Particle Analysis Instruments
Brightwell designs and manufactures MFI (Micro-Flow Imaging™) particle analysis instruments for imaging, counting, sizing, and classifying particles in liquids. The company's products have been tailored to address the challenges associated with analyzing sub-visible and visible particles present within biologic formulations. In addition to sensitivity optimization for translucent particle detection, innovations include support of small sample volumes required in formulation development, classification of extraneous particles such as silicone oil droplets or air bubbles, and management of a wide range of formulation types with respect to turbidity and viscosity.
Application areas include: Sub-Visible Population Monitoring, Sub-Population Isolation/Reporting, Formulation Stability & Comparability Studies, GMP Lot Release Testing, USP 729 Globule Detection, Silicone Oil Droplet Enumeration, Particulate Formation in MFG, Filter Design/Validation and Cell/Protein Dose Verification