In recent years, importing countries of raw materials have put forward higher requirements for the production process of Chinese pharmaceutical companies, so various certifications are rapidly launched in the pharmaceutical industry. For APIs, the focus of these certifications is on fine, dry, and packaged positions, so the rational selection of dryers is particularly important. The selection of drying equipment should be based on the characteristics of the drug and the ideal state of the finished product, especially the material and sterility assurance of the aseptic bulk drug drying equipment. At present, there are many types of bulk drug dryers in China, and their respective characteristics and applicable conditions are different.
â–² vacuum drying oven for small and medium trial production
The vacuum drying oven is an older drying device, and the heating plate in the box is divided into several layers. Hot water or low-pressure steam is used as a heating medium in the heating plate, and the tray on which the medicine to be dried is placed is placed on the heating plate, the box is closed, and the vacuum is pumped in the box. The heating plate heats the drug to a specified temperature in the circulating flow of the heating medium, and the moisture begins to evaporate and is gradually withdrawn by vacuuming.
The device is easy to control, can condense and recover the evaporated solvent, and the drug is not easily contaminated during the drying process, and can be used for drying the drug, packaging sterilization and heat treatment. In the 1980s, the bulk pharmaceutical industry used this equipment as the main dryer, but because it is not easy to clean the tray (CIP) and online sterilization (SIP), the drying speed is slow, the labor intensity of the workers is large, and the medicine is realized. Uniformity, after mixing, it must be mixed by mixing equipment. Nowadays, it has been rarely used in large-scale production of raw materials, and it is mostly used for medium or small trial production or heat treatment of packaging materials.
â–² vacuum rotary dryer must consider hollow shaft sealing effect
The vacuum rotary dryer is derived from a double cone mixer, which is mostly a cylindrical body and a two-headed cone. It is also commonly known as a double cone dryer. There are two hollow suspension shafts in the middle of the cone for the equipment to rotate the support and the passage of vacuum and hot water. The medicine rotates while drying in the dryer, which guarantees the uniformity of the whole batch of drugs. The heat medium enters the jacket from the hollow tube at one end, and the hot gas in the device is discharged along the exhaust pipe in the hollow tube at the other end, and the volatile solvent is recovered by condensation. This equipment was developed by Shanghai Pharmaceutical Industry Research Institute in the 1980s. It was successfully tested on penicillin production and was quickly promoted in the national antibiotic industry. At present, there are many domestic manufacturers. Later, a multi-axis rotary dryer, a tilt rotary dryer and the like were introduced. The equipment is equipped with vacuum system, solvent recovery system, cleaning and sterilization system.
Because this equipment is easy to operate, batch production, easy to adjust, online cleaning and online sterilization, it is the preferred dryer for small and medium-sized antibiotic raw material medicine companies, such as penicillin, lincomycin, chlortetracycline, caffeine, etc. Use. When selecting the equipment, the concentricity of the two hollow shafts and the sealing problem of the hollow shaft are mainly considered. In order to ensure the smooth operation of the equipment, the concentricity requires that the shaft end runout amount is less than 0.01 mm. The sealing effect of the hollow shaft is mainly to prevent the lubricant or filler from contaminating the medicine. .
â–²Three-in-one equipment domestic equipment quality needs to be improved
The three-in-one refers to the three processes of filtration, washing and drying combined in the same equipment, which is very representative in the pharmaceutical industry. Three-in-one equipment developed rapidly after the 1990s, and is divided into belt type, tank type, and centrifugal type according to the form of equipment.
The belt type three-in-one has two types of stepping and continuous type, mainly because the filter belt has different advancement modes, and the work flow is completely the same. The material is evenly laid on the filter belt by the feeder, and the filter belt is dragged by the transmission device in the dryer. Move inside. The washing and suction filtration sections are subjected to solvent washing, and the solvent mother liquor is recovered by vacuum cooling; the hot air in the drying section is entered, and the solvent is removed by vacuum distillation. It is used for batch production in large quantities. It is suitable for the drying of granular materials with good gas permeability and uniform drying of Finished Products. It is widely used in vitamin C and penicillin industries in China. Due to the relatively poor airtightness of the device, online cleaning and in-line sterilization cannot be well arranged, so it is only suitable for drying non-sterile bulk drugs and pharmaceutical intermediates. The equipment feeder and the filter belt correcting device play a key role in the normal operation of the equipment, and the supporting facilities such as the heater and the vacuum system also have a great influence on the equipment yield.
Such equipment used in the pharmaceutical industry is mainly imported or imported mainly by self-assembly. Domestically produced such equipment is only used in chemical, food, Chinese medicine and other industries. In recent years, there are also companies in the pharmaceutical industry to copy, but successful in the pharmaceutical industry. Applications are rare.
The tank of the tank type three-in-one equipment is similar to a large suction filter. The bottom plate is a combination of a metal sintered plate filter, a support plate and a heating plate. The can body has a jacket for heating and cooling, and the tank has a stirring motion that can move up and down. The agitator is a hollow structure, and the medium is used for heating and cooling, and plays a major role in the drying stage.
After the material enters the equipment, it is filtered first, then added to the washing medium for a certain period of time, cold pumping or pressurized suction filtration to a certain extent, stirring, chassis, jacket simultaneously into the heating medium, while vacuuming for drying, sampling according to experience After passing the test, the drying is stopped and the discharge is discharged from the discharge port. The equipment's agitated seal and sintered plate are the key, and the supporting equipment includes hydraulic system, vacuum system, heating and cooling unit. Since the equipment is fully enclosed, such as the addition of automatic discharge system, the equipment can be fully CIP and SIP, so it is very suitable for the production of sterile bulk drugs.
In recent years, such equipment has been widely used in the production of penicillin sodium salt and semi-synthetic resistance. In the 21st century, with the acceleration of GMP certification, China's pharmaceutical industry vigorously develops or imitates similar imported equipment, but due to the gap between processing precision and process control, domestic 3-in-1 equipment is mainly used in non-sterile bulk drugs. Production.
Centrifugal three-in-one equipment adds hot air drying function to the vertical filter centrifuge. It has various forms such as filter bags or metal filter plates. The production process is basically the same as the tank type three-in-one. Drying into centrifugal drying can greatly reduce the production time of single batch of materials, but limited by the volume of the centrifuge silo, the production capacity of single batch is limited, which is more suitable for the production of medium and small batches of sterile bulk drugs. Since the equipment can place the silo and the transmission device in the sterile room and the outside, the equipment maintenance does not need to enter the sterile room, and the production and use are convenient. In recent years, domestic raw material medicine industry has joint ventures to introduce such equipment, and domestic imitations have also appeared in recent years.
â–² spray dryer for liquid materials
The drying process of the spray dryer is similar to air drying. After the air is initially filtered, it is heated by the heater, and the generated hot air is filtered through several stages (selected according to the grade of the medicine), and then the vortex channel at the top of the drying chamber is uniformly swirled by the hot air distributor to enter the drying chamber. The material is filtered through a centrifugal atomizing disk or a pressure nozzle to produce a dispersed, fine mist. The mist is in contact with the swirling hot air, and the moisture evaporates rapidly, and the material is dried in a very short period of time.
This equipment is suitable for drying liquid materials with good fluidity such as solution, emulsion, suspension, paste, etc. Now the drying of streptomycin, gentamicin and various biological extracts in the raw material medicine industry can be used. This device. }
â–²Boiled bed to achieve CIP and SIP
During the drying process, the medicine is added from the body of the bed, the hot air is blown from the bottom, and the porous distribution plate is contacted with the material of a certain thickness of the layer, and the material is fluidized and boiled, and is turned up and down in the airflow and mixed with each other. Compared with collision and gas-solid contact area, it carries out intense heat and mass transfer, which greatly improves drying speed and drying efficiency. It is an ideal drying equipment. Some wet materials can be dried at one time to achieve the required moisture index. The fluidized boiling state is highly efficient. The residence time can be adjusted to make it easy to get a low moisture finished product. The sized particles can be classified on the bed surface, the coarse particles can be discharged from the bed, and the fine powder is discharged from the dust collector. Some materials, bag dust removal can be done in the host (built-in), saving floor space, simple structure, and low investment.
This equipment is suitable for the drying of powder, granules and silk, strip materials, equipment is fully enclosed, CIP and SIP can be used, and it is widely used in the production of antibiotics and semi-synthetic antibiotics in the pharmaceutical industry.
â–²The fluidized bed has high thermal efficiency and no dead angle
The fluidized bed is divided into a common fluidized bed and a vibrating fluidized bed. The drying of the drug is mostly affected by the fluidity, and the vibrating fluidized bed is mostly used. The dryer generates vibration force by the vibration motor to make the machine vibrate. The material jumps forward under the excitation force in a given direction, and the hot air enters the bottom of the bed to make the material in a fluidized state, and the material particles are in full contact with the hot air, and the material is transmitted violently. The heat mass transfer process, at which time the thermal efficiency is high. The upper chamber is in a state of micro-negative pressure, the humid air is taken out by the induced draft fan, and the dry material is discharged from the discharge port to achieve the desired drying effect.
The device has uniform fluidization, no dead angle, uniform temperature distribution and high thermal efficiency. It is suitable for the drying of granules, powders, strips and silk stalks, such as starch, glucose and many medicinal intermediates produced in large quantities.
â–² freeze dryer to increase the mixer to ensure uniformity
Vacuum freeze dryer is suitable for the drying of heat-sensitive or easily oxidizable drugs. It is commonly known as freeze-drying machine, mainly including freeze-drying box, vacuum system, heating system, refrigeration system and so on. According to the shelf area, it can be divided into small experimental freeze dryer, medium production freeze dryer, and large industrial freeze dryer. The drying of the drug substance and the preparation drug is a lot of lyophilizers. It is mainly required to have high reliability and complete sterilization function. The temperature difference between the same shelf and the layer is not more than 1.5 °C, which requires the flatness of the shelf to be better.
When using this equipment to dry the drug substance, in order to ensure the uniformity of the product, zui is good to increase the mixer. Ampicillin, a large number of blood products, artificial culture drugs, antibodies, vaccines, etc. are mostly used in freeze dryers.
â–² vacuum drying oven for small and medium trial production
The vacuum drying oven is an older drying device, and the heating plate in the box is divided into several layers. Hot water or low-pressure steam is used as a heating medium in the heating plate, and the tray on which the medicine to be dried is placed is placed on the heating plate, the box is closed, and the vacuum is pumped in the box. The heating plate heats the drug to a specified temperature in the circulating flow of the heating medium, and the moisture begins to evaporate and is gradually withdrawn by vacuuming.
The device is easy to control, can condense and recover the evaporated solvent, and the drug is not easily contaminated during the drying process, and can be used for drying the drug, packaging sterilization and heat treatment. In the 1980s, the bulk pharmaceutical industry used this equipment as the main dryer, but because it is not easy to clean the tray (CIP) and online sterilization (SIP), the drying speed is slow, the labor intensity of the workers is large, and the medicine is realized. Uniformity, after mixing, it must be mixed by mixing equipment. Nowadays, it has been rarely used in large-scale production of raw materials, and it is mostly used for medium or small trial production or heat treatment of packaging materials.
â–² vacuum rotary dryer must consider hollow shaft sealing effect
The vacuum rotary dryer is derived from a double cone mixer, which is mostly a cylindrical body and a two-headed cone. It is also commonly known as a double cone dryer. There are two hollow suspension shafts in the middle of the cone for the equipment to rotate the support and the passage of vacuum and hot water. The medicine rotates while drying in the dryer, which guarantees the uniformity of the whole batch of drugs. The heat medium enters the jacket from the hollow tube at one end, and the hot gas in the device is discharged along the exhaust pipe in the hollow tube at the other end, and the volatile solvent is recovered by condensation. This equipment was developed by Shanghai Pharmaceutical Industry Research Institute in the 1980s. It was successfully tested on penicillin production and was quickly promoted in the national antibiotic industry. At present, there are many domestic manufacturers. Later, a multi-axis rotary dryer, a tilt rotary dryer and the like were introduced. The equipment is equipped with vacuum system, solvent recovery system, cleaning and sterilization system.
Because this equipment is easy to operate, batch production, easy to adjust, online cleaning and online sterilization, it is the preferred dryer for small and medium-sized antibiotic raw material medicine companies, such as penicillin, lincomycin, chlortetracycline, caffeine, etc. Use. When selecting the equipment, the concentricity of the two hollow shafts and the sealing problem of the hollow shaft are mainly considered. In order to ensure the smooth operation of the equipment, the concentricity requires that the shaft end runout amount is less than 0.01 mm. The sealing effect of the hollow shaft is mainly to prevent the lubricant or filler from contaminating the medicine. .
â–²Three-in-one equipment domestic equipment quality needs to be improved
The three-in-one refers to the three processes of filtration, washing and drying combined in the same equipment, which is very representative in the pharmaceutical industry. Three-in-one equipment developed rapidly after the 1990s, and is divided into belt type, tank type, and centrifugal type according to the form of equipment.
The belt type three-in-one has two types of stepping and continuous type, mainly because the filter belt has different advancement modes, and the work flow is completely the same. The material is evenly laid on the filter belt by the feeder, and the filter belt is dragged by the transmission device in the dryer. Move inside. The washing and suction filtration sections are subjected to solvent washing, and the solvent mother liquor is recovered by vacuum cooling; the hot air in the drying section is entered, and the solvent is removed by vacuum distillation. It is used for batch production in large quantities. It is suitable for the drying of granular materials with good gas permeability and uniform drying of Finished Products. It is widely used in vitamin C and penicillin industries in China. Due to the relatively poor airtightness of the device, online cleaning and in-line sterilization cannot be well arranged, so it is only suitable for drying non-sterile bulk drugs and pharmaceutical intermediates. The equipment feeder and the filter belt correcting device play a key role in the normal operation of the equipment, and the supporting facilities such as the heater and the vacuum system also have a great influence on the equipment yield.
Such equipment used in the pharmaceutical industry is mainly imported or imported mainly by self-assembly. Domestically produced such equipment is only used in chemical, food, Chinese medicine and other industries. In recent years, there are also companies in the pharmaceutical industry to copy, but successful in the pharmaceutical industry. Applications are rare.
The tank of the tank type three-in-one equipment is similar to a large suction filter. The bottom plate is a combination of a metal sintered plate filter, a support plate and a heating plate. The can body has a jacket for heating and cooling, and the tank has a stirring motion that can move up and down. The agitator is a hollow structure, and the medium is used for heating and cooling, and plays a major role in the drying stage.
After the material enters the equipment, it is filtered first, then added to the washing medium for a certain period of time, cold pumping or pressurized suction filtration to a certain extent, stirring, chassis, jacket simultaneously into the heating medium, while vacuuming for drying, sampling according to experience After passing the test, the drying is stopped and the discharge is discharged from the discharge port. The equipment's agitated seal and sintered plate are the key, and the supporting equipment includes hydraulic system, vacuum system, heating and cooling unit. Since the equipment is fully enclosed, such as the addition of automatic discharge system, the equipment can be fully CIP and SIP, so it is very suitable for the production of sterile bulk drugs.
In recent years, such equipment has been widely used in the production of penicillin sodium salt and semi-synthetic resistance. In the 21st century, with the acceleration of GMP certification, China's pharmaceutical industry vigorously develops or imitates similar imported equipment, but due to the gap between processing precision and process control, domestic 3-in-1 equipment is mainly used in non-sterile bulk drugs. Production.
Centrifugal three-in-one equipment adds hot air drying function to the vertical filter centrifuge. It has various forms such as filter bags or metal filter plates. The production process is basically the same as the tank type three-in-one. Drying into centrifugal drying can greatly reduce the production time of single batch of materials, but limited by the volume of the centrifuge silo, the production capacity of single batch is limited, which is more suitable for the production of medium and small batches of sterile bulk drugs. Since the equipment can place the silo and the transmission device in the sterile room and the outside, the equipment maintenance does not need to enter the sterile room, and the production and use are convenient. In recent years, domestic raw material medicine industry has joint ventures to introduce such equipment, and domestic imitations have also appeared in recent years.
â–² spray dryer for liquid materials
The drying process of the spray dryer is similar to air drying. After the air is initially filtered, it is heated by the heater, and the generated hot air is filtered through several stages (selected according to the grade of the medicine), and then the vortex channel at the top of the drying chamber is uniformly swirled by the hot air distributor to enter the drying chamber. The material is filtered through a centrifugal atomizing disk or a pressure nozzle to produce a dispersed, fine mist. The mist is in contact with the swirling hot air, and the moisture evaporates rapidly, and the material is dried in a very short period of time.
This equipment is suitable for drying liquid materials with good fluidity such as solution, emulsion, suspension, paste, etc. Now the drying of streptomycin, gentamicin and various biological extracts in the raw material medicine industry can be used. This device. }
â–²Boiled bed to achieve CIP and SIP
During the drying process, the medicine is added from the body of the bed, the hot air is blown from the bottom, and the porous distribution plate is contacted with the material of a certain thickness of the layer, and the material is fluidized and boiled, and is turned up and down in the airflow and mixed with each other. Compared with collision and gas-solid contact area, it carries out intense heat and mass transfer, which greatly improves drying speed and drying efficiency. It is an ideal drying equipment. Some wet materials can be dried at one time to achieve the required moisture index. The fluidized boiling state is highly efficient. The residence time can be adjusted to make it easy to get a low moisture finished product. The sized particles can be classified on the bed surface, the coarse particles can be discharged from the bed, and the fine powder is discharged from the dust collector. Some materials, bag dust removal can be done in the host (built-in), saving floor space, simple structure, and low investment.
This equipment is suitable for the drying of powder, granules and silk, strip materials, equipment is fully enclosed, CIP and SIP can be used, and it is widely used in the production of antibiotics and semi-synthetic antibiotics in the pharmaceutical industry.
â–²The fluidized bed has high thermal efficiency and no dead angle
The fluidized bed is divided into a common fluidized bed and a vibrating fluidized bed. The drying of the drug is mostly affected by the fluidity, and the vibrating fluidized bed is mostly used. The dryer generates vibration force by the vibration motor to make the machine vibrate. The material jumps forward under the excitation force in a given direction, and the hot air enters the bottom of the bed to make the material in a fluidized state, and the material particles are in full contact with the hot air, and the material is transmitted violently. The heat mass transfer process, at which time the thermal efficiency is high. The upper chamber is in a state of micro-negative pressure, the humid air is taken out by the induced draft fan, and the dry material is discharged from the discharge port to achieve the desired drying effect.
The device has uniform fluidization, no dead angle, uniform temperature distribution and high thermal efficiency. It is suitable for the drying of granules, powders, strips and silk stalks, such as starch, glucose and many medicinal intermediates produced in large quantities.
â–² freeze dryer to increase the mixer to ensure uniformity
Vacuum freeze dryer is suitable for the drying of heat-sensitive or easily oxidizable drugs. It is commonly known as freeze-drying machine, mainly including freeze-drying box, vacuum system, heating system, refrigeration system and so on. According to the shelf area, it can be divided into small experimental freeze dryer, medium production freeze dryer, and large industrial freeze dryer. The drying of the drug substance and the preparation drug is a lot of lyophilizers. It is mainly required to have high reliability and complete sterilization function. The temperature difference between the same shelf and the layer is not more than 1.5 °C, which requires the flatness of the shelf to be better.
When using this equipment to dry the drug substance, in order to ensure the uniformity of the product, zui is good to increase the mixer. Ampicillin, a large number of blood products, artificial culture drugs, antibodies, vaccines, etc. are mostly used in freeze dryers.
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