This article explores how you can measure particle size CQAs in (sterile) pharmaceutical packaging, and discusses non-invasive measurements using SR-DLS.
Sponsored by InProcess-LSPFeb 15 2024 Authors: Albert Grau-Carbonell, Roberta Bartucci, Yan Wang, Carl Schuurmans, Michiel Damen, Ad Gerich
INTRODUCTION Particle size is a Critical Quality Atribute 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.
SR-DLS is based on measuring the diffusion rate of particles suspended in a liquid by illuminating them and analysing the fluctuations in scattered light signal at a given collection angle . Suspended particles diffuse via Brownian motion, therefore constantly changing their relative positions in the scattering volume. As a result, the scattered signal fluctuates, at a rate which is proportional to the particles diffusion rate.
The NanoFlowSizer: A geometry independent particle size tool Dedicated vial and clamp modules: Comfort and robustness The NanoFlowSizer is a versatile, modular system to which the front module can be exchanged to accommodate the sample of interest. The main task of the modules is to ensure that samples sit at the right position to be measured. Here, we focus on two different commercially available modules: the vial and the clamp modules .
The NanoFlowSizer capabilities were demonstrated by measuring particle size inside two common, but challenging geometries: large 20 litres plastic containers of varying plastic composition and closed, sterilisable, IV bags. For larger, or odd sized containers, unspecific module measurements can also easily be performed. To illustrate this, PSD was characterized inside large plastic containers of varying plastic composition and inside IV bags.
Besseling, R., R. Arribas-Bueno, R. van Tuijn, and A. Gerich. November 2023. https://www.azonano.com/article.aspx?ArticleID=5679.