Recently, Zhejiang Tailin Biotechnology Co., Ltd. will take the lead, and cooperate with Zhejiang University, China Food and Drug Control Research Institute, Zhejiang Institute of Metrology, Zhengda Qingchunbao Pharmaceutical Co., Ltd., Hangzhou Dianzi University and other units to organize development The “Development and Application of High-Performance Intelligent Aseptic Detector” project was approved as a special project of “National Key Ru0026D Program”-“Development of Major Scientific Instruments and Equipment”. The total planned investment of the project is 45 million yuan, and the implementation period is July 2016. From January to June 2020, after the successful implementation of the project, it is expected to greatly improve the efficiency and level of sterility inspection in China, support emergency detection of emergencies, and increase the market share of domestic instruments. In recent years, many food and drug quality and safety incidents have occurred in my country, which has caused the government and the public to attach great importance to the quality assurance of food and drugs. As a key item of food and drug quality control, sterility inspection has clear requirements in the latest
2010 version of GMP 'Good Manufacturing Practice for Drugs' and 2015 version of the Pharmacopoeia. It is an important item for enterprises and regulatory agencies to inspect qualified products. For routine sterility inspection, a laminar flow table with unidirectional airflow is installed in a controlled environment, and a bacteria collector is placed on the laminar flow table to complete the sterility test. The sterility inspection instrument includes sterile isolators, membrane filtration systems (bacteria operation instrument and bacterial incubator), microorganism incubators and other components, which replace conventional sterility inspection methods, provide a controlled sterile environment and implement sterility inspections , With the characteristics of high integration, low investment cost, and better environmental controllability, more and more attention has been paid to it, and it has been widely used. In recent years, domestic companies have continued to increase their market share through continuous Ru0026D investment, and have surpassed foreign instruments. However, high-end instruments are still controlled by foreign manufacturers, and there is an urgent need to improve product quality and performance. As far as the current technology is concerned, the existing sterility inspection still has the following shortcomings: the monitoring and control technology of key parameters such as sterilant concentration is immature, which may easily lead to the risk of false positives or false negatives; the collection of bacteria and sterility testing rely on manual labor. , The level of automation, integration and intelligence is low, and the sterility inspection efficiency is low; some key components rely on imports, such as VHP (Vaporized Hydrogen Peroxide) concentration sensors and microporous membranes. In order to solve the above-mentioned problems, this project plans to carry out the instrument research and development, application research and engineering industrialization research of high-performance intelligent food and drug sterility detector. In response to the high-performance requirements of sterility detectors, we will study a continuously controllable aseptic isolation environment to avoid false positives or false negatives in sterility tests due to unstable sterilization effects, and focus on the development of efficient and stable VHP vaporization technology research and rapid real-time Research on VHP concentration detection technology; in response to the intelligent requirements of sterile detectors, carry out automated and intelligent research on instrument operation, replace the current manual operation mode, improve the detection efficiency of sterility inspection, and focus on the development of automated bacteria collection operation technology and automatic Research on detection technology and intelligent system integration technology; according to the application requirements of enterprises and drug testing institutions, research targeted operating methods and software, solve the specific testing needs of instruments in representative application units, and focus on the development of special products for food and drug testing institutions A variety of sample sterility inspection software and high-volume sample testing process optimization technology for production enterprises; according to the engineering and industrialization requirements of the instrument, research reliability schemes, quality control schemes and other related industrialization schemes to ensure the industrialization of instrument engineering Successful implementation. After the completion of the project, the positioning technology of the precise transfer mechanism and the multifunctional manipulator will be applied in the isolator, and the technology of automatic precise sampling and automatic filling of positive bacteria will be supported. This will standardize and model the sterility inspection process, and the entire process will be completely affected. Control, avoid the ills that the previous sterile inspections were all dependent on personnel operations, and the results were greatly affected by human factors. Greatly improve the efficiency of sterility inspection and the accuracy and credibility of sterility inspection results. The sterility inspection of products or samples of sterile preparation companies or other testing institutions has always been a labor-intensive industry. After applying the product of this project for sterility inspection, the system will automatically perform positioning, sample addition, and cultivation observation according to the set program. , The results of the whole process are recorded and analyzed in real time, and all data can be synchronized and checked on the supervisory system. This application will greatly reduce the labor cost of the enterprise and double the efficiency of sterility inspection. at the same time. The improvement of the efficiency and accuracy of the sterility inspection also reduces the bacteria in the sterility inspection samples caused by the irregular operation of the personnel or the mistakes of the personnel, and reduces the enterprise's expenditure on repeated inspections and cause analysis. At the same time, all data is real-time. Uploading can realize early detection, early prevention, and early treatment of possible abnormal situations.
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