GBPI GB-HQ1000 Medical Mask Exhalation Valve Air-Tightness Tester
| Brand | GBPI |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | GB-HQ1000 |
| Price Range | USD 14,000 – 42,000 |
| Air Source | Compressed Air |
| Vacuum Pump Flow Rate | 2 L/min |
| Buffer Tank Volume | 5 L |
| Pressure Sensor Range | −1000 Pa to 0 Pa |
| Pressure Sensor Accuracy | ±1% FS |
| Pressure Resolution | 1 Pa |
| Flow Meter Range | 0–100 mL/min |
| Flow Meter Accuracy | ±1% FS |
| Flow Resolution | 0.1 mL/min |
| Display | Integrated HD Touchscreen Interface |
| Power Supply | 220 V AC, 50 Hz |
Overview
The GBPI GB-HQ1000 Medical Mask Exhalation Valve Air-Tightness Tester is a purpose-built instrumentation system engineered for quantitative evaluation of leakage integrity at the exhalation valve assembly of disposable and reusable respiratory protective devices. It operates on the principle of controlled negative pressure differential testing—applying a regulated vacuum to the mask interior while monitoring real-time airflow across the exhalation valve under defined pressure conditions. This methodology aligns with the physical verification requirements specified in GB 2626–2019 “Respiratory Protective Devices – Non-powered Air-purifying Particulate Respirators”, particularly Clause 6.7 (Exhalation Valve Air Tightness), where a maximum allowable leakage rate of ≤30 mL/min at −1000 Pa differential pressure is mandated for KN95-class respirators. The instrument delivers traceable, repeatable measurements suitable for quality control laboratories, regulatory compliance verification, and R&D validation in medical device manufacturing environments.
Key Features
- Integrated high-accuracy differential pressure sensor (range: −1000 Pa to 0 Pa; resolution: 1 Pa; accuracy: ±1% full scale) enabling precise vacuum control and dynamic pressure monitoring during test cycles.
- Dual-channel digital flow measurement system with calibrated range of 0–100 mL/min (resolution: 0.1 mL/min; accuracy: ±1% FS), supporting both real-time display and endpoint leakage quantification.
- Dedicated specimen holder designed for standardized mounting of flat-fold, cup-shaped, and contoured masks with integrated exhalation valves—ensuring consistent sealing geometry and minimizing operator-induced variability.
- Onboard 5 L buffer tank and 2 L/min vacuum pump provide stable, pulse-free negative pressure generation compliant with GB 2626–2019 ramp and dwell time specifications.
- Embedded HD capacitive touchscreen interface (≥7″) with intuitive test sequence navigation, parameter configuration, and pass/fail threshold setting per regulatory criteria.
- Built-in thermal line printer enables immediate hardcopy output of test reports—including date/time stamp, pressure/flow curves, peak leakage value, and compliance status—supporting GLP documentation requirements.
Sample Compatibility & Compliance
The GB-HQ1000 accommodates all commercially available surgical masks, N95/KN95 respirators, and reusable elastomeric facepieces equipped with mechanical exhalation valves. Fixture geometry supports valve diameters from 8 mm to 25 mm and accommodates both snap-in and adhesive-mounted valve configurations. Test protocols are preconfigured to meet GB 2626–2019 Annex B (Valve Leakage Test Procedure), including 60-second pressure stabilization at −1000 Pa followed by 30-second leakage measurement. While primarily aligned with Chinese national standards, the instrument’s metrological traceability path (via NIST-traceable pressure and flow calibration references) permits adaptation for comparative assessments against ISO 13485 production audits or FDA QSR-aligned internal validation protocols.
Software & Data Management
Firmware v2.1 includes audit-ready data handling capabilities: all test sessions are timestamped, user-ID logged, and stored locally in non-volatile memory (≥10,000 records). Export options include CSV via USB port for integration into LIMS or statistical process control (SPC) platforms. Optional firmware upgrade supports 21 CFR Part 11-compliant electronic signatures and role-based access control (administrator/operator modes), enabling deployment in GMP-regulated facilities requiring documented change control and data integrity assurance.
Applications
- Final product release testing of exhalation valve-equipped respirators prior to sterilization and packaging.
- Supplier qualification of valve components—evaluating batch-to-batch consistency in diaphragm elasticity and seat sealing performance.
- Design verification during new mask development, correlating valve geometry, material durometer, and hinge design with measured leakage profiles.
- Root cause analysis of field failures—reproducing environmental stressors (e.g., temperature cycling, humidity exposure) followed by air-tightness retest.
- Internal calibration verification using certified reference leaks (NIST SRM 2197A equivalent).
FAQ
Does the GB-HQ1000 comply with international standards beyond GB 2626–2019?
Yes—while optimized for GB 2626–2019, its pressure and flow metrology meets ISO/IEC 17025 calibration requirements when used with accredited external standards. Comparative testing against EN 149:2001+A1:2009 Annex A is feasible via custom protocol configuration.
Can the instrument be integrated into an automated production line?
It supports RS-232 and Modbus RTU communication protocols for PLC handshake and pass/fail signal output, enabling inline QC gating in high-volume manufacturing cells.
What maintenance is required for long-term accuracy?
Annual recalibration of pressure and flow sensors is recommended; vacuum pump oil replacement every 500 operational hours; buffer tank moisture trap inspection prior to each shift.
Is technical support available outside mainland China?
GBPI provides remote diagnostics and firmware updates globally via secure VPN; local service partners exist in Southeast Asia, Middle East, and Latin America.
