KANOMAX 65 Series Intelligent Environmental Monitor for Pharmaceutical Cleanrooms
| Brand | KANOMAX |
|---|---|
| Origin | Japan |
| Model | 65 Series |
| Instrument Type | Thermal Anemometer |
| Resolution | 0.01 m/s (wind speed) |
| Measurement Range | Wind Speed – dependent on probe selection (e.g., 0.01–30 m/s typical for cleanroom probes) |
| Temperature | –20 to +70 °C |
| Relative Humidity | 2.0–98.0 % RH |
| Differential Pressure | ±5.00 kPa |
| Accuracy | Wind Speed: ±2% of reading or ±0.015 m/s (whichever is greater) |
| Temperature | ±0.5 °C |
| Humidity | ±2.0 % RH (2–80 % RH), ±3.0 % RH (80–98 % RH) |
| Pressure | ±3% of reading |
| Operating Environment | –20 to +70 °C, 2.0–98.0 % RH |
| Data Storage Capacity | 20,000 records |
| Communication Interface | USB |
| Analog Output | 0–1 V |
| Power Supply | 6 × AA alkaline batteries or optional AC adapter |
| Dimensions | 88 × 188 × 41 mm |
| Weight | 400 g |
| Probe Compatibility | 8 interchangeable thermal anemometer probes (e.g., straight, bent, retractable, multi-point array) |
| Data Functions | Real-time hold, statistical calculation (mean, max, min), cross-sectional area input for volumetric airflow derivation |
Overview
The KANOMAX 65 Series Intelligent Environmental Monitor is a purpose-engineered portable instrument designed specifically for validation, routine monitoring, and qualification of controlled environments in pharmaceutical cleanrooms (ISO 14644-1 Class 5–8, EU GMP Annex 1). It operates on the constant-temperature anemometry (CTA) principle—measuring convective heat transfer from a heated sensor element to quantify air velocity with high temporal resolution and low-flow sensitivity. Integrated temperature, relative humidity, and differential pressure sensors enable simultaneous multi-parameter acquisition critical for HVAC performance verification, filter integrity assessment, and unidirectional airflow characterization. Its compact form factor, battery-operated architecture, and probe interchangeability support rapid deployment across laminar flow hoods, isolators, RABS, and supply/exhaust ducts—ensuring compliance with regulatory expectations for environmental data integrity.
Key Features
- Simultaneous real-time measurement of air velocity, temperature, relative humidity, and differential pressure—eliminating sequential instrument switching and reducing operator-induced variability.
- Probe-flexible platform supporting eight certified KANOMAX thermal anemometer probes, including straight-tip, 90° bent, telescopic, and multi-sensor array variants optimized for duct traverses, glove port access, and ISO 14644-3 recommended grid sampling.
- On-device volumetric airflow calculation: users input duct geometry (rectangular, circular, or irregular cross-section) and the instrument computes average velocity × area, outputting m³/h or CFM with traceable arithmetic logic.
- Embedded statistical engine performing live calculation of mean, maximum, and minimum values over user-defined intervals—essential for ISO 14644-3 airflow uniformity reporting and trend analysis.
- 20,000-point internal memory with timestamped records (date/time, parameter values, probe ID), exportable via USB to CSV or proprietary KANOMAX software for audit-ready reporting.
- Compliant analog output (0–1 V) for integration into building management systems (BMS) or continuous monitoring platforms requiring analog signal inputs.
Sample Compatibility & Compliance
The 65 Series is validated for use with KANOMAX-certified cleanroom probes calibrated per ISO/IEC 17025-accredited procedures. Its measurement uncertainty budget aligns with ASTM D1071 (air velocity in ducts), ISO 14644-3 Annex B (cleanroom airflow testing), and EU GMP Annex 1 §4.22–4.25 requirements for environmental control system verification. The instrument’s operating range (–20 to +70 °C, 2–98 % RH) ensures stable performance during cold storage room qualification and high-humidity incubator chamber assessments. All firmware and data handling routines support ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), facilitating 21 CFR Part 11 readiness when paired with validated software workflows.
Software & Data Management
Data export via USB enables seamless import into KANOMAX’s PC-based analysis suite (KANOMAX Data Manager v3.x), which supports automated report generation compliant with ISO 14644-3 test plans. The software provides graphical time-series plots, statistical summaries, pass/fail flagging against user-defined limits, and PDF/Excel export with embedded metadata (operator ID, location tag, calibration due date). Audit trail functionality logs all data modifications, user logins, and configuration changes—meeting GLP/GMP documentation standards for regulated environments.
Applications
- Airflow velocity mapping across HEPA-filtered supply diffusers and return grilles in Grade A/B cleanrooms.
- Volumetric airflow verification in supply/exhaust ducts during commissioning, qualification (IQ/OQ/PQ), and periodic requalification.
- Temperature and humidity stability profiling in stability chambers and environmental simulation rooms.
- Differential pressure gradient monitoring between adjacent classified zones (e.g., Grade C to Grade D corridors).
- Filter leak testing support via upstream/downstream velocity comparison in conjunction with particle counters.
- Environmental baseline establishment for risk-based monitoring (RBM) programs aligned with ICH Q5, Q9, and Q10 frameworks.
FAQ
Is the 65 Series suitable for ISO 14644-3 cleanroom certification testing?
Yes—the instrument meets the metrological requirements for air velocity and uniformity measurements specified in ISO 14644-3 Annex B, particularly when used with KANOMAX’s NIST-traceable probe calibration certificates.
Can the device store data without a connected PC?
Yes—it retains up to 20,000 timestamped records internally, including parameter values, probe identification, and user-defined location tags.
Does it support 21 CFR Part 11-compliant electronic records?
The hardware itself is Part 11–capable; full compliance requires implementation of validated software controls, audit trails, and electronic signatures using KANOMAX Data Manager in a validated environment.
What probe types are recommended for ISO Class 5 laminar flow workstations?
The KANOMAX 6511 (straight 100-mm probe) and 6512 (90° bent probe) are most commonly deployed for vertical/horizontal laminar flow hood velocity profiling per ISO 14644-3 Section B.3.
How often does the unit require recalibration?
Annual recalibration against accredited standards is recommended; KANOMAX provides ISO/IEC 17025-certified recalibration services with full uncertainty reporting.
