Abstract
A glass syringe barrel is provided that has a bottom end and a top end with a cone region, a shoulder region, a body region, and a flange region therebetween. The glass syringe barrel is configured so that f(x) defines an absolute value of a vertical distance between any point of a first outer contour and a straight line f.sub.o at a position x, with f(x)=0 at point P.sub.1, wherein x is a horizontal distance between any given point on the straight line f.sub.o and point P.sub.0 at which the straight line f.sub.o crosses a line L.sub.1 that runs parallel to the longitudinal axis and that touches an outer surface of the body region, and a maximum value for the term f(x) in a range from x=P.sub.0 to x=P.sub.1 is f(x).sub.max determined at position x.sub.max.
Claims
1. A glass syringe barrel, comprising: a bottom end through which a liquid can be ejected; a top end into which a plunger stopper can be pushed; and a longitudinal axis defined through the bottom and top ends; wherein the glass syringe barrel, in a direction from the bottom end to the top end, includes: a cone region having a first end that corresponds to the bottom end and a second end; a shoulder region having a third end adjacent to the second end and a fourth end; a body region with a first outer diameter (d.sub.1) having a fifth end that is adjacent to the fourth end and a sixth end; and a flange region having, at least in parts, a circular shape, the flange region having a seventh end that is adjacent to the sixth end and an eighth end that corresponds to the top end, wherein the flange region has a second outer diameter (d.sub.2), the second outer diameter (d.sub.2) being larger than the first outer diameter (d.sub.1), wherein the flange region has a first outer contour at the seventh end and a second outer contour at the eighth end; wherein for any cut surface that includes the longitudinal axis and is obtainable by cutting the glass syringe barrel in a plane at which a shape of the flange region is circular: f.sub.o is a straight line that runs perpendicular to the longitudinal axis and touches the first outer contour at a deepest point (P.sub.1), f.sub.o is a straight line that runs perpendicular to the longitudinal axis and touches the second outer contour at a highest point (P.sub.2), f(x) defines an absolute value of a vertical distance between any point of the first outer contour and the straight line f.sub.o at a position x, with f(x)=0 at point P.sub.1, wherein x is a horizontal distance between any given point on the straight line f.sub.o and point P.sub.0 at which the straight line f.sub.o crosses a line L.sub.1 that runs parallel to the longitudinal axis and that touches an outer surface of the body region, and a maximum value for the term f(x) in a range from x=P.sub.0 to x=P.sub.1 is f(x).sub.max determined at position x.sub.max; wherein f(x) defines an absolute value of the vertical distance between any point of the second outer contour and the straight line f.sub.o at a position x, with f(x)=0 at point P.sub.2, and wherein the following condition is fulfilled: f(x.sub.max)/f(x).sub.max>1.
2. The glass syringe barrel of claim 1, wherein f(x.sub.max) is in a range from 0.15 to 0.7 mm.
3. The glass syringe barrel of claim 1, wherein f(x).sub.max is in a range from 0.01 to 0.65 mm.
4. The glass syringe barrel of claim 1, wherein D1 is a distance between the point P.sub.1 on the first outer contour and a point P.sub.3 on the second outer contour, wherein the point P.sub.3 is located vertically above point P.sub.1 and D.sub.2 is a distance between a point of the first outer contour and the outer contour at position x.sub.max and wherein the following condition is fulfilled: D.sub.1/D.sub.2<1.6.
5. The glass syringe barrel of claim 1, wherein d is a distance between point x.sub.max on a left side of the flange region and point x.sub.max on a right side of the flange region on the straight line f.sub.o, x.sub.max and x.sub.max corresponding to points at which the function f(x) reaches a maximum value on the left side and the right side, wherein d is in a range from 12.5 to 15 mm.
6. The glass syringe barrel of claim 1, wherein d is a distance between point P.sub.1 on a left side of the flange region and point P.sub.1 on a right side of the flange region on the straight line f.sub.0, wherein d/d.sub.2 is in a range from 0.8 to 0.95.
7. The glass syringe barrel of claim 6, wherein d is in a range from 8 to 20 mm and the second outer diameter (d.sub.2) is in a range from 12 to 22 mm.
8. The glass syringe barrel of claim 1, wherein the first outer diameter (d.sub.1) is in a range from 6 to 20 mm.
9. The glass syringe barrel of claim 1, wherein a tangent that touches the second outer contour at position x.sub.max includes an angle with the straight line f.sub.o and wherein the angle is in a range from 10 to 28 degrees.
10. The glass syringe barrel of claim 1, wherein: L.sub.2 is a straight line that touches the deepest point P.sub.1 of the first outer contour on the left side of the flange region and the deepest point P1 of the first outer contour on the right side of the flange region; L.sub.3 is a straight line that touches the first outer contour on the left side of the flange region at a position x at which f(x) reaches the maximum value f(x).sub.max and the deepest point P.sub.1 of the first outer contour on the right side of the flange region; and the straight lines L.sub.2 and L.sub.3 enclose an angle of less than 3 degree.
11. The glass syringe barrel of claim 1, wherein d.sub.2d.sub.1 is in a range from 5 to 8 mm.
12. The glass syringe barrel of claim 1, wherein the flange region, in a plane that is perpendicular to the longitudinal axis, has the shape of a circle or the shape of a circle where two opposite sections of the circle have been removed.
13. A nest box comprising: a plurality of the glass syringe barrels of claim 1, wherein at least one of the following conditions is fulfilled: a relative standard deviation of a flange thickness is less than 6%; and a relative standard deviation of a length of the glass syringe barrels is less than 12%.
14. The nest box of claim 13, wherein both conditions are fulfilled.
15. A syringe comprising: the glass syringe barrel of claim 1; and a plunger stopper pushed into the top end.
16. The syringe of claim 15, further comprising a pharmaceutical composition in the glass syringe barrel.
17. A process for the preparation of a glass syringe barrel, comprising: providing a glass syringe barrel precursor having a longitudinal axis, the glass syringe barrel precursor comprising a body region with a bottom end and a top end; heating the top end, while rotating the glass syringe barrel precursor around the longitudinal axis, to prepare a ring of molten glass at the top end and forming a flange region by pushing the ring of molten glass out beyond an edge of the body region at the top end; and shaping, while the glass syringe barrel precursor is rotating around the longitudinal axis, the flange region to obtain a bottom side with a first outer contour and a top side with a second outer contour, wherein the bottom side is shaped by contact with a shaping tool.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0109] FIG. 1 shows a cross-sectional view of a nest 200 holding glass syringe barrels 100;
[0110] FIG. 2 shows a cross-sectional enlarged view a syringe barrel 100 according to the present invention;
[0111] FIG. 3 shows a cross-sectional enlarged view of a part of the flange region 113 in a glass syringe barrel 100 according to the present invention and the determination of the outer contour c1 and c2 by means of functions f(x) and f(x);
[0112] FIG. 4 shows in a further a cross-sectional enlarged view of the shape of a flange region 113 in a glass syringe barrel 100 according to the present invention and the determination of P;
[0113] FIG. 5 shows in a further a cross-sectional enlarged view of the shape of a flange region 113 in a glass syringe barrel 100 according to the present invention and the determination of d and d;
[0114] FIG. 6A shows in a side view the localization of plane 116 that is used to determine the outer contour c1 and c2 in the flange region 113;
[0115] FIG. 6B shows in a top view the localization of plane 116 that is used to determine the outer contour c1 and c2 in the flange region 113;
[0116] FIGS. 7A-7B show a top-view two different shapes of the flange region;
[0117] FIG. 8 shows a cross-sectional enlarged view of a part a syringe according to the present invention into which a plunger 118 has been inserted into the opening at the side of the flange region 113;
[0118] FIG. 9 illustrates step III) of process 1 according to the invention for the preparation of a glass syringe barrel 100.
DETAILED DESCRIPTION
[0119] FIG. 1 shows a cross-sectional view of a nest 200 that is holding a plurality of glass syringe barrels 100. Such a nest 200 is used in automated syringe fill-finish machines, in which a plurality of syringe barrels 100 that are closed at the conus-shaped end by means of appropriate closure systems 124 are filled with a pharmaceutical composition. The nest 200 comprises a plurality of recesses (not visible in FIG. 1) into which the syringe barrels 100 are introduced in such a way that they rest with the lower (first) end 114 on the upper surface of the nest 200.
[0120] FIG. 2 shows a cross-sectional enlarged view a syringe barrel 100 according to the present invention. The syringe barrel 100 has a longitudinal axis L.sub.barrel and comprises a bottom end 101 through which a liquid can be ejected and which is usually shaped in the form of a conus, and a top end 102 into which a plunger stopper 103 (or a plug) can be pushed. The glass syringe barrel 100 comprises in a direction from the bottom end 101 to the top end 102 a cone region 104 having a first end 105 that corresponds to the bottom end 101 of the glass syringe barrel 100 and a second end 106, a shoulder region 107 having a first end 108 that is adjacent to the second end 106 of the cone region 104 and a second end 109, a body region 110 with an outer diameter d.sub.1 having a first end 111 that is adjacent to the second end 109 of the shoulder region 107 and a second end 112, and a flange region 113 which, at least in parts of the flange region 113, is formed in the shape of a plate, the flange region 113 having a first end 114 that is adjacent to the second end 112 of the body region 110 and a second end 115 that corresponds to the top end 102 of the glass syringe barrel 100, wherein the flange region 113 has an outer diameter d.sub.2>d.sub.1. As also shown in FIG. 2, the length of the body region 110 is l.sub.1 and the length of the upper most end on top of the flange region 113 determined at position P.sub.2 to the bottom end (i. e. the lower end of the conically shaped region) is l.sub.2.
[0121] FIG. 3 shows a cross-sectional enlarged view of a part of the flange region 113 in a glass syringe barrel 100 according to the present invention and the determination of the outer contour c1 and c2 by means of functions f(x) and f(x). FIG. 3 just shows the left part of the flange region in a cross-section of the glass syringe barrel 100 that is located in a plane 116 being centrically located in the glass syringe barrel 100 and comprising the longitudinal axis L.sub.barrel of the glass syringe barrel (see FIGS. 6A and 6B). The corresponding part on the right (which is shown in FIGS. 4 and 5) is not shown in FIG. 3. As can be seen in FIG. 3, flange region 113 has an outer diameter d.sub.2>d.sub.1 and is characterized by an outer contour c1 at its first end 114 (dotted lined on the top surface of the flange region 113) and an outer contour c2 at its second end 115 (dashed line on the bottom of the flange region 113). f.sub.o and f.sub.o are straight lines that run vertically to longitudinal axis L.sub.barrel, wherein f.sub.o touches the outer contour c1 at its deepest point P.sub.1 and f.sub.o touches the outer contour c2 at its highest point P.sub.2. As can also be seen in FIG. 3, f(x) defines the absolute value of the vertical distance between any point of the outer contour c1 and straight line f.sub.o at a position x (with f(x)=0 at point P.sub.1), wherein x is the horizontal distance between any given point on straight line f.sub.o and point P.sub.0 at which straight line f.sub.o crosses a line L.sub.1 that runs parallel to longitudinal axis L.sub.barrel and that touches the outer surface of the body region 110. The maximum value for the term f(x) in the range from x=P.sub.0 to x=P.sub.1 is f(x).sub.max determined at position x.sub.max. f(x) defines the absolute value of the vertical distance between any point of the outer contour c2 and straight line f.sub.o at a position x (with f(x)=0 at point P.sub.2), The glass syringe barrel according to the present invention is characterized in that the flange region 113 has a shape such that condition f(x.sub.max)/f(x).sub.max>1 is fulfilled. As can also be seen in FIG. 3, D1 is the distance between point P.sub.1 on the outer contour c1 and a point P.sub.3 on outer contour c2, point P.sub.3 being located vertically above point P.sub.1(=thickness of the flange region at its deepest point). According to a preferred embodiment of the glass syringe barrel according to the present invention condition D.sub.1/D.sub.2<1.5 is fulfilled.
[0122] FIG. 4 shows in a further a cross-sectional enlarged view of the shape of a flange region 113 in a glass syringe barrel 100 according to the present invention and the determination of R. As shown in FIG. 4, L.sub.2 is a straight line at touches the deepest point P.sub.1 of the outer contour c1 on the left side of the flange region 113 (that is also shown in FIG. 3) and the deepest point P.sub.1 of the outer contour c1 on the right side of the flange region 113 (that is not shown in FIG. 3). L.sub.3 is a straight line at touches the outer contour c1 on the left side of the flange region 113 at a position x at which f(x) reaches the maximum value f(x).sub.max and the deepest point P.sub.1 of the outer contour c1 on the right side of the flange region 113. According to a preferred embodiment of the glass syringe barrel according to the present invention condition straight lines L.sub.2 and L.sub.3 enclose an angle of less than 2.5 degree.
[0123] FIG. 5 shows in a further a cross-sectional enlarged view of the shape of a flange region 113 in a glass syringe barrel 100 according to the present invention and the determination of d and d. As shown in FIG. 5, d is the distance between point x.sub.max on the left side of the flange region 113 and point x.sub.max on the right side of the flange region 113 on straight line f.sub.o, x.sub.max and x.sub.max corresponding to the points at which function f(x) reaches its maximum value on the left side and the right side of the flange region 113, respectively. According to a preferred embodiment of the glass syringe barrel according to the present invention d is in the range from 9 to 14 mm. As can also be seen in FIG. 5, d is the distance between point P.sub.1 on the left side of the flange region 113 and point P.sub.1 on the right side of the flange region 113 on straight line f.sub.o. According to a further preferred embodiment of the glass syringe barrel according to the present invention wherein d is preferably in the range from 8 to 20 mm. According to a further preferred embodiment of the glass syringe barrel according to the present invention, d/d.sub.2 is in the range from 0.8 to 0.95.
[0124] FIGS. 6A and 6B show in a side view and in a top view the localization of plane 116 in the glass syringe barrel 100 that is used to determine the outer contour c1 and c2 in the flange region 113. Plane 116 corresponds to the plane that is centrically located in the glass syringe barrel 100 and that comprises the longitudinal axis L.sub.barrel of the glass syringe barrel 100.
[0125] FIGS. 7A and 7B show a top-view two different shapes of the flange region 113. The flange region 113 shown in FIG. A as a (full) circular shape, whereas the flange region 113 shown in FIG. 7B has been derived from a flange region 113 by cutting off pieces of the flange region 113 on two opposite sides. In case of such cut-flange, plane 116 that is used to determine the outer contour c1 and c2 in the flange region 113 as shown in FIGS. 6A and 6B is located in a plane being centrically located in the glass syringe barrel 100 at a position at which the outer contour of the flange region 113 is circular shaped. Planes 116 that fulfil this requirement are the dotted lines 116a, whereas a plane that does not fulfil this requirement is dashed line 116b.
[0126] FIG. 8 shows a glass syringe barrel 100 according to the present invention with a tip cap 124 attached to the conically shaped side at the lower end and with a plug 118 that is inserted into the open end of the glass syringe barrel 100 at the upper end at which the flange region 113 is located.
[0127] FIG. 9 illustrates step III) of process 1 according to the invention for the preparation of a glass syringe barrel 100. In the process for the preparation of a glass syringe barrel 100 according to the present invention in a first process step a glass syringe barrel precursor 119 is provided having a longitudinal axis L.sub.barrel, the glass syringe barrel precursor 119 comprising a body region 110 with a bottom end and a top end, the body region 100 preferably having an outer diameter d.sub.1. In a particular embodiment of the process according to the present invention, the bottom end is already shaped in the form of a conus to obtain the cone region 104 as shown in FIG. 2. In a further process step the top end 120 of the body region 110, while rotating the glass syringe barrel precursor 119 around its longitudinal axis L.sub.barrel, is heated to prepare a ring of molten glass 121 at the top end, wherein heating is preferably accomplished by means of flames from a gas burner that are directed onto the top surface 115 of the glass syringe barrel precursor 119 to obtain a molten ring of glass 121. A flange region 113 is formed by pushing the glass mass 121 out beyond the edge of the body region 110 at the top end of the glass syringe barrel precursor 119. In process step III) of the process according to the present invention (shown in FIG. 9), the thus obtained flange region 113 is finally shaped to obtain a bottom side 114 having an outer contour c1 and a top side 115 having an outer contour c2. As shown in FIG. 9, the final shape on the bottom side 114 of the flange region 113 is prepared by bringing the mass of molten glass 121 into contact with a shaping tool 122 in such a way that the shaping tool 122 somehow lifts the mass of glass 121 upwards, thereby reducing the deepest indentation on the lower side of the flange region 113 (f(x).sub.max). At the same time, the top side 115 of the flange region 113 is cooled by means of an air stream 123 (applied in an angle of approximately 50) that primarily serves to cool down the surface of the flange region 113 on the top side 115, thereby stabilizing the shape of the flange region 113 on that side.
LIST OF REFERENCE NUMERALS
[0128] 100 glass syringe barrel according to the invention [0129] 101 bottom end [0130] 102 top end [0131] 103 plunger stopper [0132] 104 cone region [0133] 105 first end of the cone region 104 (=bottom end 101) [0134] 106 second end of the cone region 104 (=first end 108 of the shoulder region 107) [0135] 107 shoulder region [0136] 108 first end of the shoulder region 107 (=second end 106 of the cone region 104) [0137] 109 second end of the shoulder region 107 (=first end 111 of the body region 110) [0138] 110 body region [0139] 111 first end of the body region 110 (=second end 109 of the shoulder region 107) [0140] 112 second end of the body region 110 (=first end 114 of the flange region 113) [0141] 113 flange region [0142] 114 first end (bottom side) of the flange region 113 (=the second end 112 of the body region 110) [0143] 115 second end (top side) of the flange region 113 (=top end 102) [0144] 116 cross-sectional plane in the middle of the glass syringe barrel 100 [0145] 117 a tangent that touches outer contour c2 at position x.sub.max [0146] 118 plug [0147] 119 glass syringe barrel precursor [0148] 120 top end of glass syringe barrel precursor 119 [0149] 121 ring of molten glass [0150] 122 shaping tool [0151] 123 gas stream [0152] 124 tip cap
