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.
Reliable Seal Integrity Testing for Medicine BottlesEngineered for pharmaceutical labs, this tester utilizes both vacuum decay and burst modes to ensure comprehensive evaluation of induction seal strength on medicine bottles. Its adjustable test speed, digital touchscreen, and high accuracy make it a trusted choice for ensuring product safety and compliance with industry standards.
Advanced Data Management and Output OptionsStore up to 10,000 test records and export results easily in CSV or PDF format. USB and RS232 connectivity, along with optional thermal printer output, allow users to maintain thorough documentation and streamline workflows, while supporting compliance with FDA and GMP requirements.
User-Friendly, Multilingual Operation and Safety ControlsThis tester features a multilingual interface (English, Chinese, Hindi) and intuitive touchscreen control. Essential safety mechanisms, such as emergency stop and overcurrent protection, provide a secure testing environment suitable for daily laboratory use.
FAQ's of Testing Induction Seals on Medicine Bottles:
Q: How does the Induction Seal Strength Tester evaluate seal integrity on medicine bottles?
A: The tester uses vacuum decay and burst test modes to assess the strength and leakage resistance of induction seals. By applying and measuring controlled force and pressure, it identifies weak seals or leaks on up to three bottles per test cycle, ensuring pharmaceutical packaging integrity.
Q: What process is followed to operate the tester and record results?
A: Operation involves placing up to three sample bottles in the adjustable fixture, setting desired test parameters via the digital touchscreen, and initiating the test. Data is automatically logged, with the tester storing up to 10,000 results, which can be exported as CSV or PDF files for further analysis.
Q: When should I calibrate the device for accurate measurements?
A: Calibration is recommended before initial use, after maintenance, or if test results appear inconsistent. The tester supports both automatic and manual calibration using included calibration weights to maintain measurement accuracy.
Q: Where can the Induction Seal Strength Tester be used effectively?
A: This equipment is ideally suited for pharmaceutical testing laboratories, manufacturing lines, and quality control departments where accurate and repeatable assessment of induction seal strength is critical for compliance and product safety.
Q: What accessories and features come with the tester to enhance its usage?
A: The tester includes sample bottles, induction seal fixtures, and calibration weights to facilitate immediate setup and operation. Additional features such as digital LCD display, multilingual interface, emergency stop, and overload protection ensure safety, convenience, and adaptability in routine laboratory testing.
Q: What are the benefits of using this seal strength tester for pharmaceutical applications?
A: It offers precise measurement with 1% accuracy, adjustable test parameters, rapid response time, and automatic data logging, enabling laboratories to comply with FDA and GMP guidelines while improving operational efficiency and data traceability.