Container Closure Integrity

Have the data you need to mitigate product quality risk

As new biologics are developed and storage conditions and packaging become more complex, it is increasingly crucial to understand the integrity of the packaging and the appropriate methods for evaluating and testing it.

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Capabilities and Expertise

West Analytical Services Particle Lab partners with customers to utilize existing West component-specific methods, or for more complex drug delivery or containment products, methods can be developed. The Particle Lab performs testing to support every phase of your drug product from compatibility studies through to commercialization and lifecycle management. With the ability to handle biosafety level 1 and 2 drug products, our ability to partner and design studies to meet your portfolio of drug products is extensive.

Particle characterization and identification capabilities:

  • Optical Microscopy – particle sizing and imaging
  • Particle isolation
  • Fourier Transform Infrared Spectroscopy (FT-IR)
  • Micro FT-IR Scanning Electron Microscopy (SEM)/Energy Dispersive X-ray
Capabilities and Expertise
Plan for your drug product packaging testing needs

Glass Delamination

Glass delamination remains a significant concern for the storage of biologics. This is especially the case for large molecule formulations with high pH levels. The Particle Lab can perform glass delamination testing using Differential Interference Contrast Microscopy (DICM) to determine if glass delamination has the potential to occur on selected glass.

In addition, the Particle Lab has the capability to perform particle counting and sizing for sub-visible and visible particles using:

  • Membrane Microscopy
  • Light Microscopy Image Analysis (LM/IA)
  • Light Obscuration (LO)
Glass Delamination

Capabilities and Expertise

West Analytical Services Particle Lab partners with customers to utilize existing West component-specific methods, or for more complex drug delivery or containment products, methods can be developed. The Particle Lab performs testing to support every phase of your drug product from compatibility studies through to commercialization and lifecycle management. With the ability to handle biosafety level 1 and 2 drug products, our ability to partner and design studies to meet your portfolio of drug products is extensive.

Particle characterization and identification capabilities:

  • Optical Microscopy – particle sizing and imaging
  • Particle isolation
  • Fourier Transform Infrared Spectroscopy (FT-IR)
  • Micro FT-IR Scanning Electron Microscopy (SEM)/Energy Dispersive X-ray
Capabilities and Expertise
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West Services and Solutions LLC is a wholly-owned subsidiary of West Pharmaceutical Services Inc.