Here > Home > Service & Support > Industry Info > Details Page
API equipment development and new technology (2)
Updated:2011-11-09 12:16:42    Copyfrom:sdhuge    Hits: Notice: Undefined index: clicknum in /data/user/htdocs/en/APP/special/view.php on line 72
2.1.2 Drying Equipment
2.1.2.1 new spiral dryer - a combination of drying and cooling
In order to achieve in a small space on the drug 'drying + cooling' of the production process, the company designed and manufactured in Germany heinen a new spiral dryer [4], shown in Figure 2, it has two independent and well co-ordinated system: the first is responsible for the drying process, the second is responsible for the cooling process. This makes the entire duration of the production process, equipment, there are two completely different temperature regions. The drying process is bottom-up manner, and this bottom-up path is a spiral band. After completing the drying process of drug, into the cooling zone at the top starts to cool. Drugs in the cooling process is under the control of the cooling system, top to bottom is to be the spiral. So, drug through the bottom of the drying and cooling from top to bottom, the last to leave the equipment was transported to the packing line for packing. In the dryer, the air will be most used for circulating the air throughout the process, this approach makes the whole device emissions are minimized, and thus efficient use of energy. In addition, the entire equipment of the air handling system, including filters, wet, heat exchangers, blowers, automatic control valves and activated carbon filters are independent of the technology space operation, this design reduces the intermittent and purification of the time, which means savings in production costs.

2.1.2.2 Vertical automatic filter press - a combination of filtration and separation and drying
As the particle size constantly thinning trend, a growing number of pharmaceutical companies in the use of low-consumption high-yield technology, is one of the main part of the advanced methods of dehydration, to reduce energy consumption and product waste and loss of . Finland Larox automatic solid-liquid separation solutions [5] significantly reduces energy consumption, water consumption, manpower requirements and wastewater treatment costs, and improved product recovery. Larox automatic filter press and other conventional vertical dehydration completely different way, it is not centrifugal, vacuum, thermal, or other similar methods, but the combination of hydraulic and expansion diaphragm, shown in Figure 3, the separation of power maximum, minimum energy consumption in order to be more effective solid-liquid separation. And centrifuges, vacuum filters, in comparison, Larox filter can significantly improve the existing vertical dryer capacity. For example, 3% lower cake moisture drying equipment can increase the handling capacity of 16%. If you do not need to increase production, you can significantly reduce the drying unit energy consumption (costs / t product).


2.2 Application of security
In the pharmaceutical companies, many in the production of raw materials before processing the form of powder or bulk material state. The powdered material mixed with air form a mixture containing dust explosion is often easy to dangerous goods. The production process in order to prevent accidents, hazardous materials are not allowed deflagration free 'flow.'
Figure 4 shows the vacuum conveying system [6], the use of modular design, the use of very flexible, widely used. It can be extracted from the tube-shaped container of raw materials, can also be assembled from a variety of containers to transport raw materials, process equipment, for example, production beginning stages of mixing equipment, filtration equipment, feeding equipment, and filling and packaging equipment tablet .


Figure 5 is a modular vacuum and pressure silty material transport system, which is silty and raw material transport system combines barrel emptying system of the new system, to make loading and unloading equipment, raw materials, completely isolated from the surrounding environment. Can not withstand the pressure and the impact of a variety of other isolation systems, this new 'double solution' can be used to withstand the temperature, pressure or vacuum the impact of the reactor. Even in a corrosive environment, they simply replace the output of a corrosion-resistant valves on it.
Features: (1) no electrical system components, so will never spark caused by deflagration; (2) there is no rotation system parts, such as bearings, etc., so there is no friction, so there is no heat caused by friction deflagration explosive burning conditions; (3) additional dedicated inert gas (eg nitrogen) protection device, in order to meet the standard vacuum is not suitable for the delivery of equipment; (4) transport systems and material combinations barrel emptying systems (including CIP) , so that loading and unloading of raw materials with the surrounding environment is completely isolated; (5) feeding system modular design, enabling the user to select and achieve the best configuration as needed to prevent pollution, protect the safety. For example, the use of vacuum conveying device can be different raw materials are transported to the mixer.

2.3 On-line technology and automation
Pharmaceutical production process 'online' real-time and production are inseparable. To really 'online' (detection, control ...), must rely on automation technology and its application to real-time detection and process control.
2.3.1 The real online CIP, SIP
With the quality of drug production is rising, there is growing emphasis on the pharmaceutical manufacturing process and the reliability of each process contaminants in the final product, which is a very important process equipment cleaning and sterilization. The cleaning in place (CIP) and sterilization in place (SIP) for pharmaceutical manufacturing equipment has made to put forward higher requirements. However, the current for some devices are called with a CIP or SIP is the existence of errors or misleading [7-8], such as single or single with a clean steam inlet nozzle, and no system design; poorly designed and do not control procedures, control systems; not according to the URS (user requirement standards) do DQ file support. In fact, these are no CIP / SIP sense. The real line CIP / SIP process should have control, system design, from URS to design validation, simulation techniques to determine the design and so on.

2.3.2 accurately monitor the temperature of the sterilization process
Automated production processes in order to ensure high-quality, pharmaceutical production must meet very strict requirements, the risks of microbial contamination will minimize. The key is to prevent pollution plant and equipment, regular cleaning and sterilization, disinfection by-line process, with 121 ~ 135 ℃ steam cleaning 15 ~ 30 min. But temperature measurements must be hygienic design, and does not allow contamination accumulations. Figure 6 shows the plug-in sensor with a standard measuring instrument with a precise measurement of the effect, but there are several important shortcomings: (1) must be welded to the pipeline system, the welding must be polished, welded in most small point there will be tiny particles of pollution risk; (2) will hinder the flow of liquid pipelines; (3) will result in inconsistent measurements. Ideal solution is shown in Figure 7 Pipe Clamp resistance thermometer, it is a special silver temperature sensor, continuous stretch through the back pressure in the pipeline, to be fit for the plug-in measurement. Pipe Clamp without welding resistance thermometer, easy to install; measuring pipe temperature will not affect the internal pipe, do not interfere with the production process, accurate temperature control, high precision measurements with high repeatability, and easy to clean corners, costs Low [9].
    

2.3.3 On-line corrosion inspection - to achieve corrosion controllability
API equipment corrosion is a phenomenon can not be ignored, will bring to the enterprise of its annual economic loss is not small, only the German economy caused by the corrosion of the total losses as high as several one hundred billion euros [10]. However, these losses as part of corrosion can be avoided. Unfortunately, this is not for corrosion before there is a clear and grading, can not be as direct as pressure or temperature measurement, the reason is not to establish effective corrosion detection method. However, with the continuous development of microelectronics technology, based on the 'leaving the current changes due to corrosion - sensing electrode - test' principle SmartCET corrosion sensor, shown in Figure 8, solve the problem. The sensor is the United States InterCorr company's patented product, it is considered a 'corrosion of the electrodes of electronic parts' [10].




Corrosion sensors can achieve the following functions: (1) accurate dynamic calculations. Equipment and pipeline corrosion is a dynamic process of change, corrosion, the system is different sensing parameters, which can be accurately calculated by dynamic measurements; (2) determine the location of corrosion holes, to ensure measurement reliability. Corrosion is a hole of expression, which represents the homogeneous material is not homogeneous with the local point. In SmartCET corrosion sensor detection technology, according to different points measured by the feedback information, you can determine the corrosion point of the defect structure, in order to achieve corrosion holes to determine the location. Can be seen, the use of corrosion sensors, corrosion controllability can be realized. Corrosion detection is no longer a theoretical science and technology, bulk drugs and devices will become an integral part of the real.

2.3.4 Diagnostic and monitoring conditions
Equipment downtime not only increase production costs, and will cause the entire batch of product obsolescence, caused serious losses for the enterprise. Therefore, diagnostic and equipment condition monitoring technology in the pharmaceutical and other process applications in industrial production growing enterprise.

Diagnosis of conditions there are three levels: a simple monitoring (fault identification), location analysis (determination of fault location analysis), diagnosis (failure defined) [11]. For example, the control valve piping systems and equipment condition monitoring, shown in Figure 9. (1) the use of sensors to monitor the pressure and flow; (2) According to the first level of the operating parameters derived from analysis of equipment evaluation, and the state of Notes; (3) all diagnostic information to be uploaded and visual display , the operator has purposefully taken to facilitate maintenance measures.

Therefore, fault diagnosis system is not just a flashing LED light-emitting diode system, diagnostics and condition monitoring technology will be useful API device technology, which the sustainable reduction of equipment life cycle maintenance costs. At the same time, you can ensure high quality products, fast and efficient maintenance and repair, improve equipment utilization.