How to choose drug drier China's APIs and pharmaceutical intermediates (hereinafter referred to as APIs) occupy an important position in the international market at a low price. China's accession to the WTO not only brings opportunities for the pharmaceutical industry, but also brings to the pharmaceutical industry. New challenges. For various purposes, the importing countries of raw material drugs have made higher demands on the production process and social responsibilities of pharmaceutical companies in China in the past two years. Therefore, various certifications are rapidly launched in the pharmaceutical industry, and at the same time, the quality of pharmaceutical production in China. Management Practices (GMP) certification is also accelerating the process. The focus of these certifications is on concentrates, stems, and packages for APIs, and the proper selection of dryers is particularly important. The drying device must comply with GMP requirements to ensure that the drug production process is reasonable, the product is uniform, there is no accumulation of material, and the cleaning inplace (CIP) requirements can be met. The drying device for the sterile bulk drug must also meet the on-line sterilization ( SterilizinginPlace, SIP) requirements. At present, there are many kinds of raw material drug dryers in China, roughly including vacuum drying ovens, vacuum rotary dryers, three-in-one, air dryers, spray dryers, fluidized beds, fluidized beds, and freeze dryers. The following is a brief discussion of their respective characteristics and applicable conditions.
1. Vacuum drying oven The vacuum drying oven is an older drying device. The heated plate in the oven is divided into several layers. The hot plate or the low-pressure steam is used as a heating medium in the heating plate. The tray plated with the medicine to be dried is placed on the heating plate, the door is closed, and the inside of the box is vacuumized by a vacuum pump. The heating plate heats the medicine to a specified temperature in the circulating flow of the heating medium, and the water starts to evaporate and gradually withdraws with vacuum. This equipment is easy to control, can condense and recover the evaporated solvent, and the drug can not be contaminated during the drying process. It can be used for drying medicines, sterilization of packaging materials and heat treatment. In the 1980s, the bulk drug industry used this equipment as the main dryer. However, because it was not easy to perform on-line cleaning and on-line sterilization of the tray, the drying speed was slow and the labor intensity of the workers was large. In order to achieve the homogeneity of the drug, after drying, Mixing by powder mixing device, the raw material drug has been rarely used in large-scale production, and is mostly used for medium and small pilot production or heat treatment of packaging materials.
2. Vacuum Rotary Dryer The vacuum rotary dryer comes from a double cone mixer, mostly cylindrical body, two-cone, also known as double cone dryer. There are two hollow suspension shafts in the middle of the cone, which are used to support the rotation of the equipment and the passage of vacuum and hot water. The medicines rotate while drying in the desiccator, which ensures good uniformity of the whole batch of medicine. The heat medium enters the jacket from a hollow tube at one end, and the hot gas in the apparatus is exhausted with the exhaust pipe in the hollow tube at the other end, and the volatilized solvent is recovered through condensation. This equipment was developed by the Shanghai Pharmaceutical Industry Research Institute in the 1980s [1]. The trial of penicillin production in our company was successful, and it was quickly promoted in the national antibiotic industry. There are many domestic manufacturers. Later, the uniaxial rotary dryer multi-dimensional rotary dryer, inclined rotary dryer and similar products appeared. This equipment is equipped with a vacuum system, solvent recovery system, cleaning and sterilization systems. Because this equipment is easy to operate, batch production is easy to adjust, online cleaning and on-line sterilization are possible. Therefore, it is the preferred dryer for small and medium-sized antibiotics pharmaceutical companies, such as penicillin, lincomycin, and chlortetracycline. When selecting the equipment, the concentricity of the two hollow shafts and the sealing of the hollow shaft are mainly considered. In order to ensure a stable operation of the equipment, the concentricity requires the axial runout to be less than 0.01 mm. The sealing effect of the hollow shaft is mainly to prevent the lubricant or filler from contaminating the medicine. .
3. Three-in-one equipment Three-in-one means that the three processes of filtration, washing and drying are combined in the same equipment. It is very representative in the pharmaceutical industry. Such equipment has developed rapidly since the 1990s. For belt, tank, centrifugal and other types.
Belt type three-in-one has two kinds of step type and continuous type. The main method is that the filter belt has different advancement methods. The work flow is exactly the same and the material is evenly spread on the filter belt by the feeder. The filter belt is dragged by the transmission device in the dryer. Move inside. In the washing and filtering section, the solvent is washed, and the solvent mother liquor is vacuum-cooled to recover the solvent; the hot air in the drying section enters, and the vacuum is removed and condensed to recover the solvent. For mass production batch production, suitable for drying of particles with good air permeability, and the finished product is evenly dried. It is widely used in the vitamin C and penicillin industries in China. Due to the relatively poor tightness of this equipment, online cleaning and online sterilization cannot be well arranged, so it is only suitable for the drying of non-sterile APIs and pharmaceutical intermediates. This device feeder and filter belt correction device play a key role in the normal operation of the equipment. In addition, supporting facilities such as heaters and vacuum systems also have a great influence on the equipment yield. Such equipment used in the pharmaceutical industry is mainly imported or self-assembled with imported major components. Domestically produced equipment of this type is used only in chemical and food medicine and other industries. In recent years, companies in the pharmaceutical industry also have imitations, but have succeeded in the pharmaceutical industry. Applications are rare. Three-in-one can, the tank is similar to a large suction filter, the chassis is a combination of metal sintered plate filter, support plate and heating plate, the can body has a jacket for heating and cooling, the tank has a stirrer that can move up and down The stirrer is a hollow structure that is passed through a medium for heating and cooling and plays a major role in the drying stage. After the material enters the equipment, it shall be filtered by suction, then added to the washing medium for a certain period of time, cold or pressure filtered to a certain extent, the stirring, the chassis, and the jacket shall be passed into the heating medium at the same time, and vacuum shall be used for drying. According to experience and sampling Stop drying after passing and discharge from the discharge port. Stirring and sintering plates for this equipment are the most critical. The supporting equipment includes hydraulic systems, vacuum systems, heating and cooling units. Because this equipment is completely enclosed, if additional automatic discharge system is provided, the equipment can be fully cleaned online (CIP) and online sterilized (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 hemizygous antibiotics. In the 21st century, with the accelerating pace of GMP certification, China's pharmaceutical machinery industry has vigorously developed or copied similar imported equipment. However, because of the gap in processing accuracy and process control, domestically produced three-in-one equipment is mainly used in the production of non-sterile APIs. on.
Centrifugal three-in-one, on the basis of the vertical filter centrifuge to increase the function of hot air drying, filter bags or metal filter plate and other forms, the production process and the tank three-in-one is basically the same, but the pumping Changing to centrifugal drying can greatly reduce the production time of a single batch of materials, but due to the limitation of the volume of the centrifuge bin, the single batch production capacity is limited, and it is more suitable for the production and use of sterile bulk pharmaceuticals in medium and small batches. Because this equipment can put the bin and transmission device separately in the sterile room and outside, the equipment maintenance does not need to enter the sterile room, and the production and use are very convenient. In recent years, there have been joint ventures in the domestic raw material medicine industry to introduce such equipment. Domestically, imitation products have also been introduced in recent years. 4. Air drying device The air flow dryer is suitable for particles and powdery materials that are easy to dehydrate, and can quickly remove material moisture (mainly surface moisture). In air drying, the quality of the dried product is best controlled due to the short residence time of the material in the dryer. The wet material is thoroughly mixed with the hot air stream through the feeder, and dried under the suction of the wind into the drying tube for further uniform drying. The wet weight particles that cannot be attracted by the wind continue to be impacted, broken, and dried in the dryer until they can be sucked into the drying tube by the wind. The end of the drying tube is a cyclone separator. This equipment is mainly used for the production of oxytetracycline and some health products in the pharmaceutical industry.
5. The spray dryer spray drying process is similar to air drying. After the air is initially filtered, it is heated by a heater, and the resulting hot air is filtered through several stages (selected according to the grade of the drug). Then, a uniform rotating air stream is generated in the volute passage at the top of the drying chamber to enter the drying chamber by the hot air distributor. The material is filtered through centrifugal atomizer discs or pressure nozzles to produce a dispersed, fine material mist. The material mist is in contact with the swirling hot air and the moisture rapidly evaporates. The material is dried in a very short time. This equipment is suitable for the drying of liquid materials with good fluidity such as solution, emulsion, suspension, paste and so on.
6. Fluidized bed fluidized bed In the process of drying, drugs are added from the upper part of the bed, hot air is blown in from the bottom, and the porous distribution plate is in contact with the material of a certain material thickness. The material is fluidized and boils, and flows up and down in the airflow. Turning, mixing and colliding with each other, large contact area between gas and solid, intense heat and mass transfer, greatly improving the drying speed and drying efficiency, is an ideal drying equipment. For some of the more humid materials can be dried once to achieve the required moisture index. Fluidized boiling thermal efficiency. Residence time can be adjusted to easily obtain a low moisture product. Size particles can be graded on the bed surface, coarse particles can be discharged from the bed, and fine powder discharged from the dust collector. Some materials, bag dusting can be done in the host (built-in type), saving floor space, simple structure, and low investment. This equipment is suitable for the drying of powder, granules, and silk and strip materials. The equipment is fully enclosed and can be cleaned and sterilized online. It is widely used in the pharmaceutical industry for the production of antibiotics and semi-conformants.
7. Fluidized bed The fluidized bed is divided into ordinary fluidized bed and vibrated fluidized bed. The drying of the drug is affected by fluidity. Most of the fluidized bed is selected. The dryer is excited by the vibration motor to make the machine vibrate. The material leaps forward under the exciting force in a given direction. At the same time, the hot air at the bottom of the bed makes the material in a fluidized state, and the material particles are in full contact with the hot air to make a violent transmission. Heat mass transfer process, the highest thermal efficiency at this time. The upper chamber is in a state of slight negative pressure, the humid air is led by the induced draft fan, and the dry material is discharged from the discharge outlet, so as to achieve an ideal drying effect. The equipment is fluidized evenly, with no dead angle, even temperature distribution, and high thermal efficiency. It is suitable for the drying of granules, powders, bars and filaments, and can be used for pharmaceutical intermediates such as starch, glucose and many high-volume production.
8, freeze dryer vacuum freeze dryer is suitable for drying heat-sensitive or easily oxidized drugs, commonly known as lyophilizers, mainly including freeze-dried boxes, vacuum systems, heating systems, refrigeration systems. According to the shelf area can be divided into small experimental freeze dryer, medium production freeze dryer, large industrial production freeze dryer. Drying of APIs and preparations There are many applications of freeze dryers. The main requirements are its high reliability and complete sterilization function. The temperature difference between the same shelf and the slab is not more than 1.5°C[2], which means that the flatness of the shelf must be better. When using this equipment to dry raw materials, in order to ensure the homogeneity of the product, it is best to add a powder mixer. Ampicillin, a large number of blood products, artificial culture drugs, antibodies, vaccines, etc. are mostly used freeze dryer.
In the past 20 years, with the process of reform and opening up, the pharmaceutical industry has witnessed rapid development. At the same time, the pharmaceutical machine industry has also shown a flourishing situation. The author has had the privilege of having experience in the above drying equipments due to work reasons. Due to the limited knowledge, there are many good things. The dryers are not described, such as tray dryers, spouted bed dryers, flash dryers, microwave series dryers, and the like. When the dryer is selected, it must be determined according to the characteristics of the drug and the desired state of the finished product. In particular, the material and sterility of the aseptic material drying equipment must be considered. China's pharmaceutical drying equipment has developed rapidly, and there are many professional drying equipment factories. Its products are both versatile and have their own characteristics. This is the localization and selection of imported equipment used for drying raw material medicines in line with the "Quality Control Practice for Pharmaceutical Production". The ideal dryer (GMP) provides the conditions.
1. Vacuum drying oven The vacuum drying oven is an older drying device. The heated plate in the oven is divided into several layers. The hot plate or the low-pressure steam is used as a heating medium in the heating plate. The tray plated with the medicine to be dried is placed on the heating plate, the door is closed, and the inside of the box is vacuumized by a vacuum pump. The heating plate heats the medicine to a specified temperature in the circulating flow of the heating medium, and the water starts to evaporate and gradually withdraws with vacuum. This equipment is easy to control, can condense and recover the evaporated solvent, and the drug can not be contaminated during the drying process. It can be used for drying medicines, sterilization of packaging materials and heat treatment. In the 1980s, the bulk drug industry used this equipment as the main dryer. However, because it was not easy to perform on-line cleaning and on-line sterilization of the tray, the drying speed was slow and the labor intensity of the workers was large. In order to achieve the homogeneity of the drug, after drying, Mixing by powder mixing device, the raw material drug has been rarely used in large-scale production, and is mostly used for medium and small pilot production or heat treatment of packaging materials.
2. Vacuum Rotary Dryer The vacuum rotary dryer comes from a double cone mixer, mostly cylindrical body, two-cone, also known as double cone dryer. There are two hollow suspension shafts in the middle of the cone, which are used to support the rotation of the equipment and the passage of vacuum and hot water. The medicines rotate while drying in the desiccator, which ensures good uniformity of the whole batch of medicine. The heat medium enters the jacket from a hollow tube at one end, and the hot gas in the apparatus is exhausted with the exhaust pipe in the hollow tube at the other end, and the volatilized solvent is recovered through condensation. This equipment was developed by the Shanghai Pharmaceutical Industry Research Institute in the 1980s [1]. The trial of penicillin production in our company was successful, and it was quickly promoted in the national antibiotic industry. There are many domestic manufacturers. Later, the uniaxial rotary dryer multi-dimensional rotary dryer, inclined rotary dryer and similar products appeared. This equipment is equipped with a vacuum system, solvent recovery system, cleaning and sterilization systems. Because this equipment is easy to operate, batch production is easy to adjust, online cleaning and on-line sterilization are possible. Therefore, it is the preferred dryer for small and medium-sized antibiotics pharmaceutical companies, such as penicillin, lincomycin, and chlortetracycline. When selecting the equipment, the concentricity of the two hollow shafts and the sealing of the hollow shaft are mainly considered. In order to ensure a stable operation of the equipment, the concentricity requires the axial runout to be less than 0.01 mm. The sealing effect of the hollow shaft is mainly to prevent the lubricant or filler from contaminating the medicine. .
3. Three-in-one equipment Three-in-one means that the three processes of filtration, washing and drying are combined in the same equipment. It is very representative in the pharmaceutical industry. Such equipment has developed rapidly since the 1990s. For belt, tank, centrifugal and other types.
Belt type three-in-one has two kinds of step type and continuous type. The main method is that the filter belt has different advancement methods. The work flow is exactly the same and the material is evenly spread on the filter belt by the feeder. The filter belt is dragged by the transmission device in the dryer. Move inside. In the washing and filtering section, the solvent is washed, and the solvent mother liquor is vacuum-cooled to recover the solvent; the hot air in the drying section enters, and the vacuum is removed and condensed to recover the solvent. For mass production batch production, suitable for drying of particles with good air permeability, and the finished product is evenly dried. It is widely used in the vitamin C and penicillin industries in China. Due to the relatively poor tightness of this equipment, online cleaning and online sterilization cannot be well arranged, so it is only suitable for the drying of non-sterile APIs and pharmaceutical intermediates. This device feeder and filter belt correction device play a key role in the normal operation of the equipment. In addition, supporting facilities such as heaters and vacuum systems also have a great influence on the equipment yield. Such equipment used in the pharmaceutical industry is mainly imported or self-assembled with imported major components. Domestically produced equipment of this type is used only in chemical and food medicine and other industries. In recent years, companies in the pharmaceutical industry also have imitations, but have succeeded in the pharmaceutical industry. Applications are rare. Three-in-one can, the tank is similar to a large suction filter, the chassis is a combination of metal sintered plate filter, support plate and heating plate, the can body has a jacket for heating and cooling, the tank has a stirrer that can move up and down The stirrer is a hollow structure that is passed through a medium for heating and cooling and plays a major role in the drying stage. After the material enters the equipment, it shall be filtered by suction, then added to the washing medium for a certain period of time, cold or pressure filtered to a certain extent, the stirring, the chassis, and the jacket shall be passed into the heating medium at the same time, and vacuum shall be used for drying. According to experience and sampling Stop drying after passing and discharge from the discharge port. Stirring and sintering plates for this equipment are the most critical. The supporting equipment includes hydraulic systems, vacuum systems, heating and cooling units. Because this equipment is completely enclosed, if additional automatic discharge system is provided, the equipment can be fully cleaned online (CIP) and online sterilized (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 hemizygous antibiotics. In the 21st century, with the accelerating pace of GMP certification, China's pharmaceutical machinery industry has vigorously developed or copied similar imported equipment. However, because of the gap in processing accuracy and process control, domestically produced three-in-one equipment is mainly used in the production of non-sterile APIs. on.
Centrifugal three-in-one, on the basis of the vertical filter centrifuge to increase the function of hot air drying, filter bags or metal filter plate and other forms, the production process and the tank three-in-one is basically the same, but the pumping Changing to centrifugal drying can greatly reduce the production time of a single batch of materials, but due to the limitation of the volume of the centrifuge bin, the single batch production capacity is limited, and it is more suitable for the production and use of sterile bulk pharmaceuticals in medium and small batches. Because this equipment can put the bin and transmission device separately in the sterile room and outside, the equipment maintenance does not need to enter the sterile room, and the production and use are very convenient. In recent years, there have been joint ventures in the domestic raw material medicine industry to introduce such equipment. Domestically, imitation products have also been introduced in recent years. 4. Air drying device The air flow dryer is suitable for particles and powdery materials that are easy to dehydrate, and can quickly remove material moisture (mainly surface moisture). In air drying, the quality of the dried product is best controlled due to the short residence time of the material in the dryer. The wet material is thoroughly mixed with the hot air stream through the feeder, and dried under the suction of the wind into the drying tube for further uniform drying. The wet weight particles that cannot be attracted by the wind continue to be impacted, broken, and dried in the dryer until they can be sucked into the drying tube by the wind. The end of the drying tube is a cyclone separator. This equipment is mainly used for the production of oxytetracycline and some health products in the pharmaceutical industry.
5. The spray dryer spray drying process is similar to air drying. After the air is initially filtered, it is heated by a heater, and the resulting hot air is filtered through several stages (selected according to the grade of the drug). Then, a uniform rotating air stream is generated in the volute passage at the top of the drying chamber to enter the drying chamber by the hot air distributor. The material is filtered through centrifugal atomizer discs or pressure nozzles to produce a dispersed, fine material mist. The material mist is in contact with the swirling hot air and the moisture rapidly evaporates. The material is dried in a very short time. This equipment is suitable for the drying of liquid materials with good fluidity such as solution, emulsion, suspension, paste and so on.
6. Fluidized bed fluidized bed In the process of drying, drugs are added from the upper part of the bed, hot air is blown in from the bottom, and the porous distribution plate is in contact with the material of a certain material thickness. The material is fluidized and boils, and flows up and down in the airflow. Turning, mixing and colliding with each other, large contact area between gas and solid, intense heat and mass transfer, greatly improving the drying speed and drying efficiency, is an ideal drying equipment. For some of the more humid materials can be dried once to achieve the required moisture index. Fluidized boiling thermal efficiency. Residence time can be adjusted to easily obtain a low moisture product. Size particles can be graded on the bed surface, coarse particles can be discharged from the bed, and fine powder discharged from the dust collector. Some materials, bag dusting can be done in the host (built-in type), saving floor space, simple structure, and low investment. This equipment is suitable for the drying of powder, granules, and silk and strip materials. The equipment is fully enclosed and can be cleaned and sterilized online. It is widely used in the pharmaceutical industry for the production of antibiotics and semi-conformants.
7. Fluidized bed The fluidized bed is divided into ordinary fluidized bed and vibrated fluidized bed. The drying of the drug is affected by fluidity. Most of the fluidized bed is selected. The dryer is excited by the vibration motor to make the machine vibrate. The material leaps forward under the exciting force in a given direction. At the same time, the hot air at the bottom of the bed makes the material in a fluidized state, and the material particles are in full contact with the hot air to make a violent transmission. Heat mass transfer process, the highest thermal efficiency at this time. The upper chamber is in a state of slight negative pressure, the humid air is led by the induced draft fan, and the dry material is discharged from the discharge outlet, so as to achieve an ideal drying effect. The equipment is fluidized evenly, with no dead angle, even temperature distribution, and high thermal efficiency. It is suitable for the drying of granules, powders, bars and filaments, and can be used for pharmaceutical intermediates such as starch, glucose and many high-volume production.
8, freeze dryer vacuum freeze dryer is suitable for drying heat-sensitive or easily oxidized drugs, commonly known as lyophilizers, mainly including freeze-dried boxes, vacuum systems, heating systems, refrigeration systems. According to the shelf area can be divided into small experimental freeze dryer, medium production freeze dryer, large industrial production freeze dryer. Drying of APIs and preparations There are many applications of freeze dryers. The main requirements are its high reliability and complete sterilization function. The temperature difference between the same shelf and the slab is not more than 1.5°C[2], which means that the flatness of the shelf must be better. When using this equipment to dry raw materials, in order to ensure the homogeneity of the product, it is best to add a powder mixer. Ampicillin, a large number of blood products, artificial culture drugs, antibodies, vaccines, etc. are mostly used freeze dryer.
In the past 20 years, with the process of reform and opening up, the pharmaceutical industry has witnessed rapid development. At the same time, the pharmaceutical machine industry has also shown a flourishing situation. The author has had the privilege of having experience in the above drying equipments due to work reasons. Due to the limited knowledge, there are many good things. The dryers are not described, such as tray dryers, spouted bed dryers, flash dryers, microwave series dryers, and the like. When the dryer is selected, it must be determined according to the characteristics of the drug and the desired state of the finished product. In particular, the material and sterility of the aseptic material drying equipment must be considered. China's pharmaceutical drying equipment has developed rapidly, and there are many professional drying equipment factories. Its products are both versatile and have their own characteristics. This is the localization and selection of imported equipment used for drying raw material medicines in line with the "Quality Control Practice for Pharmaceutical Production". The ideal dryer (GMP) provides the conditions.
Product Description
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