MFI™ 5000 Series

The MFI 5000 series of imaging-based particle counters are designed to address the US FDA's requirement to characterize and quantify aggregates and particulates in biotherapeutics. Yielding consistent, precise and repeatable results, MFI 5000 systems allow users to optimize and monitor their formulations with novel and unique characterization metrics. When integrated with the Bot1 high throughput autosampler the MFI 5000 series dramatically reduces operator hands-on time while increasing sample throughput. Automated sample delivery ensures consistency streamlining the particle analysis process.

MFI 5000

Features

  • Individually images, counts and sizes particles in liquid formulations
  • Optimized detection sensitivity for translucent particles
  • Qualified for cGMP applications
  • Automated sample introduction and analysis
  • Automated system flushing/cleaning, focus and verification
  • Unattended overnight operation
  • Multi-sample analysis with full 21 CFR Part 11 security

Typical Applications

  • Address US FDA requirements for subvisible particle analysis
  • Optimize mAb formulations to minimize subvisible particle formation
  • Characterize and quantify particles after reconstituting lyophilized samples
  • Distinguish silicone oil droplets from aggregates
  • Investigate aggregates and particulates in vaccine development
  • Monitor and control process variables contributing to particle formation

MFI 5000 Series Flow Microscope Specifications

To provide you with the most accurate and sensitive particle analysis system we offer two system configurations.

Series Highlights

  • Calibrated for the dedicated particle size range-ideal for challenging protein formulations
  • Optimized for maximum detection sensitivity
  • Designed and engineered to yield optimal results with high instrument-to-instrument repeatability
Parameter MFI 5100 MFI 5200
Size Range 2 µm to 300 µm - single optical configuration 1 µm to 70 µm - single optical configuration
Sample Analyzed/Vol. Dispensed > 85% - entire size range > 85% - entire size range
Depth of Field (DOF) 400 µm 100 µm
Flow Cell Depth 400 µm - DOF matched 100 µm - DOF matched
Analysis Rate 200 µl/min 150 µl/min
Maximum Concentration (@ 2.5 µm) 175,000 particles/ml 900,000 particles/ml