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.
Send product request
Other supplier products
 |
Battery Safety Compliance Nail Puncture Tester UL Certified Method | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com Standards (1) GB/T 18332.2-2001 General Specification for Lithium-Ion Batte... |
 |
Shoelace anti-siphon tester丨Shoelace anti-siphon test mechine | |
 |
Laboratory Rolling Bearing Fatigue Tester Manufacturer China | Get a quote： Whats/App: +86 156 1874 6768 Web: standard-groups.com Rolling Contact Fatigue Tester is a specialized testing system designed to in... |
 |
Friction and wear testing machine | Whats/App: +86 156 1874 6768 Web: standard-groups.com Standards ASTM G99-04 ASTM G77-16 ISO 9352:1995 GB/T 12444-2006 GB/T 12607-2007 GB/T ... |
 |
20L Spherical Explosion Tester，ASTM E1226 alternative to explosion tester | Whats/App: +86 156 1874 6768 Web: standard-groups.com 20L Spherical Explosion Tester is characterized by accurate test data and ease of use. Its ... |
Same products
 |
China factory electrode TGYS125 for power station Selection of advanced | Seller: DONGFANG YOYIK (DEYANG) ENGNIEERING CO; LTD | "China factory electrode TGYS125 for power station Selection of advanced technology, absolutely f... |
 |
Laser Chuck | Seller: Drake precision technology (changzhou) Co.,Ltd. | Laser Chuck Introduce foreign advanced technology and management concept, High precision pro... |
 |
Power Pallet Jack For Sale | Seller: Jinan Hulk Machinery Co., Ltd | Power Pallet Jack For Sale Electric Pallet Truck For Sale As a supplier of power pallet jac... |
 |
Multi Directional Forklift For Sale | Seller: Jinan Hulk Machinery Co., Ltd | Multi Directional Forklift For Sale Multi Directional Forklift For Sale As a supplier of mu... |
 |
Narrow Aisle Forklift For Sale | Seller: Jinan Hulk Machinery Co., Ltd | Narrow Aisle Forklift For Sale Narrow Aisle Forklift For Sale As a supplier of , we provide... |
