Tablet press four definitions:
1. Tablet pressing machine, a machine that presses dry granular or powdery materials into tablets through a mold.
2. Single-punch tablet press machine, a tablet press machine with a pair of molds for vertical reciprocating motion.
3. Rotary tablet press machine, a tablet press machine in which multiple pairs of molds evenly distributed on the rotating turntable perform vertical reciprocating motions according to a certain trajectory.
4. High-speed rotary tablet press, a rotary tablet press in which the axis of the mold rotates with the turntable at a linear speed of not less than 60m/min.
Tablet press classification:
The models can be divided into single-punch tablet presses, flower basket tablet presses, rotary tablet presses, sub-high-speed rotary tablet presses, fully automatic high-speed tablet presses and rotary core-spun tablet presses.
Tablet machine tablet principle:
1. Dose control
Various tablets have different dosage requirements, and the large dosage adjustment is realized by choosing dies with different punch diameters. After the die size is selected, the tiny dose adjustment is to adjust the depth of the lower punch into the middle die hole, thereby changing the actual length of the middle die hole after the back cover, to achieve the purpose of adjusting the filling volume of the drug in the die hole. Therefore, the tablet press should have a mechanism to adjust the original position of the lower punch in the die hole to meet the dosage adjustment requirements.
2. Tablet thickness and compaction control
The dose of the drug is determined according to the prescription and pharmacopoeia and cannot be changed. For storage, storage and disintegration time limit requirements, a certain dose of pressure is also required during tablet compression, which will also affect the actual thickness and appearance of the tablet. Pressure regulation during tablet compression is required. This is achieved by adjusting the downward movement of the upper punch in the die hole. Some tablet presses not only have the upward and downward movements of the upper punch, but also the upward movement of the lower punch during the tablet pressing process. The relative movement of the upper and lower punches together completes the tablet pressing process. However, pressure regulation is mostly achieved by adjusting the mechanism of the upstroke and downstroke.
The working process of the tablet press:
The working process of the tablet press can be divided into the following steps:
1. The punch part of the lower punch (its working position is upward) extends from the lower end of the middle die hole into the middle die hole to seal the bottom of the middle die hole;
2. Use the feeder to fill the drug into the die hole;
3. The punch part of the upper punch (its working position is facing downward) falls from the upper end of the middle die hole into the middle die hole, and moves down a certain stroke to press the powder into tablets;
4. The upper punch is lifted out of the hole. The lower punch rises to push the tablet out of the middle die hole, completing a tablet pressing process;
5. Lower the punch down to the original position, ready for the next filling.
The structure of the tablet press:
A machine that places granules or powdered materials in a die hole and presses them into tablets with a punch is called a tablet press. The earlier tablet press consisted of a pair of dies, and the punch moved up and down to press the granular material into a sheet. This machine was called a single-punch tablet press, and later developed into an electric flower basket tablet press. The working principle of these two tablet presses is still one-way tablet pressing based on manual compression molding, that is, the lower punch is fixed during tablet compression, and only the upper punch moves to pressurize. Due to the inconsistency of the upper and lower forces in this tablet pressing method, the density inside the tablet is not uniform, and problems such as splits are prone to occur.
Aiming at the shortcomings of the unidirectional tablet press, a rotary multi-punch bidirectional tablet press was born. This kind of tablet press presses up and down uniformly at the same time, so that the air in the drug particles has enough time to escape the die hole, which improves the uniformity of the tablet density and reduces the phenomenon of splitting. In addition, the rotary tablet press also has the advantages of low machine vibration, low noise, low energy consumption, high efficiency and accurate tablet weight.
Rotary tablet press machine is a machine that presses granular materials into tablets by means of a plurality of punches evenly distributed on the turntable that move up and down in a circle according to a certain trajectory. The tablet press whose linear speed of the punch rotates with the turntable ≥ 60m/min is called a high-speed rotary tablet press. This high-speed rotary tablet press has a forced feeding mechanism, and the machine is controlled by a PLC. It has automatic pressure adjustment, control Functions such as tablet weight, discarding waste, printing data, and displaying fault shutdown can control the difference in tablet weight within a certain range, and can automatically identify and eliminate quality problems such as missing corners and loose slivers.
The shape of the tablet pressed by the tablet press is mostly oblate at first, and later developed into a shallow arc shape and a deep arc shape on the upper and lower sides, which is for the needs of coating. With the development of special-shaped tablet presses, oval, triangular, oblong, square, rhombus, circular and other tablets are produced. In addition, with the continuous development of preparations, due to the requirements of compound preparations and time-release preparations, special tablets such as double-layer, triple-layer, and core-coated tablets have to be made on special tablet presses.
With the development of market demand, the scope of application of the tablet press is becoming wider and wider. It is no longer limited to pressing Chinese and Western medicine tablets, but can also widely press health food, veterinary medicine tablets, and chemical tablets: such as mothballs. Hygienic balls, washing blocks, Smurf blocks, art powder cakes, pesticide tablets, etc., food tablets: chicken essence blocks, Banlan root blocks, Divine Comedy tea blocks, compressed biscuits, etc.
The development history of tablet press:
Tablet presses appeared earlier in Europe and the United States, with a history of nearly a hundred years. In CHINA, in 1949, the Tianxiang Huaji Iron Factory in Shanghai imitated the British 33 punching tablet machine; in 1951, it was transformed into a domestic 18 punching tablet machine based on the American 16 punching machine. Machinery; in 1957, designed and manufactured the ZP25-4 tablet press; in 1960, successfully designed and manufactured the 60-30 tablet press, which has the function of automatic rotation and tablet compression. tablets, coffee tablets, etc. In the same year, ZP33 and ZP19 tablet presses were also designed and manufactured.
In the 1970s, Shanghai No. 1 Pharmaceutical Machinery Factory and Nantong Shengkaiya Machinery Co., Ltd. began to produce ZP series tablet presses in large quantities. During the "Seventh Five-Year Plan" period, the HZP26 high-speed tablet press was successfully developed in the 206th Institute of the Ministry of Aeronautics and Astronautics. In 1980, Shanghai No. 1 Pharmaceutical Machinery Factory designed and manufactured the ZP-21W tablet press, which reached the international professional level in the early 1980s and is a unique and novel product. In 1987, we introduced the microcomputer control technology from Fette Company of the Federal Republic of Germany, and designed and manufactured the P3100-37 rotary tablet press, which has functions such as automatic control of tablet weight, pressure, automatic counting of tablets, and automatic removal of waste tablets. The closed structure is tight and clean The degree meets the requirements of GMP. In 1997, Shanghai Tianxiang Jiantai Pharmaceutical Machinery Co., Ltd. developed ZP100 series rotary tablet presses and GZPK100 series high-speed rotary tablet presses.
In the 21st century, with the deepening of GMP certification, ZP series rotary tablet presses that fully comply with GMP have appeared one after another: ZP35A from Shanghai, ZP35D from Nantong Shengkaia Machinery, etc. The high-speed rotary tablet press has made considerable progress in production, pressure signal collection, waste rejection and other technologies. The maximum production is generally greater than 300,000 tablets/hour, the maximum pre-pressure is 20kN, and the maximum main pressure is 80kN or above 100kN. For example, the GZPLS-620 series high-speed rotary tablet press of Nantong Shengkaiya Machinery Co., Ltd., the GZPK3000 series high-speed rotary tablet press of Nantong Shengkaiya Machinery Co., Ltd., and the PG50 series high-speed rotary tablet press of Beijing Aviation Manufacturing Engineering Research Institute. Tablet presses, etc.
With the improvement of manufacturing and processing technology, automation control technology and various special needs of tablet press manufacturers, various special-purpose tablet presses have also appeared one after another. For example, ZP5 rotary tablet press for laboratory use, dry powder rotary tablet press for dry powder tablet pressing, explosion-proof ZPYG51 series rotary tablet press for gunpowder tablets, etc.
The status quo of tablet press at home and abroad:
Domestic Tablet Press Status
1. There are many specifications and large quantities of tablet presses. Although the tablet press is the pharmaceutical equipment with the longest production history in my country, it is also the pharmaceutical equipment that was exported earlier and has a large output. According to incomplete statistics: there are nearly 40 tablet press manufacturers in my country, with an output of nearly 2,000 units per year, and as many as 60 product specifications, which can press round tablets, engraved tablets, special-shaped tablets, double-layer tablets, multi-layer tablets, and ring-shaped tablets. chip, package chip and other chip types. It is an indisputable fact that the number, variety, specifications and output of tablet press manufacturers rank first in the world.
2. Easy to operate. In recent years, tablet press manufacturers have begun to pay attention to product quality, and most of them believe in the business philosophy of "winning by quality". Aiming at the characteristics of numerous domestic pharmaceutical manufacturers, various types of tablets, and small production scale. As a tablet press manufacturer, the tablet press products developed have the characteristics of simple operation, convenient and quick cleaning, especially when changing varieties, the clearing is quick and convenient.
3. The technical content is low, and the force behind technological innovation is insufficient. At present, more than 40 domestic pharmaceutical equipment companies produce more than 60 types of tablet presses.
Summary of the status quo of domestic tablet presses:
Although, new products are constantly being launched every year. But among them, there are not many varieties with high technical level and high added value. Repeated product development is serious, plagiarism is prevalent, and there are as many as dozens of tablet press manufacturers of a certain type. In order to survive, many small-scale pharmaceutical equipment companies not only adopt the "imitation" strategy in technological innovation, some manufacturers even completely rely on copying other people's technology as their own technological "innovation", and some even "shoddy". In order to compete for orders, prices are often lowered, because brand loyalty is low. After the price war started, these brands suffered even more, and now the brand is constantly depreciating. If this situation is not reversed, it will inevitably lead to the overall regression of the design and manufacturing level of tablet presses in my country.
The vast majority of enterprises in our country are private enterprises, which do not have advantages in technology, equipment, talents, etc., which seriously restricts the technological innovation of enterprises. Some enterprises lack research and development institutions, the innovation system is not perfect, technical personnel lack awareness of technological innovation, the overall technical strength of the enterprise is not strong, and the update speed of scientific research and production technology equipment is very slow. The most noteworthy thing is that the scientific and technological talents in the entire industry are in a stage of "short supply". It can be said that the talent crisis is spreading throughout the industry.
Status quo of foreign tablet presses
The gap between our tablet presses and tablet press technology with developed countries is still widening. High-speed, high-yield, airtight, modular, automated, large-scale and professional testing technologies are the most important development direction of foreign tablet press technology. Professional tablet presses are basically located in Europe and the United States, such as FETTE and KORSCH in Germany, MANESTY in the UK, COURTOY in Belgium, and STOKES in the United States. 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 are the goals that tablet press manufacturers have been pursuing for many years. At present, the major tablet press manufacturers in the world have tablet presses with an hourly output of 1 million tablets. For example, the Xpress700 tablet press produced by Manestry has a maximum output of 1 million tablets; the XL800 tablet press produced by Korsch has a maximum output of 1.02 million tablets/h; the ModulD tablet press produced by Courtoy has a maximum output of 1.07 million tablets /h; the 4090i tablet press produced by Fette Company has a maximum output of 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 the flow of people and goods.
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 from flying and particle stratification. The pressed tablets enter through sieves, in-tablet detection, metal detection, etc. Packaging process, the whole process is quite airtight. However, most of the domestic tablet presses are open or not completely closed during the tablet pressing process, and the broken process causes dust to fly between the tablets. With the in-depth implementation of GMP, the airtightness of the tableting process and the isolation of people and logistics have become particularly important. This is the basic function that we need to design and manufacture equipment.
3. Cleaning in place.
WIP (cleaning in place) tablet press greatly reduces 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 effectiveness of cleaning.
4.21 Application of CFR Part11 (electronic records and electronic signatures) on tablet presses.
1997年8月20日，FDA颁发的21CFR11第6部分“电子记录、电子签名（ER/ES）的有关条例规定开始生效。对电子签名和电子记录而言，本条例是强制执行的，此项条例的目的在于，可以为药业及食品的产品加工过程中引入电子技术而提供便利。其可以提供适用而又实用的指导方针，阐述如何通过电子形式来完成过去以书面形式完成的任务。电子记录指的是诸如文本、图形、数据、音频、图示或其他通过计算机系统所创建、修改、维持、存档、调取或分配的数字形式的信息表达之间的任意组合。电子签名指的是由个人执行、采用或授权，并经过计算机数据编译的任意一个或一系列符号，这些符合与个人手写签名具有同等的法律效力。21CFRPart11技术在压片机上的应用，使得压片机具有设备诊断记录日志、事故记录日志和警报提示日志。这些电子记录和电子签名上都详细地记录了各种操作数据、事故数据。符合安全进入控制，需要用户名和密码才能进入操作。所有数据都使用了电子签名功能，包括操作者姓名、日期、时间、序列号、问题、解决办法、工况数据。所有原始数据都是不可被人为地修改，保证了结果之可靠性和真实性。系统和用户存在的这些日志会自动存入整个“痕迹审查”文件夹。这些安全属性数据格式“保证了数据的变动是在整体检查控制下进 压片机行的。21CFRPart11技术目前已被世界各主要压片机厂商认同，并在其产品上广泛应用，国内在这方面还仅仅刚刚开始。
5.与整条生产线连接的控制技术。
The ability to connect a tablet press to a production line, both German and British tablet presses have this capability. It has start, end and speed adjustment functions. With this optional function, it can be reliably and automatically connected with other equipment of the production line, such as sieving, vacuuming, detection, conveying, barreling, etc., to complete the tablet pressing production task synchronously. At the same time, different monitoring methods are also used on the external equipment, which provides high security and reliability. The on-line Detector can be used to remove burrs, flashes and dust from 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) in the suction pipe within 10s, the tablet press will issue a fault alarm and stop running. This function better guarantees the reliability of production and can continuously remove dust during the production process of tablet pressing. The control technology connected with the whole tablet production line is a new technology of tablet production control and will be the development trend in the future. This technology has just started in CHINA.
6. Remote monitoring and remote diagnosis system of tablet press.
With the rapid development of computer high-tech such as network, broadband network and virtualization, the remote monitoring and remote diagnosis technology of equipment is also rising day by day. Computer-controlled tablet presses have been widely used in pharmaceutical factories, making advanced remote monitoring and remote diagnosis technologies useful in the tablet press industry. At present, remote monitoring and remote diagnosis functions are generally available on professional tablet presses in developed countries. The establishment of this system is also to realize the network dialogue between the technical support center (service party) and the user (user) of the tablet machine through the Internet, so that the service party can understand the faults of the user's tablet machine through the Internet in different places, and the tablet press. The machine is in the working state of executing the instruction, and then judges the fault of the tablet machine and proposes a feasible solution. 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 ability 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 processes of fault monitoring, analysis, feedback, release and real-time solution services, thereby ensuring the entire system effective operation.
