Bettersize Showcases Advanced Particle Characterization at FDA–CRCG Workshop

On September 23–24, 2025, the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) held the workshop “Mastering Particle Size Analysis: A Step-By-Step Illustration of Techniques and Best Practices” in Rockville, Maryland, with both in-person and virtual participation. The two-day program focused on practical demonstrations and regulatory perspectives for particle size analysis, a crucial technique in the development and quality control of pharmaceutical products, especially complex generics.

The event gathered scientists, regulatory specialists, and industry experts from around the world to exchange knowledge and best practices. As an active participant, Bettersize joined the workshop to engage in technical discussions and to contribute its expertise in advanced particle characterization technologies, highlighting the company’s ongoing commitment to supporting scientific innovation and regulatory compliance in the pharmaceutical field.

At the workshop, Bettersize was honored to have Mr. Kiwan Park, Sales Manager, and Mr. Matthew McGann, DLS Product Manager, deliver technical presentations that showcased the company’s leadership in particle characterization. Their talks attracted strong attention from both regulatory experts and academic researchers.

Bettersizer 2600 Particle Size & Particle Shape Analyzer   Laser Diffraction & Dynamic Image Analysis  Wide particle size range: 0.02 to 2,600 μm (wet/dry dispersion) 2.0 to 3,500 μm (dynamic imaging) Flexible switch between 6 dispersion units for wet and dry measurements PIC-1 DIA module for particle shape

Mr. Park introduced the Bettersizer 2600, focusing on its integrated laser diffraction and dynamic image analysis capabilities. He emphasized how the system’s Pic-1 module allows direct visualization of particles, enabling users to verify laser diffraction results and to distinguish issues such as agglomerates or oversized particles. His presentation highlighted how combining these two techniques establishes a more robust standard for accurate particle size distribution.

BeNano 180 Zeta Max Nanoparticle Size and Zeta Potential Analyzer   ● Size range: 0.3 nm - 15 μm ● Minimum sample volume: 3 μL ● DLS backscattering (173°) detection technique ● PALS (Phase Analysis Light Scattering) technique ● Programmable temperature control range from -15 ℃ to 120 ℃ ● Refractive index measurement ● Concentration measurement ● Sedimentation-based size measurement

Mr. McGann followed with a detailed session on the BeNano 180 Zeta Max, demonstrating its dynamic light scattering (DLS) and electrophoretic light scattering (ELS) performance. He illustrated how accurate measurements of nanoparticle size, zeta potential, and microrheological properties provide deeper insight into complex systems such as proteins and polymers.

The presentations sparked lively discussions and positive feedback from participants, further confirming Bettersize’s role as a trusted partner in advancing analytical technologies for the pharmaceutical and scientific communities.

For readers who wish to explore the full presentation slides, the materials are available here: Bettersizer 2600 Presentation and BeNano 180 Zeta Max Presentation.

The workshop concluded with strong recognition of Bettersize’s technical expertise and product innovation. By contributing advanced analytical solutions and engaging directly with regulatory and scientific leaders, Bettersize demonstrated its continued commitment to supporting pharmaceutical development and ensuring high standards of particle characterization worldwide.

About Bettersize Instruments:

Bettersize Instruments is a leading manufacturer of advanced particle characterization instruments. Our portfolio includes state-of-the-art solutions for particle size, shape, and zeta potential analysis, serving industries from pharmaceuticals and chemicals to semiconductors and aerospace. With technologies such as static light scattering and dynamic light scattering, our instruments deliver high accuracy, repeatability, and comprehensive data for research and quality control. Flagship models like the Bettersizer S3 Plus and BeNano 180 Zeta Max are designed to meet both R&D and production needs. Bettersize also offers tailored application support, sample testing, and flexible upgrade options to ensure our customers achieve optimal performance and value.