Research On SPC In The Production Process Of PSS Based On Data Mining

With the increasingly fierce market competition, many enterprises have recognized that quality is the key to the enterprise survival, and competitive advantage and thus a higher quality management is required. Propylene glycol alginate sodium sulfate is a novel marine drug. As that the production quality mainly relies on artificial control and the finished products on the post hoc test based on human experience, the real-time quality information of the intermediates and the process is unavailable. That results in the delayed production management and the unstable quality of the final products. Based on the data mining, for the commercial process of propylene glycol alginate sodium sulfate and the reducing rate of side reaction, it is very important to use statistical process control tools to analyze and monitor their production processes, thus promote the quality of the final products.In this study, a large number of literatures of marine bio-pharmaceutical, PSS, NaAlg, pharmaceutical technology, pharmaceutical equipment, and the pharmaceutical manufacturing quality standards are consulted, and publications of data mining and the SPC techniques are referred. On the base of visiting to Haier Pharmaceutical, the extraction of sodium alginate, the synthesis of PSS and preparation process and production processes were investigated; the key processes are found and the key indicators are characterized. The requirements analysis of the SPC system of the PSS's production process based on data mining is carried out, a SPC system model is built; the SPC system of the PSS's production process based on data mining is designed, and the data mining algorithm is given; the application example of the SPC system is also given, based on the rearch about Haier Pharmaceutical company and the Yellow Sea Pharmaceutical company.The findings and conclusions of the thesis are as follows:The production process of PSS including the extraction process of its main raw material-sodium alginate, the synthesis of API, the dosage form and the preparation process for PSS are described, the key processes and key indicators are identified;The SPC system of the production process of PSS based on data mining is designed; the main tasks are including requirements analysis, function model building, system framework designing, hardware composing and software system designing, data mining algorithm selection;The application example of the designed SPC system of the production process of PSS based on data mining is given.