IntroductionAUTO GBM-L2 Dual-Pressure Methods Vacuum Decay Leak Detection Tester adopts the vacuum decay method and pressure decay method to detect micro-leakage of finished packaging. It is applicable to pharmaceutical packaging (vials, ampoules, prefilled syringes, infusion bottles/bags, prefilled needles, eye drop bottles), food packaging and chemical industry packaging.
Test principleThe host connects to a sealed test chamber customized for the sample. For the vacuum decay method, the instrument evacuates the test chamber to create a pressure difference; gas/liquid in the sample enters the chamber through any leak and absolute and differential pressure sensors monitor chamber pressure change to determine leakage. For the pressure decay method, the instrument pressurizes the chamber to a predetermined air pressure and sensors monitor pressure change to determine leakage.
StandardASTM F2338-2009(2013); YY-T 0681.18-2020; USP 1207.2; ASTM F2095
SpecificationItem - Parameters
Absolute Pressure Testing Range : (0 - 300) kPa
Differential Pressure Testing Range : (-2 - 2) kPa
Detection Sensitivity : 1 - 3 μm
Balancing/Testing Time : 1 - 3600 s
Vacuum Purge Time : 1 - 3600 s
Set Flow Rate : 0 - 3 mL/min
Testing System : Dual Sensor Technology/Dual Cycle Testing
Testing Chamber : Customized according to the sample
Applicable Products : Vials, Ampoules, Prefilled Syringes, Infusion Bottles/Bags, etc.
Detection Principle : Vacuum Decay Method/Pressure Decay Method
Dimensions of the Main Unit : 495 mm x 455 mm x 280 mm
Ambient Temperature : 20°C - 25°C
Relative Humidity : 40% - 60%
Working Power Supply : AC 220V, 50HZ
Features- Dual-pressure methods (vacuum decay and pressure decay) to reduce misjudgment and false negatives, especially for samples with internal vacuum (e.g., freeze-dried powder injections).
- Dual-sensor and dual-circulation system technology with high-quality absolute and differential pressure sensors (accuracy 0.1% FS) for detection of large and small leaks and leak hole diameter calculation with pass/fail judgment.
- High sensitivity and good test repeatability: detection sensitivity as low as 1 μm for rigid samples; repeatability down to 0.8%.
- Imported vacuum pump (pumping rate up to 3 L/s, low noise ~50 dB) and imported gas mass flow controller (resolution 0.001 mL/min) to support method verification.
- Large color 7-inch touch screen for intelligent operation, micro-printer, USB data interface and support for PC software measurement and control.
- Test software designed according to GMP computerized system requirements with audit trail and multi-level user authority management for pharmaceutical data traceability.
- Personalized customization: supports customized test chambers and nesting modes to meet different sample requirements.
Application- Freeze-dried powder injections
- Injections and vials
- Prefilled needles/syringes
- Eye drops
- Infusion bottles and infusion bags
- Various pharmaceutical, food and chemical packaging requiring micro-leak detection
Factory configurationStandard: Host machine, vacuum pump, test chamber and 3 sets of yin and yang control (customized as required), 11-inch touch panel, professional GMP software. Optional: imported gas flow meters, air compressors, printers, calibration certificates.
Technical specifications- Absolute Pressure Testing Range: (0 - 300) kPa
- Differential Pressure Testing Range: (-2 - 2) kPa
- Detection Sensitivity: 1 - 3 μm
- Balancing/Testing Time: 1 - 3600 s
- Vacuum Purge Time: 1 - 3600 s
- Set Flow Rate: 0 - 3 mL/min
- Testing System: Dual Sensor Technology / Dual Cycle Testing
- Testing Chamber: Customized according to the sample
- Applicable Products: Vials, Ampoules, Prefilled Syringes, Infusion Bottles/Bags, etc.
- Detection Principle: Vacuum Decay Method / Pressure Decay Method
- Dimensions (Main Unit): 495 mm x 455 mm x 280 mm
- Ambient Temperature: 20°C - 25°C
- Relative Humidity: 40% - 60%
- Working Power Supply: AC 220V, 50HZ