Vacuum decay leak tester MK-500H

for seal integrityfor vialsfor ampoules

The MK-500H Vacuum Decay Leak Tester specializes in the detection of leaks in ampoules, vials, injection bottles, freeze-dried powder injection bottles, and pre-filled packages.Product 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 MethodTest 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.Test Principle:The testing principle of the MK-500H vacuum decay leak detector is fully compliant with ASTM F2338-09 standards and USP 40-1207 regulations, based on vacuum decay methodology employing dual sensor technology and a dual-cycle system. The main unit of the micro-leak seal tester is connected to a specially designed test chamber that accommodates the package to be tested. The instrument evacuates the test chamber to create a pressure differential between the interior and exterior of the package. Under this pressure gradient, gas from inside the package diffuses through potential leaks into the test chamber. The dual sensor technology monitors the time-pressure variation relationship, which is then compared against standard values to determine whether the sample exhibits leakage.Test Standards:This test instrument conforms to many national and international standards: USP1207, YY/T 0681.18-2020Technical Specifications:Application: Ampoule, Vial, Injection Bottle, and Pre-filled PackageTest Method: Vacuum Decay Method (Non-destructive Test)Test Chamber: Customization per SamplesVacuum Degree: 0 ~ -100 kPaTesting System: Dual-sensor TechnologyDetection Sensitivity: 1 ~ 2 µm in diameterTest Time: Less than 30sEquipment Operation: HMIVacuum Source: Vacuum PumpEnvironment Temperature: 15°C ~ 30°CRelative 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 kgConfigurations:Instrument, Vacuum Pump, Micro Printer, Test Chamber, Calibrated Flow Meter, Customized Test chamber, Positive Specimen, Negative SpecimenJinan Saicheng is always dedicated to the innovation and improvement of product performance and function. Therefore, technical specifications are subject to change without further notice. Jinan Saicheng reserves the rights of final interpretation and revision.