Compressed air leak detector C690B

for the pharmaceutical industryfor medical disposablesfor bags

The C690B nondestructive package leak detector is a vacuum-decay based tester for trace leak detection of food and pharmaceutical packaging (bottles, cans, boxes, vials, ampoules, cartridge bottles, infusion bottles, prefilled syringes, IV bags, flexible packaging, etc.). It is designed to meet ASTM F2338 and related standards and provides traceable measurement components and high repeatability.


Features

• Multi-stage vacuum
• Vacuum-decay method suitable for diverse packaging styles.
• Operator-settable target vacuum degree for different sample requirements.
• Transparent test cell for visual observation during testing.
• Precise data
• Advanced pressure detection using internationally recognized components for stable results independent of ambient conditions.
• Automatic microflow control to simulate different leak hole sizes without manual adjustment.
• Differential pressure transducer and flow meter traceable to NIST.
• System test repeatability achievable to ±1 µm.
• Intelligent control
• 12.1 industrial touchscreen with tile-based operation interface.
• Real-time pressure curve display and automatic result counting.
• Automatic leakage amount calculation and automatic data storage with memory protection on power loss.
• Optional micro-printer and USB data interface.
• Security & compliance
• Compensation and calibration verification methods supported.
• Multi-level user management for operation permissions.
• Optional compliance with GMP data traceability and 21 CFR Part 11 electronic signature package.

Test principle
The sealed sample is placed in the test cell; the cell is evacuated and 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 — various vial leak tests.
• Food packaging — leak tests for bottles, tubes, cans, boxes and other food containers.
• Extended applications
• Ampoules — ampoule leak tests.
• Cartridge bottles — cartridge bottle leak tests.
• Injection/infusion bottles — injection/infusion bottle leak tests.
• Flexible packaging — IV bags and other flexible packaging leak tests.

Product configuration & options

• Standard configuration: Mainframe, software, flow meter, vacuum pump, Φ6 mm polyurethane tube.
• Customization: Test cell and negative/positive reference samples designed to sample specifications.
• Optional parts / upgrades: Computer and GMP computer system, 21 CFR Part 11 package, air compressor, IQ/OQ/PQ documentation, micro-printer, USB data interface.

Technical specifications

• Model: C690B
• Testing principle: Vacuum decay (nondestructive)
• Testing range (reference aperture size USP <1207>): µm (3 → 8 → greater leakage)
• Detection lower limit: ≤ 3 µm
• Resolution: 0.1 µm
• Repeatability: ±1 µm
• Pressure range: -100 0 kPa
• Testing cell: 1 set
• Sample size: ≤ Φ45 mm × 80 mm (Group C test cell customizable; limits may change)
• Sample quantity per test: 1 piece
• Gas specification: Compressed air (user-provided)
• Gas source pressure: 0.5 mPa ~ 0.7 mPa (72.5 PSI ~ 101.5 PSI)
• Port size: Φ6 mm polyurethane tube
• Dimensions: 10 H × 13 W × 17 D (25 cm × 33 cm × 44 cm)
• Power: 120 VAC ±10% 60 Hz or 220 VAC ±10% 50 Hz (select one)
• Net weight: 22 lbs (10 kg)
• Extended functions (optional): 21 CFR Part 11; GMP computer system requirements (optional)