Pharmaceutical Dissolution Tester Apparatus

Pharmaceutical Dissolution Tester Apparatus

1.Feature and Description It has eight vessels and six poles, with six vessels and six poles in front and other two vessels at back. The head moves up/down automatically. The basket units and paddle units are made of imported stainless steel (SUS316L). The magnetism-pumped circular water current can heat the system evenly, and the bath liquid can achieve an equal temperature. A MPU is used in dissolution tester to automatically control the temperature, rotational speed and time, and the parameters can be preset at any time. It can be operated conveniently by keystroke. The measurement result is displayed by LED. The preset and real data can be displayed alternately in time. Automation: auto-test, auto-diagnose, auto-alarm. It can test by self and alarm automatically. The dissolution parameters of' Chinese codex 2010' are stored in and can be taken out at anytime. Time can be preset at many points. The beeper sounds automatically to any point, and then the tester automatically runs to the next one.
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Description

Technical Parameters

Ningbo Scientz Biotechnology Co.,Ltd. is one of the leading pharmaceutical dissolution tester apparatus suppliers in China. Welcome to buy our quality and cheap products for sale in bulk. We also welcome wholesale orders and customized orders. Now, please be free to check the price list with our factory.

 

1.Feature and Description

It has eight vessels and six poles, with six vessels and six poles in front and other two vessels at back.
The head moves up/down automatically.
The basket units and paddle units are made of imported stainless steel (SUS316L).
The magnetism-pumped circular water current can heat the system evenly, and the bath liquid can achieve an equal temperature.
A MPU is used in dissolution tester to automatically control the temperature, rotational speed and time, and the parameters can be preset at any time.
It can be operated conveniently by keystroke. The measurement result is displayed by LED. The preset and real data can be displayed alternately in time.
Automation: auto-test, auto-diagnose, auto-alarm.
It can test by self and alarm automatically. The dissolution parameters of' Chinese codex 2010' are stored in and can be taken out at anytime.
Time can be preset at many points. The beeper sounds automatically to any point, and then the tester automatically runs to the next one.

product-656-398

product-991-706

 

 

 

1, Performance characteristics

(1) Dissolution instrument part

1. It fully meets the requirements of Chinese Pharmacopoeia and American Pharmacopoeia.

2. Swing amplitude of mixing paddle: ≤ 0.5 mm.

3. Dissolution speed: 10 ~ 300rpm, speed accuracy: ± 0.5rpm, speed resolution 0.1 rpm.

4. The dissolution instrument is equipped with 14 cups and 14 paddles, two of which are independent isothermal rehydration cups. The compatible design of large cup method and small cup method can be switched quickly, and the operator can operate simply.

5. The dissolution cup adopts embedded fixed hoop design to achieve better centering and verticality of the dissolution cup. The cup edge is designed with an indicator strip and a diagonal fixing device to achieve higher reproducibility. 1000ml and 250ml specifications are available, and the dissolution cup can be selected as transparent or low photochemical Brown products for photosensitive substances.

6. There is no joint inside the water tank, with round corner design, bottom slope drainage, and standard quick adapter, which is convenient for rapid emptying and cleaning.

7. ★ through the segmented propeller shaft design, 316L medical grade stainless steel material, the paddle method and basket method can be quickly switched without re setting the height. The small cup method, paddle disc method and rotary drum method can be quickly switched through simple height setting tools.

8. ★ equipped with two groups of independent rotating shafts, the speed of the two groups of experiments can be controlled independently. Double 4 cup, double 5 cup, double 6 cup and double 7 cup parallel comparison experiments and single 4, 5, 6, 7, 8, 10, 12, 14 cup experiments can be done to increase the flexibility of the experiment.

9. The corresponding positions of dissolution cup, paddle, basket and other accessories are laser marked to avoid mechanical errors caused by accessories with different cup numbers.

10. ★ the machine head operates stably and always remains horizontal, and the height difference between the left and right is ≤ 1mm. The left and right symmetrical silent large torque double lifting and lowering columns are used to ensure that the center of gravity of the machine head is centered and stable, and the electronic monitoring function of levelness is provided, which can be displayed in the operation interface in real time, with the locked rotor detection function, and the alarm prompt when the lifting state is abnormal.

11. Equipped with an independent anti-evaporation lid which rises and falls synchronously with the nose to effectively prevent the influence of longtime experiment solution evaporation. The lid rises synchronously before experiment to facilitate the operator to add liquid and other operations. The lid can be automatically centered with the dissolving cup to achieve better closing effect. ★  the bottom plate and the head bottom plate are made of aluminum alloy lightweight material, which has high hardness, deformation resistance and corrosion resistance. The pipelines are made of imported acid and alkali resistant PP, TPE, PTFE and other engineering plastics and 316L stainless steel, which have good corrosion resistance and adsorption resistance.

12. The nonresident sampling needle and temperature probe are designed to automatically drop when sampling and automatically rise after sampling, so as to reduce the influence of the interference of the dissolved medium on the experiment.

13. ★ it has the manual sampling function of automatic height setting of the sampling rack. The sampling height is automatically calculated according to the dissolution procedure, without manual positioning. It is equipped with a manual sampling auxiliary device to realize convenient and fast manual sampling. The manual sampling point has a voice reminder function, which is convenient for the operator to prepare for sampling in advance.

14. It adopts independent rotary dosing, which can realize integrated dosing and sequential dosing. It has the function of customized dosing stop time. The dosing time point can be recorded and tracked by the system. It has anti sticking design, which is convenient for disassembly and cleaning.

15. PT1000 temperature sensor is adopted, which has small temperature drift, high temperature stability and fast response speed. The temperature resolution reaches 0.1 ℃.

16. ★ a 10.1-inch color touch screen is used for human-computer interaction. When dissolution sampling is used in conjunction, the sampling instrument can be set and used uniformly only by a single human-computer interaction interface of the dissolution instrument. The sampling instrument does not need an independent operation interaction interface to improve the integrity and convenience of operation.

17. Support switching between Chinese and English. The main operation interface can display the instrument operation status, log information, instrument alarm reminder information, program parameters, user list, etc. The screen is equipped with a protection mechanism for operators to leave to prevent others from touching it by mistake.

18. ★ provide four levels of management authority that meets the requirements of audit tracking, which can be divided into super administrator, administrator, senior user and operator, and can control access and prevent unnecessary instrument settings or method changes.

19. ★ the instrument needs to be equipped with group management function, which can realize the different operations of multiple groups with the same instrument. The user and program parameter settings between groups do not interfere with each other, and meet the audit tracking requirements. It can store no less than 57 login accounts and passwords, and the operation authority is controlled by levels.

20. The instrument is equipped with an independently controlled heating cycle system and has the function of unattended reservation.

21. The instrument is equipped with a micro printer as standard, which can print operator information, operation experimental program data, temperature and actual speed information of each sampling point. The experimental data and all operations of the system record log information in real time. The log information has an encryption and upgrade tracking system, and can export data through USB port. The exported data cannot be modified, which meets the requirements of audit tracking.

22. ★ the instrument can store 144 experimental methods, and the instrument methods can be imported and exported through USB one key, avoiding the cumbersome steps of method transfer between different instruments.

23. ★ the instrument has a built-in voice reminder, which can give voice prompts in Chinese (English can be selected) during program operation, instrument reminder and instrument alarm to assist users in operation.

24. ★ the instrument has heating over temperature alarm, liquid leakage detection and motor locked rotor alarm. It can set the water bath temperature difference excess alarm, solvent temperature difference excess alarm, mixing speed excess alarm and water bath heating timeout alarm.

25. The manufacturer provides AIQ certification services, mechanical verification services, instrument training, installation site training and other technical and application related support services that meet the standards.

(2) Sampler section

1. The sampler adopts the automatic door opening mode, and the sampling rack enters and exits the warehouse with one key. The sample rack meets the rapid switching of 2ml liquid phase bottle and 10ml test tube (224) methods, with a maximum number of 16 sampling times. It has a dual sampling mode to achieve a maximum sampling volume of 20ml.

2. The sampling accuracy error is less than ± 0.8%.

3. The sample holder adopts the design of easy to take out and place, and has the function of detection of installation in place, detection of leakage and abnormal protection, which effectively reduces the harm caused by Improper operation.★ the liquid tank side of the sampler adopts a pull-out design, which facilitates the cleaning operation of the liquid tank after long-term use, and there is no need to disassemble and reinstall the pipeline. The liquid tank has the function of up and down liquid level detection to ensure that there is no lack of liquid and no overflow.

4. It can automatically calculate the sampling height, and can accurately sample at the position in line with the provisions of the Pharmacopoeia according to the solvent volume at the sampling time;

5. The sampler is equipped with two-stage filtration, and the initial filtration is 10μM pore diameter cylindrical filter head, secondary filtration can be selected as unfiltered or 0.8 according to actual needsμm/0.45μm/0.22μM aperture needle filter.

6. ★ high precision imported syringe and multi-channel integrated drive structure are adopted to improve the consistency of multi-channel sampling and reduce the dead volume of injection pipeline. The dead volume of each injection pipeline is ≤ 0.15ml.

7. ★ the sampler provides at least 3 multi angle transparent observation windows, which is convenient for the operator to observe the real-time state of the syringe pump and sample rack during the experiment.

8. Continuous sampling, double sample sampling, automatic sample dilution and other functions are available. The first interval is 1 minute and 20 seconds.

9. The instrument has its own program parameter setting limits. If the sampling volume and dilution volume exceed the maximum volume of the selected container, it will be automatically modified to the maximum value that can be used; The sampling time interval is automatically calculated, and the alarm reminder of too small interval is set. Check the program parameters before operation to avoid experiment failure or instrument damage caused by operator error.

10. The head runs stably and keeps level all the time. The height difference between left and right is less than or equal to 1mm. The symmetrical and mute large torque double lifting column ensures that the center of gravity of the head is in the middle and stable.

11. The sampling has the function of automatic isothermal and equal fluid replenishment.

12. Sampling volume: 1ml ~ 10ml (single time), 2ml ~ 20ml (double sampling).

 

2, Technical parameters:

1.Dissolution apparatus

project

index

Instrument performance index

Number of dissolution cups: 14

Heating range of water bath: room temperature -45.0 ℃

Temperature resolution: 0.1 ℃

Temperature control accuracy: ± 0.2 ℃

Mixing speed range: 10.0-300rpm

Speed resolution: 0.1rpm

Speed accuracy: ± 0.5rpm

Heating over temperature alarm: Yes

Night leakage alarm: Yes

Motor stalling alarm: Yes

Excessive temperature difference alarm of solvent: Yes

Water bath temperature difference excess alarm: Yes

Water bath heating excess alarm: Yes

Excessive mixing speed alarm: Yes

Intelligent voice reminder: Yes

Network interface: 100M RJ45

Display size: 10.1 inches

Permission setting: Level 4

Number of accounts: 57

Number of methods: 144

Swing amplitude of propeller shaft: ≤ 0.5mm

Swing amplitude of basket: ≤ 1.0mm

Concentricity between basket (paddle) shaft and dissolution vessel

Propeller rod symmetry: ≤ 0.5mm

Levelness of dissolution instrument: 0.5 °

Height difference between the left and right of the machine head: ≤ 1mm

Perpendicularity of propeller shaft and blade: 90 ° ± 0.2 °

Inner diameter deviation of dissolution cup (cylindrical part): ≤ 0.5mm

working temperature

(5~40) ℃

Storage temperature

(-20~60) ℃

Working humidity

(20~80)% RH

Storage humidity

(5~95)% RH

 

 

2. Sampler

project

index

performance parameter

Number of sampling channels: 14

Single sampling volume: 0.1-10ml (single); 0.2-20ml (double)

Sampling times: 1-16 times (single); 1-8 times (double)

Number of samples: 224

Sampling accuracy: ≤ 0.8% (10ml sampling)

Minimum sampling interval: 1 minute 20 seconds

Automatic dilution accuracy: ± 1%

Temperature control accuracy of fluid infusion: ≤± 0.5 ℃

Primary filtration: 10μM cylindrical filter head

Secondary filtration: 0.8μm/0.45μm/0.22μM needle filter

Dead volume of injection pipeline ≤ 0.15ml

Maximum working time: Unlimited

Automatic calculation of sampling height: Yes

    Isothermal rehydration: Yes

    Visual observation window: 3

 

Control interface: RS422

Instrument function

Automatic moistening, filling, dropping, sampling, replenishment, dilution, emptying and cleaning

Precise sampling by syringe pump, and the suction stop time can be set

working temperature

(5~40) ℃

Storage temperature

(-20~60) ℃

Working humidity

(20~80)% RH

Storage humidity

(5~95)% RH

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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