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.

New technology application


Research on environmental protection and energy conservation


Among the 6066 key industrial pollution source monitoring enterprises announced by the State Environmental Protection Administration in March 2007, pharmaceutical companies accounted for 117, and most of the fermentation-based API manufacturers, some of which were suspended due to environmental problems. 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.


Freeze drying equipment


Liquid nitrogen vacuum freeze dryer


The lyophilizer's refrigeration system provides a cold source for the drying oven and 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.

New sterilization of freeze-drying equipment - H2O2 disinfection at room temperature


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 a new sterilization process for freeze-drying equipment [3] - under the action of the existing vacuum system, the gaseous state H2O2 is transported to the pipe of the lyophilizer for sterilization by hydrogen peroxide. The significant difference between this process and other disinfection processes is that the gaseous H2O2 sterilization process is carried out at room temperature and under vacuum, 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 for overpressure explosion-proof containers, which reduces the cost of use; (3) disinfectants can be used well without the need for additional gas distribution equipment. Distributed in all corners of the dryer to achieve a full range of disinfection work (which is not achieved by ordinary steam sterilization); (4) reduce the cost of 20% in each sterilization cycle and 50 compared with steam sterilization % disinfection time.


Drying equipment


New spiral dryer - a combination of drying and cooling


In order to realize the production process of "drying + 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 sets of independent and very good. Coordinated system: * The set is responsible for the drying process and the second set 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, leaving the device and transported to the packaging line for packaging. In the dryer, most of the air used is used as circulating air in the whole process. This way, the exhaust gas emissions of the entire equipment are reduced to low, so that the energy is efficiently utilized. 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.


Vertical automatic filter press - combination of filtration separation and drying


With the trend of shrinking product size, more and more pharmaceutical companies are using low-consumption and high-output processes. One of the main parts is the advanced nature of dehydration methods to reduce energy consumption and product waste and loss. Larox's fully automated solid-liquid separation solution in Finland significantly reduces energy, water, manpower and wastewater treatment costs and increases product recovery. The Larox vertical automatic filter press is completely different from other conventional dewatering methods. Instead of using centrifugal, vacuum, thermal or other similar methods, it combines hydraulic and inflatable diaphragms, as shown in Figure 3, to separate forces. The zui is enlarged, so that a more effective solid-liquid separation effect is obtained with a small energy consumption of zui. Compared with centrifuges, vacuum filters, etc., the Larox vertical filter press can greatly improve the processing capacity of existing dryers. For example, a 3% reduction in filter cake moisture can increase the throughput of the drying equipment by 16%. If you do not need to increase production, you can significantly reduce the unit drying energy consumption (cost / t products).

Single Sifter

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