ATI 4B Laskin Nozzle Aerosol Generator

Overview

The ATI 4B Laskin Nozzle Aerosol Generator is an engineered solution for generating reproducible, polydisperse, submicron aerosols in controlled environmental and industrial testing applications. Based on the well-established Laskin nozzle principle—where pressurized air shears liquid through precision-machined orifices to produce a stable, multi-modal droplet distribution—the 4B model delivers consistent aerosol output across a wide airflow range (405–8,100 CFM). It is specifically designed for in-situ challenge testing of high-efficiency particulate air (HEPA) and ultra-low penetration air (ULPA) filtration systems, including those installed in cleanrooms, biological safety cabinets (BSCs), fume hoods, gloveboxes, nuclear containment enclosures, pharmaceutical isolators, and hospital ventilation systems. Its operation aligns with established test protocols referenced in ISO 14644-3, IEST-RP-CC001, NSF/ANSI 49, and USP , ensuring compatibility with regulatory validation frameworks.

Key Features

• True Laskin III-A compliant aerosol generation: Produces repeatable, polydisperse aerosol with a mass median aerodynamic diameter (MMAD) typically centered near 0.7–0.9 µm when using PAO-4 (polyalphaolefin) or equivalent test agents.
• Adjustable aerosol concentration output: Capable of delivering challenge concentrations from 10 µg/L to 100 µg/L across its full airflow range, enabling precise tailoring to filter integrity test sensitivity requirements.
• Robust stainless-steel construction: Fully welded 304 stainless steel housing ensures corrosion resistance, structural integrity, and long-term reliability under repeated sterilization or decontamination cycles.
• Integrated pressure and flow control: Equipped with calibrated pressure regulators, needle valves, and visual flow indicators for stable, operator-controlled aerosol delivery.
• Large fill port and sanitary 3-inch tri-clamp outlet: Facilitates rapid refilling and hygienic connection to ductwork or test manifolds; compatible with standard cleanroom-grade piping systems.
• Modular accessory support: Designed to accept optional hose adapter kits (sold separately) for remote aerosol injection into complex duct networks or hard-to-reach locations.

Sample Compatibility & Compliance

The ATI 4B is validated for use with industry-standard test aerosols including PAO-4, DOP (di-octyl phthalate), DOS (di-ethylhexyl sebacate), and mineral oil-based agents. It meets mechanical and performance criteria outlined in ISO 29463-4 (for HEPA/ULPA filter testing), IEST-RP-CC034.2 (aerosol generators for cleanroom certification), and ASTM F50 (standard practice for continuous monitoring of airborne particles). Its design supports GLP-compliant documentation workflows and integrates seamlessly into FDA 21 CFR Part 11–aligned validation protocols when paired with compliant data acquisition systems and audit-trail-enabled software.

Software & Data Management

While the ATI 4B operates as a standalone, analog-controlled generator without embedded firmware or digital interfaces, it is routinely deployed alongside certified photometric aerosol photometers (e.g., ATI TDA-9200 series) and automated data logging platforms. When integrated into validated qualification systems, its operational parameters—including inlet pressure, liquid reservoir level, and airflow rate—are manually recorded or captured via external sensors and logged in electronic batch records (EBRs) that comply with GMP Annex 11 and ALCOA+ data integrity principles. Optional calibration certificates traceable to NIST standards are available upon request.

Applications

• In-place HEPA/ULPA filter leak testing per ISO 14644-3 and EU GMP Annex 1.
• Performance qualification of biosafety cabinets (BSCs) and fume hoods according to NSF/ANSI 49 and EN 12469.
• Filter integrity verification in pharmaceutical aseptic processing suites and isolator systems.
• Challenging ventilation systems in radiological containment facilities and critical infrastructure environments.
• Calibration and verification of aerosol detection instrumentation, including optical particle counters and condensation particle counters (CPCs).
• Research-grade aerosol exposure studies requiring stable, quantifiable submicron challenge conditions.

FAQ

What test agents are compatible with the ATI 4B generator?

PAO-4, DOP, DOS, and mineral oil-based aerosol agents are approved for use, provided they meet viscosity and volatility specifications defined in IEST-RP-CC034.2.
Does the 4B require electrical power?

No—it is pneumatically driven and requires only a clean, dry, oil-free compressed air supply at 80–120 psi.
Can the 4B be used in classified cleanroom environments?

Yes—its stainless-steel construction, absence of moving electrical components, and tri-clamp interface make it suitable for ISO Class 5 and higher environments when properly decontaminated.
Is the 4B compliant with FDA 21 CFR Part 11 requirements?

The unit itself is not digitally regulated; however, its use within a validated system—including documented operating procedures, calibration logs, and electronic data capture—supports Part 11 compliance.
What maintenance is required?

Routine cleaning of nozzles and reservoir after each agent change; annual inspection of seals, pressure gauges, and flow controls per manufacturer’s maintenance schedule.