MLT-01 Micro Leak Tester

MLT-01 Micro Leak Tester
Micro Leak Testing Machine MLT-01

The MLT-01 Micro Leak Tester utilizes advanced vacuum decay technology for precise and non-destructive leak testing of various packaging forms, ensuring high accuracy in detecting even micro-level leaks.

Introduction

ASTM F2338 Vacuum Decay Leak Tester

The MLT-01 Micro Leak Tester applies the vacuum decay method, a non-destructive technique ideal for identifying micro-leaks in rigid and flexible packaging. With dual-sensor technology and a highly sensitive detection system, the MLT-01 guarantees reliable results for industries focused on product protection and safety.

The MLT-01 Micro Leak Tester is designed to provide advanced leak detection using the vacuum decay method. This non-destructive, highly accurate testing technique ensures the integrity of various packaging types, from vials to infusion bags, by detecting leaks within the headspace or below the product fill line. Equipped with dual-sensor technology, it offers precision measurement for micro-leak detection, making it suitable for industries requiring stringent packaging validation.

The system’s automated functions, intuitive PLC controls, and HMI interface streamline testing processes, enabling reliable and repeatable results. Capable of customizing test parameters, the MLT-01 caters to a broad range of applications, ensuring package integrity and compliance with critical standards like ASTM F2338, YY-T 0681.18, and USP <1207.2>.

Plastic Ampoule Vacuum Decay Leak Test
Plastic Ampoule Vacuum Decay Leak Test
Syringe in Vacuum Decay Leak Test
Syringe in Vacuum Decay Leak Test

Application

The MLT-01 Micro Leak Tester is primarily used to evaluate the packaging integrity of sealed containers that require sterility and product safety. It is ideally suited for applications requiring stringent leak detection.

  • Vials
  • Ampoules
  • Prefilled syringes
  • Infusion bottles and bags
  • Pharmaceutical and medical device packaging

By identifying micro-leaks that can’t be seen with the naked eye, the MLT-01 helps companies protect their products from contamination and ensure compliance with regulatory standards.

Test Method

The MLT-01 employs the vacuum decay method, which detects leaks by measuring pressure loss in a vacuum-sealed chamber. The test process consists of several phases:

Test Process:

Fill: The sample is secured in the test chamber, and negative pressure is applied.
Settle: The pressure is stabilized to allow for any stretching or flexing.
Test: Any increase in pressure during the vacuum decay phase indicates a leak.
Vent: The chamber returns to atmospheric pressure.
Pass/Fail: The system evaluates the pressure data to determine if the sample passes or fails based on predefined criteria.

This non-destructive testing method is highly sensitive, with the ability to detect leaks as small as 1-2 microns.

Vacuum Leak Rate Profiles and Test Stages
Vacuum Leak Rate Profiles and Test Stages

Key Technical Specifications

Absolute Pressure Range (0~300) kPa
Differential Pressure Range (-2~2) kPa
Sensitivity 1~2 μm
Balance/Test time 1~3600 s
Vacuum Time 1~3600 s
Set Flow Rate0-3 ml/min
Test SystemDual Sensor Technology / Dual Cycle Test
Test ChamberCustomized based on sample dimensions
Configuration:
Standard: Main machine, vacuum pump, high-precision gas flowmeter, test chamber, 3 sets of positive and negative control
Optional: Software, customized test chambers

Technical Features

Dual-Sensor Technology

Offers highly precise pressure monitoring and leak detection.

Customizable Settings

Adjustable vacuum pressure, sensitivity, and test parameters to suit various applications.

User-friendly Interface

7-inch color HMI for easy operation and data monitoring.

Wide Application Range

Compatible with multiple package types, from rigid to flexible packaging.

High-quality vacuum components for stable performance

Multiple user-level authority settings to meet GMP requirements

Non-destructive Testing

Ensures the sample remains intact post-test.

High Sensitivity

Capable of detecting micro-leaks down to 1-2 μm.

Advanced Reporting

Test result printing and data storage. Auditing and access level setting.

Advanced Reporting

Test result printing and data storage. Auditing and access level setting.

PC software (optional) for enhanced monitoring and data management

Switchable pressure units between mbar and Pa for versatile applications

Frequently Asked Questions

Standards

Complying with Global Standards for Leak Testing

ASTM F2338: Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
YY/T 0681.18-2020: Test methods for sterile medical device package–Part 18: Nondestructive detection of leaks in packages by vacuum decay method
USP 1207.2〉: Package Integrity Leak Test Technologies

Still have a question?

If you have any other queries, feel free to reach out to us. Our knowledgeable team is here to help!

Contact Us

Address

No. 5577, Gongyebei Rd, Licheng Dist. 250109, Jinan, Shandong, China

+86 185 6001 3985
08.00am – 06.00pm (GMT+8)
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