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[ Focus on Chemical Machinery and Equipment Network ] There are many types of medicines.
If they are classified according to their physical state, they can be divided into solid, semi-solid, liquid and gas dosage forms.
Among them, solid preparations account for about 70% of all medicines and are the main dosage form of medicines.
It has the advantages of good physical and chemical stability, lower production and manufacturing costs, and convenient taking and carrying, so it is very popular with patients.
Chemical machinery and equipment network hotspots pay attention to chemical machinery and equipmentIf they are classified according to their physical state, they can be divided into solid, semi-solid, liquid and gas dosage forms.
Among them, solid preparations account for about 70% of all medicines and are the main dosage form of medicines.
It has the advantages of good physical and chemical stability, lower production and manufacturing costs, and convenient taking and carrying, so it is very popular with patients.
Pharmaceutical solid preparations use powder as the starting material.
In order to ensure the product quality of the solid preparation and the smooth progress of the production process, it is often necessary to process and treat the drug, such as crushing, grading, mixing, granulating, drying, and tableting.
Among them, granulation is a very important process in the production process of pharmaceutical solid preparations.
In order to ensure the product quality of the solid preparation and the smooth progress of the production process, it is often necessary to process and treat the drug, such as crushing, grading, mixing, granulating, drying, and tableting.
Among them, granulation is a very important process in the production process of pharmaceutical solid preparations.
It is understood that in the past, the traditional granulation process generally used "mixing and stirring-swing granulation-oven drying".
The disadvantage of this process is that the production capacity is weak, the operation is cumbersome, and it is prone to cross-contamination, which affects the quality of the product.
Safety.
In order to strengthen the supervision and management of drug production and drug quality, and to ensure the safety of drug use by patients, my country has implemented a Good Manufacturing Practice (GMP) certification system.
Under this system, plant design and equipment configuration, water, ventilation and air conditioning Systems, warehouse conditions, production management and quality management document systems, organizational structures, etc.
are all facing stricter requirements, including the requirements for preventing cross-contamination.
The disadvantage of this process is that the production capacity is weak, the operation is cumbersome, and it is prone to cross-contamination, which affects the quality of the product.
Safety.
In order to strengthen the supervision and management of drug production and drug quality, and to ensure the safety of drug use by patients, my country has implemented a Good Manufacturing Practice (GMP) certification system.
Under this system, plant design and equipment configuration, water, ventilation and air conditioning Systems, warehouse conditions, production management and quality management document systems, organizational structures, etc.
are all facing stricter requirements, including the requirements for preventing cross-contamination.
In this context, the traditional granulation process obviously cannot meet the requirements of certified companies and gradually becomes unpopular, and a new type of "high-efficiency wet granulation-boiling drying" production process was born.
Its obvious feature is : The production efficiency is high, the cycle is short, and it meets GMP requirements.
At present, this new granulation process is being widely recognized and applied by pharmaceutical companies.
Its obvious feature is : The production efficiency is high, the cycle is short, and it meets GMP requirements.
At present, this new granulation process is being widely recognized and applied by pharmaceutical companies.
The production process of "high efficiency wet granulation-boiling drying" includes two parts: high efficiency wet granulation and boiling drying.
Among them, high efficiency wet granulation refers to the simultaneous mixing-humidification-stirring-high-speed cutting granulation in the same equipment container.
The granulation method is characterized by avoiding cross-contamination, convenient operation, reducing labor intensity, and conforming to GMP requirements; boiling drying means that the dried granular material is in a boiling state in a clean hot air stream, and the hot air and the material are in a boiling state.
Heat exchange realizes rapid drying of materials.
Among them, high efficiency wet granulation refers to the simultaneous mixing-humidification-stirring-high-speed cutting granulation in the same equipment container.
The granulation method is characterized by avoiding cross-contamination, convenient operation, reducing labor intensity, and conforming to GMP requirements; boiling drying means that the dried granular material is in a boiling state in a clean hot air stream, and the hot air and the material are in a boiling state.
Heat exchange realizes rapid drying of materials.
It is worth mentioning that although the advantages of the new granulation process are prominent, the key to the normal use of the new process equipment is the key to the success or failure of the commissioning.
Many users have reported that the above-mentioned wet granulation and boiling drying equipment often have quality problems such as "too many materials" during the commissioning process, which seriously affects the granulation effect.
Many users have reported that the above-mentioned wet granulation and boiling drying equipment often have quality problems such as "too many materials" during the commissioning process, which seriously affects the granulation effect.
In order to solve the quality problems such as "too many materials" in the trial production and commissioning, some domestic manufacturers have also started with the working principles of wet granulation and boiling drying, combined with the traditional granulation process, and carried out experimental analysis and discussion on boiling drying.
Debugging of new type wet granulation and boiling drying equipment , and improvement of the equipment in the debugging.
Drying equipment Debugging of new type wet granulation and boiling drying equipment , and improvement of the equipment in the debugging.
For example, a granulator manufacturer explored the problems in the production and debugging of its equipment and found that the key to debugging the equipment is to make the material flow sufficient.
Therefore, after the high-efficiency wet granulation, the manufacturer added a wet granulation procedure to Enhance the fluidity of materials.
At the same time, the manufacturer also improved the operating procedures to ensure that the fan is heated first and then fed after the fan is started, reducing the phenomenon of re-aggregation of materials after entering the dryer room.
Granulator Therefore, after the high-efficiency wet granulation, the manufacturer added a wet granulation procedure to Enhance the fluidity of materials.
At the same time, the manufacturer also improved the operating procedures to ensure that the fan is heated first and then fed after the fan is started, reducing the phenomenon of re-aggregation of materials after entering the dryer room.
There are also companies that have designed a wet granulation and boiling drying connection unit through extensive absorption and combining the characteristics of domestic and foreign solid preparation production processes.
It is a wet granulator, a wet granulator, a boiling dryer, a dry granulator, The material conveying, mixer, etc.
are effectively combined, and the new model developed in accordance with the actual domestic production needs has a reasonable structure and stable performance.
It also avoids the problem of "too many materials".
It is suitable for the previous processes such as tablets and capsules.
And the production of granules.
It is a wet granulator, a wet granulator, a boiling dryer, a dry granulator, The material conveying, mixer, etc.
are effectively combined, and the new model developed in accordance with the actual domestic production needs has a reasonable structure and stable performance.
It also avoids the problem of "too many materials".
It is suitable for the previous processes such as tablets and capsules.
And the production of granules.
In general, under the background of increasing aging and consumption upgrading, the market demand for solid pharmaceutical preparations will also continue to grow.
At the same time, as industry supervision becomes stricter and quality requirements continue to increase, the production process and production of solid pharmaceutical preparations The equipment also needs to keep pace with the times and continuously upgrade to meet the production requirements of higher quality products.
At the same time, as industry supervision becomes stricter and quality requirements continue to increase, the production process and production of solid pharmaceutical preparations The equipment also needs to keep pace with the times and continuously upgrade to meet the production requirements of higher quality products.
Original title: Focusing on the production of solid pharmaceutical preparations, granulation is an important process
