MFIThe microfluidic imaging particle analysis system integrates digital microscopy technology, microfluidics, and image processing technology into a fully automated instrument for analyzing particles or cells. When the sample flows through the detection area,MFIIt will capture the mirror image of the sample, and each particle in the mirror image will be analyzed to generate data on the quantity, size, transparency, morphology, and other aspects of the particles. It can also be used for real-time analysis of the dynamic process of particles. Morphological analysis software can also be used to analyze particles with special morphologies, or to separate some sub particle populations. Compliant with the United StatesFDANew requirements for qualitative and quantitative sub visible aggregates and particles.

Protein aggregated particles have strong transparency, resulting in a high rate of missed detections in the photoresist method.MEI can improve the detection rate of protein aggregation particles.

Detection Principle

MFI technology is the abbreviation for Micro Flow Imaging, which stands for Micro Flow Imaging Particle Analysis System. The detection principle is that during the process of flowing through the sample detection pool, the high-frequency imaging detector dynamically and continuously detects particles in the sample at a fixed detection window, obtains a series of data photos, and finally uses software to classify and count the obtained particle photos in an automated system.

The core of this technology lies in precisely controlling the sample detection poolThe flow rate in the Flow Cell, combined with static image capture, ensures that the liquid columns of adjacent imaging detections do not overlap, thereby avoiding repeated counting of particles in the sample. At the same time, it ensures that the total volume of the interval liquid column (undetected liquid column) flowing between the two detected liquid columns is less than 15% of the total volume of the detected sample, that is, more than 85% of the samples have obtained imaging detection of particles, ensuring high coverage and accuracy of sample detection. Combined with panoramic deep stereo imaging, it ensures that all detected particles are within the depth of field range, making the technology accurate in determining particle size.

unique advantages

1Can detect2-10 μ m sub visible particles

2Easily detect semi transparent and highly transparent sub visible protein aggregation particles

3Accurately detect particle size in high concentration or high viscosity solutions and count them

4Can effectively distinguish different particle sources, such as protein aggregation, silicone oil, bubbles, fibers, etc

5MFI's existing public literature data shows that internationally renowned companies such as PepsiCo, Bristol Myers Squibb (BMS), Celgen, etc. are using it in various aspects such as formulation, stress assessment, and raw material screening

application software

Each application in the MFl view application software has an intuitive user interface, guidance program, and powerful reporting function. Through optimization that meets pharmaceutical needs, the MFI view makes complex particle analysis simple. It has the following characteristics:

◆ Compliant with 21 CFR Part 11 standards

Method based analysis plan

◆ User permission management

◆ Protected data storage

Comprehensive and diverse report

Simultaneously evaluate images, parameter data, and graphics

◆ One screen, multiple interfaces seamlessly connected

◆ Use the "find smilar" function to easily distinguish subcategories

◆ Custom filtering of different morphological parameters

◆ Data is automatically transmitted to the designated path

◆ Traceability of original particle images

◆ Create reusable analysis templates

Analyze a single sample or multiple samples simultaneously