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Tablet Press Machine

Tablet Press Machine

 
The Tablet Press is mainly used for tablet process research in pharmaceutical industry. The tablet press machine presses the pellets into a circular, profiled, and automatic continuous production device with text, symbols, and graphic sheets having a diameter of no more than 13 mm.
 

Chinese Name: 压片机 English Name: Tablet Press Machine, Tablet compression machine
Classification: Single punch tablet press, flower basket tablet press Usage: Tablet technology research in pharmaceutical industry
 

The Contents

1. Definitions
2. Classification
3. Structure Composition
4. Development history
5. Development status
    -In domestic of China
    -In Abroad
6. Summary
7. Working Principle


I. Definitions

Definitions for Tablet Press: According to the terminology standard, the tablet press has the following definitions:
 
1. Tablet Press Machine:A machine for pressing dry granules or powdered materials into tablets by means of a mold.
2. Single Punch Tablet Press: a tablet press with a pair of molds for vertical reciprocating motion
3. Rotary Tablet Press Machine: A tablet press that is vertically reciprocated by a plurality of pairs of dies that are evenly distributed on the rotary turret.
4. High Speed Rotary Tablet Press:The rotary tablet press with a linear speed of the mold rotating with the turntable of not less than 60 m/min.


II. Classification

The models can be divided into single punch press, flower basket press, rotary tablet press, sub-high speed rotary tablet press, automatic high speed tablet press and rotary core tablet press
 

III. Structure Composition

A machine in which a granule or powder material is placed in a die hole and pressed into a tablet by a punch we can call it tablet press.
 
The earliest tablet press consisted of a pair of dies, which were pressed up and down to press the granular material into a sheet. This machine was called a single punch machine and later developed into an electric basket tablet press.The working principle of these two types tablet press is still in one-way tablet pressing based on manual stamping, that is, the undershoot is fixed when the tablet is pressing, and only the upper punching motion is pressurized. In this manner of tablet press, the density of the inside of the tablet is not uniform due to the inconsistent force on the upper and lower sides, and problems such as splitting are likely to occur.
 
In view of this disadvantage of existing unidirectional tablet pressing machine, a rotary tablet compression machine bidirectional multi-start punching was burn. The tablet press is uniformly pressed up and down, so that the air in the drug particles has a sufficient time to escape the die hole, thereby improving the uniformity of the tablet density and reducing 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.
 
The rotary tablet press is a machine in which a plurality of pairs of dies which are evenly distributed on the turntable are moved in a circular motion according to a certain trajectory, and the granular material is pressed into a tablet by a pressure roller. The tablet press with the linear speed of the turret rotating with the turntable is ≥60m/min. It is called high-speed rotary tablet press. This high-speed rotary tablet press has a forced feeding mechanism. The machine is controlled by PLC and has automatic pressure adjustment and control. The functions of weight, elimination of waste, printing data, display of fault shutdown, etc., in addition to the control of the difference in weight of the film within a certain range, can automatically identify and eliminate quality problems such as missing corners and loose pieces.
 
The sheet shape pressed by the tablet press is mostly flat and round, and later developed into a shallow circular arc shape and a deep circular arc shape on the upper and lower sides, which is required for coating. With the development of special-shaped tablet presses, the tablet shape such as oval, triangular, oblong, square, diamond, and circular are coming out. In addition, with the continuous development of the preparation, special preparations such as double-layer, three-layer, and core-free are prepared according to the requirements of the compound preparation and the time-release preparation, which are all required to be completed on a special tablet compression machine.
 
With the development of market demand, the scope of application of tablet presses is becoming wider and wider. It is no longer limited to suppressing Chinese and Western medicine tablets, but also can widely suppress health foods, veterinary tablets, and chemical tablets: Such as camphor ball hygienic ball, washing block, Smurf block, art powder cake, pesticide tablets, etc., food tablets: chicken fine block, Banlang root block, Shenqu tea block, compressed biscuits and so on.
 
The working process of the tablet making machine  The working process of the tablet press can be divided into the following steps:
 
1. The punch portion of the lower punch (with its working position facing 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. Filling medicine into the middle mold hole with a doser
3. The punching part of the upper punch (with its working position facing down) falls into the middle die hole from the upper end of the middle die hole, and descends a certain stroke to press the powder into tablets.
4. Undershooting, the tablet is pushed out of the middle die hole to complete a tablet processing.
5. Undershoot down to the original position and prepare for the next filling.
 
IV. Development History
 
The tablet press appeared earlier in Europe and the United States, nearly one hundred years history. But in China in 1949, the Tianxiang Huaji Iron Works in Shanghai resembled the British-style 33 punching machine; In 1951, according to the US 16 punching machine changed into a domestic 18 stamping machine, this is the earliest pharmaceutical machinery manufactured in China. In 1957, the ZP25-4 tablet press was designed and manufactured. In 1960, the 60-30 type tablet press was designed and manufactured by ourselves. It has the functions of automatic rotation and tablet compression. The pressed varieties include tablets, sugar tablets, calcium tablets and coffee tablets. In the same year, the ZP33 and ZP19 tablet presses were also designed and manufactured.
 
In the 1970s, Shanghai No. 1 Pharmaceutical Machinery Factory (predecessor of Shanghai Tianxiang) and Shandong Medical Instrument Factory began to produce ZP series tablet presses as fixed-point manufacturers of tablet presses. During the "Seventh Five-Year Plan" period, the HZP26 high-speed tablet press of the Aerospace Department 206 was successfully developed. In 1980, Shanghai No. 1 Pharmaceutical Machinery Factory designed and manufactured the ZP-21W tablet press, which reached the advanced level in the early 1980s and is the first domestic product in China. In 1987, the introduction of Federal Republic of Germany Fette company computer control technology, design and manufacture P3100-37 rotary type tablet pressing machine having the automatic control of the tablet weight, pressure, number of sheets automatically, automatically removed waste film etc., tightly closed structure, purification the extent to GMP requirements.
 
In the 21st century, with the deepening of GMP certification, ZP series rotary tablet presses that are fully GMP-compliant have appeared one after another: ZP35A in Shanghai and ZP35D in Liaocheng, Shandong. The high speed rotary tablet press has made great progress in the production, pressure signal acquisition, waste rejection and other technologies. The maximum output is generally more than 300,000 pieces / hour, the maximum pre-pressure is 20kN, and the maximum main pressure is 80kN or more. For example, GZPLS-620 series high speed rotary tablet press from Beijing Sinopian Longli Technology Co., Ltd., GZPK3000 series high speed rotary tablet press from Shanghai Tianxiang Jiantai Pharmaceutical Machinery Co., Ltd., and PG50 series high speed from Beijing Aviation Manufacturing Engineering Research Institute Rotary tablet press, etc. With the improvement of the manufacturing process level, the automation control technology and the various special needs of the tablet press manufacturers, various special-purpose tablet presses have also appeared. For example, the laboratory uses ZP5 rotary tablet press, dry powder rotary tablet press for dry powder tablet pressing, and explosion-proof ZPYG51 series rotary tablet press for gunpowder tablets.

 

V. Development status

A. In domestic of China



1. There are many specifications and a large number of tablet press machines. The tablet press is the oldest pharmaceutical equipment in China, and it is also the earliest export and the largest output. It can suppress the shape of a circular piece, an engraving piece, a shaped piece, a double layer piece, a multilayer piece, a ring type piece, a package chip, and the like. The number, variety specifications and output of the tablet press manufacturers rank first in the world.

2. In recent years, the manufacturers of tablet presses have begun to pay more attention to the product qualities, and believe in the business philosophy of “winning by quality”.The tablet presses developed have the characteristics of simple operation and convenient and quick cleaning. Especially when changing varieties, the clearance is quick and convenient.
3. The technical content is low and the technical innovation is insufficient. More than 40 domestic pharmaceutical equipment companies produce more than 60 varieties of tablet presses. Although new products are being introduced every year, there are very few varieties with high technical level and high added value. Product duplication is serious, and plagiarism is rampant. In order to survive, many small-scale pharmaceutical equipment companies not only adopt a "imitation" strategy in technological innovation, but some manufacturers even rely on others' technology to "innovate" their own technology. In order to compete for orders, they often resort to price reduction. Because the brand loyalty is low, after the price war is launched, these brands are more disadvantaged, which will inevitably lead to the overall retrogression of the design and manufacturing level of China's tablet presses.
4. Most of China's enterprises are private enterprises, and they do not have advantages in technology, equipment and talents, which seriously restricts technological innovation of enterprises. Some enterprises lack R&D institutions, the innovation system is not perfect, the technical staff lacks the awareness of technological innovation, the overall technical strength of the enterprise is not strong, and the update speed of scientific research production technology equipment is very slow. The most noteworthy is that the entire industry technology professionals are in a "lean" stage. It can be said that the talent crisis is spreading throughout the industry.
 

B. In Abroad

The gap between our tablet press machine and tablet compression technology in developed countries is still widening. High speed, high output, airtight, modular, automated, large-scale and advanced detection technologies are the most important development direction of foreign tablet press technology. The 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 are highly automated and meet FDA requirements and 21CFRPART11 requirements.



1. High speed and high output. High-speed and high-yield is the goal that the tablet press manufacturers have been pursuing for many years. The main tablet press manufacturers have a tablet press with an output of 1 million pieces per hour. The maximum output of the ModulD type tablet press produced by Courtoy is 1.07 million pieces/h. The 4090i tablet press produced by Fette has a maximum output of 1.5 million pieces/h. Its output is much higher than the output of domestic tablet presses. If domestic tablet presses have to catch up with foreign countries in terms of speed output, and there is a long-term development in the design innovation, processing technology and automatic control of tablet presses.
2. The sealing of the tablet press processing and the isolation of people and logistics. The sealing performance of the input and output of foreign tablet presses is very good, and cross contamination is reduced as much as possible. The granules for tablet pressing enter the hopper through the closed barrel and the closed conveying system. During the tablet compression process, effective means are taken to prevent dust flying and granule stratification. The pressed tablets enter through the sieve, the sheet detection, the metal detection, etc. In the packaging process, the whole process is quite closed. However, most of the domestic tablet presses are open, or are not completely sealed, and the process of breaking causes the dust to fly between the tablets.
3. In-place cleaning. The CIP (in-place cleaning) tablet press greatly reduces the cost of user equipment. To improve the cleaning function of the tablet press, in addition to the design to fully consider the cleaning of each part, the cleaning function of the tablet press emphasizes the detachability, and only the convenient and quick disassembly can ensure the thoroughness of the cleaning.
4. Application of electronic records and electronic signatures on the tablet machine. On August 20, 1997, the relevant regulations of the 21st part of 21CFR11 “Electronic Records, Electronic Signature (ER/ES) issued by the FDA came into effect. This regulation is enforced for electronic signatures and electronic records. The purpose of this regulation is to facilitate the introduction of electronic technology into the processing of pharmaceuticals and food products. It provides practical and practical guidelines on how to accomplish tasks that were previously done in writing in electronic form.
 
Electronic records refer to any combination of information such as text, graphics, data, audio, graphics, or other forms of information that are created, modified, maintained, archived, retrieved, or distributed by a computer system. An electronic signature refers to any one or series of symbols that are executed, adopted, or authorized by an individual and compiled by computer data, which is equivalent to the legal effect of a personal handwritten signature.



 
The application of 21CFRPart11 technology on the tablet press enables the tablet press to have a device diagnostic log, an accident log, and an alert log. Various operational data and accident data are recorded in detail on these electronic records and electronic signatures. Compliance with security access control, requires a user name and password to enter operation. All data uses electronic signatures, including operator name, date, time, serial number, problem, solution, and condition data. All raw data cannot be artificially modified to ensure the reliability and authenticity of the results. These logs for the system and user are automatically saved to the entire Trace Review folder. These security attribute data format "to ensure the variable data is carried out under the overall control of inspection
 
5. Control technology connected to the entire production line. To a tablet press machine can be connected to a production line, Germany and the UK tablet machine having such a function are. It has start, end and speed adjustment. With this option function, it can be reliably and automatically connected with other equipment of the production line, such as sieve, vacuuming, detection, conveying, barreling, etc., to simultaneously complete the pressing production task of the tablet.
At the same time, different monitoring methods are adopted on the external equipment, which provides high safety and reliability. The on-line detector can be used to remove burrs, flash and dust from the pressed tablets. The vacuum monitoring function uses a flow monitor to periodically detect the suction pressure at a specified 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 for 10s, the tablet presser will give a fault alarm prompt and stop running. This function maximizes the reliability of production and continuously removes dust from the tablet during production. The control technology connected to the entire tablet production line is a new technology for tablet production control and is a future development trend. This technology has just started in China.
 
6. Remote monitoring and remote diagnostic system. With the rapid development of computer high-tech such as network, broadband network and virtual, remote monitoring and remote diagnosis technology of equipment is also emerging. Computer-controlled tablet presses are beginning to be widely used in pharmaceutical companies, making remote monitoring and remote diagnostics a useful tool in the tablet press industry. Remote monitoring and remote diagnosis functions have been widely used on advanced tablet presses in developed countries.
 
The establishment of such a system is also to achieve a network dialogue between the technical support center (servant) and the tablet press user (user) via the Internet, so that the service party can understand the fault of the user tablet machine through the Internet in different places, and press The machine is in the working state of the command, and then judges the failure of the tablet press and proposes a feasible solution.
 
Through the establishment of the remote monitoring and remote diagnosis system of the tablet press, the fault 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 equipment, network construction, hardware facilities, software selection, etc., to complete the fault monitoring, analysis, feedback, release and real-time solution services to ensure the entire system run effectively.

 

VI. Summary

At present, the development direction of foreign tablet press technology is to be intelligent, flexible, precise and meet the requirements of GMP. The high-tech content of products is continuously improved, and the automation technology and numerical control technology of machinery, gas, liquid, light and magnet are integrated. Sensor technology, new material technology, etc. are widely used in tablet presses.
 
The domestic design and production level of tablet press has been greatly developed in recent years, but there is still a big gap compared with foreign tablet presses. The development of domestic tablet presses has a long way to go, and we need to constantly working hard.
 
In recent years, with the deepening of pharmaceutical factory GMP transformation, the production of tablet press has also developed to an unprecedented level. According to the latest statistics of China Pharmaceutical Industry Equipment Association, the sales volume of rotary tablet presses in China has reached 1,627 units in 2003. Compared with 2002, it has increased by 9%. There are 31 manufacturers in production and 176 high-speed tablet presses, which is 16% higher than that in 2002. There are more than 40 kinds of products. There are many specifications and large quantities of tablet presses. Although the tablet press is the oldest pharmaceutical equipment in China, and the earliest export and largest output of pharmaceutical equipment, according to incomplete statistics: China's tablet press manufacturers nearly 40, the output is nearly 2,000 sets / year, product specifications Up to 60, can be pressed round, engraving, heterosexual, double-layer, multi-layer, ring, package chip and other film types. It is an indisputable fact that the number, variety specifications and output of the tablet press manufacturers rank first in the world. The tablet press is suitable for pharmaceutical, food, coal, chemical, metallurgy, building materials, refractory and other industries. Each type of dry and wet powdery granular material can be pressed into a round piece or a special shape.
 
Punching and die: Punching and die are the basic components of the tablet press. As shown in Figure 14-7(a), each die consists of three parts: upper punch, middle die and lower punch. The structure of the upper and lower punches is similar, and the punch diameters are also equal. The upper and lower punches are matched with the die holes of the middle die, and can slide freely up and down in the middle die hole, but there is no gap that can leak the powder. Die processing dimensions are uniform standard sizes and are interchangeable. The specifications of the die are expressed by the diameter of the punch or the diameter of the middle die, which is generally 5.5-12 mm, and each 0.5 mm is a specification with 14 specifications.


VII. Working Principle

Punches and dies are subjected to a large pressure during the tablet press process, and are usually made of bearing steel (such as crl5) and heat treated to increase their hardness.
 
There are many types of punches, and the shape of the punch depends on the shape of the tablet. According to the shape of the die structure, it can be divided into a circular shape and a special shape (including a polygonal shape and a curved shape); the shape of the cross section of the punch has a planar shape, a beveled shape, a shallow concave shape, a deep concave shape and a comprehensive shape. The flat and beveled punches are used for pressing flat cylindrical tablets, the shallow concave shape is used for pressing biconvex tablets, the deep concave shape is mainly used for pressing the coated tablets, and the integrated shape is mainly used for pressing shaped piece. In order to facilitate the identification and taking of drugs, the name of the drug, the dose and the vertical and horizontal lines can also be engraved on the end face of the die. For tablets of different doses, a suitable size should be selected.

 
Working process of the Pharmaceutical tablet press  The working process of the tablet press can be divided into the following steps:
 
1. The punch portion of the lower punch (with its working position facing 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. Filling medicine into the middle mold hole with a doser
3. The punching part of the upper punch (with its working position facing down) falls into the middle die hole from the upper end of the middle die hole, and descends a certain stroke to press the powder into tablets.
4. Undershooting, the tablet is pushed out of the middle die hole to complete a tablet processing.
5. Undershoot down to the original position and prepare for the next filling.

 
Working Principle for Tablet Making Machine:
1. Dosage control. Various tablets have different dosage requirements, and large dose adjustments are achieved by selecting dies of different punch diameters, such as punches having diameters of 6 mm, 8 mm, 11.5 mm, and 12 mm. After the die size is selected, the slight dose adjustment is made by adjusting 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, and adjusting the filling volume of the drug in the die hole. Therefore, there should be a mechanism on the tablet press to adjust the original position of the undershoot in the die hole to meet the dose adjustment requirements. This adjustment function is necessary because of the difference in specific volume of different batches of powder.
 
In the dose control, the action principle of the feeder also has a considerable influence. For example, the granular drug is self-weight, and when it is freely rolled into the middle die hole, the filling condition is loose. If multiple obsessive-entry methods are used, more holes will be filled in the mold holes, and the filling situation will be more dense.
 
2. Tablet thickness and degree of compaction control. The dose of the drug is determined according to the prescription and pharmacopoeia and cannot be changed. For the storage, storage and disintegration time limit, there is also a requirement for a certain dose of pressure during tablet press processing, which will also affect the actual thickness and appearance of the tablet. Pressure regulation during tablet pressing is essential. This is achieved by adjusting the amount of downstroke in the die hole. This is achieved by adjusting the amount of downstroke in the die hole. Some tablet presses not only have the upper punching down action during the tablet press process, but also have the undershooting up action, and the pressing process is completed by the up and down punching relative motion. However, the pressure regulation is mostly to achieve pressure regulation and control by adjusting the mechanism of the upper stroke.