Medical device leak tester C690H

for the pharmaceutical industryfor packagingfor seal integrity

The C690H Container Closure Integrity Testing (CCIT) Nondestructive Package Leak Detector uses the vacuum decay and pressure decay method and is designed and manufactured to ASTM F2338 and related standards. It is intended for batch leak testing of vial seals and for trace leak detection on ampoules, cartridge bottles, infusion bottles, prefilled syringes and other pharmaceutical packaging.




Features

• Batch Testing
• Fully automatic gravity-fed sample feeder for continuous testing of 20 to 120 samples.
• A & B dual-channel design enables simultaneous testing of two sample specifications.
• Operator-configurable target vacuum level to suit different packaging types.
• Dual test modes (vacuum decay and pressure decay) for flexibility across package types.
• Precise Data
• High-precision pressure detection using internationally certified components for stable data independent of ambient conditions.
• Advanced microflow automatic control simulates different leak-hole sizes without manual adjustment.
• Differential pressure transducer and flow meter traceable to NIST.
• System repeatability: ±1 μm.
• Intelligent Control
• 15.6 embedded touch tablet running Windows with a vertical GUI layout.
• Automatic alarms, capture and collection of nonconforming samples; real-time pressure-curve display and automatic result counting.
• Automatic leakage-rate calculation; multiple sensors provide intelligent operational prompts for safer control.
• Universal printer connection; embedded USB and network ports for data export and remote upgrades.
• Security Compliance
• Verification by compensation and calibration methods to ensure measurement validity.
• Complies with GMP requirements for data traceability relevant to pharmaceutical production.
• Multi-level user permissions configurable as required.
• Electronic signature designed to meet 21 CFR Part 11 requirements (optional).

Test Principle
The sample is loaded into the feeder and automatically delivered into the test cell; pressure change data measured by the sensor are analyzed to calculate leak rate and test results.




Reference Standards
ASTM F2338, YY-T 0681.18, USP 1207.




Applications

• Basic — Vials: Seal leak testing of various vial types.
• Extended — Ampoules: Trace leak testing of ampoules.
• Extended — Cartridge Bottles: Leak testing of cartridge-type containers.
• Extended — Injection/Infusion Bottles: Leak testing of injection and infusion bottles.
• Extended — Flexible Packaging: IV bags and other flexible pharmaceutical packaging.

Technical Specifications

• Testing range (reference aperture size per USP 1207): μm — presented on-site as 2–8–greater leakage (concept per USP 1207).
• Detection lower limit: ≤ 2 μm.
• Resolution: 0.1 μm.
• Repeatability: ±1 μm.
• Pressure range: -100 ~ 0 ~ 100 kPa.
• Optional functions: 21 CFR Part 11 support; GMP computer-system compliance.
• Test cells: 1 set for group A and 1 set for group B.
• Sample feeders: 1 set for group A and 1 set for group B.
• Sample size (note): ≤ Φ45 mm × 80 mm (Group C test cell customizable for larger samples; detection limits may vary).
• Continuous sample capacity: 20–120 pieces.
• Gas specification: 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: 33.4 H × 19.6 W × 28.7 D (85 cm × 50 cm × 73 cm).
• Power: 120 VAC ±10% 60 Hz or 220 VAC ±10% 50 Hz (selectable).
• Net weight: 209 lbs (95 kg).
• Standard configuration: Mainframe, embedded tablet PC, software, flow meter, European vacuum pump, Φ6 mm polyurethane tubing.
• Customization: Test cell and sample feeder for groups A and B; positive/negative reference samples per customer specifications.
• Optional accessories: GMP computer-system packages, 21 CFR Part 11, air compressor, IQ/OQ/PQ documentation.