Container-closure system for use in lyophilization applications

Abstract

A container closure system for use in lyophilization processes employing depressurization to initiate nucleation is provided. The present container closure system includes a container and a closure element disposed proximate to and adapted for sealing the opening of the container. The closure element includes a first sealing surface adapted for sealably contacting an interior surface of the container and a second sealing surface adapted for sealably contacting the top surface of the container when the container closure system is in a closed position. The closure element also includes a plurality of closure legs extending from the second sealing surface that define a plurality of side vents between each of the closure legs when the container closure system is in the open position. The length, thickness, number, and shape of the legs are chosen to produce an effective total side vent area that is at least 50% of the area of the container opening. Alternatively, the length, thickness, number, and shape of the legs are chosen to produce an effective total side vent area that is greater than the cumulative surface area of the outwardly facing surface of the closure legs.

1 . A container-closure system comprising:
 a container having an upper section defining an opening having a cross sectional area and the container having a top surface and an interior surface adjacent to the opening; the container further comprising a body section defining a cavity in fluid communication with the opening;   a closure element disposed proximate to the container and adapted for sealing the opening of the container when in a closed position, the closure element having a first sealing surface adapted for sealably contacting the interior surface of the container when in the closed position, the closure element having a second sealing surface adapted for sealably contacting the top surface of the container when in the closed position, and the closure element having a plurality of closure legs extending from the first or second sealing surface toward the body section;   wherein the closure legs define a plurality of side vents between each of the closure legs when the container closure system is in an open position and the cumulative area of the side vents is greater than or equal to 50% of the cross sectional area of the opening; and   wherein the side vents define a fluid path between the cavity within the container and an atmosphere surrounding the container to facilitate nucleation of freezing of a material disposed within the cavity of the container upon depressurization of the atmosphere surrounding the container.   
   
   
       2 . The container-closure system of  claim 1  wherein the cumulative area of the side vents is greater than or equal to 80% of the cross sectional area of the opening. 
   
   
       3 . The container-closure system of  claim 1  wherein the closure element further defines a mouth vent proximate the distal end of the closure legs when the container closure system is in an open position and the cumulative area of the mouth vent is greater than or equal to 50% of the cross sectional area of the opening. 
   
   
       4 . The container-closure system of  claim 1  wherein the closure legs have a length and a non-uniform cross-sectional configuration along the length. 
   
   
       5 . The container-closure system of  claim 1  wherein the closure element is disposed partially within the opening of the container. 
   
   
       6 . The container-closure system of  claim 1  wherein the closure element is disposed on the top surface of the container and the closure legs are aligned with the opening of the container. 
   
   
       7 . The container-closure system of  claim 6  wherein the closure legs have one or more protrusions disposed proximate a distal end of the closure legs. 
   
   
       8 . The container-closure system of  claim 1  wherein the closure element is suspended above the container and the closure legs are aligned with the opening of the container. 
   
   
       9 . The container-closure system of  claim 8  further comprising a collapsible device attached to the closure element and container, the collapsible device suspending the closure element above the container and aligning the closure legs with the opening of the container. 
   
   
       10 . The container-closure system of  claim 1  further comprising a sealing flange disposed in the first sealing surface of the closure element. 
   
   
       11 . A lyophilization stopper comprising:
 a sealing element defining an annular sealing surface;   a cap section disposed adjacent to the sealing element and having a second sealing surface disposed in an orthogonal orientation relative to the annular sealing surface; and   one or more closure legs extending from the annular sealing surface, the closure legs defining an outwardly facing surface and the closure legs further defining vents between the closure legs;   wherein the cumulative area of the vents is equal to or greater than the cumulative area of the outwardly facing surfaces of the closure legs.   
   
   
       12 . The lyophilization stopper of  claim 11  wherein the cumulative area of the vents is greater than or equal to 80% of the cumulative area of the outwardly facing surfaces of the closure legs. 
   
   
       13 . The lyophilization stopper of  claim 11  wherein the closure legs have a length and a non-uniform cross-sectional configuration along the length. 
   
   
       14 . The lyophilization stopper of  claim 11  wherein the closure legs have one or more protrusions disposed proximate a distal end of the closure legs. 
   
   
       15 . The lyophilization stopper of  claim 11  further comprising a sealing flange disposed in the annular sealing surface of the sealing element. 
   
   
       16 . The lyophilization stopper of  claim 11  further comprising a suspension structure coupled to the cap section and adapted to suspend the cap section above a lyophilization container. 
   
   
       17 . A container-closure system comprising:
 a container having an upper section defining an opening having a cross sectional area and the container having a top surface and an interior surface adjacent to the opening; the container further comprising a body section defining a cavity in fluid communication with the opening;   a closure element disposed proximate to the container and adapted for sealing the opening of the container when in a closed position, the closure element having a first sealing surface adapted for sealably contacting the interior surface of the container when in the closed position, the closure element having a second sealing surface adapted for sealably contacting the top surface of the container when in the closed position;   wherein the closure element defines a vent area when the container closure system is in an open position and wherein the vent area defines a fluid path between the cavity within the container and an atmosphere surrounding the container to facilitate nucleation of freezing of a material disposed within the cavity of the container upon depressurization of the atmosphere surrounding the container and wherein the vent area is greater than or equal to 50% of the cross sectional area of the opening.   
   
   
       18 . The container-closure system of  claim 17  further comprising a suspension structure coupled to the container and the closure element and wherein the closure element is suspended above and aligned with the opening of the container.