Fully Automatic DISI – Disintegration Tester
The DISI tablet disintegration tester combines a proven design with new innovative concepts of data acquisition and data analysis. DISI has been developed in conjunction with the well-known PH21 pharmaceutical production control software system. The tester is built with high quality components and offers the following features and advantages:
• Cable and Contactless Test Baskets
• Easy, computer-assisted operation
• Precise and reliable measuring system
• Innovative concept• Provides additional information / disintegration profile
• Precise and service friendly thermostat heater• Very service friendly
All operations of the DISI are performed via the PC’s Windows-based human machine operating interface. The software profits from all possibilities of the Windows® 32bit operation system and corresponds to the latest requirements of FDA 21CFR Part 11. The measurement is based on a new, patented principle. The decrease of the tablet’s heights will be sent to the connected PC and displayed graphically and in real time at the PC’s monitor.
Energy supply and signal coupling between the basket assembly and the tester’s frame is done electromagnetically. This will prevent all contact problems caused by corrosion or contamination found with many traditional designs. The magnetic coupling to the swing mechanism allows a quick and safe basket handling.
The basket assembly itself is extremely robust. Because of the lack of cables and connectors, it may be easily disassembled and for cleaning even be fully submerged into a cleaning bath.
The baskets are moved vertically by stepping motors on a linear drive unit. This ensures that the movement is in a strictly sinusoidal way and exactly identical in time and speed.
The DISI tester incorporates a surprisingly easy and fully automatic self-adjusting facility. All adjustments are done electronically. The data analysis concept is based on the successful PH21 MI production control software. Each sampled data may be traced back to the batch, press, outlet, or even the container the sample had been taken from. Tabular and/or graphical reports may be printed for single tests, for the whole batch or any other level (e.g. all tests of a certain container). It is also possible to print out summary statistics of several batches.