ATI iProbe Plus Aerosol Scanning Probe

Overview

The ATI iProbe Plus is a purpose-engineered aerosol scanning probe designed for high-integrity filter integrity testing in regulated cleanroom environments, pharmaceutical manufacturing facilities, and biomedical research laboratories. It operates on the principle of photometric aerosol detection—quantifying downstream particle concentration relative to upstream challenge aerosol (e.g., PAO, DOP, or equivalent test agents) using calibrated light-scattering photometry. Unlike legacy handheld probes, the iProbe Plus integrates real-time valve actuation, on-device data governance, and full traceability architecture to meet stringent quality assurance requirements under ISO 14644-3, EU GMP Annex 1, and USP <1207>. Its standalone operation eliminates dependency on external controllers during routine leak scanning, enabling rapid, operator-independent execution of HEPA and ULPA filter qualification and periodic requalification per ASTM F50-22 and IEST-RP-CC001.8.

Key Features

• Integrated touchscreen-controlled upstream/downstream/zero valve actuation—eliminates manual hose switching and reduces procedural error risk.
• On-device encrypted data storage supporting up to ~150,000 scan records; each record includes timestamp, operator ID, filter tag, scan path metadata, and quantitative leakage rate (%).
• Compliant with FDA 21 CFR Part 11 through password-protected configuration access, cryptographic data immutability, and system-generated electronic audit trails for all critical actions (e.g., time/date adjustment, data deletion, test parameter modification).
• Ruggedized mechanical design validated to IEC 60068-2-27 (10 drops from 1 m), IEC 60068-2-6 (1 h vibration at 10/100/200 Hz), and IEC 60068-2-14 (−20 °C to +70 °C thermal cycling), ensuring operational reliability in demanding production and validation environments.
• 4.3-inch high-contrast color touchscreen with intuitive UI—displays real-time maximum leakage %, filter identifier, elapsed scan time, and battery status without requiring host PC connection.
• USB-A interface enables secure firmware updates and direct export of CSV and PDF reports—no proprietary software or network dependency required.
• Ergonomic hand-held form factor with molded finger grooves and thumb rest, optimized for extended use during large-scale filter surveys.
• Patent-pending 10-second “rewind” function allows immediate reversal of accidental trigger events—preserving data continuity and reducing repeat-scan overhead.

Sample Compatibility & Compliance

The iProbe Plus is fully compatible with ATI’s 2i photometer platform (firmware v4.6.1 or later) and supports standard polyalphaolefin (PAO), di(2-ethylhexyl) sebacate (DEHS), and corn oil challenge aerosols per ISO 14644-3 Annex B and IEST-RP-CC001.8. It meets electromagnetic compatibility (EMC) requirements per IEC 61326-1 and carries CE marking for conformity with EU Machinery Directive 2006/42/EC and Low Voltage Directive 2014/35/EU. All stored test data comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and support GLP/GMP audit readiness. Device calibration verification is traceable to NIST-certified reference standards.

Software & Data Management

No host PC or dedicated application is required for operation or reporting. All data—including raw photometric response curves, calculated leakage percentages, and operator-entered identifiers—are stored locally in tamper-evident format. Each scan generates dual-format outputs: machine-readable CSV files for statistical process control (SPC) integration and human-readable PDFs containing header metadata, scan trajectory map (if applicable), and pass/fail determination per user-defined acceptance criteria. Export occurs via standard USB-A flash drive; no drivers or authentication tokens are needed. Firmware updates are performed offline using signed binary packages loaded from USB media—ensuring air-gapped deployment in classified or validated networks.

Applications

• HEPA/ULPA filter leak testing in ISO Class 5–8 cleanrooms per EU GMP Annex 1 and FDA guidance.
• Pre- and post-installation qualification of terminal filters in HVAC systems and isolators.
• Periodic requalification of critical process air filtration in aseptic filling lines and lyophilizer chambers.
• Validation support for sterilizing-grade filters used in bioprocess fluid handling (e.g., buffer, media, harvest streams).
• Root cause analysis of filter degradation through longitudinal leakage trend analysis across multiple scan cycles.
• Training and competency assessment of QA/QC technicians via standardized digital record generation and review.

FAQ

Is the iProbe Plus compatible with older 2i photometer units?
Yes—provided the 2i host runs firmware version 4.6.1 or higher. No hardware modifications or firmware updates to the 2i unit are required; the iProbe Plus operates as a plug-and-play accessory.
Can scan data be modified after saving?
No. All stored records are cryptographically sealed upon capture. Attempts to alter timestamps, leakage values, or operator IDs will invalidate the file signature and trigger audit log entries.
What regulatory standards does the device support for data integrity?
It satisfies core technical controls outlined in FDA 21 CFR Part 11 Subpart B (electronic records) and Annex 11 of the EU Commission’s Good Manufacturing Practice guidelines, including role-based access control, electronic signatures, and immutable audit trails.
How is calibration maintained?
The probe itself does not require field calibration. Its photometric response is factory-aligned to the connected 2i photometer, which undergoes annual NIST-traceable calibration per ATI’s service protocol.
Does the device support multi-language interfaces?
The current firmware supports English only; language localization is not available in this release.