Gillson Sciences provides particulate matter testing to detect visible and subvisible particles that can affect product safety, quality, and regulatory compliance in life sciences manufacturing. Every test we perform is designed to safeguard your products and the patients who rely on them — and our particulate matter testing services often work alongside analytical testing and material characterization to support comprehensive product quality programs. Our particulate matter testing capabilities include a range of validated methods designed to detect, quantify, and characterize visible and subvisible particles to support product quality and regulatory compliance. We offer a complete range of particulate matter testing services including: - USP <729> Globule Size Distribution in Lipid Injectable Emulsions - USP <787> Subvisible Particulate Matter in Therapeutic Protein Injections - USP <788> Particulate Matter in Injections. Method I, Light Obscuration, and Method II, Microscopic Particle Count Test - USP <789> Particulate Matter in Ophthalmic Solutions. Light Obscuration and Microscopic Particle Count Test - ISO 8871-3 Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use - ISO 8536 Infusion Equipment for Medical Use - ISO 14708 Implants for Surgery. Active implantable medical devices - BS EN 45502-2-1:2003 Active implantable medical devices Particular requirements for active in plantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) - ASTM International Testing Procedures - Continuous Training – Ongoing training for all our employees ensures that our employees maintain an in-depth knowledge of cGMP requirements, current compendial requirements (USP/EP/JP/BP/ASTM/ISO), and internal SOPs. - Additional methods as required by regional or product-specific regulations
