The entire production line wire uses a full enclosed negative pressure, and the production site will never have dust and dust pollution. With PLC programming control, safety measures are multi-visual, parallel work, only one of the measures can effectively function, to eliminate safety hazards. In terms of security, the inert gas protection airflow pulverization classifier mainly has the following characteristics: isolation oxygen. In the process, the oxygen content tester continuously monitors the oxygen content in the airflow, and nitrogen is supplemented immediately when it exceeds some extent, so that the oxygen content is always maintained within the safety production standard. Control the gas powder concentration: The feeding system supporting the feature is fully closed, uniform, and is controlled by the control cabinet. Fully enclose the effect of isolating oxygen, uniform speed, controls the material concentration inside the added device, and can be arranged any. Timely release of static electricity and elimination of fire: Pulse anti-blow collector with carbon wire special filter material, can eliminate static electricity in time while ensuring pulse clear ash clean thoroughly. The equipment is all metal components, all grounded to try to release powder static electricity. Circulation cooling: explosion-proof dustproof, emergency stop.
A product of
raw material drug micro powder generally refers to a product having less than 20 um. The gas flow of fine powder is a process of pulverizing particles or powders of large particles or powder into a smaller particle or powder, which is generally required to be crushing. The product particle diameter is less than 20 um. The purpose is to reduce the particle size, increase the specific surface area, and increase the distribution section of the demand particle size.
The significance of drug pulverization is: 1) The drug after pulverization is conducive to the dissolution and absorption of solid drugs, and can improve the bioavailability of the difficult soluble drug; 2) The drug after pulverization is advantageous for the suspension or solid preparation. The mixing homogeneity of the component, the mixing degree is related to the particle size of each component; 3) The pulverized drug is advantageous to increase the dispersibility of the solid drug in the liquid, semi-solid, gas, and improve the utilization of the drug.
The airflow pulverizer is mainly divided into two types of hits and cyclones. Its working principle is to use compressed air (or nitrogen) as a power, and the material that will be pulverized to high speed movement in the pulverizer, so that it has collided with the inner chamber of the pulverizer, mainly to change the particle size of the material and Its surface activity, etc. It can change the particle size of the material to between 1 um to 100 um. Below, I will combine my own experience to make some preliminary discussions on drug micro-powder.
The cyclonic pulverizer affects the micro-powder crushing effect during use.The factors mainly have the following aspects.
1) The reason for affecting the particle size of the product is mainly pulverized material feed speed and pulverization pressure. Crushing pressure is the most important control parameter, the same material at the same feed, the larger the crushing pressure, the larger the parameters of the unit product, the collision is better.
2) The higher particle size after the higher pulverization pressure is smaller, but the product is limited to the product particle size after the product is less than 13bar. If the material of the crushing pressure reaches 13bar, the material remains does not reach the results we need, it is recommended to find other more suitable pulverization methods.
3) Change the product particle size distribution after the pulverization can be achieved by adjusting the distribution tube and the classifier of the gas flow pulverizer. In the case where the pulverization pressure and feed speed do not change, the smaller the particle size is obtained.
(1) The distribution tube of the gas flow pulverizer can be adjusted to the lowest end, which can increase the amount of residence time in the airflow pulverizer, and the increase in residence time is equal to the increasing collision time of the product, and the pulverization effect is better.
(2) The classifier of the gas flow pulverizer can be adjusted to the uppermost end. The classifier is adjusted to the uppermost end corresponding to the space within the classifier, and the airflow energy loss in the pulverized material is reduced, and the pulverization is reduced. The effect is natural. In practice, in the actual production, the distribution tube and classifier of the adjustment gas flow pulverizer are generally used to achieve the best effect.
4) The selection of the gas flow pulverizer, especially the influence of the character shape of the pulverizer to the product particle size. Discy, there is generally two cases of excessive transition and elliptical in vivo. The crushing of the right angle transition is not a collision speed, and the crushing effect is not ideal. Materials with elliptical transitions in the crusher cavity will form a cyclone with gas flow, and the crushing effect has obvious improvement. However, the manufacturing process of the elliptical transition machine machine has more complex determined a one-time input cost, which requires the company to select rationally according to their own needs.
5) Upper and lower classifiers. Select the device with a top and bottom classifier as much as possible when the pulverizer is selected. The upper and lower classifier can prevent large material materials from entering the upper portion of the upper portion and enter the gas-solid whirlwind separator with gas. Therefore, the airflow pulverizer selected by the upper and lower classifier can effectively reduce the tip of the large particulate material on the particle size, so that the productThe particle size distribution is more concentrated.
6) The angle of airflow pulverizer accelerates the nozzle. The angle of the accelerating nozzle determines the time of the material to stay in the gas flow pulverizing cavity, and the particle size after the material is pulverized. Accelerating the nozzle and the center of the pulverizer, the shorter the time of the product, the greater the particle size. In production practice, it demonstrates that the accelerating nozzle and the airflow pulverizer are at 30 ° ~ 40 °, the finest angle is the best angle.
7) Airflow pulverizer accelerates the diameter of the nozzle. The larger the diameter of the nozzle, the greater the amount of air in the unit time, the larger the energy from the unit product, the smaller the product particle size.
8) The angle of airflow pulverizer feed nozzle. The angle of the feed nozzle determines the initial speed of the material in the outer chamber of the pulverizer, by adjusting the initial speed of the material in the outer chamber by using different angles, the material is passed through the accelerated nozzle by accelerating the nozzle by accelerating the nozzle. In the inner cavity of the machine, it is possible to obtain a product of a relatively smaller particle size.
9) Selection of airflow pulverizing cavity material: If the material is viscous and the hardness is not too high, the PTFE material can be used, and the cavity of the PTFE material can effectively avoid a large amount of material adhesion in the pulverizer cavity. Indoor wall; high hardness material uses stainless steel lumen, stainless steel quality inner hardness, basically meets the majority of large enterprises to crushing, and it is also easy to clean and maintenance, if it is a sterile product, It can support online pure steam sterilization. Most of the aseptic pharmaceutical enterprises use 316L material in the inner cavity; for material, stainless steel, the inner chamber of stainless steel can not satisfy the production needs, ceramic material can be selected. The cavity, the cavity of the ceramic material has the advantages of hardness, wear resistance, etc., but it also has difficulty in maintenance, and cannot be inadequately sterilized in line with pure steam sterilization.
10) Touching the cultivation chamber in the chamber of the chamber during the pulverization of the material, the main reasons are:
(1) The material is viscous, and the material can reduce the viscosity of material (eg, by reducing the material). Water content to reduce product viscosity).
(2) There is too much material in the cavity, and can be solved by reducing the feed speed.
11) If the above method cannot achieve the ideal and crushing material, it can be considered to use a deep cold pulverization method.Crush the material. It is best to use nitrogen, nitrogen, and there is no condensed water after cooling. If the compressed air is used, if the cooling, the cold aggregate will be frozen, and the wandering will break the filter cartridge with the gas. In the actual application, the gas is generally cooled to -4 ° C by a cold dryer, and the material temperature will decrease after the material and the material after cooling, and the viscosity will also reduce the material surface tension change to make the material brittle, more It is easy to reach the requirements of smashing to smaller particle size. Because the material is heat-generated during the crash, the material temperature will rise, so this method is especially suitable for thermal materials. The disadvantage of this method is that the technical requirements are too high, and the equipment is investigated, and the operating cost is high.
2 There is often problems during the pulverization process
1) The mill is worn too fast. (1) The material hardness is too large, and the inner cavity of the pulverizer of the appropriate material should be selected. (2) The equipment operates for a long time, which requires a periodic replacement loss consumption.
2) Uniform product is uniform. The products after the crushing products are generally single peaks, and if there is a double-peak or peak, it is:
(1) The pulverization pressure is unstable. Solution: Based on the air supply of gas source equipment to meet the amount of gas required for work, it is ensured that the lowest air supply pressure of the gas is 2 to 3 bar than the working pressure.
(2) The feed speed is unstable. Solution: Check if there is a blockage at the feed valve; the material is not very viscous, uniform in liquidity, and the stable control feed speed.
(3) The pulverizer is formed in the chamber. Solution: Suspension of pulverization, remove the filter cake in the crushed chamber to restore production. The Influence of Detection Method. The product particle size detection results after the crushing are not required. After the problem of excluding the pulverization process, the product particle size detection results may not be required to consider whether the detection method of the particle size is reasonable. For example, the material is highly viscous, and the material is easily tuned. If a dry detection method is obvious, it is obvious that it can be considered using a wet method, so that the substance is sufficiently dispersed in the solution and then detected, thus obtained. The result is the true test result. Effect of Cyclone Separation on Crushing Effect. After the crushing material is maintained in the pressure of the cyclone after the cyclone is separated from 200 to 300MBAR, this pressure can be packaged directly using a packaging bag in a whirlwind, which is the optimum state of the whirlwind separation. If the pressure in the cyclone separator is too pressure, it will show that the air export of the pulverizer is large, which will have an effect on the crushing effect.
3 Conclusion
The raw material powder microf powder is increasing in modern pharmaceutical applications, and the demand for fine powder products is growing year by year. The gas flow crushing process of fine powder has the advantages of low drug pollution and high yields have been widely used by the company. The characteristics of fluidized bed vignette are high, and the pipelines and equipment are compressed. These are the risk points of certain safety hazards. How to use as low gas flow pressure in the pulverization process The fine powder product requires us to discover in practice.
Excellent strife, win! In order to ensure the "zero-defect, continuous improvement" quality improvement and effective development, Shandong ALPA Powder Technology Co., Ltd. Quality Management Committee actively explores the management of new models, receiving the study of 8D working methods in recent hours, and combines enterprises Operation status, initially formed organic combination, comprehensive quality control system and successful practice, effectively improved the company's quality risk prevention and control ability, in order to promote the high-quality development of enterprises to build a solid foundation.
