Lyophilizer process validation

Freeze-Drying/Lyophilization of Bharmaceutical and Biological Products

Volumn , Issue , 2004, Pages 535-573

  Bindschaedler, Christian ^a  

^a Serono Laboratories   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84889268978     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (18)

1. EH Trappier. Validation of lyophilized products. In: IR Berry and RA Nash, eds. Pharmaceutical Process Validation. 2nd ed. New York: Marcel Dekker, 1993, pp 445-477.
2. AP MacKenzie. Collapse during freeze-drying—qualitative and quantitative aspects. In: SA Goldblith, L Rey and WW Rothmayr, eds. Freeze-Drying and Advanced Food Technology. New York: Academic Press, 1974, pp 277-307.
3. ML Roy, MJ Pikal. Process control in freeze-drying: determination of the end point of sublimation drying by an electronic moisture sensor. J Parenter Sci Technol 43:60-66, 1989.
4. K Murgatroyd. The freeze-drying process. In: P Cameron, ed. Good Pharmaceutical Freeze-Drying Practice. Buffalo Grove, IL: Interpharm Press, 1997, pp 1-58.
5. N Milton, MJ Pikal, ML Roy, SL Nail. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilization. J Pharm Sci Technol 51:7-16, 1997.
6. SL Nail. The effect of chamber pressure on the heat transfer in freeze-drying of parenteral formulations. J Parenter Drug Assoc 34:358-368, 1980.
7. TA Jennings. Effect of pressure on the sublimation rate of ice. J Parenter Sci Technol 40:95-97, 1986.
8. RG Livesey, TWG Rowe. A discussion of the effect of chamber pressure on heat and mass transfer in freeze-drying. J Parenter Sci Technol 41:169-171, 1987.
9. TA Jennings. Discussion of primary drying during lyophilization. i Parenter Sci Technol 42:118 121, 1988.
10. MJ Pikal. Freeze-drying of proteins. I. Process design. Pharm Technol Int 37-43, January 199L
11. MJ Pikal. ML Roy, S Shah, Mass and heat transfer in vial freeze-drying of pharmaceuticals: role of the vial. J Pharm Sci. 73:1224-1237, 1984.
12. MJ Pikal. Use of laboratory data in freeze-drying process design: heat and mass transfer coefficients and the computer simulation of freeze-drying. J Parenter Sci Technol 39:1 15 139, 1985.
13. FDA Guide to Inspections of Lyophilization of Parenterals. Food and Drug Administration, Rockville, MD, July 1993.
14. E Trappier. Lyophilization. In: MJ Groves and R Murty, eds. Aseptic Pharmaceutical Manufacturing II. Buffalo Grove, IL: Interpharm Press, 1995, pp 291-309.
15. DC Montgomery, Introduction to Statistical Quality Control New York: John Wiley & Sons, 1996, pp 430-474.
16. V Kumar, R Murty. Validation of aseptic process. In: MJ Groves and R Murty, eds. Aseptic Pharmaceutical Manufacturing II. Buffalo Grove, IL: Interpharm Press, 1995, pp 101 116.
17. DC Montgomery. Introduction to Statistical Quality Control, New York: John Wiley & Sons, 1996, pp 179-312.
18. JD Mellor. Fundamentals of Freeze-Drying. London: Academic Press, 1978.