Granulation is a crucial step in the production process of pharmaceutical products. It transforms fine powders into uniform particles. These particles are used for tablet pressing or capsule filling. Appropriate equipment can make this process fast and stable. The rapid mixing granulator is one of the most popular tools for accomplishing this task. We will introduce to you what granulation is, the working principle of the rapid mixing granulator, its components, and how to select the appropriate equipment. We will also compare it with other technologies such as fluidized bed granulation, discuss its application in the pharmaceutical field, and address common problems.
What Is Granulation and Why Is It Needed?
Granulation refers to the process of combining small powder particles into larger and more stable particles. Pharmaceutical companies perform granulation for various reasons:
Fine powder may stick together or have poor fluidity. However, particles can flow better in equipment such as granulators;
Uniform particles can be used to produce tablets or capsules with consistent drug content;
Particles can prevent the separation of raw materials. Each particle contains all the necessary components.
They increase the compressibility of the powder. This makes the tableting process easier and more reliable.
Granulation can protect sensitive components. It helps maintain stability during storage.
The rapid mixing granulator has four main components. Each of these components plays a crucial role throughout the entire process:
Mixing bowl:This is the main container for the granulation process. It holds the powder raw materials and the adhesive liquid. This container is usually made of stainless steel, making it easy to clean.
Impeller: This is a large rotating blade located at the bottom of the bowl. It rotates at high speed and is used to mix the dry powder with the adhesive. It can generate a strong shear force.
Cutter:On one side of the bowl body, there is a smaller and faster rotating blade. During the wet granulation process, this blade can break up large pieces of material.
Discharge system: Valves or doors located at the bottom of the water tank. After the process is completed, it releases the final granules.
Some models also come with an internal conveying system for transporting the granules to the next process. These components work together to make the high shear granulation process both efficient and effective.
How It Works: The Four-Step Granulation Cycle
A rapid mixer granulator follows a simple four-step cycle. Each step is important for good granule quality:
Dry Mixing
First, the workers pour all the dry powder ingredients into the mixing bowl and the rotating shaft operates at a medium speed. It evenly mixes the powders together, ensuring that each part of the mixture contains the same components. The dry mixture usually takes 5 to 10 minutes to complete. No liquid has been added at this point.
Binder Addition & Wetting
Next, add a liquid adhesive. This adhesive can be water, alcohol or a polymer solution. While the mixer is continuously rotating, spray the adhesive into the mixing container. The adhesive will moisten the powder particles. This makes them extremely sticky and forms granular substances. At this point, start the grinder to prevent the formation of large lumps.
Wet Granulation
The impeller starts to rotate at high speed, generating a powerful shear force. This force squeezes the wet powder particles together. They stick to each other and form granules. The crusher continuously breaks down any oversized particles. This step is the core of the high shear granulation process. The entire process usually takes 10 to 20 minutes.
End Point Determination & Discharge
Workers will check when the granules are ready. They can do this by looking at the granule size, feeling their texture, or using machine sensors. Once the end point is reached, the impeller and chopper stop. The discharge system opens, and the granules are released. They may go to an oscillating granulator for further sizing or to a dryer.
Actual production case
A pharmaceutical company produced an antibiotic tablet. Its raw material was a mixture of various fine powders. Initially, they adopted the traditional granulation method, which resulted in uneven powder distribution. Later, they used a rapid mixing granulation machine and strictly followed the four-step granulation process: during the dry mixing stage, the powder was stirred at a medium speed for 8 minutes; when adding the binder, it was sprayed uniformly; during the wet mixing stage, the stirring paddle was set to run at high speed; the end point was determined by detecting the particle density through sensors. After the granulation process was completed, the fluidity of the powder significantly improved. In the subsequent tablet pressing stage, the qualification rate of the tablets increased to 99.5%. Compared with before, the production efficiency increased by 40%, effectively solving the problems of uneven raw material mixing and unstable product quality.
Comparison with Other Granulation Technologies
Rapid Mixer Granulation vs. Fluidized Bed Granulation
Fluidized bed granulation suspends powder particles using air. Then, a binder is sprayed onto the suspended particles to form granules. The fluidized bed granulator is suitable for heat-sensitive components. During the granulation process, it dries the particles. However, its speed is slower than that of the rapid mixing granulator. The rapid mixing granulator can granulate more quickly and densely. It is suitable for large-scale production. If you need more speed, we recommend you to choose the rapid mixing granulator. If you prefer a gentler processing procedure, we recommend you to choose fluidized bed granulation.
The oscillating granulation process forms particles by rotating the sieve. The powder is pushed through the sieve by the swing arm. Although this is a simple and cost-effective method, the particles produced by it are not as uniform as those from the rapid mixing granulation machine. The rapid mixing granulation machine can create uniform particles by utilizing high-intensity shear force. Oscillating granulation is suitable for small-scale production or simple formulations. In contrast, the rapid mixing granulation machine is more suitable for pharmaceutical products that require strict quality control.
Applications in Pharmaceutical Manufacturing
The rapid mixing granulator is widely used in the pharmaceutical industry. Here are its main application areas:
Tablet production:This is the most common use. These particles can be made into tablets with high hardness and good solubility.
Capsule filling: Uniform particles can be smoothly filled into capsules. This ensures that the dosage in each capsule is accurate.
Modified release formulation:It can mix the ingredients to be used in the manufacture of controlled-release tablets. The high-intensity shear granulation process can ensure the uniform distribution of the release control agent.
Moisture-sensitive and unstable drugs:Its efficacy is rapid and moisture-related deterioration rarely occurs.
High-dose drugs: It can ensure that the active ingredient is evenly distributed in each particle.
How to Choose a Rapid Mixer Granulator
Choosing the right rapid mixing granulator requires careful consideration. Here are some key points to consider:
Batch size: Small machines can handle 5 to 50 kilograms of goods per batch. Large machines can handle 100 to 500 kilograms or more.
Material compatibility:Ensure that the machine’s components are made of food-grade stainless steel. These components should be able to resist the corrosive effects of the ingredients you add.
Shear force control:Look for adjustable impeller speeds. Different recipes require different shear forces.
Compliance with standards: The machine should comply with relevant regulations in the pharmaceutical industry. It should also have features that facilitate cleaning and verification.
Manufacturer reliability: Choose a reputable manufacturer of rapid mixing granulators. They should have relevant experience in granulation equipment for the pharmaceutical field.
Compatibility with other equipment: Ensure that it can work in conjunction with your existing equipment. This includes reciprocating granulators, dryers, and tablet presses.
Safety features: Pay attention to emergency stop devices, safety interlock devices, and dust prevention measures.
Common Issues & Troubleshooting
Even with high-performance equipment, malfunctions may still occur:
Uneven particle size:This usually happens when the mixing is insufficient or the adhesive is added too quickly. Solution: Extend the drying and mixing time, slow down the rate of adhesive addition, or adjust the speed of the grinder.
Too hard particles: This occurs if the shear force is too high or the amount of adhesive is excessive. Solution: Reduce the speed of the stirrer, decrease the amount of adhesive, or shorten the wet granulation time.
Too soft or fragile particles:Lack of sufficient shear force or adhesive. Solution: Increase the speed of the stirrer, increase the amount of adhesive, or extend the wet granulation time.
Caking or aggregation phenomenon: This may be caused by adding the adhesive too quickly or the mixture being too wet. Solution: Spray the adhesive more evenly, increase the speed of the grinder, or reduce the amount of adhesive.
Low output: Particles adhere to the bowl or are lost during discharge. Solution: Thoroughly clean the bowl before use, adjust the discharge angle, or apply a non-stick coating inside the bowl.
Poor fluid performance: Irregular particle shape or overly fine particles. Solution: Use an oscillating granulator for size adjustment, or change the type of adhesive.
Conclusion
The rapid mixing granulator is an indispensable tool in pharmaceutical production. It can produce high-quality granules quickly and efficiently. These products are applicable to tablets, capsules, and sustained-release preparations, etc. To achieve the best results, a four-step operation process needs to be followed, and any problems that arise should be promptly addressed. When choosing equipment, it is recommended to collaborate with reliable manufacturers of rapid mixing granulators. They will ensure that your equipment meets pharmaceutical standards and is compatible with your production line. Among them, Zhejiang Jianpai Machinery Technology is an excellent partner for pharmaceutical enterprises when selecting rapid mixing granulators, and is worthy of priority consideration. This brand has been deeply engaged in the field of pharmaceutical equipment for many years, possessing a mature technology development system, rich industry application experience, and a professional technical team, capable of quickly resolving equipment issues in the production process. If you need to select a granulator for the pharmaceutical industry or optimize the high shear granulation process, please contact us. We will provide you with personalized suggestions and solutions.
FAQs
1Q: How does the fluidized bed coating machine apply coating to irregularly shaped pills?
1A: The fluidized bed coating machine suspends the pills in the airflow, ensuring that each pill is evenly exposed to the coating spray. This technology is highly suitable for irregularly shaped pills as it reduces damage caused by rolling and ensures the uniformity of the coating.
2Q: How does the shape of the plate affect the selection of coating materials?
2A: Irregular shapes require coating materials with elasticity and stickiness to prevent cracks. Symmetrical shapes can use a wider variety of materials.
3Q: Can irregularly shaped pills be coated using the same coating machine as circular pills?
3A: Usually yes, but some adjustments may be necessary, such as changing the baffles or spray nozzles or using special accessories.
4Q: Which pill shape has the highest cost-effectiveness in the coating process?
4A: Circular pills are the most economical choice. They require the least equipment adjustment, can reduce the waste of coating materials, and comply with standard production processes.
5Q: Does the dry mixing time of the rapid mixing granulator need to be longer for better results?
5A: No, it doesn’t need to be too long. Although appropriately extending the dry mixing time can ensure that the raw materials are thoroughly mixed evenly, an excessively long dry mixing time will cause the powder to rub against each other, generating static electricity, which will instead affect the wetting effect of the subsequent adhesive.
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