Particle Measuring Systems Lasair III Portable Airborne Particle Counter

Overview

The Particle Measuring Systems (PMS) Lasair III is a high-precision, handheld airborne particle counter engineered for compliance-driven environmental monitoring in regulated pharmaceutical, biotechnology, semiconductor, and medical device manufacturing facilities. It operates on the principle of light scattering—using a high-stability 650 nm laser diode to illuminate individual particles suspended in sampled air; scattered photons are detected by a low-noise photodiode and processed via an onboard Pulse Height Analyzer (PHA) to assign particles to user-defined size channels with traceable resolution. Designed to meet ISO 21501-4:2018 requirements for optical particle counters, the Lasair III delivers metrologically sound data essential for ISO 14644-1/2 classification, EU GMP Annex 1, USP , and FDA 21 CFR Part 11–compliant environments. Its modular flow architecture supports three certified volumetric flow rates—28.3 L/min (1 CFM), 50 L/min, and 100 L/min—enabling both routine surveillance and full-scale cleanroom certification per ISO 14644-3.

Key Features

• Triple-flow flexibility: Selectable 28.3, 50, or 100 L/min sampling rates—each independently calibrated and NIST-traceable.
• ISO 21501-4-compliant PHA electronics with real-time pulse amplitude discrimination for accurate multi-channel sizing (e.g., ≥0.3 µm, ≥0.5 µm, ≥1.0 µm, ≥5.0 µm).
• Rugged, chemically resistant enclosure with smooth, non-porous surfaces minimizing particle adhesion and facilitating ISO 14644-2–aligned cleaning protocols.
• Integrated 7-inch infrared capacitive touchscreen with glove-compatible UI, supporting multilingual operation and context-sensitive help.
• Built-in audit trail with time-stamped event logging (power cycles, calibration changes, parameter edits) meeting ALCOA+ principles for data integrity.
• Optional HPD III High-Pressure Diffuser enables direct sampling from compressed air lines up to 100 psi—critical for verifying Grade A/B compressed gas purity per ISO 8573-1 and PDA TR29.

Sample Compatibility & Compliance

The Lasair III is validated for continuous or discrete sampling of ambient air, laminar flow hoods, isolators, and compressed gases (with HPD III). It complies with international standards including ISO 14644-1 (cleanroom classification), ISO 14644-2 (monitoring requirements), ISO 21501-4 (instrument performance), and EU GMP Annex 1 (2022 revision) for viable and non-viable particle control. All firmware and calibration certificates are generated under a documented quality management system aligned with ISO 9001 and ISO/IEC 17025. Data output formats (CSV, PDF reports) support integration into validated environmental monitoring systems (EMS) and satisfy 21 CFR Part 11 requirements when deployed with appropriate electronic signature controls.

Software & Data Management

The Lasair III operates standalone or integrates seamlessly with PMS EnviroTrak™ software for centralized data aggregation, trend analysis, and automated report generation. Raw count data—including timestamp, location ID, operator ID, flow rate, and channel-specific concentrations—is stored internally with 16 GB of encrypted flash memory. All data exports include embedded metadata required for regulatory submissions. The instrument’s firmware supports secure over-the-air (OTA) updates verified via SHA-256 signatures. Audit trails record every configuration change, calibration action, and user login, with exportable logs formatted for GLP/GMP audits.

Applications

• Cleanroom qualification and routine monitoring in Grade A–D environments per EU GMP and FDA guidance.
• Compressed air and nitrogen system validation per ISO 8573-1 Class 1–3 specifications.
• Filter integrity verification through upstream/downstream particle challenge testing.
• Process simulation studies (e.g., aseptic filling line monitoring during media fills).
• Environmental baseline establishment and excursion investigation in controlled manufacturing areas.
• Support for ISO/IEC 17025-accredited laboratory particle counting services.

FAQ

Does the Lasair III require annual recalibration?
Yes—annual recalibration against NIST-traceable polystyrene latex (PSL) standards is recommended and documented per ISO/IEC 17025 procedures. Calibration certificates include uncertainty budgets for all reported parameters.
Can it be used for compressed gas monitoring without the HPD III accessory?
No—direct connection to pressurized gas lines requires the HPD III High-Pressure Diffuser to ensure laminar flow, pressure regulation, and particle resuspension control per ISO 8573-1 Annex B.
Is the touchscreen compatible with sterile gloved operation in Grade A zones?
Yes—the infrared capacitive interface responds reliably through standard nitrile and sterile polyethylene gloves, eliminating the need for stylus-based interaction in aseptic settings.
How is data integrity ensured during power loss or unexpected shutdown?
All measurements are written to non-volatile memory in real time; no data is held solely in RAM. Power-fail recovery preserves session state and resumes logging from the last confirmed timestamp.
Does the Lasair III support 21 CFR Part 11 compliant electronic signatures?
When integrated with validated EMS platforms using PMS-certified middleware, full Part 11 compliance—including role-based access, biometric or PKI-based e-signatures, and immutable audit trails—is achievable.