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How to Qualify Container Closure Systems for Intended Use, Part 1.

International journal of pharmaceutical compounding·2019

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Long-Term Study of Container Closure Integrity of Rubber-Glass Vial Systems by Multiple Methods.

Matthew R Gehrmann¹, T Page Mcandrew²

¹West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341.

PDA Journal of Pharmaceutical Science and Technology

|August 18, 2019

Summary

Container closure integrity (CCI) of rubber stoppers and glass vials remains robust over time. Lower compression and residual seal force (RSF) values showed slightly reduced performance, indicating the need for adequate sealing in pharmaceutical packaging.

Keywords:

CCI Container closure integrity Frequency modulated spectroscopy Gas permeability Leak rate Residual seal force Tracer gas leak detection Vial system

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Area of Science:

Pharmaceutical Packaging
Materials Science
Analytical Chemistry

Background:

Container closure integrity (CCI) is critical for pharmaceutical product stability and safety.
Rubber stoppers and glass vials are common primary packaging systems.
Understanding CCI performance variations is essential for regulatory compliance.

Purpose of the Study:

To evaluate the container closure integrity (CCI) performance of rubber stopper and glass vial systems over one year.
To investigate the impact of time, compression levels, and residual seal force (RSF) on CCI.
To assess variations in CCI based on deterministic measurement methods.

Main Methods:

A one-year study utilizing a design of experiments approach.
Evaluation of various stopper formulations, sizes, configurations, and vial types/suppliers.
Assessment of different compression levels and residual seal force (RSF) values.
Use of tracer gas and frequency modulated spectroscopy for CCI measurement.

Main Results:

All tested rubber stopper and glass vial systems demonstrated good container closure integrity (CCI).
No decrease in CCI was observed over the one-year study period, indicating system robustness.
Lower compression/RSF values correlated with slightly reduced performance and increased data variability.
A minor oxygen exchange was detected, consistent with the inherent gas permeability of rubber.

Conclusions:

Rubber-glass vial systems exhibit robust container closure integrity (CCI) over time.
Adequate compression and residual seal force (RSF) are recommended for optimal and consistent CCI in commercial applications.
The inherent gas permeability of rubber stoppers should be considered in pharmaceutical packaging design.