct modification
• Environmental monitoring program (EMP) support for trend analysis of airflow stability over time

FAQ

Is the KA25 suitable for ISO Class 5 (Grade A) laminar airflow verification?
Yes—the 0.01 m/s resolution and sub-0.1 m/s accuracy enable precise detection of velocity gradients across laminar flow work surfaces, meeting the ≤20% variation criterion specified in EU GMP Annex 1.

Can the probe be sterilized or cleaned with IPA or VHP?
The probe housing is compatible with 70% isopropyl alcohol wipe-downs; however, vaporized hydrogen peroxide (VHP) exposure is not recommended due to potential sensor drift from prolonged oxidative stress.

Does the instrument meet FDA 21 CFR Part 11 requirements out-of-the-box?
No—the KA25 lacks built-in electronic signature, audit trail, or user access controls. Compliance requires integration with validated data capture software and procedural controls per ALCOA+ principles.

What is the recommended recalibration interval?
Annual calibration against a NIST-traceable reference anemometer is advised per ISO/IEC 17025 and internal SOPs for regulated environments.

Can duct dimensions be saved for repeated measurements?
No—the KA25 does not store geometric presets; dimensions must be re-entered for each new duct measurement session.