Spray Dryer
Analysis of Development Prospect of Special Spray Dryer for
Time：2018.03.19
In the past two years, raw material drug importing countries have put forward higher requirements for the production process and social responsibilities of pharmaceutical companies in China. Therefore, various certifications are rapidly launched in the pharmaceutical industry, and at the same time, China's "Good Manufacturing Practice" (GMP) certification are also in the works to speed up the process.
The focus of these certifications is to concentrate on the essence, 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 material accumulation, and the cleaning inplace (CIP) requirements can be met. The drying device for the sterile bulk drug must also meet the requirements of sterilizinginplace,(SIP). At present, there are many kinds of raw material drug dryers in China, roughly including vacuum drying ovens, vacuum rotary dryers, three-in-ones, air dryers, spray dryers, ebullated beds, fluidized beds, and freeze dryers, etc. 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 plates in the oven are divided into several layers. The heating plate is filled with hot water or low pressure steam as the heating medium. 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 vacuumed 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 raw material medicine industry used this equipment as the main dryer. However, due to the difficulty in 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 medicine, it was necessary to dry it. Mixing by powder mixing device, the raw material drug has been rarely used in large-scale production, and it is mostly used for medium and small pilot production or heat treatment of packaging materials.
2. vacuum rotary dryer
Vacuum rotary dryers are derived from double cone mixers, which is mostly cylindrical body, two cones, also known as double cone dryers. 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 and successfully tested on the penicillin production of our company. It was quickly promoted in the national antibiotics industry. Currently, there are many domestic manufacturers.
Later, a single - shaft rotary drier, multi - dimensional rotary dryer, inclined rotary drier and other similar products.The equipment is equipped with vacuum system, solvent recovery system, cleaning and sterilization system, etc. Because this equipment is easy to operate, batch production is easy to adjust, online cleaning and on-line sterilization are possible. Therefore, it has become the preferred desiccator for small and medium-sized antibiotics pharmaceutical companies, such as penicillin, lincomycin, chlortetracycline, and caffeine, etc. 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, which is very representative in the pharmaceutical industry. Such equipment has developed rapidly since the 1990s and is divided into equipment types such as belt, tank, centrifugal and other types. Belt type three-in-one has two kinds like step by step type and continuous type. The main reason is that the driving type of the filter belt is different. The same work flow is evenly spread on the filter belt by the feeder, and the filter belt is dragged by the transmission device in the dryer, and 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. It is used for large production batch production, which is suitable for the drying of granular materials with good air permeability. The finished products are evenly dried, and it is widely used in the industry of 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. Such domestically produced equipment is used only in chemical and food medicine and other industries. In recent years, companies in the medicine machine industry have also been imitations, but have succeeded in the pharmaceutical industry. Applications are rare.
Three-in-one tank, 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 tank 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 qualified, then stop drying and discharge from the outlet. Stirring and sintering plates for this equipment are the most critical, and supporting equipment includes hydraulic systems, vacuum systems, heating and cooling units, etc. 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.
The focus of these certifications is to concentrate on the essence, 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 material accumulation, and the cleaning inplace (CIP) requirements can be met. The drying device for the sterile bulk drug must also meet the requirements of sterilizinginplace,(SIP). At present, there are many kinds of raw material drug dryers in China, roughly including vacuum drying ovens, vacuum rotary dryers, three-in-ones, air dryers, spray dryers, ebullated beds, fluidized beds, and freeze dryers, etc. 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 plates in the oven are divided into several layers. The heating plate is filled with hot water or low pressure steam as the heating medium. 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 vacuumed 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 raw material medicine industry used this equipment as the main dryer. However, due to the difficulty in 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 medicine, it was necessary to dry it. Mixing by powder mixing device, the raw material drug has been rarely used in large-scale production, and it is mostly used for medium and small pilot production or heat treatment of packaging materials.
2. vacuum rotary dryer
Vacuum rotary dryers are derived from double cone mixers, which is mostly cylindrical body, two cones, also known as double cone dryers. 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 and successfully tested on the penicillin production of our company. It was quickly promoted in the national antibiotics industry. Currently, there are many domestic manufacturers.
Later, a single - shaft rotary drier, multi - dimensional rotary dryer, inclined rotary drier and other similar products.The equipment is equipped with vacuum system, solvent recovery system, cleaning and sterilization system, etc. Because this equipment is easy to operate, batch production is easy to adjust, online cleaning and on-line sterilization are possible. Therefore, it has become the preferred desiccator for small and medium-sized antibiotics pharmaceutical companies, such as penicillin, lincomycin, chlortetracycline, and caffeine, etc. 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, which is very representative in the pharmaceutical industry. Such equipment has developed rapidly since the 1990s and is divided into equipment types such as belt, tank, centrifugal and other types. Belt type three-in-one has two kinds like step by step type and continuous type. The main reason is that the driving type of the filter belt is different. The same work flow is evenly spread on the filter belt by the feeder, and the filter belt is dragged by the transmission device in the dryer, and 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. It is used for large production batch production, which is suitable for the drying of granular materials with good air permeability. The finished products are evenly dried, and it is widely used in the industry of 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. Such domestically produced equipment is used only in chemical and food medicine and other industries. In recent years, companies in the medicine machine industry have also been imitations, but have succeeded in the pharmaceutical industry. Applications are rare.
Three-in-one tank, 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 tank 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 qualified, then stop drying and discharge from the outlet. Stirring and sintering plates for this equipment are the most critical, and supporting equipment includes hydraulic systems, vacuum systems, heating and cooling units, etc. 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.