Foreign Particle Identification

GMP-compliant identification of visible and subvisible particles to support contamination investigations and product quality

The presence of foreign particles in pharmaceutical products is a critical quality concern, particularly for injectable and ophthalmic formulations. Identifying the nature and origin of particulate contamination is essential to ensure product safety and meet regulatory expectations.

Kymos Group provides GMP-compliant foreign particle identification services using a combination of complementary analytical techniques. Our approach enables accurate characterization of contaminants and supports root cause investigations across manufacturing, packaging, and environmental sources.

Services

Our catalog of services include:

  • Identification of visible and subvisible particles in drug products using optical microscopy and polarized light microscopy (PLM)
  • Morphological evaluation including size, shape, color, and optical properties
  • Identification of organic materials using Raman microscopy and FTIR spectroscopy
  • Raman spectroscopy for molecular fingerprinting of particles
  • FTIR for complementary characterization of chemical structure and functional groups
  • Characterization of inorganic particles using scanning electron microscopy with energy-dispersive X-ray spectroscopy (SEM-EDX)
  • Identification of inorganic particles such as metals, glass, or environmental contaminants
  • Differentiation of intrinsic, extrinsic, and process-related particles based on morphology and composition
  • Support for OOS/OOT investigations, deviation analysis, and CAPA definition

Where can we help

Key Applications

Foreign particle identification is essential in situations where product quality and patient safety may be compromised, requiring a clear understanding of contamination sources and their impact.

  • Investigation of particulate contamination in injectable and ophthalmic products

  • Troubleshooting of out-of-specification (OOS) and out-of-trend (OOT) results

  • Identification of particles linked to extractables and leachables or packaging interactions

  • Support for deviation investigations, CAPA definition, and regulatory responses

OUR EXPERIENCE

We can help you with:

Our experience covers a wide range of pharmaceutical products and potential contamination sources, including:

  • Sterile and non-sterile drug products, with a focus on liquid formulations and injectables

  • Biologics and complex formulations

  • APIs and excipients (linked to contamination sources)

  • Packaging and manufacturing materials

Team Discussion

Why Choose KYMOS?

  • GMP Expertise:

    • GMP-certified laboratories supporting foreign particle identification in compliance with regulatory expectations.
  • Advanced Analytical Techniques:

    • Combination of microscopy and micro-spectroscopy techniques to achieve reliable and comprehensive particle characterization.
  • Investigation-Focused Approach:

    • Support beyond identification, contributing to root cause analysis and corrective action strategies.
  • Proven Track Record

    • Extensive experience supporting pharmaceutical companies in contamination investigations and regulatory-driven studies.

Services

All Solid-State Characterization Services

Particle Characterization & Testing

GMP-compliant characterization of particle size, morphology, and solid-state properties to support development and quality control.

Foreign Particle Identification

GMP-compliant identification and characterization of visible and subvisible particles to support contamination investigations and root cause analysis.

Reverse Engineering & Comparative Studies

GMP-compliant analytical comparison of pharmaceutical products to support development, troubleshooting, and lifecycle management.

Contact

Avez-vous besoin de plus d’informations ou d’un devis ?

    Veuillez sélectionner votre type de demande :