PMS Lasair Pro Portable Airborne Particle Counter

Overview

The PMS Lasair Pro Portable Airborne Particle Counter is a high-performance, handheld instrument engineered for real-time monitoring of airborne particulate contamination in critical environments. Utilizing light scattering detection principles—where particles passing through a focused laser beam generate scattered photons proportional to their size—the Lasair Pro delivers rapid, quantitative measurements across multiple user-selectable size channels (e.g., ≥0.3 µm, ≥0.5 µm, ≥1.0 µm, ≥5.0 µm). Designed for ISO Class 5–8 cleanrooms, pharmaceutical manufacturing suites, aseptic processing isolators, and controlled laboratory spaces, it supports continuous environmental monitoring (CEM) strategies aligned with EU GMP Annex 1 (2022), ISO 14644-1:2015, and FDA Guidance for Industry on Sterile Drug Products. Its compact form factor, integrated battery, and ergonomic grip enable mobility without compromising measurement integrity or regulatory traceability.

Key Features

• High-flow sampling at 1.0 CFM (28.3 L/min), enabling statistically robust data collection per ISO 14644-1 sampling plans with reduced dwell time per location
• Touchscreen interface with intuitive, icon-driven menu navigation—designed for glove-compatible operation in cleanroom settings
• Full-color LCD display with dynamic status indicators (e.g., flow stability, battery level, alarm thresholds, Wi-Fi/Ethernet connectivity)
• Chemically resistant enclosure compliant with USP and disinfectant protocols—including compatibility with 70% IPA, hydrogen peroxide vapor (HPV), and quaternary ammonium compounds
• Integrated dual communication architecture: 10/100 Mbps Ethernet port + IEEE 802.11 b/g/n Wi-Fi for remote configuration, real-time data streaming, and centralized fleet management
• Built-in non-volatile memory (≥16 GB) with automatic timestamped logging, supporting audit-ready data retention for GLP/GMP compliance

Sample Compatibility & Compliance

The Lasair Pro is validated for use with ambient air, compressed gases (including nitrogen and filtered compressed air), and HVAC supply/exhaust streams under controlled pressure differentials. It meets IEC 61000-4 electromagnetic compatibility requirements and operates within temperature (10–30 °C) and relative humidity (10–95% RH, non-condensing) ranges typical of regulated facilities. All firmware and data handling modules are designed to satisfy FDA 21 CFR Part 11 requirements—including electronic signatures, role-based access control, audit trail generation (with immutable timestamps and operator IDs), and data encryption at rest and in transit. Calibration is traceable to NIST SRM 1930 and performed per ISO 21501-4:2018 using polystyrene latex (PSL) reference particles.

Software & Data Management

The instrument interfaces natively with PMS’s validated ParticleTrack™ software suite (v5.2+), which provides comprehensive data visualization, trend analysis, deviation alerting, and automated report generation (PDF/CSV/XLSX). Raw datasets include full metadata: location ID, operator ID, sampling duration, flow rate, temperature/humidity (via optional external sensor input), and instrument serial number. Software supports ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and facilitates seamless integration into MES, LIMS, or SCADA systems via OPC UA or RESTful API endpoints. Audit trails are retained for ≥30 years and exportable in FDA-compliant formats.

Applications

• Environmental monitoring during aseptic filling operations and lyophilization cycles
• Routine qualification and requalification of cleanrooms and isolators per ISO 14644-2
• Investigation of particle excursions and root cause analysis (RCA) in contamination events
• Validation of HEPA filter integrity and airflow patterns (smoke studies)
• Monitoring of compressed gas quality per ISO 8573-1 Class 1–3 specifications
• Supporting risk-based monitoring (RBM) frameworks under ICH Q9 and Q10 guidelines

FAQ

Is the Lasair Pro compliant with 21 CFR Part 11 out-of-the-box?
Yes—firmware v3.8.2 and later includes fully enabled electronic signature workflows, system-level audit trails, and configurable user roles meeting all technical and procedural requirements of 21 CFR Part 11.
Can the instrument be calibrated in-house?
No—calibration must be performed by an ISO/IEC 17025-accredited service provider using NIST-traceable PSL standards; however, field verification checks using zero-count and challenge aerosols are supported.
What is the maximum allowable operating altitude?
The Lasair Pro is rated for operation up to 2,500 meters above sea level, with automatic pressure compensation applied to volumetric flow calculations.
Does it support multi-point sequential sampling?
Yes—via ParticleTrack™ scheduler, users can define location-specific sampling sequences, durations, and frequency intervals for unattended deployment across up to 128 predefined zones.
How is data security enforced during Wi-Fi transmission?
All wireless communications use WPA2-Enterprise authentication with TLS 1.2 encryption; no data is stored on intermediate access points or cloud relays unless explicitly configured in a validated private network environment.