# US 11,897,681 B2 · Separating layer for the transport of pharmaceutical secondary packagings > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,897,681 B2 - Document ID: US11897681B2 - Status: Granted - Kind: B2 - Application number: 17/811,852 - Filed: 2022-07-11 - Published: 2022-10-27 - Granted: 2024-02-13 - Earliest claimed: 2020-01-10 - Assignees: SCHOTT Pharma Schweiz AG - Applicants: SCHOTT Schweiz AG - Inventors: Patrick Wolf; Elisa Wiesner; Arne Kloke - Web page: https://patentgrep.com/patent/US11897681B2 ## CPC - B65D 25/108: {Devices, e.g. plates, presenting apertures through which the articles project} - B65D 77/26: Elements or devices for locating or protecting articles - A61J 1/16: Holders for containers - B65D 57/003: {for horizontally placed articles, i.e. for stacked or nested articles} - B65D 71/70: Trays provided with projections or recesses in order to assemble multiple articles, e.g. intermediate elements for stacking - B65D 77/06: Liquids or semi-liquids {or other materials or articles} enclosed in flexible containers disposed within rigid containers - B65D 77/2024: {the cover being welded or adhered to the container} - B65D 81/133: of a shape specially adapted to accommodate contents, e.g. trays {(B65D81/053 takes precedence; thermally insulated trays B65D81/3816, B65D81/3827)} - B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES - 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 A separating layer for the transport of pharmaceutical secondary packagings and to a transport system for transporting pharmaceutical secondary packagings which comprises the separating layer are provided. The separating layer is a polymer layer having a planar section extending in an axial direction along a longitudinal axis and an elevation extending normal to the longitudinal axis. The separating layer has in the axial direction a normal spring force that is 0.2 to 5 N. ## Claims ### Claim 1 A transport system for transporting pharmaceutical secondary packagings, comprising: a transport box; a separating layer; and two pharmaceutical secondary packagings in the transport box, the separating layer separating the two pharmaceutical secondary packagings from one another and from the transport box, wherein the two pharmaceutical secondary packagings comprise each 10 to 200 pharmaceutical primary packagings, wherein, after running a transport simulation program according to ASTM D4169-16, DC12, not including program I, safety level I, the pharmaceutical primary packagings have a condition selected from a group consisting of: 2.0 or less particles per cm2 having a size of 2 μm to 25 μm on an outside and/or an inside of each of the pharmaceutical primary packagings; 6.0 or less particles per cm2 having a size of 5 μm to 25 μm on the outside and/or the outside of each of the pharmaceutical primary packagings; 2.0 or less particles per cm2 having a size of 10 μm to 25 μm on the outside and/or the inside of each of the pharmaceutical primary packagings; less than 0.1 particles per cm2 having a size of 25 μm or more on the outside and/or the inside of each of the pharmaceutical primary packagings; and any combinations thereof. ### Claim 2 (depends on 1) The transport system of claim 1, wherein the separating layer comprises a planar section, and wherein the separating layer is between the two pharmaceutical secondary packagings in the transport box. ### Claim 3 (depends on 2) The transport system of claim 2, wherein the separating layer comprises a polymer layer having a planar section extending in an axial direction along a longitudinal axis and an elevation extending normal to the longitudinal axis, the separating layer having a normal spring force that is 0.2 to 5 N. ### Claim 4 (depends on 3) The transport system of claim 3, wherein the separating layer further comprises a second planar section, wherein the elevation is arranged between the planar section and the second planar section. ### Claim 5 (depends on 4) The transport system of claim 4, wherein the separating layer is arranged such that the planar section and the second planar section are in contact with bottom faces of the two pharmaceutical secondary packagings, respectively, with the elevation projecting between the two pharmaceutical secondary packagings so that the two pharmaceutical secondary packagings are not in contact with one another. ### Claim 6 (depends on 3) The transport system of claim 3, wherein the planar section contacts a bottom face of a first of the two pharmaceutical secondary packagings and contacts a top face of a second of the two pharmaceutical secondary packagings. ### Claim 7 (depends on 3) The transport system of claim 3, wherein the normal spring force is 0.5 to 2 N. ### Claim 8 (depends on 3) The transport system of claim 3, wherein the separating layer has an axial spring force that is 1 to 50 N. ### Claim 9 (depends on 8) The transport system of claim 8, wherein the axial spring force is 20 to 30 N. ### Claim 10 (depends on 1) The transport system of claim 1, wherein the two pharmaceutical secondary packagings are trough-shaped with an edge along a top face which extends along a plane of the top face. ### Claim 11 (depends on 1) The transport system of claim 1, wherein the two pharmaceutical secondary packagings have a sterile interior. ### Claim 12 (depends on 1) The transport system of claim 1, wherein the transport box is made of the polymer of the separating layer. ### Claim 13 (depends on 1) The transport system of claim 1, wherein the separating layer has a width and the transport box has an internal width and the transport system further comprises a ratio of the width to the internal width of 0.8 to 1.5. ### Claim 14 (depends on 13) The transport system of claim 13, wherein the separating layer has a length and the transport box has an internal length and the transport system further comprises a ratio of the length to the internal length of 1.1 to 2.0. ### Claim 15 (depends on 1) The transport system of claim 1, wherein the separating layer has a length and the transport box has an internal length and the transport system further comprises a ratio of the length to the internal length of 1.1 to 2.0. ### Claim 16 (depends on 1) The transport system of claim 1, wherein the transport system, in an impact test according to the Incline Impact Test ASTM D880-92 (2015) with an impact speed of 2.14 m/s, exhibits damage to not more than 50% of the pharmaceutical primary packagings. ### Claim 17 (depends on 1) The transport system of claim 1, wherein, after running a transport simulation program according to ASTM D4169-16, DC12, not including program I, safety level I, the condition is selected from a group consisting of: 40.0 or less particles per cm2 having a size of 2 μm to 25 μm on each individual internal wall of the pharmaceutical secondary packaging; 16.0 or less particles per cm2 having a size of 5 μm to 25 μm on each individual internal wall of the pharmaceutical secondary packaging; 3.5 or less particles per cm2 having a size of 10 μm to 25 μm on each individual internal wall of the pharmaceutical secondary packaging; 0.9 or less particles per cm2 having a size of 15 μm to 25 μm on each individual internal wall of the pharmaceutical secondary packaging; 0.0 particles per cm2 having a size of 25 μm or more on each individual internal wall of the pharmaceutical secondary packaging; and any combinations thereof. ### Claim 18 (depends on 1) The transport system of claim 1, wherein, after running a transport simulation program according to ASTM D4169-16, DC12, not including program I, safety level I, there are 6000 or less particles having a size of 15 μm to 25 μm on an outside or an inside of each individual pharmaceutical primary packaging. ### Claim 19 (depends on 1) The transport system of claim 1, wherein, after running a transport simulation program according to ASTM D4169-16, DC12, not including program I, safety level I, there are 50000 or less particles having a size of 2 μm to 25 μm on an outside or an inside of each individual pharmaceutical primary packaging. ### Claim 20 A transport system for transporting pharmaceutical secondary packagings, comprising: a transport box; a separating layer; and two pharmaceutical secondary packagings in the transport box, the separating layer separating the two pharmaceutical secondary packagings from one another and from the transport box, wherein the two pharmaceutical secondary packagings comprise each 10 to 200 pharmaceutical primary packagings, wherein, after running a transport simulation program according to ASTM D4169-16, DC12, not including program I, safety level I, the pharmaceutical primary packagings have a condition selected from a group consisting of: 40.0 or less particles per cm2 having a size of 2 μm to 25 μm on each individual internal wall of the pharmaceutical secondary packaging; 16.0 or less particles per cm2 having a size of 5 μm to 25 μm on each individual internal wall of the pharmaceutical secondary packaging; 3.5 or less particles per cm2 having a size of 10 μm to 25 μm on each individual internal wall of the pharmaceutical secondary packaging; 0.9 or less particles per cm2 having a size of 15 μm to 25 μm on each individual internal wall of the pharmaceutical secondary packaging; 0.0 particles per cm2 having a size of 25 μm or more on each individual internal wall of the pharmaceutical secondary packaging; and any combinations thereof. ### Claim 21 A transport system for transporting pharmaceutical secondary packagings, comprising: a transport box; a separating layer; and two pharmaceutical secondary packagings in the transport box, the separating layer separating the two pharmaceutical secondary packagings from one another and from the transport box, wherein the two pharmaceutical secondary packagings comprise each 10 to 200 pharmaceutical primary packagings, wherein, after running a transport simulation program according to ASTM D4169-16, DC12, not including program I, safety level I, there are 6000 or less particles having a size of 15 μm to 25 μm on an outside or an inside of each individual pharmaceutical primary packaging.