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Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography.

Robert Ovadia1, Philippe Lam1, Vassia Tegoulia1

  • 1Pharmaceutical Processing and Technology Development, Genentech, A Member of the Roche Group, San Francisco, CA USA.

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Summary
This summary is machine-generated.

Serum stoppers require higher residual seal force (RSF) for container closure integrity (CCI) than lyophilization stoppers. Micro-computed tomography (micro-CT) confirmed component offsets impact RSF and vial seal quality.

Keywords:
CCIContainer closure integrityCrimp capHelium leakageMicro-CTMicro-computed tomographyPrimary packaging componentsRSFResidual seal forceStopperVialVial capping

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Engineering

Background:

  • Residual Seal Force (RSF) quantifies vial capping, correlating with Container Closure Integrity (CCI).
  • Component positional offsets are a key source of RSF variability.
  • Stopper geometry significantly influences CCI, particularly for serum stoppers.

Purpose of the Study:

  • Investigate the impact of stopper geometry on CCI.
  • Compare CCI performance between serum and lyophilization stoppers.
  • Quantify positional offsets using micro-computed tomography (micro-CT).

Main Methods:

  • Utilized helium leak testing for CCI assessment.
  • Measured RSF for serum and lyophilization stoppers.
  • Employed micro-CT to quantify cap and stopper positional offsets.

Main Results:

  • Serum stoppers require RSF > 15.8 N for CCI, unlike lyophilization stoppers.
  • Both stopper types showed a critical lower RSF limit of 19-20 N without the plug.
  • Micro-CT revealed direct correlation between positional offsets and RSF variability.
  • Lyophilization stoppers demonstrated more robust CCI despite similar RSF variations.

Conclusions:

  • Stopper geometry critically affects CCI, with serum stoppers being less robust.
  • Micro-CT is an effective, non-destructive tool for analyzing vial component features and RSF variability.
  • Understanding these factors is crucial for ensuring pharmaceutical product stability and safety.