FODC-III Standard Testing Kitis a set of mechanical parameter testing devices for dissolution apparatuses, developed in accordance with the requirements of the Guidelines for Mechanical Validation of Drug Dissolution Apparatus and the Metrological Verification Procedures for Dissolution Apparatus issued by the Chinese National Medical Products Administration. The kit consists of various digital meters, parameter testing fixtures, and a comprehensive parameter testing apparatus. The guiding operating system, designed according to the verification procedures, enables convenient and efficient self-checking of the mechanical parameters of FOCS's entire series of dissolution apparatuses and other standard dissolution apparatuses from different brands, giving accurate and comprehensive testing reports.
Technical Features:
The testing kit is well-equipped, with the digital meters which can transmit the testing data accurately and timely to the comprehensive parameter testing apparatus through Bluetooth wireless transmission and RS485 bus mode. The comprehensive parameter testing apparatus automatically records, stores, and generates testing reports. It can meet the quantitative testing requirements for all parameters outlined in the Guidelines for Mechanical Validation of Drug Dissolution Apparatus.
Horizontal level measurement
Verticality measurement of basket/paddle spindle
Verticality measurement of dissolution cup
Temperature measurement of cup
Comprehensive parameter testing apparatus
Basket/Paddle rotation speed measurement
Coaxiality measurement of basket/paddle spindle
Basket/Paddle spindle deflection measurement
Basket/Paddle depth measurement
RS485 Transmission
Bluetooth Transmission
After entering the testing process, the guiding software automatically compares the measured values with the standard values and determines whether each test result is within the acceptable range. It then generates a test report showing whether the results are qualified or not.