The C690M Nondestructive Package Leakage Detector is a laboratory instrument based on vacuum decay and pressure decay methods, designed for trace leakage detection of pharmaceutical packaging such as vials, ampoules, cartridges, infusion bottles and prefilled syringes according to ASTM F2338 and related standards. It delivers precise leakage measurement with automated control, real‑time pressure curve display and configurable test parameters.
Features- Multi-stage vacuum: dual methods (vacuum decay and pressure decay) to accommodate various package types; automatic clamping for reliable test cell fastening; operator-set target vacuum; custom transparent test cell for visual inspection; optional built-in European oil-free vacuum pump.
- Precise data: advanced pressure detection using high‑quality components for stability; microflow automatic flow control to simulate different aperture sizes without manual adjustment; differential pressure transducer and flow meter traceable to NIST; test repeatability up to ±1 μm.
- Intelligent control: 12.1 embedded touch tablet with Windows OS; real‑time pressure curve display and automatic result counting; automatic leakage-rate calculation; universal printer connectivity; USB and network ports for data export and remote upgrades.
- Security & compliance: verification via compensation and calibration methods; supports GMP traceability requirements; multi-level user permissions; electronic signature design per 21 CFR Part 11 (optional).
Test Principle- The sample is sealed in the test cell and the sealed test cell is vacuumized; the pressure change measured by the sensor is analyzed to calculate the sample leakage rate.
Reference Standards- ASTM F2338
- YY-T 0681.18
- USP <1207>
Applications- Basic applications
- Vials — hermeticity tests for various vial types.
- Extended applications
- Ampoules — leak testing for ampoule bottles.
- Cartridge bottles — leak testing for cartridge containers.
- Injection bottles — leak testing for injection containers.
- Flexible packaging — IV bags and other flexible pouches.
Technical specifications- Model: C690M
- Testing range: μm (reference aperture size USP <1207>) — typ. 2 8 (large leakage)
- Detection lower limit: ≤ 2 μm
- Resolution: 0.1 μm
- Repeatability: ±1 μm
- Pressure range: -100 0 100 kPa
- Extended functions: 21 CFR Part 11 (optional); GMP computer system requirements (optional)
- Testing cell: 1 set (custom transparent cell available)
- Sample size: ≤ Φ45 mm × 80 mm (larger samples customizable; detection limits may vary)
- Sample quantity: 1 piece per test
- Gas specifications: compressed air (user supplied)
- Gas source pressure: 0.5 mPa ~ 0.7 mPa (72.5 PSI ~ 101.5 PSI)
- Port size: Φ6 mm polyurethane tube
- Dimensions: 12 H × 22 W × 15 D (30 cm × 56 cm × 37 cm)
- Power: 120 VAC ±10% 60 Hz or 220 VAC ±10% 50 Hz (select one)
- Net weight: 58 lbs (26 kg)
- Standard configuration: mainframe, embedded tablet computer, software, flow meter, vacuum pump, Φ6 mm polyurethane tube
- Customization / optional parts: test cell design, negative/positive standard reference samples, GMP computer requirements, 21 CFR Part 11, air compressor, built‑in European vacuum pump, IQ/OQ/PQ documents