Zyzhan guide: In recent years, isolation technology has been applied to aseptic preparations. We have focused on the application of isolation technology in sterile preparations. Powdered needles (or freeze-dried powder needles), large and small volume injections, and antibiotic water bottles are involved in the preparation of sterile preparations. From the perspective of the equipment in the aseptic production area, there are many operators required, mainly engaged in the installation. Quantity inspection and adjustment, material transportation and equipment operation.
In recent years, the application of isolation technology in pharmaceutical machinery can be said to be a series of results produced by certain efforts, but most of these applications are in solid preparation equipment, such as vacuum transportation, cross-layer air control intermediate transfer barrel transportation, etc. Relatively isolated automatic delivery and control.
However, this model is based on the design of a new multi-storey building, and its system is also constrained by many factors such as materials, process connections, and buildings. However, in recent years, isolation technology has been applied to aseptic preparations. We have focused on the application of isolation technology in sterile preparations.
Powdered needles (or freeze-dried powder needles), large and small volume injections, and antibiotic water bottles are involved in the preparation of sterile preparations. From the perspective of the equipment in the aseptic production area, there are many operators required, mainly engaged in the installation. Quantity inspection and adjustment, material transportation and equipment operation. For example, the dispensing section in the production of powder needles involves the transportation of sterile powder and the pouring of hopper personnel, the transportation of rubber stoppers and the pouring into the oscillating bucket, the equipment operators (operation and capacity adjustment) and the sampling inspection. personnel;
Another example is the filling and half-filling section in the freeze-dried powder needle, which also involves the operator of the sterile liquid transport, the transportation of the rubber plug and the pouring into the shock bucket, the equipment operator (operation and capacity adjustment), and the quantity. Sampling personnel, semi-plugged vial bottles and personnel transported to the lyophilizer, and after lyophilization, the full-pressure stopper bottle is moved to the capping section. It can be seen that there are many operators in these aseptic areas, and the action caused by the dust will bring about the intensification of insoluble particulate pollution, and the relative fluctuation of the pressure difference in the clean area formed by the walking will also increase the pollution.
Although the linkage line has been solved in the past few years to solve the problem of access to the sterile area of ​​the vial, the plastic plug needs to be manually operated into the area. After the filling is half-filled, the vial is also manually operated. The isolation technology application of these production equipment mainly solves: (1) high automation control and adjustment of equipment; (2) high automatic quality inspection and automatic rejection; (3) full automatic entry and exit of pharmaceutical raw materials and pharmaceutical packaging materials. Only by solving the above problems can we achieve isolation in a true sense.
In recent years, the application of isolation technology in pharmaceutical machinery can be said to be a series of results produced by certain efforts, but most of these applications are in solid preparation equipment, such as vacuum transportation, cross-layer air control intermediate transfer barrel transportation, etc. Relatively isolated automatic delivery and control.
However, this model is based on the design of a new multi-storey building, and its system is also constrained by many factors such as materials, process connections, and buildings. However, in recent years, isolation technology has been applied to aseptic preparations. We have focused on the application of isolation technology in sterile preparations.
Powdered needles (or freeze-dried powder needles), large and small volume injections, and antibiotic water bottles are involved in the preparation of sterile preparations. From the perspective of the equipment in the aseptic production area, there are many operators required, mainly engaged in the installation. Quantity inspection and adjustment, material transportation and equipment operation. For example, the dispensing section in the production of powder needles involves the transportation of sterile powder and the pouring of hopper personnel, the transportation of rubber stoppers and the pouring into the oscillating bucket, the equipment operators (operation and capacity adjustment) and the sampling inspection. personnel;
Another example is the filling and half-filling section in the freeze-dried powder needle, which also involves the operator of the sterile liquid transport, the transportation of the rubber plug and the pouring into the shock bucket, the equipment operator (operation and capacity adjustment), and the quantity. Sampling personnel, semi-plugged vial bottles and personnel transported to the lyophilizer, and after lyophilization, the full-pressure stopper bottle is moved to the capping section. It can be seen that there are many operators in these aseptic areas, and the action caused by the dust will bring about the intensification of insoluble particulate pollution, and the relative fluctuation of the pressure difference in the clean area formed by the walking will also increase the pollution.
Although the linkage line has been solved in the past few years to solve the problem of access to the sterile area of ​​the vial, the plastic plug needs to be manually operated into the area. After the filling is half-filled, the vial is also manually operated. The isolation technology application of these production equipment mainly solves: (1) high automation control and adjustment of equipment; (2) high automatic quality inspection and automatic rejection; (3) full automatic entry and exit of pharmaceutical raw materials and pharmaceutical packaging materials. Only by solving the above problems can we achieve isolation in a true sense.
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