A particle size analyzer measures the size distribution of particles in a sample. There are various techniques used in particle size analysis, but one common method is laser diffraction. With this technique, a laser beam is directed through a sample containing suspended particles. As the laser beam interacts with the particles, it scatters in different directions depending on the size of the particles. A detector measures the intensity of scattered light at different angles, and sophisticated algorithms are used to analyze this data and calculate the particle size distribution. Another technique is dynamic light scattering (DLS), which measures the fluctuations in scattered light caused by Brownian motion of particles in solution. By analyzing these fluctuations, DLS can determine the size of particles in the sample. Other methods include sedimentation, microscopy, and electrical sensing. Particle size analyzers provide valuable information about the size distribution of particles in a sample, which is essential in various industries such as pharmaceuticals, cosmetics, and food processing for quality control and product development.
Particles are common in drug products and are a leading cause of injectable drug product recalls. They can be extrinsic (foreign contaminants), intrinsic (rubber, plastic, or glass from consumables or process impurities), or inherent (protein, capsid, or cell aggregates). These particles threaten patient safety, impact product quality and efficacy, and are monitored closely by the FDA.
Aura is the only system designed to bridge the gap from early-stage development through QC with low volume requirements (as little as 5 µL), high-throughput (1 minute per sample), particle ID capabilities using side illumination membrane imaging (SIMI) and fluorescence membrane microscopy (FMM), and compatibility with regulatory requirements <787>, <788>, and <789>.
Comparison
Particle Analyzers by Therapeutic Area
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Aura+Aura+
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Aura PTxAura PTx
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Aura GTAura GT
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Aura CLAura CL
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Biologics Particle Analysis |
Biologics Particle Analysis |
Biologics Particle Analysis |
Biologics Particle Analysis |
Biologics Particle Analysis |
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Biologics Particle Analysis |
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Particle Analysis + ID |
Particle Analysis + ID |
Particle Analysis + ID |
Particle Analysis + ID |
Particle Analysis + ID |
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Particle Analysis + ID |
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Protein Therapy |
Protein Therapy |
Protein Therapy |
Protein Therapy |
Protein Therapy |
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Protein Therapy |
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Gene Therapy |
Gene Therapy |
Gene Therapy |
Gene Therapy |
Gene Therapy |
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Gene Therapy |
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Cell Therapy |
Cell Therapy |
Cell Therapy |
Cell Therapy |
Cell Therapy |
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Cell Therapy |
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Particle Analyzers by Application
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Aura+Aura+
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Aura PTxAura PTx
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Aura GTAura GT
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Aura CLAura CL
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Particle Detection/Quantitation |
Particle Detection/Quantitation |
Particle Detection/Quantitation |
Particle Detection/Quantitation |
Particle Detection/Quantitation |
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Particle Detection/Quantitation |
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Extrinsic Particles |
Extrinsic Particles |
Extrinsic Particles |
Extrinsic Particles |
Extrinsic Particles |
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Extrinsic Particles |
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Protein ID |
Protein ID |
Protein ID |
Protein ID |
Protein ID |
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Protein ID |
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Polysorbate ID |
Polysorbate ID |
Polysorbate ID |
Polysorbate ID |
Polysorbate ID |
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Polysorbate ID |
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Cell Aggregate ID |
Cell Aggregate ID |
Cell Aggregate ID |
Cell Aggregate ID |
Cell Aggregate ID |
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Cell Aggregate ID |
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Capsid Aggregate ID |
Capsid Aggregate ID |
Capsid Aggregate ID |
Capsid Aggregate ID |
Capsid Aggregate ID |
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Capsid Aggregate ID |
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Immunoassays |
Immunoassays |
Immunoassays |
Immunoassays |
Immunoassays |
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Immunoassays |
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Cellular Assays |
Cellular Assays |
Cellular Assays |
Cellular Assays |
Cellular Assays |
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Cellular Assays |
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DNA Leakage |
DNA Leakage |
DNA Leakage |
DNA Leakage |
DNA Leakage |
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DNA Leakage |
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High Magnification Microscopy |
High Magnification Microscopy |
High Magnification Microscopy |
High Magnification Microscopy |
High Magnification Microscopy |
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High Magnification Microscopy |
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FAQ
The most efficient method often depends on specific characteristics of the sample and the requirements of the analysis. However, laser diffraction is widely considered one of the most efficient techniques for particle size analysis. Laser diffraction offers advantages such as rapid analysis times, wide measurement ranges, and suitability for a variety of sample types including powders, suspensions, and emulsions. It provides accurate and reliable results with minimal sample preparation. The Aura family of particle analyzers are quickly becoming recognized for their abilities to generate size, count and aggregate data for fast and accurate particle analysis.
Particle size analyzers provide essential information about the size distribution of particles in a sample. This data is vital for quality control, ensuring product consistency, and meeting regulatory requirements. Particle size analysis is integral to product development, helping optimize formulations and processes. By understanding particle size distribution, manufacturers can enhance product performance, stability, and effectiveness. In addition to measuring particle size, these analyzers are also capable of determining particle concentration, providing a comprehensive understanding of the particle characteristics within a given sample.
Determining the best particle analyzer depends on specific application requirements, such as sample type, size range, and analysis objectives. There isn't a one-size-fits-all solution. However, popular particle analyzers often utilize laser diffraction, dynamic light scattering (DLS), or microscopy-based techniques. The Aura suite of analyzers from Halo Labs can provide more detailed particle analysis than DLS or microscopy for particles ≥1 µm, offering BMI and FMM to find and characterize more particles, including subvisible particles that otherwise go undetected.
Quality control (QC) equipment used for particle size analysis typically includes particle size analyzers such as laser diffraction instruments, dynamic light scattering (DLS) systems, light obscuration, or microscopy-based imaging systems. These instruments allow manufacturers to perform routine analysis of their products to ensure that particle size specifications are met and maintain consistent product quality.
See every visible and subvisible particle in your sample—even the transparent ones missed by other methods—with innovative BMI technology. Learn how BMI sees it all.
With the FMM technology that’s part of Aura particle analyzers, you can uncover particle identity for faster, more streamlined development. Learn about how FMM identifies particles.
Interrogate and characterize for extrinsic and inorganic particles like glass and metals, which are the leading cause of drug product recalls. Learn more about how you can detect subvisible impurities with higher specificity.
