Automatic disintegrator
The test complies with usp701 and usp2040, including EP and JP methods consistent with USP. Well designed, efficient and easy-to-use, it provides fast and low maintenance cost disintegration
laboratory solutions for new product development and mass production testing.
Each test position can be independently programmed and operated, allowing up to four products to be tested simultaneously in four test positions. The complex software controls, measures and stores the test data, and displays the disintegration value and process in real time in a graphical manner. Data tracking, security and advanced user permission settings are required by complying with 21cfrpart11 security guidelines.
Monitor the process of disintegration in real time
Highly precise detection technology can automatically detect the disintegration process of tablets. Using the principle of magnetic induction, the copper ring is embedded in the disc and placed on each tablet to be tested. In each journey, it can capture the instantaneous small electromagnetic changes according to the change of the tablet thickness. The sensor built in the smart basket component continuously measures the temperature of the disintegrating medium. After 100% disintegration is completed, the system senses the completion of the test and automatically lifts the basket from the beaker. The accurate temperature and disintegration percentage readings are displayed on the computer screen in real time, and are automatically stored in the database for future retrieval or report output in tabular and graphical formats.
Compliance with 21 CFR Part 11
Each auto sensing system is controlled by a Windows based client / server software operating system. The system can automatically generate a complete audit trail to assist in meeting the requirements of 21cfr Part11. The automatic sensing system of each dis has built-in Pharmacopoeia compliance features, so that the test results of each tablet can be tracked by its batch ID number. The multi-stage disintegration of standard tablets, capsules and special products is accurately monitored and fully recorded. In the monitoring system, the "residual height" trigger can be customized by the user to adapt to any non disintegrating change that often occurs in some capsules.