Experimental study and modeling of freeze-drying in syringe configuration. Part II: Mass and heat transfer parameters and sublimation end-points

Drying Technology

Volumn 27, Issue 1, 2009, Pages 49-58

  Hottot, A ^a   Andrieu, J ^a   Hoang, V ^a   Shalaev, E Y ^b   Gatlin, L A ^b   Ricketts, S ^b  

^a UNIVERSITÉ LYON 1   (France)

^b PFIZER INC   (United States)

Author keywords

Freeze drying; Heat transfer; Mass transfer; Sublimation end point; Syringe

Indexed keywords

CURING; DEWATERING; GASES; HEAT EXCHANGERS; HEAT RESISTANCE; HEAT TRANSFER; HEAT TRANSFER COEFFICIENTS; LOW TEMPERATURE DRYING; MASS TRANSFER; ORGANIC POLYMERS; POINT CONTACTS; SENSORS; SIGNAL TO NOISE RATIO; SUBLIMATION; THERMOANALYSIS; WATER ANALYSIS; WATER VAPOR;

ANALYSIS METHODS; EXPERIMENTAL STUDIES; FREEZE DRYING; GAS PRESSURES; GAS TEMPERATURES; IN-SITU; MASS TRANSFER RESISTANCES; MASS-TRANSFER COEFFICIENTS; MODEL FORMULATION; NOISE RATIOS; PHARMACEUTICAL PROTEINS; PIRANI GAUGE; PRESSURE RISE; SUBLIMATION END-POINT; SUBLIMATION RATES; SYRINGE; TEMPERATURE INFLUENCE; TOTAL GAS PRESSURE; TRANSFER COEFFICIENTS; TRANSFER PARAMETERS;

SYRINGES;

EID: 58449135138     PISSN: 07373937     EISSN: 15322300     Source Type: Journal    
DOI: 10.1080/07373930802565814     Document Type: Article

References (20)

1. Nail, S. L. (1980) The effect of chamber pressure on heat transfer in the freeze-drying of parenteral solutions. Journal of Parenteral Drug Association, 34, pp. 358-368.
2. 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 and Technology, 39:3, pp. 115-139.
3. Franks, F. (1998) Freeze-drying of bioproducts: Putting principle into practice. European Journal of Pharmacy Biopharm, 43:3, pp. 221-229.
4. Pikal, M. J. (1984) Mass and heat transfer in vial freeze-drying of pharmaceuticals: Role of the vial. Journal of Pharmaceutical Science, 73:9, pp. 1224-1237.
5. Hottot, A., Vessot, S. and Andrieu, J. (2005) Determination of mass and heat transfer parameters during freeze-drying cycles of pharmaceutical products. PDA Journal of Pharmaceutical Science and Technology, 59:2, pp. 138-154.
6. Gan, K. H., Bruttini, R., Crosser, O. K. and Liapis, A. I. (2004) Heating policies during the primary and secondary drying stages on lyophilization in vials: Effects of the arrangement of the vials in clusters of square and hexagonal arrays on trays. Drying Technology, 22, pp. 1539-1575.
7. Mascarenhas, W. J., Akay, H. U. and Pikal, M. J. (1997) A computational model for finite element analysis of the freeze-drying process. Computer Methods Applied to Mechanical Engineering, 148, pp. 105-124.
8. Brulls, M. and Rasmuson, A. (2002) Heat transfer in vial lyophilisation. International Journal of Pharmaceutics, 246, pp. 1-16.
9. Hottot, A., Peczlaski, R., Vessot, S. and Andrieu, J. (2006) Freeze-drying of pharmaceutical proteins. Modelling of freezing and sublimation steps. Drying Technology, 24:4, pp. 561-570.
10. Nail, S. L. (1990)pp. 137-151. International Symposium on Biological Product Freeze-Drying and Formulation, Bethesda, MD
11. Roy, M. L. and Pikal, M. (1989) Process control in freeze-drying: Determination of the point of sublimation drying by an electronic moisture sensor. Journal of Parenteral Science and Technology, 43, pp. 60-66.
12. 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 and Technology, 51:1, pp. 7-16.
13. Obert, J. P.
14. Chouvenc, P., Vessot, S., Andrieu, J. and Vacus, P. (2004) Optimization of the freeze-drying cycle: A new model for pressure rise analysis. Drying Technology, 22:7, pp. 1577-1601.
15. Chouvenc, P., Vessot, S., Andrieu, J. and Vacus, P. (2005) Optimisation of the freeze-drying cycle: Adaptation of the pressure rise analysis model to non instantaneous isolation valves. PDA Journal of Pharmaceutical Sciences and Technology, 45, pp. 783-791.
16. Xiang, J., Hey, J. M., Liedtke, V. and Wang, D. Q. (2004) Investigation of freeze-drying sublimation rates using a freeze-drying microbalance technique. International Journal of Pharmaceutics, 279:26, pp. 95-105.
17. Pikal, M. J., Shah, S., Senior, D. and Lang, J. E. (1983) Physical chemistry of freeze-drying: Measurement of sublimation rates for frozen aqueous solutions by a microbalance technique. Journal of Pharmaceutical Science, 72, pp. 635-650.
18. Nomine, C. (2006) Lyotrack 100, Moisture Sensor for Freeze Drying
19. Hottot, A., Vessot, S. and Andrieu, J. (2007) Sublimation kinetics during freeze-drying of pharmaceutical protein formulation. Drying Technology, 25, pp. 753-758.
20. Nakagawa, K., Hottot, H., Vessot, S. and Andrieu, J. (2006) Influence of controlled nucleation by ultrasounds on ice morphology of frozen formulations for pharmaceuticals proteins freeze-drying. Chemical Engineering and Processing, 45, pp. 783-791.