Evaluation of manometric temperature measurement, a process analytical technology tool for freeze-drying: Part 1, product temperature measurement

AAPS PharmSciTech

Volumn 7, Issue 1, 2006, Pages

  Tang, Xiaolin ^a   Nail, Steven L ^b,c   Pikal, Michael J ^d  

^a CENTOCOR INC   (United States)

^b PURDUE UNIVERSITY   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d UNIVERSITY OF CONNECTICUT   (United States)

Author keywords

Freeze drying lyophilization; Manometric temperature measurement; Process analytical technology for freeze drying; Product temperature heterogeneity

Indexed keywords

ACCURACY; ANALYTIC METHOD; ANALYTICAL ERROR; ARTICLE; CALIBRATION; FREEZE DRYING; LOW TEMPERATURE PROCEDURES; MANOMETRY; PRESSURE; SIMULATION; TEMPERATURE MEASUREMENT; VALIDATION PROCESS; METHODOLOGY; PHARMACEUTICS; TEMPERATURE;

FREEZE DRYING; MANOMETRY; PRESSURE; TECHNOLOGY, PHARMACEUTICAL; TEMPERATURE;

EID: 33644752601     PISSN: 15309932     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/pt070114     Document Type: Article

References (12)

1. Pikal MJ. Lyophilization. In: Swarbrick J, Boylan J, eds. Encyclopedia of Pharmaceutical Technology. New York, NY: Marcel Dekker, 2001; 1299-1326.
2. Carpenter JF, Pikal MJ, Chang BS, Randolph TW. Rational design of stable lyophilized protein formulations: some practical advice. Pharm Res. 1997;14:969-975.
3. Pikal MJ, Roy ML, Shah S. Mass and heat transfer in vial freeze-drying of pharmaceuticals: role of the vial. J Pharm Sci. 1984;73:1224-1237.
4. Pikal MJ. 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. 1985;39:115-139.
5. Pikal MJ. Freeze-drying of proteins: process, formulation, and stability. ACS Symp Series. Washington, DC: American Chemical Society; 1994:120-133.
6. Roy ML, Pikal MJ. Process control in freeze-drying: determination of the end point of sublimation drying by an electronic moisture sensor. J Parenter Sci Technol. 1989;43:60-66.
7. Milton N, Pikal MJ, Roy ML, Nail SL. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilization. PDA J Pharm Sci Technol. 1997; 51:7-16.
8. Pikal MJ. Freeze-drying of proteins. II. Formulation selection. BioPharm. 1990;3:26-30.
9. Pikal MJ, Shah S, Senior D, Lang JE. Physical chemistry of freeze-drying: measurement of sublimation rates for frozen aqueous solutions by a microbalance technique. J Pharm Sci. 1983; 72:635-650.
10. Tang XC, Nail SL, Pikal MJ. Mass transfer in freeze-drying: Measurement of dry layer resistance by a non-steady state method (the MTM procedure). AAPS PharmSci (supplement). 1999;S-564 Abstract 3740.
11. Tang XC, Nail SL, Pikal MJ. Freeze-drying process design by manometric temperature measurement: design of a smart freeze-dryer. Pharm Res. 2005;22:685-700.
12. Tang X, Pikal MJ. Design of freeze-drying processes for pharmaceuticals: practical advice. Pharm Res. 2004;21: 191-200.