Observation and Discussion on Foreign Dry Granulator

Abstract: Taking the WP120Pharma dry granulator designed by Alexanderwerk Company of Germany as an example, the concept and technology of foreign dry granulation equipment are introduced, which can be used for reference by relevant domestic units.

Key words: dry granulator; WP120Pharma; equipment characteristics; structure and principle With the concept of quality from design (QualitybyDesign), pharmaceutical production process research and development and pilot test are increasingly being valued by the pharmaceutical industry, aiming to solve The current situation of many problems in the process of drug production from the process of experiment amplification to mass production.

Compared with the traditional wet granulation, the dry granulation method has the granular raw materials directly prepared to meet the user's requirements, without any intermediates and additives. After granulation, the product has uniform particle size and the bulk density is significantly increased, which not only controls pollution, but also controls the pollution. It also reduces powder and energy costs, improves material appearance and fluidity, facilitates storage and transportation, and controls many advantages such as solubility, porosity and specific surface area. It is especially suitable for wet mixed granulation and one-step boiling granulation. .

Based on the above two points, Germany Alexanderwerk has designed a new type of WP120Pharma dry granulator suitable for R&D experiments and pilot tests, which can be widely used in drug research and development departments or small batch production.

1 Equipment characteristics Because in the process of drug development or pilot test, in order to save costs, the production volume is usually relatively small, which is more obvious in some costly biopharmaceuticals. The TZ120 Pharma dry granulator has a small batch size of 5g/batch and has a granulation capacity of 8-40kg/h under continuous production, which makes the equipment fully meet the requirements of drug development and pilot testing.

In addition, the variety needs to be changed frequently in the R&D or pilot test, and the press cantilever mounting of the device makes it easy to disassemble and clean the equipment between different varieties. The R&D lab or pilot requires equipment with certain mobility and flexibility. The device is designed as a mobile unit and integrates the control and operator panels directly on the device (as shown in Figure 2) so that it can be different The place of use is quickly put into production.

In addition to the above characteristics, WP120Pharma is designed to meet the regulatory and technical requirements of the pharmaceutical industry: (1) the granulation device and the power unit are spatially separated; (2) the vertical alignment of the pressure roller eliminates the influence of gravity; (3) equipment Designed to comply with cGMP; (4) two-stage screening granulation system to ensure the production of qualified particles; (5) medical grade stainless steel; (6) all non-metallic materials meet FDA-related requirements; (7) automated PLC; (8) Optional functions: online cleaning; (9) optional functions: electronic records (in accordance with the relevant requirements of 21 CFR Part 11); (10) optional features: sound insulation; (11) can be carried out according to customer demand standards (URS) design.

2 Structure and principle 2.1 Structure WP120Pharma dry granulator is mainly divided into granulating device and power device, the two parts are completely isolated in space. The granulating device is mainly divided into 8 modules (as shown in Fig. 3): 1 is a feeding hopper; 2 is a screw feeding system; 3 is a pressing unit, a pressing roller; 4 is a pre-pressing unit; 5 is a sampling port; 6 is a two-stage screening granulation system; 7 is a sampling port; 8 is a particle outlet.

This equipment is different from the conventional granulator. The addition of 5 and 7 sampling ports is precisely the need to take frequent and multiple sampling in the process of process parameter analysis in drug development or pilot test.

2.2 Working principle of granulation 2.2.1 Drying process The basic principle of rolling process in granulation process is very simple. The dry powder or fine crystal material is pressed into a thin sheet by the pressing roller, and the quality of the flake determines the final particle of zui. quality.

The rolling pressure of the ordinary dry granulator and the gap of the pressure roller are relatively fixed, and the difference between different materials and different batches of the same material cannot be considered. The WP120Pharma dry granulator uses the new rolling control technology of Zui. The control equipment of the equipment can adjust the fluctuation of any physical properties between different materials and different batches of the same material (such as local unevenness), so that dry granulation Process parameters (such as throughput, sheet density, roll pressure, speed, etc.) can be precisely and repeatedly adjusted to efficiently produce high quality particles.

In addition, there is a clear, modular separation between the feed and roll processing of the apparatus, and the screw feed system 2 delivers the powder directly to the press roll 3 so that the roll press process does not affect the screw feed system. Initial suppression process.

2.2.2 Granulated granules usually have corresponding particle size requirements. Generally, the above lower limit forms indicate that particles exceeding the specified particle size and insufficient particle size do not meet the requirements. After the rolling treatment, the pre-pressed flakes are obviously larger than the upper limit of the size of the Zui final particles, and only after the pulverization of the granulation system can the zui final granules be produced. Moreover, the downstream processing of the Zui final granules (e.g., tableting) requires that the particle size fluctuations of the particles be controlled to a small extent.

In response to this problem, the granulation system of WP120Pharma adopts two-stage diagonal design, the * level is the pre-granulation device, the second stage is the Zui final granulation device, and the two-stage granulation system is adjusted by the control system to produce Particles with relatively stable particle size.

3 is more suitable for GMP

From the consumer's point of view, purity is an important attribute of pharmaceuticals; from the perspective of pharmaceutical manufacturers, equipment should have certain flexibility in function, especially for experimental or pilot equipment. The WP120Pharma dry granulator meets both of these requirements – clean and flexible. First of all, WP120Pharma is a completely closed dry granulation system, which can reduce the dust pollution in the production process, thus reducing the risk of pollution and pollution. Secondly, the equipment adopts a modular design, and the entire granulation device can use only a small amount of tools. It can be disassembled for easy cleaning of all modular units and the screw and press rolls can be easily replaced to suit different granulation tasks.

4 Conclusion At present, WP120Pharma has been widely used in laboratory or pilot plants to determine the process parameters in subsequent mass production. The process parameters measured on this equipment can be easily scaled up to large machines such as the WP200 Pharma manufactured by Alexanderwerk. It can be said that WP120Pharma is an ideal experimental dry granulator in the current drug development or pilot test.

(Research Center of Pharmaceutical Industry Development, China Pharmaceutical University, Nanjing 210009, China)

[references]

[1]Feng Xiongfeng.Characteristics of dry granulation and equipment and factors affecting dry rolling effect[J].Electromechanical Information,2006,4:49~50

[2] Liang Yi. GMP Course [M]. Beijing: China Medical Science and Technology Press, 2003

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