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:

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

Plan for your drug product packaging testing needs

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Analytical Techniques

USP <787> Sub-visible particulate matter in therapeutic proteins
UPS <788> Particulate Matter in Injections
USP <789> Particulate Matter in Ophthalmic Solutions

New and Novel Technology

FlowCam®

The FlowCam® 8100 (Yokogawa Fluid Imaging Technologies) is used for sub-visible particle analysis. The instrument captures digital images of particles suspended in liquid as they pass through a flow cell. Each individual particle captured in the field of view has over 40 morphological characteristics, which can be used to create image libraries for particle characterization. The instrument uses the 21 CFR Part 11 compliant software program VisualSpreadsheet® to process captured images and generate customizable reports containing particle count and size.

The FlowCam 8100 can be used to monitor particle levels in drug products and can be used as a complement to Light Obscuration (LO) analysis for early phase compatibility studies. It is especially convenient for biologics because of the small sample volume requirements - as little as 300 µL per sample analysis.

Understanding particle origin and being able to differentiate between intrinsic (related to manufacturing process), extrinsic (foreign to manufacturing process) and inherent (related to product) particles is critical to understanding the risks associated with particles in the formulation. The FlowCam, which enables particle characterization, allows for determination of particle type which can provide a deeper understanding of the particles that are present in drug products.