Particle Analysis

Problem-solving expertise

Due to the impact on patient safety, particles are a regulatory concern and a focal point of the pharmaceutical industry. West’s Analytical Services Particle Laboratory provides services such as USP <787>, <788> and <789>, and <790> testing with the ability of counting and sizing sub-visible and visible particulate using technologies such as Light Obscuration (LO), microscopy and light microscopy/image analysis (LM/IA) for automated particle detection. The Analytical Services Particle Lab also collaborates with the West Scientific Insights Lab, an R&D laboratory which has the capability of performing cutting edge techniques such as Resonance Mass Measurement which is capable of sizing and counting sub-micron particles in the size range of 300 nm to 2 mm. With West’s Analytical Services Particle Lab’s intimate understanding of particle sources related to packaging and delivery systems such as drug precipitates, glass, fibers and solvent impurities, and can develop robust studies to meet your specific needs.

West’s Particle Lab offers problem-solving expertise and the capability to isolate size, count and identify particulate from 5 µm to visible particles > 100 µm. This is especially important as West understands the components and devices utilized in combination products that allow for drug product differentiation and ease of use for at-home care.

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Capabilities and Expertise

West Analytical Services Particle Lab partners with customers to develop methods for analyzing unique drug delivery or containment products as well as utilize existing West component-specific methods. 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
Fourier Transform Infrared Spectroscopy (FT-IR)
Micro FT-IR Scanning Electron Microscopy (SEM)/Energy Dispersive X-ray Spectroscopy (EDS)
Raman
Laser Induced Breakdown-Spectroscopy (LIBS)

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)

Case Studies

Particle — FDA Requirement

New and Novel Techniques

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.

FlowCam^® and VisualSpreadsheet^® are registered trademarks of Fluid Imaging Technologies, Inc.