1、 Introduction to the new model
The BJ-4DF intelligent disintegrator is a four basket working position and is a patented product of Tianjin Chuangxing Electronic Equipment Manufacturing Co., Ltd. (patent number: ZL201220446045.8). A high-precision and intelligent disintegration time limit tester developed and produced for professional users, in accordance with the provisions of the 2020 edition of the Chinese Pharmacopoeia regarding the disintegration time limit of tablets, capsules, pills, etc. Its main technical indicators comply with the regulations of USP, BP, and JP on disintegration time limit testing.
2、 System configuration
2.1 BJ-4DF intelligent disintegrator 1 set
2.2 Four sets of disintegration baskets
2.3 One water bath box
2.4 Four 1000ml beakers
2.5 24 baffles
3、 Working conditions
3.1 Safety Performance: Complies with the relevant provisions of the Chinese pharmaceutical industry standards for "disintegrators"
3.2 Working power supply: AC 220V ± 10% 50Hz ≤ 1000W
3.2 Environmental conditions: Room temperature 5-40 ℃, humidity ＜ 80%
4、 Technical indicators and characteristics
4.1 Four basket working position: Each basket can be lifted and lowered independently, or two baskets can be lifted and lowered in two groups, or four baskets can be lifted and lowered synchronously.
4.2 System permission management; Three level, multi-user (login method: username+password).
4.3 Audit Tracking Records: Audit records can be traced and queried by date or number, and can also be selectively printed or printed in full.
4.4 Rapid quantification of disintegration and dispersion ratio:
4.5 Real time display of basket lifting and lowering times, independent counting of four baskets.
4.6 Printing content: Sample identification, name, number, water temperature, timing of each basket, lifting and lowering times, disintegration and dissolution ratio:
(Actual fragmentation ratio of 24 pipelines), tester, supervisor, start time, end time, measurement
Test date
4.7 High resolution color touch screen; Interactive control and intelligent management.
4.8 Working mode:
① Basic experiment; The timing is positive and can be paused or continued for the convenience of research experiments.
② Program control test; Time is a countdown that can be pre-set and saved for easy routine repeatability testing.
4.9 Timing range: freely set within 24 hours,
4.10 Display resolution, hours: minutes: seconds.
4.11 Temperature control range: 5 ℃ to 50 ℃
4.12 Temperature resolution: 0.01 ℃.
4.13 Temperature control accuracy: ≤± 0.3 ℃
4.14 Temperature control sensor: Imported 1/3B high-precision Pt1000.
4.15 Basket lifting frequency: 30-31 times/minute.
4.16 Basket lifting amplitude: 55mm
4.17 Accuracy of lifting amplitude: ≤± 0.5mm
4.18 Bottom spacing of sieve cup: 25mm
4.19 Sieve aperture: 2mm (standard), optional 0.425mm, 1mm, 0.71mm
4.20 Dimensions: Length 570mm, Width 350mm, Height 550mm
4.21 Weight: Approximately 26Kg
The 4.22 real-time display function of the lifting frequency of the suspended basket provides users with a reliable method for monitoring the lifting frequency of the suspended basket.
At the end of the 4.23 experiment, the basket will automatically stop at a higher position for easy loading and unloading of the basket and beaker.
4.24 The instrument provides timed shutdown and timed automatic preheating functions.
4.25 The instrument provides intelligent temperature calibration function, and users can easily, simply, and reliably complete temperature calibration through interactive operation.
The 4.26 instrument has functions such as temperature abnormality, temperature over limit alarm, and automatic protection against secondary overheating.
4.27 The instrument provides real-time display of "year, month, day, hour, minute, and second" functions.
The 4.28 instrument provides two operation interfaces in Chinese and English, with one click switching.
5、 Applicable standards
5.1 Chinese Pharmacopoeia 2020 edition.
5.2 Comply with current GMP regulations in China.
