MC-H52 Helium Leak Detector

Developed and manufactured through a collaboration, the MC-H52 incorporates a highly sensitive mass spectrometer detector. It can be equipped with 21 CFR Part 11-compliant software for full data traceability and secure electronic records, ensuring data integrity. It is an ideal tool for pharmaceutical R&D, QC, and production sampling.

A package pre-filled with helium is placed in a custom test chamber. The chamber is evacuated, creating a pressure differential. Helium escaping through any leak is detected by the integrated mass spectrometer, which converts the signal into a quantitative helium leak rate displayed on the interface. A result exceeding a pre-set threshold indicates a package failure.

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Test Method

Helium Leak Detection

Application

Why Choose the MC-H52 Helium Leak Detector?

Ultra-High Leak Detection Sensitivity

The MC-H52 provides quantitative helium leak measurement with a minimum detectable leak rate of:

1 × 10⁻¹⁰ mbar·L/s

This makes the system suitable for high-sensitivity package development and microleak studies where very small leakage pathways need to be evaluated.

Under optimized package-specific conditions, the system can support detection of defects below 0.1 μm.

Actual defect detection capability depends on package configuration, tracer gas concentration, test method, fixture design and validation conditions.

Quantitative Helium Leak Rate

Unlike qualitative pass/fail methods, the MC-H52 measures and reports a numerical helium leak rate.

This enables engineers to:

● Compare different closure systems
● Evaluate sealing process changes
● Compare packaging materials
● Investigate microleaks
● Establish package integrity acceptance criteria
● Monitor changes during package development

Quantitative results are particularly valuable during pharmaceutical packaging R&D and CCIT method development.

Mass Spectrometer Detection

The MC-H52 uses a highly sensitive mass spectrometer to identify helium escaping from the package.

Because helium has a low natural atmospheric concentration, small molecular size and chemical inertness, it is well suited as a tracer gas for high-sensitivity leak testing.

Custom Test Fixtures

Different pharmaceutical packages have different potential leak pathways.

Zholion can provide customized chambers and fixtures for:

● Complete package testing
● Closure interface evaluation
● Specific package areas
● Container body testing
● Component-level integrity studies

This allows the helium leak test configuration to be adapted to the actual packaging risk rather than relying on one universal chamber design.

Where Is Helium Leak Testing Most Useful?

Package Development

During early packaging development, helium leak testing can help compare different container materials, stopper systems, crimping conditions and sealing parameters.

Closure System Comparison

Quantitative helium leak rates allow different closure designs or manufacturing conditions to be compared objectively.

Microleak Investigation

When routine leak testing identifies inconsistent results or a package failure needs further investigation, the high sensitivity of helium detection can help characterize very small leakage pathways.

Mold and Tooling Qualification

The MC-H52 can support evaluation of packages produced from different molds, tooling or process settings during package development and qualification.

Transportation and Stability Studies

Helium leak testing can also be used as part of package integrity studies to understand whether transportation, aging or environmental challenges have affected container closure performance.

MC-H52 vs. Vacuum Decay Leak Testing

Requirement	MC-H52 Helium	Vacuum Decay
Quantitative leak rate	Yes	Pressure change measurement
Ultra-small leak investigation	Recommended	Suitable within validated capability
Tracer gas required	Yes	No
Mass spectrometer	Yes	No
Routine non-destructive testing	Test configuration dependent	Recommended
Package development	Highly recommended	Recommended
High-throughput routine QC	Less typical	More suitable
Closure comparison studies	Highly recommended	Suitable

Choose the MC-H52 Helium Leak Detector when very high sensitivity, quantitative leak-rate measurement or detailed package development data are required.

Choose vacuum decay Leak Detector when the priority is routine, non-destructive pharmaceutical package integrity testing without tracer gas preparation.

Need High-Sensitivity Helium Leak Testing?

If your application requires quantitative leak-rate measurement or detection of very small package defects, the MC-H52 provides higher sensitivity for pharmaceutical package development and CCIT studies.

Send Zholion your package type, dimensions, closure configuration and required leak detection level. Our technical team can evaluate the appropriate helium preparation method, test fixture and MC-H52 configuration.

Contact Zholion for MC-H52 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	Package design/development testing, mold qualification, line setup, ongoing product quality monitoring.
Minimum Detectable Leak Rate	1x10⁻¹⁰ mbar·L/sec
Software	Optional FDA 21 CFR Part 11 compliant software for data integrity
Options	Validation Package (IQ/OQ) available
Dimension	781 × 642 × 1153 mm (LxWxH)
Weight	21 kg
Power Supply	100-240 VAC, 50/60 Hz