Fused quartz tubing for pharmaceutical packaging
View Patent ↗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.
1. A pharmaceutical packaging container comprising a silica glass composition comprising about 92 to about 99.9 wt. % SiO 2 and about 0.1 to about 8 wt. % selected from Al 2 O 3 , GeO 2 , Ga 2 O 3 , CeO 2 , ZrO 2 , TiO 2 , Y 2 O 3 , a rare earth oxide, or mixtures of two or more thereof, wherein the composition does not contain an appreciable amount of alkali metals, alkaline earth metals, or borate ions.
2. The pharmaceutical packaging container of claim 1 , where the silica glass composition comprises about 96 to about 99.9 wt % SiO 2 .
3. The pharmaceutical packaging container of claim 1 , where the container is formed by thermal conversion processing of a glass article formed from the silica glass composition.
4. The pharmaceutical packaging container of claim 1 in the form of one of a vial, cartridge, syringe barrel, or ampoule.
5. The pharmaceutical packaging container of claim 1 , wherein said container is designed for the liquid or dry (lyophilized) storage of drugs.
6. The pharmaceutical packaging container of claim 1 , wherein the inner surface of the packaging container is substantially free of a coating.
7. The pharmaceutical packaging container of claim 1 , wherein the container 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.
8. The pharmaceutical packaging container of claim 1 , wherein the container 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), Ba (<0.003 mg/L), K (<0.03 mg/L), or Mg (<0.01 mg/L).
9. The pharmaceutical packaging container of claim 1 , wherein the container 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), K(<0.01 mg/L), or Mg (<0.01 mg/L).
10. The pharmaceutical packaging container of claim 1 , wherein the total concentration of metal impurities is about 0.5 wt. % or less.
11. The pharmaceutical packaging container of claim 1 , wherein the total concentration of metal impurities is about 0.015 wt. % or less.
12. The pharmaceutical packaging container of claim 1 , wherein the container produces 1000 particles/cm 2 or less when in contact with a pharmaceutical aqueous solution at pH from about 3 to 10 for 60 days.
13. The pharmaceutical packaging container of claim 1 , wherein the container produces 500 particles/cm 2 or less when in contact with a pharmaceutical aqueous solution at pH from about 3 to 10 for 60 days.
14. The pharmaceutical packaging container of claim 1 , wherein the container produces 100 particles/cm 2 or less when in contact with a pharmaceutical aqueous solution at pH from about 3 to 10 for 60 days.
15. The pharmaceutical packaging container of claim 1 , wherein the container produces 50 particles/cm 2 or less when in contact with a pharmaceutical aqueous solution at pH from about 3 to 10 for 60 days.
16. The pharmaceutical packaging container of claim 1 , wherein the container produces 10 particles/cm 2 or less when in contact with a pharmaceutical aqueous solution at pH from about 3 to 10 for 60 days.
17. The pharmaceutical packaging container of claim 1 , wherein the container has a OH concentration of 0.5% or less, a Cl concentration of 0.5% or less, or a OH concentration and Cl concentration of 0.5% or less.
18. The pharmaceutical packaging container of claim 1 , wherein the container has a OH concentration of 150 ppm or less, a Cl concentration 150 ppm or less, or a OH concentration and Cl concentration of 150 ppm or less.
19. The pharmaceutical packaging container of claim 1 , wherein the container has a OH concentration of 50 ppm or less, a Cl concentration of 50 ppm or less, or a OH concentration and Cl concentration of 50 ppm or less.
20. The pharmaceutical packaging container of claim 1 , wherein the container has a OH concentration of 10 ppm or less, a Cl concentration of 10 ppm or less, or a OH concentration and Cl concentration of 10 ppm or less.
21. The pharmaceutical packaging container of claim 1 , wherein the concentration of cations or metal ions leached from the container is lower than the concentration of cations or metals leached from a borosilicate glass and/or soda lime glass when the respective glasses are in contact with an aqueous solution.
22. The pharmaceutical packaging container of claim 1 , wherein the container is formed by a continuous draw process comprising drawing a glass composition into a rod or tube, and converting the rod or tube into the container.
23. The pharmaceutical packaging container of claim 1 , wherein the container is formed from a glass composition comprising a fine metal oxide dispersing agent.
24. The pharmaceutical packaging container of claim 21 , wherein the aqueous solution is a liquid pharmaceutical drug formulation.
25. A pharmaceutical packaging container comprising a silica glass composition comprising at least 99.9% wt. % SiO 2 and a dopant selected from Al 2 O 3 , GeO 2 , Ga 2 O 3 , CeO 2 , ZrO 2 , TiO 2 , Y 2 O 3 , a rare earth oxide, or mixtures of two or more thereof in an amount of about 0.1 to about 0.0001 wt. %.
26. The pharmaceutical packaging container of claim 25 comprising greater than about 99.95 wt. % SiO 2 .