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How can you measure particle size CQAs in (sterile) pharmaceutical packaging?
Non-invasive measurements using SR-DLS
Particle size is a Critical Quality Atribute (CQA) for many products and formulations, and thus it requires streamlined, robust measurement protocols for batch quality control. These protocols typically involve sampling and process development: representative extraction, controlled preparation, dilution protocols, transport to characterization facilities and trained specialists.
A technique capable of measuring particle size inside close containers of arbitrary geometry at the product’s native turbidity is desired as it would lead to faster, non-invasive measurements without any risk of breaking the sterility of the product.
Spatially Resolved Dynamic Light Scattering (SR-DLS), the technology behind the NanoFlowSizer, directly tackles this challenge. SR-DLS is a light scattering technique based on Fourier Domain Low-Coherence Interferometry (FDLCI), and resolves the scattered signal of an illuminated volume as a function of depth in the sample.
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Up to millions is lost per year due to the absence of appropriate
particle size monitoring solutions…