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Time-Dependent Testing Evaluation and Modeling for Rubber Stopper Seal Performance.

Qingyu Zeng1, Xia Zhao2

  • 1West Pharmaceutical Services, Inc., Exton, PA qingyu.zeng@westpharma.com.

PDA Journal of Pharmaceutical Science and Technology
|November 22, 2017
PubMed
Summary
This summary is machine-generated.

Rubber stopper sealing force in parenteral packaging decays exponentially over time due to viscoelasticity, eventually leveling off. This study developed a nonlinear, time-dependent model to predict sealing performance throughout the product lifecycle.

Keywords:
CapCappingCompression stress relaxation (CSR)Container closure integrity (CCI)Container closure system (CCS)Kohlrausch-Williams-Watts (KWW) stretched exponential functionMaxwell-Wiechert modelResidual seal force (RSF)SealStopperTemperature-dependentTime-dependentVial

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Area of Science:

  • Materials Science
  • Pharmaceutical Packaging
  • Rheology

Background:

  • Container closure integrity is critical for parenteral packaging.
  • Previous studies lacked systematic analysis of time-dependent viscoelastic effects on rubber stopper sealing performance.
  • Understanding these effects is crucial for maintaining product stability and safety.

Purpose of the Study:

  • To investigate the time-dependent influence of rubber stopper viscoelasticity on sealing performance.
  • To develop a nonlinear, time-dependent sealing force model.
  • To provide a framework for proactive management of stopper sealing throughout the product lifecycle.

Main Methods:

  • Compression stress relaxation testing.
  • Residual seal force testing for time-dependent data collection.
  • Modeling using Maxwell-Wiechert theory modified with Kohlrausch-Williams-Watts stretched exponential function.

Main Results:

  • Sealing force decays exponentially over time and stabilizes due to rubber viscoelasticity.
  • Nonlinearity in stress relaxation arises from viscoelastic properties and large deformation.
  • Stress relaxation is both time- and temperature-dependent.

Conclusions:

  • The developed model accurately predicts time-dependent sealing force.
  • The integrated methodology offers insights for designing and controlling parenteral packaging.
  • This work enhances the understanding and management of rubber stopper sealing performance.