Pharmaceutical containers and methods for producing, registration, identification and authentication of such containers

Patent metadata

Field	Value
Publication number	US-12083071-B2
Application number	US-202117221526-A
Country	US
Kind code	B2
Filing date	Apr 2, 2021
Priority date	Apr 6, 2020
Publication date	Sep 10, 2024
Grant date	Sep 10, 2024

Abstract

Pharmaceutical containers and methods for producing, registration, identification and authentication of such containers and for determining the operation state of machines for producing pharmaceutical containers are provided.

First claim

What is claimed is:

1. A plurality of pharmaceutical containers, comprising:
a plurality of geometric parameters defined for each container of the plurality of containers,
each geometric parameter of the plurality of geometric parameters having a mean value and a standard deviation,
wherein for a group of the plurality of geometric parameters, each geometric parameter of the group has a standard deviation that is greater than or equal to a lower threshold value specific for the geometric parameter, and
wherein the lower threshold value is at least 1% of the mean value of the geometric parameter, and
wherein the plurality of geometric parameters are a unique identifier for each container in the plurality of pharmaceutical containers without any extra added or molded element on the plurality of containers.

2. The containers of claim 1 , wherein each container is a tube with a first end and a further end, wherein the tube has a center axis and has, in a direction from a top to a bottom, a part selected from a group consisting of: a top region at the first end, a collar region comprising a collar, a collar region comprising a collar that follows the top region, a neck region comprising a neck, a neck region comprising a neck that follows the collar region, a shoulder region comprising a shoulder, a shoulder region comprising a shoulder that follows the neck region, a body region comprising a body, a body region comprising a body that follows the shoulder region, and any combinations thereof.

3. The containers of claim 2 , wherein each container, in the direction from the top to the bottom, further comprises a part selected from a group consisting of: a heel region comprising a heel, a heel region comprising a heel that follows the body region, a heel region that follows the body region and extends to the further end of the tube, a bottom region comprising a bottom, a bottom region comprising a bottom that follows the heel region, a bottom region comprising a bottom that follows the body region, a bottom region comprising a bottom that closes the tube at the further end, and any combinations thereof.

4. The containers of claim 2 , wherein the top region has an outer diameter (d t ), the neck region has an outer diameter (d n ), and wherein d n <d t .

5. The containers of claim 2 , wherein the top region has an outer diameter (d t ), the body region has an outer diameter (d b ), and wherein d b >d t .

6. The containers of claim 1 , wherein each geometric parameter is assigned to a class selected from a group consisting of: a geometric parameter of an overall container, a geometric parameter of a part of the tube, and any combinations thereof.

7. The containers of claim 1 , wherein the group comprises a geometric parameter for an overall container and a geometric parameter for one or more parts of each container.

8. The containers of claim 7 , wherein the geometric parameter for the overall container comprises a total height.

9. The containers of claim 8 , wherein the one or more parts of each container comprises one to six parts.

10. The containers of claim 8 , wherein the geometric parameter for the one or more parts comprises a parameter selected from a group consisting of: an outer diameter of a collar region, an outer diameter of a neck region, a shoulder angle of a shoulder region, a heel radius of a heel region, a bottom print of a bottom region, and any combinations thereof.

11. The containers of claim 1 , wherein the group comprises a parameter selected from a group consisting of: bottom perpendicularity, lower collar angle, upper collar angle, collar facet angle, shoulder angle, body outer diameter, collar outer diameter, collar thread outer diameter, neck outer diameter, bottom print, eccentricity, circular run out tolerance, total height, body height, collar height, neck height, total collar height, total collar height plus neck height, body height with shoulder, sealing surface perpendicularity, shoulder radius, heel radius, collar and neck radius, collar facet radius, lower collar radius, radius at bottom of neck, ovality, wall thickness, bottom thickness, bottom inner radius, neck inner diameter, bottom depth, and any combinations thereof.

12. The containers of claim 1 , wherein each container of the plurality of containers comprises a material selected from a group consisting of glass, silicate glass, alumosilicate glass, and borosilicate glass.

13. The containers of claim 1 , wherein each container of the plurality of containers comprises a material selected from a group consisting of polymer, cycloolefin-copolymer (COC), and cyclic olefin polymer (COP).

14. The containers of claim 1 , wherein the plurality of containers comprises a number of between 5 and 10000 containers.

15. The containers of claim 1 , wherein the plurality of containers comprises a number of between 50 and 200 containers.

16. The containers of claim 1 , wherein each container of the plurality of containers is a vial or a cartridge.

17. The containers of claim 1 , wherein the group comprises a first geometric parameter that is a total height, a second geometric parameter that is a shoulder angle, and a third geometric parameter that is a heel radius.

18. The containers of claim 17 , wherein the group comprises geometric parameters selected from a group consisting of the first geometric parameter with a mean value of between 10 and 100 mm, the first geometric parameter with a standard deviation of at least 2% of the mean value, the second geometric parameter with a mean value of between 10 and 50 degrees, the second geometric parameter with a standard deviation of at least 3% of the mean value, the third geometric parameter with a mean value of between 1 and 5 mm, the third geometric parameter with a standard deviation of at least 1% of the mean value, and any combinations thereof.

19. A method for producing a plurality of pharmaceutical containers, comprising:
forming a plurality of containers each container having a plurality of geometric parameters that are a unique identifier for each container in the plurality of pharmaceutical containers without any extra added or molded element on the plurality of containers, each geometric parameter of the plurality of geometric parameters having a mean value and a standard deviation, wherein for a group of the plurality of geometric parameters, each geometric parameter of the group has a standard deviation that is greater than or equal to a lower threshold value specific for the geometric parameter, and wherein the lower threshold value is at least 1% of the mean value of the geometric parameter; and
storing the geometric parameters as the unique identifier in at least one database.

Assignees

• Schott Pharma Schweiz Ag

Inventors

• Eugster Dominik
• Willmes Daniel

Classifications

• C03B23/08

  to exact dimensions, e.g. calibrating · CPC title

• C03B23/045

  Tools or apparatus specially adapted for re-forming tubes or rods in general, e.g. glass lathes, chucks (C03B23/043 takes precedence) · CPC title

• A61J1/06

  Ampoules or carpules (syringe ampoules or carpules A61M5/28) · CPC title

• A61J1/14

  Details; Accessories therefor (A61J7/00 takes precedence; openers B65D, B67B7/00) · CPC title

• A61J2205/40

  by shape or form, e.g. by using shape recognition · CPC title