Particle Analysis in Pharmaceutical Applications

Measuring and analyzing particles (size, concentration, morphology) in parenteral formulations and suspensions is critical at every step of the drug development continuum including research, formulation development, validation, manufacturing and quality control.

MFI can be used with any suspension or parenteral formulation including proteinaceous, lipids, emulsions, API suspensions and lyophilized.

For pharmaceutical scientists, the advantages of MFI are its sensitivity to highly transparent particles (which can go undetected by other methods), the additional insights provided by particle images and morphology and the speed compared to manual microscopic methods.

MFI Flow Microscopy measures protein aggregations, air bubbles, silicone oil droplets and contaminants in both the sub-visible (from 0.75 to approximately 50µm) and visible range (up to 300µm). MFI measures very high concentrations and very low concentrations.

Application Notes (Case Studies):

• Detecting and Counting Air Bubbles Using MFI
• Compendial Methods and MFI
• Analyzing Formulation Stability Using MFI
• MFI and Silicone Oil Droplets

Reference Materials:

• Qualification Study - Application of Micro-Flow Imaging (MFI) to the Analysis of Particles in Parenteral Fluids - Contact Brightwell Technologies for a copy 
• Flow Microscopy for Particulate Analysis in Parenteral and Pharmaceutical Fluids, Sharma et al, EJPPS, October 2007 - www.fip.org/pswc 
• Qualification of Protein Particles in Parenteral Solutions Using Light Obscuration and Micro-Flow Imaging, Huang et al, Colorado Protein Stability Conference, 2007
• Light Obscuration Particulate Analysis for Protein Solutions: Challenges and Limitations, Ives et al, Colorado Protein Stability Conference, 2007