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Design and Use of a Full Flow Sampling System FFS for the Quantification of Methane Emissions

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A Multicompany Survey Study for Helium Leak Container Closure Integrity Test.

Roman Mathaes¹, Klaus Wuchner², David Riesop³

¹Drug product services, Lonza AG, Basel, Switzerland.

PDA Journal of Pharmaceutical Science and Technology

|November 16, 2021

Summary

This summary is machine-generated.

Ensuring sterile product quality requires robust container closure integrity (CCI). This study evaluated the real-world performance of the helium leak method for CCI testing across multiple laboratories, highlighting variability in results.

Keywords:

Artificial leaks Container closure integrity testing Container closure system Helium leak test Industry multicompany study Primary packaging USP <1207>

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Area of Science:

Pharmaceutical Science
Analytical Chemistry
Quality Assurance

Background:

Sterile products must remain free of microbial contamination throughout their shelf life, a critical quality attribute.
Container closure integrity (CCI) is essential for maintaining sterility and requires a comprehensive lifecycle strategy.
The helium leak method is the most sensitive technique for CCI testing, crucial for container closure system (CCS) qualification.

Purpose of the Study:

To assess the real-world performance of the helium leak method for CCI testing across different laboratories.
To characterize the performance of artificial leaks and helium leak standards in a multi-company setting.
To compare the variability of CCI test results obtained using in-house methods.

Main Methods:

A multicompany study involving 17 artificially prepared leak samples.
Distribution of common artificial leak types and sizes to participating companies.
Each company applied their established in-house helium leak testing methods and parameters.

Main Results:

The study revealed variability in helium leak test results across different laboratories.
Performance data for artificial leaks and helium leak standards were generated in a real-world context.
No standardized method was applied, reflecting current industry practices.

Conclusions:

The real-world performance of the helium leak method for CCI testing shows inter-laboratory variability.
Further characterization of method performance parameters is needed for consistent CCI assessment.
Understanding this variability is key for robust quality by design (QbD) strategies in sterile product manufacturing.