Special Issues-01-02-2005

The 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.

A 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.

This 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.

A 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.

The authors describe the in-line moisture measurement of a pharmaceutical granulation of lactose, microcrystalline cellulose, and crospovidone in a fluid bed granulator-dryer using top sprayed granulating liquid. A near-infrared (NIR) prediction model was developed for moisture on spectra collected during a calibration run. Subsequent granulations were analyzed for moisture content real-time throughout the granulation and drying process using the NIR process instrument.

What does the accelerating adoption of PAT-based approaches to pharmaceutical manufacturing mean for the makers and users of spectroscopic systems?

NIR-CI adds a completely new dimension to conventional NIR spectroscopy.