HJ ZJSJ-012 Portable Cold Aerosol Generator
| Brand | HJ |
|---|---|
| Origin | Jiangsu, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | ZJSJ-012 |
| Aerosol Output Volume Flow | 1–2.5 m³/h |
| Aerosol Generation Rate | 0.5–2×10¹³ particles/h |
| 雾化压力 (Atomization Pressure) | 10–80 kPa (adjustable) |
| Aerosol Particle Size Distribution | 0.02–2 µm |
| Aerosol Types | DEHS, PAO, DOP (cold, polydisperse) |
| Dimensions (H×W×L) | 200×250×370 mm |
| Weight | 3 kg |
| External Air Supply Requirement | Clean, oil-free compressed air ≤0.7 MPa |
Overview
The HJ ZJSJ-012 Portable Cold Aerosol Generator is an engineered solution for controlled, on-site generation of polydisperse test aerosols in cleanroom qualification, HEPA/ULPA filter integrity testing, and HVAC system validation. It operates on the principle of pneumatic atomization—utilizing clean, oil-free compressed air to nebulize liquid challenge agents (e.g., DEHS, PAO, or DOP) into a stable, reproducible aerosol cloud without thermal degradation. Unlike heated generators, the cold-generation method preserves chemical integrity and avoids volatile decomposition, making it suitable for applications requiring strict compliance with ISO 14644-3, IEST-RP-CC001, and EU GMP Annex 1 protocols. Designed for field deployment, the unit delivers continuous aerosol output at volume flow rates of 1–2.5 m³/h and particle generation rates ranging from 0.5×10¹³ to 2×10¹³ particles per hour—sufficient to challenge airflow systems up to 50,000 m³/h when used with appropriate dilution or distribution manifolds.
Key Features
- Compact, portable architecture (200 × 250 × 370 mm; 3 kg) enables rapid setup in cleanrooms, isolators, and gloveboxes.
- Cold aerosol generation ensures no thermal alteration of test agents—critical for maintaining consistency with USP , ISO 14644-3, and FDA-recommended challenge materials.
- Adjustable atomization pressure (10–80 kPa) allows fine-tuning of aerosol concentration and droplet size distribution (0.02–2 µm median aerodynamic diameter).
- Integrated reservoir design supports quick refilling with minimal downtime; compatible with standard 100–500 mL solvent bottles.
- No internal compressor—reduces heat load, electrical complexity, and maintenance requirements; relies on externally supplied clean, oil-free compressed air (≤0.7 MPa).
- Robust aluminum-alloy housing with chemical-resistant wetted parts ensures long-term compatibility with organic aerosol agents including DEHS, PAO-4, and DOP.
Sample Compatibility & Compliance
The ZJSJ-012 is validated for use with internationally accepted non-hazardous surrogate test aerosols, including Di-Ethyl-Hexyl-Sebacate (DEHS), Polyalphaolefin (PAO-4), and Dioctyl Phthalate (DOP). Its cold-generation mechanism aligns with ISO 21501-4 for particle sizing instrument calibration and meets the aerosol stability and monodispersity prerequisites outlined in EN 1822-5 for filter testing. While not intrinsically certified to ATEX or IECEx standards, the device is intended for use in non-explosive environments under controlled laboratory or cleanroom conditions. All operational parameters comply with Good Manufacturing Practice (GMP) documentation requirements, supporting full audit trails when integrated with validated data acquisition systems.
Software & Data Management
The ZJSJ-012 is a standalone hardware generator with no embedded firmware or digital interface. It is designed for integration into validated test workflows where aerosol delivery timing, duration, and pressure are manually or externally controlled (e.g., via programmable pressure regulators or PLC-triggered solenoid valves). For regulated environments, users may pair the generator with third-party particle counters (e.g., TSI 3350, Grimm 1.108) equipped with 21 CFR Part 11-compliant software for electronic recordkeeping, user access control, and audit trail generation. Calibration certificates for associated flow meters and pressure transducers must be maintained per ISO/IEC 17025 requirements.
Applications
- HEPA and ULPA filter leak testing per ISO 14644-3 and IEST-RP-CC034.
- Filter efficiency validation in pharmaceutical isolators and aseptic processing suites.
- Aerosol challenge studies for respirator filtration testing (e.g., ASTM F2299, EN 149).
- Calibration and performance verification of optical particle counters and condensation particle counters.
- Contamination control training and procedural validation in Class 5–8 cleanrooms.
- Field-based HVAC duct leakage assessment and air distribution uniformity mapping.
FAQ
What compressed air specifications are required?
Clean, dry, oil-free compressed air at ≤0.7 MPa supply pressure and dew point ≤−40°C is mandatory. Particulate filtration to ISO 8573-1 Class 1.1.1 is recommended.
Can the ZJSJ-012 generate monodisperse aerosols?
No—it produces cold, polydisperse aerosols only. Monodisperse generation requires differential mobility analyzers (DMA) or vibrating orifice aerosol generators, which are not supported by this platform.
Is DOP still acceptable for filter testing under current regulations?
While DOP remains technically valid per ISO 14644-3 Annex B, DEHS and PAO-4 are preferred in GMP environments due to lower toxicity and better regulatory acceptance per EU GMP Annex 1 (2022) and USP 2023 updates.
Does the unit include a built-in pressure regulator or flow meter?
No—the ZJSJ-012 requires external regulation of inlet air pressure and monitoring of output aerosol flow; these components must be provided and qualified by the end user.
What maintenance intervals are recommended?
Daily visual inspection of the atomizer nozzle and reservoir seal; quarterly ultrasonic cleaning of wetted parts with isopropanol; annual verification of pressure gauge accuracy against NIST-traceable standards.
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