Particle Analysis

Problem Solving Expertise

Parenteral therapies and the containers that they are stored and delivered in are becoming more complex and expensive. With the requirement of Annex 1 it is more important than ever to understand the concentration and origin of the particles present in a delivery system.

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Particle Analysis

Problem Solving Expertise

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Capabilities and Expertise

Glass Delamination

Analytical Techniques

New and Novel Technology

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

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: