Development situation of foreign tablet presses

The gap between our tablet presses and tablet press technology and those of developed countries is still widening. High speed, high yield, airtightness, modularization, automation, scale and advanced detection technology are the main development directions of foreign tablet press technology. Advanced tablet presses are basically in Europe and the United States, such as Germany's FETTE, KORSCH, Britain's MANESTY, Belgium's COURTOY, and the United States' STOKES. Its products have a high degree of automation and meet the requirements of FDA and 21CFRPART11.

1. High speed and high yield. High speed and high yield have been the goals that tablet press manufacturers have always pursued for many years. Major tablet press manufacturers already have tablet presses with an hourly output of 1 million tablets. The ModulD tablet press produced by Courtoy has a maximum output of 1.07 million tablets/h; the 4090i tablet press produced by Fette has a maximum output of 1.5 million tablets/h. Its output is much higher than that of domestic tablet presses. If domestic tablet presses want to catch up with and surpass foreign countries in terms of speed and output, they need to make great progress in tablet press design innovation, processing technology, and automatic control.

2. The airtightness of the tableting process and the isolation of human and logistics flows. The airtightness of the input and output of foreign tablet presses is very good, which minimizes cross contamination as much as possible. The particles used for tableting enter the hopper through a closed barrel and a closed conveying system. Effective measures are taken during the tableting process to prevent dust from flying and particle stratification. The pressed tablets enter the packaging process through screens, tablet detection, metal detection, etc. The whole process is quite airtight. However, the tableting process of most domestic tablet presses is open, or not completely airtight, and the broken process causes dust to fly between tablets.

3. Cleaning in place. CIP (cleaning in place) tablet presses greatly reduce the cost of user equipment. To improve the cleaning function of the tablet press, in addition to fully considering the cleaning of each part in the design, the cleaning function of the tablet press emphasizes detachability. Only convenient and quick disassembly can ensure the thoroughness of cleaning.

4. The application of electronic records and electronic signatures in tablet presses. On August 20, 1997, the relevant regulations of 21CFR11 Part 6 "Electronic Records, Electronic Signatures (ER/ES)" issued by FDA came into effect. This regulation is mandatory for electronic signatures and electronic records. The purpose of this regulation is to facilitate the introduction of electronic technology in the product processing of pharmaceuticals and food. It can provide applicable and practical guidelines on how to complete tasks that were previously completed in written form in electronic form.

Electronic records refer to any combination of information expressions such as text, graphics, data, audio, graphics or other digital forms created, modified, maintained, archived, retrieved or distributed by computer systems. Electronic signature refers to any one or a series of symbols executed, adopted or authorized by an individual and compiled by computer data. Numbers, which are in compliance with the same legal effect as personal handwritten signatures.

The application of 21CFRPart11 technology in tablet presses enables tablet presses to have equipment diagnostic record logs, accident record logs and alarm prompt logs. These electronic records and electronic signatures record various operation data and accident data in detail. In compliance with security access control, user name and password are required to enter the operation. All data use the electronic signature function, including operator name, date, time, serial number, problem, solution, and working condition data. All original data cannot be modified manually, ensuring the reliability and authenticity of the results. These logs existing in the system and users are automatically stored in the entire "trace review" folder. These "security attribute data formats" ensure that data changes are carried out under overall inspection control.

5. Control technology connected to the entire production line. A tablet press can be connected to a production line. Tablet presses in Germany and the United Kingdom have this function. It has start, end and speed adjustment functions. With this option function, it can be reliably and automatically connected with other equipment of the production line, such as screens, dust collection, detection, transportation, barreling, etc., to complete the tablet pressing production task synchronously.

At the same time, different monitoring methods are also used on external equipment to provide high safety and reliability. The online detector can be used to remove burrs, flashes and dust for the pressed tablets; the dust collection monitoring function uses the flow monitor to regularly detect the suction pressure at the specified position in the suction pipe. Continuously compare the set value and the measured value. If the detector does not detect the suction pressure (no flow) in the suction pipe within 10s, the tablet press will issue a fault alarm prompt and stop running. This function guarantees the reliability of production to the greatest extent and can continuously remove dust during the tablet pressing production process. The control technology connected to the entire tablet production line is a new technology for tablet production control and a future development trend. This technology has just started in China.

6. Remote monitoring and remote diagnosis system. With the rapid development of computer high-tech such as networks, broadband networks, and virtualization, equipment remote monitoring and remote diagnosis technology is also increasingly emerging. Computer-controlled tablet presses have begun to be widely used in pharmaceutical factories, making remote monitoring and remote diagnosis technology useful in the tablet press industry. Advanced tablet presses in developed countries abroad are generally equipped with remote monitoring and remote diagnosis functions.

The establishment of this system is also to enable the technical support center (service provider) and the tablet press user (user) to conduct network dialogues through the Internet, so that the service provider can understand the faults of the user's tablet press through the Internet in a remote location, as well as the working status of the tablet press in executing instructions, and then judge the tablet press faults and propose feasible solutions.

Through the establishment of a tablet press remote monitoring and remote diagnosis system, faults can be eliminated in real time, which greatly improves the after-sales service response capability and speed of tablet press manufacturers, and also improves the economic benefits of enterprises. The tablet press remote monitoring and remote diagnosis system should include personnel deployment, network construction, hardware facilities, software selection, etc., to complete the fault monitoring, analysis, feedback, issuance and real-time solution services respectively, to ensure the effective operation of the entire system.