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In order to comply with the trend of intelligentization and informationization of freeze dryers, some experts have carried out data cloud transformation of freeze dryers. The main steps of the whole project are the project architecture; the hardware preparation work required for system development, including the hardware required for system development, the hardware connection methods; the construction of the operating environment; the construction of the development environment; the PLC communication protocol; data preparation; Including the serial port expression string of the development board and the data acquisition program of the freeze dryer.
In this project, the expert used the ARM development board to replace the traditional PC. Compared with the traditional PC system architecture, the ARM development board has many advantages, such as small size, low power consumption, low heat generation, stable operating system, and easy installation. You can use the universal ARM development board that can install the Linux operating system and has its own RS232/485 serial port.
This project is not only a product of the era of intelligent medical equipment, but also provides a reference for the information transformation of various other types of pharmaceutical equipment. More importantly, the data collection process has stored all the medical equipment operation data in the cloud database in the cloud, which is of great significance for the future statistics of various big data and the traceability of drug quality.
In addition to the development of compliance with the intelligent development of lyophilizers, and in accordance with the development of regulatory requirements, many lyophilizer companies have further explored. Taking the complete detection method of the lyophilizer filter core as an example, most of the sterile preparations produced by the lyophilizer are non-terminally sterilized sterile preparations. For non-terminally sterilized sterile preparations, the sterility assurance of the preparation relies primarily on sterility control during the production process, while the sterile preparations are controlled during the production process prior to entering the lyophilizer, each filter element Integrity plays a key role.
There are different international standards for the integrity of filter cartridges. For example, in the EU GMP 2017 revision, it is explicitly required that for non-terminally sterilized drugs, filter integrity testing should be performed online to prevent any deterioration in product quality. Bad effects. The FDA believes that integrity testing can be performed prior to filtration and should be routinely tested after filtration. After filtration, it is very important to pass the integrity test to detect possible leaks or breakage during the filtration process.
Article 42 of the Appendix of China GMP (2010 Edition) also clearly stipulates that the production gas (such as compressed air, nitrogen, but not including flammable gas) entering the aseptic production area should be sterilized and filtered, and should be regularly checked. The integrity of the bacteria filter and breathing filter.
Although the standards are different, it is certain that each standard emphasizes the importance of filter integrity testing. The author is informed that integrity testing methods mainly include destructive integrity testing and non-destructive testing. For filters used in aseptic production, destructive integrity testing is generally not suitable, and non-destructive filter integrity testing methods are generally used. The author also learned that many pharmaceutical companies' integrity testing equipment mainly includes PALL integrity tester and MILLPORE integrity tester, which will ensure aseptic control to a certain extent.
For the freeze dryer industry in China, the level of freeze-drying technology in China has been increasing in recent years, and enterprises are also giving new kinetic energy to freeze-drying machines, such as intelligence and informationization. Of course, the lyophilizer industry has not forgotten to develop in a standardized way. However, there are still some problems to be solved, such as how to improve the freeze-drying efficiency and shorten the drying time under the premise of ensuring product quality. The industry also said that energy conservation will become the research direction and goal of the freeze dryer industry.
At present, concepts such as "Internet +", "Internet of Things", "Intelligent Control", and "Industrial Internet" are emerging one after another. The research and development trends and applications of freeze dryers are becoming increasingly intelligent and informative. The author understands that the freeze dryer originated from the vacuum freeze-drying technology in the 1920s. The vacuum freeze-drying technology has been widely used in medicine, food, blood products, and active substances. An important role.