C690H Nondestructive Package Leak Detector is based on    the testing principle of the vacuum decay method, designed    and manufactured according to ASTM F2338 and other    standards. It is professionally suitable for batch sealing leak    detection of vials, and trace leakage detection of ampoule,    cartridge bottles, infusion bottles, prefilled syringes and other    pharmaceutical packaging.
    Featuresnote1
    Batch Testing
    -         Equipped with fully-automatic gravity fed sample feeder, which is Labthink’s latest scientific and        technological achievement that can facilitate continuous testing of 20 to 120 samples.    
     -         A & B dual-channel design can test samples of two different specifications simultaneously.    
     -         The target vacuum degree can be set by the operator to meet testing requirements of different samples.    
     -         Dual methods of vacuum decay and pressure decay provide the flexibility to accommodate various        types of package samples.    
 
    Precise Data
    -         Advanced pressure detection technology, using world renowned components for data stability which        is not affected by ambient environment.    
     -         Advanced microflow automatic flow control technology that can accurately simulate different sizes        of leakage holes without manual adjustment.    
     -         Both the differential pressure transducer and flow meter are traceable to NIST.    
     -         The system can achieve a higher test repeatability of ±1um.    
 
    Intelligent Control
    -         15.6" embedded touch tablet computer with Windows OS.    
     -         New longitudinal interface layout, and easy to use graphic user interface.    
     -         Automatic alarm, automatic capture, automatic collection of unqualified samples.    
     -         The pressure curve is displayed in real time, and the test results are counted automatically.    
     -         Leakage rates are calculated automatically.    
     -         The system is equipped with various sensors as intelligent reminders for safer operation and        control.    
     -         Universal printer can be connected for test results output.    
     -         The system features embedded with USB and network ports to facilitate the external access and        data transmission of the system, which can be upgraded remotely    
 
    Security Compliance
    -         Verified by compensation and calibration methods.    
     -         The leak tester meets GMP requirements for data traceability and meets the needs of the        pharmaceutical industry.    
     -         User operation permission is managed at multiple levels, and the permission content can be        configured on demand.    
     -         Electronic signature is designed according to the standard requirements of 21 CFR Part11.    
 
    Test Principle
    The sample is placed in the sample feeder and automatically delivered into the test cell. The leak rate and other results can be calculated and obtained by analyzing pressure changes measured by the    sensor.
    Reference Standards
ASTM F2338, YY-T 0681.18, and USP<1207>
    Applications
                        | Basic Applications |             Vials |             Various vial leak test. |         
                    | Extended Applications |             Ampoule |             Various ampoule bottle leak tests. |         
                    |  Cartridge Bottles |             Various cartridge bottle leak tests. |         
                    | Injection bottles |             Various injection bottles leak test. |         
            | Flexible Packaging Bags |             Various IV bags and flexible packaging bags. |         
     
    Technical Parameters
    Table 1: Test Parameters Note2
                        | Parameter\Model |             C690H |         
                    | Testing Range |              um(Reference aperture size                    USP1207) |             2~8~great leakage |         
                    | Detection Lower Limit |             um |             ≤2 |         
                    | Resolution |             um |             0.1 |         
                    | Repeatability |             um |             ±1 |         
                    | Pressure Range  |             kPa |             -100~0~+100 |         
                    | Extended Functions |             21 CFR Part11  |             Optional |         
                    | GMP computer system requirements  |             Optional |         
    
    Table 2: Technical Specifications
                        | Testing Cell |             1 set for A group and 1 set for B group |         
                    | Sample Feeder |             1 set for A group and 1 set for B group |         
                    | Sample Size |             ≤Φ45 mm×80mmNote3 |         
                    | Sample Quantity |             20~120 pieces |         
                    | Gas Specifications |             Compressed Air (Gas source is provided by the user) |         
                    | Gas Source Pressure |             ≥ 40.6 PSI / 500 kPa |         
                    | Port Size |             Φ6 mm Polyurethane tube |         
                    | Dimensions |             33.4” H x 19.6” W x 28.7” D (85cm× 50cm× 73cm) |         
                    | Power |             120VAC±10% 60Hz / 220VAC±10% 50Hz(select one from the two) |         
                    | Net weight |             209Lbs (95kg) |         
    
    Product Configuration
                        | Standard Configuration |             Mainframe, embedded tablet computer, software, flow meter, European vacuum pump, Φ6 mm polyurethane tube |         
                    | Customization |             Test cell and sample feeder of group A, test cell and sample feeder of group B, negative standard reference sample and positive standard reference sample designed according to sample specifications |         
                    | Optional Parts |             GMP computer system requirements, 21 CFR Part11, air compressor, IQ/OQ/PQ documents |         
    
    Note 1: The described product characteristics are subject to the specific annotation of the "Technical Parameters"    table.
    Note 2: The parameters in the table are measured in the Labthink laboratory by professional operators according to    the requirements and conditions of the relevant laboratory environmental standards.
    Note 3: Group C test cell can be customized for samples beyond the "Sample Size", but the lower detection limit and    test range will change according to the sample size, and the actual delivery shall prevail.
    Contact Us!                        We can help you select or customize the proper unit for your test requirements.