APPARATUS AND METHOD FOR DEVELOPING FREEZE DRYING PROTOCOLS USING SMALL BATCHES OF PRODUCT

摘要

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.

主权项

1. An apparatus to simulate in a development freeze dryer containing a small sample of product in center and outer edge vials freezing and sublimation conditions of product in center and outer edge vials in a larger batch target freeze dryer, comprising:
a temperature controlled surface in close proximity or connected to the outer edge vials in the development freeze dryer to simulate by varying the temperature of the temperature controlled surface the conditions of the center vials and/or the outer edge vials of the target freeze dryer.