TSE Systems Aerosol & Vapor Generation System

Overview

The TSE Systems Aerosol & Vapor Generation System (AVGS-Series) is a modular, research-grade platform engineered for precise, reproducible generation of inhalable challenge agents in controlled laboratory environments. Designed explicitly for inhalation toxicology and respiratory pharmacology studies, the system operates on well-established physical principles—including pneumatic dispersion, ultrasonic atomization, thermal vaporization, and controlled pyrolysis—to produce aerosols (solid particulates, liquid droplets, or engineered nanoparticles) and vapors (volatile organic compounds, solvents, or thermally labile substances) with defined mass concentration, particle size distribution (PSD), and temporal stability. Its architecture supports integration into whole-body or nose-only exposure chambers compliant with OECD TG 412, ISO 10993-12, and EPA OPPTS 870.3465 protocols. The AVGS-Series does not perform real-time particle sizing or vapor concentration measurement; instead, it delivers traceable, metrologically anchored output when paired with calibrated cascade impactors, optical particle sizers (e.g., SMPS, APS), or gas chromatography–mass spectrometry (GC-MS) validation.

Key Features

• Modular design enabling configuration-specific generator selection: dry powder dispersers, ultrasonic liquid nebulizers, thermal vaporizers, cigarette smoke generators, and nanoparticle synthesis modules (e.g., spark discharge, flame spray pyrolysis)
• ISO-compliant cigarette smoke generation with dual-port and multi-port configurations supporting automated puffing cycles per ISO 3308 and ISO 4387
• Dust generators capable of continuous or pulsed delivery of micron- to submicron-range powders (e.g., TiO₂, carbon black, cellulose, asbestos analogs) and fibrous materials (e.g., glass wool, ceramic fibers)
• Ultrasonic nebulizers with adjustable frequency and duty cycle for stable liquid aerosol generation (e.g., saline, surfactant suspensions, drug solutions) without thermal degradation
• Vapor generation units featuring PID-controlled heating blocks, inert carrier gas (N₂ or synthetic air) regulation, and condensation traps to ensure stoichiometric evaporation of VOCs (e.g., formaldehyde, benzene, ethanol) without decomposition
• Aerosol conditioning train options including diffusion dryers, electrostatic precipitators, and differential mobility analyzers (DMA) for post-generation PSD refinement and charge neutralization
• Gas-tight stainless-steel and borosilicate glass construction with VCR and Swagelok fittings for leak integrity (<1×10⁻⁶ mbar·L/s helium leak rate)

Sample Compatibility & Compliance

The AVGS-Series accommodates a broad spectrum of test substances: crystalline and amorphous powders, water- and solvent-based liquids, thermally stable and labile organics, and commercial tobacco products. All modules comply with GLP requirements for auditability—each includes serial-numbered components, calibration certificate traceability to NIST or PTB standards, and documented maintenance logs. System operation adheres to ISO/IEC 17025-accredited calibration practices. When integrated into OECD-guideline-compliant exposure systems (e.g., TSE’s INHALE series), the full setup supports regulatory submissions to EMA, FDA, and PMDA under ICH S7A and S7B frameworks. Full compliance documentation—including risk assessments, IQ/OQ/PQ protocols, and 21 CFR Part 11–ready electronic records—is available upon request.

Software & Data Management

Generator modules are operated via TSE ControlSuite™ v4.x—a deterministic, real-time control application running on Windows 10 IoT Enterprise. It enables synchronized parameter logging (flow rates, temperature profiles, puff timing, ultrasonic amplitude) at 10 Hz resolution with timestamped CSV export. The software supports method-based operation: preconfigured exposure protocols (e.g., “28-day subchronic diesel exhaust,” “acute nicotine vapor challenge”) can be loaded, executed, and archived with digital signatures. Audit trails record all user actions, parameter changes, and system events in immutable format. Optional integration with LabArchives ELN or Benchling allows direct metadata ingestion into institutional data management workflows. All firmware and control logic undergo annual third-party cybersecurity review per IEC 62443-3-3.

Applications

• Inhalation toxicity assessment of nanomaterials (e.g., metal oxides, quantum dots) per OECD TG 419 and ISO/TR 16193
• Preclinical evaluation of inhaled therapeutics (e.g., mRNA lipid nanoparticles, dry powder insulin) in rodent and non-human primate models
• Generation of reference aerosols for respirator filter testing (NIOSH 42 CFR Part 84, EN 149:2001+A1:2009)
• Controlled cigarette smoke exposure for COPD and cardiovascular disease modeling
• VOC inhalation studies addressing occupational exposure limits (ACGIH TLVs®, OSHA PELs)
• Development and validation of real-time aerosol sensors and exposure biomonitoring assays

FAQ

Can the AVGS-Series generate aerosols with a defined geometric standard deviation (GSD) and count median diameter (CMD)?
Yes—when coupled with a classified aerosol conditioner (e.g., DMA + CPC) and validated using SMPS or APS, the system achieves GSD < 1.3 and CMD repeatability ±5% across ≥5 consecutive runs.
Is remote monitoring supported during long-term exposure studies?
Yes—via optional TSE RemoteLink™ module with TLS 1.3-encrypted MQTT telemetry; enables real-time status dashboards and SMS/email alerts for flow deviation or temperature excursion.
Does TSE provide method transfer support for regulatory submissions?
Yes—comprehensive technical transfer packages include SOPs, validation reports, uncertainty budgets, and protocol alignment letters co-signed by TSE Application Scientists and certified metrologists.
Are replacement parts and consumables supplied with lot-specific CoAs?
Yes—all critical wear items (ultrasonic transducers, quartz vaporization tubes, ceramic dust dispersion nozzles) ship with individual CoAs referencing batch-specific dimensional inspection and functional test data.