1 High-yield, low-cost In the production of many pharmaceutical dosage forms, whether it is therapeutic drugs or health care products or nutritional products, the proportion of oral liquid agents is constantly increasing. The market competition of products will inevitably lead to the development of low cost, and one of the ways of low cost is the high production and energy saving of equipment. From the above discussion of equipment and process, it can be known that as long as the conditions of GMP and corresponding processes are met, the process should be relatively simple, and the corresponding equipment should be improved in this respect. For example: (1) can simplify the washing and drying potting linkage line, remove the drying process, and add a "bottle inverted gas blowing, then turn over the bottle" process in the process of washing the bottle machine; (2) oral or syrup containing For liquid production, the original leak detection sterilizer can be combined with the outer wall cleaning and drying equipment. Although the leak detection sterilizer has the function of cleaning the outer wall of the bottle, it may not be able to really clean the syrup on the outer wall. Combine the functions of the outer wall cleaning and drying equipment to develop new multi-functional equipment.
2 It can be cleaned and sterilized. Because most of the oral liquid preparations are produced in large quantities, the batch cleaning and disinfection sterilization of the filling equipment and the liquid dispensing system are troublesome, especially the filling part still relies on manual washing and dismounting. This part of the work is arduous, it is extremely necessary to develop a machine washing device, and can learn from foreign related products, and make the filling part that is in direct contact with the liquid medicine into a module. When cleaning is required, the robot will put the module into the automatic cleaning station. Cleaning and disinfection sterilization, and then rely on mechanical automatic reset. For ceramic positive displacement pumps, CIP and SIP systems are available. The CIP system is the same as the CIP system from the dosing tank, filtration, and pipeline to the pumping system. The SIP system is basically the same as the CIP system, so that the ceramic volumetric type is closed and a closed loop is formed for disinfection steam sterilization. These two systems are controlled by PLC.
Oral liquid dosing system is also the focus. At present, most dosing systems do not have the function of in-situ cleaning and in-situ sterilization, and some rely on only one spray ball to clean the medium or steam. Nor can it achieve a completely reliable cleaning or sterilization (disinfection) effect. Its development direction: using PLC control, touch-type liquid crystal display, display operation program, parameter setting, parameter recording, endpoint judgment, printing, etc. At the same time, the preset program in the operating program, such as normal temperature washing, hot water washing, washing liquid washing, circulating washing, disinfecting or sterilizing, can be washed in different ways and with different washing liquids. You can also set the procedures required by the process yourself. Among them, such as time, temperature, pressure and other setting parameters; set pH value, conductivity, residual amount, sterilization effect end point judgment.
3 Traceable pharmaceutical production requires a complete set of data records, while most domestic production data records remain at the print level of manual recording or single equipment. Managers need to query a certain real-time data, often need to use a lot of resources to obtain, time-consuming and laborious, and difficult to continuously observe and intercept, let alone query historical data. The data acquisition and electronic recording system can solve this problem. However, the data acquisition source will rely on the provision of the device itself, such as the record of the visible foreign object effect of the bottle, which can be recorded according to the parameters of each nozzle, but the device itself cannot provide these data sources. This is waiting for people to develop.
In addition, talking about a traceability is online detection, there are many applications of the technology, and a lot of detection content, such as the amount of filling, sealing of the seal and so on.
4 Personalization With the improvement of the aesthetic, personality, practicability and safety requirements of pharmaceutical packaging materials, the development of oral liquid packaging materials is changeable and diversified, which will put forward personalized requirements for its production equipment. .
2 It can be cleaned and sterilized. Because most of the oral liquid preparations are produced in large quantities, the batch cleaning and disinfection sterilization of the filling equipment and the liquid dispensing system are troublesome, especially the filling part still relies on manual washing and dismounting. This part of the work is arduous, it is extremely necessary to develop a machine washing device, and can learn from foreign related products, and make the filling part that is in direct contact with the liquid medicine into a module. When cleaning is required, the robot will put the module into the automatic cleaning station. Cleaning and disinfection sterilization, and then rely on mechanical automatic reset. For ceramic positive displacement pumps, CIP and SIP systems are available. The CIP system is the same as the CIP system from the dosing tank, filtration, and pipeline to the pumping system. The SIP system is basically the same as the CIP system, so that the ceramic volumetric type is closed and a closed loop is formed for disinfection steam sterilization. These two systems are controlled by PLC.
Oral liquid dosing system is also the focus. At present, most dosing systems do not have the function of in-situ cleaning and in-situ sterilization, and some rely on only one spray ball to clean the medium or steam. Nor can it achieve a completely reliable cleaning or sterilization (disinfection) effect. Its development direction: using PLC control, touch-type liquid crystal display, display operation program, parameter setting, parameter recording, endpoint judgment, printing, etc. At the same time, the preset program in the operating program, such as normal temperature washing, hot water washing, washing liquid washing, circulating washing, disinfecting or sterilizing, can be washed in different ways and with different washing liquids. You can also set the procedures required by the process yourself. Among them, such as time, temperature, pressure and other setting parameters; set pH value, conductivity, residual amount, sterilization effect end point judgment.
3 Traceable pharmaceutical production requires a complete set of data records, while most domestic production data records remain at the print level of manual recording or single equipment. Managers need to query a certain real-time data, often need to use a lot of resources to obtain, time-consuming and laborious, and difficult to continuously observe and intercept, let alone query historical data. The data acquisition and electronic recording system can solve this problem. However, the data acquisition source will rely on the provision of the device itself, such as the record of the visible foreign object effect of the bottle, which can be recorded according to the parameters of each nozzle, but the device itself cannot provide these data sources. This is waiting for people to develop.
In addition, talking about a traceability is online detection, there are many applications of the technology, and a lot of detection content, such as the amount of filling, sealing of the seal and so on.
4 Personalization With the improvement of the aesthetic, personality, practicability and safety requirements of pharmaceutical packaging materials, the development of oral liquid packaging materials is changeable and diversified, which will put forward personalized requirements for its production equipment. .
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