SUNS SANS Medical Device Testing Equipment – Negative-Pressure Air-Tightness Tester
| Brand | SUNS SANS |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | Medical Device Air-Tightness Tester (Negative Pressure) |
| Pricing | Available Upon Request |
| Test Object | Medical Devices |
| Test Principle | Vacuum-Based Leak Integrity Verification |
| Maximum Test Pressure | −70 kPa |
Overview
The SUNS SANS Medical Device Air-Tightness Tester is a purpose-built negative-pressure leak integrity verification system engineered for rigorous quality assurance in the medical device manufacturing and regulatory validation lifecycle. Designed in accordance with fundamental principles of vacuum decay testing, this instrument applies controlled sub-atmospheric pressure to sealed medical devices—such as syringes, infusion sets, catheter assemblies, respiratory masks, and sterile packaging—and monitors pressure stabilization and decay rates over defined test durations. The system operates on the physical principle that any breach in enclosure integrity results in measurable pressure rise (i.e., vacuum loss) due to ambient air ingress, enabling quantitative assessment of leak rate in accordance with ISO 11607-2, ASTM F2096, and ISO 15142-1 standards. Its robust architecture supports repeatable, operator-independent testing under GMP-aligned conditions, making it suitable for both R&D benchtop evaluation and production-line 100% final inspection.
Key Features
- Stable, digitally regulated vacuum generation with closed-loop feedback control, maintaining setpoint accuracy within ±0.5 kPa across the full −10 to −70 kPa range.
- High-resolution pressure transducer (0.01 kPa resolution) with temperature-compensated analog-to-digital conversion for low-drift measurement stability.
- Dual-phase test protocol: preconditioning (stabilization) followed by timed decay monitoring (user-configurable from 5 s to 300 s).
- Integrated pneumatic circuit with stainless-steel solenoid valves, PTFE-sealed fittings, and HEPA-filtered inlet air path to prevent particulate or moisture contamination during testing.
- Front-panel touch interface with intuitive icon-driven workflow navigation and real-time pressure curve visualization.
- Pass/fail logic engine supporting configurable thresholds—including absolute pressure decay limit (kPa/s), total pressure loss (kPa), and slope-based derivative analysis—for multi-criteria acceptance decisions.
Sample Compatibility & Compliance
The tester accommodates a broad range of medical device geometries via modular fixturing: standard ports accept Luer-lock, barbed, or custom flange interfaces; optional vacuum chambers support bulk testing of pouches, trays, or multi-unit packages. All wetted materials comply with USP Class VI biocompatibility requirements. The system meets essential safety and electromagnetic compatibility criteria per IEC 61000-6-2/6-4 and IEC 61010-1. It is validated for use in environments governed by ISO 13485:2016 quality management systems and supports audit-ready documentation for FDA 21 CFR Part 820 and EU MDR Annex II conformity assessments. Optional IQ/OQ documentation packages are available for installation and operational qualification under GLP/GMP frameworks.
Software & Data Management
Optional PC-based software (SUNS TestSuite v3.x) enables advanced data handling: automated report generation (PDF/CSV), user-level access control (admin/operator/guest), electronic signature support compliant with 21 CFR Part 11, and full audit trail logging—including parameter changes, test start/stop timestamps, operator ID, and raw pressure vs. time datasets. All test records are stored with immutable metadata tags (device ID, batch number, test date, environmental conditions) and support traceability to individual serial-numbered units. Data export is compatible with LIMS integration via ODBC or RESTful API endpoints.
Applications
- Leak testing of Class II and III single-use devices including IV administration sets, blood collection tubes, and surgical suction kits.
- Validation of barrier integrity for terminally sterilized packaging per ISO 11607-2 Clause 6.4.
- Process capability studies during packaging line qualification (e.g., heat seal strength correlation with vacuum decay performance).
- Root cause analysis of field failures involving ingress-related sterility breaches.
- Supporting design verification per ISO 14971 risk management files where leak integrity is a critical hazard control.
FAQ
What is the maximum allowable leak rate this system can detect?
Detection sensitivity is functionally dependent on test volume, duration, and temperature stability; under typical conditions (100 mL test volume, 60 s decay phase), the system reliably identifies leaks ≥5 × 10⁻³ mbar·L/s (equivalent to ~0.3 mL/min at ambient conditions).
Can the system be integrated into an automated production line?
Yes—digital I/O signals (pass/fail, cycle complete, fault) and Modbus TCP communication enable seamless PLC interfacing for inline deployment.
Is calibration traceable to national standards?
All pressure sensors are factory-calibrated against NIST-traceable reference standards, with certificate of calibration included; annual recalibration services are available through SUNS authorized labs.
Does the tester support positive-pressure testing?
This model is optimized for negative-pressure (vacuum decay) methodology; SUNS offers complementary positive-pressure decay and mass flow instruments for differential application requirements.
What training and technical support options are available?
SUNS provides on-site installation qualification, operator training (including SOP development), and remote diagnostics support with SLA-backed response times for critical issues.
