Particulate Matter Test (as per USP 788 / 789)
It consists of Trasnmitted/ Reflected Microscope (Nikon / Zeiss/ Cosmo-MIC) , Scientific Camera , motorized stage for microcope and Software to capture the images/ video of particles.
Software will scan the entire filter paper under microscope using motorized XY and Z stage. It will analyse all the particles present on filter paper and generate report as per USP 788, USP 789 and ISO 8871.
Our system comes with 21CFR Part 11 or EU 11 complaint.
B. Particle Analysis Software (Motorized scanning of complete sample)
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 through motorized scanning
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, 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 Particulate Matter Test (USP 788, 789 and ISO 8871)
Analysis of filter paper sample for particle count as per USP 788, 789 and ISO 8871
Reports can be obtained as per ml or per container basis
System will generate PASS / FAIL remark automatically from the already set
program of the part / sample
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
