# US 12,213,942 B2 · System for long time storage of pharmaceutical compositions at low temperatures > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,213,942 B2 - Document ID: US12213942B2 - Status: Granted - Kind: B2 - Application number: 17/535,240 - Filed: 2021-11-24 - Published: 2022-06-02 - Granted: 2025-02-04 - Earliest claimed: 2020-11-27 - Assignees: SCHOTT Pharma AG & Co. KGaA; SCHOTT Pharma Schweiz AG; Schott Pharma USA, Inc.; Schott Pharma France SAS - Applicants: SCHOTT Pharma AG & Co. KGaA; Schott Pharma Schweiz AG; Schott Pharma USA, Inc.; Schott Pharma France SAS - Inventors: Rajendra Redkar; Luce Sohier; Alexander Humbertjean; Diana Löber; Alexander Traxl - Web page: https://patentgrep.com/patent/US12213942B2 ## CPC - A61J 1/065: {Rigid ampoules, e.g. glass ampoules} - A61J 1/1412: {Containers with closing means, e.g. caps} - A61J 1/1406: {Septums, pierceable membranes} - A61J 1/1468: {Containers characterised by specific material properties} - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE ## Abstract At least one system for storage of pharmaceutical compositions includes: a container including a neck and a crown that includes an upper crown surface; a stopper including a flange and a plug, the flange including 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 has a size of 30 mm2 to 300 mm2 and the flange height is compressed at least partially in the horizontal contact area by 10% to 40%. ## Claims ### Claim 1 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, and wherein the container comprises an opening and the flange extends radially away from the opening past the upper crown surface. ### Claim 2 (depends on 1) The at least one system of claim 1, wherein an angle between a line defined by the upper crown surface and a line defined by a center axis of the container is 75° to 89.99°. ### Claim 3 (depends on 2) The at least one system of claim 2, wherein the angle is 85.5° to 88.5°. ### Claim 4 (depends on 1) The at least one system of claim 1, wherein at least one of the following is satisfied: a ratio [mm/mm] of values of a minimal inner crown diameter and a maximal inner crown diameter is 0.95 to 1.00; or the upper crown surface has an average surface roughness Ra of 2 nm to 200 nm. ### Claim 5 (depends on 1) The at least one system of claim 1, wherein at least one of the following is satisfied: at least one of an inner surface or an outer surface of the container is coated; or the upper crown surface is uncoated. ### Claim 6 (depends on 5) The at least one system of claim 5, wherein the container is coated by a coating comprising silicone or a coating obtained by a chemical vapor deposition method. ### Claim 7 (depends on 1) The at least one system of claim 1, wherein at least one of the following is satisfied: the stopper comprises a thermoplastic elastomer; an E Module of the stopper is 1 N/mm2 to 10 N/mm2; or a shore hardness A of the stopper is 40 to 80. ### Claim 8 (depends on 7) The at least one system of claim 7, wherein the thermoplastic elastomer comprises butyl groups and halogen. ### Claim 9 (depends on 1) The at least one system of claim 1, wherein the horizontal contact area has a size of 50 mm2 to 250 mm2. ### Claim 10 (depends on 1) The at least one system of claim 1, wherein the horizontal contact area has a width of 0.1 mm to 5 mm. ### Claim 11 (depends on 1) The at least one system of claim 1, wherein the flange height is compressed by 15% to 30%. ### Claim 12 (depends on 1) The at least one system of claim 1, wherein the horizontal contact area comprises an upper inner crown edge and the flange height is compressed at the upper inner crown edge by 10% to 40%. ### Claim 13 (depends on 12) The at least one system of claim 12, wherein a distance between the upper inner crown edge and a lower inner crown edge is 3 mm to 5 mm. ### Claim 14 (depends on 1) The at least one system of claim 1, wherein the at least one system passes a container closure integrity test according to DIN EN ISO 8871-5:2016; chapter 4.4 in combination with Annex D. ### Claim 15 (depends on 1) The at least one system of claim 1, wherein the container comprises a pharmaceutical composition at a temperature that is −200° C. or more and less than 0° C. ### Claim 16 (depends on 15) The at least one system of claim 15, wherein the pharmaceutical composition comprises 50 wt-% to 99 wt-% water. ### Claim 17 (depends on 15) The at least one system of claim 15, wherein the pharmaceutical composition is at a temperature that is −80° C. or more and −20° C. or less. ### Claim 18 (depends on 1) The at least one system of claim 1, wherein the at least one system comprises 5 or more systems forming a bundle. ### Claim 19 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.