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US 12,515,984 B2Granted
Glass tube for pharmaceutical containers and manufacturing process for a glass tube
AssigneeSchott AG
InventorsSusanne Krüger, Ulrich Lange, Peter Nass, Arne Riecke, Detlef Köpsel, Rainer Erwin Eichholz, Andreas Langsdorf
Life of this patent
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Abstract
A glass tube for pharmaceutical containers and a manufacturing process for a glass tube are provided. The glass tubes are characterized by a homogenous and low alkali leachability on the inner surface.
Claims21
A glass tube for pharmaceutical containers, comprising:
- a wall made of glass, the wall having an inner surface with an inner diameter (di) and an outer surface with an outer diameter (do), the outer diameter (do) being from 6 mm to 55 mm;
- a thickness of the wall defined between the inner and outer diameters (di, do), the thickness being between 0.4 mm to 2.5 mm;
- a length (la) defined along a longitudinal axis from a first edge to a second edge, the length (la) being from 500 to 3500 mm, wherein the first edge and the second edge extend 6.67% of the length (la);
- a first discrete section configured as a first annular cross-sectional portion that extends on the inner surface at least 60 mm along the longitudinal axis and extends on the inner surface between the first and second edges;
- a second discrete section configured as a second annular cross-sectional portion that extends on the inner surface at least 60 mm along the longitudinal axis and extends on the inner surface between the first and second edges, wherein the first and second discrete sections do not overlap one another;
- a first hydrolytic resistance comprising a ratio of a first alkali leachability of the glass of the inner surface in the first discrete section to the thickness;
- a second hydrolytic resistance comprising a ratio of a second alkali leachability of the glass of the inner surface in the second discrete section to the thickness, wherein the first and second alkali leachabilities being determined as Na2O equivalents in an eluate prepared according to ISO 4802-2:2010;
- and
- an absolute difference of the first and second hydrolytic resistances that is less than 0.20 μg cm−2.
6 more elements
A glass tube for pharmaceutical containers, comprising:
- a wall made of glass, the wall having an inner surface with an inner diameter (di) and an outer surface with an outer diameter (do), the outer diameter (do) being from 6 mm to 55 mm;
- a thickness of the wall defined between the inner and outer diameters (di, do), the thickness being between 0.4 mm to 2.5 mm;
- a length (la) defined along a longitudinal axis, the length (la) being from 500 to 3500 mm;
- a first discrete section configured as a first annular cross-sectional portion that extends on the inner surface at least 60 mm along the longitudinal axis;
- a second discrete section configured as a second annular cross-sectional portion that extends on the inner surface at least 60 mm along the longitudinal axis, wherein the first and second discrete sections do not overlap one another;
- a first hydrolytic resistance comprising a ratio of a first alkali leachability of the glass of the inner surface in the first discrete section to the thickness;
- a second hydrolytic resistance comprising a ratio of a second alkali leachability of the glass of the inner surface in the second discrete section to the thickness, wherein the first and second alkali leachabilities being determined as Na2O equivalents in an eluate prepared according to ISO 4802-2:2010;
- and
- an absolute difference of the first and second hydrolytic resistances that is greater than 0 μg cm−2 and less than 0.20 μg cm−2.
6 more elements
Dependencies are inferred from the claim text.