Foreign Particle Identification<\/h1><\/div>GMP-compliant identification of visible and subvisible particles to support contamination investigations and product quality<\/p>\n<\/div>
Talk to an expert<\/span><\/i><\/a><\/div><\/div><\/div><\/div><\/div>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.<\/p>\n
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.<\/p>\n<\/div><\/div><\/div>
![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%272000%27%20height%3D%271334%27%20viewBox%3D%270%200%202000%201334%27%3E%3Crect%20width%3D%272000%27%20height%3D%271334%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div><\/div><\/div>![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%272042%27%20height%3D%271292%27%20viewBox%3D%270%200%202042%201292%27%3E%3Crect%20width%3D%272042%27%20height%3D%271292%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div>Services<\/p>\n<\/div>
<\/div><\/div>Our catalog of services include:<\/h2><\/div><\/i><\/i><\/span>Particle Identification & Isolation<\/span><\/a><\/h3><\/div>\n\n- Identification of visible and subvisible particles in drug products using optical microscopy and polarized light microscopy (PLM)<\/li>\n
- Isolation of particles from complex matrices using filtration and micro-manipulation techniques<\/span><\/li>\n
- Morphological evaluation including size, shape, color, and optical properties<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Chemical Characterization<\/span><\/a><\/h3><\/div>\n\n- Identification of organic materials using Raman microscopy and FTIR spectroscopy<\/li>\n
- Raman spectroscopy for molecular fingerprinting of particles<\/li>\n
- FTIR for complementary characterization of chemical structure and functional groups<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Elemental Analysis<\/span><\/a><\/h3><\/div>\n\n- Characterization of inorganic particles using scanning electron microscopy with energy-dispersive X-ray spectroscopy (SEM-EDX)<\/li>\n
- Identification of inorganic particles such as metals, glass, or environmental contaminants<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Root Cause Investigation Support<\/span><\/a><\/h3><\/div>\n\n- Differentiation of intrinsic, extrinsic, and process-related particles based on morphology and composition<\/li>\n
- Support for OOS\/OOT investigations, deviation analysis, and CAPA definition<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Where can we help<\/p>\n<\/div>
<\/div><\/div>Key Applications<\/h2><\/div>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.<\/p>\n<\/div>
- <\/i><\/span>\n
Investigation of particulate contamination in injectable and ophthalmic products<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Troubleshooting of out-of-specification (OOS) and out-of-trend (OOT) results<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Identification of particles linked to extractables and leachables or packaging interactions<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Support for deviation investigations, CAPA definition, and regulatory responses<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271920%27%20height%3D%27900%27%20viewBox%3D%270%200%201920%20900%27%3E%3Crect%20width%3D%271920%27%20height%3D%27900%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div><\/div><\/div>OUR EXPERIENCE<\/p>\n<\/div>
<\/div><\/div>We can help you with:<\/h2><\/div>Our experience covers a wide range of pharmaceutical products and potential contamination sources, including:<\/p>\n<\/div>
- <\/i><\/span>\n
Sterile and non-sterile drug products, with a focus on liquid formulations and injectables<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Biologics and complex formulations<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
APIs and excipients (linked to contamination sources)<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Packaging and manufacturing materials<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/i><\/span><\/div><\/i><\/span><\/div><\/i><\/span><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>![\"Team](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27988%27%20height%3D%27988%27%20viewBox%3D%270%200%20988%20988%27%3E%3Crect%20width%3D%27988%27%20height%3D%27988%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" "\\"Team")
<\/span><\/div><\/div><\/div>Why Choose KYMOS?<\/h2><\/div>- <\/i><\/span>\n
GMP Expertise:<\/strong><\/h3>\n\n- GMP-certified laboratories supporting foreign particle identification in compliance with regulatory expectations.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Advanced Analytical Techniques:<\/strong><\/h3>\n\n- Combination of microscopy and micro-spectroscopy techniques to achieve reliable and comprehensive particle characterization.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Investigation-Focused Approach:<\/strong><\/h3>\n\n- Support beyond identification, contributing to root cause analysis and corrective action strategies.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Proven Track Record<\/h3>\n\n- Extensive experience supporting pharmaceutical companies in contamination investigations and regulatory-driven studies.<\/li>\n<\/ul>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><\/span><\/span><\/span>
Services<\/p>\n<\/div>
<\/div><\/div>All Solid-State Characterization Services<\/h2><\/div><\/div><\/div><\/span><\/a><\/span>![](\"https:\/\/kymos.com\/wp-content\/uploads\/2026\/04\/Raman-scaled-1.jpg\" "\\"A,Scientific,Sample,Being,Investigated,Using,A,Raman,Microscope,-\\"")
<\/span><\/div>Particle Characterization & Testing<\/h3><\/h4><\/div>GMP-compliant characterization of particle size, morphology, and solid-state properties to support development and quality control.<\/p>\n<\/div><\/div><\/div>
GMP-compliant identification of visible and subvisible particles to support contamination investigations and product quality<\/p>\n<\/div>
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.<\/p>\n
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.<\/p>\n<\/div><\/div><\/div>
Services<\/p>\n<\/div>
Our catalog of services include:<\/h2><\/div><\/i><\/i><\/span>Particle Identification & Isolation<\/span><\/a><\/h3><\/div>\n\n- Identification of visible and subvisible particles in drug products using optical microscopy and polarized light microscopy (PLM)<\/li>\n
- Isolation of particles from complex matrices using filtration and micro-manipulation techniques<\/span><\/li>\n
- Morphological evaluation including size, shape, color, and optical properties<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Chemical Characterization<\/span><\/a><\/h3><\/div>\n\n- Identification of organic materials using Raman microscopy and FTIR spectroscopy<\/li>\n
- Raman spectroscopy for molecular fingerprinting of particles<\/li>\n
- FTIR for complementary characterization of chemical structure and functional groups<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Elemental Analysis<\/span><\/a><\/h3><\/div>\n\n- Characterization of inorganic particles using scanning electron microscopy with energy-dispersive X-ray spectroscopy (SEM-EDX)<\/li>\n
- Identification of inorganic particles such as metals, glass, or environmental contaminants<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Root Cause Investigation Support<\/span><\/a><\/h3><\/div>\n\n- Differentiation of intrinsic, extrinsic, and process-related particles based on morphology and composition<\/li>\n
- Support for OOS\/OOT investigations, deviation analysis, and CAPA definition<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Where can we help<\/p>\n<\/div>
<\/div><\/div>Key Applications<\/h2><\/div>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.<\/p>\n<\/div>
- <\/i><\/span>\n
Investigation of particulate contamination in injectable and ophthalmic products<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Troubleshooting of out-of-specification (OOS) and out-of-trend (OOT) results<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Identification of particles linked to extractables and leachables or packaging interactions<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Support for deviation investigations, CAPA definition, and regulatory responses<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/div><\/div><\/div><\/div>OUR EXPERIENCE<\/p>\n<\/div>
<\/div><\/div>We can help you with:<\/h2><\/div>Our experience covers a wide range of pharmaceutical products and potential contamination sources, including:<\/p>\n<\/div>
- <\/i><\/span>\n
Sterile and non-sterile drug products, with a focus on liquid formulations and injectables<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Biologics and complex formulations<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
APIs and excipients (linked to contamination sources)<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Packaging and manufacturing materials<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/i><\/span><\/div><\/i><\/span><\/div><\/i><\/span><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/span><\/div><\/div><\/div>Why Choose KYMOS?<\/h2><\/div>- <\/i><\/span>\n
GMP Expertise:<\/strong><\/h3>\n\n- GMP-certified laboratories supporting foreign particle identification in compliance with regulatory expectations.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Advanced Analytical Techniques:<\/strong><\/h3>\n\n- Combination of microscopy and micro-spectroscopy techniques to achieve reliable and comprehensive particle characterization.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Investigation-Focused Approach:<\/strong><\/h3>\n\n- Support beyond identification, contributing to root cause analysis and corrective action strategies.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Proven Track Record<\/h3>\n\n- Extensive experience supporting pharmaceutical companies in contamination investigations and regulatory-driven studies.<\/li>\n<\/ul>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><\/span><\/span><\/span>
Services<\/p>\n<\/div>
<\/div><\/div>All Solid-State Characterization Services<\/h2><\/div><\/div><\/div><\/span><\/a><\/span><\/span><\/div>Particle Characterization & Testing<\/h3><\/h4><\/div>GMP-compliant characterization of particle size, morphology, and solid-state properties to support development and quality control.<\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Particle Identification & Isolation<\/span><\/a><\/h3><\/div>\n\n- Identification of visible and subvisible particles in drug products using optical microscopy and polarized light microscopy (PLM)<\/li>\n
- Isolation of particles from complex matrices using filtration and micro-manipulation techniques<\/span><\/li>\n
- Morphological evaluation including size, shape, color, and optical properties<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Chemical Characterization<\/span><\/a><\/h3><\/div>\n\n- Identification of organic materials using Raman microscopy and FTIR spectroscopy<\/li>\n
- Raman spectroscopy for molecular fingerprinting of particles<\/li>\n
- FTIR for complementary characterization of chemical structure and functional groups<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Elemental Analysis<\/span><\/a><\/h3><\/div>\n\n- Characterization of inorganic particles using scanning electron microscopy with energy-dispersive X-ray spectroscopy (SEM-EDX)<\/li>\n
- Identification of inorganic particles such as metals, glass, or environmental contaminants<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Root Cause Investigation Support<\/span><\/a><\/h3><\/div>\n\n- Differentiation of intrinsic, extrinsic, and process-related particles based on morphology and composition<\/li>\n
- Support for OOS\/OOT investigations, deviation analysis, and CAPA definition<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Where can we help<\/p>\n<\/div>
<\/div><\/div>Key Applications<\/h2><\/div>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.<\/p>\n<\/div>
- <\/i><\/span>\n
Investigation of particulate contamination in injectable and ophthalmic products<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Troubleshooting of out-of-specification (OOS) and out-of-trend (OOT) results<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Identification of particles linked to extractables and leachables or packaging interactions<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Support for deviation investigations, CAPA definition, and regulatory responses<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/div><\/div><\/div><\/div>OUR EXPERIENCE<\/p>\n<\/div>
<\/div><\/div>We can help you with:<\/h2><\/div>Our experience covers a wide range of pharmaceutical products and potential contamination sources, including:<\/p>\n<\/div>
- <\/i><\/span>\n
Sterile and non-sterile drug products, with a focus on liquid formulations and injectables<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Biologics and complex formulations<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
APIs and excipients (linked to contamination sources)<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Packaging and manufacturing materials<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/i><\/span><\/div><\/i><\/span><\/div><\/i><\/span><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/span><\/div><\/div><\/div>Why Choose KYMOS?<\/h2><\/div>- <\/i><\/span>\n
GMP Expertise:<\/strong><\/h3>\n\n- GMP-certified laboratories supporting foreign particle identification in compliance with regulatory expectations.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Advanced Analytical Techniques:<\/strong><\/h3>\n\n- Combination of microscopy and micro-spectroscopy techniques to achieve reliable and comprehensive particle characterization.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Investigation-Focused Approach:<\/strong><\/h3>\n\n- Support beyond identification, contributing to root cause analysis and corrective action strategies.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Proven Track Record<\/h3>\n\n- Extensive experience supporting pharmaceutical companies in contamination investigations and regulatory-driven studies.<\/li>\n<\/ul>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><\/span><\/span><\/span>
Services<\/p>\n<\/div>
<\/div><\/div>All Solid-State Characterization Services<\/h2><\/div><\/div><\/div><\/span><\/a><\/span><\/span><\/div>Particle Characterization & Testing<\/h3><\/h4><\/div>GMP-compliant characterization of particle size, morphology, and solid-state properties to support development and quality control.<\/p>\n<\/div><\/div><\/div>
- \n
- Identification of visible and subvisible particles in drug products using optical microscopy and polarized light microscopy (PLM)<\/li>\n
- Isolation of particles from complex matrices using filtration and micro-manipulation techniques<\/span><\/li>\n
- Morphological evaluation including size, shape, color, and optical properties<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Chemical Characterization<\/span><\/a><\/h3><\/div>
\n- \n
- Identification of organic materials using Raman microscopy and FTIR spectroscopy<\/li>\n
- Raman spectroscopy for molecular fingerprinting of particles<\/li>\n
- FTIR for complementary characterization of chemical structure and functional groups<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Elemental Analysis<\/span><\/a><\/h3><\/div>
\n- \n
- Characterization of inorganic particles using scanning electron microscopy with energy-dispersive X-ray spectroscopy (SEM-EDX)<\/li>\n
- Identification of inorganic particles such as metals, glass, or environmental contaminants<\/li>\n<\/ul>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Root Cause Investigation Support<\/span><\/a><\/h3><\/div>
\n- \n
- Differentiation of intrinsic, extrinsic, and process-related particles based on morphology and composition<\/li>\n
- Support for OOS\/OOT investigations, deviation analysis, and CAPA definition<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Where can we help<\/p>\n<\/div>
<\/div><\/div>Key Applications<\/h2><\/div>
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.<\/p>\n<\/div>
- <\/i><\/span>\n
Investigation of particulate contamination in injectable and ophthalmic products<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nTroubleshooting of out-of-specification (OOS) and out-of-trend (OOT) results<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nIdentification of particles linked to extractables and leachables or packaging interactions<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nSupport for deviation investigations, CAPA definition, and regulatory responses<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
OUR EXPERIENCE<\/p>\n<\/div>
<\/div><\/div>We can help you with:<\/h2><\/div>
Our experience covers a wide range of pharmaceutical products and potential contamination sources, including:<\/p>\n<\/div>
- <\/i><\/span>\n
Sterile and non-sterile drug products, with a focus on liquid formulations and injectables<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nBiologics and complex formulations<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nAPIs and excipients (linked to contamination sources)<\/p>\n<\/div><\/li>
- <\/i><\/span>
\nPackaging and manufacturing materials<\/p>\n<\/div><\/li><\/ul><\/div><\/div>
<\/i><\/span><\/div><\/i><\/span><\/div><\/i><\/span><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/a><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Why Choose KYMOS?<\/h2><\/div>
- <\/i><\/span>\n
GMP Expertise:<\/strong><\/h3>\n
- \n
- GMP-certified laboratories supporting foreign particle identification in compliance with regulatory expectations.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Advanced Analytical Techniques:<\/strong><\/h3>\n
- \n
- Combination of microscopy and micro-spectroscopy techniques to achieve reliable and comprehensive particle characterization.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Investigation-Focused Approach:<\/strong><\/h3>\n
- \n
- Support beyond identification, contributing to root cause analysis and corrective action strategies.<\/li>\n<\/ul>\n<\/div><\/li>
- <\/i><\/span>\n
Proven Track Record<\/h3>\n
- \n
- Extensive experience supporting pharmaceutical companies in contamination investigations and regulatory-driven studies.<\/li>\n<\/ul>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div><\/span><\/span><\/span>
Services<\/p>\n<\/div>
<\/div><\/div>All Solid-State Characterization Services<\/h2><\/div><\/div><\/div>
<\/span><\/a><\/span><\/span><\/div>Particle Characterization & Testing<\/h3><\/h4><\/div>
GMP-compliant characterization of particle size, morphology, and solid-state properties to support development and quality control.<\/p>\n<\/div><\/div><\/div>
- Extensive experience supporting pharmaceutical companies in contamination investigations and regulatory-driven studies.<\/li>\n<\/ul>\n<\/div><\/li><\/ul><\/div><\/div><\/div><\/div>
- <\/i><\/span>
- <\/i><\/span>
- <\/i><\/span>
- Morphological evaluation including size, shape, color, and optical properties<\/li>\n<\/ul>\n<\/div><\/div><\/div>
![\"Team](\"https:\/\/kymos.com\/wp-content\/uploads\/2025\/02\/why-choose-kymos.png\" "\\"Team")
<\/span><\/div><\/div><\/div>![](\"https:\/\/kymos.com\/wp-content\/uploads\/2026\/04\/Scanning-Electron-Microscopy-SEM-2.jpg\" "\\"Scanning-Electron-Microscopy-SEM-2\\"")
<\/span><\/div>![](\"https:\/\/kymos.com\/wp-content\/uploads\/2026\/04\/opened-medical-capsule-to-show-beige-powder-on-gre-1-1.jpg\" "\\"opened-medical-capsule-to-show-beige-powder-on-gre-1-1\\"")
<\/span><\/div>