System for long time storage of pharmaceutical compositions at low temperatures

At least one system for storage of pharmaceutical compositions, the at least one system comprising:

• a container comprising a neck and a crown, the crown comprising an upper crown surface;
• a stopper comprising a flange and a plug, the flange comprising a lower flange surface and a flange height;
• and
• a holding element configured to exert a force on the crown and the flange to form a horizontal contact area between the upper crown surface and the lower flange surface, the horizontal contact area having a size of 30 mm2 to 300 mm2 and the flange height being compressed at least partially in the horizontal contact area by 10% to 40%, wherein the horizontal contact area and the flange height are configured to maintain tightness at low temperatures, wherein the at least one system passes a modified container closure integrity test, wherein the modified container closure integrity test is a test according to DIN EN ISO 8871-5:2016;
• chapter 4.4 in combination with Annex D, wherein a pressure in part D.4.2 in Annex D is increased to 2 bar instead of decreased to 27 kPa, and wherein the container comprises an opening and the flange extends radially away from the opening past the upper crown surface.