Process Analytical Technologies
Sara J. Hamilton, Amanda E. Lowell
Process analytical technologies (PAT) represent the future of pharmaceutical analysis. U.S. drug products are of generally high quality, but there is an increasing trend toward manufacturing-related problems that lead to recalls, shortages of essential drugs, disruption of manufacturing operations, and interference with new drug approvals. PATs offer means of reducing manufacturing problems. Modern spectrometric technology is capable of accomplishing much more in pharmaceutical analysis than it currently does. Hyperspectral UV-visible, near-IR, and IR imagers in combination with tunable lasers are now being applied in Dr. Lodder's labs to remote sensing of small samples. Improving the pharmaceutical industry to reduce manufacturing problems depends on such rapid online sample analysis replacing old QA methods.
In Dr. Lodder's lab, NIR imaging of tablets inside blister packs has been shown to analyze over 1000 samples simultaneously in seconds. Remote sensing of lysine crosslinks in single gelatin capsules at large distances (e.g., one mile) demonstrates that useful spectra can be obtained remotely with good signal-to-noise ratio. These studies, in conjunction with successful experiments demonstrating remote sensing of bacterial biofilms, suggest that hyperspectral imaging will be profitably applied to in situ cleaning validation and sample analysis in a production environment.