Next generation fluidized bed granulator automation

1bstract1 system for fluidized bed granulator automation with in-line multichannel near infrared (NIR) moisture measurement and a unique air flow rate measurement design was assembled, and the information gained was investigated. The multivariate process data collected was analyzed using principal component analysis (PCA). The test materials (theophylline and microcrystalline cellulose) were granulated and the calibration behavior of the multichannel NIR set-up was evaluated against full Fourier Transform (FT) NIR spectra. Accurate and reliable process air flow rate measurement proved critical in controlling the granulation process. The process data describing the state of the process was projected in two dimensions, and the information from various trend charts was outlined simultaneously. The absorbence of test material at correction wavelengths (NIR region) and the nature of material-water interactions affected the detected in-line NIR water signal. This resulted in different calibration models for the test materials. Development of process analytical methods together with new data visualization algorithms creates new tools for in-process control of the fluidized bed granulation.

[1]  S. Wold,et al.  Multivariate Data Analysis in Chemistry , 1984 .

[2]  Bruce R. Kowalski,et al.  Chemometrics, mathematics and statistics in chemistry , 1984 .

[3]  J. Remon,et al.  Formation of theophylline monohydrate during the pelletisation of microcrystalline cellulose-anhydrous theophylline blends , 1988 .

[4]  Pentti Niemela Integrated Infrared Detectors For Industrial Process Analyzers , 1988, Other Conferences.

[5]  J. E. Jackson A User's Guide to Principal Components , 1991 .

[6]  Keijiro Terashita,et al.  Development and Application of Infrared Moisture Sensor to Complex Granulation , 1991 .

[7]  J. Edward Jackson,et al.  A User's Guide to Principal Components. , 1991 .

[8]  J. Drennen,et al.  Determination of film-coated tablet parameters by near-infrared spectroscopy. , 1995, Journal of pharmaceutical and biomedical analysis.

[9]  K. List,et al.  Überwachung und Steuerung von Granulationsprozessen mit Hilfe der Nah-Infrarot-Spektroskopie , 1996 .

[10]  P. K. Aldridge,et al.  On-line monitoring of powder blend homogeneity by near-infrared spectroscopy. , 1996, Analytical chemistry.

[11]  P. K. Aldridge,et al.  Automated system for the on-line monitoring of powder blending processes using near-infrared spectroscopy. Part I. System development and control. , 1996, Journal of pharmaceutical and biomedical analysis.

[12]  P. Frake,et al.  Process control and end-point determination of a fluid bed granulation by application of near infra-red spectroscopy , 1997 .

[13]  J. Rantanen,et al.  On-line monitoring of moisture content in an instrumented fluidized bed granulator with a multi-channel NIR moisture sensor , 1998 .

[14]  H. J. Browne,et al.  DISCUSSION OF CONTROL SYSTEMS IN PHARMACEUTICAL MANUFACTURING , 1998 .

[15]  S. Sekulic,et al.  Automated system for the on-line monitoring of powder blending processes using near-infrared spectroscopy. Part II. Qualitative approaches to blend evaluation. , 1998, Journal of pharmaceutical and biomedical analysis.

[16]  S. Goebel,et al.  Online-Messung der Produktfeuchte und Korngrösse in der Wirbelschicht mit der Nah-Infrarot-Spektroskopie , 1998 .

[17]  Svante Wold,et al.  Modelling and diagnostics of batch processes and analogous kinetic experiments , 1998 .

[18]  Jerry Workman,et al.  Process analytical chemistry. , 2005, Analytical chemistry.

[19]  Michael A. Johnson,et al.  Supervisory Control and Data Acquisition (SCADA) Systems , 1999 .

[20]  J. Rantanen,et al.  Use of the Near-Infrared Reflectance Method for Measurement of Moisture Content During Granulation , 2000, Pharmaceutical development and technology.

[21]  J. Drennen,et al.  Near-Infrared Spectroscopic Monitoring of the Film Coating Process , 1996, Pharmaceutical Research.

[22]  J. G. White On-Line Moisture Detection for a Microwave Vacuum Dryer , 1994, Pharmaceutical Research.