Vacuum decay leak detection tester Features

Dual-sensor dual-cycle technology, non-destructive testing

Utilizing dual-sensor and dual-circulation system technology, our system employs high-quality absolute pressure sensors and differential pressure sensors, boasting an accuracy of 0.1% FS. This enables effective detection of both large and small leaks, precise calculation of leak hole diameters, and accurate pass or fail determinations. Our non-destructive testing method ensures that finished packages undergo leak testing without sustaining any damage, preserving the integrity of the sample post-test.

The instrument has low sensitivity and good test repeatability

For rigid samples, our detection sensitivity reaches as low as 1 μm, with test repeatability as low as 0.8%. The instrument offers stable performance, minimal noise, and excellent repeatability.

High quality components, excellent performance

Featuring a world-class brand vacuum pump, our system offers a pumping rate of up to 3 L/s, with noise levels as low as 50 dB and a high ultimate vacuum. Additionally, it includes convenient oil level detection and replacement functionalities. 

Furthermore, the imported gas mass flow controller allows for the simulation of micro-leaks with precision, offering a resolution of 0.001 mL/min. This feature provides a reliable means for method verification, ensuring the sensitivity of the instrument.

Large size touch screen, intelligent operation

Featuring a vibrant 7-inch touch screen display, our system offers a clear view, sensitive touch controls, and intuitive operation. It comes equipped with a micro-printer and USB data interface, supporting PC software for measurement and control operations.

The test software adheres to the GMP appendix "Computerized System", incorporating an audit trail function and multi-level user authority settings. These features ensure compliance with pharmaceutical industry requirements for data traceability.

Personalized customization to meet the needs of different samples

Our system offers customization options for test chambers to accommodate various types of test samples, ensuring versatility to meet diverse testing needs.

Furthermore, for samples of the same type, our system supports customized nesting modes, enabling the sharing of a single test chamber among samples of different specifications. This flexibility enhances efficiency and streamlines testing processes.

Vacuum Decay Leak Detection Tester

Test principle

Utilizing dual sensor technology and the vacuum decay method principle with a dual circulation system, the microleak leak tester's main unit is connected to a specially designed test chamber to accommodate the package under examination. The instrument then evacuates the test chamber, creating a pressure differential between the inside and outside of the package. As pressure is applied, gas from the package permeates into the test chamber through any leak points. The dual-sensor technology monitors the relationship between time and pressure, comparing it to a predefined standard value to ascertain whether the sample exhibits any leaks.

Standards:
ASTM F2338-2009(2013), YY-T 0681.18-2020, USP<1207.2>

ASTM F2338-09(2020): Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
Leaks in medical devices, pharmaceuticals, and food packages can lead to the entry of undesirable gases, often oxygen, along with potentially harmful microbiological or particulate contaminants. These leaks may manifest as flaws in the package components or at the seal junction where components are joined. Detecting leaks is crucial for maintaining the consistency and integrity of packages.

Applications:

Freeze-dried powder injection	Injection	Prefill needle
Eye drops	Plastic Ampoule BFS	Infusion bags