Quantitative and Consistent Visible Particle Analysis in Biologics using Flow Imaging Microscopy


visible-particles-app-note-pdf-thumbnailVisible particles in drug products present serious risks, including safety concerns and regulatory non-compliance. The ability to accurately and consistently monitor visible particle content is critical for pharmaceutical manufacturers and researchers working with biologics and other parenteral drug products.

This free application note explores how Flow Imaging Microscopy (FIM) with FlowCam provides a robust, quantitative solution for detecting, characterizing, and controlling visible particles in biotherapeutics.

 

What You’ll Learn:

  • The limitations of traditional visual inspection for visible particle monitoring

  • How FlowCam's Flow Imaging Microscopy provides quantitative and consistent visible particle analysis—including gray zone particles

  • How FIM supports root cause analysis to minimize withheld drug product units and batches

  • The advantages of combining subvisible, gray zone, and visible particle analysis with Flow Imaging Microscopy for comprehensive particle control

 

Why Download This Application Note?

  • Improve Product Quality – Reduce visible particle formation and prevent costly recalls

  • Accelerate Root Cause Analysis – Identify and address particle sources efficiently

  • Support Compliance – Minimize visible particle content in samples to help guarantee compliance with USP <790> criteria

  • Optimize Inspection Processes – Strengthen visual inspection with quantitative insights

Flow Imaging Microscopy is revolutionizing the way researchers monitor visible particles in biologics. Fill out the form to access the application note and take the next step in improving the quality and safety of your biotherapeutic products.

Download Application Note