Charles Ischi produces the DISI-A Touch, an automatic disintegration tester that allows the user to control all operation and data analysis using a computer and PH21 software.
The system fulfils the requirements of FDA 21 CFR Part 11, and operation procedures are password-protected and monitored continuously.
All procedures, including amendments to master data and calibration, are automatically recorded in the log book for an audit trail.
The standalone variant, DISI-A Touch, is easy-to-operate using an integrated touchscreen, and can be upgraded to a PC version.
DISI-A Touch has 4GB of memory and the standard printout offers an overview of results in a table format. Users can export data via a USB stick.