MC-E24 High Voltage Leak Detector

The MC-E24 High Voltage Leak Detector 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-E24 is ideally suited for both laboratory QC applications and 100% inline inspection for small-batch production.

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Test Method

High Voltage Leak Detection

Application

Why Choose the MC-E24 High Voltage Leak Detector?

Non-Destructive HVLD Testing

The MC-E24 performs High Voltage Leak Detection without opening or intentionally damaging suitable packages.

This allows tested samples to remain available for additional analysis where required.

High-Sensitivity Micro Leak Detection

The system is designed for high-sensitivity detection of small package defects.

Under optimized, package-specific test conditions, the MC-E24 can achieve a detection resolution down to 0.2 μm, with 1 μm used as a standard reference condition.

Actual detection capability depends on the package material, product conductivity, fill level, defect location and validated test parameters.

Automatic Electrode Scanning

The MC-E24 uses automatically moving electrode probes to scan critical package areas.

For suitable vials and ampoules, the container can rotate through 360° during testing, helping reduce missed inspection areas and operator-dependent variation.

Adjustable 0–30 kV Test Voltage

The test voltage can be adjusted from 0 to 30 kV according to the package material, container geometry, product conductivity and required test conditions.

Suitable for Small-Batch 100% Inspection

In addition to laboratory QC, the MC-E24 can support rapid testing for applications requiring 100% inspection of small production batches.

This makes it suitable for pharmaceutical manufacturers that need higher inspection throughput without moving directly to a fully integrated high-speed production line.

When Is HVLD Suitable?

The MC-E24 is particularly suitable when the product-package system meets several basic conditions.

Conductive Liquid Product

The product must provide sufficient electrical conductivity for a measurable electrical response.

Electrically Insulating Package

The primary container should generally be made from materials such as suitable glass or polymer that can act as an electrical barrier.

Suitable Fill Level

The liquid must contact or provide an electrical pathway to the area being inspected.

Fill level and package orientation therefore need to be considered during method development.

Accessible Inspection Area

Electrodes must be positioned so that critical package areas can be scanned effectively.

Package geometry may therefore influence fixture and electrode design.

Applications of High Voltage Leak Detector

Ampoule Leak Testing

Glass ampoules are a strong application for HVLD because the glass container provides electrical insulation while the liquid formulation provides the conductive medium.

The MC-E24 can scan the ampoule body and sealing area to identify cracks, pinholes and seal defects.

Vial Leak Testing

For suitable liquid-filled vials, the MC-E24 can evaluate container body defects and closure-related leak pathways.

Prefilled Syringe Leak Testing

The system can be configured for suitable prefilled syringes to evaluate critical areas around the barrel and closure interfaces.

BFS and Liquid Packaging

HVLD can also be evaluated for suitable BFS containers, infusion bottles, ophthalmic bottles and flexible liquid-filled packaging.

CCIT and Validation Support

For pharmaceutical applications, HVLD parameters should be developed and validated for each specific product-package system.

Important factors include:

● Test voltage
● Electrode position
● Package rotation speed
● Product conductivity
● Fill volume
● Container material
● Known defect size
● Acceptance criteria

Zholion can provide IQ/OQ/PQ documentation as well as method development and validation support for MC-E24 applications.

Need a High Voltage Leak Detector for Your Packaging?

Send Zholion your container type, product characteristics, fill volume and required detection level.

Our technical team can evaluate whether the MC-E24 High Voltage Leak Detector is suitable and recommend the appropriate electrode configuration, test parameters and validation approach.

Contact Zholion for MC-E23 Pricing & Technical Evaluation.

More Information

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Frequently Asked Questions

Q:
How does ECA stipulate about visible particulates for injectable drugs?

A:

4.3 What aspects should be considered when assessing artificially created test kits, and how should their suitability be justified?

Artificially created test kits are often used when representative production samples are unavailable, technically unsuitable, or cannot be obtained in sufficient quantity for qualification, training, or evaluation purposes.

Their suitability should be assessed based on the inspection technology used and the required level of representativeness. Artificially created defects and conforming units should exhibit optical, physical, and mechanical characteristics comparable to those of the real product under routine inspection conditions.

For AI-based inspection systems, higher requirements regarding representativeness may apply, as these systems often utilize very subtle features and characteristics to distinguish between acceptable and defective units. For example, a genuine lyophilized cake with crystalline reflective properties can generally be distinguished from a matte plaster-based imitation if these differences are visible in the image data.

If artificially created defects differ in relevant characteristics—such as texture, reflectivity, contrast, size, movement behaviour, or other optical or physical properties—there is a risk that the neural network learns features introduced by the artificial manufacturing process rather than the actual defect itself. Likewise, particle detection may be influenced by factors such as viscosity, turbidity, fill height particle size, or particle contrast. These factors should therefore be considered when assessing the suitability of artificially created test kits and may also affect the performance of conventional rule-based inspection systems.

Conventional rule-based systems are generally less susceptible to such effects because they evaluate predefined image features rather than learning complex representations. Although these approaches are often less selective and may be less suitable for highly challenging inspection tasks, they typically demonstrate greater robustness against variations or realism drifts within artificially created test kits.

Consequently, the suitability of artificially created test kits should always be justified and documented with regard to the inspection technology and the intended application. The decisive criterion is not whether defects are artificially created or taken from routine production, but whether the test kit reliably reproduces the behaviour of the final drug product under the selected inspection strategy.
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.

Application	Research & Development in Pharmaceutical Factories Sampling Inspection for lab 100% Inspection for Small-Batch Production
Operator Interface	Large Touchscreen
Detection Voltage	0 – 30 kV (adjustable)
Power Supply	100 – 240 VAC; 50/60 Hz
Validation Package	IQ/OQ Validation / Method Development & Validation