Xinye XY-9600 Dual-Operator Nucleic Acid Sampling Isolation Booth

Overview

The Xinye XY-9600 Dual-Operator Nucleic Acid Sampling Isolation Booth is an engineered biosafety solution designed to support high-throughput, low-risk molecular testing operations in public health infrastructure. Built upon the principles of negative-pressure isolation and laminar airflow containment, the booth employs a certified HEPA filtration system (ISO Class 5 compliant at the operator breathing zone) to maintain a continuously purified internal environment. Unlike open-air sampling tents or conventional fixed kiosks, the XY-9600 integrates structural integrity, environmental control, and workflow ergonomics into a single modular unit—enabling two trained operators to perform simultaneous sample collection while maintaining physical separation from subjects via sealed glove ports and a transparent polycarbonate barrier. Its design aligns with WHO interim guidance on safe specimen collection during respiratory pathogen outbreaks and supports implementation of layered infection prevention protocols in decentralized testing environments.

Key Features

• Dual-operator configuration with independent glove access ports (left/right), each fitted with medical-grade nitrile gloves and replaceable sleeve seals
• Integrated HVAC system delivering 1050 m³/h of conditioned air, achieving ≥85 air changes per hour (ACH) with real-time differential pressure monitoring (−15 to −25 Pa relative to ambient)
• ULPA-class pre-filter + H14 HEPA main filter (EN 1822-1:2019 certified), validated for ≥99.95% particle capture efficiency at 0.3 µm
• UV-C germicidal irradiation module (254 nm, 30 W) with interlocked safety cutoff activated when front panel is opened
• LED lighting system providing uniform ≥350 lx illuminance across the entire work surface, compliant with ISO 8995-1 for clinical task lighting
• Modular stainless steel frame with anti-microbial powder-coated enclosure; fully relocatable on integrated casters with locking brakes
• Pass-through chamber (400 × 400 × 400 mm) with dual-door interlock mechanism and UV sterilization cycle for secure specimen transfer

Sample Compatibility & Compliance

The XY-9600 is compatible with standard nasopharyngeal/oropharyngeal swab collection kits, saliva collection tubes, and dry transport media used in RT-qPCR, rapid antigen, and sequencing-based SARS-CoV-2 detection workflows. It does not process or analyze samples internally but serves as a controlled biosafety interface between subject and laboratory personnel. The booth meets national GB/T 25915.3–2021 (equivalent to ISO 14644-3) requirements for cleanroom performance validation and complies with Chinese YY 0569–2011 Class II biological safety cabinet standards for directional airflow containment. Structural materials conform to GB 50325–2020 limits for volatile organic compound emissions. All electrical components are CE-marked and rated IP54 for dust/moisture resistance.

Software & Data Management

The XY-9600 operates as a hardware-only platform with no embedded software or network connectivity—intentionally designed to minimize cybersecurity risk and simplify regulatory validation in GLP/GMP-aligned public health laboratories. Operational parameters (airflow rate, pressure differential, UV cycle status, and lamp runtime) are displayed via a local LED control panel with non-volatile memory logging (72-hour buffer). Optional RS-485 interface allows integration with facility-wide BMS systems for centralized environmental monitoring. Audit trails for UV usage and door-open events comply with basic ALCOA+ data integrity principles when paired with external logbook documentation per ISO/IEC 17025:2017 Clause 7.5.2.

Applications

• Community-based mass screening programs requiring sustained daily throughput (>500 tests/operator/day)
• Frontline deployment at transportation hubs, border checkpoints, and emergency response staging areas
• Supporting “test-to-treat” pathways in outpatient clinics where rapid triage and specimen handoff must occur within <15 minutes
• Field-deployable units for mobile testing fleets operating under variable ambient conditions (−10°C to +45°C operational range)
• Backup capacity augmentation during surge events without requiring permanent HVAC retrofitting of existing facilities

FAQ

Does the XY-9600 require external ducting or building exhaust integration?

No. It operates as a self-contained recirculating system with internal HEPA filtration and optional activated carbon layer for odor control. Exhaust is released back into the ambient space after purification.
Can the unit be validated for ISO 14644-1 Class 5 certification?

Yes—when installed on a level, vibration-isolated surface with ≥1 m clearance on all sides, it achieves ≤3,520 particles/m³ (≥0.5 µm) at the operator breathing zone under steady-state operation, meeting ISO 14644-1:2015 Class 5 criteria.
What maintenance intervals are recommended for filter replacement?

HEPA filters should be replaced every 6 months under continuous operation (24/7), or after 4,000 hours of cumulative runtime—whichever occurs first—as verified by differential pressure sensor readings exceeding 250 Pa.
Is the booth suitable for use with PCR reagents or RNA extraction kits?

It is not designed for molecular assay preparation. Its role is strictly limited to specimen acquisition and secure transfer. Downstream nucleic acid handling must occur in dedicated ISO Class 7 or better laboratories per CLSI MM19-A3 guidelines.
How is user training and operational SOP documentation provided?

Xinye provides bilingual (English/Chinese) installation qualification (IQ) and operational qualification (OQ) protocols, including pressure decay test procedures, UV intensity verification methods, and glove integrity check workflows—all aligned with ISO/IEC 17025 Annex A.2 requirements.