ASTM F2338 Non-destructive Micro-leak Seal Tester Micro Leakage Detector Packaging Container Bottles Bag Seal Integrity Analyzer

Product Introduction

This non-destructive micro-leak seal tester is designed for testing the seal integrity of packaging. It utilizes the vacuum decay test principle—a completely non-destructive technology—and complies with ASTM test methods and FDA standards. It is ideally suited for detecting micro-leaks and verifying container closure integrity in pharmaceutical packaging such as vials, pre-filled syringes, cartridges, ampoules, infusion bottles, and infusion bags. It is also applicable to food packaging (bags, cans, bottles) for micro-leak detection and container closure integrity testing.

Technical Features

1. Employs a multi-sensor approach (vacuum, pressure, and micro-differential pressure) for non-destructive seal integrity testing.

2. Features a precision pressure testing system that significantly enhances testing accuracy.

3. Equipped with a high-speed, high-precision sampling chip to ensure real-time data and accuracy.

4. Utilizes imported pneumatic components and sensors (micro-differential pressure and pressure) from world-renowned brands for stable, reliable performance.

5. Supports multi-level vacuum presets to analyze the leakage pressure of samples.

6. Incorporates an external, imported high-precision micro-flow meter to optimize measurement and validation methods.

7. Uses a high-end imported vacuum pump to generate the system vacuum, meeting high-vacuum testing requirements.

8. Features a unique test chamber clamping mechanism that allows for easy chamber replacement while maintaining system-wide seal integrity.

9. Includes a 12-inch industrial-grade HD touchscreen for real-time viewing of test data and curves.

10. Offers one-touch operation and an intuitive interface, with support for remote upgrades and maintenance.

11. Allows for adjustable vacuum, test, and infiltration times, with settings stored in the database to ensure consistent testing conditions.

12. Displays test curves in real-time and performs intelligent data statistics for quick review of results.

13. Complies with GMP requirements for data traceability and meets pharmaceutical industry standards; includes multi-level permission management.

14. Features automatic data storage and power-loss memory functions.

15. Allows for quick viewing and printing of historical data.

16. Equipped with a micro-printer and standard data interfaces for convenient data output and transfer.

Test Principle

Based on the vacuum decay method (ASTM F2338 standard) and utilizing multi-sensor technology (vacuum, pressure, and micro-differential pressure). The main unit is connected to the test chamber, and the specimen is placed inside for vacuum evacuation. A pressure differential is created between the inside and outside of the specimen, allowing gas to flow through any leak paths into the vacuum decay chamber and the main unit. The main unit employs pressure and differential pressure sensors to monitor changes in the vacuum level within the test chamber, determining the specimen's acceptability based on the magnitude of this change.

Reference Standards

ASTM F2338, YY/T 0681.18-2020, GB/T 15171-2025, etc.

ASTM F2338 Non-destructive Micro-leak Seal Tester Micro Leakage Detector Packaging Container Bottles Bag Seal Integrity Analyzer

Technical Parameters