The wet mixing granulator is a relatively fast solid pharmaceutical preparation equipment developed in recent years. The process combines the two-step mixing and granulation process, which saves time and meets GMP requirements and reduces cross-contamination. Improving efficiency is a quick and easy way to save and is very popular among users. In the current solid preparation process, the wet mixing granulator is a granulating device which is used more than Zui, and is also economical. According to incomplete statistics in the pharmaceutical industry, it accounts for 70% of all solid preparation granulation equipment.
Generally speaking, the particles prepared by wet mixing granulation have irregular shape, uniform particle size distribution, better structure than other conventional granulation processes, strong compressibility, good solubility and moderate moisture permeability. At different granulating speeds, the particle size of the particles is between 12 and 100 mesh. The distribution range can be selected from different granulation speeds and stirring paddle speeds. (When the granulation speed is slow, the particle size becomes larger and the rotation speed is gradually increased. Accelerate and gradually reduce the particle size; when the stirring paddle speed is slow, the particle size is small, the rotation speed is gradually increased and the particle size is gradually increased, and the two functions are just the opposite).
Conventional wet mixing granulators can be used to manually adjust the speed of the paddles and granulation paddles in order to find out the experimental process parameters. That is to say, the two blade speeds are changed through different time, and the particle size parameter of Zuijia is obtained. According to this, two frequency converters are input for program control, thereby ensuring stable and uniform quality of batch and batch production.
1. Preparation before commissioning and empty vehicle test 1. Check whether electricity, gas and water in the workshop are in place and in standby mode.
2. Rotate the potentiometer switch on the operation panel counterclockwise to the ziu slow speed position.
3. Since the cover cannot be opened during operation, it will automatically stop after opening the cover to ensure safety, so it needs to be set before starting. Check the mixing paddle from the mirror on the lid. Press the paddle start button (green) to observe the steering of the paddle. - It should be counterclockwise. If the steering is not correct, the motor should be reversing, confirm the steering. start up. If there is abnormal noise during slow rotation, stop the inspection.
4. Check that the steering of the granulating knife should be clockwise and the method of inspection is the same as above.
5. Commission air seal, hermetic seal and water cooling system.
Gas seals and hermetic seals are performed by a common set of tubing. When debugging, first turn the command switch to the stop position, observe whether the air chamber overflows or leaks in the air chamber, and if necessary, check the check valve. The second step is to turn the command switch to the intake position to check for gas. After the zui, turn the command switch to the water inlet position for water. If there is any abnormality, check the diaphragm valve. The water cooling is determined according to the temperature of the pot body and the process requirements. When the pot body is heated and needs to be cooled after continuous operation, the cooling water outlet valve can be opened to adjust the flow rate, and the flow rate is greatly cooled. At the same time, the required temperature setting is determined and automatically performed by temperature control.
Second, the material granulation can be put into the material for physical granulation after a series of empty operation debugging:
1. Preparation for feeding: switch on water, electricity and gas. Open the lid, check whether the discharge door is closed, and place the finished container under the discharge port. Prepare the raw materials for the test and various accessories, adhesives, water or alcohol on the backing plate.
2. Physical debugging: Open the lid and pour the powder into the pot. Start the mixing paddle and add the binder, then start the granulation paddle. Adjust the manual potentiometer to the medium and low speed for 1 to 2 minutes and then adjust the stirring paddle speed to medium and high speed. The current of the stirring paddle is gradually increased. After 2 to 5 minutes, the current reaches a peak value, and stirring can be continued for 1 minute to form a pellet. If the current does not reach the peak, add a small amount of binder and continue stirring for 1-2 minutes.
The peak current of each material should be obtained according to the actual test. By manually adjusting the speed, continuously explore and record, sum up the parameters and values ​​of the speed and running time of the Zuijia stirring paddle and granulating knife, and then press the required parameters during mass production. Enter the inverter for program control.
3. Discharge: After the granulation is completed, the discharge door is opened, and the discharge port is dropped into the container by the discharge nozzle.
4. Cleaning (CIP): At the end of the granulation production or when changing the variety, the machine must be cleaned in time to remove the residue. Air pressure must be maintained during cleaning to allow the door and lid to work properly, and then the discharge door is closed. Open the lid and turn the command switch to the water inlet position. Into the pot into the water, then pay attention to the water level should be lower than the position of the granulator. After the water is completed, close the lid, open the stirring paddle, and rotate slowly. After the end of the cleaning instruction switch to the location of feed gas, the purge pot residual water, with a dry cloth. Prepare for the next production.
Here the user in the use of wet mixing granulator often encountered as: agitation, a control program and the chronological granulation, the slurry concentration control, serving to extract and alcohol granulation and granulated dextrin differences and masterbatch centrifugal granulation of debugging techniques to make some elaboration.
(A) mixing, granulating and chronological control program when the impeller is rotated, a three-dimensional space of the pot roll material, while the material from the bottom of the pot in the pot wall is formed toss rotation, followed by a wave crest exactly one, and softwood granulation into fast cutting blade, then the irregularly shaped soft material is cut into different sizes round prismatic particles, as the particles between each tumbled over time, gradually rounded corners are small particles spherical. From the above principle, we can achieve the granularity achieved by adjusting the speed and time of the two propellers. On the granulator, we use a double-conversion motor to control the movement of the scull, and at the same time, we program it to achieve the uniformity of batch and batch quality. Below we make a little bit of the time and program control of typical Chinese and Western medicine granulation. Introduction.
1) Western medicine: * step, mixing: the stirring paddle speed is set at 40 Hz, the granulating knife is set at 10 Hz, and the mixing time is 2 to 3 minutes.
In the second step, the slurry is granulated: the stirring blade speed is set at 35 Hz, the granulating knife is set at about 30 Hz, and the granulation time is 5 to 7 minutes.
The third step, the discharge: the stirring paddle speed is set at 45 Hz, the granulating knife is set at about 20 Hz, and the discharge time is about one minute.
2) TCM: Step *, mix: impeller speed set at 30Hz, granulating knife disposed about 10Hz, the mixing time is 2 to 3 minutes.
The second step is slurry granulation: the stirring paddle speed is set at 30 Hz, and the granulating knife is set at about 20 Hz.
The third step, the discharge: the stirring paddle speed is set at 30 Hz, and the granulating knife is set at about 15 Hz.
The above cases are for reference only, but in practice each material has a different viscosity and can be adjusted.
(2) Mastering the slurry concentration When using the wet mixing granulator, whether it is diluted with concentrated extract as a slurry or a paste of dextrin or other binder, it is generally used when making small particles. The concentration of the slurry is dilute, and the slurry is slightly thick when making large particles. Under the premise of not affecting the effect of the slurry, the binder for heavy materials should be less, and the binder for lightweight materials should be slightly increased.
(3) Experience of extracting the extract Because the viscosity of the traditional Chinese medicine extract is high, it cannot be self-flowing. For example, if the extract slurry is directly poured into the stirring pot, the extract slurry and the auxiliary material cannot be uniformly mixed. Moreover, it will cause the granulation and agglomeration to become a large group phenomenon, that is, it can be cut by using a high-speed granulating knife. Because the concentrated extract is much harder than the western medicine. According to our debugging experience, Zui's good method is to first dilute the extract with more than 95% alcohol, and the diluted extract can self-flow, then put it into a sealed slurry container, and compress it. Air pressure, using a porous nozzle, sprays the diluted slurry evenly and quickly onto the material. This time should be as short as possible because Chinese medicine is easy to absorb moisture. The alcohol evaporates quickly, and the general control is better in one minute. The whole granulation process should also be short, generally within 2 to 5 minutes. Of course, the physical properties of various materials will also vary, so the process should make some adjustments to the specific data.
(4) Differences between alcohol granules and paste refined granules Alcohol granulation is a common method because alcohol plastids do not have viscosity, and it also plays a loose role, so the granules produced are relatively small and fine. The advantage is that the drying is fast, and the granulation effect of the Chinese medicinal alcohol with high viscosity is ideal. If the paste is used to refine the granules, since the dextrins are viscous, it acts as a polymerization, so the granules produced are relatively large and coarse, and the disadvantage is that the drying is slow, and the effect of the medicinal paste-free granules having no viscosity is better.
(5) Preparation of masterbatch for centrifugal granulation Many granules that pharmaceutical users wish to make on wet mixing granulators are used as pellets for centrifugal granulation in the subsequent process, which are dried after wet granulation. The granules are irregularly rounded, so it is recommended to add a spheronization process. The process can be carried out on a sugar-coated machine. When spheronizing, some water can be sprayed appropriately. After this process, the roundness of the mother granules is greatly improved, and the granulation or granulation is carried out. Clothing treatment is much more desirable.
The wet mixing granulator is an advanced mixing granulation equipment which is prepared by placing the mixing and granulating processes on one machine. Due to the different drug varieties of various manufacturers, the granulation process is different. After using this equipment, after a period of exploration, we will find a suitable granulation process for the company.
Generally speaking, the particles prepared by wet mixing granulation have irregular shape, uniform particle size distribution, better structure than other conventional granulation processes, strong compressibility, good solubility and moderate moisture permeability. At different granulating speeds, the particle size of the particles is between 12 and 100 mesh. The distribution range can be selected from different granulation speeds and stirring paddle speeds. (When the granulation speed is slow, the particle size becomes larger and the rotation speed is gradually increased. Accelerate and gradually reduce the particle size; when the stirring paddle speed is slow, the particle size is small, the rotation speed is gradually increased and the particle size is gradually increased, and the two functions are just the opposite).
Conventional wet mixing granulators can be used to manually adjust the speed of the paddles and granulation paddles in order to find out the experimental process parameters. That is to say, the two blade speeds are changed through different time, and the particle size parameter of Zuijia is obtained. According to this, two frequency converters are input for program control, thereby ensuring stable and uniform quality of batch and batch production.
1. Preparation before commissioning and empty vehicle test 1. Check whether electricity, gas and water in the workshop are in place and in standby mode.
2. Rotate the potentiometer switch on the operation panel counterclockwise to the ziu slow speed position.
3. Since the cover cannot be opened during operation, it will automatically stop after opening the cover to ensure safety, so it needs to be set before starting. Check the mixing paddle from the mirror on the lid. Press the paddle start button (green) to observe the steering of the paddle. - It should be counterclockwise. If the steering is not correct, the motor should be reversing, confirm the steering. start up. If there is abnormal noise during slow rotation, stop the inspection.
4. Check that the steering of the granulating knife should be clockwise and the method of inspection is the same as above.
5. Commission air seal, hermetic seal and water cooling system.
Gas seals and hermetic seals are performed by a common set of tubing. When debugging, first turn the command switch to the stop position, observe whether the air chamber overflows or leaks in the air chamber, and if necessary, check the check valve. The second step is to turn the command switch to the intake position to check for gas. After the zui, turn the command switch to the water inlet position for water. If there is any abnormality, check the diaphragm valve. The water cooling is determined according to the temperature of the pot body and the process requirements. When the pot body is heated and needs to be cooled after continuous operation, the cooling water outlet valve can be opened to adjust the flow rate, and the flow rate is greatly cooled. At the same time, the required temperature setting is determined and automatically performed by temperature control.
Second, the material granulation can be put into the material for physical granulation after a series of empty operation debugging:
1. Preparation for feeding: switch on water, electricity and gas. Open the lid, check whether the discharge door is closed, and place the finished container under the discharge port. Prepare the raw materials for the test and various accessories, adhesives, water or alcohol on the backing plate.
2. Physical debugging: Open the lid and pour the powder into the pot. Start the mixing paddle and add the binder, then start the granulation paddle. Adjust the manual potentiometer to the medium and low speed for 1 to 2 minutes and then adjust the stirring paddle speed to medium and high speed. The current of the stirring paddle is gradually increased. After 2 to 5 minutes, the current reaches a peak value, and stirring can be continued for 1 minute to form a pellet. If the current does not reach the peak, add a small amount of binder and continue stirring for 1-2 minutes.
The peak current of each material should be obtained according to the actual test. By manually adjusting the speed, continuously explore and record, sum up the parameters and values ​​of the speed and running time of the Zuijia stirring paddle and granulating knife, and then press the required parameters during mass production. Enter the inverter for program control.
3. Discharge: After the granulation is completed, the discharge door is opened, and the discharge port is dropped into the container by the discharge nozzle.
4. Cleaning (CIP): At the end of the granulation production or when changing the variety, the machine must be cleaned in time to remove the residue. Air pressure must be maintained during cleaning to allow the door and lid to work properly, and then the discharge door is closed. Open the lid and turn the command switch to the water inlet position. Into the pot into the water, then pay attention to the water level should be lower than the position of the granulator. After the water is completed, close the lid, open the stirring paddle, and rotate slowly. After the end of the cleaning instruction switch to the location of feed gas, the purge pot residual water, with a dry cloth. Prepare for the next production.
Here the user in the use of wet mixing granulator often encountered as: agitation, a control program and the chronological granulation, the slurry concentration control, serving to extract and alcohol granulation and granulated dextrin differences and masterbatch centrifugal granulation of debugging techniques to make some elaboration.
(A) mixing, granulating and chronological control program when the impeller is rotated, a three-dimensional space of the pot roll material, while the material from the bottom of the pot in the pot wall is formed toss rotation, followed by a wave crest exactly one, and softwood granulation into fast cutting blade, then the irregularly shaped soft material is cut into different sizes round prismatic particles, as the particles between each tumbled over time, gradually rounded corners are small particles spherical. From the above principle, we can achieve the granularity achieved by adjusting the speed and time of the two propellers. On the granulator, we use a double-conversion motor to control the movement of the scull, and at the same time, we program it to achieve the uniformity of batch and batch quality. Below we make a little bit of the time and program control of typical Chinese and Western medicine granulation. Introduction.
1) Western medicine: * step, mixing: the stirring paddle speed is set at 40 Hz, the granulating knife is set at 10 Hz, and the mixing time is 2 to 3 minutes.
In the second step, the slurry is granulated: the stirring blade speed is set at 35 Hz, the granulating knife is set at about 30 Hz, and the granulation time is 5 to 7 minutes.
The third step, the discharge: the stirring paddle speed is set at 45 Hz, the granulating knife is set at about 20 Hz, and the discharge time is about one minute.
2) TCM: Step *, mix: impeller speed set at 30Hz, granulating knife disposed about 10Hz, the mixing time is 2 to 3 minutes.
The second step is slurry granulation: the stirring paddle speed is set at 30 Hz, and the granulating knife is set at about 20 Hz.
The third step, the discharge: the stirring paddle speed is set at 30 Hz, and the granulating knife is set at about 15 Hz.
The above cases are for reference only, but in practice each material has a different viscosity and can be adjusted.
(2) Mastering the slurry concentration When using the wet mixing granulator, whether it is diluted with concentrated extract as a slurry or a paste of dextrin or other binder, it is generally used when making small particles. The concentration of the slurry is dilute, and the slurry is slightly thick when making large particles. Under the premise of not affecting the effect of the slurry, the binder for heavy materials should be less, and the binder for lightweight materials should be slightly increased.
(3) Experience of extracting the extract Because the viscosity of the traditional Chinese medicine extract is high, it cannot be self-flowing. For example, if the extract slurry is directly poured into the stirring pot, the extract slurry and the auxiliary material cannot be uniformly mixed. Moreover, it will cause the granulation and agglomeration to become a large group phenomenon, that is, it can be cut by using a high-speed granulating knife. Because the concentrated extract is much harder than the western medicine. According to our debugging experience, Zui's good method is to first dilute the extract with more than 95% alcohol, and the diluted extract can self-flow, then put it into a sealed slurry container, and compress it. Air pressure, using a porous nozzle, sprays the diluted slurry evenly and quickly onto the material. This time should be as short as possible because Chinese medicine is easy to absorb moisture. The alcohol evaporates quickly, and the general control is better in one minute. The whole granulation process should also be short, generally within 2 to 5 minutes. Of course, the physical properties of various materials will also vary, so the process should make some adjustments to the specific data.
(4) Differences between alcohol granules and paste refined granules Alcohol granulation is a common method because alcohol plastids do not have viscosity, and it also plays a loose role, so the granules produced are relatively small and fine. The advantage is that the drying is fast, and the granulation effect of the Chinese medicinal alcohol with high viscosity is ideal. If the paste is used to refine the granules, since the dextrins are viscous, it acts as a polymerization, so the granules produced are relatively large and coarse, and the disadvantage is that the drying is slow, and the effect of the medicinal paste-free granules having no viscosity is better.
(5) Preparation of masterbatch for centrifugal granulation Many granules that pharmaceutical users wish to make on wet mixing granulators are used as pellets for centrifugal granulation in the subsequent process, which are dried after wet granulation. The granules are irregularly rounded, so it is recommended to add a spheronization process. The process can be carried out on a sugar-coated machine. When spheronizing, some water can be sprayed appropriately. After this process, the roundness of the mother granules is greatly improved, and the granulation or granulation is carried out. Clothing treatment is much more desirable.
The wet mixing granulator is an advanced mixing granulation equipment which is prepared by placing the mixing and granulating processes on one machine. Due to the different drug varieties of various manufacturers, the granulation process is different. After using this equipment, after a period of exploration, we will find a suitable granulation process for the company.
Xi'an Henrikang Biotech Co., Ltd., was established in May 2010, and located in Gaoling Industrial Park, Xi`an city, Shaanxi Province, China. It is a professional supplier of Body building products : sarms products ; peptides products ; steroids ; Finished Oil ; hormone products , and natural active ingredients. It has absolute advantage because of strong research strength, modern management system and high-quality marketing team.
Now we have 3 GMP standard workshop, Meanwhile, the factory is equipped with the researching and quality inspection centre, with strong technology research and development strength. We also have 3 salesdepartments over 30 people and sell our products all over the world.
For customer`s needs, OEM service is also acceptable. If you have a good idea in new product production but lack of laboratory device and human resource, we are glad to solve this problem for you. Sincerely hope to strengthen exchanges and cooperation with friends from both home and abroad.
Body building, sarms products, peptides products, steroids, finished oil
Xi'an Hollysince Biotech Co., Ltd. , https://www.hollysince.com