Lasair III Optical Airborne Particle Counter

Overview

The Lasair III Optical Airborne Particle Counter is a high-precision, ISO 21501-compliant instrument engineered for real-time, quantitative monitoring of airborne particulate contamination in controlled environments. Based on the principle of single-particle light scattering (SPLS), it detects and sizes particles by measuring the intensity of laser light scattered as individual particles pass through a focused optical sensing zone. This method enables accurate, traceable particle counting across six user-selectable size channels, supporting compliance with critical international standards including ISO 14644-1 (cleanroom classification), EU GMP Annex 1, and FDA 21 CFR Part 11 for electronic records and signatures. Designed specifically for pharmaceutical manufacturing, biotechnology cleanrooms, semiconductor fabrication facilities, and aseptic processing suites, the Lasair III delivers metrologically robust data essential for environmental monitoring (EM) programs, qualification studies (IQ/OQ/PQ), and ongoing process validation.

Key Features

• Integrated Pulse Height Analyzer (PHA) ensures compliance with ISO 21501-4 for calibration accuracy and counting efficiency verification.
• Three flow rate options: 1.0 CFM (28.3 LPM), 50 LPM, or 100 LPM — enabling rapid sampling (e.g., 1 m³ acquisition in ≤10 minutes at 100 LPM).
• 8.4-inch color VGA infrared touch screen (IP65 rated) with intuitive graphical interface; supports nine selectable display and report languages.
• Chemical-resistant polyphenylene sulfide (PPS) housing with carbon nanotube reinforcement provides mechanical durability and minimal particle retention.
• Ultra-low-noise internal pump (<45 dBA) enhances operator comfort during extended monitoring sessions.
• Removable, hot-swappable lithium-ion battery pack — standard configuration supports up to 4 hours (single battery) or 8 hours (dual battery) of continuous operation.
• Onboard thermal printer and USB port enable immediate hard-copy reporting and offline data export without external peripherals.
• Full audit trail capability with immutable data storage: 3,000 complete sample records retained internally, each timestamped and non-editable per 21 CFR Part 11 requirements.

Sample Compatibility & Compliance

The Lasair III is validated for use with standard cleanroom sampling tubing (ID 3/8″, 1/2″, or 3/4″; max length 8 m per configuration) and operates within ambient conditions of 10–40 °C and 20–95% RH (non-condensing). Its counting efficiency meets or exceeds JIS B 9921:2010 specifications (50% ±10% at nominal channel thresholds), with maximum detectable concentration exceeding 200,000 particles/ft³ (for 100 LPM model). Calibration is NIST-traceable and JIS-compliant, supported by a comprehensive validation manual covering IQ/OQ protocols, sensor linearity verification, and zero-count performance testing per JIS standards. The system satisfies EU GMP Annex 1 requirements for continuous particle monitoring and supports formal cleanroom certification reporting aligned with ISO 14644-1 Class 1–9 classifications.

Software & Data Management

Data acquisition, visualization, and reporting are managed via embedded firmware and optional enterprise software platforms: Facility Net™ and Pharmaceutical Net™. Remote access is enabled through secure HTTP/HTTPS web browser control (IE 5.0+ compatible), allowing full configuration, real-time sampling initiation, live trend viewing, and historical data retrieval from any networked workstation. Communication interfaces include Ethernet (TCP/IP), RS-232 serial, and USB 2.0; optional wireless Ethernet module supports Wi-Fi-enabled deployment. All stored datasets include full metadata (sample ID, location tag, operator ID, environmental sensor inputs, calibration status) and support automated report generation compliant with ISO 14644-1 statistical analysis and EC GMP Annex 1 documentation templates. Audit trails record all user actions, parameter changes, and system events with time/date stamps and operator authentication.

Applications

• Continuous environmental monitoring (CEM) in Grade A/B pharmaceutical cleanrooms per EU GMP Annex 1.
• ISO 14644-1 cleanroom classification and re-certification surveys.
• Filter integrity testing and HVAC system performance validation.
• Particle challenge studies during aseptic process simulation (media fills).
• In-line monitoring of isolators, RABS, and gloveboxes.
• Contamination control investigations in semiconductor fabs and medical device manufacturing.
• Supporting FDA and EMA regulatory submissions requiring documented particulate data traceability.

FAQ

Is the Lasair III compliant with 21 CFR Part 11?
Yes — all internal data storage is tamper-evident and non-editable; user authentication, electronic signatures, and full audit trails are implemented per 21 CFR Part 11 Subpart B requirements.
What calibration standards does it support?
NIST-traceable polystyrene latex (PSL) spheres and JIS B 9921-compliant reference materials; calibration certificates include uncertainty budgets and traceability documentation.
Can it be integrated into a central monitoring system?
Yes — via Ethernet or optional wireless Ethernet, using Facility Net™ or Pharmaceutical Net™ for centralized data aggregation, alarm management, and automated reporting.
Does it support real-time remote monitoring?
Yes — through any modern web browser; users can configure sampling, view live counts, download data, and print reports remotely without proprietary client software.
What environmental sensors are built-in?
Four 4–20 mA analog inputs allow integration with external temperature, humidity, differential pressure, or airflow sensors for correlated environmental context in reports.