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In the production of pharmaceutical solid preparations, have you ever encountered the following phenomena: the drug varieties are prone to bed collapse, the process transfer is not smooth and the yield is not high, the high shear melt granulation time is long, the Chinese medicine needs to be granulated multiple times due to the high extract content, the particle size is uncontrollable, the particle density does not meet the standard, etc.?
In the production process of solid preparations such as medicines (traditional Chinese medicine, chemical medicine), health products and foods, granulation is widely used as a key prcess to improve the physical properties and process performance of basic materials and provide more optimized operating conditions for subsequent processes. At present, the mainstream granulation process in the pharmaceutical industry mainly includes a variety of technical routes such as high-efficiency wet granulation, fluidized bed granulation, centrifugal granulation, extrusion soft material granulation and roller dry granulation to meet the specific needs of different types of products.
Among the many granulation processes, high-efficiency wet granulation, fluidized bed granulation and dry granulation have become the most representative granulation technology in the production of solid preparations due to their significant process advantages.
Wet granulator | Fluidized bed granulator dryer | Vacuum granulator |
High-efficiency wet granulation process: This process is carried out in a conical container, and the powder is fully mixed by the strong mixing action of the bottom stirring paddle. At the same time, the binder (or extract) is evenly sprinkled and sprayed through the pressure nozzle to form a moist soft material structure, and then sheared by the side high-speed pelletizer to finally obtain wet granules with uniform particle size distribution.
Fluidized bed granulation process: After the material is placed in the hopper, the hot air purified by the high-efficiency filter enters the granulation chamber from the bottom under the action of negative pressure, so that the material is in a continuous boiling state. At the same time, the binder (or extract) is evenly sprinkled and sprayed through the pressure nozzle to bond with the powder to form a granular shape. The granules quickly evaporate the water under the action of the hot air flow, and finally form dry granules with ideal porosity and uniform particle size distribution.
Dry granulation process: The granules enter the granulator cavity, and the adjustable pelletizer and granulation screen holes in the cavity make the granules collide, squeeze, and shear, and then granulate uniform qualified granules through the screen holes.
Although the above three granulation processes show many advantages in industrial production, they each still have certain technical limitations and transportation labor costs.
High-efficiency wet granulation: Under the action of the rotating tumbling mechanism of the stirring paddle, the granules produced in this process show that some of the granules are not uniform, resulting in weakened binding force between particles and significantly reduced compressibility. Although its granulation efficiency is high, subsequent drying usually requires the help of a fluidized bed and there is a lot of fine powder. In the process of material transfer, incomplete transfer is prone to occur, which not only reduces the product yield but also increases the additional labor intensity. In addition, in the fluidized drying stage, due to the large dead weight of the wet particles, once the air volume and material volume are not well matched, the bed collapse phenomenon is very likely to occur, which seriously affects the stability of product quality.
Fluidized bed granulation: This process is based on the adhesion of atomized droplets to the material in a boiling state, and the granules produced have a high porosity. Although the granules have good fluidity, they have poor compressibility, and too low a bulk density (such as metformin preparations) may lead to insufficient filling depth in the subsequent tableting process. Since the particles are always in a semi-dry state during the granulation process, if larger particles are required, it often takes a long time and has a low success rate, which is particularly unfavorable for Chinese medicine varieties that require specific particle size and density. In addition, Chinese medicine prescriptions often contain a high proportion of extracts or sugar components. Excessive moisture during the granulation process can easily cause the material to be too wet, increase the risk of bed collapse and agglomeration, and affect process stability.
Dry granulation: In the traditional solid preparation production process, dry granulation is an independent link, which needs to be operated separately from wet granulation, drying and other processes, and the material turnover is frequent between different equipment. This not only increases the material transfer time and labor costs, but also easily causes material loss and cross-contamination during the transfer process, affecting product quality and production efficiency. Limited optimization of particle characteristics: Dry granulation mainly passes the particles through the screen by collision, extrusion, and shearing. For some products with special requirements for particle shape, density, and porosity, this method is difficult to deeply optimize the particle characteristics. For example, it is impossible to control the porosity and dryness of the particles by hot air flow during the granulation process like fluidized bed granulation, and it is also difficult to effectively regulate the binding force and compressibility of the particles during the granulation stage like efficient wet granulation.
In the context of the continuous optimization of the current solid preparation production process, is there an innovative equipment that can effectively integrate the core advantages of efficient wet granulators, fluidized bed granulators and dry granulation, while overcoming the technical limitations of turnover space pollution, process stability, particle characteristics and manual transportation costs?
Guided by customer needs and driven by technological innovation, Jianpai has consistently implemented this development concept. As a representative of the new generation of pharmaceutical equipment, Jianpai-High-efficiency Three-in-One Granulator integrates the advanced concepts of modern pharmaceutical technology, and provides a comprehensive and efficient solution for the technical difficulties of Chinese medicine and health products in the granulation process. This equipment not only achieves a breakthrough in technological innovation, but also opens up a new way to improve product quality and production efficiency.
The high-efficiency three-in-one granulator is an innovative granulation equipment carefully developed by Jianpai with years of technical accumulation. The equipment innovatively adopts an integrated design, which organically combines the high-efficiency wet granulation unit, fluidized bed granulation unit and dry granulation unit: the bottom of the equipment is equipped with a high-performance shear granulation system, equipped with precision stirring paddles and high-speed cutters to ensure the granulation effect; the upper part is integrated with an advanced fluidized bed granulation drying system to achieve granulation and drying in one step. Through the unique integrated combination system, seamless connection can be achieved, eliminating the material transfer link in the traditional process, and significantly improving production efficiency and product yield.
The technical advantages of the equipment are mainly reflected in: First, the precise coordination of the high shear unit and the fluidized granulation unit ensures process stability and completely avoids the risk of bed collapse; secondly, the integrated design realizes a continuous and intelligent production process from raw material dry mixing, slurry granulation, wet granulation to fluidized bed drying and dry granulation, significantly shortening the production cycle and improving production efficiency. It is particularly suitable for the production of granules for Chinese and Western medicines and health products.
Traditional crafts |
Feeding →→ (dry mixing) wet granulation (wet granulation) →→ drying →→ dry granulation or Feeding →→ wet granulation →→ wet granulation →→ drying →→ wet granulation →→ drying →→ dry granulation →→ arrows represent turnover |
High-efficiency three-in-one granulator process |
Note: The turnover steps are reduced many times, and the material loss is small. |
You may have questions? Will the wet granulation process cause agglomeration or bed collapse after the wet granulation drying process? No!
1.In the high shear granulation unit, we use an innovative in-bowl stirring and shearing structure design. Its unique rotating stirring blade can achieve all-round circulation of the material through centrifugal mechanics optimization. With the patented cutting blade system, this structure can ensure that the material has an ideal mixing balance effect within a wide parameter range of 20% to 80% of the loading capacity.
Photo of the material pot of the high-efficiency three-in-one granulator |
2. In terms of equipment configuration, we provide users with the industry-leading imported atomization system technology, using internationally advanced industry benchmark technology. The spray guns all use precision atomization technology, which can accurately control the droplet particle size distribution and ensure the uniformity of granulation.
3. The high-efficiency three-in-one granulator is equipped with a patented high-speed cutter system and a unique static and dynamic blade structure, which can achieve an efficient particle crushing process and increase the controllable uniformity of the particles.
High-efficiency three-in-one granulator: It integrates advanced granulation technology and intelligent control system. With its innovative three-in-one synchronous granulation technology and precise process parameter control, it will bring revolutionary solutions to solid dosage pharmaceutical production.
With technological innovation as the engine and customer needs as the guide, Jianpai Technology is committed to empowering and improving pharmaceutical production. If you want to know more about the high-efficiency three-in-one granulator, please call or leave a message for consultation. Domestic Sales Department: 0577-86932768