Glass containers and sealing assemblies for maintaining seal integrity at low storage temperatures

A sealed pharmaceutical container comprising:

• a shoulder;
• a neck extending from the shoulder;
• a flange extending from the neck;
• an inner surface defining an opening extending through the neck and the flange, wherein the flange comprises an upper sealing surface extending from the inner surface, a portion of the upper sealing surface comprises a length of at least 4 mm;
• and
• a sealing assembly, the sealing assembly comprising:
• a stopper extending over the sealing surface of the flange and covering the opening;
• and
• a metal-containing cap crimped to the flange, the metal-containing cap compressing the stopper against the upper sealing surface, wherein the compression is maintained on the upper sealing surface as the sealed pharmaceutical container is cooled to a temperature of less than or equal to −80° C. such that a helium leakage rate of the sealed pharmaceutical container is less than or equal to 1.4×10−6 cm3/s at the temperature.

A method of sealing a sealed pharmaceutical container, the method comprising the steps of:

• providing a sealed 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
• a sealing surface extending between the outer surface to an inner surface of the sealed pharmaceutical container that defines an opening;
• inserting a pharmaceutical composition into the sealed pharmaceutical container;
• providing a sealing assembly comprising a stopper extending over the sealing surface of the flange and covering the opening;
• crimping a metal-containing cap over the stopper and against flange to thereby compress the stopper against the sealing surface;
• and
• cooling the sealed pharmaceutical container to a temperature of less than or equal to −45° C., wherein, after the cooling of the sealed pharmaceutical container, the compression is maintained on the sealing surface such that a helium leakage rate of the sealed pharmaceutical container is less than or equal to 1.4×10−6 cm3/s at the temperature.