Control tester DISI-4A

calibrationdisintegrationthickness

The disintegration process is continuously monitored by measuring the tablets thickness with every upward stroke. With DISI-A, you control all operation and data analysis safely and easily via computer and PH21 software. The system fulfils the requirements of FDA 21 CFR Part 11. All operation procedures are password-protected and monitored continuously by the system. All relevant procedures, for example amendments to master data, calibration and much more, are automatically recorded in the audit trail. As each station is powered separately, you can test up to four different products at the same time. The softstart function ensures that the testing basket is immersed in a controlled manner. The baskets move vertically by stepping motors running in micro step mode. This allows the baskets to move smoothly in and out of the media and ensures strictly sinusoidal motion. Also, with multiple station testers the up and down movements are exactly identical in time and speed. All the DISI-A operations are performed through Ph21 Software via the PC’s Windows based operating interface. Thanks to the very well-known Windows operating environment the user will become familiar in a very short period of time. The system corresponds to the latest requirements of FDA 21CFR11. All operations are password protected. A flexible access management scheme allows tailoring the access control to any customer specific requirements. All relevant operations will be logged into a protected event logbook (audit trail).