IP Library Granted Patent US 11,897,681
Granted Patent B2
US 11,897,681 · App. 17/811,852 · Granted Feb 13, 2024

Separating layer for the transport of pharmaceutical secondary packagings

Inventors: Patrick Wolf (St. Gallen, CH); Elisa Wiesner (Ludesch, AT); Arne Kloke (St. Gallen, CH)
Assignee: SCHOTT PHARMA SCHWEIZ AG
B65D77/26A61J1/16B65D77/06B65D77/2024
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Quick Facts
Patent No.
US 11,897,681
App. No.
17/811,852
Granted
Feb 13, 2024
Kind
B2
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 (53)

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 cm 2 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 cm 2 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 cm 2 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 cm 2 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The transport system of claim 3 , wherein the normal spring force is 0.5 to 2 N.

8. The transport system of claim 3 , wherein the separating layer has an axial spring force that is 1 to 50 N.

9. The transport system of claim 8 , wherein the axial spring force is 20 to 30 N.

10. 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.

11. The transport system of claim 1 , wherein the two pharmaceutical secondary packagings have a sterile interior.

12. The transport system of claim 1 , wherein the transport box is made of the polymer of the separating layer.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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 cm 2 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 cm 2 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 cm 2 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 cm 2 having a size of 15 μm to 25 μm on each individual internal wall of the pharmaceutical secondary packaging;

0.0 particles per cm 2 having a size of 25 μm or more on each individual internal wall of the pharmaceutical secondary packaging; and

any combinations thereof.

18. 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.

19. 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.

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 cm 2 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 cm 2 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 cm 2 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 cm 2 having a size of 15 μm to 25 μm on each individual internal wall of the pharmaceutical secondary packaging;

0.0 particles per cm 2 having a size of 25 μm or more on each individual internal wall of the pharmaceutical secondary packaging; and

any combinations thereof.

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.

Assignments (2)
CHANGE OF NAME Recorded Nov 7, 2022
From: SCHOTT SCHWEIZ AG
To: SCHOTT PHARMA SCHWEIZ AG
Reel/Frame 061895/0026 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 12, 2022
From: WOLF, PATRICK, DR.; WIESNER, ELISA; KLOKE, ARNE, DR.
To: SCHOTT SCHWEIZ AG
Reel/Frame 060487/0387 →
Priority Claims (3)
EP 20151303 · Jan 10, 2020 · regional
EP 20151443 · Jan 13, 2020 · regional
EP 20189762 · Aug 6, 2020 · regional
Continuity (2)
Continuation 17145483 · Jan 11, 2021
Related Publication 20220340349A1 · Oct 27, 2022