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API development and new technology equipment (3)
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2.4 Design Method - Application of simulation technology, combined with the actual situation
In today's industrial design, CAD / CAM / CAE has been very common, but the simulation technology, virtual technology in the API design and manufacture of equipment in the application are still to be further developed and deepened. In fact, simulation and virtual technology, make raw material medicine equipment designers and producers of program planning to obtain a wide range of benefits. 2.4.1 virtual model - clear, timely inspection Figure 10 (a) for the air compressor, Figure 10 (b) for the virtual design of the air compressor [12]. Through interactive virtual reality, visualization, design process, so that planning is very easy to understand and improve the planning and design quality. Meanwhile, during the planning and design, multi-program can be compared to choose the best option. Virtual prototyping, the use of detailed modules, can be virtual assembly, timely inspection to check the size and components can be assembled, to identify problems early and accurately define the scope of the problem may arise early to consider alternatives, be revised error , convenient and safe performance testing; through virtual prototyping, virtual testing can be, but no longer do more physical test, so saving time and saving costs. Can be seen, simulation technology will gradually become the most important planning and design of the device. 2.4.2 Network work - do more with less Simulation technology makes better intuitive process, you can more easily analyze the production process, so designers in the planning and design process tend to use this "virtual reality scenes" work with customers to discuss, such as Figure 11 [13]. Moreover, in this virtual reality world of the future can also be detected in the equipment performance, optimize it to improve, in order to save future equipment maintenance and repair time. Virtual reality, intelligent design software can make a number of designers involved in the project planning and design at the same time, exchange ideas and develop test equipment, look for maintenance strategy. In addition, object-oriented data model and modular design as the overall design is very effective, integrated planning and design to make it adapt quickly to different applications. In short, simulation technology, virtual technology, the design - the whole process faster and debugging legible, rapid implementation project design changes, new equipment designed to reduce costs significantly, the results of the planning project design speed can be increased by 30%; project Design costs can be reduced by 40%; project investment costs can be reduced by 30% [13].  2.5 Modular structure design In the pharmaceutical industry, the demand for new equipment is often caused by several factors. First, the geographical concentration of production is increasingly evident, followed by a number of lines necessary to re-equip. Second, new drugs with high active ingredients have been developed, which also calls for upgrading the old equipment to meet new production needs, while meeting the requirements of GMP and FDA regulations. The characteristics of pharmaceutical technology, GMP and new production needs, equipment, pharmaceutical products that are from simple to systematic mechanical and electrical integration, development of modular solutions to suit the user's changes and update the fastest and best products. 2.5.1 The combination of multi-modular Modular design is to coordinate the diverse needs of customers, fast response and reduce the product cost effective way. Figure 12 shows the M5 multifunction system that combines the most commonly used pharmaceutical industry grinding concept, can be converted into different functions within a few minutes of grinding machines [14].  M5 multi-function system consists of standard components (measurement unit, access to materials unit, CIP unit, control unit, chassis structure) and functional unit (spiral jet mill, fluidized bed jet mill stream, impact grinding / classification round of the combination, fine grading machine) composed of standard components and the different functional units that together constitute the different functions grinder. + Standard components such as spiral jet mill to form a spiral flow mill combination, as shown in Figure 13; standard components + fluidized bed jet stream to form a fluidized bed jet mill mill stream combination, as shown in Figure 14 shown; standard components + to form ultra-fine impact mill can be combined impact of the mill, as shown in Figure 15  Combination of multi-functional modular design can be seen flexible, fast combinations, and can effectively isolate and save space. 2.5.2 and the process of combining modular With the implementation of in-depth GMP, pharmaceutical products and equipment are also from simple mechanical and electrical integration and production process operation to a combination of modular unit direction [15], in order to improve their level of technology equipment. Figure 16 shows the API crystallization equipment, which is characterized by mixing modular approach is the application form developed: the different types of materials, mixing different forms, and then through the modular design, the use of fluid analysis, design a special structure blade, to protect the crystal formation and not broken, to ensure that equipment is reasonable and optimization.  Figure 17 shows the CIP modular workstations, is based on CIP process through a combination of modular design. The specification forms, covering a wide range, from fermentation, herbal extracts, raw material drug production equipment can be cleaned to blood products, cleaning equipment for the pharmaceutical companies to provide effective protection verification. Figure 18 System Integration Module for drug ingredient, is thick with, dilute with filtered, sterilized, clean liquid transportation and other processes combined in a modular device, the system easy to operate, the material enclosed run, two-way reduced pollution, compliance with GMP requirements. Figure 19 is a modular multi-function extraction and concentration device, which combines dynamic / static water extraction, dynamic / static alcohol extraction, heat reflux extraction, Soxhlet extraction, percolation extraction, steam distillation in one, to be completed the extraction of a variety of ways process, is a modern technology with traditional extraction method of the combination. In short, with the process of combining modular design, allowing the system or device can be combined according to process requirements, operational simplicity, easy to use, closed operation, prevent pollution, and to achieve environmental protection, energy saving, in line with GMP and other requirements of the pharmaceutical equipment direction of technological innovation.   3 Conclusion China's accession to WTO, the market becomes more open Pharmaceutical machinery, pharmaceutical equipment, the economy is a profound, fundamental and a bright future full of change and innovation. China's pharmaceutical products as one of the major equipment API equipment, in this change and innovation in the development to be satisfactory, must meet the national environmental protection and energy conservation-oriented policies, follow the safety rules apply, to the development of automation technology and virtual technology, modular design, the only way the development of China's API in order to realize the device from imitation to their own development, to innovation, and thus with international standards and advanced technologies into the ranks of the world. |
