ATI 2i Portable Aerosol Photometer

Overview

The ATI 2i Portable Aerosol Photometer is a precision-engineered instrument designed for quantitative integrity testing of high-efficiency particulate air (HEPA) and ultra-low penetration air (ULPA) filtration systems in regulated environments. Operating on the principle of light scattering photometry, the 2i detects and quantifies airborne aerosol concentration downstream of filters by measuring the intensity of light scattered by particles—typically polyalphaolefin (PAO-4), di-octyl phthalate (DOP), or DEHS—introduced upstream as a challenge agent. Its optical architecture employs a solid-state light source and optimized detector geometry to ensure stable signal response across its full dynamic range (0.0001–120 mg/m³), enabling reliable detection of leaks as small as 0.01% of total upstream concentration. The system is purpose-built for compliance-driven applications in pharmaceutical manufacturing, hospital cleanrooms, biosafety cabinets (BSCs), fume hoods, nuclear facilities, and aerospace clean environments where regulatory adherence and measurement traceability are non-negotiable.

Key Features

• Integrated iProbe Plus scanning probe with 4.3-inch color touchscreen, enabling full control of upstream/downstream sampling valves and zeroing functions directly from the probe handle—eliminating manual valve actuation at the main unit (patented design)
• 21 CFR Part 11–compliant data management: encrypted storage, role-based password authentication, electronic signatures, and immutable audit trails for all scan events
• ATI CALIBRA™ 800 aerosol generation system with gravimetric calibration traceability and automated multi-point linearity verification (LVT), ensuring metrological rigor across the entire operational range
• Ergonomic probe design with thumb rest, finger grooves, and real-time display of critical parameters—including maximum leak percentage, filter ID, elapsed scan time, and pass/fail status
• On-device “10-second rewind” function (patent-pending) to discard accidental alarm triggers without interrupting workflow or compromising data continuity
• Firmware updates via standard USB-A flash drive—no proprietary software or network dependency required
• Thermal printer and dual-format (CSV + PDF) export support for immediate reporting and long-term archival in accordance with GLP/GMP documentation standards

Sample Compatibility & Compliance

The 2i supports a broad spectrum of test aerosols approved under international standards, including PAO-4, DOP, DOS/DEHS, Ondina, PEG, Krydol, corn oil, mineral oil, and paraffin. Its flow control system maintains a precise 28.3 L/min (1 ft³/min) sampling rate ±10%, meeting the volumetric requirements specified in ISO 14644-3, NSF/ANSI 49, IEST-RP-CC034, and EN 12469. Electrical safety and electromagnetic compatibility conform to EN 61010-1:2010 (measurement category II), EN 61326-1:2006, CE, UKCA, FCC Part 15 Subpart B, and ISED Canada ICES-003 Issue 7. For nuclear and ASME-regulated applications, the optional 2i-N variant includes a sealed sample cart and full compliance with ASME AG-1, ASME NQA-1, and ASME Section III Division 1 requirements.

Software & Data Management

All scan data generated by the 2i—when paired with iProbe Plus—is stored locally with cryptographic integrity. Each record contains a unique identifier, operator ID, room/filter designation, timestamp, maximum leakage percentage, effective scan duration, alarm event log, and final pass/fail determination. Data retention capacity exceeds 150,000 scans. Exported CSV files are structured for direct import into LIMS or QA databases; PDF reports include embedded digital signatures and tamper-evident metadata. Audit trail functionality satisfies FDA 21 CFR Part 11 requirements for electronic records and signatures, including user action logging, system-generated timestamps, and protected history of all modifications. No cloud dependency or third-party server access is required—data sovereignty remains fully under end-user control.

Applications

The 2i serves as the primary verification tool for HEPA/ULPA filter integrity in GMP-compliant pharmaceutical production suites, aseptic processing isolators, and sterile compounding facilities. It is routinely deployed for routine certification of biosafety cabinets (Class II and III), laminar flow hoods, cleanroom supply and exhaust ductwork, and HVAC terminal filters per ISO 14644-3 Annex B. In healthcare settings, it supports Joint Commission and CMS-mandated ventilation system validation in operating rooms and isolation wards. Nuclear laboratories utilize the 2i-N configuration for containment verification in gloveboxes and hot cells under ASME NQA-1 quality assurance programs. Its portability and battery-ready architecture (with optional external power bank) also enable rapid-response leak surveys during commissioning, requalification, or post-maintenance verification.

FAQ

Does the 2i require annual recalibration by an accredited lab?
Yes. While the built-in CALIBRA™ system enables daily verification and multi-point linearity checks, ATI recommends annual full-scale calibration performed by an ISO/IEC 17025-accredited laboratory using NIST-traceable reference standards.
Can the 2i be used with alternative aerosols not listed in the manual?
Only aerosols explicitly validated and referenced in ATI’s technical documentation—such as PAO-4, DOP, DEHS, and corn oil—are supported for compliant testing. Substitution requires documented equivalency studies per ISO 14644-3 Annex C.
Is remote firmware update possible over Wi-Fi or Bluetooth?
No. Firmware updates are exclusively performed via USB-A flash drive to maintain air-gapped security and prevent unauthorized modification in regulated environments.
What is the expected lifetime of the photometric sensor and light source?
The solid-state light source and silicon photodetector are rated for ≥10,000 hours of continuous operation with no degradation in linearity or sensitivity when operated within specified environmental conditions (15–30°C, <80% RH non-condensing).
How does the 2i handle ambient light interference during scanning?
The optical chamber incorporates spectral filtering and modulated detection circuitry to reject ambient photons outside the 650–670 nm emission band, ensuring immunity to fluorescent, LED, and daylight sources during field use.