Examples of traditional particle size analysis techniques include sieving, laser diffraction, dynamic light scattering, and electrozone sensing. Offline particle analysis. Traditional particle size analysis using an offline analyzer is a powerful and widely used technique for the measurement of particle size in quality control (QC) labs. While the visual observation of crystallization mechanisms is simple, very little is revealed in terms of the actual crystallization mechanism in real time. If crystallization is occurring, the solution will become turbid. Visual observation. Visual observation can help to determine what is happening in a crystallization mechanism at a basic level. The benefits and drawbacks of each are described below. By combining in-process particle measurement for understanding, optimizing and troubleshooting processes with traditional particle size analysis for quality control, scientists can develop particle processes with higher quality in less time at a lower total cost.Ĭrystallization mechanisms can be studied using three main techniques: visual observation, offline microscopy and real-time microscopy. Likewise, in-process particle measurement can predict when a process will move out of specification and can help identify when a sample should be taken from a process for offline analysis and quality verification. If a quality control lab reports a deviation from specification, in-process particle measurement can be used to perform a root cause analysis. In-process particle measurement complements traditional particle size analysis by providing extra information about how particles actually behave naturally in process. This allows for the creation of fit-for-purpose particles and monitoring of processes to be optimized using evidence-based methods and for troubleshooting to be executed during production. By understanding how particles behave from the beginning until the end of a process, and by comparing particle changes to process parameters, scientists can develop a deep understanding of particle systems. In-process measurement instruments offer an opportunity to track how particle size, count, and composition change directly in the process in real time. The time delay and potential for particle changes between sampling and analysis make the traditional particle size analysis approach challenging for process optimization and improvement. Traditional offline particle size analyzers are used in the quality control laboratory to measure particle properties with accuracy however, care must be taken to prepare the sample to allow for a consistent measurement. Particle size and count, as well as chemical composition, are important to characterize effectively for the successful development, transfer and operation of processes in numerous industries. Understanding how process parameters influence key transformations, such as nucleation, growth and breakage, allows scientists to develop and manufacture crystals that will have the desired attributes and be efficient to bring to market. In a pharmaceutical compound, bioavailability and efficacy are often related to particle size with smaller particles frequently desired for their enhanced solubility and dissolution characteristics.Ĭrystal size distribution can be optimized and controlled by carefully choosing the correct crystallization conditions and process parameters. Similarly, the final crystal size can also directly influence the quality of the final product. Crystal size and shape directly influence key steps downstream of the crystallizer, with filtration and drying performance being particularly susceptible to changes in these important attributes. While crystals have many important attributes, the crystal size distribution likely has the greatest impact on the quality and effectiveness of the final product (and the process needed to deliver it).
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