Time Temperature Superposition Evaluation and Modeling for Container Closure System's Seal Performance at Low...

Area of Science:

• Pharmaceutical Packaging
• Materials Science
• Rheology

Background:

• Container closure systems (CCS) are critical for parenteral drug product integrity.
• Previous studies overlooked the dynamic time-temperature effects on CCS sealing performance.
• Rubber stopper viscoelasticity significantly influences CCS sealing over time and temperature.

Purpose of the Study:

• To systematically investigate the impact of time-temperature transitions on CCS sealing performance.
• To demonstrate the time- and temperature-dependent nature of CCS sealing.
• To provide a predictive modeling framework for CCS sealing force.

Main Methods:

• Compression stress relaxation (CSR) testing on rubber stoppers.
• Modeling evaluation using Maxwell-Wiechert theory.
• Application of time-temperature superposition principles (Arrhenius, Williams-Landel-Ferry methods).

Main Results:

• Experimental and modeling data confirmed that CCS sealing performance is inherently time- and temperature-dependent.
• A significant decrease in rubber stopper sealing force was observed at lower temperatures.
• The study highlights potential risks to container closure integrity (CCI) at reduced storage and transport temperatures.

Conclusions:

• The viscoelastic nature of rubber stoppers causes inevitable changes in sealing force with time and temperature transitions.
• Predictive modeling can assess time- and temperature-dependent sealing force throughout the product lifecycle.
• This research offers a framework for proactive CCS design and management in the pharmaceutical industry, especially before the glass transition temperature (Tg).