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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

Application

Features

Technical Specifications

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

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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