Particle Analyzers (PSA) – Size, Shape and Distribution using Microscopy
It consists of Trasnmitted/ Reflected Microscope (Nikon / Zeiss/ Cosmo-MIC) along with Scientific Camera and Software to capture the images/ video of particles.
Software will automatically analyse each and every particle under the microscope for its length, width, area, circularity, aspect ration, sphericity, convexity and many more parameters.
Our system comes with 21CFR Part 11 or EU 11 complaint.
Particle Analysis Software (Batch Image Analysis)
Package software for particle analysis dedicatedly developed for pharmaceutical and
similar industries. Software broadly has following features
B.1 Acquisition
Capturing of set of images in pre-defined folder with single clicks
B.2 Batch Run
Swift Batch Run (processing batch of images in one go) for effective and faster processing
of large number of images captured
B.3 Particle Size Analysis (PSA)
Customized Method development as per standards.
Identification and isolation of particles depending on size(0.1 µm to 2000 µm),
shape and color.
Measurement– Simultaneous Measurement of all the particles in set of images for
their total numbers, length, width, area, perimeter etc.
Individual particle morphological parameters like AED, CED, Aspect Ratio,
Circularity etc.
Intelligent Agglomerates Separation
Distribution - Distribution of all the analyzed particles as per their length/width/area into
various user defined size classes.
D values – Software shall compute and report all D values from D1 to D100
B.4 Report
Reports shall be generated to offer all D values D1 to D100.
C. 21 CFR compliance features
1. User Policy - System access is controlled by authorized users with Unique ID and
password
2. Password policy - Password Length, password complexity, auto logoff time
3. Audit trails - System generated user readable and printable audit trails for activities
performed in software. Audit trails shall be date and time stamped.
4. Roles and privileges - System has predefined roles namely Administrator, Manager,
Supervisor, Analyst, Service engineer. One can assign any user to only one role.
5. Data backup/restore
6. User readable and non-editable reports
7. Qualification documents - System comes with IQ, OQ and PQ documents