HJ FX-2S Nucleic Acid Sampling Booth

Overview

The HJ FX-2S Nucleic Acid Sampling Booth is an engineered environmental isolation system designed for safe, efficient, and compliant sample collection in high-throughput molecular testing environments. It operates on the principle of controlled positive-pressure ventilation: an integrated centrifugal blower forces ambient air through a certified HEPA filter (≥99.995% efficiency at 0.3 µm), delivering ISO Class 7 (10,000-grade) clean air into the operator compartment. This sustained positive pressure differential—typically maintained at +15 to +25 Pa relative to ambient—prevents unfiltered external air ingress, thereby establishing a physical and aerodynamic barrier between healthcare personnel and potentially infectious aerosols generated during nasopharyngeal or oropharyngeal swabbing. Unlike disposable PPE-dependent workflows, the FX-2S decouples biosafety from personal protective equipment constraints, enabling extended shift durations without thermal stress or tactile impairment. Its structural modularity supports rapid deployment in outdoor clinics, community health centers, border checkpoints, and mobile diagnostic units—meeting operational demands where fixed HVAC infrastructure is unavailable or impractical.

Key Features

• Modular prefabricated panel construction enables factory-assembled delivery, site-level installation within 4–6 hours, and reconfiguration for multi-booth clusters or variable footprint requirements.
• Dual-operator ergonomics: internal dimensions (2000 × 1300 × 2040 mm) accommodate two seated personnel with independent access zones, coordinated workflow sequencing, and shared instrument staging via stainless steel shelving and waste receptacles.
• Integrated environmental control: 1-ton split-system air conditioner maintains stable thermal conditions (operational range: −10°C to +40°C; RH 45–60%) independent of external climate fluctuations.
• Full-spectrum operator interface: laminated front window with integrated long-reach nitrile gloves (EN 455-compliant), dual-unit intercom with noise-cancelling microphones, and adjustable LED lighting (≥300 lx average illuminance, flicker-free).
• Automated decontamination cycle: 20 W UV-C lamp (254 nm) mounted internally ensures validated surface disinfection between shifts, with safety interlocks preventing accidental exposure during operation.
• Pass-through transfer chamber (400 × 400 × 400 mm) permits contactless specimen handoff while preserving cabin pressure integrity—critical for maintaining chain-of-custody compliance in CLIA- or ISO 15189-aligned labs.

Sample Compatibility & Compliance

The FX-2S is not a sample analysis instrument but a biosafety engineering platform supporting standardized nucleic acid collection protocols per WHO, CDC, and China’s National Health Commission guidelines. It accommodates all standard flocked nylon or polyester swabs (e.g., Copan, Puritan) and compatible transport media (UTM, VTM). Its airflow design complies with ISO 14644-1 Class 7 particulate cleanliness requirements for cleanrooms. Pressure differentials, filtration performance, and UV irradiance output are verifiable using calibrated instrumentation (e.g., manometers, particle counters, radiometers), facilitating internal QA audits and third-party validation. While not FDA-cleared as a medical device, its architecture aligns with ISO 13485 risk management principles and supports adherence to GLP/GMP documentation standards for sample integrity tracking.

Software & Data Management

The FX-2S operates as a standalone hardware system with no embedded firmware or cloud connectivity. All operational parameters—including runtime hours, UV lamp usage cycles, and filter service intervals—are logged manually in facility-maintained logbooks per institutional biosafety protocols. Optional integration with external building management systems (BMS) is supported via dry-contact relay outputs for fan status, door interlock signals, and UV lamp activation. For regulated environments requiring electronic audit trails (e.g., FDA 21 CFR Part 11), users may pair the booth with validated external environmental monitoring platforms that record temperature, humidity, pressure differential, and lighting intensity at configurable intervals.

Applications

• Community-based mass screening programs requiring rapid, weather-resilient deployment under variable outdoor conditions.
• Hospital outpatient triage zones where spatial separation between symptomatic patients and clinical staff is mandated by infection control policy.
• International travel health checkpoints performing pre-departure PCR/antigen testing under national public health directives.
• Research field stations conducting longitudinal epidemiological surveillance in resource-constrained settings.
• Pharmaceutical clinical trial sites requiring auditable, repeatable biospecimen collection environments compliant with ICH-GCP Annex 4 standards.

FAQ

Is the FX-2S certified to any international cleanroom or biosafety standards?
The unit meets ISO 14644-1 Class 7 airborne particulate limits and incorporates components certified to EN 1822 (HEPA filters) and IEC 60335 (electrical safety). It is not classified as a BSL-2 cabinet per NSF/ANSI 49, as it does not provide personnel or product protection via inward airflow—its function is environmental containment via positive pressure.
Can the booth be powered by a generator during off-grid operation?
Yes—its 220 V ±10%, 50 Hz ±1 Hz input tolerance and 2 kW nominal load allow compatibility with industrial-grade inverters or diesel generators rated ≥3 kVA with stable voltage regulation.
What maintenance schedule is recommended for the HEPA filter?
Filter replacement is advised every 6–12 months depending on ambient particulate load, verified by differential pressure monitoring across the filter bank. Pre-filters should be inspected monthly and cleaned or replaced as needed.
Does the UV lamp provide sufficient dose for SARS-CoV-2 inactivation?
At 20 W output and typical chamber geometry, the installed UV-C system delivers ≥10 mJ/cm² surface dose within 30 minutes—exceeding the 3.7 mJ/cm² threshold required for >3-log reduction of coronaviruses per IUVA guidance.
Are spare parts and technical documentation available internationally?
HJ Purification provides English-language operation manuals, dimensional drawings, and component datasheets upon request. Critical spares—including HEPA modules, UV lamps, and glove assemblies—are stocked globally through authorized distribution partners in APAC, EMEA, and LATAM regions.