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.

Inquire Now Next Products Download

Test Method

Helium Leak Detection

Application

More Solutions

Package Development & Verification

Packageing system development, packaging integrity component inspection
Storage & Transport

CCIT verification against integrity challenges in low temperature

Features

01

Exceptional sensitivity capable of detecting leaks below 0.1 μm.
02

Custom fixtures available for targeted testing of specific package areas.
03

Uses inert helium gas, ensuring safety and preventing chemical interactions.
04

Simple operation: connect the test chamber or use the sniffer probe to begin. Automated data display and logging post-test.
05

Complies with USP <1207> and USP <382> requirements.

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

Related articles
Frequently Asked Questions

Q:
What is the difference between probabilistic and deterministic test methods?

A:

Probabilistic and deterministic methods differ fundamentally in principle, output, and reliability.

- Probabilistic methods (e.g., microbial ingress, dye ingress) – Results are influenced by variable factors. Output is typically qualitative or semi‑quantitative, and cannot precisely locate or size leaks. They provide probability‑based, indirect evidence of integrity.

- Deterministic methods (e.g., vacuum decay, laser-based headspace analysis) – Based on physical principles, measuring quantifiable parameters to directly detect leaks. Results are objective, quantitative, and highly repeatable, enabling calibration, trend analysis, and statistical process control. They provide a higher level of assurance and reliability.
Q:
What is Container Closure Integrity (CCI)?

A:

Container Closure Integrity (CCI) refers to the ability of a packaging system to prevent product loss, microbial ingress, and entry of gases (oxygen, air, water vapor, etc.) or other substances, thereby ensuring that the drug product remains safe and meets quality standards throughout its shelf life.

For injectable packaging systems, CCI requirements fall into three categories:

1. maintain sterility and product composition without the need to preserve headspace gas;

2. maintain sterility, product composition, and headspace gas;

3. for multi-dose containers that must maintain sterility after opening – prevent microbial ingress and product leakage during use. CCI studies for injectable products should be tailored to product characteristics.

A packaging system is generally considered to have acceptable CCI when it has passed or is capable of passing a microbial challenge test. In a broader sense, CCI means the absence of any leakage that could compromise drug quality. Based on scientific research and risk assessment, the Maximum Allowable Leakage Limit (MALL) should be determined considering packaging composition and assembly, product contents, and the environment to which the product may be exposed over its lifecycle. If a package’s leakage does not exceed its MALL, the closure system is considered integral.
Q:
Which regulations and guidelines address Container Closure Integrity?

A:

Key regulatory and technical guidance documents for CCI include:

- EU GMP Annex 1 – Mandates container closure integrity verification and testing for terminally sterilized products, with differentiated requirements based on container type.

- USP <1207> – A comprehensive technical guide widely accepted as the industry standard, systematically describing test method categories, selection, validation, and lifecycle application. FDA guidance also permits physical CCI testing as an alternative to some sterility tests in stability studies.

- China NMPA – "Technical Guideline for Packaging System Integrity Study of Chemical Injectables (Trial)" – Signals increasing regulatory attention and alignment with international standards.