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 Non-Destructive Testing TechnologyEmploying the vacuum decay method, this equipment enables manufacturers to verify seal integrity and packaging leaks without damaging products. With a customizable chamber that accommodates packages up to 300 mm wide and 150 mm high, the stainless steel build ensures industrial-grade longevity, supporting rigorous QC and research environments.
User-Centric Automation and Digital ControlThe system features a digital LCD touchscreen, automated test reports, and interfaces such as RS232/USB for streamlined workflow integration. Adjustable test speeds and semi-automatic operation boost productivity while maintaining less than 65 dB noise levels, making it suitable for controlled, dust-free settings in any manufacturing facility.
FAQ's of Non-Destructive Seal Testing for Packaging Manufacturing:
Q: How does the vacuum decay method ensure non-destructive seal testing for packaging?
A: The vacuum decay method works by detecting pressure changes within a sealed test chamber. If the packaging has a leak, the vacuum will decay at a measurable rate, allowing the system to accurately determine seal integrity without causing any damage to the package.
Q: What types and sizes of packaging can be tested with this equipment?
A: The device accommodates a single package per test cycle with customizable specimen sizes up to 300 mm wide and 150 mm high. This flexibility supports a wide range of packaging materials used in industries such as food, pharma, and consumer goods.
Q: When should seal integrity testing be performed during the packaging process?
A: Seal integrity testing is recommended at several stages: during product development (R&D), after production as part of quality control (QC), and in periodic audits to ensure ongoing packaging reliability. Regular testing helps maintain compliance and product safety.
Q: Where is the optimal environment to operate this seal testing equipment?
A: For accurate and reliable results, the machine should be used in dust-free, vibration-free environments with relative humidity between 10%-90% (non-condensing) and temperatures ranging from 5C to 35C. Such controlled settings minimize the risk of external factors affecting test outcomes.
Q: What is the calibration and maintenance process for the system?
A: Each unit is factory calibrated and comes with an official calibration certificate. Regular calibration checks are suggested in alignment with internal QC protocols to maintain accuracy, but minimal routine maintenance is required due to the robust stainless steel construction.
Q: How does digital control and data storage benefit operational efficiency?
A: With a digital LCD touchscreen interface and storage for up to 500 test records, users can quickly access, review, and export test data. Automated reports enhance traceability, making compliance with standards such as ASTM F2096 and ISO 11607-1 straightforward and auditable.
Q: What safety and compliance features are included to protect users and ensure quality?
A: The equipment includes overpressure protection and an emergency stop function to guarantee operator safety. It is fully compliant with international standards like ASTM F2096 and ISO 11607-1, ensuring reliable and standardized testing for global packaging requirements.