PAT SUPPLEMENT
areas of research and development including analytical method development, software development, its validation, design of feedback mechanisms and control systems. The adoption of a multidisciplinary approach involving
REFERENCES
1. Food and Drug Administration, 2004.
http://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/ucm0 70305.pdf
2. EMEA PAT team, Reflection Paper: Chemical, pharmaceutical and biological information to be included in dossiers when Process Analytical Technology (PAT) is employed, EMEA/INS /277260/2005, March 2006
3. Baughman E., 2005. Process analytical chemistry: introduction and historical perspective, In Proces analytical technology, edited by Bakeev K.A. Blackwell publishing, Oxford, UK
4. Rajan M.G., Bhattacharjee H., Bedi S., Reo J. 2010. Primer on NIR Spectroscopy as a PAT tool in the Tablet Manufacture Process. Pharmaceutical Review. September/October 2010, 128-135
5. De Beer T, Burggraeve A., Fonteyne M., Saerens L., Remon J.P., Vervaet C. 2011. Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes International Journal of Pharmaceutics 417, 32– 47
6. Saerens L., Dierickx L., Lenain B., Vervaet C., Remon J.P., De Beer T. 2011. Raman spectroscopy for the in-line polymer–drug quantification and solid state characterization during a pharmaceutical hot-melt extrusion process. Eur J Pharm Biopharm. 77:158–163
7. Kelly A.L., 2011. In process monitoring of drug loading during twin scre extrusion of pharmaceuticalpolymer compounds. ANTEC 2011. PENG-11-2010-0356
8. Chirkot T., Halsey S., Swanborough A. Monitoring the
Output of Pharmaceutical Hot Melt Extruders with Near-infrared Spectroscopy. Thermo Fisher Scientific Application Note: 51836
9. Dhumal R.S., Kelly A., Coates P.D., York P. Paradkar A.R. 2010. Cocrystalization and simultaneous agglomeration using hot melt extrusion. Pharm. Res. 27
http://www.springerlink.com/content/0724- 8741/27/12/, 2725-2733
10. De Beer T.R, Baeyens W.R., Ouyang J., Vervaet C., Remon J.P., 2006. Raman spectroscopy as a process analytical technology tool for the understanding and the quantitative in-line monitoring of the homogenization process of a pharmaceutical suspension. Analyst 131, 1137–1144
11. Yu LX, Lionberger RA, Raw AS, D'Costa R, Wu H, Hussain AS. 2004. Applications of process analytical technology to crystallization processes. Adv Drug Deliv Rev. 56:349-369
12. Harner R. S., Ressler R. J., Briggs R. L., Hitt J. E., Larsen P. A. and Frank T. C. 2009. Use of a Fiber-Optic Turbidity Probe to Monitor and Control Commercial-Scale Unseeded Batch Crystallizations. Org. Process Res. Dev., 13, 114–124
13. List K., Steffens K.J., 1996. Supervising and controlling of granulation processes by near-infrared spectroscopy. Pharm. Ind. 58, 347–353
14. Rantanen, J., Räsänen, E., Antikainen, O., Mannermaa, J.P., Yliruusi, J. 2001. In-line moisture measurement during granulation with a four-wavelength near- infrared sensor: an evaluation of process-related variables and a development of non-linear calibration model. Chemom. Intell. Lab. Syst. 56, 51-58
experts from the areas of pharmaceutical manufacturing, method development, process, software and control system engineers coupled with enhanced process understanding can lead to the successful development of PAT analysers.
BIOGRAPHY
Ravindra Dhumal is Research and Knowledge Transfer Officer at Centre for Pharmaceutical Engineering Science, University of Bradford, UK. He holds a degree in Pharmacy and a PhD in Pharmaceutical Sciences from Bharati Vidyapeeth, India. He worked as a post
doc with an interdisciplinary team at Institute of Pharmaceutical Sciences (IPI) and Interdisciplinary Research Centre (IRC) in Polymer Engineering at University of Bradford. As a post doc, he has developed novel applications of Hot Melt Extrusion (HME) in crystal engineering. He has worked in formulation development in pharmaceutical industry for two years. His current research interests include process and product development. He is working closely with process engineers and trying to understand the processes by application of Process Analytical Technology (PAT) using in-line rheology, NIR and Raman spectroscopy.
BIOGRAPHY
Tim Gough is a Senior Lecturer in Fluid Mechanics at University of Bradford. He holds a degree in Mechanical Engineering and a PhD in Fluid Mechanics from the University of Surrey. At Bradford, his work focuses on the application of optical, spectroscopic,
neutron and x-ray probes to polymeric matter and pharmaceuticals undergoing deformation and crystallisation to elucidate the effects of processing on structure and product properties. He is a frequent user of large scale x-ray and neutron facilities worldwide. He has many active links with industry and academia and has published over 20 academic journal papers as well as 80 conference papers.
Accurate and real-time insight into dynamic processes. Implementing PAT with complete confidence.
The FTPA2000-260PH is a multi-point FT-NIR process analyzer for real-time remote control of pharmaceutical and biopharmaceutical unit operations. Using fiber optics-coupled sampling accessories like probes or flow-through cells, this highly stable analyzer enables implementationof a process control strategy based on frequent measurements of product Critical Quality Attributes. An extensive range of application-specific diagnostics provides early detectionof process upsets and accurate determination of process end point. Find how ABB can help you to overcome your technical challenges:
www.abb.com/analytical
ABB Analytical Measurements Phone: +1 418-877-2944 1 800 858-3847 (North America) Email:
ftir@ca.abb.com
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