Vial with optimized neck for improved side compression performance
A glass container is provided having a glass tube with a first end and a second end and a glass bottom closing the second end. The glass tube has a longitudinal axis and has, in a direction from the first to the second end, a top region, a junction region, a neck region, a shoulder region, and a body region. The top region is at the first end and has an outer diameter (d t ), the neck region has an outer diameter (d n ) with d n <d t , the body region extends to the second end and has an outer diameter (d b ) with d b >d t , and the glass tube in the body region has a thickness (l b ). The outer contour in a transition area between the top and neck regions is defined by a radius of curvature. The glass containers have a neck squeeze test load of at least 1100 N.
1. A glass container, comprising:
a glass tube made of a glass, the glass tube having a first end, a second end, and a longitudinal axis L tube therebetween, the glass tube has, in a direction from the first end to the second end, a top region, a junction region, a neck region, a shoulder region, and a body region, wherein the top region is at the first end and has an outer diameter (d t ), the neck region has an outer diameter (d n ) with d n <d t and the glass in the neck region has a minimum thickness (l n ), and the body region extends to the second end, wherein the body region has a glass thickness (l b ) and an outer diameter (d b ) with d b >d t ; and
a glass bottom closing the glass tube at the second end; and
an interior volume between 1 ml and 150 ml,
wherein the junction region has an outer surface and a substantially circular arc-shaped area, the substantially circular arc-shaped area being where the junction region merges into the neck region, the substantially circular arc-shaped area having an outer radius (r s ),
wherein 2×[l n /l b ]×r s ≥2.17 mm,
wherein the neck region has a mechanical resistance against diametral compression according to a neck squeeze test of at least 1100 N, and
wherein the mechanical resistance against diametral compression is determined by a diametral load strength testing adapted from DIN EN ISO 8113 where a compressive force is applied in diametral direction at two opposing positions of an outer surface of the neck region using two opposing, uniaxial concave steel surfaces having a radius of the concavity that is 25% larger than a radius of the outer diameter of the neck region so that the compressive force is applied along two opposing lines, wherein the concave steel surfaces have a width that is shorter than a height of the neck region, and wherein the compressive force is increased at a constant load rate of 2000 N/min until breakage using a universal testing is detected as a sudden drop in the force-time diagram F(t),
wherein the glass is selected from the group consisting of a borosilicate glass, an aluminosilicate glass, a soda lime glass, and a fused silica; or a combination of at least two thereof,
wherein r s is in the range from 0.5 to 1.0 mm, and
l b is in range of from 0.4 to 2.5 mm.
2. The glass container of claim 1 , wherein, when an outer surface of the body region is placed on a plane horizontal substrate, within any given cross-section of the glass container that is located in a plane centrically located in the glass container and comprising the longitudinal axis L tube , f(x) defines a vertical distance between the plane horizontal substrate and the outer surface of the junction region at a given position x and l(x) defines a thickness of the glass tube at the given position x, wherein the thickness of the glass tube l(x) is measured in a direction perpendicular to the longitudinal axis L tube ,
wherein k(x)=|f″(x)/[1+f′(x) 2 ] 3/2 | defines an absolute value of a curvature of f(x) at the given position x; and
wherein, in an interval defined at the junction region between x=P 1 and x=P 2 for any concave curvature in the interval, a minimum value for [l(x)/l b ] 3 /k(x) is at least 0.35 mm, wherein P 2 defines the x-position at which f(x) is ½×d b −¼×d t −¼×d n and P 1 is P 2 −d t /2+d n /2.
3. The glass container of claim 1 , wherein the glass container is a vial with the interior volume of 1 to 8 ml, d n ≥9.7 ml.
4. The glass container of claim 3 , wherein the vial has a size designation “2R” or “4R” according to DIN EN ISO 8362-1:2016-06.
5. The glass container of claim 1 , wherein the glass container is a vial with the interior volume of 8.5 to 22 ml, d n ≥15.5 ml.
6. The glass container of claim 5 , wherein the vial has a size designation “6R”, “8R” or “10R” according to DIN EN ISO 8362-1:2016-06.
7. The glass container of claim 1 , wherein the glass container is a vial with the interior volume of 22.5 to 150 ml, d n ≥16.5 ml.
8. The glass container of claim 7 , wherein the vial has a size designation “20R”, “25R”, “30R”, “50R” or “100R” according to DIN EN ISO 8362-1:2016-06.
9. The glass container of claim 1 , wherein l 1 /l b ≥1.4.
10. The glass container of claim 1 , wherein l n ×r s /l b ≥0.7 mm.
11. The glass container of claim 1 , further comprising a pharmaceutical composition in the interior volume and a closure closing the glass tube at the first end.
12. The glass container of claim 1 , wherein the glass thickness (l b ) throughout the body region is in a range from ±0.2 mm based on a mean value of the glass thickness in the body region.
13. The glass container of claim 1 , wherein the glass container has a mass of glass mg and the interior volume V i , wherein m g /V i 0.75 <2.0.
14. The glass container of claim 1 , further comprising a coating that at least partially superimposes the exterior surface, the interior surface or the exterior and the interior surface of the glass tube.
15. The glass container of claim 14 , wherein the coating comprises a silicone, a silane or a mixture thereof, wherein the silicone or the silane can be crosslinked or non-crosslinked.
16. The glass container of claim 1 , wherein the glass container at least in the neck region is characterized by a substantially homogeneous distribution of sodium across a thickness of the glass at least in the neck region.
17. The glass container of claim 1 , wherein the glass container at least in the neck region is characterized by a substantially homogeneous distribution of potassium across a thickness of the glass at least in the neck region.
18. The glass container of claim 1 , wherein the glass of the glass container at least in the neck region is characterized by a compressive stress (CS) in an outer surface in the neck region which is lower than 500 MPa.
19. The glass container of claim 1 , wherein the body region has a mechanical resistance to a side compression test of 16% greater than a glass container that does not satisfy 2×[l n /l b ]×r s ≥0.9 mm, wherein the mechanical resistance against diametral compression is determined by a diametral load strength testing adapted from DIN EN ISO 8113 where a compressive force is applied in diametral direction at two opposing positions of an outer surface of the body region using two opposing, uniaxial concave steel surfaces having a radius of the concavity that is 25% larger than a radius of the outer diameter of the body region so that the compressive force is applied along two opposing lines, wherein the concave steel surfaces have a width that is larger than a height of the body region, and wherein the compressive force is increased at a constant load rate of 1500 N/min until breakage using a universal testing is detected as a sudden drop in the force-time diagram F(t).
20. The glass container of claim 1 , wherein the following conditions are fulfilled:
2×[l n /l b ]×r s ≥1.5 mm;
the vial has a size designation according to DIN EN ISO 8362-1:2016-06 selected from a group consisting of “2R”, “4R”, “6R”, “8R”, and “10R”;
l b is in a range from 0.8 to 1.3 mm; and
r s is in a range from 0.6 to 0.95 mm.
21. A glass container, comprising:
a glass tube having a first end, a second end, and a longitudinal axis L tube therebetween, the glass tube having, in a direction from the first end to the second end, a top region, a junction region, a neck region, a shoulder region, and a body region;
a bottom closing the glass tube at the second end; and
an interior volume between 1 ml and 150 ml,
wherein the top region is at the first end and has an outer diameter (d t ),
wherein the neck region has an outer diameter (d n ) with d n <d t and a minimum thickness (l n ),
wherein the body region extends to the second end and has a glass thickness (l b ) and an outer diameter (d b ) with d b >d t ,
wherein the junction region has an outer surface and a substantially circular arc-shaped area, the substantially circular arc-shaped area being where the junction region merges into the neck region, the substantially circular arc-shaped area having an outer radius (r s ),
wherein 2×[l n /l b ]×r s ≥2.17 mm,
wherein the body region has a mechanical resistance to a side compression test of 16% greater than a glass container that does not satisfy 2×[l n /l b ]×r s ≥0.9 mm, and
wherein the mechanical resistance against diametral compression is determined by a diametral load strength testing adapted from DIN EN ISO 8113 where a compressive force is applied in diametral direction at two opposing positions of an outer surface of the body region using two opposing, uniaxial concave steel surfaces having a radius of the concavity that is 25% larger than a radius of the outer diameter of the body region so that the compressive force is applied along two opposing lines, wherein the concave steel surfaces have a width that is larger than a height of the body region, and wherein the compressive force is increased at a constant load rate of 1500 N/min until breakage using a universal testing is detected as a sudden drop in the force-time diagram F(t),
wherein the glass is selected from the group consisting of a borosilicate glass, an aluminosilicate glass, a soda lime glass, and a fused silica; or a combination of at least two thereof,
wherein r s is in the range from 0.5 to 1.0 mm, and
l b is in range of from 0.4 to 2.5 mm.
22. The glass container of claim 21 , wherein the neck region has a mechanical resistance against diametral compression according to a neck squeeze test of at least 1100 N, wherein the mechanical resistance against diametral compression is determined by a diametral load strength testing adapted from DIN EN ISO 8113 where a compressive force is applied in diametral direction at two opposing positions of an outer surface of the neck region using two opposing, uniaxial concave steel surfaces having a radius of the concavity that is 25% larger than a radius of the outer diameter of the neck region so that the compressive force is applied along two opposing lines, wherein the concave steel surfaces have a width that is shorter than a height of the neck region, and wherein the compressive force is increased at a constant load rate of 2000 N/min until breakage using a universal testing is detected as a sudden drop in the force-time diagram F(t).