Powder GMP workshop project
Powder GMP workshop project
The powder has a relatively large degree of pulverization in the preparation process, a large specific surface area, and is easy to disperse. It is convenient to transport and carry; the preparation process...
Text label: Powder GMP pharmaceutical cleanroom, GMP workshop design and decoration, powder GMP project
Powder GMP pharmaceutical cleanroom project
The powder has a relatively large degree of pulverization in the preparation process, a large specific surface area, and is easy to disperse. The transportation and carrying are relatively convenient; the preparation process is short and the process is simple. The general process flow of powder preparation is: material pretreatment → pulverization → sieving → mixing → dose division → quality inspection → packaging; commonly used pulverization methods include dry pulverization, wet pulverization, separate pulverization, mixed pulverization, low temperature pulverization, ultra Micro pulverization, etc., can be selected according to the state, composition, environmental conditions, dispersion method and other conditions of the material when it is pulverized; the more commonly used pulverizing equipment includes ball mill and jet pulverizer.
The degree of pulverization of powder is not the finer the better. The appropriate fineness should be determined according to the physical and chemical properties, stability, purpose and way to achieve the purpose of being effective, safe, time-saving and energy-saving; mixing is prepared by powder One of the important technological processes, the purpose of mixing is to make the powder, especially the compound powder, mix evenly and uniformly in color to ensure accurate dosage; the commonly used mixing methods between solid powders include stirring, grinding and sieving. Etc., the first two methods are usually mixed, and then the sieving mixing method is used to ensure the uniformity of mixing. The mechanism is generally considered to be the result of convection mixing, shear mixing, diffusion mixing or the combination of various mixing mechanisms; The multi-purpose rotary mixer has different shapes of mixing cylinders, which can carry out large-scale and high-efficiency mixing operations. Among them, the three-dimensional mixer has a higher efficiency, with strong overturning effect and better mixing effect; the mixing effect of powder is affected by each component. Influenced by factors such as proportion, bulk density, and physical and chemical properties, uneven mixing will seriously affect the quality of the powder. It is necessary to fully pay attention to the proportion, density, adsorption and chargeability of components, as well as components containing liquid or hygroscopicity, containing For problems such as components that can form eutectic mixtures, for powders that can form eutectic compounds, corresponding measures should be taken according to the changes in the effect after eutectic and the amount of other solid components contained in the formulation. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and purification workshops.
The uniformly mixed powder is divided into equal parts according to the quality requirements. Common methods include visual inspection, mass method, volume method, and volumetric method is used for mechanized production. The quality of the powder is closely related to the packaging and storage conditions of the powder. The packaging of the divided-dose powder is mainly plastic bags or paper bags, and the external powder of the undivided dose or the non-single-dose powder. Large-scale can be packed in plastic bags, cartons, glass tubes or bottles. When packing in plastic bags, they should be tightly heat-sealed. The key point of powder packaging and storage is to prevent moisture, because the powder has a large specific surface area, and its hygroscopicity and weatherability are both high. It is more obvious. If moisture absorption is caused by improper packaging and storage, a series of unstable phenomena such as deliquescence, agglomeration and mildew will easily occur, which will seriously affect the quality and safety of powders. important content of quality.
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