FUSED QUARTZ TUBING FOR PHARMACEUTICAL PACKAGING
A high silica glass composition comprising about 82 to about 99.9999 wt. % SiO 2 and from about 0.0001 to about 18 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 silica glass composition comprising about 82 to about 99.9999 wt. % SiO 2 and about 0.0001 to about 18 wt. % of a dopant selected from f Al 2 O 3 , GeO 2 , Ga 2 O 3 , CeO 2 , ZrO 2 , TiO 2 , La 2 O 3 . Y 2 O 3 , Nd 2 O 3 , a rare earth oxides, and mixtures of two or more thereof.
2 . The glass composition of claim 1 , wherein the glass composition exhibits a working point temperature in the range of from about 600 to about 2,000.
3 . 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.
4 . The glass composition of claim 1 , wherein the concentration of cations or metal ions leached from a glass article formed from the glass composition 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.
5 . The glass composition of claim 1 , wherein a fused glass article formed from the glass composition exhibits the following leaching characteristics, the following species in after the glass is subjected to HCl digestion: Na (<0.1 mg/L), Ca (<0.05 mg/L), B (<0.01 mg/L), Al (<0.05 mg/L), Fe (<0.05 mg/L) Mg (<0.01 mg/L), K(<0.01 mg/L), As (<0.02 mg/L), Cd (<0.001 mg/L), Cr (<0.008 mg/L), Pb (<0.009 mg/L), and Sb (<0.01 mg/L).
6 . The glass composition of claim 1 , wherein a fused glass article formed from the glass composition exhibits the following leaching characteristics, the following species in after the glass is 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), Fe (<0.01 mg/L), K (<0.03 mg/L), Mg (<0.01 mg/L) As (<0.02 mg/L), Cd (<0.001 mg/L), Cr (<0.008 mg/L), Pb (<0.009 mg/L), and Sb (<0.01 mg./L).
7 . The glass composition of claim 1 , 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 %
8 . The glass composition of claim 1 , wherein the glass composition exhibits a coefficient of thermal expansion of less than 3 ppm/K.
9 . The glass composition of claim 1 , wherein the glass composition exhibits a coefficient of thermal expansion less than 2 ppm/K.
10 . The glass composition of claim 1 , wherein the glass composition exhibits a coefficient of thermal expansion of less than 1 ppm/K.
11 . The glass composition of claim 1 , wherein the glass exhibits no volatile borate formation on the surface of a pharmaceutical packaging container during or immediately after flame conversion.
12 . The glass composition of claim 1 , wherein the total dopant concentration is from about 0.0001 to about 18 wt. %.
13 . The glass composition of claim 1 , wherein the total dopant concentration is from about 0.01 to about 8 wt. %.
14 . The glass composition of claim 1 , comprising from about 0.1 to about 18 wt. % Al 2 O 3 .
15 . The glass composition of claim 1 , comprising from about 0.5 to about 5 wt. % Al 2 O 3 .
16 . The glass composition of claim 1 , comprising from about 0.1 to about 5 wt. % Al 2 O 3 , from about 0.1 to about 0.5 wt. % C e O 2 , and from about 0.01 to about 0.05 wt. % TiO 2 .
17 . The glass composition of claim 1 , having a working point temperature of about 1,550° C. or less.
18 . A pharmaceutical packaging container comprising a silica glass composition comprising about 82 to about 99.9999 wt. % SiO 2 and about 0.0001 to about 18 wt. % of a dopant selected from Al 2 O 3 , GeO 2 , Ga 2 O 3 , CeO 2 , ZrO 2 , TiO 2 , La 2 O 3 , Y 2 O 3 , Nd 2 O 3 , a rare earth oxides, and mixtures of two or more thereof
19 . The pharmaceutical packaging container of claim 18 comprising from about 0.01 to about 18 wt. % of a dopant.
20 . The pharmaceutical composition of claim 18 comprising from about 0.01 to about 8 wt. % of a dopant.
21 . The pharmaceutical packaging container of claim 18 in the form of one of a vial, cartridge, syringe barrel, or ampoule.
22 . The pharmaceutical packaging container of claim18, wherein said container is designed for the liquid or dry (lyophilized) storage of drugs.
23 . The pharmaceutical packaging container of claim 18 , wherein the inner surface of the packaging container is substantially free of a coating.
24 . The pharmaceutical packaging container of claim 18 , wherein the container exhibits the following leaching characteristics when subjected to HCl digestion: Na (<5.0 mg/L), Ca (<1.0 mg/L), B (<2.5 mg/L), Al (<1.25 mg/L), Ba (<0.003 mg/L), Fe (<0.01 mg/L), K (<0.03 mg/L), Mg (<0.01 mg/L) As (<0.02 mg/L), Cd (<0.001 mg/L), Cr (<0.008 mg/L), Pb (<0.009 mg/L), and Sb (<0.01 mg./L).
25 . The pharmaceutical packaging container of claim 18 , 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), Fe (<0.05 mg/L) Mg (<0.01 mg/L), K(<0.01 mg/L), As (<0.02 mg/L), Cd (<0.001 mg/L), Cr (<0.008 mg/L), Pb (<0.009 mg/L), and Sb (<0.01 mg/L).
26 . The pharmaceutical packaging container of claim 18 , 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.
27 . The pharmaceutical packaging container of claim 26 , wherein the aqueous solution is a liquid pharmaceutical drug formulation.