Accuracy Of Particle Analysis Impacts （粒子分析精度的影响）.pdf

APPLICATIONS Accuracy Of Particle Analysis Impacts Manufacturing Process And Final Product Image analysis systems measure particle size, shape, and concentration and allow users to set parameters for viewing specific particles. BY PETER BOUZA Particle analysis plays a key role in the approximately 63 µm, which is calculated pharmaceutical industry — in both product by approximating a sphere with the same efficacy and manufacturing. Particle size amount of area as the particle silhouette. can impact the dissolution rate of an Although the reported particle size results excipient or active pharmaceutical would render similar statistical histograms, ingredient (API) and can impact these particles would not behave similarly. formulation or tableting of a drug. Various Figure 1: Both particles have an In a production environment, shape established techniques serve the particle equivalent spherical diameter of irregularity would affect flowability, sharp sizing needs of the pharmaceutical market approximately 63 μm. However, edges would affect the ability to adhere to both are clearly different in shape today. and most likely behave differently. other particles, and the amount of exposed However, in some situations, simply surface would affect the amount of coating monitoring particle size is not enough to control a required. If these or other sha