TSI 9306-V Handheld Optical Particle Counter

Overview

The TSI 9306-V Handheld Optical Particle Counter is a precision-engineered instrument designed for real-time, quantitative monitoring of airborne particulate contamination in cleanrooms, controlled environments, and critical manufacturing processes. It operates on the principle of light scattering—where particles drawn through a focused laser beam scatter light proportionally to their size—and converts this signal into calibrated particle counts per unit volume. Engineered to meet the stringent metrological requirements of ISO 21501-4, the 9306-V delivers traceable, repeatable measurements across six user-selectable size channels from 0.3 µm to 10 µm. Its 2.83 L/min (0.1 ft³/min) volumetric flow rate is maintained via closed-loop electronic flow control, ensuring compliance with international sampling standards. The device is routinely factory-calibrated using NIST-traceable polystyrene latex (PSL) spheres and validated against TSI’s proprietary aerosol calibration infrastructure—including differential mobility analyzers and condensation particle counters—establishing metrological continuity from primary standards to field deployment.

Key Features

• User-configurable six-channel detection: Select any combination of six size thresholds within the 0.3–10 µm range, including standard configurations (e.g., 0.3/0.5/1.0/3.0/5.0/10.0 µm) or custom binning optimized for specific process validation needs.
• Ergonomic handheld architecture: Integrated contoured grip and thumb-actuated interface enable stable single-hand operation during extended walk-through surveys or point-of-use verification.
• QVGA 9.1 cm color touchscreen: High-contrast, capacitive display supports intuitive menu navigation, real-time data visualization, and on-device report generation—even under variable ambient lighting conditions.
• Dual communication interfaces: Simultaneous USB 2.0 and Ethernet connectivity support both local data transfer and networked configuration via Modbus® RTU protocol, enabling integration into facility monitoring systems (FMS) and centralized data archives.
• Robust environmental resilience: Operates reliably at 5–35 °C and up to 95% non-condensing relative humidity; housing constructed from high-impact polymer with IP54-rated ingress protection for dust and splash resistance.
• Extended data autonomy: Internal memory stores up to 10,000 complete sample records—including timestamp, location ID (999 programmable slots), six-channel counts, flow rate, and pass/fail status—without external storage media.

Sample Compatibility & Compliance

The 9306-V is validated for use in ISO Class 3–8 cleanrooms and regulated pharmaceutical, semiconductor, and medical device production environments. Its optical design and counting efficiency curve—50% at 0.3 µm, ≥98% above 0.45 µm—conform strictly to ISO 21501-4 and JIS B9921. Zero-count stability (<1 count per 5 minutes) and flow accuracy (±5% of 2.83 L/min) are verified per ISO 21501-4 Annex A. Instrument outputs satisfy statistical reporting requirements for ISO 14644-1 (cleanroom classification), EU GMP Annex 1 (sterile manufacturing), and FS209E (legacy U.S. standard). Optional temperature and humidity probes (TSI Part No. 9701) allow concurrent environmental parameter logging, supporting holistic environmental monitoring programs aligned with FDA 21 CFR Part 11 and EU Annex 11 data integrity expectations.

Software & Data Management

The 9306-V is fully compatible with TSI’s TrakPro™ Lite (local analysis and report export) and FMS 5 (enterprise-level facility monitoring system) software suites. TrakPro™ Lite enables post-processing of stored datasets—including statistical analysis, trend charting, and automated ISO 14644-1 compliance assessment—with configurable pass/fail thresholds and audit-trail-enabled user authentication. All exported reports include instrument ID, calibration date, operator credentials, and full metadata required for GLP/GMP documentation. Data transmission via USB or Ethernet preserves raw channel counts and timestamps without loss of resolution. Firmware updates and remote configuration—including IP address assignment, language selection (English, German, French, Spanish, Italian, Japanese, Simplified Chinese), and alarm threshold definition—are supported over Ethernet without physical access to the device.

Applications

• Cleanroom qualification and routine monitoring per ISO 14644-1 and EU GMP Annex 1
• Filter integrity testing and HEPA/ULPA performance verification
• Environmental monitoring in aseptic processing suites and isolators
• Contamination source identification during root cause investigations
• Process equipment validation (e.g., filling lines, lyophilizers, gloveboxes)
• ISO Class 5–8 certification audits and requalification campaigns
• Facility commissioning and periodic surveillance in semiconductor fabs and biotech labs

FAQ

What calibration standards does the 9306-V follow?
The instrument is calibrated using NIST-traceable PSL spheres and verified against TSI’s ISO 21501-4–compliant reference instrumentation. Annual recalibration is recommended to maintain metrological traceability.
Can the 9306-V be integrated into an existing FMS?
Yes—via Modbus® RTU over Ethernet, it transmits real-time particle counts, flow status, and alarm states to third-party SCADA or FMS platforms compliant with Modbus TCP/RTU protocols.
Is the internal battery replaceable in the field?
Yes—the rechargeable lithium-ion battery is user-removable and hot-swappable; spare batteries (TSI Part No. 9702) are available as optional accessories.
Does the device support multi-location sampling with automatic ID tagging?
Yes—up to 999 unique location IDs (16-character alphanumeric) can be pre-programmed; each sample record embeds the assigned location, timestamp, and operator ID when enabled.
How is data integrity ensured for regulated environments?
TrakPro™ Lite supports electronic signatures, password-protected configuration changes, and time-stamped audit logs—features aligned with FDA 21 CFR Part 11 and EU Annex 11 requirements for electronic records and signatures.