Product Description
Featuresnote1
Batch Testing
- Equipped with fully-automatic gravity fed sample feeder, which is Labthinks 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 sealing test. |
| Extended Applications |
Ampoule |
Various ampoule bottle sealing tests. |
| Cartridge Bottles |
Various cartridge bottle sealing tests. |
| Injection bottles |
Various injection bottles sealing test. |
Technical Parameters
Table 1: Test Parameters Note2
| ParameterModel |
C690H |
| Testing Range |
um(Reference aperture size USP1207) |
3i8igreat leakage |
| Detection Lower Limit |
um |
3 |
| Resolution |
um |
0.1 |
| Repeatability |
um |
1 |
| Pressure Range |
kPa |
-100i0ii14100 |
| 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 |
I45 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 |
I6 mm Polyurethane tube |
| Dimensions |
33.4 H x 19.6 W x 28.7 D (85cm 50cm 73cm) |
| Power |
120VAC10% 60Hz / 220VAC10% 50Hzi14select one from the twoi14 |
| Net weight |
209Lbs (95kg) |
Product Configuration
| Standard Configuration |
Mainframe, embedded tablet computer, software, flow meter, European vacuum pump, I6 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.
Advanced Leak Detection TechnologyLeveraging non-destructive testing (NDT), this leak tester delivers high sensitivity for pinpointing even the smallest leaks. Suitable for both flexible and rigid packaging, it ensures intact package seals and product safety, while allowing for multi-specimen evaluation in a single run.
Streamlined Operation and Data ManagementThe equipment features user-friendly touch screen and PLC controls. Its inbuilt memory stores data from over 1,000 tests, with straightforward options for data printout and strong connectivity via RS232/USB. Data retrieval and printout simplify record-keeping for ISO and ASTM compliance purposes.
Reliable Compliance and Material QualityBuilt from Stainless Steel 304 or 316, the tester promises durability and corrosion resistance. Its operation complies with ISO 11607 and ASTM F2338, making it suitable for critical industries. The benchtop design supports automatic processes, optimized test speeds, and ensures accurate results within 1% of full scale.
FAQ's of Preventing Packaging Failures with NDT Leak Testing:
Q: How does the NDT Leak Tester help prevent packaging failures?
A: The NDT Leak Tester prevents packaging failures by using advanced non-destructive testing techniques to detect leaks and seal imperfections. Audio-visual alarms immediately notify operators of leaks, ensuring only intact packages proceed for distribution. This process safeguards product quality and maintains compliance with ISO 11607 and ASTM F2338 standards.
Q: What types of packaging can be tested, and what are the material construction options?
A: You can test both flexible and rigid packaging on this equipment. The machine is constructed from high-grade Stainless Steel 304 and 316, providing superior durability, performance in demanding environments, and resistance to corrosion.
Q: When should I perform leak testing with this equipment?
A: Leak testing should be performed during quality control processes before packaging products for storage or shipment. It's especially critical before exporting items, ensuring packages maintain seal integrity under transport and storage conditions.
Q: Where can the NDT Leak Tester be used within a production facility?
A: This NDT Leak Tester is designed as a benchtop model. It fits easily into quality control labs or packaging lines within manufacturing, export, and supply centers-wherever precise package integrity testing is required.
Q: What is the process for conducting a leak test on this machine?
A: Packages are placed and sealed in the test chamber. The built-in vacuum pump introduces air or inert gas at set pressures (0-250 kPa). The system detects any leaks instantly, displaying data on a digital LCD and triggering both audio and visual alarms if a leak is present. Results are stored and can be printed as needed.
Q: How does the system store and manage test data?
A: With inbuilt memory capable of holding over 1,000 test records, the system allows you to retrieve and print test data easily via RS232 or USB. This feature is ideal for audits, record-keeping, and regulatory compliance.
Q: What are the main benefits of using this automatic NDT Leak Tester?
A: Using this NDT Leak Tester delivers rapid, reliable, and repeatable results, reduces the risk of product recalls, and ensures compliance with stringent packaging standards. Its high sensitivity, instant response, and support for multiple specimen testing offer significant productivity and quality assurance advantages.