Pharmaceutical glass packaging assuring pharmaceutical sterility

Patent metadata

Field	Value
Publication number	US-10350139-B2
Application number	US-201414573606-A
Country	US
Kind code	B2
Filing date	Dec 17, 2014
Priority date	Oct 25, 2011
Publication date	Jul 16, 2019
Grant date	Jul 16, 2019

Abstract

A sterile glass pharmaceutical container or vessel such as, but not limited to, vials for holding pharmaceutical products or vaccines in a hermetic and/or sterile state. The sterile glass pharmaceutical container undergoes a strengthening process that produces compression at the surface and tension within the container wall. The strengthening process is designed such that the tension within the wall is great enough to ensure catastrophic failure of the pharmaceutical container, thus rendering the product unusable, should sterility be compromised by a through-wall crack. The tension is greater than a threshold central tension, above which catastrophic failure of the pharmaceutical container is guaranteed, thus eliminating any potential for violation of pharmaceutical integrity or sterility (such as stable cracks) in the glass packaging which are not easily identifiable in an otherwise seemingly intact pharmaceutical container.

First claim

The invention claimed is:

1. A sterile packaged pharmaceutical composition comprising: a sterile pharmaceutical container comprising a delamination resistant glass and a sterile pharmaceutical composition contained in the sterile pharmaceutical container;
wherein the sterile pharmaceutical container comprises a first surface and a second surface separated by glass having a thickness;
a first region under a compressive stress, the first region extending from at least one of the first surface or the second surface to a depth of layer in the glass of at least about 10 μm;
a second region under a central tension of at least about 15 MPa, the second region extending from the depth of layer, wherein the central tension is greater than a threshold central tension that is sufficient to allow self-propagation of a crack front through the thickness from the first surface to the second surface which renders the pharmaceutical container unsuitable for its intended use such that the pharmaceutical composition remains sterile so long as the crack front does not extend into the second region; and
wherein the delamination resistant glass comprises a laminate, the laminate comprising a first glass disposed on the first surface and a second glass disposed between the first glass and the second surface.

2. The sterile pharmaceutical container of claim 1 , wherein the delamination resistant glass comprises an alkali aluminosilicate glass.

3. The sterile pharmaceutical container of claim 1 , wherein the sterile pharmaceutical composition is a vaccine, a biologic, or a solution comprising an active pharmaceutical ingredient.

4. The sterile pharmaceutical container of claim 1 , wherein the self-propagation of the crack front from the first surface to the second surface further comprises bifurcation of the crack front across at least the first surface.

5. The sterile pharmaceutical container of claim 1 , wherein the self-propagation of the crack front from the first surface to the second surface further comprises self-propagation of the crack front laterally across at least the first surface, and wherein the self-propagation of the crack front renders the pharmaceutical container unsuitable for its intended use.

6. The sterile pharmaceutical container of claim 1 , wherein (CT 2 /E)·(t−2DOL)·(1−ν)≥9.5 MPa·μm.

7. The sterile pharmaceutical container of claim 6 , wherein (CT 2 /E)·(t−2DOL)·(1−ν)≥15.0 MPa·μm.

8. The sterile pharmaceutical container of claim 1 , wherein the central tension is greater than or equal to about 30 MPa.

9. The sterile pharmaceutical container of claim 8 , wherein the central tension is greater than or equal to about 45 MPa.

10. The sterile pharmaceutical container of claim 1 , wherein the compressive stress is at least about 200 MPa.

11. The sterile pharmaceutical container of claim 1 , wherein the depth of layer is at least about 30 μm.

12. The sterile pharmaceutical container of claim 1 , wherein the depth of layer is in a range from about 15% to about 25% of the thickness.

13. The sterile pharmaceutical container of claim 1 , wherein the thickness is up to about 6 mm.

14. The sterile pharmaceutical container of claim 13 , wherein the thickness is in a range from about 0.3 mm to about 2.0 mm.

15. The sterile packaged pharmaceutical composition of claim 1 , wherein the first glass has a first CTE and the second glass is adjacent to the first glass and has a second CTE, wherein the first CTE is greater than the second CTE.

16. The sterile packaged pharmaceutical composition of claim 1 , wherein the first glass has a first Young's modulus and the second glass is adjacent to the first glass and has a second Young's modulus, wherein the first Young's modulus is greater than the second Young's modulus.

17. A sterile packaged pharmaceutical composition comprising: a sterile pharmaceutical container comprising a delamination resistant glass and a sterile pharmaceutical composition contained in the sterile pharmaceutical container comprising:
an active pharmaceutical ingredient; and
wherein the sterile pharmaceutical container comprises:
a first surface and a second surface separated by glass having a thickness;
a first region under a compressive stress, the first region extending from at least one of the first surface and the second surface to a depth of layer in the glass of at least about 10 μm; and
a second region under a central tension of at least about 15 MPa, the second region extending from the depth of layer, wherein the central tension is greater than a central tension that is sufficient to allow self-propagation of a crack front through the thickness from the first surface to the second surface which renders the pharmaceutical container unsuitable for its intended use such that the active pharmaceutical ingredient remains sterile so long as the crack front does not extend into the second region; and

wherein the glass comprises a laminate, the laminate comprising a first glass disposed on the first surface and a second glass disposed between the first glass and the second surface.

18. The sterile packaged pharmaceutical composition of claim 17 , wherein the glass comprises an alkali aluminosilicate glass.

19. The sterile packaged pharmaceutical composition of claim 17 , wherein the self-propagation of the crack front from the first surface to the second surface further comprises bifurcation of the crack front across at least the first surface.

20. The sterile packaged pharmaceutical composition of claim 19 , wherein the self-propagation of the crack front from the first surface to the second surface further comprises self-propagation of the crack front laterally across at least the first surface, and wherein the self-propagation of the crack front renders the container unsuitable for its intended use.

21. The sterile packaged pharmaceutical composition of claim 17 , wherein (CT 2 /E)·(t−2DOL)·(1−ν)≥9.5 MPa·μm.

22. The sterile packaged pharmaceutical composition of claim 21 , wherein (CT 2 /E)·(t−2DOL)·(1−ν)≥15.0 MPa·μm.

23. The sterile packaged pharmaceutical composition of claim 17 , wherein the threshold tensile stress is greater than or equal to about 30 MPa.

24. The sterile packaged pharmaceutical composition of claim 23 , wherein the threshold tensile stress is greater than or equal to about 45 MPa.

25. The sterile packaged pharmaceutical composition of claim 17 , wherein the compressive stress is at least about 200 MPa.

26. The sterile packaged pharmaceutical composition of claim 17 , wherein the depth of layer is at least about 30 pna.

27. The sterile packaged pharmaceutical composition of claim 17 , wherein the depth of layer is in a range from about 15% to about 25% of the thickness.

28. The sterile packaged pharmaceutical composition of claim 17 , wherein the thickness is up to about 6 mm.

29. The sterile packaged pharmaceutical composition of claim 28 , wherein the thickness is in a range from about 0.3 mm to about 2.0 mm.

30. The sterile packaged pharmaceutical composition of claim 17 , wherein the first glass has a first CTE and the second glass is adjacent to the first glass and has a second CTE, wherein the first CTE is greater than the second CTE.

31. The sterile packaged pharmaceutical composition of claim 17 , wherein the first glass has a first Young's modulus and the secon

Assignees

• Corning Inc

Inventors

• Demartino Steven Edward
• Schaut Robert Anthony

Classifications

• C03C21/007

  in gaseous phase · CPC title

• Y10T29/49

  Method of mechanical manufacture · CPC title

• C03B27/065

  Stresses, e.g. patterns, values or formulae · CPC title

• Y10T428/131

  Glass, ceramic, or sintered, fused, fired, or calcined metal oxide or metal carbide containing [e.g., porcelain, brick, cement, etc.] · CPC title

• C03C21/002

  to perform ion-exchange between alkali ions (C03C21/005 takes precedence) · CPC title