In-line control of a freeze-drying process in vials

Drying Technology

Volumn 26, Issue 6, 2008, Pages 685-694

  Fissore, Davide ^a   Velardi, Salvatore A ^a   Barresi, Antonello A ^a  

^a POLITECNICO DI TORINO   (Italy)

Author keywords

Feedback control; Freeze drying control; Model based control; Primary drying

Indexed keywords

CURING; CURVE FITTING; DEWATERING; DRYING; LOW TEMPERATURE DRYING; OPTICAL VARIABLES MEASUREMENT;

CHAMBER PRESSURES; CONTROL PURPOSES; CONTROLLED VARIABLE; DETAILED MODELS; FEEDBACK CONTROL; FEEDBACK CONTROLLERS; FREEZE-DRYING CONTROL; FREEZE-DRYING PROCESS; IN-LINE; IN-LINE CONTROL; MATHEMATICAL SIMULATIONS; MAXIMUM TEMPERATURE; MODEL-BASED CONTROL; OFF-LINE OPTIMIZATION; PRIMARY DRYING; PROCESS CONSTRAINTS; PROPORTIONAL-INTEGRAL; SOFT SENSORS;

PROCESS CONTROL;

EID: 46049114282     PISSN: 07373937     EISSN: 15322300     Source Type: Journal    
DOI: 10.1080/07373930802046161     Document Type: Article

References (38)

1. Liapis, A. I., Pikal, M. J. and Bruttini, R. (1996) Research and development needs and opportunities in freeze-drying. Drying Technology, 14, pp. 1265-1300.
2. Rene, F., Wolff, E. and Rodolphe, F. (1993) Vacuum freeze-drying of a liquid in a vial: Determination of heat and mass-transfer coefficients and optimisation of operating pressure. Chemical Engineering and Processing, 32, pp. 245-251.
3. Lombrana, J. I., De Elvira, C., Villaran, M. C. and Izcara, J. (1993) Simulation and design of heating profiles in heat controlled freeze-drying of pharmaceuticals in vials by the application of a sublimation semispherical model. Drying Technology, 11:3, pp. 471-487.
4. Lombrana, J. I., De Elvira, C. and Villaran, M. C. (1993) Simulation and design of heating profiles in heat controlled freeze-drying of pharmaceuticals in vials by the application of a sublimation cylindrical model. Drying Technology, 11:1, pp. 85-102.
5. Boss, E. A., Filho, R. M. and Vasco de Toledo, E.C. (2004) Freeze drying process: Real time model and optimization. Chemical Engineering and Processing, 43, pp. 1475-1485.
6. Velardi, S. A. and Barresi, A. A. (2008) Development of simplified models for the freeze-drying process and investigation of the optimal operating conditions. Chemical Engineering Research & Design, 86:1, pp. 9-22.
7. Gan, K. H., Bruttini, R., Crosser, O. K. and Liapis, A. I. (2004) 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, 22:7, pp. 1539-1575.
8. Gan, K. H., Crosser, O. K., Liapis, A. I. and Bruttini, R. (2005) Lyophilization in vials on trays: Effects of tray side. Drying Technology, 23:1, pp. 341-363.
9. Sadikoglu, H., Ozdemir, M. and Seker, M. (2006) Freeze-drying of pharmaceutical products: Research and development needs. Drying Technology, 24:7, pp. 849-861.
10. Sandall, O. C. and Wilke, C. R. (1967) The relationship between transport properties and rates of freeze drying poultry meats. AIChE Journal, 12, pp. 428-438.
11. Nail, S. L. (1980) The effect of pressure on heat transfer in the freeze-drying of parenteral solutions. Journal of the Parenteral Drug Association, 34, pp. 358-368.
12. Pikal, M. J., Roy, M. L. and Shah, S. (1984) Mass and heat transfer in vial freeze-drying of pharmaceuticals: Role of the vial. Journal of Pharmaceutical Sciences, 73, pp. 1224-1237.
13. Jennings, T. A. (1986) Effect of pressure on the sublimation rate of ice. Journal of Parenteral Science and Technology, 4, pp. 95-97.
14. Livesey, R. G. and Rowe, T. W. G. (1987) A discussion of the effect of chamber pressure on heat and mass transfer in freeze-drying. Journal of Parenteral Science and Technology, 41, pp. 169-171.
15. Franks, F. (1998) Freeze-drying of bioproducts: Putting principles into practice. European Journal of Pharmaceutics and Biopharmaceutics, 45, pp. 221-229.
16. Oetjen, G. W. (1999) Freeze-Drying, Wiley-VCH, Weinheim
17. Trelea, I. C., Passot, S., Fonseca, F. and Marin, M. (2007) An interactive tool for the optimization of freeze-drying cycles based on quality criteria. Drying Technology, 25:5, pp. 741-751.
18. Liapis, A. I. and Litchfield, R. J. (1979) Optimal control of a freeze dryer-I. Theoretical development and quasi steady-state analysis. Chemical Engineering Science, 34, pp. 975-981.
19. Sadikoglu, H., Liapis, A. I. and Crosser, O. K. (1998) Optimal control of the primary and secondary drying stages of bulk solution freeze drying in trays. Drying Technology, 16:3, pp. 399-431.
20. Litchfield, R. J. and Liapis, A. I. (1982) Optimal control of a freeze dryer-II. Dynamic analysis. Chemical Engineering Science, 37, pp. 45-55.
21. Lombrana, J. I. and Diaz, J. M. (1987) Heat programming to improve efficiency in a batch freeze-dryer. The Chemical Engineering Journal, 35, pp. B23-B30.
22. Lombrana, J. I. and Diaz, J. M. (1987) Coupled vacuum and heating power control for freeze-drying time reduction of solutions in phials. Vacuum, 37, pp. 473-476.
23. Sadikoglu, H., Ozdemir, M. and Seker, M. (2003) Optimal control of the primary drying stage of freeze drying of solutions in vials using variational calculus. Drying Technology, 21:7, pp. 1307-1331.
24. Sadikoglu, H. (2005) Optimal control of the secondary drying stage of freeze drying of solutions in vials using variational calculus. Drying Technology, 23:1, pp. 33-57.
25. Tang, X. C., Nail, S. L. and Pikal, M. J. (2005) Freeze-drying process design by manometric temperature measurement: Design of a smart freeze-dryer. Pharmaceutical Research, 22:4, pp. 685-700.
26. Pikal, M. J., Tang, X. and Nail, S. L. (2005)
27. Milton, N., Pikal, M. J., Roy, M. L. and Nail, S. L. (1997) Evaluation of Manometric Temperature Measurement as a method of monitoring product temperature during lyophilization. PDA Journal of Pharmaceutical Science Technology, 51, pp. 7-16.
28. Oetjen, G. W. and Haseley, P. (2004) Freeze-Drying,, Wiley-VCH, Weinheim
29. Mason, E. A., Malinauskas, A. P. and Evans III, R.B. (1967) Flow and diffusion of gases in porous media. The Journal of Chemical Physics, 46, pp. 3199-3216.
30. Kast, W. and Hohenthanner, C. R. (2000) Mass transfer within the gas phase of porous media. International Journal of Heat and Mass Transfer, 43, pp. 807-823.
31. Pikal, M. J. (1985) Use of laboratory data in freeze-drying process design: Heat and mass transfer coefficients and the computer simulation of freeze-drying. Journal of Parenteral Science Technology, 39, pp. 115-139.
32. Brulls, M. and Rasmuson, A. (2002) Heat transfer in vial lyophilization. International Journal of Pharmaceutics, 246, pp. 1-16.
33. Rey, L. and May, J. C. (2004) Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Marcel Dekker, New York
34. Barresi, A. A., Velardi, S., Fissore, D. and Pisano, R. (2006) Proceedings of Automation 2006-Methodologies for Emerging Technologies in Automation On the use of soft-sensors for monitoring and controlling processes with complex dynamics, pp. 13-15.
35. Barresi, A. A., Velardi, S., Fissore, D. and Pisano, R. (2008) Control and Optimisation of Continuous Processes, Ottawa, Canada
36. Velardi, S. A., Hammouri, H. and Barresi, A. A. (2008) On line monitoring of the primary drying of a freeze-drying process in vial. Kalman filter and high gain based observers. Chemical Engineering Research & Design
37. Velardi, S. A., Hammouri, H. and Barresi, A. A. (2005) Proceedings of AFSIA 2005 Conference A non-linear observer for real-time monitoring and control of the freeze-drying process of pharmaceuticals in vial, pp. 12-13.
38. Galan, M., Velardi, S., Pisano, R., Rasetto, V. and Barresi, A. A. (2007) Proceedings of the Conference of the International Institute of Refrigeration-New Ventures in Freeze-Drying A gentle PAT approach to in-line control of the lyophilisation process, 3, pp. 7-9.