Development trend of APIs and application of new technologies
Raw material medicine machinery and equipment is one of the 8 major categories of pharmaceutical equipment in China, including reaction equipment, tower equipment, crystallization equipment, separation equipment, filtration equipment, extraction equipment, distillation equipment, heat exchangers, evaporation equipment, drying equipment, screening Equipment, storage equipment and sterilization equipment. As we all know, China is a big country in the production of bulk drugs, but it is not a strong country in the production of bulk drugs. There are many reasons for this, but one of the most important reasons is that there is a certain gap between the production of APIs and the application of new technologies and the international high-end level. Therefore, in order to improve the quality level of China's API production, in addition to improving the control standards of production enterprises from hardware and software, we should also strengthen the application of new technologies for APIs in accordance with new changes in the global market, and truly integrate with the international market.
1. Application of new technologies 1.1 Research on environmental protection and energy conservation Among the 6066 industrial pollution source key monitoring enterprises announced by the State Environmental Protection Administration in March 2007, pharmaceutical companies accounted for 117, mostly fermentation-based raw material manufacturers, some of which were environmentally friendly. It was discontinued. Therefore, tapping potential to reduce consumption and improve economic efficiency will become an important task for raw material drug manufacturers in the future. The following is a few practical examples to illustrate the development and application of APIs in environmental protection and energy conservation.
1.1.1 Freeze-drying equipment 1.1.1.1 Liquid nitrogen vacuum freeze dryer The refrigeration system of the freeze dryer can provide a cold source for the drying oven and the vacuum condenser. Among them, it is more common to freeze the dryer with a compression mechanism, but the heart component compressor often causes many failures due to various factors and requires frequent maintenance. Today, the new liquid nitrogen vacuum freeze dryer solves this problem, which effectively reduces the probability of failure of the refrigeration system.
The liquid nitrogen lyophilizer is a lyophilizer that uses liquid nitrogen as a cold source to cool the system. Unlike a conventional lyophilizer, the cold source is liquid nitrogen. The air contains 78% of nitrogen. Therefore, the preparation of liquid nitrogen is very convenient and can be said to be an inexhaustible environmentally friendly energy source. In addition, due to the use of liquid nitrogen refrigeration, the compressor and water cooler are no longer used, so the noise is low, the operation is reliable, the maintenance of the heart parts is not required, the maintenance is simple, and the power consumption is reduced by more than 50%, which will bring the enterprise Come to the long-term economic benefits.
2.1.1.2 New Sterilization of Freeze-Drying Equipment——H2O2 Disinfection at Room Temperature According to the pig e-net users, in order to improve the sanitary condition of the production line and achieve certain disinfection conditions to avoid pollution, Vapovac Disinfection Equipment Co., Ltd. provides freeze-drying equipment. A new sterilization process [3] - under the action of the existing vacuum system, the gaseous H2O2 is transported to the pipeline of the lyophilizer to perform hydrogen peroxide sterilization. The significant difference between this process and other disinfection processes is that the gaseous H2O2 sterilization process is carried out under room temperature and vacuum conditions, so it has the following characteristics: (1) Compared with other chemical disinfection methods, the manpower is reduced and the pressure is reduced. The equipment is at risk of contamination, and does not produce carcinogenic or by-products that cause genetic mutations; (2) no need to over-explosion-proof containers, correspondingly reduce the input cost; (3) no additional gas distribution equipment, disinfectant can be very good Distributed in all corners of the dryer to achieve a full range of disinfection work (this is not achieved by ordinary steam sterilization); (4) reduce the cost of 20% in each sterilization cycle compared with steam sterilization and 50% disinfection time.
1.1.2 Drying equipment 1.1.2.1 New type of spiral dryer - combination of drying and cooling In order to realize the production process of "dry cooling" of drugs in a small space, Heinen of Germany designed and produced a new type of screw dryer [ 4], as shown in Figure 2, it has two independent and well coordinated systems: the first is responsible for the drying process and the second is responsible for the cooling process. This results in two completely different temperature zones in the equipment throughout the continuous production process. The entire drying process is carried out from the bottom up, and this bottom-up path is a spiral belt. After the drug completes the drying process, it enters the cooling zone at the top to begin cooling. The cooling process of the drug is carried out in a spiral from top to bottom under the control of the cooling system. In this way, the drug is dried from the bottom up and cooled from top to bottom, and finally leaves the device and is transported to the packaging line for packaging. In the dryer, most of the air used is used as circulating air throughout the process, which minimizes the exhaust emissions of the entire plant and makes efficient use of energy. In addition, the system's complete air handling equipment, including filters, humidifiers, heat exchangers, blowers, automatic control valves and activated carbon filters, are operated in separate technical spaces, which reduces batch and purge Time means saving production costs.
1. Application of new technologies 1.1 Research on environmental protection and energy conservation Among the 6066 industrial pollution source key monitoring enterprises announced by the State Environmental Protection Administration in March 2007, pharmaceutical companies accounted for 117, mostly fermentation-based raw material manufacturers, some of which were environmentally friendly. It was discontinued. Therefore, tapping potential to reduce consumption and improve economic efficiency will become an important task for raw material drug manufacturers in the future. The following is a few practical examples to illustrate the development and application of APIs in environmental protection and energy conservation.
1.1.1 Freeze-drying equipment 1.1.1.1 Liquid nitrogen vacuum freeze dryer The refrigeration system of the freeze dryer can provide a cold source for the drying oven and the vacuum condenser. Among them, it is more common to freeze the dryer with a compression mechanism, but the heart component compressor often causes many failures due to various factors and requires frequent maintenance. Today, the new liquid nitrogen vacuum freeze dryer solves this problem, which effectively reduces the probability of failure of the refrigeration system.
The liquid nitrogen lyophilizer is a lyophilizer that uses liquid nitrogen as a cold source to cool the system. Unlike a conventional lyophilizer, the cold source is liquid nitrogen. The air contains 78% of nitrogen. Therefore, the preparation of liquid nitrogen is very convenient and can be said to be an inexhaustible environmentally friendly energy source. In addition, due to the use of liquid nitrogen refrigeration, the compressor and water cooler are no longer used, so the noise is low, the operation is reliable, the maintenance of the heart parts is not required, the maintenance is simple, and the power consumption is reduced by more than 50%, which will bring the enterprise Come to the long-term economic benefits.
2.1.1.2 New Sterilization of Freeze-Drying Equipment——H2O2 Disinfection at Room Temperature According to the pig e-net users, in order to improve the sanitary condition of the production line and achieve certain disinfection conditions to avoid pollution, Vapovac Disinfection Equipment Co., Ltd. provides freeze-drying equipment. A new sterilization process [3] - under the action of the existing vacuum system, the gaseous H2O2 is transported to the pipeline of the lyophilizer to perform hydrogen peroxide sterilization. The significant difference between this process and other disinfection processes is that the gaseous H2O2 sterilization process is carried out under room temperature and vacuum conditions, so it has the following characteristics: (1) Compared with other chemical disinfection methods, the manpower is reduced and the pressure is reduced. The equipment is at risk of contamination, and does not produce carcinogenic or by-products that cause genetic mutations; (2) no need to over-explosion-proof containers, correspondingly reduce the input cost; (3) no additional gas distribution equipment, disinfectant can be very good Distributed in all corners of the dryer to achieve a full range of disinfection work (this is not achieved by ordinary steam sterilization); (4) reduce the cost of 20% in each sterilization cycle compared with steam sterilization and 50% disinfection time.
1.1.2 Drying equipment 1.1.2.1 New type of spiral dryer - combination of drying and cooling In order to realize the production process of "dry cooling" of drugs in a small space, Heinen of Germany designed and produced a new type of screw dryer [ 4], as shown in Figure 2, it has two independent and well coordinated systems: the first is responsible for the drying process and the second is responsible for the cooling process. This results in two completely different temperature zones in the equipment throughout the continuous production process. The entire drying process is carried out from the bottom up, and this bottom-up path is a spiral belt. After the drug completes the drying process, it enters the cooling zone at the top to begin cooling. The cooling process of the drug is carried out in a spiral from top to bottom under the control of the cooling system. In this way, the drug is dried from the bottom up and cooled from top to bottom, and finally leaves the device and is transported to the packaging line for packaging. In the dryer, most of the air used is used as circulating air throughout the process, which minimizes the exhaust emissions of the entire plant and makes efficient use of energy. In addition, the system's complete air handling equipment, including filters, humidifiers, heat exchangers, blowers, automatic control valves and activated carbon filters, are operated in separate technical spaces, which reduces batch and purge Time means saving production costs.
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