Apparatus and method for developing freeze drying protocols using small batches of product
AssigneeMillrock Technology, Inc.
InventorsT. N. Thompson, Qiming Wang, Richard Martino
Life of this patent
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Abstract
A method and apparatus for eliminating or minimizing the non-uniformity of edge vials compared to center vials during freezing or primary drying of product therein in a freeze dryer. A temperature controlled surface is positioned in close proximity to or in contact with the edge vials to control the temperature thereof. The method and apparatus may be used to simulate in a development freeze dryer the conditions of the center and edge vials in a larger batch target freeze dryer.
Claims19
An apparatus for eliminating or minimizing non-uniformity of edge vials compared to center vials during freezing and/or primary drying of product therein in a freeze dryer, comprising:
- a temperature controlled surface surrounding both the edge vials and the center vials, wherein the temperature controlled surface is positioned in direct contact with or direct connection to the edge vials, or connected to the edge vials via a thermal conductor, to control the temperature of the edge vials, the temperature controlled surface is closer to the surrounded edge vials than the surrounded center vials,
- wherein the non-uniformity of the edge vials compared to the center vials during freezing and/or primary drying of product therein in the freeze dryer is reduced by adjusting the temperature of the temperature controlled surface.
An apparatus for enabling a development freeze dryer containing a small sample of product in vials to simulate freezing and sublimation conditions of product in vials in a larger batch target freeze dryer, comprising:
- a temperature controlled surface surrounding both outer edge vials and center vials, wherein the temperature controlled surface is in direct contact with or direct connection to outer edge vials in the development freeze dryer, or connected to the outer edge vials via a thermal conductor, the temperature controlled surface is closer to the surrounded outer edge vials than the surrounded center vials,
- wherein conditions of center vials and/or outer edge vials of the larger batch target freeze dryer can be simulated by adjusting the temperature of the temperature controlled surface.
A method of enabling a development freeze dryer containing a small sample of product in vials to simulate freezing and sublimation conditions of product in vials in a larger batch target freeze dryer, comprising:
- positioning a temperature controlled surface surrounding both edge vials and center vials, wherein the temperature controlled surface is in direct contact with or direct connection to edge vials in the development freeze dryer, or connected to the edge vials via a thermal conductor, the temperature controlled surface is closer to the surrounded edge vials than the surrounded center vials, and conditions of the center vials and/or the edge vials of the larger batch target freeze dryer can be simulated by adjusting the temperature of the temperature controlled surface.
Dependencies are inferred from the claim text.