Catheter leak detection machine
Whats/App: +86 156 1874 6768
Web: standard-groups.com
Standards
YY/T 0681.18-2020: Test Methods for Sterile Medical Device Packaging - Part 18: Non-destructive Testing of Packaging Leaks Using the Vacuum Decay Method
ASTM F2338-13: Standard Test Method for Packaging Leaks - Vacuum Decay Method
USP1207: United States Pharmacopeia Standard
Features
Micro leaks are detected in packages. The samples can be reused to reduce costs effectively.
Environmental temperature and humidity monitoring device.
Detect small and large leaks and the system determines qualified or unqualified automatically.
Test method: Vacuum Decay Method
Test time is less than 30s.
Test chambers can be selected for different samples and can be easily replaced.
Print test results automatically, ensuring accuracy and objectivity.
Statistical analysis is automatically performed on the test results, including yield statistics and sample normal distribution chart.
Equipped with micro printer, USB.
Automatically save, query, and export reports to Excel and PDF formats.
Meet GMP requirement, user-graded permission setting, historical record audit tracking function.
PC software is optional.
Technical Parameters
| Technical Specification | Specification |
|---|---|
| Application | Ampoule, Vial, Injection Bottle, and Pre-filled Package |
| Test Method | Vacuum Decay Method (Non-destructive Test) |
| Test Chamber | Customization per Samples |
| Vacuum Degree | 0 ~ -100 kPa |
| Testing System | Dual-sensor Technology |
| Detection Sensitivity | 1 ~ 2 μm in diameter |
| Test Time | Less than 30s |
| Vacuum Source | Vacuum Pump |
| Environment Temperature | 15℃ ~ 30℃ |
| Relative Humidity | Up to 80%RH. No condensation. |
| Power Supply | AC 100-240V 50/60Hz (can be changed to local requirement) |
| Instrument Dimension | 320 mm (W) x 520 mm (D) x 350 mm (H) |
| Net Weight | 20 kg |
Accessoriess
Instrument, Vacuum Pump, Micro Printer, Test Chamber, Professional Software, 485 Communication Cable, Calibrated Flow Meter, Customized Test chamber, Positive Specimen, Negative Specimen.
Test Procedures
Single-sensor testing: Uses a single pressure sensor to monitor pressure changes within the test chamber throughout the process.
Dual-sensor testing: Combines a pressure sensor and a differential pressure sensor to provide more accurate measurement data, especially suitable for detecting very subtle leaks.
Multi-sensor testing: Further enhances accuracy by adding additional types of sensors (such as force sensors) for a more comprehensive assessment of leaks.
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