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文檔簡介
1、Section 1 An overview of the granulation processSection 2 Preparing the granulation processSection 3 Cleaning & maintaining equipmentSection 4 Pre-start operationsSection 5 Granulation operationsAt the end of this section, you will be able to describe or use: benefits of granulation how granulat
2、ion fits into pharmaceutical manufacturing the basic ingredients used in granulation the different granulation methods identify the main pieces of equipment used in granulation process controls used during granulation use occupational health and safety controls (PPE, use of guards, etc.) to maintain
3、 safety in the workplaceWhat are the benefits (ho ch) 好處 of granulation?Granulation is a process that prepares powdered raw materials to be used in other pharmaceutical processesfor tablet (y pian yao) 一片藥一片藥 or capsule (jiao nang) 膠囊 manufacture. Granulation is used to make powders easier to handle
4、, process and transport. Powders that are granulated usually contain: active ingredient (zhu yao)主藥 or drug (yao) 藥 (the part that will medicate the patient) excipients (they typically make up most of the volume and bind the active ingredient and can include binders, fillers, lubricants and disinteg
5、rants)Section 1 - An overview of the granulation processBlending (hun he) 混合混合 the ingredients is not enough to ensure even (yi yang de) 一樣一樣的的 distribution of the active ingredient (cheng fen). This is because the active ingredient may segregate (fn ki) 分開分開 or stay apart from the other ingredients
6、 during the blending process. Background to GranulationThe ingredients may be incompatible because of: particle size (chi cun) 尺寸 particle density (m du) 密度 flow characteristics (li dong xing) 流動性 Compressibility (ke ya xing) 可壓性 moisture content (han shui liang) 含水量Process of GranulationGranulation
7、 is a mixing technique starting with a homogeneous mix (uniform throughout) of ingredients or raw materials.Then the overall particle size of the formulation is increased and these particles adhere together to form larger, multi-particle portions of the product. These larger particles are called gra
8、nules. GranulesGranules consist of particles formed by the progressive enlargement of primary particles until their original identity is no longer visible. Picture of a Granulated ProductHow does granulation work?The particles adhere or stick together by forming bonds. The bonds are formed by: physi
9、cal compression using a binding agent using a combination of both compression and binding agentPharmaceutical granules usually range in size between 0.2 0.5 mm. Physical CompressionPRESSUREPRESSURE(yli) 壓力壓力Binding AgentCombination of Compression and Binding AgentPRESSUREPRESSUREIm a granuleWhy do r
10、aw material powders need to be granulated?reasons and benefits to granulate raw material or ingredient powders: improve the flow features of the mix improve compression characteristics of the mix decrease dustiness stop segregation of ingredients stop hydroscopic ingredients from caking (absorbing m
11、oisture)improve the flow features of the miximprove compression characteristics of the mixdecrease dustinessstop segregation of ingredientsstop hydroscopic ingredients from cakingH2OH2OH2OWhat are the different granulation methods?Pharmaceutical products are processed all over the world using the fo
12、llowing three methods: wet granulation method dry granulation method direct compressing methodThe wet granulation process involves wetting the ingredient powders so that the powder particles tack or stick to one another.What happens during wet granulation? The newly formed larger particles remain in
13、tact after drying. Some powders require the addition of only small amounts of liquid solution to form granules. Wet granulation offers a wide range of different granule types, from the production of light granules to the production of very dense granules The newly formed larger particles remain inta
14、ct after drying. Some powders require the addition of only small amounts of liquid solution to form granules. Wet granulation offers a wide range of different granule types, from the production of light granules to the production of very dense granulesWhat types of liquid solutions are used?Aqueous, or water based, solutions have the advantage of being safer to deal with than organic solvents. Although when aqueous solutions are used, some active ingredients will form bonds with water that are not strong eno
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