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MC-E23 High Voltage Leak Detector

The MC-E23 is a deterministic, non-destructive container closure integrity testing (CCIT) system specifically engineered for liquid-filled pharmaceutical packaging. The system employs high-voltage microcurrent technology to inspect a comprehensive range of parenteral containers — including vials, ampoules, pre-filled syringes, cartridges, infusion bottles, ophthalmic dropper bottles, BFS containers, and IV bags. With detection sensitivity down to 0.2 μm, the MC-E23 is ideally suited for both laboratory QC applications and 100% inline inspection for small-batch production.

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Test Method

Application

Features

Technical Specifications

Parameter

Specification

Test Principle

High Voltage Leak Detection (HVLD) — MicroCurrent

Application

Micro-leak detection for liquid-filled pharmaceutical packaging

Container Types

Vials, ampoules, pre-filled syringes, cartridges, glass infusion bottles, plastic bottles, ophthalmic dropper bottles, BFS containers, flexible infusion bags

Product Compatibility

Lipid emulsions, suspensions, liquid proteins, syrups, WFI, and other aqueous liquids

Usage

Offline sampling inspection; 100% inspection for small-batch production

Operator Interface

Large touchscreen display

Test Voltage

0 – 40 kV (adjustable)

Detection Sensitivity

Optimal resolution: 0.2 μm (1 μm standard)

Regulatory Compliance

FDA 21 CFR Part 11, USP <1207>, EU GMP, Chinese GMP, CDE Guidelines

Power Supply

100 – 240 VAC; 50/60 Hz

Validation Package

3Q Validation (IQ/OQ/PQ); Method development and validation services

More Information

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  • Frequently Asked Questions
  • Q:

    Can one instrument test different package sizes?

    A:

    Yes. Different package sizes and shapes can be tested by changing the test chamber, fixture or sample holder.

  • Q:

    Can the system test pharmaceutical vials?

    A:

    Yes. Vacuum decay testing can be configured for vials containing powder, lyophilized products or medicinal liquids. A package-specific chamber is normally required.

  • Q:

    Which mode should be used for flexible packaging?

    A:

    Pressure decay is generally more suitable for flexible packages that may deform significantly when exposed to vacuum. The final method should be confirmed through package evaluation and feasibility testing.

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