Profesional manufacturer & supplier for test equipment & analytical instruments since 2003.

Leakage Detector Non-destruction Sealing Tester

The positive and negative pressure non-destructive sealing tester is professionally suitable for micro leakage and packaging sealing integrity testing of ampoules, penicillin bottles, injection bottles, freeze-dried powder injection bottles, and pre filled packaging samples.

Inquiry

Write a Review

Features

· Non destructive testing methods are used to detect micro leaks.

· The host comes with an environmental temperature and humidity monitoring device and use steel 316.

· Check if the samples with small or large leaks are qualified

· The precision of vacuum/pressure attenuation method can reach 0.03ccm (approximately 2 microns).

· Corresponding test chambers for different samples

· Automatically print test results at the end of the experiment

· 12 inch embedded industrial control all-in-one machine(user-friendly and more convenient operation)

· Statistical analysis is automatically performed on the test results after test.

· Support for PC software measurement and control operation

· Automatically save historical test records, query locally, and export to Excel and PDF formats for saving

· User graded permission settings, meeting GMP requirements, testing record audit tracking function

Testing Standards

This instrument complies with multiple national and international standards.

YY/T 0681.18-2020: Test Methods for Packaging of Sterile Medical Devices Part 18: Non destructive Testing of Packaging Leakage by Vacuum Attenuation Method, ASTM F2338-13: Standard Test Method for Packaging Leakage - Vacuum Attenuation Method, ASTM F2095: Standard Test Method for Packaging Leakage - Pressure Attenuation Method USP1207 US Pharmacopoeia Standard, Technical Requirements for Quality and Efficacy Consistency Evaluation of Chemical Injection Generic Drugs, and Technical Guidelines for Sealing Research of Chemical Injection Packaging Systems.

Application

Micro leakage detection of ampoule bottles, penicillin bottles, injection bottles, freeze-dried powder injection bottles, and pre filled packaging samples.

Technical indicators

Index	Parameter
Screen Size	12 Inch
Test Method	Vacuum attenuation method and pressure attenuation method
Vacuum Degree	Excellent vacuum as low as 10Pa
Accuracy	0.25 level
Detection Aperture Accuracy	1-2μm (optional 5μm)
Test Chamber	Size and type are customized according to the special requirements of the sample
Detection Sensitivity	Minimum 0.01sccm (equivalent aperture of approximately 1μm)
Detection Result	Qualitative: qualified/unqualified; Quantitative: leakage amount, leakage rate, leakage hole diameter
External Dimensions	720 mm (L) x 430 mm (B) x 600 mm (H)
Source	AC 220 V 50 Hz
Net Weight	25 kg