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Related Experiment Video

Updated: May 9, 2025

The Quantification of Injectability by Mechanical Testing

The Quantification of Injectability by Mechanical Testing

Published on: May 13, 2020

Mechanical Container Closure Integrity Test: A Method for Cartridge Systems.

Michael W Foubert¹, Benoit Lux², Julie Bourguard²

¹Eli Lilly and Company foubertmw@lilly.com.

PDA Journal of Pharmaceutical Science and Technology

|April 29, 2025

Summary

This summary is machine-generated.

A new constant force mechanical method improves cartridge container closure integrity testing. This robust approach offers faster, non-destructive leak detection for pharmaceutical packaging control strategies.

Keywords:

Parenteral drugs constant force method container-closure integrity dye ingress test mechanical container-closure integrity test sterility

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Area of Science:

Pharmaceutical Packaging
Mechanical Engineering
Quality Control

Background:

Current container closure integrity (CCI) methods for drug products can be time-consuming, complex, and destructive.
Existing control strategies require improved testing methods to ensure product protection from environmental exchange.

Purpose of the Study:

To develop and validate an improved method for cartridge container closure integrity leak testing.
To mitigate limitations of existing CCI test methods, such as extended test times and destructive nature.

Main Methods:

Investigated two mechanical testing approaches: force decay and constant force methods.
Utilized a linear mechanical testing system, finite element analysis, and first principles derivation.
Optimized the constant force method for enhanced signal response and robustness.

Main Results:

The constant force method demonstrated viability for in-process CCI testing of solution products.
This method provides a robust and improved alternative to traditional leak detection techniques.
Optimization ensured optimal signal response for reliable leak detection.

Conclusions:

The constant force mechanical method is a viable and improved approach for cartridge CCI.
This method enhances in-process control strategies for solution product packaging.
The developed method offers a more efficient and non-destructive solution for ensuring container integrity.