Pharmaceutical containers including high CTE sealing assembly encircling outer surface of container

1 . A sealed pharmaceutical container comprising:

a shoulder;

a neck extending from the shoulder;

a flange extending from the neck, the flange comprising:

an underside surface extending from the neck;

an outer surface extending from the underside surface, the outer surface defining an outer diameter of the flange; and

an upper sealing surface extending between the outer surface and an inner surface defining an opening in the sealed pharmaceutical container, wherein the upper sealing surface is an inclined sealing surface extending at an angle relative to a plane extending through an end of the opening such that a distance between the inclined sealing surface and the plane increases with decreasing radial distance from the outer surface, and

a sealing assembly comprising:

a stopper including a sealing portion extending over the upper sealing surface of the flange and covering the opening, and a rim extending along the outer surface of the flange, wherein the rim has a bottom surface which extends collinear with the underside surface of the flange, the stopper having a glass transition temperature (T g ) that is greater than or equal to −70° C. and less than or equal to −10° C.; and

a metal-containing cap securing the stopper to the flange, the metal-containing cap including an underlying portion that contacts the underside surface of the flange,

wherein the sealed pharmaceutical container maintains a helium leakage rate at less than or equal to 1.4×10 −6 Cm 3 /s as the sealed pharmaceutical container is cooled to a temperature of less than or equal to −20° C.

2 . The sealed pharmaceutical container of claim 1 , wherein:

the glass transition temperature (T g ) is less than or equal to −20° C.

3 . The sealed pharmaceutical container of claim 1 , wherein the sealing assembly maintains the helium leakage rate of the sealed pharmaceutical container at less than or equal to 1.4×10−6 cm 3 /s as the sealed pharmaceutical container is cooled to a temperature of less than or equal to −80° C.

4 . The sealed pharmaceutical container of claim 1 , wherein the helium leakage rate of the sealed pharmaceutical container is less than or equal to 1.4×10 −6 cm 3 /s as the sealed pharmaceutical container is cooled to a temperature of less than or equal to −100° C.

5 . The sealed pharmaceutical container of claim 1 , wherein the angle is greater than 5 degrees.

6 . The sealed pharmaceutical container of claim 1 , wherein the angle is less than or equal to 45 degrees.

7 . The sealed pharmaceutical container of claim 1 , wherein the flange is constructed of a polymer.

8 . A method of sealing a pharmaceutical container, the method comprising:

providing a pharmaceutical container comprising a shoulder, a neck extending from the shoulder and a flange extending from the neck, the flange comprising:

an underside surface extending from the neck;

an outer surface extending from the underside surface, the outer surface defining an outer diameter of the flange; and

an upper sealing surface extending between the outer surface to an inner surface of the pharmaceutical container that defines an opening;

inserting a pharmaceutical composition into the pharmaceutical container;

providing a stopper having a glass transition temperature (T g ) that is greater than or equal to −70° C. and less than or equal to −10° C. and including a sealing portion extending over the upper sealing surface of the flange and covering the opening, and a rim extending along the outer surface of the flange, wherein the rim has a bottom surface which extends collinear with the underside surface of the flange;

crimping a metal-containing cap over the stopper and against flange, including an underlying portion that contacts the underside surface of the flange, to compress the stopper against the upper sealing surface; and

cooling the pharmaceutical container to a temperature of less than or equal to −20° C., wherein after the cooling of the pharmaceutical container the compression is maintained on the upper sealing surface such that a helium leakage rate of the pharmaceutical container is less than or equal to 1.4×10 −6 cm 3 /s at the temperature.