Special Issues-01-02-2005
IMS for Cleaning Verification (PDF)
January 2nd 2005The need to verify cleaning between manufacturing runs presents a special challenge to the analytical chemist. In this article, the principles of ion mobility spectrometry are described, its performance is compared to HPLC for the analysis of cleaning validation samples, and findings are presented from a study to establish the feasibility of using IMS in validating a cleaning verification method.
Post-Tableting NIR Analysis: A Look at PAT Applicability to the Output of Solid Dosage Forms (PDF)
January 2nd 2005A majority of current discussion about NIR's applicability to pharmaceutical manufacturing is focused on preparative processes such as granulation, drying, and blending. The author examines different considerations for NIR for the output of the manufacturing line - finished tablet analysis.
PAT, NeSSI, and Sample Conditioning Systems: State of the Technologies and Future Directions (PDF)
January 2nd 2005This article reviews the development of FDA's PAT Initiative along with CPAC's ANSI/ISA-76.00.02 (2002) (NeSSI) development. The intent is to show how the NeSSI components could contribute to the PAT philosophy and physical requirements.
Chemometrics and PAT: What Does It All Mean? (PDF)
January 2nd 2005A paradigm shift is required for chemists and engineers to best utilize chemometrics in their processes. This change demands that one not be too fixated upon ideal textbook thermodynamic models but instead continually check these models using real-time data input and chemometric analysis. The author discusses implementation strategies and the benefits that chemometrics can bring to the process environment.
