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For Yichang Humanwell Pharmaceuticals, China's largest narcotics manufacturer, the devil is in the detail. To ensure that the entire production process runs smoothly, software from AUVESY-MDT accompanies the strictly regulated production processes.
The use of narcotics can make the difference between life and death. The specifications that must be complied with in the manufacturing of anesthetic drugs are correspondingly strict. From the selection and the dosing of the raw materials, the speed of the machines, the temperature in the production hall, the duration of production to packaging, storage and transport - every step of the manufacturing process requires a high degree of stability and precision. A single mistake can result in the disposal of an entire batch of medicines worth millions of RMB.
China
3
4,700
Pharmaceutical
Safe and compliant production is critical for pharmaceutical companies, especially for narcotics. In the past, Yichang Humanwell's system parameters were set manually, controlled in multiple steps, and changes were documented at great expense. It was difficult to control parameter changes in the production process. In an effort to simplify compliance, Yichang Humanwell discovered the AUVESY-MDT solution in 2019.
This software enables centralized device management, automatic data backup, and logs all program changes. In 2020, Yichang Humanwell implemented the software in a new production line for freeze-dried emulsions. In the future, a gradual expansion to all production lines is planned in the new global headquarters, which will be built in 2021 with an investment of more than 200 million RMB and includes about 70 machines.
By introducing the AUVESY-MDT solution, we are minimizing the risk of PLC-failures that affect the quality of the medicines. This data management and change-software enables us resolve production stop issues and resume production as quickly as possible.
Yichang Humanwell Information Center, Responsible for research and development laboratory, quality management laboratory and all information in production
The AUVESY-MDT solution not only offers advantages in the safe and compliant production of pharmaceuticals, but also accelerates the development of new products. Recorded device parameters such as temperature, pressure and operating speed can be compared quickly and easily. Together with process recipes, such as raw material ratios, they are generally referred to as the "recipe" of a drug.
These parameters are continuously adjusted during development or process validation. The AUVESY-MDT solution allows a direct and fast comparison of the versions in the software. A technician from the Smart Manufacturing team points out: "As soon as the test product that best corresponds to the original design has been found, we use the AUVESY-MDT solution to immediately access the saved recipe to find the most suitable parameter ratios. This increases the efficiency of our research considerably."
Due to the potential of the AUVESY-MDT solution, Yichang Humanwell plans to secure and centrally manage all production lines and facilities with the software. Yichang Humanwell advises pharmaceutical companies during the implementation: