Product Description

Applicable Samples

Packaging pouches, infusion bags, plastic bottles, vials, ampoules

Product Introduction

ST-MLST03 multi-station micro-leak non-destructive seal integrity tester is specially designed for non-destructive seal testing of injectable products including ampoules, vials, pre-filled syringes and infusion bags, as well as rigid and flexible packaging containers. We can provide customized testing solutions and tailor-made test chambers according to customers’ injectable products, fully meeting leakage detection requirements for solid and liquid contents.

Note: The standard configuration is 12 test chambers; 16 or more chambers can be customized.

2. Product Features

1. Equipped with a 10-inch color touch screen and intelligent data processing system; real-time display of test curves and automatic data statistics.
2. Dual-sensor testing principle: vacuum decay (standard) and positive pressure decay (optional), to detect pressure and time variations.
3. Adopts trace-level pressure sensors to capture tiny pressure fluctuations.
4. Imported pneumatic components and pressure sensors ensure stable and reliable performance.
5. Fully automatic test process; the instrument automatically terminates testing and judges pass/fail results.
6. Multiple switchable test units: kPa, psi, mbar, mmHg.
7. Adjustable vacuum duration, test duration and stabilization time; parameters stored in database to guarantee consistent test conditions.
8. Built-in mini thermal printer and universal USB port for convenient data export and transmission.
9. GMP-compliant system, supporting user management, 4-level permission control and data audit trail functions.
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3. Working Principle

This non-destructive seal tester operates in accordance with ASTM F2338 Vacuum Decay Method.

Place the test sample into a tightly fitted customized test chamber (smaller clearance between chamber and sample delivers higher test resolution). An external vacuum pump evacuates the chamber to the preset vacuum level and stops automatically. After a stabilization period, the absolute/vacuum sensor continuously monitors pressure rise (vacuum decay) within the set time window. If the pressure rise exceeds the preset threshold, the sample is identified as leaking.

4. Technical Specifications

Parameter	Specification
Test Method	Vacuum Decay Method (Standard); Pressure Decay Method (Optional & Customizable)
Test Chambers	12 chambers as standard; 16+ chambers customizable
Ultimate Vacuum	Down to 10 Pa
Vacuum Accuracy	Class 0.25
Detectable Leak Hole Size	1–2 μm (customizable up to 5 μm)
Minimum Detection Sensitivity	0.01 sccm (equivalent to 1 μm leak aperture)
Test Chamber	Custom size & type based on test samples
Test Output	Qualitative: Pass / Fail Quantitative: Leakage flow rate, leak rate, equivalent hole diameter
Chamber Clamping Mode	Pneumatic
Compressed Air Supply	0.6 MPa ~ 0.7 MPa (air compressor to be prepared by user)
Overall Dimension	430mm (L) × 320mm (W) × 480mm (H)
Power Supply	220V, 50Hz
Net Weight	Approx. 26 kg

5. Compliance Standards

ASTM F2338, USP <1207, YY/T 0681.18, ISO 9650 Guidance on Container Closure Integrity Testing for Sterile Pharmaceutical Packaging Systems

6. Configuration List

Standard Configuration

Main unit, vacuum pump, test chambers, mini thermal printer

Optional Accessories

Custom test chambers, positive pressure decay testing module, GMP software

Note 1: Computer is not included in standard configuration and shall be prepared by the user separately.

Note 2: Test chambers vary by sample type and need to be customized according to test specimens.