Freeze-Drying Process Development and Scale-Up: Scale-Up of Edge Vial Versus Center Vial Heat Transfer Coefficients, Kv.
This report presents calculations of the difference between the vial heat transfer coefficient of the "edge vial" and the "center vial" at all scales. The only scale-up adjustment for center vials is for the contribution of radiation from the shelf upon which the vial sits by replacing the emissivity of the laboratory dryer shelf with the emissivity of the production dryer shelf. With edge vials, scales-up adjustments are more complex. While convection is not important, heat transfer from the wall to the bands (surrounding the vial array) by radiation and directly from the band to the vials by both radiation and conduction is important; this radiation heat transfer depends on the emissivity of the vial and the bands and is nearly independent of the emissivity of the dryer walls. Differences in wall temperatures do impact the edge vial effect and scale-up, and estimates for wall temperatures are needed for both laboratory and manufacturing dryers. Auto-loading systems (no bands) may give different edge vial heat transfer coefficients than when operating with bands. Satisfactory agreement between theoretical predictions and experimental values of the edge vial effect indicate that results calculated from the theory are of useful accuracy.
School of Pharmacy, University of Connecticut, Storrs, Connecticut 06269. Electronic address: michael.pikal@uconn.edu.
Michael J
MJ
Pikal
School of Pharmacy, University of Connecticut, Storrs, Connecticut 06269.
Robin
R
Bogner
School of Pharmacy, University of Connecticut, Storrs, Connecticut 06269.
Vamsi
V
Mudhivarthi
School of Pharmacy, University of Connecticut, Storrs, Connecticut 06269.
Puneet
P
Sharma
School of Pharmacy, University of Connecticut, Storrs, Connecticut 06269.
Pooja
P
Sane
D018481:Convection; D004349:Drug Packaging / Q000379:methods*; D004735:Energy Transfer; D005612:Freeze Drying / Q000379:methods; D006358:Hot Temperature; D013678:Technology, Pharmaceutical / Q000379:methods*
freeze drying; lyophilization; mathematical model; process analytical technology; processing; quality by design