Aseptic drug packaging sealing tester

Aseptic drug packaging sealing tester

Product Introduction

The MLT-V100 (T) micro leak non-destructive sealing tester was developed based on the standard "ASTM F2338-13 Standard Test Method for Packaging Leakage - Vacuum Attenuation Method". Professional application for non-destructive positive and negative pressure micro leak testing of various empty/pre filled syringes, water and powder injection bottles (glass/plastic), filling and capping bottles, other hard packaging containers, electrical components and other samples. This product adopts * design and rigorous, scientific calculation methods to ensure its fast testing, high accuracy, and high stability. It can also meet users' non-standard (software or testing fixture) customization needs.

Product Features

Intelligent fully automatic, fully functional, high-precision, and high-efficiency

● Optional positive and negative pressure testing principles

7-inch touch screen, user-friendly human-machine efficiency

● Meets all requirements of GMP

Multiple communication modes for easy data management and export

● Comes with a built-in printer and long-term storage of results

● Two optional vacuum principles are available for users to choose from

● Support function expansion and customized non-standard fixtures

Application field

Various empty/pre filled syringes, water and powder injection bottles (glass/plastic), filling and capping bottles, other hard packaging containers, electrical components

execution standard

ASTM F2338-13 Standard Test Method for Packaging Leakage - Vacuum Attenuation Method

USP1207 United States Pharmacopeia Standard

Drug GMP Guidelines - Sterile Drugs 11.1 Sealing Integrity Testing

Microbial examination method for Part Four of the 2020 edition of the Chinese Pharmacopoeia

Chinese Pharmacopoeia 2025 Edition

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

YYT 0681.18-2020 Test Methods for Aseptic Medical Device Packaging Part 18: Non destructive Testing of Packaging Leakage by Vacuum Attenuation Method

Technical Specifications

test methodVacuum attenuation method/pressure attenuation method

Measurement and Control TechnologyMicrocomputer, dual sensor testing technology

Vacuum methodvacuum pump

Positive pressure methodexternal air source

testing unitkPa/mbar/psi/Pa

resolution0.1Pa

test scope-99~400kPa

measurement range≥0.01ccm (约1μm )

test accuracy±0.3μm (＜3μm )

Master control chipSTM microcomputer chip

sampling frequency50~200Hz

control method10 inch LCD touch screen

control systemWindows system

Aseptic drug packaging sealing tester