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
| Parameter\Model |
C690H |
| Testing Range |
um(Reference aperture size USP1207) |
38great leakage |
| Detection Lower Limit |
um |
3 |
| Resolution |
um |
0.1 |
| Repeatability |
um |
1 |
| Pressure Range |
kPa |
-1000100 |
| 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 |
45 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 |
6 mm Polyurethane tube |
| Dimensions |
33.4 H x 19.6 W x 28.7 D (85cm 50cm 73cm) |
| Power |
120VAC10% 60Hz / 220VAC10% 50Hzselect one from the two |
| Net weight |
209Lbs (95kg) |
Product Configuration
| Standard Configuration |
Mainframe, embedded tablet computer, software, flow meter, European vacuum pump, 6 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.
Efficient Leak-Proofness VerificationDesigned for the medical industry, this Leak Testing Machine offers precise leak-proofness assessment of vacuum blood collection tubes. It combines automatic leak detection, rapid response times (2 seconds), and an adjustable test speed (5-200 mm/min) to optimize throughput and reliability. Compliance with ISO 8536-1 and EN 980 standards guarantees consistent quality and regulatory adherence.
User-Friendly Operation and ConnectivityThe intuitive touch screen interface ensures straightforward operation and parameter setting. Operators benefit from real-time digital LCD feedback, built-in Wi-Fi connectivity for remote access, and seamless Windows OS compatibility. Automatic self-calibration and PLC-based control streamline routine use, minimizing manual intervention while maximizing testing accuracy.
Robust Data Management and AnalyticsMaintain full traceability and oversight with built-in storage for up to 10,000 test records and real-time data analytics. The system supports efficient data logging and rapid statistical reporting, essential for regulatory audits and continual process improvement. Audio and visual alarms alert users instantly to over-limit conditions, reinforcing operational safety.
FAQs of Improving Vacuum Collection Tube Leak-proofness with Pressure Decay Leak Testing:
Q: How does the pressure decay leak testing process work for vacuum collection tubes?
A: The machine applies dry air or inert gas to the vacuum collection tubes and monitors the pressure within a set range (1-1000 kPa). Any pressure loss during the test indicates leakage. The automatic PLC-based system controls test speed, stroke, and pressure, ensuring precise detection according to ISO and EN standards.
Q: What are the benefits of using this machine for leak-proofness verification in medical device quality control?
A: Key benefits include high throughput (up to 480 tubes/hour), accurate and repeatable measurements (0.5% F.S.), automated data logging, real-time analytics, and stringent safety protections. Built-in self-calibration and large storage capacity help eliminate human error and support regulatory compliance for consistent product quality.
Q: When should routine maintenance be performed on this leak testing equipment?
A: It is recommended to perform routine maintenance every 12 months to maintain peak performance and ensure long-term durability. Regular calibration and checkup minimize downtime and preserve measurement reliability.
Q: Where can this leak testing machine be utilized most effectively?
A: The equipment is ideal for use in medical device manufacturing facilities, quality control laboratories, and by suppliers or exporters of vacuum blood collection tubes. Its floor-standing design and robust stainless steel frame suit industrial settings with ambient conditions of 5C to 45C and 20%-85% RH.
Q: How is real-time data analytics and storage managed on this device?
A: Test results are displayed instantly on the digital LCD, while the built-in memory automatically logs up to 10,000 records. Users can export data for analysis, and the real-time analytics function supports objective process evaluations and regulatory reporting.
Q: What safety features are incorporated to protect the operator?
A: Operator safety is reinforced through emergency stop functionality and overpressure protection. Audio and visual alarms immediately notify users of over-limit conditions, while the systems reliable construction and straightforward interface reduce operational hazards.