Pang Yushen
(Liaocheng Wanhe Industrial Manufacturing Co., Ltd., Liaocheng, Shandong 251022)
Abstract: This paper briefly introduces the meaning and classification of tablets, the process flow of tablet production, and focuses on the selection and use of tablet presses and molds.
    Key words: tablets; process flow; tablet production equipment; tablet press and mold selection and use
Solid preparations include tablets, hard capsules and pills, and tablets are a widely used dosage form in solid preparations. The oral tablet Zui has been popular and widely used since the late 19th century because of its advantages of taking, storing and carrying. Then, due to the continuous improvement and improvement of tablet processing equipment, especially the innovative use of new materials, new technologies, new processes and new structures, the rapid development and application of tablets has been greatly promoted. The connotation of tablets has expanded from the initial oral tablets of Zui to the production of tablets in the fields of food, chemical, electronics and automotive airbags.
Before describing how to select a tablet press and a mold, briefly introduce the meaning of some of the specific nouns to facilitate the description in Sections 2 and 3.
1 tablet
1.1 The meaning of tablets
It is prepared by pulverizing, mixing, granulating and tableting one or more materials with appropriate amount of auxiliary materials through tablet mechanical equipment.
1.2 Tablet shape classification
Generally divided into round pieces (including lettering, patterns), shaped pieces (including lettering, patterns), ring pieces, two-color pieces and package chips.
1.2.1 Â Â The circular piece is further divided into: a shallow concave shape, a deep concave shape, a planar oblique shape, a flat circular shape, and the like.
1.2.2 Â Â Shaped pieces are further divided into: oval, key shape, olive shape, diamond shape, polygon and irregular animal cartoon shape.
1.3 tablet production process
In a nutshell, it is a general term for the process of processing a raw material into a tablet.
1.4 tablet production machinery and equipment
It refers to the mechanical equipment for making tablets of various shapes by pulverizing, mixing, granulating, tableting, coating and packaging of raw materials and auxiliary materials.
2 tablet production main process and equipment
2.1   The tablet production process is the core of production, and the configuration design of production equipment is the means and tools to realize the core idea of ​​the process. Advanced tablet production equipment is matched to enable the process to be realized, and high-quality tablet products are produced. The two complement each other and are closely related.
2.2 Â Â Due to the different nature of each material, the process of tablet production differs from the processing equipment required, but the basic production process is: pulverization, mixing, granulation, tableting, packaging, and the like. Corresponding tablet production equipment includes: pulverizer, mixer, granulator, tablet press and packaging machine. The tablet press is one of the important equipments in the tablet production equipment. Since the tablet press is at the terminal stage of the process, it basically determines the quality index of the tablet (sheet weight, wafer weight difference, hardness, disintegration degree, etc.) ). In the tableting process, it is not enough to have a tablet press, and the matching die of the tablet press plays an important role. The relationship between the two is like the relationship between the gun and the bullet. How do users choose the tablet press and mold according to the requirements of the tablet being pressed? Let's talk about the explanation below and discuss it with the users.
3 Tablet press and mold selection and use
3.1 Selection and use of tablet press
3.1.1 Â Tablet press selection
Tablet press and tabletting technology is the main equipment and technology used in the solid preparation industry. It is also the main equipment and technology of Zui. It puts the granule or powder material into the die hole and presses it into a tablet by punch. Any kind of equipment has its own characteristics and requirements, and the tablet press is no exception. In the "Good Manufacturing Practices" (GMP), the following are the provisions for the design, selection and installation of pharmaceutical production equipment:
(1) Â Â The design, selection and installation of the equipment should meet the production requirements, easy to clean, disinfect and sterilize, easy to produce, operate and maintain, and prevent errors and reduce pollution.
(2) Â Â The surface of the equipment in direct contact with the drug should be smooth, flat, easy to clean or disinfect, corrosion-resistant, and not chemically react with the drug or adsorb the drug.
(3) Â Â Lubricants, coolants, etc. used in equipment must not cause contamination of drugs or containers.
(4) Â Â The operation of equipment installation, repair and maintenance shall not affect the quality of the product.
(5) Â Â Equipment for flammable and explosive positions shall be designed with explosion-proof function in accordance with relevant regulations.
The above are some general requirements for GMP on pharmaceutical tablet production equipment; it also has a certain reference for other types of tablet equipment.
Then, what kind of problems should the user consider when selecting the type of tablet press? The author believes that the user should first prepare what kind of tablets to be pressed according to the material of the pressed tablets, and then consider the production scale, output, tableting force, tablet diameter and whether there are special requirements. The following points are explained:
(1) Â Â There are many specifications and structures of the tablet press. From the structure, there are: single punching machine and multi-punch rotary tablet press; from the pressure of the tablet: 50kN to 50kN to 100KN and above 100KN; from the turntable speed: , Asian high-speed and high-speed tablet press three. The main technical parameters are listed in Table 1 for reference when selecting users.
Table 1: Classification of tablet presses, main technical parameters
class do not | Types of | Zui high turntable speed (r/min) | Zui high output (10,000 pieces / h) | Use die | Zui big tablet Diameter (mm) | Characteristics | application range | |
single Flush Pressure sheet machine | 50KN type | 0.6 | custom made | 12/24 | Simple structure and low price | Tablet laboratory, special small batch production of tablets | ||
100KN type | 0.3 | custom made | 40 | |||||
200KN type | 0.15 | custom made | 80 | Large pressing force, especially suitable for large diameter, difficult to press | Chemical, food, powder metallurgy, pesticide industry | |||
300KN type | 0.15 | custom made | 120 | |||||
many Flush spiral Pressure sheet machine | Ordinary medium speed type (80KN type) | 30 | 10 to 13 | ZP type | 13 | Economical and low operating costs | Medium-sized, small-volume tablet production | |
Fully automatic Subhigh speed (100KN type) | 40 | 18 to 25 | ZP type | 13 | Moderate speed, compact structure, high pressure, low operating cost and good cost performance | Large-scale, intensive tablet production | ||
I series | Type B | 16 | ||||||
Type D | twenty two | |||||||
T series | Type B | 16 | ||||||
Type D | twenty two | |||||||
Fully automatic High speed type (100KN type) | 50 | 30 to 33 | I series | Type B | 16 | Fast speed, high output, high automation and high operating cost | High-volume, large-scale, intensive tablet production | |
Type D | twenty two | |||||||
T series | Type B | 16 | ||||||
Type D | twenty two | |||||||
(2) Â Â Table 1 lists the main technical parameters, characteristics and application range of the tablet press. Customers can refer to the data in the table and select the type of tablet press in combination with their actual tablet. Then collect the presses. The product samples and technical data of the production enterprises are analyzed in detail.
(3) Â Â In the detailed comparative analysis of the product samples and technical data of each tablet press, special attention should be paid to the following technical indicators and other problems of the tablet press:
a , zui large tablet diameter - it determines the size of the tablet, but also affects the weight of the tablet.
b , zui large filling depth - it determines the tablet's large size requirements.
c , zui large tablet pressure - it affects the hardness requirements of the tablet.
d , zui large tablet thickness and zui large tablet diameter determine the size of the tablet.
e , zui large output - it determines the size of the production scale. In the actual calculation, the size of the production scale is generally estimated by 60 to 80% of the large output of Zui.
f , the model of the mold used - it affects the future operating costs of the equipment.
g , the level of electrical configuration and automation - put forward the corresponding requirements for the level of operational skills and the difficulty of maintenance.
h , the timeliness of the supply of accessories - affects the continuity of tablet production.
i , the timeliness of after-sales service and service attitude, etc.
(4) Â Â Combined with the above terms for comprehensive analysis, users can choose the tablet press equipment suitable for their own tablet production.
3.1.2 Â Â Use of tablet press
Correct and reasonable use and operation of the tablet press can extend the service life of the equipment and play its due role. During the use of the equipment, some of the faults are caused by improper operation and untimely maintenance. Pay attention to the following aspects when using:
(1) Â Â The operator should first read the instructions and operating procedures of the tablet press and be familiar with the performance and control methods.
(2) Â Â The die must be inspected strictly before normal use, and there must be no defects such as cracks, missing edges, deformation, etc., and it should be loose after installation. If it is unqualified, do not use it to avoid damage to the equipment.
(3) Â Â Granular raw materials are an important factor related to the ability to smoothly compress tablets. The quality of the granules should be controlled according to the process requirements, otherwise the quality of the tablets will be affected and the normal operation of the machine will also be affected.
(4) Â Â Tablet speed has an impact on tablet quality and equipment life. Generally, difficult-to-form materials and large-diameter tablets use slow speed, while easy-to-form small tablets use faster rotation speed.
(5) Â Â When the air is running, the filling amount should be increased to avoid the upper and lower punches colliding with each other and damaging the shape of the sheet.
(6) Â Â Do not arbitrarily disassemble the parts on the equipment. If the machine is found to have large vibration or abnormal sound during use, stop it immediately and use it after troubleshooting.
(7) Â Â The tableting room is recommended to clear the class at least once per shift. Some fine powder adheres to the punch, the punch hole and the middle die hole, which will cause the plug to punch. The punch is not flexible and affects the normal operation of the device.
(8) Â Â Regularly inspect and maintain wearable parts. Such as rail guides, pressure rollers, bridge plates and dies to prevent damage to individual machines due to damage to individual components.
(9) Â Â Stop down when the tableting speed is reduced to a low (<10 rpm) before stopping.
(10) Â Â Regularly refuel the equipment according to the instruction manual.
3.2 mold selection and use
3.2.1 Â Â Mold selection
At present, the domestic production of tablet press dies about ten several manufacturers, production scale and capacity uneven, ranging from the merits of product quality. In addition, there are about two or thirty kinds of molds, specifications and models, and the shape of the mold is as many as four or fifty. This brings certain difficulties to the mold selection work of pharmaceutical companies. The author believes that the three elements that determine the quality of the mold are: size, material and heat treatment. After comprehensive analysis, we can summarize four selection points and methods:
(1) Does the mold mounting size match the selected tablet press model and the die used?
The main installation dimensions of the standard type die currently produced in China are listed in Table 2. The user can select the die according to the size of the watch and the die described by the tablet press. Under normal circumstances, it is recommended that users use standard type die, the advantages are: a, standard specifications are delivered in a timely manner, b, the price is cheap, c, the operating cost is low.
The mold installation dimensions outside Table 2 are generally non-standard dies designed by users according to their own special needs, which meet the needs of different customers for tableting, but the price and running cost are relatively high; the delivery time is longer.
Table 2: Main installation dimensions of domestic standard die
Executive standard | model | Mold installation size (mm) | Zui big tablet Cross-sectional area (m2) | |
JB20022-2004 Tablet Press Pills | ZP type | Punch: diameter × total length = Ф 22 × 115 Medium mode: diameter × height = Ф 26 × 22 | 180 | |
JB/T20080.1-2006 "High speed tableting die ( T series) | T system Column | Type B | Punch: diameter × total length = Ф 19 × 133.35 Medium mode: diameter × height = Ф 30.16 × 22.23 | 200 |
BB type | Punch: diameter × total length = Ф 19 × 133.35 Medium mode: diameter × height = Ф 24 × 22.23 | |||
Type D | Punch: diameter × total length = Ф 25.35 × 133.35 Medium mode: diameter × height = Ф 38.1 × 23.81 | 380 | ||
JB/T20080.2-2007 "High speed tableting die ( I Series) | I system Column | Type B | Punch: diameter × total length = Ф 19 × 133.6 Medium mode: diameter × height = Ф 30.16 × 22.22 | 200 |
BB type | Punch: diameter × total length = Ф 19 × 133.6 Medium mode: diameter × height = Ф 24 × 22.22 | |||
BBS type | Punch: diameter × total length = Ф 19 × 133.6 Medium mode: diameter × height = Ф 21 × 22.22 | |||
Type D | Punch: diameter × total length = Ф 25.35 × 133.6 Medium mode: diameter × height = Ф 38.1 × 23.81 | 380 | ||
It should be noted that in the standard die shown in Table 2:
The standard stamping die of a and ZP has been implemented by the Ministry of Health since the 1970s, and later revised to the national standard. In 2004, it was revised to the industry standard. It is a true domestic brand. It is widely used in domestic applications. It is suitable for medium and low speed rotary tablet presses, and is also suitable for sub-high speed rotary tablet presses with low operating costs.
b , T series standard die is modified using the American Pharmaceutical Association 2005 version of the "Pressing Machine Specifications Manual", the tablet die from the former IPT to TSM tablet die, and is different from the European EU tablet die. It is beneficial to domestic tablet presses and molds for the needs of the US market, but the operating costs are relatively high.
c , I series standard die is mainly based on the content of ISO18084:2005 (E) "Pressing Die" (English version) formulated by the International Organization for Standardization Technical Committee. It is beneficial to domestic tablet presses and molds for the European market, but the operating costs are relatively high.
d , T series and I series molds are suitable for high speed rotary tablet presses and can also be used on sub-high speed and medium and low speed rotary tablet presses.
(2) Does the punch diameter and shape of the mold meet the size requirements of the tablet?
This content can be searched according to the three criteria listed in Table 2. The standard sheet size table is listed in the standard. For the sheet size not available in the table, users can provide customized tablet sample mapping, no longer here. Detailed.
(3) Is the material of the mold guaranteed? Do you meet your own requirements?
There are many material grades for making molds, generally: carbon tool steel (such as T7 ~ T12), bearing steel, cold work die steel (such as high speed steel, anti-wear steel, impact steel), hard alloy and ceramic materials, The use of imported mold steel. Domestic bearing steel is used as the die material. In short, no matter which material is used, the mold should have two characteristics of wear resistance and impact resistance.
The materials used in the mold are different, and their cost, price, service life and mechanical properties are also different. The material used for the die of the variety specification is different, and the price difference is 1 to 2 times. When purchasing a mold, the user should try to purchase a large-scale, powerful, and more regular manufacturer. Special requirements can be explained to the mold manufacturer and assisted by the manufacturer.
In addition, the choice of materials has a direct relationship with the price of the mold, do not blindly pursue low-cost molds, and do not pursue one-sided pursuit of high prices. Users should consider the cost, cost performance and reliability of mold operation. "It is suitable to use the right type of selection." This sentence has some truth.
(4) Does the heat treatment quality of the mold meet the standard requirements?
The quality of the heat treatment of the mold determines the intrinsic quality of the mold, which is manifested in the wear resistance, mechanical toughness and service life of the mold. The heat treatment hardness of common die steel is generally specified in the standard: 55-60HRC for punching and 60-65HRC for medium die. The internal metallographic structure of the heat treatment is also detailed in the standard (omitted).
Under normal circumstances, the quality index of the heat treatment is not convenient for the control and measurement when purchasing the mold. Instead, the mold manufacturer is required to strengthen the internal quality control during the production process to provide users with high quality and low cost molds.
3.2.2 Use of the mold
In tablet manufacturers, tablet presses and dies are devices that directly compress granules into tablets. As the main consumables of the tableting process, the mold is very large. In the process of tableting, since the die is mainly subjected to axial alternating load, the axial force it receives is generally 50-100 KN, and this force has a large loss to the die. Proper and reasonable use can guarantee the quality of the tablets and the service life of the mold, thus reducing operating costs.
The items that should be paid attention to during the use of the mold are:
(1) The die-making section shall be provided with a die chamber, and a special person shall be responsible for the verification, inspection, maintenance, storage and distribution of the mold.
(2) Check the roughness of the mold before and after use to check whether the sheet has curling, cornering, bursting and abrasion; the sheet surface of the lettering die should be bright to prevent the sheet and the tablet from being unclear and pressed. When the film is laminated, etc.
(3) In order to prevent the difference in the weight of the sheet, it is necessary to control the consistency of the length of the punch. Especially when new and old die are used, it is necessary to pay attention to the consistency of length.
(4) The adjustment of the tableting force should be as small as possible, according to the hardness of the tablet; do not use the pressure and overpressure for the pursuit of the harder the film.
(5) When loading and unloading the mold, press the operating instructions of the tablet machine.
(6) After the sheet is finished, the die should be removed in time, wiped clean and oiled in time to prevent rust.
4 Conclusion
China's pharmaceutical equipment has developed in a comprehensive, long-term and leaping manner in the past decade, which has greatly promoted the comprehensive development of China's preparation industry. However, there are still some gaps in the technical level of pharmaceutical equipment compared with internationally renowned brands, such as online cleaning and in-situ cleaning of pharmaceutical machines. Even the pharmaceutical technology of South Korea and India, which used to lag behind us, has also caught up. As the Secretary-General of China Pharmaceutical Equipment Association Shi Qing said: "China is a big country of medicine, but it is not a strong country of medicine technology." This article summarizes the current status of China's pharmaceutical equipment. China's pharmaceutical machinery manufacturing industry has a long way to go and there is still a lot of room for development. In the future, manufacturers of pharmaceutical equipment should strengthen the close integration with users and closely combine with the preparation process to create more advanced, more reliable and more practical tablet production equipment.
Part of the content and viewpoints in this article is to explain the selection and use of tablet production equipment-tableting machine and mold from the user's point of view. The purpose is to strengthen the technical exchange, experience communication and use experience between the equipment manufacturing enterprise and the customer. If it can give a little guidance to the equipment manufacturer, it is the intention of this article.
About the author: Pang Yushen (1964-), male, Liaocheng, Shandong Province, engineer, research direction: design and development of tablet equipment and molds and process manufacturing.
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