Product Overview

Operating on advanced high-voltage discharge principles, the system utilizes the electrical conductivity of the liquid product inside to detect micro-leaks, while the outer glass or plastic packaging remains completely non-conductive.

With its non-destructive scanning method, the Leak-HV delivers objective "Pass/Fail" results within a few seconds, making it an ideal choice for high-throughput quality control in the pharmaceutical industry.

Key Features & Advantages

Ultra-Fast Scanning & High Efficiency

The entire scan-test cycle is completed within just a few seconds. Equipped with specialized roller electrodes and a one-key start function, it maximizes laboratory testing throughput without sacrificing accuracy.

Non-Destructive Testing

Provides non-destructive analysis for both micro-leaks (1–3μm) and gross leaks. Tested samples remain entirely undamaged and sterile, allowing them to return to the production line, eliminating product waste.

Triple-Layer Safety Protection

Engineered with user safety as a top priority. The system features a dual-grounding system, an emergency stop button, and a triple-door protection mechanism for the testing chamber, ensuring highly visible and reliable operator safety.

Intelligent Windows OS & Real-Time Curves

Powered by an intuitive and reliable Windows operating system. The crisp LCD interface displays live test comparison curves in real time, making data analysis clear, transparent, and completely digitized.

Ultimate Compliance (FDA 21 CFR Part 11 & GMP Ready)

Audit Trail System: Fully complies with FDA 21 CFR Part 11 mandates for electronic records and signatures.

4-Level User Authority: Restricts access via unique login credentials across 4 distinct user levels.

Secure Data Export: Automatically stores and processes data locally in an unalterable format to guarantee permanent preservation and compliant PDF reporting.

Infinite Storage: No upper limit on user registration or test data storage capacity.

Flexible Modular Design

Supports rapid switching between different testing modules to perfectly fit various container capacities, shapes, and dosage forms, preventing the need for multiple machines.

Applications

To ensure optimal detection, the packaging setup must meet the following criteria:

Packaging Material: Must be non-conductive (e.g., Glass or Plastic products).

Contents: Must be a non-flammable liquid with electrical conductivity (Conductivity ≥ 1ms/cm or verified through practical testing).

Fill Volume: Liquid fill volume must be greater than 30%.

Perfectly suited for:

Ampoules & Vials (Liquid-filled)

Pre-filled Syringes (PFS)

BFS (Blow-Fill-Seal) Containers

Glass & Plastic Infusion Bottles

Eye Dropper Bottles & other hermetically sealed liquid packaging.

Technical Specifications

Compliance & Standards

ASTM F2338、YY/T 0681.18、USP<1207>