1. MFI 5000 Series Flow Microscope
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, users are able to
optimize and monitor their formulations using novel and unique
characterization metrics.
Features:
Individually images, counts and sizes particles in liquid
formulations
Optimized detection sensitivity for translucent particles
Qualified for cGMP application
High-throughput autosampler ready
“ Particle counting [using MFI] may be Typical Applications:
the most sensitive technique available
for the detection of aggregated Address US FDA requirements for subvisible particle analysis
protein.” Optimize mAb formulations to minimize subvisible particle
(2011) Journal of Pharmaceutical Sciences formation
100(2): 492-503.
Characterize and quantify particles after reconstituting
lyophilized samples
“ Subvisible particle analysis using MFI
can help present a more complete Distinguish silicone oil droplets from aggregates
picture of the solution and in some Investigate aggregates and particulates in vaccine development
cases also help to identify the origins
Monitor and control process variables contributing to particle
of the particles.”
formation
(2011) Journal of Pharmaceutical Sciences DOI:
10.1002/jps.22515.
info@brightwelltech.com t +1.613.591.7715 tf +1.866.333.8772 D-0000135-00_00
2. MFI 5000 Series Flow Microscope
Specifications
Parameter mFI 5100 mFI 5200
Size Range 2μm to 300μm - single optical configuration 1μm to 70μm - single optical configuration
Sample Analyzed/Vol. Dispensed > 85% - entire size range > 85% - entire size range
Depth of Field (DOF) 400μm 100μm
Flow Cell Depth 400μm - DOF matched 100μm - DOF matched
Analysis Rate 200μl/min 150μl/min
Maximum Concentration (@ 2.5μm) 175,000 particles/ml 900,000 particles/ml
Parameter UNIVerSaL SPecIFIcatIoNS
Translucent Particle Sensitivity Factory calibrated using proprietary protein surrogate material
Sensor Pixel Density - 1280x1024
Greyscale Resolution - 10 bit
Automation High-Throughput Autosampler (Optional)
Sample Flow Control
Sample Illumination
Precision Focusing
Particle Detection Thresholding
Sample Introduction Options Pipette Tip - 1ml manual insertion, 1ml Autosampler
Syringe Barrel - 2ml, 10ml, 20ml manual insertion
BD Hypak™ Syringe Introduction Adapter - 1ml, 2ml
Flow Cell Coatings - non-coated, hydrophobic, custom
Precision Stirring Compatible with Syringe Barrel Introduction set-up
Variable Speed Control, 200 to 2,000 RPM
Output Data Chart Formats - Histograms, Scatterplots, Trend Charts
Chart Parameters - Particle Count, Concentration, Mass, Volume
Image Format - Uncompressed TIFF (Analysis), Compressed JPG (Storage)
Key Morphological Parameters Size (ECD), Maximum Feret Diameter, Aspect Ratio, Circularity, Area, Perimeter, Intensity
MFI View System Software 21 CFR Part 11 compliant
see product brochure for full details Method-based analysis protocols
Uses data compression algorithms for maximized storage
Time-resolved analysis capability
Secure access with comprehensive audit/log files
User permission controls
Protected data repository
Comprehensive reporting
Fully compatible with MFI View Analysis Suite
MFI View Analysis Suite Review images, parametric data and charts simultaneously
see product brochure for full details Plot histograms, scatter plots, and trend charts
Cross-interactivity between charts, images, and morphological data
Easily isolate sub-populations using “find-similar” function
Develop multi-node filters with real-time population feedback
Individually highlight particles of special interest or for specific exclusion
Overlay and compare data sets
Generate comprehensive multi-element reports
Create analysis templates for repeat use
Specifications are subject to change without notice. Values shown are typical. Actual results may be influenced by sample characteristics and
operating conditions. E.&O.E. March 2011.
Onsite demonstrations and trials are available. Please contact Brightwell or your local distributor for more details.
info@brightwelltech.com t +1.613.591.7715 tf +1.866.333.8772 D-0000135-00_00
![MFI 5000 Series Flow Microscope
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, users are able to
optimize and monitor their formulations using novel and unique
characterization metrics.
Features:
Individually images, counts and sizes particles in liquid
formulations
Optimized detection sensitivity for translucent particles
Qualified for cGMP application
High-throughput autosampler ready
“ Particle counting [using MFI] may be Typical Applications:
the most sensitive technique available
for the detection of aggregated Address US FDA requirements for subvisible particle analysis
protein.” Optimize mAb formulations to minimize subvisible particle
(2011) Journal of Pharmaceutical Sciences formation
100(2): 492-503.
Characterize and quantify particles after reconstituting
lyophilized samples
“ Subvisible particle analysis using MFI
can help present a more complete Distinguish silicone oil droplets from aggregates
picture of the solution and in some Investigate aggregates and particulates in vaccine development
cases also help to identify the origins
Monitor and control process variables contributing to particle
of the particles.”
formation
(2011) Journal of Pharmaceutical Sciences DOI:
10.1002/jps.22515.
info@brightwelltech.com t +1.613.591.7715 tf +1.866.333.8772 D-0000135-00_00](https://image.slidesharecdn.com/8830756/85/microflow-imagingmfi-5000-flow-microscopes-1-320.jpg)
