Research progress on key technologies of pharmaceutical intelligent manufacturing production line

1 Status of pharmaceutical equipment

Intelligent manufacturing process refers to the advanced manufacturing process that integrates the new generation of information technology such as the Internet of Things, big data and cloud computing with all aspects of manufacturing activities such as design, production, management and service, and has functions such as self-perception of information depth, intelligent optimization and self-decision making, precise control and self-execution [6]. Intelligent robots are committed to solving highly repeatable tasks, and the use of intelligent robots in the pharmaceutical process can not only independently complete the tasks from pharmaceutical to packaging process, but also effectively control the intensity of aseptic production, and achieve efficient production while ensuring that the quality of drugs meets the testing standards.

Although China's pharmaceutical equipment has been moving toward the goal of intelligence, the development speed is still slow. The pharmaceutical industry should seize the historical opportunity of intelligent development and step up the development of new, intelligent and integrated pharmaceutical equipment [7−8]. Many teams and enterprises at home and abroad have carried out in-depth research on the pharmaceutical intelligent manufacturing industry, and achieved certain results.

Wu Chengzhong et al. [9−13] developed a number of dispensing robots and medical quality inspection robots, and conducted in-depth research on vision inspection system and foreign body detection algorithm. In view of some adverse phenomena in the development of TCM intelligent manufacturing in current TCM enterprises, Cao Tingting et al. [14] built a theoretical model of TCM intelligent manufacturing from the basic concepts of flexible production and intelligent equipment, providing a reference for the realization of TCM intelligent manufacturing. Chutian Technology Co., Ltd. has also developed a number of intelligent robots such as intelligent handling robots, packaging robots and foreign object detection robots based on machine vision.

The Brevetti CEA Group also offers a comprehensive range of automated testing equipment for injectable medicines in multi-vial forms such as syringes, ampoules and large infusions to meet the needs of the pharmaceutical industry. In addition, companies such as Italy's Seidenader and Japan's Eisai have also played an important role in promoting the development of pharmaceutical intelligent manufacturing. Although the pharmaceutical equipment of the above enterprises provides an important guarantee for the rapid and safe production of drugs, a single pharmaceutical equipment will always bring some unavoidable problems. integrated continuous manufacturing (ICM) can connect multiple pharmaceutical processes into a production line through intelligent robots to realize a complete pharmaceutical process, which is of great significance for enhancing the scalability of the production process and shortening the time to market of new drugs [15].

In view of the urgent needs of the pharmaceutical industry, the research of pharmaceutical intelligent manufacturing production lines in line with the international pharmaceutical production quality Management practice (GMP) is an important guarantee for drug quality safety, bactericidal production and intelligent production. It can minimize the occurrence of drug safety accidents, improve the pharmaceutical manufacturing and production system, and protect people's health. At present, the existing technical difficulties in pharmaceutical intelligent manufacturing production lines include the following points.

1) The pharmaceutical technology and equipment process is complex, and the control of sterilization is difficult, which is reflected in: it is easy to mix impurities in the process of production process handover, thereby introducing foreign bodies; In the process of handling, it is difficult to ensure the sterile environment of drugs, which is easy to cause oxidation and deterioration of drugs; Manual involvement in the pharmaceutical process can also lead to contamination and the destruction of the sterile environment.

2) The pollution particles in the pharmaceutical process are small, diverse, and difficult to detect. The pollutants mixed in the pharmaceutical process include silk thread, transparent plastic, glass fragments, etc., which is difficult to identify manually and the detection effect is not good.

3) There are many types of medicine bottles, which are difficult to grasp flexibly and the handling efficiency is not high. Due to the different specifications of medicine bottles, the efficiency of manual handling of drugs is not high, and the flexible grasping of intelligent handling robots is difficult.

4) The collaborative control of multi-process, multi-task and multi-machine in high-end pharmaceutical process is difficult. The whole pharmaceutical process involves the application of multi-type intelligent robots, which is of great significance for improving pharmaceutical efficiency, but the application of multi-type robots also brings problems such as complex control scheme and difficult collaborative control.