Supporting structure for concurrently supporting a plurality of vials, use thereof and process for the treatment of such vials

• US 10,703,539 B2
• Filed: 11/29/2017
• Issued: 07/07/2020
• 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
• Primary Examiner(s): Reynolds, Steven A.
• Application Number:
  US15/825,769
• Publication Number:
  US 20180148222A1
• Time in Patent Office: 951 Days
• Field of Search: 206370, 206477, 206478
• 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, comprising:

a plurality of vials, wherein each of the plurality of vials has a horizontal base, a cylindrical side wall, and an annular transition region between the horizontal base and the cylindrical side wall;

a carrier having an upper side, a lower side opposite the upper side and a plurality of receptacles into which the plurality of vials are at least partially inserted; and

a retaining protrusion in each of the plurality of receptacles that protrudes into the receptacle in an inward radial direction at a lower end of the respective receptacle,

wherein the retaining protrusion contacts or supports an associated vial of the plurality of vials at the transition region of the horizontal base so that the horizontal base of each vial juts out of the respective receptacle of the carrier and is accessible from the lower side of the carrier.

2. The supporting structure as claimed in claim 1, wherein the retaining protrusion has a shape that is matched to a shape and dimension of the transition region of the associated vial so that the transition region is supported by a positive-fit engagement.

3. The supporting structure as claimed in claim 1, wherein each of the plurality of vials comprise a neck portion, and wherein the carrier is configured so that the vials are not supported at the neck portion.

4. The supporting structure as claimed in claim 1,

wherein the transition region of each of the plurality of vials has a radius of curvature, and

wherein the retaining protrusion has a surface facing a respective transition region that is inclined toward the lower side of the carrier or is curved.

5. The supporting structure as claimed in claim 4, wherein the surface of the retaining protrusion facing the respective transition region is inclined toward the lower side of the carrier at an angle relative to a vertical axis 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 5, wherein the angle corresponds to an angle of a tangent to the transition region.

8. The supporting structure as claimed in claim 4, wherein the surface of the retaining protrusion facing the respective transition region has a concave curve.

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

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

11. The supporting structure as claimed in claim 4, wherein the radius of curvature is in a range of 1.0 to 10.0 mm, and wherein the retaining protrusion is matched to a shape of the transition region of the associated vial so that the bas of the vial juts out of the receptacles of the carrier by a distance in a range between 0.01 and 5.0 mm.

12. The supporting structure as claimed in claim 1, wherein the retaining protrusion is circumferential.

13. The supporting structure as claimed in claim 1, wherein the retaining protrusion is two retaining protrusions that are formed at the lower end of a respective receptacle at equiangular intervals, wherein the two retaining protrusions are spaced apart by gaps of a circumferential length that is smaller than a circumferential length of the two retaining protrusions.

14. The supporting structure as claimed in claim 1, wherein the receptacles are formed so that an upper end of the associated vial does not protrude beyond the upper side of the carrier.

15. The supporting structure as claimed in claim 14, wherein the receptacle is formed by a circumferential side wall and the retaining protrusion is formed integrally with the circumferential side wall at a lower end thereof.

16. The supporting structure as claimed in claim 15, further comprising:

slots formed at the lower end and on opposite sides of the circumferential side wall.

17. 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.

18. The supporting structure as claimed in claim 17, 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.

19. The supporting structure as claimed in claim 1, wherein the receptacle is matched to an outer diameter of the associated vial supported therein so that radial play exists above the transition regions.

20. The supporting structure as claimed in claim 1, wherein the retaining protrusion has a vertical straight portion at an end thereof where the retaining protrusion contacts the transition region.

21. The supporting structure as claimed in claim 1, wherein the retaining protrusion contacts the transition region so that the associated vial is centered within the receptacle.

22. The supporting structure as claimed in claim 1, wherein the plurality of vials do not project above the upper side of the carrier.

23. A supporting structure comprising:

a vial, wherein the vial has a horizontal base, a cylindrical side wall, and an annular transition region between the horizontal base, and the cylindrical side wall, and an annular transition region between the horizontal base and the cylindrical side wall;

a carrier having an upper side, a lower side that is opposite to the upper side, and a plurality of receptacles into which the vial van be at least partially inserted so that the vial is supported at the carrier; and

a plurality of retaining protrusions, one each in each of the plurality of receptables, wherein each of the plurality of retaining protrusions protrudes inwardly in a radial direction into an associated receptacle at a lower end of the associated receptacle, so that the vial, when in the receptable, is supported at the transition region, and so that the horizontal base of the vial juts out of the associated receptacle and is accessible from the lower side of supporting structure.

24. A transport or packaging container, 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 plurality of vials, wherein each of the plurality of vials has a horizontal base, a cylindrical side wall, and an annular transition region between the horizontal base and the cylindrical side wall;

a carrier having an upper side, a lower side opposite the upper side and a plurality of receptacles into which the plurality of vials are at least partially inserted;

a retaining protrusion that protrudes into a respective receptacle of the plurality of receptacles in an inward radial direction at a lower end of the respective receptacle;

wherein the retaining protrusion contacts or supports an associated vial of the plurality of vials at the transition region of the horizontal base so that the horizontal bases of the plurality of vial juts out of the respective receptacle of the carrier and is accessible from the lower side of the carrier.

25. The transport or packaging container as claimed in claim 24, wherein the plurality of vials are supported on the supporting structure.

26. 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 horizontal base, a cylindrical side wall, and an annular transition region between the horizontal base and the cylindrical side wall; and

inserting the vials, at least partially, into the apertures or receptacles so that the retaining protrusion contacts the transition region of the respectively associated vial, so that the transition regions of the vials are supported outside the horizontal bases in such a manner that the bottoms or horizontal 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.

27. 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 horizontal base, a cylindrical side wall, and an annular transition region between the horizontal base and the cylindrical side wall;

disposing the vials in the apertures or receptacles of the supporting structure so that the retaining protrusion contacts a vial at the transition region outside the horizontal bases in such a manner that the bottoms or horizontal 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.

28. The method as claimed in claim 27, 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.

29. The method as claimed in claim 27, 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 horizontal 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 horizontal bases of the vials rest directly on the cooling surface.

30. The method as claimed in claim 29, 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.

31. The method as claimed in claim 29, 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.

32. The method as claimed in claim 29, 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.

33. The method as claimed in claim 27, 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 horizontal bases of the vials to lift the vials inside the apertures or receptacles by a distance smaller than an axial length of the vials.

34. The method as claimed in claim 27, 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.

35. The method as claimed in claim 27, 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.

36. The method as claimed in claim 35, 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.

37. The method as claimed in claim 27, 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.

38. The method as claimed in claim 27, 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.