Multi-scale flowsheet simulation of an integrated continuous purification-downstream pharmaceutical manufacturing process

International Journal of Pharmaceutics

Volumn 445, Issue 1-2, 2013, Pages 29-38

  Sen, Maitraye ^a   Chaudhury, Anwesha ^a   Singh, Ravendra ^a   John, Joyce ^a   Ramachandran, Rohit ^a  

^a The State University of New Jersey   (United States)

Author keywords

Continuous processing; Crystallization; Flowsheet simulation; Population balance model; Powder mixing

Indexed keywords

ARTICLE; COOLING; CRYSTALLIZATION; DOWNSTREAM PROCESSING; DRUG MANUFACTURE; DRUG MIXTURE; DRUG PURIFICATION; FILTRATION; MULTI SCALE FLOWSHEET SIMULATION; PRIORITY JOURNAL; PROCESS MODEL; TABLET PROPERTY; TEMPERATURE;

CHEMISTRY, PHARMACEUTICAL; COMPUTER SIMULATION; CRYSTALLIZATION; DRUG COMPOUNDING; FILTRATION; MODELS, THEORETICAL;

EID: 84874026930     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2013.01.054     Document Type: Article

References (34)

1. S. Adam, D. Suzzi, C. Radeke, and J.G. Khinast An integrated quality by design (QbD) approach towards design space definition of a blending unit operation by discrete element method (DEM) simulation European Journal of Pharmaceutical Sciences 42 2011 106 115
2. B. Benyahia, R. Lakerveld, and P.I. Barton A plant-wide dynamic model of a continuous pharmaceutical process Industrial and Engineering Chemistry Research 2012 10.1021/ie3006319
3. G. Betz, P.J. Purgin, and H. Leuenberger Batch and continuous processing in the production of pharmaceutical granules Pharmaceutical Development and Technology 8 2003 289 297
4. F. Boukouvala, A. Dubey, A. Vanarase, R. Ramachandran, F.J. Muzzio, and M.G. Ierapetritou Computational approaches for studying the granular dynamics of continuous blending processes, 2-Population balance and data-based methods Macromolecular Materials and Engineering 297 2011 9 19
5. F. Boukouvala, V. Niotis, R. Ramachandran, F. Muzzio, and M.G. Ierapetritou Dynamic flowsheet modeling and sensitivity analysis of a continuous tablet manufacturing process: an integrated approach Computers and Chemical Engineering 42 2012 30 47
6. A. Chaudhury, P. Pandey, and R. Ramachandran A multi-dimensional population balance model validation approach to high-shear wet granulation (HSWG) processes AIChe Annual Meeting Minneapolis, USA, October 17-21 2011
7. K.L. Choong, and R. Smith Optimization of batch cooling crystallization Chemical Engineering Science 59 2004 313 327
8. A. Dubey, A.U. Vanarase, and F.J. Muzzio Effect of process parameters on the performance of a continuous blender: a DEM based study AIChE Journal 2012 10.1002/aic.13770
9. A. Gorsek, and P. Glavic Design of batch versus continuous processes. Part 1: Single-purpose equipment Chemical Engineering Research and Design 75 1997 709 717
10. T. Gracia, G. Cook, and R. Nosal PQLI key topics-criticality, design space and control strategy Journal of Pharmaceutical Innovation 3 2008 60 68
11. G.R. Harrison, P.W. Todd, S.R. Rudge, and D. Petrides Bioseparations Science and Engineering 2003 Oxford University Press Oxford, UK
12. H. Leuenberger New trends in the production of pharmaceutical granules: batch versus continuous processing European Journal of Pharmaceutics and Biopharmaceutics 52 2001 289 296
13. H. Leuenberger Scale-up in the 4th dimension in the in the field of granulation and drying or how to avoid classical scale-up Powder Technology 130 2003 225 230
14. H. Leuenberger, and G. Betz Chapter 15: Granulation process control-production of pharmaceutical granules: The classical batch concept and the problem of scale-up A.D. Salman, J. Seville, M. Hounslow, Handbook of powder technology: granulation 2007 Elsevier Science B.V. Amsterdam 705 733
15. R. Lionberger, S.L. Lee, L. Lee, A. Raw, and L.X. Yu Quality by design: concepts for ANDAs AAPS Journal 10 2008 268 276
16. W.L. McCabe, J.C. Smith, and P. Harriott Unit Operations of Chemical Engineering 2001 McGraw-Hill New York
17. A. Mezhericher, A. Levy, and I. Borde Modelling of particle breakage during drying Chemical Engineering and Processing 47 2008 1404 1411
18. H. Miki, T. Terashima, Y. Asakuma, K. Maeda, and K. Fukui Inclusion of mother liquor inside kdp crystals in a continuous MSMPR crystallizer Separation and Purification Technology 43 2005 71 76
19. M. Mirmehrabi, and S. Rohani An approach to solvent screening for crystallization of polymorphic pharmaceuticals and fine chemicals Journal of Pharmaceutical Sciences 94 2005 1560 1576
20. R. Nosal, and T. Schultz PQLI definition of criticality Journal of Pharmaceutical Innovation 3 2008 69 78
21. K. Plumb Continuous processing in the pharmaceutical industry: changing the mindset Chemical Engineering Research and design 83 2005 730 738
22. P.M. Portillo, F.J. Muzzio, and M.G. Ierapetritou Using compartment modeling to investigate mixing behavior of a continuous mixer Journal of Pharmaceutical Innovation 3 2008 161 174
23. R. Ramachandran, J. Arjunan, A. Chaudhury, and M.G. Ierapetritou Model-based control-loop performance assessment of a continuous direct compaction pharmaceutical process Journal of Pharmaceutical Innovation 6 2011 249 263
24. D. Ramkrishna Population Balances 2000 Academic Press San Diego
25. G.V. Reklaitis, J. Khinast, and F.J. Muzzio Pharmaceutical engineering science-new approaches to pharmaceutical development and manufacturing Chemical Engineering Science 65 2010 4 7
26. Riesen, R. Process optimization using an automatic laboratory reactor. Document of Mettler-Toledo GmbH, Schwerzenbach, Switzerland, pp. 1-8.
27. S.D. Schaber, D.I. Gerogiorgis, R. Ramachandran, J.M.B. Evans, P.I. Barton, and B.L. Trout Economic analysis of integrated continuous and batch pharmaceutical manufacturing: a case study Industrial and Engineering Chemistry Research 50 2011 10083 10092
28. M. Sen, and R. Ramachandran A multi-dimensional population balance model approach to continuous powder mixing processes Advanced Powder Technology 24 2013 51 59
29. M. Sen, R. Singh, A. Vanarase, J. John, and R. Ramachandran Multi-dimensional population balance modeling and experimental validation of continuous powder mixing processes Chemical Engineering Science 80 2012 349 360
30. M. Sen, A. Dubey, R. Singh, and R. Ramachandran Mathematical development and comparison of a hybrid PBM-DEM description of a continuous powder mixing process Journal of Powder Technology 2013 10.1155/2013/843784
31. R. Singh, K.V. Gernaey, and R. Gani Model-based computer-aided framework for design of process monitoring and analysis systems Computers and Chemical Engineering 33 2009 22 42
32. R. Singh, M. Ierapetritou, and R. Ramachandran An engineering study on the enhanced control and operation of continuous manufacturing of pharmaceutical tablets via roller compaction International Journal of Pharmaceutics 438 2012 307 326
33. J. Werani, M. Grunberg, C. Ober, and H. Leuenberger Semicontinuous granulation-the process of choice for the production of pharmaceutical granules Powder Technology 140 2004 163 168
34. L. Yu Pharmaceutical quality by design: product and process development, understanding and control Pharmaceutical Research 25 2008 781 791