By Charles Ischi…
Charles Ischi CI-AG Disintegration Testers
Charles Ischi Testing Technology offers the CI-AG range of tablet and capsule disintegration testers that allow more precise determination of disintegration time, boosted by DISI magnetic/electromagnetic basket technology that allows easier use and labor saving.
CI-AG disintegration testers are designed for precise and reliable functionality and ease of use with three levels of automation and up to four independent test stations.
CI-AG Disintegration Tester Features & Functions
The CI-AG range of Tablet Disintegration Testers provide disintegration testing equipment that conforms to US Pharmacopeia (USP) and European Pharmacopeia (EU Ph.) standards.
All machines in the range can be specified with one, two, three or four individual testing stations that can be run independently of each other, using magnetically coupled baskets, which allows quick attachment or removal, with easy dismantling for cleaning. All testing systems feature soft start operation to immerse baskets in the testing medium in a controlled manner.
Beyond that, our disintegration testers offer increasing levels of automation and functionality across the range.
DISI-M Disintegration Tester
The DISI-M Manual Tablet Disintegration Tester has been developed to provide an economic solution at a high quality standard, combining innovative technology and user friendliness, with a proven design based on more than 10 years of experience in the field of pharmaceutical electronic and software applications.
All DISI-M operations are performed via a front panel machine operating interface, featuring LCD-display and individual timer control. Testing 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. Vertical movements are synchronized for frequency across all testing stations for reliable and consistent results that are based on pharmacopeia testing standards. The basket assembly is extremely robust. It may be fully submerged into an ultrasonic cleaning bath for cleaning.
DISI-M can be specified with between one and up to four testing stations, supplied with standard baskets and optional baskets for tablets diameters upwards of 18-30mm for tablet and capsules.
DISI-A Automatic Disintegration Tester
The DISI-A features automatic operations performed via PC and PH21 Software, allowing easy access and familiarity. The PH21 software features predefined EU Ph. and USP testing methods and reporting with information about the disintegration characteristics of tablets, including disintegration curve displays and real time display of time / remaining tablet thickness.
Monitoring the remaining thickness, a height measurement is performed automatically during each upward stroke of the basket. This feature is very useful for coated tablets, capsules with a remaining shell (no special discs required) and R&D labs looking for more data about their tablet disintegration characteristics.
The system corresponds to the latest requirements of FDA 21CFR Part11 for data security with all operations password protected. A flexible access management scheme allows access control to be tailored to any customer specific requirements, with all relevant operations recorded to protected audit trail.
The data analysis concept is based on the successful and popular PH21 software. All test results may be traced back to the batch and test number. Tabular and/or graphical reports can be printed for single tests and whole batches. It is also possible to print out summary statistics of several batches.
PH21 software also allows optional communication with LIMS systems or internal production control systems.
Compared with DISI-M, DISI-A features automatic detection of disintegration time, continuous display of remaining test height and PH21 software package (21CFR part11 compliant).
The DISI-A Touch Automatic Disintegration Tester offers a standalone automatic testing solution, thanks to its integrated touchscreen control module, with 4GB of onboard memory.
The tester can also be upgraded to PC control & PH21 software for 21CFR part11 compliance and remaining tablet height monitoring.
Individual testing stations allows up to four different products to be assessed simultaneously with disintegration measurements based on a new, patented principle. Tablet disintegration times are indicated in real-time on the touch panel display.
Compared with DISI-A, DISI-A Touch is operated without PC & PH21 software and does not monitor the remaining height of tablets, instead it features a 6.5” touch display and automatic end-point detection.