SUNS SB015 Pneumatic Burst and Leak Integrity Tester
| Key | Brand: SUNS |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Direct Manufacturer |
| Model | SB015 |
| Pressure Range | 0.035–3 MPa (custom high-pressure options available) |
| Timing Range | 0–999.9 s (user-configurable) |
| Pressure Source | Clean, dry compressed air at supply pressure > test pressure and ≤ 3 MPa |
| Resolution | 0.1 kPa / 1 kPa / 0.0001 MPa |
| Accuracy | ±0.1 % FS |
| Units | kPa, bar, psi, MPa |
| Pressure Regulation | Mechanical or Electronic (optional) |
| Data Export | USB interface |
| Channels | 1 (multi-channel expansion supported) |
| Communication | RS485 (RS232 / RJ45 Ethernet optional) |
| I/O | 6 digital inputs, 6 digital outputs |
| Display | 7-inch LCD touchscreen |
| Power | AC 110–240 V, 50/60 Hz |
| Test Modes | Leak integrity, burst pressure, inversion testing |
| Operating Environment | 5–45 °C, ≤80 % RH (non-condensing) |
| Weight | 9.8–11 kg |
| Dimensions | 450 × 270 × 190 mm |
Overview
The SUNS SB015 Pneumatic Burst and Leak Integrity Tester is an engineered solution for deterministic pressure-based functional and safety validation of sealed enclosures, medical packaging, automotive components, and industrial fluidic assemblies. It operates on the principle of controlled pneumatic pressurization combined with high-resolution differential pressure monitoring and real-time event-triggered data capture. Unlike generic pressure gauges or manual test rigs, the SB015 integrates closed-loop pressure regulation, programmable timing logic, and multi-stage test sequencing—enabling standardized execution of ASTM F2096 (bubble emission), ISO 11607-2 (package integrity), and USP (leak test method selection) compliant protocols. Its architecture supports both static leak detection (pressure decay or differential pressure methods) and dynamic failure characterization (burst pressure ramping with slope analysis), making it suitable for R&D validation, incoming QC, and production line process control.
Key Features
- Triple-resolution pressure sensing (0.1 kPa, 1 kPa, and 0.0001 MPa) ensures adaptability across low-leakage medical pouches and high-strength industrial valves.
- Configurable pressure regulation: mechanical fine-tuning for lab-grade repeatability or electronic proportional-integral (PI) control for automated production integration.
- Programmable test timing from 0.1 to 999.9 seconds enables precise dwell time definition for ASTM F2338 (vacuum decay) or custom hold-and-ramp profiles.
- Dual-mode operation: simultaneous support for leak integrity (pressure decay, mass flow equivalent) and destructive burst testing with automatic termination at peak pressure or rate-of-rise threshold.
- Industrial-grade I/O architecture (6 in / 6 out) allows hardware synchronization with PLCs, pneumatic actuators, safety interlocks, and reject station triggers—fully compatible with Industry 4.0 MES integration.
- 7-inch resistive LCD touchscreen with intuitive icon-driven workflow navigation; firmware supports multi-language UI (English, German, Japanese, Simplified Chinese) and user-level access control (operator, engineer, admin).
Sample Compatibility & Compliance
The SB015 accommodates rigid and semi-rigid test specimens up to Ø150 mm × 200 mm height via standard quick-connect fittings (¼″ NPT, BSPP, or custom adapters). It is validated for use with Class 0–3 medical device packaging (blister, pouch, clamshell), battery module housings, EV coolant connectors, and HVAC refrigerant lines. All pressure transducers are traceably calibrated per ISO/IEC 17025 requirements, with certificate-of-calibration included. The system meets CE marking directives (2014/30/EU EMC, 2014/35/EU LVD), RoHS 2011/65/EU, and supports 21 CFR Part 11-compliant audit trails when paired with SUNS LabManager v3.2+ software (electronic signatures, change history, locked data archives).
Software & Data Management
Data acquisition and reporting are managed through SUNS LabManager — a Windows-based application supporting local USB export (CSV, PDF, XML) and networked database logging (SQL Server or SQLite). Each test record includes full waveform capture (pressure vs. time), annotated event markers (pressurize, hold, vent), and statistical summaries (mean, SD, Cp/Cpk) per batch. Audit trail functionality logs all user actions, parameter changes, and calibration events with timestamps and operator IDs. Optional cloud gateway module enables secure TLS 1.2 transmission to enterprise QMS platforms (e.g., MasterControl, Veeva Vault) for centralized CAPA linkage and regulatory submission readiness.
Applications
- Medical Device Packaging: Quantitative verification of seal strength and microchannel leakage in sterile barrier systems per ISO 11607-2 Annex D.
- Automotive Electrification: Validation of IP67/IP6K9K-rated enclosures for battery management units and DC-DC converters under thermal cycling preconditioning.
- Pharmaceutical Primary Packaging: Deterministic detection of channel leaks in pre-filled syringes and vials using pressure decay methodology aligned with USP .
- Consumer Electronics: Functional testing of waterproof smartphone and wearable housings following IEC 60529 ingress protection criteria.
- Industrial Valves & Fittings: Burst pressure certification of brass, stainless steel, and polymer-bodied solenoid valves per ANSI/ISA-75.01.01.
FAQ
Can the SB015 perform vacuum decay testing?
Yes — when configured with optional vacuum pump module and negative-pressure transducer, it executes ASTM F2338-compliant vacuum decay tests with identical resolution and timing precision.
Is calibration documentation provided with shipment?
Each unit ships with a factory calibration certificate traceable to NIM (China National Institute of Metrology), including as-found/as-left data, uncertainty budgets, and environmental conditions during calibration.
How is test method validation supported?
SUNS provides IQ/OQ protocol templates, risk-based URS alignment guidance, and on-site DQ support for GMP-regulated environments upon request.
What is the maximum allowable test specimen volume?
The internal test chamber volume is not fixed; external fixtures accommodate volumes up to 5 L when using remote test fixtures with low-compliance tubing (≤0.5 mL dead volume recommended for sub-10 cc/min leak rate sensitivity).
Does the system support SPC charting directly on the touchscreen?
Real-time X-bar/R charts are available via LabManager desktop software; the embedded HMI displays pass/fail status, current test curve, and last 10 result trends only.
