Fused quartz tubing for pharmaceutical packaging

Patent metadata

Field	Value
Publication number	US-9919948-B2
Application number	US-201615176259-A
Country	US
Kind code	B2
Filing date	Jun 8, 2016
Priority date	Jun 20, 2006
Publication date	Mar 20, 2018
Grant date	Mar 20, 2018

Abstract

A high silica glass composition comprising about 92 to about 99.9999 wt. % SiO 2 and from about 0.0001 to about 8 wt. % of at least one dopant selected from Al 2 O 3 , CeO 2 , TiO 2 , La 2 O 3 , Y 2 O 3 , Nd 2 O 3 , other rare earth oxides, and mixtures of two or more thereof. The glass composition has a working point temperature ranging from 600 to 2,000° C. These compositions exhibit stability similar to pure fused quartz, but have a moderate working temperature to enable cost effective fabrication of pharmaceutical packages. The glass is particularly useful as a packaging material for pharmaceutical applications, such as, for example pre-filled syringes, ampoules and vials.

First claim

The invention claimed is:

1. A silica glass composition comprising about 92 to about 99.9 wt. % SiO 2 and about 0.1 to about 8 wt. % of a dopant selected from Al 2 O 3 , GeO 2 , Ga 2 O 3 , CeO 2 , ZrO 2 , Y 2 O 3 , a rare earth oxide, or mixtures of two or more thereof, wherein the composition contains less than 1 wt. % of metal impurities chosen from alkali metals and/or alkaline earth metals, and less than 3 wt. % of borate ions; and further comprising a UV blocker comprising Ti, Ce, Fe, or combinations of two or more thereof, the UV blocker being present in amount of from about 0.001 to about 0.5 wt %.

2. The glass composition of claim 1 , wherein a fused glass article formed from the composition has a total extractable metal concentration of about 8 mg/L or less when subjected to HCl digestion, the total extractable metal concentration being represented by the total concentration of Al, B, Na, Ca, K, Li, Ba, and Mg extracted upon HCl digestion.

3. The glass composition of claim 1 comprising about 96 to about 99.9 wt % SiO 2 .

4. The glass composition of claim 2 , wherein the total extractable metal concentration is about 5 mg/L or less.

5. The glass composition of claim 2 , wherein the total extractable metal concentration is about 1 mg/L or less.

6. The glass composition of claim 1 , wherein the glass composition exhibits a working point temperature in the range of from about 1,000 to about 2,000° C.

7. The glass composition of claim 1 , wherein the glass composition exhibits a softening point temperature in the range of about 500 to about 1,700° C.

8. The glass composition of claim 1 , wherein a fused glass article formed from the glass composition exhibits the following leaching characteristics when subjected to HCl digestion: Na (<7.0 mg/L), Ca (<1.0 mg/L), B (<2.5 mg/L), Al (<1.25 mg/L), K (<0.03 mg/L), or Mg (<0.01 mg/L).

9. The glass composition of claim 1 , wherein a fused glass article formed from the glass composition exhibits the following leaching characteristics when subjected to HCl digestion: Na (<7.0 mg/L), Ca (<1.0 mg/L), B (<2.5 mg/L), Al (<1.25 mg/L), K (<0.03 mg/L), and Mg (<0.01 mg/L).

10. The glass composition of claim 1 , wherein a fused glass article formed from the glass composition exhibits the following leaching characteristics when subjected to HCl digestion: Na (<0.1 mg/L), Ca (<0.05 mg/L), B (<0.01 mg/L), Al (<0.05 mg/L), Mg (<0.01 mg/L), or K (<0.01 mg/L).

11. The glass composition of claim 1 , wherein a fused glass article formed from the glass composition exhibits the following leaching characteristics when subjected to HCl digestion: Na (<0.1 mg/L), Ca (<0.05 mg/L), B (<0.01 mg/L), Al (<0.05 mg/L), Mg (<0.01 mg/L), and K (<0.01 mg/L).

12. The glass composition of claim 1 , wherein the total concentration of metal impurities is about 0.5 wt. % or less.

13. The glass composition of claim 1 , wherein the total concentration of metal impurities is about 0.015 wt. % or less.

14. The glass composition of claim 1 , wherein a fused glass article formed from the glass composition has an OH concentration of 0.5% or less, a Cl concentration of 0.5% or less, or an OH concentration and Cl concentration of 0.5% or less.

15. The glass composition of claim 1 , wherein a fused glass article formed from the glass composition has an OH concentration of 150 ppm or less, a Cl concentration 150 ppm or less, or an OH concentration and Cl concentration of 150 ppm or less.

16. The glass composition of claim 1 , wherein a fused glass article formed from the glass composition has an OH concentration of 50 ppm or less, a Cl concentration of 50 ppm or less, or an OH concentration and Cl concentration of 50 ppm or less.

17. The glass composition of claim 1 , wherein a fused glass article formed from the glass composition has an OH concentration of 10 ppm or less, a Cl concentration of 10 ppm or less, or an OH concentration and Cl concentration of 10 ppm or less.

18. The glass composition of claim 1 , wherein the glass composition exhibits a coefficient of thermal expansion of less than 3 ppm/K.

19. The glass composition of claim 1 , wherein the glass composition exhibits a coefficient of thermal expansion less than 2 ppm/K.

20. The glass composition of claim 1 , wherein the glass composition exhibits a coefficient of thermal expansion of less than 1 ppm/K.

21. The glass composition of claim 1 , having a working point temperature of about 1,700° C. or less.

22. A glass article comprising a silica glass composition comprising about 92 to about 99.9 wt. % SiO 2 and about 0.1 to about 8 wt. % of a dopant selected from Al 2 O 3 , GeO 2 , Ga 2 O 3 , CeO 2 , ZrO 2 , Y 2 O 3 , a rare earth oxide, or mixtures of two or more thereof, wherein the silica glass composition contains less than 1 wt. % of metal impurities chosen from alkali metals and/or alkaline earth metals, and less than 3 wt. % of borate ions, the article having a total extractable metal concentration of about 8 mg/L or less when subjected to HCl digestion, the total extractable metal concentration being represented by the total concentration of Al, B, Na, Ca, K, Li, Ba, and Mg extracted upon HCl digestion; wherein the glass article is formed by a continuous draw process.

23. A silica glass composition comprising at least 99.9% wt. % SiO 2 and a dopant selected from GeO 2 , TiO 2 , or mixtures thereof in an amount of about 0.1 to about 0.0001 wt. %, wherein the composition contains less than 1 wt. % of metal impurities chosen from alkali metals and/or alkaline earth metals, and less than 3 wt. % of borate ions.

24. The glass composition of claim 23 comprising greater than about 99.95 wt. % SiO 2 .

Assignees

• Momentive Performance Mat Inc

Inventors

• Ahn Kipyung
• Xu Guangjun
• Panchula Martin
• Conzone Samuel
• Rong Tianjun
• Zuyev Konstantin S
• Zhou Yen

Classifications

• C03C4/00

  Compositions for glass with special properties · CPC title

• C03C2204/00

  Glasses, glazes or enamels with special properties · CPC title

• B65D1/00

  Rigid or semi-rigid containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material or by deep-drawing operations performed on sheet material (with curved or partially-curved cross-section made by winding or bending paper B65D3/00; with polygonal cross-section formed by folding B65D5/00; specially constructed to be opened by cutting, piercing or tearing of wall portions B65D17/00; rigid pallets with side walls B65D19/02) · CPC title

• C03C2201/23

  containing hydroxyl groups · CPC title

• A61J1/00

  Containers specially adapted for medical or pharmaceutical purposes (capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00) · CPC title