.

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 SpecificationSpecification
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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