1、 Model Introduction
RC12DF drug dissolution instrument is a high-precision drug dissolution instrument developed and produced by Tianjin Chuangxing Electronic Equipment Manufacturing Co., Ltd. Compliant with the 2020 edition of the Chinese Pharmacopoeia and the Guiding Principles for Mechanical Validation of Drug Dissolution Testers issued by the State Food and Drug Administration. This instrument adopts an innovative structure of fourteen cups and twelve paddles, which is patented by our company (patent number: ZL201220446265.0). It can perform two batches of drug dissolution tests simultaneously. Two storage cups for backup. The newly designed electrical control and operating system is powerful, easy to operate, and has stable performance.
2、 Working conditions
2.1 Safety Performance: Complies with the relevant provisions of China's pharmaceutical industry standards for dissolution testers
2.2 Power supply voltage: AC 220V ± 10%; Frequency: 50HZ; Power: 2.1KW
2.3 Environmental conditions: 5 ℃ to 40 ℃, relative humidity of 20% to 80%, and indoor air environment without condensation water.
3、 Main technical indicators:
3.1 12 paddles and 14 cups (12 mixing paddles and 12 rotating baskets, 14 185mm high dissolution cups).
3.2 The coaxiality between the dissolution cup and the basket (paddle) axis should deviate from the axis by ≤ 1.0mm.
3.3 Anti detachment device to prevent the shaft from falling off.
3.4 Speed range: 25-250 rpm
3.5 Speed Accuracy Resolution: 0.1 RPM
3.6 Basket (paddle) shaft speed deviation: ＜ ± 4%
3.7 Water bath temperature control range: 5 º C (room temperature) -45 º C (intelligent temperature correction)
3.8 Temperature Control Display Resolution: 0.01 º C
3.9 Temperature control accuracy: ≤± 0.3 º C
3.10 Medium temperature in each dissolution cup: 37 º C ± 0.3 º C
3.11 Levelness: Tilt ≤ 0.5 degrees (measured in two vertical directions after installation)
3.12 Verticality of basket paddle (shaft): Deviation from vertical direction ≤ 0.5 degrees
3.13 Verticality of dissolution cup: Deviation from vertical direction ≤ 1 degree
3.14 Basket (Paddle) Shaft Swing: Swing ≤ 0.3mm
3.16 Basket Swing: Swing ≤ 0.5mm
3.17 Working depth deviation of basket (paddle): 25 ± 1mm
3.18 Vibration tolerance: ≤ 0.1mi1
3.19 Continuous working time: 100h
3.20. Work noise: ＜ 60db
3.21 Electric heating power: 1900W
3.22 Programmable sampling frequency; 1-24 different sampling periods can be pre-set
3.23 Program controlled sampling period: 99 hours and 59 minutes per week can be set arbitrarily, and 24 sampling periods can be counted down in sections or continuously.
3.24 Basic experiment timing: 99 hours, 59 minutes, and 59 seconds.
3.25 Electric lifting of machine head
3.26 System permission management: multi-level, multi-user. (Login method: username+password login).
3.27 Audit Tracking Record: (No entries, no days limit).
3.28 Audit records can be queried by date or number, and can be selectively printed or printed in full.
3.29 provides an electronic "message board" function, which can write and save text prompts or important notes for shift operators on the touch screen.
4、 Instrument structure and characteristics:
4.1 RC-12DF adopts industrial grade high-resolution color touch screen, 32-bit 400MHz MCU, easy and fast operation, precise control, user-friendly human-computer interaction interface, and users can enjoy intelligent operation according to screen prompts.
4.2 The dissolution cup and water tank are designed with no gap to ensure automatic center positioning. Eliminate systematic errors.
4.3 The instrument provides options for "Basic Test" and "Program Test", and the basic test function can change the test parameters as needed at any time to facilitate research experiments. The program testing function can execute 16 pre-set program modes, facilitating routine repetitive testing.
4.4 Intelligent temperature calibration function, users can easily, simply, and reliably complete temperature calibration and correction through interactive operation.
The operation monitoring interface of the 4.5 instrument provides users with 7 real-time data display windows; Real time temperature display, real-time speed display, cumulative timing display, current waiting for sampling times, current "nth" sampling time, remaining time waiting for the current "nth" sampling (countdown), current "year month day", "hour minute second" display.
4.6 The instrument provides USB real-time information download and massive experimental data storage functions. Complete preservation of all data from the experimental process.
4.7 The instrument provides two operation interfaces in Chinese and English, with one click switching.
4.8 The instrument provides timed shutdown and timed automatic preheating functions.
4.9 The instrument provides editing functions for Chinese characters, numbers, and English. It can be stored or printed out via USB, providing data such as sample number, sample name, test parameters, test method, real-time printing date and time, sampling status, temperature, speed, etc.
4.10 has self checking and automatic protection functions, and can provide various fault alarm prompts and secondary overheating protection.
4.11 Dissolution cup lid to prevent evaporation of dissolution medium.
5、 Applicable standards:
5.1 Chinese Pharmacopoeia 2020 Edition
5.2 Current Regulations of China GMP
5.3 Guiding Principles for Mechanical Validation of Drug Dissolution Instruments issued by the Food and Drug Administration
