APPARATUS FOR MAINTAINING A CONTROLLED ENVIRONMENT
First Claim
1. A lyophilization nest for preparing lyophilized substances, the nest comprising:
- a base comprising a bottom plate having a base edge extending upwardly from a perimeter thereof, the bottom plate having a top surface adapted to support a plurality of receptacles thereon;
a cover comprising a top plate having a cover edge extending downwardly from a perimeter thereof, the top plate having one or more vent holes extending therethrough;
an interior space defined by the base and the cover when the base and the cover are in a closed relationship, the interior space being sized to accommodate the receptacles;
a gasket situated between the base edge and the cover edge when the base and the cover are in the closed relationship, the gasket forming an air tight seal when compressed between the base edge and the cover edge;
one or more sealing elements, each of the sealing elements being in closeable engagement with a corresponding one of the vent holes, such that the sealing elements and the corresponding vent holes are operable between;
an open configuration in which the positions of the sealing elements relative to the corresponding vent holes permit fluid communication between the interior space and air external to the nest when the base and the cover are in the closed relationship; and
a closed configuration in which the positions of the sealing elements relative to the corresponding vent holes do not permit fluid communication between the interior space and air external to the nest when the base and the cover are in the closed relationship, such that the interior space is sealed off to air external to the nest when the base and the cover are in the closed relationship.
3 Assignments
0 Petitions
Accused Products
Abstract
A lyophilization nest and method of using the same is described herein. In various embodiments, the lyophilization nest is configured to support one or more receptacles each supporting one or more substances within an interior space of the lyophilization nest. The interior space may be in fluid communication with the exterior of the lyophilization nest through one or more vent holes extending through a surface of the lyophilization nest. Each of the one or more vent holes have a corresponding sealing element configured to selectively form an air-tight seal within the vent holes, such that a controlled environment may be maintained within the interior space when the ambient conditions surrounding the lyophilization nest are not lyophilization conditions. The one or more sealing elements may be operable while the lyophilization nest is positioned within a sealed lyophilizer by depressing the sealing elements into corresponding vent holes to form the air-tight seal.
-
Citations
31 Claims
-
1. A lyophilization nest for preparing lyophilized substances, the nest comprising:
-
a base comprising a bottom plate having a base edge extending upwardly from a perimeter thereof, the bottom plate having a top surface adapted to support a plurality of receptacles thereon; a cover comprising a top plate having a cover edge extending downwardly from a perimeter thereof, the top plate having one or more vent holes extending therethrough; an interior space defined by the base and the cover when the base and the cover are in a closed relationship, the interior space being sized to accommodate the receptacles; a gasket situated between the base edge and the cover edge when the base and the cover are in the closed relationship, the gasket forming an air tight seal when compressed between the base edge and the cover edge; one or more sealing elements, each of the sealing elements being in closeable engagement with a corresponding one of the vent holes, such that the sealing elements and the corresponding vent holes are operable between; an open configuration in which the positions of the sealing elements relative to the corresponding vent holes permit fluid communication between the interior space and air external to the nest when the base and the cover are in the closed relationship; and a closed configuration in which the positions of the sealing elements relative to the corresponding vent holes do not permit fluid communication between the interior space and air external to the nest when the base and the cover are in the closed relationship, such that the interior space is sealed off to air external to the nest when the base and the cover are in the closed relationship. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 22)
-
-
16. A method for lyophilizing a substance, the method comprising the steps of:
-
(a) positioning a lyophilization nest on a bottom shelf contained within a chamber of a lyophilizer, the lyophilization nest supporting one or more receptacles contained within an interior space of the lyophilization nest, at least one of the receptacles containing a substance to be lyophilized, wherein the interior space of the lyophilization nest is in fluid communication with air external to the nest through one or more vent holes extending through a top plate of a cover of the lyophilization nest, and wherein each of the vent holes has a sealing element in closeable engagement therewith; (b) closing the chamber containing the lyophilization nest; (c) creating lyophilization conditions within the chamber for a period of time sufficient for the substance contained in at least one of the receptacles to be lyophilized; (d) while the chamber is closed, causing at least one of the bottom shelf and a top shelf contained within the chamber to move so that the top shelf engages the sealing elements, thereby closing the vent holes so that the interior space of the lyophilization nest is sealed off to air external to the nest and the absolute humidity within the interior space of the lyophilization nest is stabilized; and (e) opening the chamber and removing the nest from the lyophilizer. - View Dependent Claims (17, 18, 19, 20, 21, 23, 24, 25, 26, 27, 28, 29, 30, 31)
-
Specification