ATI TDA-100 Aerosol Dilutor

Overview

The ATI TDA-100 Aerosol Dilutor is a precision-engineered, benchtop gas-phase dilution device designed for controlled attenuation of high-concentration aerosol challenges in cleanroom validation, filter integrity testing, and airborne particle characterization workflows. Operating on the principle of laminar-flow proportional dilution, the TDA-100 introduces a precisely metered stream of clean, particle-free air (typically HEPA- or ULPA-filtered) into the primary aerosol flow path via calibrated orifices and pressure-balanced mixing chambers. This ensures stoichiometric dilution without turbulent dispersion, agglomeration, or wall deposition—critical for maintaining aerosol size distribution fidelity across the full operational range (typically 0.1–5.0 µm). The unit is intended for integration between an aerosol generator (e.g., TDA-4B, TDA-9HA, or equivalent) and a 28.3 L/min optical particle counter (OPC), enabling quantifiable challenge concentrations within the linear response range of downstream instrumentation while preserving counting accuracy and statistical confidence.

Key Features

• Two fixed dilution ratios: 10:1 and 100:1, selected via internal valve configuration—no external calibration required
• Minimal pressure drop (< 250 Pa at 28.3 L/min), reducing backpressure on upstream generators and minimizing flow instability
• Low-loss internal geometry with electropolished stainless-steel and fluoropolymer-wetted surfaces to suppress particle adhesion and electrostatic retention
• Modular design allows series connection of two TDA-100 units for extended dilution ranges (e.g., 1000:1), supporting ultra-low concentration validation protocols
• Compatible with all industry-standard 28.3 L/min particle counters (e.g., Met One GT-526, Climet CI-450, TSI 3350/3360) via ISO 5632-1 compliant 3/4″ Swagelok® or VCR® fittings
• No moving parts or electronic components—passive operation ensures long-term reliability and eliminates electromagnetic interference in sensitive test environments

Sample Compatibility & Compliance

The TDA-100 is validated for use with polydisperse and monodisperse test aerosols including Polystyrene Latex (PSL) spheres (0.1–5.0 µm), Di-Octyl Phthalate (DOP), Polyalphaolefin (PAO), and sodium chloride (NaCl) dry powder aerosols. Its inert wetted path meets USP and ISO 14644-3 requirements for pharmaceutical cleanroom certification. When deployed in ISO 14644-1 classified environments or FDA-regulated facilities, the dilutor supports GMP-compliant filter leak testing per IEST-RP-CC034.2 and EN 1822-4, where accurate, repeatable challenge concentration delivery is essential for HEPA/ULPA filter qualification. No regulatory submission requires device-specific software validation; however, its passive architecture inherently satisfies 21 CFR Part 11 data integrity principles when paired with compliant OPCs featuring audit-trail-enabled firmware.

Software & Data Management

As a purely mechanical dilution device, the TDA-100 does not incorporate embedded firmware, control software, or digital interfaces. All operational parameters are defined by physical orifice geometry and inlet pressure differentials—ensuring deterministic performance independent of firmware version or network connectivity. Integration into automated test systems relies solely on upstream aerosol generator control (e.g., ATI AeroTrak® software) and downstream OPC data acquisition platforms (e.g., TSI FMS, Climet IQ-Link). Traceability is maintained through documented installation qualification (IQ), operational qualification (OQ), and periodic verification using NIST-traceable PSL standards and calibrated flow meters per ISO 21501-4.

Applications

• HEPA and ULPA filter integrity testing in pharmaceutical manufacturing, biotech cleanrooms, and hospital isolation suites
• Calibration and linearity verification of optical particle counters operating at low-concentration thresholds
• Aerosol transport studies requiring precise mass or number concentration reduction without altering size distribution
• Validation of containment systems (e.g., isolators, gloveboxes) per ISO 14644-7 and ASTM E2952
• Respirator fit-testing equipment qualification where controlled NaCl or PAO challenge levels must be reproducibly delivered
• Research applications involving aerosolized therapeutics, nanomaterials, or viral surrogate particles under GLP conditions

FAQ

Does the TDA-100 require electrical power or compressed air?

No—it operates passively using differential pressure between the aerosol source and ambient or vacuum-driven particle counter inlet.
Can the dilution ratio be adjusted continuously?

No—only discrete 10:1 and 100:1 configurations are factory-set; variable-ratio dilution requires alternative instrumentation such as thermal mass-flow-controlled systems.
Is the TDA-100 suitable for corrosive or reactive aerosols?

Only with prior consultation and optional material upgrades (e.g., Hastelloy C-276 wetted parts); standard configuration is rated for organic vapors and non-oxidizing particulates.
How often should the TDA-100 be verified for performance?

Annually or after any physical impact or cleaning procedure; verification involves flow rate measurement at inlet/outlet ports and aerosol transmission efficiency testing using PSL reference standards.
Does ATI provide IQ/OQ documentation support?

Yes—ATI supplies a comprehensive User Qualification Guide (UQG) containing protocol templates, acceptance criteria, and traceable calibration references aligned with ISO/IEC 17025-accredited laboratories.