Micro-leakage Sealing Tester

MLT Series Micro-Leak Seal Tester is professionally suitable for packaging samples such as ampoules, vial injection bottles, and pre-filled syringes in pharmaceutical packaging. It employs a non-destructive testing method, also known as a vacuum decay seal tester, vacuum decay leak detector, and micro-leak seal tester.

Micro-Leak Seal Tester Technical Parameters:https://www.paratronixcn.com/products/show-91.html

Micro-Leak Seal Tester

MLT Series Micro-Leak Seal Tester is developed based on the standard ASTM F2338-2013 Standard Test Method for Leak Detection in Packaging by Vacuum Decay Method. The micro-leak seal detector is professionally suitable for non-destructive micro-leak testing under positive and negative pressure for various empty/pre-filled syringes, liquid and powder injection bottles (glass/plastic), filled and capped bottles, milk powder cans, other rigid packaging containers, and electronic components. This seal tester adopts advanced design and rigorous, scientific calculation methods to ensure fast testing, high accuracy, and high stability. It can also meet users' custom requirements for non-standard (software or test fixtures) configurations.

Testing Principle:

By comparing the pressure between the standard chamber and the test chamber, it determines whether there is gas leakage in the test chamber.

Both the reference container and the test container are ensured to be sealed without leakage. After placing the sample into the test container, gas leakage from the sample causes a pressure change in the test container. The pressure change is detected by a differential pressure sensor, and the leakage aperture and leakage flow rate are derived through formula calculations.

Compliant Standards:

ASTM F2338-13 Standard Test Method for Leak Detection in Packaging by Vacuum Decay Method    USP1207 United States Pharmacopeia Standard

Pharmaceutical GMP Guidelines—Sterile Pharmaceuticals  11.1 Seal Integrity Testing

Chinese Pharmacopoeia 2020 Edition, Part IV, Microbial Examination Methods

Technical Guidelines for Seal Integrity Research of Chemical Drug Injection Packaging Systems (Trial)

YY/T 0681.18-2020 Test Methods for Sterile Medical Device Packaging—Part 18: Non-Destructive Inspection of Package Leaks by Vacuum Decay Method

Technical Advantages:

★ Built-in 10-inch touchscreen computer with an option for an external computer;

★ Accurately displays leakage aperture (≥1μm) and leakage flow rate ;

★ Test chamber and main unit are separate; one test chamber is suitable for over 5 types of sample specifications;

★ Test chamber is made of aluminum alloy or stainless steel with pneumatic clamping;

★ Built-in flow meter for one-click flow calibration;

★ Features three calibration methods: zero point, leak hole, and flow rate;

★ Test results support three judgment modes: pressure decay, leakage aperture, and leakage flow rate;

★ Leakage flow rate error ≤ 0.1 sccm;

★ Vacuum resolution ≤ 1 Pa / 0.01 mbar / 0.0001 psi;

★ Supports unit conversion (kPa/mbar/Pa/psi);

★ Capable of positive and negative pressure decay testing for various soft and hard samples such as vials, infusion bags, contact lenses, milk powder cans, and electronic components;