Monitoring of the primary drying of a lyophilization process in vials

Chemical Engineering and Processing: Process Intensification

Volumn 48, Issue 1, 2009, Pages 408-423

  Barresi, Antonello A ^a   Pisano, Roberto ^a   Fissore, Davide ^a   Rasetto, Valeria ^a   Velardi, Salvatore A ^a   Vallan, Alberto ^a   Parvis, Marco ^a   Galan, Miquel ^b  

^a POLITECNICO DI TORINO   (Italy)

^b Telstar Lyo   (Spain)

Author keywords

Freeze drying; Monitoring; Observer; Pressure rise test; Primary drying

Indexed keywords

CONTROL LOOP; CONTROL PURPOSE; FREEZE-DRYING; HEAT AND MASS TRANSFER COEFFICIENTS; IMPROVED ALGORITHM; INTERFACE TEMPERATURES; MODULAR SYSTEM; MOISTURE SENSORS; MULTIPOINT; OBSERVER; PRESSURE GAUGES; PRESSURE RISE TEST; PRIMARY DRYING; SOFT SENSORS; TEMPERATURE MEASUREMENT SYSTEMS; TEMPERATURE PROFILES;

CURING; DEWATERING; GAGES; LOW TEMPERATURE DRYING; MASS SPECTROMETRY; MASS TRANSFER; MONITORING; SENSORS; TEMPERATURE MEASUREMENT;

MOISTURE CONTROL;

EID: 67649836871     PISSN: 02552701     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cep.2008.05.004     Document Type: Article

References (64)

1. Snowman J.W. Freeze drying of sterile products. In: Groves M.J., Olson W., and Anisfeld M. (Eds). Sterile Pharmaceutical Manufacturing (1991), Interpharm Press, Buffalo Grove 79-108 (Chapter 5)
2. Liapis A.I. Freeze drying. In: Mujumdar A.S. (Ed). Handbook of Industrial Drying (1987), Marcel Dekker, Inc., New York 295-326 (Chapter 9)
3. Roy M.L., and Pikal M.J. Process control in freeze drying: determination of the end point of sublimation drying by an electronic moisture sensor. Journal of Parenteral Science and Technology 43 (1989) 60-66
4. Oetjen G.W., and Haseley P. Freeze-Drying (2004), Wiley-VHC, Weinheim
5. Mayeresse Y., Veillon R., Sibille P.H., and Nomine C. Freeze-drying process monitoring using a cold plasma ionization device. PDA Journal of Pharmaceutical Science and Technology 61 (2007) 160-174
6. Milton N., Pikal M.J., Roy M.L., and Nail S.L. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilisation. PDA Journal of Pharmaceutical Sciences 5 (1997) 7-16
7. Chouvenc P., Vessot S., Andrieu J., and Vacus P. Optimization of the freeze-drying cycle: a new model for pressure rise analysis. Drying Technology 22 (2004) 1577-1601
8. Chouvenc P., Vessot S., Andrieu J., and Vacus P. Optimization of the freeze-drying cycle: adaptation of the Pressure Rise Analysis to non-instantaneous isolation valves. PDA Journal of Pharmaceutical Science and Technology 5 (2005) 298-309
9. Vallan A., Corbellini S., and Parvis M. A Plug&Play architecture for low-power measurement systems. Proceedings of Instrumentation and Measurement Technology Conference-IMTC 2005, vol. 1. Ottawa, Canada, May 16-19 (2005) 565-569 10.1109/IMTC.2005.1604180
10. A. Vallan, M. Parvis, A.A. Barresi, Sistema per la misurazione in tempo reale di massa e temperatura di sostanze sottoposte a liofilizzazione, Italian Patent Application no. B02005A000320, 2005
11. Vallan A. A measurement system for lyophilization process monitoring. 5 pp. Proceedings of Instrumentation and Measurement Technology Conference-IMTC 2007. Warsaw, Poland, May 1-3 (2007) 10.1109/IMTC.2007.379000
12. 3NEDIA, Ottawa, 2008 (Chapter 7).
13. Becerra V.M., Roberts P.D., and Griffiths G.W. Applying the extended Kalman filter to systems described by non-linear differential-algebraic equations. Control Engineering Practice 9 (2001) 267-281
14. Velardi S.A., and Barresi A.A. Development of simplified models for the freeze-drying process and investigation of the optimal operating conditions. Chemical Engineering Research & Design 86 (2008) 9-22
15. S.A. Velardi, H. Hammouri, A.A. Barresi, In-line monitoring of the primary drying phase of the freeze-drying process in vial using a Kalman filter based observer, Chemical Engineering Research & Design, Submitted for publication.
16. A.A. Barresi, G. Baldi, M. Parvis, A. Vallan, S. Velardi, H. Hammouri, Optimization and control of the freeze-drying process of pharmaceutical products, International patent application No. PCT/IB2007/051276, International Publication No. WO2007/116371 A2 (18 October 2007), World Intellectual Property Organization [Priority data TO2006A000270, 11/04/2006], 2007.
17. M. Galan, S.A. Velardi, R. Pisano, V. Rasetto, A.A. Barresi, A gentle PAT approach to in-line control of the lyophilization process. In: New Ventures in Freeze-drying, Refrigeration Science and Technology Proceedings No. 2007-3 (IIR & Aerial), Strasbourg, France, November 7-9, 2007, CD-ROM Edition, Institut International du Froid, Paris, 17 pp.
18. Monteiro Marques J.P., Le Loch C., Wolff E., and Rutledge D.N. Monitoring freeze-drying by low resolution NMR: Determination of sublimation endpoint. Journal of Food Science 56 (1991) 1707-1728
19. Schelenz G., Engel J., and Rupprecht H. Sublimation drying lyophilization detected by temperature profile and X-ray technique. International Journal of Pharmaceutics 113 (1994) 133-140
20. Jennings T.A., and Duan N. Calorimetric monitoring of lyophilization. PDA Journal of Pharmaceutical Science and Technology 49 (1995) 272-282
21. Jennings T.A. Lyophilization: Introduction and Basic Principles (1999), Interpharm/CRC Press, Boca Raton
22. Remmele R.L., Stushnoff C., and Carpenter J.F. Real-rime in situ monitoring of lysozyme during lyophilization using infrared spectroscopy: Dehydration stress in the presence of sucrose. Pharmaceutical Research 14 (1997) 1548-1555
23. Brülls M., Folestad S., Sparén A., and Rasmuson A. In-situ near-infrared spectroscopy monitoring of the lyophilization process. Pharmaceutical Research 20 (2003) 494-499
24. I. Presser, Innovative Online Messverfahren zur Optimierung von Gefriertrocknungsprozessen, Ph.D. Thesis, University of Munich, Department of Pharmaceutical Technology, Germany, 2003.
25. Suherman P.M., Taylor P.M., and Smith G. Development of a remote electrode system for monitoring the water content of materials inside a glass vial. Pharmaceuticals Research 19 (2002) 337-344
26. Rey L.R. Automatic regulation of the freeze-drying of complex systems. Biodynamica 8 (1961) 241-260
27. Bouldoires J.P. Etude expérimentale des transferts de chaleur et de masse en cours de lyophilisation par mesures diélectriques et par mesure de pression de vapeur. Symposium on Thermodynamic Aspects of Freeze-drying. International Institute of Refrigeration, Cleveland, USA (1969)
28. Nail S.L., and Gatlin L.A. Advances in control of production freeze-dryers. Journal of Parenteral Science and Technology 39 (1985) 16-27
29. Nail S., and Gatlin L. Freeze drying: principles and practice. In: Avis A., Liebermann A., and Lachmann L. (Eds). Pharmaceutical Dosage Forms vol. 2 (1993), Marcel Dekker, New York 163-333
30. Tang X., and Pikal M.J. Design of freeze-drying processes for pharmaceuticals: practical advice. Pharmaceuticals Research 21 (2004) 191-200
31. R. Bruttini, G. Rovero, G. Baldi, Impiego di un impianto pilota per lo studio cinetico di un processo di liofilizzazione. Il farmaco, Edizione Pratica 11 (1986) 346-357.
32. Bruttini R., Rovero G., and Baldi G. Experimentation and modelling of pharmaceutical lyophilisation using a pilot plant. Chemical Engineering Journal 45 (1991) 67-77
33. Rovero G., Ghio S., and Barresi A.A. Development of a prototype capacitive balance for freeze-drying studies. Chemical Engineering Science 56 (2001) 3575-3584
34. M. Christ, Freeze-drying plant, International Patent Classification no. WO1994EP02426 19940722, 1994.
35. Roth C., Winter G., and Lee G. Continuous measurement of drying rate of crystalline and amorphous systems during freeze-drying using an in situ microbalance technique. Journal of Pharmaceutical Science 90 (2001) 1345-1355
36. R. Pisano, V. Rasetto, A.A. Barresi, A. Vallan, Modelling and experimental investigation of radiation effects in a freeze-drying process, in: Proceedings of 5th Chemical Engineering Conference for Collaborative Research in Eastern Mediterranean Countries (EMCC5), Cetraro, Italy, May 24-29, 2008, 394-397.
37. Armstrong J.G. Use of the capacitance manometer gauge in vacuum freeze-drying. Journal of the Parenteral Drug Association 34 (1980) 473-483
38. Salzberg F. Pulsed Pirani Vacuum Gauge. Abstracts of 4th International Conference on Lyophilization and Freeze-Drying. Dublin, 17-19 October (2007)
39. Bardat A., Biguet J., Chatenet E., and Courteille F. Moisture measurement: a new method for monitoring freeze-drying cycles. PDA Journal of Parenteral Science and Technology 47 (1993) 293-299
40. Genin N., Rene F., and Corrieu G. A method for on-line determination of residual water content and sublimation end-point during freeze-drying. Chemical Engineering and Processing 35 (1996) 255-263
41. S. Rambhatla, R. Ramot, C. Bhugra, M.J. Pikal, Heat and mass transfer scale-up issues during freeze drying. II. Control and characterization of the degree of supercooling. AAPS Pharmaceutical Science and Technology 5 (4) (2004), 9 pp., article 58, http://www.aapspharmscitech.org.
42. F. René, N. Genin, G. Corrieu, Procédé et dispositif de contrôle de la lyophilisation sous vide, International application No. PCT/FR95/00563, International Publication No. WO95/30118 (9 November 1995), World Intellectual Property Organization [Priority data 94/05398, 3/05/1994 FR], 1995.
43. Trelea I.C., Passot S., Fonseca F., and Marin M. An interactive tool for the optimization of freeze-drying cycles based on quality criteria. Drying Technology 25 (2007) 741-751
44. Jennings T.A. Residual gas analysis and vacuum freeze drying. Journal of Parenteral Drug Association 34 (1980) 62-69
45. Connelly J.P., and Welch J.V. Monitor lyophilization with mass spectrometer gas analysis. Journal of Parenteral Science and Technology 47 (1993) 70-75
46. Chase D.R. Monitoring and control of a lyophilization process using a mass flow controller. Pharmaceutical Engineering 18 (1998) 11-17
47. Kessler W.J., Davis S.J., Mulhall A., Silva M., Pikal M.J., and Luthra S. Lyophilizer monitoring using Tunable Laser Absorption Spectroscopy. Proceedings of the 18th International Forum Process Analytical Chemistry (IFPAC). Arlington, VA, USA (2004)
48. S.A. Velardi, V. Rasetto, A.A. Barresi, The dynamic parameters estimation method (DPE): an advanced Manometric Temperature Measurement approach for freeze-drying monitoring of pharmaceutical solutions, Industrial & Engineering Chemistry Research, in press.
49. X.C. Tang, S.L. Nail, M.J. Pikal, Evaluation of manometric temperature measurement, a process Analytical Technology Tool for freeze-drying. Part I. Product temperature measurement, AAPS Pharmaceutical Science and Technology 7 (1) (2006), 9 pp., article 14, http://www.aapspharmscitech.org.
50. Liapis A.I., and Sadikoglu H. Dynamic pressure rise in the drying chamber as a remote sensing method for monitoring the temperature of the product during the primary drying stage of freeze-drying. Drying Technology 16 (1998) 1153-1171
51. Sadikoglu H., and Liapis A.I. Mathematical modelling of the primary and secondary stages of bulk solution freeze-drying in trays: parameter estimation and model discrimination by comparison of theoretical results with experimental data. Drying Technology 13 (1997) 43-72
52. Brülls M., and Rasmuson A. Heat transfer in vial lyophilization. International Journal of Pharmaceutics 246 (2002) 1-16
53. Hottot A., Peczalski R., Vessot S., and Andrieu J. Freeze-drying of pharmaceutical proteins in vials: modeling of freezing and sublimation steps. Drying Technology 24 (2006) 561-570
54. Velardi S., Barresi A.A., Hottot A., and Andrieu J. Pharmaceuticals freeze-drying in vials: a new heat transfer model including the effect of the vial sidewall. Proceedings of the Joint conference of AFSIA and Drying Working group of EFCE. Paris, France, May 12-13 (2005) 20-21
55. Liapis A.I., and Litchfield R.J. Optimal control of a freeze dryer. I. Theoretical development and quasi steady-state analysis. Chemical Engineering Science 34 (1979) 975-981
56. Litchfield R.J., and Liapis A.I. Optimal control of a freeze dryer. II. Dynamic analysis. Chemical Engineering Science 37 (1982) 45-55
57. Hottot A., Vessot S., and Andrieu J. Determination of mass and heat transfer parameters during freeze-drying cycles of pharmaceutical products. PDA Journal of Pharmaceutical Science and Technology 59 (2005) 138-153
58. Tang X.C., Nail S.L., and Pikal M.J. Freeze-drying process design by manometric temperature measurement: design of a smart freeze-dryer. Pharmaceutical Research 22 (2005) 685-700
59. Pikal M.J., Roy M.L., and Shah S. Mass and heat transfer in vial freeze-drying of pharmaceuticals: role of the vial. Journal of Pharmaceutical Sciences 73 (1984) 1224-1237
60. Liapis A.I., Pikal M.J., and Bruttini R. Research and development needs and opportunities in freeze-drying. Drying Technology 14 (1996) 1265-1300
61. Velardi S.A., Hammouri H., and Barresi A.A. A non-linear observer for real-time monitoring and control of the freeze-drying process of pharmaceuticals in vial. Proceedings of the AFSIA 2005 Conference. Paris, France, May 12-13 (2005) 2 pp.
62. Fissore D., Velardi S.A., and Barresi A.A. In-line control of a freeze-drying process in vial. Drying Technology 26 (2008) 685-694
63. X.C. Tang, S.L. Nail, M.J. Pikal, 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 7 (4) (2006), 7 pp., article 97, http://www.aapspharmscitech.org.
64. V. Rasetto, D.L. Marchisio, D. Fissore, A.A. Barresi, Model-based monitoring of a non-uniform batch in a freeze-drying process, B. Braunschweig & X. Joulia, (Eds.), in: Proceedings of 18th European Symposium on Computer Aided Process Engineering, Computer-Aided Chemical Engineering Series, vol. 25, paper FP_00210, 6 pp. Elsevier, Amsterdam, CD Edition.