Status of foreign tablet presses

Status of foreign tablet presses

Status of foreign tablet presses

The gap between us and foreign developed countries' tablet presses and tableting technology is still widening. High-speed and high-yield, airtightness, modularization, automation, scale and advanced testing technology are the most important development directions of foreign tableting machine technology. Advanced tablet presses are basically in Europe and America, such as Germany FETTE, KORSCH, UK MANESTY, Belgium COURTOY, US STOKES and so on. Its products have a high degree of automation and meet the requirements of FDA and 21CFRPART11.

1. High speed and high output.

High speed and high output is the goal that tablet press manufacturers have been pursuing for many years. At present, the world's major tablet press manufacturers already have tablet presses with an output of 1 million tablets per hour. For example, the Xpress700 tablet press produced by Manestry Company has a high output of 1 million tablets; the XL800 tablet press produced by Korsch Company has a maximum output of 1.02 million tablets/h; the ModulD tablet press produced by Courtoy Company has a maximum output of 1.07 million tablets. /h; the maximum output of the 4090i tablet press produced by Fette is 1.5 million tablets/h. Its output is much higher than that of domestic tablet presses. To catch up with foreign countries in terms of speed and output, domestic tablet presses 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 people and logistics.

The airtightness of the input and output of foreign tablet presses is very good, reducing cross-contamination as much as possible. The granules used for tableting enter the hopper through a closed material barrel and a closed conveying system. During the tableting process, effective measures are taken to prevent dust flying and particle stratification. Packaging process, the whole process is quite airtight. However, most of the tablet presses in China are open or not completely sealed, and the broken process causes dust to fly between the tablets. With the in-depth implementation of GMP, the airtightness and isolation of people and logistics in the tableting process have become particularly important, which are the basic functions that we must have in designing and manufacturing equipment. 3. Cleaning in place.

WIP (clean-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 disassembly. Only convenient and quick disassembly can ensure the thoroughness of cleaning.

4.21CFRPart11 (electronic records and electronic signatures) on 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. For electronic signatures and electronic records, this regulation is mandatory. The purpose of the regulations is to facilitate the introduction of electronic technology in the processing of pharmaceutical and food products. It can provide applicable and practical guidelines on how tasks that were previously done in writing can be accomplished electronically. A record refers to any combination of expressions of information such as text, graphics, data, audio, diagrams, or other digital forms of information created, modified, maintained, archived, retrieved, or distributed by a computer system. Electronic signatures refer to Any one or a series of symbols executed, adopted or authorized by an individual and compiled with computer data, these comply with the same legal effect as an individual's handwritten signature. The application of 21CFRPart11 technology on tablet presses enables tablet presses to have equipment diagnostic records Log, accident record log and alarm prompt log. These electronic records and electronic signatures record various operational data and accident data in detail. In line with security access control, user name and password are required to enter the operation. All data use electronic signatures Functions, including operator name, date, time, serial number, problem, solution, working condition data. All original data cannot be modified artificially, ensuring the reliability and authenticity of the results. These exist in the system and users Logs are automatically stored in the entire "trace audit" folder. These secure attribute data formats "ensure that changes to the data enter the press under overall audit control. The 21CFRPart11 technology has been recognized by the world's major tablet press manufacturers and is widely used in their products, but it has only just begun in China.

5. Control technology connected to the entire production line.

A tablet press can be connected to a production line, both German and British tablet presses have this function. It has start, end and speed adjustment functions. Using this option function, it can be reliably and automatically connected with other equipment in the production line, such as sieving, vacuuming, testing, conveying, barreling, etc., to synchronously complete the tablet pressing production task. At the same time, different monitoring methods are also used in external equipment, which provides high safety and reliability performance. The online detector can be used to remove burrs, burrs and dust for the pressed tablets; the dust suction monitoring function is to use the flow monitor to regularly detect the suction pressure at the designated position in the suction pipe. Continuously compare the set value with the measured value. If the detector does not detect the suction pressure (no flow) within 10s in the suction pipe, the tablet press will send out a fault alarm and stop running. This feature maximizes production reliability and enables continuous dust removal during tablet compression production. The control technology connected with the entire tablet production line is a new technology for tablet production control, which is the future development trend. This technology has just started in China.

6. Remote monitoring and remote diagnosis system of tablet press.
With the rapid development of high-tech computers such as network, broadband network, and virtualization, remote monitoring and remote diagnosis technologies for equipment are also emerging. Computer-controlled tablet presses began to be widely used in pharmaceutical factories, making remote monitoring and remote diagnosis technologies useful in the tablet press industry. At present, the advanced tablet presses in foreign developed countries are generally equipped with remote monitoring and remote diagnosis functions. The establishment of this system is also to realize the network dialogue between the technical support center (service party) and the tablet press user (user) through the Internet, so that the service party can learn about the failure of the user's tablet press through the Internet in different places, as well as the tablet press. The machine is in the working state of executing the instruction, and then the failure of the tablet press is judged and a feasible solution is proposed. Through the establishment of the remote monitoring and remote diagnosis system of the tablet press, faults can be eliminated in real time, which greatly improves the after-sales service response capability and speed of the tablet press manufacturer, and also improves the economic benefits of the enterprise. The remote monitoring and remote diagnosis system of the tablet press should include personnel allocation, network construction, hardware facilities, software selection, etc., to complete the process of fault monitoring, analysis, feedback, release and real-time solution services, so as to ensure the entire system. effective operation.

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