SUPPORTING STRUCTURE FOR CONCURRENTLY SUPPORTING A PLURALITY OF VIALS, USE THEREOF AND PROCESS FOR THE TREATMENT OF SUCH VIALS

• US 20180148222A1
• Filed: 11/29/2017
• Published: 05/31/2018
• Est. Priority Date: 11/30/2016
• Status: Active Grant

• Current Assignee: Schott Pharma AG & Company KGaA (Carl-Zeiss-Stiftung)
• Original Assignee: Schott AG (Carl-Zeiss-Stiftung)
• Inventors: Deutschle, Gregor Fritz, Pawlowski, Edgar
• Granted Patent: US 10,703,539 B2
• Time in Patent Office: Days
• CPC Class Codes: A61J 1/065 Rigid ampoules, e.g. glass ampoules
• CPC Class Codes: A61J 1/16 Holders for containers
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2300/0829 Multi-well plates; Microtitration plates
• CPC Class Codes: B01L 2300/0835 Ampoules
• CPC Class Codes: B01L 9/06 Test-tube stands; Test-tube holders
• CPC Class Codes: B65D 25/108 Devices, e.g. plates, presenting apertures through which the articles project
• CPC Class Codes: B65D 85/30 for articles particularly sensitive to damage by shock or pressure

Abstract

A supporting structure for concurrently supporting a plurality of vials is provided. The supporting structure includes a carrier having apertures or receptacles, into which the vials can be inserted to be supported therein on the carrier. The vials have a bottom that forms a base, a cylindrical side wall, and an annular transition region between the base and the cylindrical side wall. The carrier has a retaining protrusion at a lower end of the aperture or receptacle that extends into the respective aperture or receptacle inward in radial direction. The retaining protrusion supports the vial in cooperation with the transition region outside the base in such a manner that the bottoms or bases of the vials jut out of the apertures or receptacles of the carrier and are freely accessible from the lower side of the carrier.

Claims

1. A supporting structure for concurrently supporting a plurality of vials, comprising:

a carrier having an upper side, a lower side opposite the upper side and a plurality of apertures or receptacles into which the vials can be inserted, at least partially, to be supported therein at the carrier, wherein the vials have a bottom, which forms a base, a cylindrical side wall, and an annular transition region between the base and the cylindrical side wall; and

a retaining protrusion that protrudes into the respective aperture or receptacle inward in radial direction at a lower end of a respective aperture or receptacle for supporting the associated vial in cooperation with the transition region outside the base in such a manner that the bottoms or bases of the vials jut out of the apertures or receptacles of the carrier and are freely accessible from the lower side of the carrier.

2. The supporting structure as claimed in claim 1, wherein the retaining protrusions are matched to a shape and dimension of the transition regions of the vials in such a manner that the transition regions are supported in a positive-fit manner.

3. The supporting structure as claimed in claim 1, wherein the carrier is configured so that the vials are not additionally supported at constricted neck portions.

4. The supporting structure as claimed in claim 1, wherein the transition regions of the vials have a radius of curvature, wherein surfaces of the retaining protrusions facing a respective transition region are inclined toward the lower side of the carrier at least in sections or curved at least in sections.

5. The supporting structure as claimed in claim 4, wherein the surfaces of the retaining protrusions facing the respective transition region are inclined toward the lower side of the carrier at an angle relative to a vertical line perpendicular to a plane spanned by the carrier.

6. The supporting structure as claimed in claim 5, wherein the angle is in a range between 10 and 70 degrees.

7. The supporting structure as claimed in claim 4, wherein the surfaces of the retaining protrusions which are facing the respective transition region are concave curved.

8. The supporting structure as claimed in claim 4, wherein the retaining protrusions have a front end with a straight portion, the straight portion extending perpendicular to a plane spanned by the carrier.

9. The supporting structure as claimed in claim 8, wherein the straight portions have an axial length in a direction perpendicular to the plane spanned by the carrier that is in a range 0.1 to 5.0 mm.

10. The supporting structure as claimed in claim 4, wherein the radius of curvature of the transition regions of the vials is in the range of 1.0 to 10.0 mm, and wherein the retaining protrusions are matched to a shape of the transition regions of the vials such that the bottoms or bases of the vials jut out of the apertures or receptacles of the carrier by a distance in the range between 0.01 and 5.0 mm.

11. The supporting structure as claimed in claim 1, wherein the retaining protrusion at the lower end of a respective aperture or receptacle is circumferential.

12. The supporting structure as claimed in claim 1, wherein two retaining protrusions are formed at the lower end of a respective aperture or receptacle at equiangular intervals, wherein a circumferential length of gaps between the two retaining protrusions is respectively smaller than a circumferential length of the respective retaining protrusions.

13. The supporting structure as claimed in claim 1, wherein the apertures or receptacles are formed such that upper ends of the vials do not protrude beyond the upper side of the carrier.

14. The supporting structure as claimed in claim 13, wherein the apertures or receptacles are formed by circumferential side walls, the retaining protrusions being formed integrally with the side walls at lower ends thereof.

15. The supporting structure as claimed in claim 14, wherein slots are formed at the lower ends and on opposite sides of the side walls.

16. The supporting structure as claimed in claim 1, wherein the carrier is formed as a supporting plate, in which the apertures are formed, wherein the retaining protrusions are formed integrally with the supporting plate at lower ends of the apertures.

17. The supporting structure as claimed in claim 16, wherein guiding members are provided at least in sections on the upper side of the supporting plate along edges of the apertures, which extend perpendicular to the upper side of the supporting plate for preventing a collision of vials supported in directly adjacent apertures.

18. The supporting structure as claimed in claim 1, wherein the apertures or receptacles are matched to an outer diameter of the vials supported therein such that a radial play exists above the transition regions.

19. A supporting structure comprising a plurality of vials which are supported in apertures or receptacles of the supporting structure, wherein the vials have a bottom, which forms a base, a cylindrical side wall, and an annular transition region between the base and the cylindrical side wall, and wherein the apertures or receptacles are configured to support the vials at the transition regions outside the bases such that the bottoms or bases of the vial jut out of the apertures or receptacles and are freely accessible from a lower side of the supporting structure.

20. The supporting structure as claimed in claim 19, further comprising:

a carrier having an upper side, the lower side that is opposite to the upper side, and the plurality of apertures or receptacles into which the vials are inserted, at least partially, so that the vials are supported at the carrier; and

a retaining protrusion that protrudes into the respective aperture or receptacle at a lower end of a respective aperture or receptacle inward in radial direction, so that the respectively associated vials are supported at the transition regions outside the bases.

21. A transport or packaging container for a plurality of vials, comprising:

a box-shaped transport or packaging container; and

a supporting structure accommodated in the box-shaped transport or packaging container for supporting the plurality of vials inside the transport or packaging container, the supporting structure comprising;

a carrier having an upper side, a lower side opposite the upper side, and a plurality of apertures or receptacles into which the vials can be inserted, at least partially, to be supported therein at the carrier, wherein the vials have a bottom, which forms a base, a cylindrical side wall, and an annular transition region between the base and the cylindrical side wall, and

a retaining protrusion that protrudes into the respective aperture or receptacle inward in radial direction at a lower end of a respective aperture or receptacle for supporting the associated vial in cooperation with the transition region outside the base in such a manner that the bottoms or bases of the vials jut out of the apertures or receptacles of the carrier and are freely accessible from the lower side of the carrier.

22. The transport or packaging container as claimed in claim 21, further comprising the plurality of vials supported or held on the supporting structure.

23. A method of concurrently supporting a plurality of vials using a supporting structure, comprising:

selecting a supporting structure that comprises a carrier having an upper side, a lower side opposite to the upper side, and a plurality of apertures or receptacles, the carrier having a retaining protrusion that protrudes into a respective aperture or receptacle at the lower end of a respective aperture or receptacle inward in radial direction;

selecting vials that have a bottom, which forms a base, a cylindrical side wall, and an annular transition region between the base and the cylindrical side wall; and

inserting the vials, at least partially, into the apertures or receptacles so that the retaining protrusion cooperates with the transition region of the respectively associated vial, so that the transition regions of the vials are supported outside the bases in such a manner that the bottoms or bases of the vials jut out of the apertures or receptacles of the carrier and are freely accessible from the lower side of the carrier.

24. A method for the treatment of vials, comprising:

providing a supporting structure having an upper side, a lower side opposite to the upper side, and a plurality of apertures or receptacles, the supporting structure having a retaining protrusion that protrudes into the respective aperture or receptacle at a lower end of a respective aperture or receptacle inward in radial direction;

providing a plurality of vials, wherein the vials have a bottom, which forms a base, a cylindrical side wall, and an annular transition region between the base and the cylindrical side wall;

disposing the vials in the apertures or receptacles of the supporting structure so that the vials are supported in cooperation with the transition region outside the bases in such a manner that the bottoms or bases of the vials jut out of the apertures or receptacles of the carrier and are freely accessible from the lower side of the carrier; and

treating the vials while being supported at the supporting structure and while being accommodated in the apertures or receptacles.

25. The method as claimed in claim 24, wherein the treating step is a process selected from the group consisting of freeze-drying or lyophilization of a substance inside the vials;

axially displacing the vials in the apertures or receptacles by fluid flow acting on the vials;

cleaning of outer surfaces of the vials by fluid flowing into the apertures or receptacles;

drying the outer surfaces of the vials by a gas flow flowing into the apertures or receptacles of the supporting structure; and

any combinations thereof.

26. The method as claimed in claim 24, wherein the treating step comprises freeze-drying or lyophilization of a substance for pharmaceutical or medical applications inside the vials, wherein the freeze-drying or lyophilization comprises:

disposing the supporting structure together with the vials supported by it on a cooling surface so that the bottoms or bases of the vials rest directly on the cooling surface; and

lyophilizing the substance for pharmaceutical or medical applications inside the vials, wherein the vials continue to be accommodated in the apertures or receptacles during lyophilization while the bottoms or bases of the vials rest directly on the cooling surface.

27. The method as claimed in claim 26, wherein the apertures or receptacles of the supporting structure are formed by circumferential side walls, wherein the vials are completely accommodated in the apertures or receptacles, wherein interspaces are formed between the side walls of directly adjacent apertures or receptacles of the supporting structure into which cooling fingers protrude which surround the apertures or receptacles of the supporting structure at least in sections.

28. The method as claimed in claim 26, wherein the carrier is formed as a supporting plate, in which the apertures or receptacles are formed, wherein the retaining protrusions are formed integrally with the supporting plate at lower ends of the apertures or receptacles, wherein the lower side of the supporting plate rests directly on the cooling surface.

29. The method as claimed in claim 26, wherein:

the bottoms of the vials are flat and the bottoms are in full surface contact with the cooling surface during lyophilization;

or

the bottoms of the vials are concavely curved or flat and a gap is formed between the cooling surface and the associated bottoms of the vials during lyophilization;

or

the bottoms of the vials are concavely curved and respectively rest on convex projections on the cooling surface.

30. The method as claimed in claim 24, wherein the treating step comprises axially displacing the vials in the apertures or receptacles by the action of fluid flow, wherein the axially displacing comprises:

ejecting fluid from nozzles or tubes disposed below the vials and centered with the respective aperture or receptacle in a direction perpendicular to a plane spanned by the carrier so that the fluid acts on the bottoms or bases of the vials to lift the vials inside the apertures or receptacles by a distance smaller than an axial length of the vials.

31. The method as claimed in claim 24, wherein the treating step comprises axially displacing the vial in the apertures or receptacles by the action of fluid flow, wherein the axially displacing comprises discharging fluid from nozzles or tubes that are disposed above the vials and centered with the respective aperture or receptacle in a direction perpendicular to a plane spanned by the carrier so that the fluid acts on upper ends of vials to push the vials down inside the apertures or receptacles to push the vials out of the apertures or receptacles.

32. The method as claimed in claim 24, wherein the treating step comprises cleaning the outer surfaces of the vials by fluid flow, wherein the cleaning step further comprises spraying fluid by a spraying device that is below and/or above the apertures or receptacles and in alignment with the apertures or receptacles so that outer surfaces of the vials are cleaned by the fluid.

33. The method as claimed in claim 32, wherein the fluid is sprayed as a liquid or liquid mist from the lower side into the apertures or receptacles, wherein the vials are lifted inside the apertures or receptacles by the spraying of the liquid and are temporarily not supported on the retaining protrusions.

34. The method as claimed in claim 24, wherein the treating step comprises the step of drying the outer surfaces of the vials further comprises:

spraying gas into the apertures or receptacles at least from the lower side of the supporting structure for drying outer surfaces of the vials, wherein the vials are lifted in the apertures or receptacles by the spraying of the gas and are temporarily not supported on the retaining protrusions.

35. The method as claimed in claim 24, wherein the step of disposing the vials in the apertures or receptacles comprises one of:

inserting the vials into the apertures or receptacles vertically from the upper side of the carrier;

inserting the vials into the apertures or receptacles vertically from the lower side of the carrier under elastic deformation of the retaining protrusions;

inserting the vials into the apertures or receptacles vertically from the lower side of the carrier under elastic deformation of side walls of the apertures or receptacles; and

inserting the vials into the apertures or receptacles vertically from the lower side of the carrier under elastic deformation of the retaining protrusions and of side walls of the apertures or receptacles.