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.
ASTM F2338, YY-T 0681.18, and USP<1207>
Basic Applications | Vials | Various vial sealing test. |
Extended Applications | Ampoule | Various ampoule bottle sealing tests. |
Cartridge Bottles | Various cartridge bottle sealing tests. | |
Injection bottles | Various injection bottles sealing test. |
Table 1: Test Parameters Note2
Parameter\Model | C690H | |
---|---|---|
Testing Range | um(Reference aperture size USP1207) | 3ï8ïgreat leakage |
Detection Lower Limit | um | 3 |
Resolution | um | 0.1 |
Repeatability | um | ±1 |
Pressure Range | kPa | -100ï0ïï¼100 |
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 | Î45 mm80mmNote3 |
Sample Quantity | 20120 pieces |
Gas Specifications | Compressed Air (Gas source is provided by the user) |
Gas Source Pressure | 40.6 PSI / 500 kPa |
Port Size | Î6 mm Polyurethane tube |
Dimensions | 33.4 H x 19.6 W x 28.7 D (85cm 50cm 73cm) |
Power | 120VAC±10% 60Hz / 220VAC±10% 50Hzï¼select one from the twoï¼ |
Net weight | 209Lbs (95kg) |
Standard Configuration | Mainframe, embedded tablet computer, software, flow meter, European vacuum pump, Î6 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.
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