Evaluation of PAT Methods for Potential Application in Small-Scale, Multipurpose Pharmaceutical Manufacturing Platforms

Small-scale (refrigerator-sized, 1.0 (width) × 0.7 (length) × 1.8 m (height)), multipurpose pharmaceutical manufacturing platforms (PMP) necessitate unique high demands on process analytical technologies (PAT), for instance, in in situ, real-time monitoring of liquid formulations (solution and suspension) to determine the strength prior to the release from PMPs that are not comparable to lab-scale or industrial-scale needs. Commercially available plug-and-play PATs were evaluated for their potential application in PMPs regarding versatility, flexibility, reliability, and physical size (including the control box). The results presented here indicate that single-frequency ultrasounds currently surpass commercially available plug-and-play PATs in ways such as focused beam reflectance measurements, conductivity, and turbidity as well as UV–vis, Fourier transform infrared, near-infrared, and Raman spectroscopy for the purpose of in situ, real-time concentration monitoring of aqueous and alcohol-based solutions and suspension-formulated drugs in one single PAT device, as it is preferred in PMPs to maintain a small footprint.