In this article, InProcess demonstrates the potential of in-line nanoparticle size measurements using the NanoFlowSizer (NFS) as a PAT method.
Sponsored by InProcess-LSPNov 8 2023 Authors: Albert Grau-Carbonell, Yan Wang, Marko Verbeek, Remy van Tuijn, Carl Schuurmans, Rut Besseling, Ad Gerich
INTRODUCTION The final objective when integrating Process Analytical Technologies is to acquire process control and, optionally, real-time release by automatically regulating Critical Process Parameters . These CPPs are defined as the parameters that determine the final Critical Quality Attributes of the product, those properties of that are critical for its performance for end-users or as intermediate products.
The NanoFlowSizer The NanoFlowSizer is an analytical instrument to measure submicron particle size . The measurements are based on novel Spatially Resolved Dynamic Light Scattering . Figure 1. The NanoFlowSizer and Spatially Resolved Dynamic Light Scattering A. Probe unit of the NFS, with a flow cell adaptor mounted to connect to a process for in-line or on-line particle sizing in flow. B. SR-DLS detects broadband light backscattered from a suspension via interferometry and resolves scattered light fluctuations, and thereby particle diffusion and flow, at different depths. For laminar flow, the velocity vanishes at the walls and is at its maximum in the middle of the tubing.
Figure 2. Proportional-Integral-Derivative process control and NanoFlowSizer implementation. A. The operation of a PID controller is based on changes of a critical control parameter of a process by measuring Critical Quality Attributes and comparing the measurements to a target value. ‘Proportional control’ relies on CPP changes proportional to the difference ‘e’ between measured and target value .
Figure 3. High-Pressure Homogenization automated control via particle size measurement. A. Setup of a NanoFlowSizer for real-time droplet sizing, integrated in-line in a homogenization loop with a GEA Xstream Lab Homogenizer 1000 HPH with pressure controlled by the NFS-PID. B. Schematic of the HPH-NFS set-up. The PID feedback allows NFS-control of the High-Pressure valve to process the emulsion.
CONCLUSION Continuous process control via real-time particle size measurement was achieved for High-Pressure Homogenization of emulsions and Turbulent Injection continuous manufacturing of liposomes. The NanoFlowSizer was integrated into the processes in an in-line configuration, and PID control was achieved via the dedicated PID module of the XsperGo software. Communication between the NanoFlowSizer and other equipment was established via PLC with a Profinet protocol.
ACKNOWLEDGEMENTS The authors would like to acknowledge the contributions of Eric Ardeche for his help integrating the NanoFlowSizer with the GEA Xstream Lab Homogenizer 1000 HPH and of Dr. Costa for providing the data on liposome production by a LiFT skid with an integrated NanoFlowSizer. Einstein, A. "On the Movement of Small Particles Suspended in Stationary Liquids Required by the Molecular-Kinetic Theory of Heat." Annalen der Physik, 1905: 549-560.
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