Model-based monitoring and control of industrial freeze-drying processes: Effect of batch nonuniformity

Drying Technology

Volumn 28, Issue 5, 2010, Pages 577-590

  Barresi, Antonello A ^a   Pisano, Roberto ^a   Rasetto, Valeria ^a   Fissore, Davide ^a   Marchisio, Daniele L ^a  

^a POLITECNICO DI TORINO   (Italy)

Author keywords

Batch heterogeneity; CFD; Dynamic Parameter Estimation; Freeze drying; LyoDriver; Product monitoring

Indexed keywords

COMPUTATIONAL FLUID DYNAMICS SIMULATIONS; DYNAMIC PARAMETERS; FREEZE DRYER; FREEZE DRYING; FREEZE-DRYING PROCESS; ICE CONTENT; MODEL-BASED MONITORING; MONITORING AND CONTROL; MONITORING AND CONTROL SYSTEMS; NEW TOOLS; NONUNIFORM; NONUNIFORMITY; PRESSURE RISE; PRIMARY DRYING; PRODUCT MONITORING; TEMPERATURE GRADIENT; TIME EVOLUTIONS;

COMPUTATIONAL FLUID DYNAMICS; DRYING; FLUID DYNAMICS; ICE CONTROL; PRESSURE EFFECTS;

PARAMETER ESTIMATION;

EID: 77952641622     PISSN: 07373937     EISSN: 15322300     Source Type: Journal    
DOI: 10.1080/07373931003787934     Document Type: Article

References (34)

1. Liapis, A.I.; Bruttini, R. Freeze-drying of pharmaceutical crystalline and amorphous solutes in vials: Dynamic multi-dimensional models of the primary and secondary drying stages and qualitative features of the moving interface. Drying Technology 1995, 13, 43-72.
2. Liapis, A.I.; Pikal, M.J.; Bruttini, R. Research and development needs and opportunities in freeze drying. Drying Technology 1996, 14, 1265-1300.
3. Sadikoglu, H.; Liapis, A.I. Mathematical modelling of the primary and secondary drying stages of bulk solution freeze drying in trays: Parameter estimation and model discrimination by comparison of theoretical results with experimental data. Drying Technology 1997, 15,791-810.
4. Tang, X.; Pikal, M.J. Design of freeze-drying processes for pharmaceuticals: Practical advice. Pharmaceutical Research 2004, 21,191-200.
5. Sadikoglu, H.; Ozdemir, M.; Seker, M. Freeze-drying of pharmaceutical products: Research and development needs. Drying Technology 2006,24,849-861.
6. U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Manufacturing & Quality Assurance. 2004. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf
7. Galan, M.; Velardi, S.A.; Pisano, R.; Rasetto, V.; Barresi, A.A. A gentle PAT approach to in-line control of the lyophilization process. Refrigeration Science and Technology Proceedings No. 2007-3, "New Ventures in Freeze-Drying," Strasbourg, France, November 7-9, 2007 (CD-ROM), 17 pp.
8. Barresi, A.A.; Pisano, R.; Fissore, D.; Rasetto, V.; Velardi, S.A.; Vallan, A.; Parvis, M.; Galan, M. Monitoring of the primary drying of a lyophilization process in vials. Chemical Engineering and Processing 2009, 48, 403-423.
9. Velardi, S.A.; Rasetto, V.; Barresi, A.A. Dynamic Parameters Estimation method: Advanced manometric temperature measurement approach for freeze-drying monitoring of pharmaceutical. Industrial & Engineering Chemistry Research 2008, 47, 8445-8457.
10. Fissore, D.; Velardi, S.A.; Barresi, A.A. In-line control of a freeze-drying process in vial. Drying Technology 2008, 26, 685-694.
11. Tang, X.C.; Nail, S.L.; Pikal, M.J. Freeze-drying process design by manometric temperature measurement: Design of a smart freeze-dryer. Pharmaceutical Research 2005, 22, 685-700.
12. Pikal, M.J.; Tang, X.; Nail, S.L. Automated process control using manometric temperature measurement. U.S. Patent No. 6,971,187 B1, 2005.
13. Milton, N.; Pikal, M.J.; Roy, M.L.; Nail, S.L. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilisation. PDA Journal of Pharmaceuticals Science 1997, 51, 7-16.
14. Gieseler, H.; Kramer, T.; Pikal, M.J. Use of manometric temperature measurement (MTM) and SMART™ freeze dryer technology for development of an optimized freeze-drying cycle. Journal of Pharmaceutical Sciences 2007, 96, 3402-3418.
15. Oetjen, G.W. Freeze-Drying; Wiley-VCH Verlag: Weinheim, 1999.
16. Oetjen, G.W.; Haseley, P. Freeze-Drying, 2nd Ed.; Wiley-VCH Verlag: Weinheim, 2004.
17. Gan, K.H.; Bruttini, R.; Crosser, O.K.; Liapis, A.A. Heating policies during the primary and secondary drying stages of the lyophilization process in vials: Effects of the arrangement of vials in clusters of square and hexagonal arrays on trays. Drying Technology 2004, 22, 1539-1575.
18. Gan, K.H.; Bruttini, R.; Crosser, O.K.; Liapis, A.I. Freeze-drying of pharmaceuticals in vials on trays: Effects of drying chamber wall temperature and tray side on lyophilization performance. International Journal of Heat and Mass Transfer 2005, 48, 1675-1687.
19. Gan, K.H.; Crosser, O.K.; Liapis, A.I.; Bruttini, R. Lyophilisation in vials on trays: Effects of tray side. Drying Technology 2005, 23, 341-363.
20. Kobayashi, M.; Harashima, K.; Sunama, R.; Yao, A.R. Inter-vial variance of the sublimation rate in shelf freeze-dryer. Proceedings of 18th International Refrigeration Congress, Saint Hyacinthe, Quebec, Canada, August 10-17, 1991, pp. 1711-1715.
21. Sennhenn, B.; Gehrmann, D.; Firus, A. Freeze drying apparatus. U.S. Patent No. 6,931,754 B2, 2005.
22. Rasetto, V.; Marchisio, D.L.; Fissore, D.; Barresi, A.A. Model-based monitoring of a non-uniform batch in a freeze-drying process. Proceedings of the 18th European Symposium on Computer Aided Process Engineering-ESCAPE 18, Lyon, France, June 1-4, 2008 (CD-ROM), paper 210, 6 pp.
23. Rasetto, V.; Pisano, R.; Barresi, A.A.; Vallan, A. Modelling and experimental investigation of radiation effects in a freeze-drying process. Proceedings of the 5th Chemical Engineering Conference for Collaborative Research in Eastern Mediterranean Countries EMCC5, Cetraro (CS), Italy, May, 24-29, 2008, pp. 394-397.
24. Velardi, S.A.; Barresi, A.A. Development of simplified models for the freeze-drying process and investigation of the optimal operating conditions. Chemical Engineering Research & Design 2008, 86, 9-22.
25. Ferziger, J.H.; Peric, M. Computational Methods for Fluid Dynamics; Springer: Berlin, 2002.
26. Tang, X.C.; Nail, S.L.; Pikal, M.J. Evaluation of manometric temperature measurement, a process analytical technology tool for freeze-drying, part II: Measurement of dry-layer resistance. AAPS Pharmaceutical Science and Technology 2006, 7, article 93.
27. Tang, X.C.; Nail, S.L.; Pikal, M.J. Evaluation of manometric temperature measurement (MTM), a process analytical technology tool in freeze drying, part III: Heat and mass transfer measurement. AAPS Pharmaceutical Science and Technology 2006, 7, article 97.
28. Barresi, A.A.; Rasetto, V.; Pisano, R.; Fissore, D.; Marchisio, D.L.; Vanni, M. Multiscale modelling of freeze-drying for optimisation and quality control of pharmaceutical products. Proceedings of the 5th Chemical Engineering Conference for Collaborative Research in Eastern Mediterranean Countries EMCC5, Cetraro (CS), Italy, May 24-29, 2008, pp. 390-393.
29. Rasetto, V. Use of Mathematical Models in the Freeze-Drying Field: Process Understanding and Optimal Equipment Design; Ph.D. dissertation, Politecnico di Torino, Italy, 2009.
30. Velardi, S.A., Barresi, A.A. Method and system for controlling a freeze drying process. International (No. PCT/EP2007/059921) and U.S. (No. 12/441,752) Patent application. International Publication No. WO 2008/034855 A2, World Intellectual Property Organization, 2008.
31. Pisano, R. Monitoring and Control of a Freeze-Drying Process of Pharmaceutical Products in Vials; Ph.D. dissertation, Politecnico di Torino, Italy, 2009.
32. Pisano, R.; Fissore, D.; Velardi, S.A.; Barresi, A.A. In-line optimization and control of an industrial freeze-drying process for pharmaceuticals. Journal of Pharmaceutical Sciences 2010. In press. [DOI: 10.1002/jps.22166]
33. Fissore, D.; Pisano, R.; Barresi, A.A. On the design of an in-line control system for a vial freeze-drying process: The role of chamber pressure. Chemical Product and Process Modeling 2009, 4 (2), article 9.
34. Rasetto, V.; Marchisio, D. L.; Fissore, D.; Barresi, A. A. On the use of a dual-scale model to improve understanding of a pharmaceutical freeze-drying process. Journal of Pharmaceutical Sciences 2010. In press. [DOI:10.1002/jps.22127]