Kasper J C, Winter G, Friess W. Recent advances and further challenges in lyophilization[J]. European Journal of Pharmaceutics and Biopharmaceutics, 2013, 85: 162-169.
[2]
Tang X C, Pikal M J. Design of freeze-drying processes for pharmaceuticals: Practical advice[J]. Pharmaceutical Research, 2004, 21: 191-200.
[3]
Costantino H R, Pikal M J. Lyophilization of Biopharmaceuticals (Biotechnology: Pharmaceutical Aspects)[M]. Virginia: American Association of Pharmaceutical ScientistsAmerican Association of Pharmaceutical ScientistsAmerican Association of Pharmaceutical Scientists, 2005.
[4]
Fissore D, Pisano R, Velardi S, et al. PAT tools for the optimization of the freeze-drying process[J]. Pharmaceutical Engineering, 2009, 29(5): 58-68.
[5]
Velardi S A, Rasetto V, Barresi A A. Dynamic parameters estimation method: Advanced manometric temperature measurement approach for freeze-drying monitoring of pharmaceutical solutions[J]. Industrial and Engineering Chemistry Research, 2008, 47(21): 8445-8457.
[6]
Fissore D, Pisano R, Rasetto V, et al. Applying process analytical technology (PAT) to lyophilization processes[J]. Analytical Technologies, 2009, 27(2): 7-11.
[7]
Barresi A A, Pisano R, Fissore D, et al. Monitoring of the primary drying of a lyophilization process in vials[J]. Chemical Engineering and Processing, 2009, 48: 408-423.
[8]
Barresi A A, Velardi S A, Pisano R. In-line control of the lyophilization process. A gentle PAT approach using software sensors[J]. International Journal of Refrigeration, 2009, 32: 1003-1014.
[9]
郭彦伟. 真空冷冻干燥动压测温技术研究及应用软件开发[D]. 上海: 上海理工大学, 2014.
[10]
Velardi S A, Hammouri H, Barresi A A. In-line monitoring of the primary drying phase of the freeze-drying process in vial by means of a Kalman filter based observer[J]. Chemical Engineering Research and Design, 2009, 87: 1409-1419.
[11]
Bosca S, Fissore D. Design and validation of an innovative soft-sensor for pharmaceuticals freeze-drying monitoring[J]. Chemical Engineering Science, 2011, 66: 5127-5136.
[12]
华泽钊.冷冻干燥新技术[M]. 北京: 科学出版社, 2005: 244-245.
[13]
Bosca S, Barresi A A, Fissore D. Fast freeze-drying cycle design and optimization using a PAT based on the measurement of product temperature[J]. European Journal of Pharmaceutics and Biopharmaceutics, 2013, 85: 253-262.
[14]
Bosca S, Barresi A A, Fissore D. Use of a soft sensor for the fast estimation of dried cake resistance during a freeze-drying cycle[J]. International Journal of Pharmaceutics, 2013, 451: 23-33.
Patel S M, Pikal M. Process analytical technologies (PAT) in freeze-drying of parenteral products[J]. Pharmaceutical Development and Technology, 2009, 14(6): 567-587.
[17]
Daraoui N, Dufour P, Hammouri H, et al. Optimal operation of sublimation time of the freeze drying process by predictive control: Application of the MPC@CB software[J]. Computer Aided Chemical Engineering, 2008, 25: 453-458.
[18]
Daraoui N, Dufour P, Hammouri H, et al. Model predictive control during the primary drying stage of lyophilisation[J]. Control Engineering Practice, 2010, 18: 483-494.
[19]
Pisano R, Fissore D, Barresi A A. Freeze-drying cycle optimization using model predictive control techniques[J]. Industrial and Engineering Chemistry Research, 2011, 50: 7363-7379.
[20]
Smith G, Polygalov E, Arshad M S, et al. An impedance-based process analytical technology for monitoring the lyophilisation process[J]. International Journal of Pharmaceutics, 2013, 449: 72-83.
[21]
Dragoi E, Curteanu S, Fissore D. Freeze-drying modeling and monitoring using a new neuro-evolutive technique[J]. Chemical Engineering Science, 2012, 72: 195-204.
[22]
Beer D, Wiggenhorn M, Hawe A, et al. Optimization of a pharmaceutical freeze-dried product and its process using an experimental design approach and innovative process analyzers[J]. Talanta, 2011, 83: 1623-1633.
[23]
Rosas J G, Waard H, Beer T D, et al. NIR spectroscopy for the in-line monitoring of a multicomponent formulation during the entire freeze-drying process[J]. Journal of Pharmaceutical and Biomedical Analysis, 2014, 97: 39-46.
Velardi S A, Barresi A A. Development of simplified models for the freeze-drying process and investigation of the optimal operating conditions[J]. Chemical Engineering Research and Design, 2008, 86: 9-22.