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 basket reciprocation mechanism
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).
Continuous indication of the current tablet height. The operator will be informed immediately about unsuccessful tests, if for example not all tablets disintegrate in the expected time.
When tests are performed using discs, the heights of the tablets will be sensed whenever the basket moves upward. The decrease of the tablet’s heights will be sent to the connected PC and displayed graphically and in real time on the PC’s monitor. If the use of discs is not permitted by the monograph, the operator will be prompted to enter the disintegration results manually.
The patented principle of measurement is the attenuation of an electromagnetic field when moving a short-circuited coil through this field. The electromagnetic fields are produced by six coils located in the basket’s lower plate. The electromagnetic circuits for signal conditioning are also hermetically sealed into this base plate. A tiny copper ring is moulded into each of the six discs. This ring will attenuate the electromagnetic flux when the disc moves up or down. 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.
A few quick steps is all it takes to dismantle the testing baskets ready for cleaning. The basket assembly is extremely robust. It can be easily disassembled and even be fully submerged into a cleaning bath.
The testing baskets can be attached and removed quickly thanks to the magnetic coupling. No wires at all!
The disintegration test basket design ensures a easy visual inspection.
The temperature control
The water bath is heated by a thermostatic temperature control unit.
This provides quick and reliable heating and will keep the temperature of the immersion fluid within close limits. Each basket is equipped with its own temperature sensor (pin).
The temperatures will be recorded continually and any variation outside the limits will raise an alarm and abort the test.
On top of the baskets is a quick lock system to ensure that disks dont get lost.
The data analysis concept is based on the successful PH21 production control Software. All data points are stored and may be traced back to the batch and test number. Tabular and / or graphical reports may be printed for single tests and whole batches. It is also possible to print out summary statistics of several batches.