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Related Concept Videos

Sample Handling01:02

Sample Handling

88
Transportation of samples from the collection point to the laboratory, as well as storage and preservation techniques, are crucial for maintaining sample integrity and ensuring accurate and reliable test results.
Samples should be transported carefully from collection points to the laboratory. They should be properly sealed and clearly labeled to prevent cross-contamination. To preserve the sample integrity, optimal temperature conditions during transport are essential. This could involve using...
88

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Cryogenic Sample Loading into a Magic Angle Spinning Nuclear Magnetic Resonance Spectrometer that Preserves Cellular Viability
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A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis.

Allison Alix Caudill1, Ken Victor2, James Veale2

  • 1Lighthouse Instruments, LLC., Charlottesville, VA 22902 acaudill@lighthouseinstruments.com.

PDA Journal of Pharmaceutical Science and Technology
|November 23, 2024
PubMed
Summary
This summary is machine-generated.

A new laser-based headspace oxygen analysis method detects container closure integrity (CCI) breaches in pharmaceutical vials stored at cryogenic temperatures. This method identifies temporary or permanent leaks by measuring changes in oxygen levels due to nitrogen ingress.

Keywords:
Container closure integrityCryogenic storageFMSHeadspace gas analysisHeadspace oxygenUSP <1207>

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Area of Science:

  • Pharmaceutical Packaging
  • Cryogenic Storage
  • Analytical Chemistry

Background:

  • Pharmaceuticals increasingly require cryogenic storage (-150°C to -190°C) for stability.
  • Extreme cold can compromise vial container closure integrity (CCI) due to stopper glass transition and thermal expansion differences.
  • CCI breaches may temporarily reseal upon warming, complicating detection.

Purpose of the Study:

  • To present a novel CCI test method for cryogenic conditions.
  • To evaluate the method's ability to detect both temporary and permanent seal defects.
  • To assess the method's performance across different vial types.

Main Methods:

  • Utilized laser-based headspace oxygen analysis.
  • Leveraged the nitrogen-rich cryogenic environment to detect leaks.
  • Monitored headspace oxygen concentration changes in vials stored at cryogenic temperatures.

Main Results:

  • The method successfully detected CCI breaches in glass and plastic vials.
  • Detected defects as small as 5 μm in vial bodies.
  • Identified leaks at the stopper-seal interface with varying effective defect sizes.

Conclusions:

  • Laser-based headspace oxygen analysis is a robust method for detecting CCI defects in cryogenically stored vials.
  • The method is effective regardless of whether defects are temporary or permanent.
  • This technique ensures the integrity of pharmaceutical packaging under extreme cold conditions.