Vacuum decay leak tester MK-500H

for packagingfor seal integrityfor vials

Product Overview
The MK-500H is a high-performance vacuum decay leak tester specifically designed for inspecting ampoules, vials, injection bottles, lyophilized powder vials, and prefilled syringes or cartridges. It delivers reliable, non-destructive leak detection with advanced sensitivity and operational flexibility.

Key Features

Detects micro-leaks while allowing samples to be reused, significantly reducing testing costs.

Integrated environmental temperature and humidity monitoring.

Capable of identifying both small and large leaks, with an automatic pass/fail judgment system.

Test duration of less than 30 seconds per cycle.

Interchangeable test chambers tailored to different sample types, enabling quick changeovers.

Automatic printout of test results for guaranteed accuracy and objectivity.

Built-in statistical analysis functions, including yield statistics and normal distribution charts for sample populations.

Equipped with a micro printer and USB interface for data output.

Automatic saving, querying, and export of reports in Excel and PDF formats.

Meets GMP requirements with user-tiered permission settings and full historical record audit trail functionality.

Optional PC software for extended data management and remote control.

Test Principle
The MK-500H operates in full compliance with ASTM F2338‑09 and USP guidelines. It employs a vacuum decay method based on dual‑sensor technology and a dual‑cycle system. The main unit connects to a purpose‑designed test chamber that holds the sample. During testing, the chamber is evacuated to create a pressure differential between the package interior and the external environment. Under this gradient, any gas escaping through leaks enters the chamber. The dual‑sensor system continuously monitors pressure changes over time and compares the resulting curve against predefined reference values to determine whether the sample passes or fails.

Standards Compliance
The instrument conforms to USP and YY/T 0681.18‑2020, among other national and international standards.

Technical Specifications
Applications:Ampoules, vials, injection bottles, prefilled packages
Test Method:Vacuum Decay (Non‑destructive)
Test Chamber:Custom‑designed per sample type
Vacuum Range:0 ~ –100 kPa
Detection System:Dual‑sensor technology
Sensitivity:Detects leaks down to 1–2 µm in diameter
Test Time:< 30 seconds
Operation:HMI touch interface
Vacuum Source:Built‑in vacuum pump
Ambient Temperature: 15 °C – 30 °C
Relative Humidity Up to 80 % RH (non‑condensing)
Power Supply :AC 100–240 V, 50/60 Hz (adaptable to local requirements)
Dimensions 320 mm (W) × 520 mm (D) × 350 mm (H)
Net Weight 20 kg

Standard Configurations
Instrument main unit, vacuum pump, micro printer, test chamber, calibrated flow meter, customized test chamber, positive control specimen, and negative control specimen.