Abstract
A container for accommodating pharmaceutical compositions, which is installable in a medical device, is provided. The container includes a hollow cylindrical body having an open end and a dead end opposite to the open end. The dead end is closed by a bottom portion. The hollow cylindrical body and the bottom portion are formed integrally and of the same material. The bottom portion transitions into the hollow cylindrical body via a curved heel that is defined by an outer radius r.sub.o, an inner radius r.sub.i and a thickness d.sub.h in a center portion of the curved heel, wherein the following condition is fulfilled: r.sub.i+d.sub.hr.sub.o>0 mm.
Claims
1. A container for accommodating pharmaceutical compositions, the container comprising: a hollow cylindrical body having an open end and a dead end opposite to the open end, the open end being configured to receive a plunger that is slidable relative to the hollow cylindrical body from the open end towards the dead end; a bottom portion closing the dead end, the hollow cylindrical body and the bottom portion being formed integrally and of a common material, the common material comprises glass or polymer a curved heel between the bottom portion and the hollow cylindrical body, wherein the curved heel is defined by an outer radius (r.sub.o) in mm, an inner radius (r.sub.i) in mm, and a thickness (d.sub.h) in mm in a center portion of the curved heel, and wherein the curved heel fulfills: r.sub.i+d.sub.hr.sub.o>0 mm.
2. The container of claim 1, wherein the hollow cylindrical body has a length (L) in mm, an outer diameter (D.sub.O) in mm, an inner diameter (D.sub.I) in mm, a difference (D) between the outer diameter (D.sub.O) and the inner diameter (D.sub.I) in mm, wherein the common material has a tensile strength (Ts) in MPa, and wherein 1.00 MPaA12.00 MPa, where A=DTsL.
3. The container of claim 1, wherein the hollow cylindrical body has a length (L) in mm, an outer diameter (D.sub.o) in mm, an inner diameter (D.sub.I) in mm, a difference (D) between the outer diameter (D.sub.O) and the inner diameter (D.sub.I) in mm, wherein the common material has a Young's modulus (E) in GPa, and wherein 0.10 GPa.B10.00 GPa, where B=DEL.
4. The container of claim 1, further comprising a pressure compliance of at least 0.64 N/mm.sup.2(inner diameter).sup.2.
5. The container of claim 1, wherein the hollow cylindrical body has a wall thickness (d.sub.w) in mm, a length (L) between 35 mm and 120 mm, an outer diameter (D.sub.o) between 8.65 mm and 30 mm, an inner diameter (D.sub.I) between 4.65 mm and 27 mm, and a ratio of the length (L) to the outer diameter (D.sub.O) of between 3:1 and 15:1.
6. The container of claim 1, wherein the hollow cylindrical body has an outer diameter (D.sub.O) in mm, an inner diameter (D.sub.I) in mm, and a length (L) in mm, wherein the outer diameter (D.sub.O) and/or the inner diameter (D.sub.I) varies not more than 5% over the length (L).
7. The container of claim 1, further comprising a burst pressure of at least 110% compared to an identical container with a curved heel that does not fulfill r.sub.i+d.sub.hr.sub.o>0 mm.
8. The container of claim 1, further comprising a vertical load strength of at least 110% compared to an identical container with a curved heel that does not fulfill r.sub.i+d.sub.hr.sub.o>0 mm.
9. The container of claim 1, wherein the hollow cylindrical body has a wall thickness (d.sub.w) in mm, and wherein one or more of the following conditions is/are fulfilled: d.sub.h.sup.3(r.sub.od.sub.w)>0.8 mm, [100(d.sub.h.sup.3 r.sub.i)(d.sub.wD.sub.O.sup.2)]+(4.4 mm.sup.2D.sub.O)>0.55 mm, and r.sub.i>0.7 mm.
10. The container of claim 1, wherein the bottom portion is a circular bottom having a minimum thickness (d.sub.b,min), and wherein d.sub.hd.sub.b,min<3.0.
11. The container of claim 1, wherein the common material is selected from a group consisting of borosilicate glass, alumino-silicate glass, soda lime glass, and a fused silica.
12. The container of claim 1, wherein the common material is cycloolefin copolymer or cycloolefin polymer.
13. The container of claim 1, further comprising an inner surface having an average Zn-leachability of 0.00085 g/cm.sup.2 or less.
14. The container of claim 1, further comprising an inner surface having an average Zn-leachability of 0.00055 g/mm.sup.2 or less.
15. A container assembly for accommodating pharmaceutical compositions, the container assembly comprising: a plunger configured to be pierceable by a cannula; a hollow cylindrical body having an open end and a dead end opposite to the open end, the open end receiving the plunger at the open end so as to sealingly close the open end, the plunger being slidable relative to the hollow cylindrical body from the open end towards the dead end; a bottom portion closing the dead end, the hollow cylindrical body and the bottom portion being formed integrally and of a common material, the common material comprises glass or polymer a curved heel between the bottom portion and the hollow cylindrical body, wherein the curved heel is defined by an outer radius (r.sub.o) in mm, an inner radius (r.sub.i) in mm, and a thickness (d.sub.h) in mm in a center portion of the curved heel, and wherein the curved heel fulfills: r.sub.i+d.sub.hr.sub.o>0 mm.
16. The container assembly of claim 15, further comprising a burst pressure of at least 110% compared to an identical container with a curved heel that does not fulfill r.sub.i+d.sub.hr.sub.o>0 mm.
17. The container of claim 15, further comprising a vertical load strength of at least 110% compared to an identical container with a curved heel that does not fulfill r.sub.i+d.sub.hr.sub.o>0 mm.
18. The container assembly of claim 15, wherein the hollow cylindrical body has a length (L) in mm, an outer diameter (D.sub.O) in mm, an inner diameter (D.sub.I) in mm, a difference (D) between the outer diameter (D.sub.O) and the inner diameter (D.sub.I) in mm, wherein the common material has a tensile strength (Ts) in MPa and a Young's modulus (E) in GPa, wherein 1.00 MPaA12.00 MPa, where A=DTsL, and/or wherein 0.10 GPa.B10.00 GPa, where B=DEL.
19. The container assembly of claim 15, further comprising a pharmaceutical composition in the hollow cylindrical body.
20. A medical device for expelling or injecting pharmaceutical compositions, comprising: the container assembly of claim 19; a cannula for expelling the pharmaceutical composition from the container assembly through the cannula, wherein the cannula is arranged so as to pierce the plunger upon actuation, and an actuation mechanism configured to move the container and the plunger relative to each other in a substantially axial direction to apply pressure to the pharmaceutical composition accommodated in the container for expelling the pharmaceutical composition through the cannula.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0089] For a better understanding of embodiments of the invention and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings in which like numerals designate corresponding elements or sections throughout.
[0090] In the accompanying drawings:
[0091] FIG. 1 shows a schematic cross sectional view of a common prior art container assembly.
[0092] FIG. 2 shows a schematic cross sectional view of a curved heel of a common prior art container.
[0093] FIG. 3 shows a schematic cross sectional view of a container assembly according to the present invention.
[0094] FIG. 4 shows a schematic cross sectional view of a medical device according to the present invention comprising the container assembly of FIG. 2.
[0095] FIG. 5 shows a cross sectional view of a container according to the invention, wherein for the purpose of an improved illustration the parts of the container have been separated from each other.
[0096] FIG. 6A shows a schematic depiction of the bottom portion of the container.
[0097] FIG. 6B shows a top view of the bottom portion of the container.
[0098] FIG. 6C shows a cross sectional view of the bottom portion of the container.
[0099] FIG. 7 shows a cross sectional view of a further container according to the invention.
[0100] FIG. 8 shows an enlarged cross sectional view of the curved heel of a container according to the invention.
[0101] FIG. 9 shows an enlarged cross sectional view of a further embodiment of the curved heel of a container according to the invention.
[0102] FIG. 10A shows in a side view the localization of plane that is used to determine r.sub.o, r.sub.i, and d.sub.h by means of the approaches that are shown in FIGS. 11A, 11B, 11C, 12A and 12B.
[0103] FIG. 10B shows in a top view the localization of plane that is used to determine r.sub.o, r.sub.i and d.sub.h by means of the approaches that are shown in FIGS. 11A, 11B, 11C, 12A and 12B.
[0104] FIG. 11A illustrates the determination of d.sub.h in a curved heel.
[0105] FIGS. 11B-11C show different shapes of the exterior surface of a curved heel.
[0106] FIG. 12A illustrates the determination of r.sub.o in a curved heel.
[0107] FIG. 12B illustrates the determination of r.sub.i in a curved heel.
[0108] FIG. 13A illustrates steps I), II) and III) of a process for the preparation of a glass container according to the invention.
[0109] FIG. 13B illustrates step IV) of the process for the preparation of a glass container according to the invention.
[0110] FIG. 14A illustrates a sub-step in the formation of the shape of the curved heel according to the present invention.
[0111] FIG. 14B illustrates a further sub-step in the formation of the shape of the curved heel according to the present invention.
[0112] FIG. 15 shows a flow chart of another process for packaging a pharmaceutical composition in a container assembly according to the invention.
DETAILED DESCRIPTION
[0113] Examples of embodiments of the present invention will be explained in more detail by virtue of the following embodiments illustrated in the figures and/or described below.
[0114] FIG. 1 shows a container assembly 10 commonly known from the prior art. The container assembly 10 comprises a container 12 having a body portion with an open end 14 and a closed end 16 opposite to the open end 14. In the region of the closed end 16, the body portion comprises a neck portion 18 with a reduced diameter and an adjacent flange portion, wherein the flange portion is closed by a metal crimp 20. The container assembly 10 further comprises a plunger 22 that is slidably arranged inside the body portion via the open end 14.
[0115] A pharmaceutical composition P is accommodated in the hollow body portion of the container 12. For expelling or dispensing the pharmaceutical composition P from the container 12, a plunger actuation 24 (relative to the container 12) and a fluidic connection 26 are provided on opposite sides of the container assembly 10. Upon actuation, the plunger actuation 24 acts on the container assembly 10 and causes expelling of the pharmaceutical composition P via the opposite fluidic connection 26. The plunger actuation 24 and the fluidic connection 26 are components of a corresponding medical device (not shown in FIG. 1) and are therefore only schematically illustrated by the arrows 24, 26. The fluidic connection 26 is usually a cannula that before or upon actuation of the medical device pierces through the crimp 20 and a subjacent rubber seal (not shown), which rubber seal is arranged between the crimp 20 and the accommodated pharmaceutical composition P. The container assembly 10 is installable in the corresponding medical device which is therefore designed in accordance with and dependent on the design and configuration of the container assembly 10.
[0116] FIG. 2 shows a cross-sectional view of a curved heel 15 of a common prior art container, which can be a curved glass heel. FIG. 2 illustrates the characterization of such a curved heel 15 by means of the inner radius r.sub.i, the outer radius r.sub.o and the thickness of the material d.sub.h in the curved heel 15. In an ordinary glass container of the prior art as shown in FIG. 2, in which a bottom portion (not shown in FIG. 2) has been prepared by simply bending over the heat softened areas of a mother tube and in which no particular measures have been taken to shape the form of the curved heel 15, the circle defined by inner radius r.sub.i and the circle defined by outer radius r.sub.o are located concentric to one another. Under these circumstances, in common prior art containers condition r.sub.o=r.sub.i+d.sub.h is fulfilled. However, according to the present invention the resistance of a container towards axial loads and the burst pressure can be improved if a curved heel is formed deviant from the heel structure of prior art containers.
[0117] FIG. 3 a schematic cross sectional view of a container assembly 50 according to an exemplary embodiment of the present invention. The container assembly 50 comprises container 100 having a hollow cylindrical body 101 with an open end 103 and a dead end 102 opposite to the open end 103. The cylindrical shape, i.e. the outer diameter D.sub.o and the inner diameter D.sub.I, of the hollow cylindrical body 101 is substantially constant over the entire length of the hollow cylindrical body 101 and does not comprise any taper or neck portion. The container assembly 50 further comprises a rubber plunger 60. The rubber plunger 60 is received via the open end 103 in the container 100 and is slidable relative to the hollow cylindrical body 101 from the open end 103 towards the dead end 102.
[0118] The dead end 102 is closed by a bottom portion 104 which is formed integrally with and of the same material as the hollow cylindrical body 101, i.e. as the lateral surface (shell surface) of the container 100. In the present example, the container 100, more precisely the hollow cylindrical body 101 and the bottom portion 104 are made of glass, e.g. borosilicate glass. Alternatively, in other embodiments the container 100 can be made of a polymer. The inner surface of the container 100 has an average Zn-leachability of 0.00085 g/cm.sup.2 or less.
[0119] In the example shown in FIG. 3, the hollow cylindrical body 101 of the container 100 has a length L of 45 mm, an outer diameter D.sub.o of 15 mm and an inner diameter D.sub.I of 12 mm, with a length to outer diameter ratio of 3:1. Alternatively, in other embodiments the container 100 may have a length between 35 mm and 120 mm, preferably between 42 and 70 mm, an outer diameter between 6.85 mm and 30 mm, preferably between 8.65 and 22.05mm, and/or an inner diameter between 4.65 mm and 27 mm, preferably between 6.85 mm and 19.05 mm, with a length to diameter ratio between 3:1 and 15:1, preferably between 3:1 and 12:1, preferably between 3:1 and 10:1, more preferably between 3:1 and 7:1, more preferably between 4:1 and 7:1, more preferably between 5:1 and 7:1 and more preferably between 6:1 and 7:1.
[0120] A pharmaceutical composition P is accommodated in the hollow cylindrical body 101 of the container 100. For expelling or dispensing the pharmaceutical composition P from the container 100, both a plunger actuation 140 (relative to the container 100) and a fluidic connection 160 are realized on the same side of the container 100, i.e. at the open end 103 of the container 100. The plunger actuation 140 and the fluidic connection 160 are components of a corresponding medical device (shown in FIG. 4) and are therefore only schematically illustrated by the arrows 140, 160 in FIG. 3. The fluidic connection 160 can be a cannula that upon actuation of the medical device pierces through the rubber plunger 60. Further, upon and during actuation, the container 100 is moved axially relative to the plunger 60 and the fluidic connection 160.
[0121] By providing the container 100 with a dead end 102 in contrast to the prior art crimp assembly, the neck portion, the flange, the rubber seal and the crimp can be omitted. Thus, the container 100 comprises less components than the prior art assembly and has a more compact size and shape. The dashed area A shown in FIG. 3 represents the overall volume reduction in a corresponding medical device that can be gained by the container 100 according to the present invention compared to the prior art crimp-type container.
[0122] The container assembly 50 is installable in a medical device. A medical device 200 according to an exemplary embodiment of the present invention is schematically shown in FIG. 4. The medical device 200 comprises a hollow device body 202 (a device housing), in which the container assembly 50 and further components of the medical device 200 are housed. Same reference signs are used throughout the figures for the same or mutually corresponding elements and features.
[0123] As shown in FIG. 4 the fluidic connection 160 is a cannula that pierces through the plunger 60 and extends with a first end 160A into the hollow cylindrical body 101 of the container 100. An opposite second end of the cannula 160 is fluidically connected to a tube 204 for expelling the pharmaceutical composition P accommodated in the container 100 via the cannula 160 and the tube 204. The tube 204 can be fluidically connected to further components of the medical device 200 or a connected device.
[0124] In the example of FIG. 4, the plunger actuation 140 relative to the container 100, more precisely the movement of the container 100 relative to the plunger 60 is realized by the actuation mechanism 206. The actuation mechanism 206 comprises a spring 208, which in an initial position (unactuated state) is preloaded. The actuation mechanism 206 further comprises a trigger 210. Upon actuation of the medical device 200 by operating the trigger 210, the spring 208 applies force to and thus moves the container 100 relative to the plunger 60 and relative to the cannula 160. The plunger 60 and the cannula 160 maintain stationary during actuation and use of the medical device 200. By moving the container 100 relative to the stationary plunger 60, the plunger 60 applies pressure to the accommodated pharmaceutical composition P, which is thus expelled via the cannula 160 and the fluidically connected tube 204.
[0125] FIG. 5 shows a cross-sectional view of the container 100 according to the invention. In the shown example, the container 100 is a glass container. For the purpose of an improved illustration the individual parts of the container 100 (i. e. the hollow cylindrical body 101, the bottom portion 104 and the curved heel 105) have been illustrated separate from each other, even though these components are formed integrally. However, as the container 100 according to the invention is preferably obtained by a process in which a mother tube (which forms the hollow cylindrical body 101), while rotating around its major axis, is heated to its softening point with flames, in which the heated glass is pulled along its major axis for stretching and creating a container dead end and in which the container dead end has been shaped to form a bottom portion 104 and a curved heel 105, these parts are integrally connected in the container 100 according to the present invention. As shown in FIG. 5, the hollow cylindrical body 101 is characterized by the dead end 102 and the opposite open end 103. The bottom portion 104 comprises an outer region 106 that in the container 100 is connected to the curved heel 105. The bottom portion 104 is characterized by a thickness in the centre d.sub.cgb of the bottom portion 104, whereas the hollow cylindrical body 101 is characterized by a wall thickness d.sub.w.
[0126] FIG. 6 shows the bottom portion 104 from different perspectives, wherein in the shown example the bottom portion 104 is a circular glass bottom. FIG. 6A shows a schematic depiction of the bottom portion 104 and the outer region 106 of the bottom portion that in the container 100 according to the invention merges into the curved glass heel 105 (which then merges into the dead end 102 of the hollow cylindrical body 101). FIG. 6B shows a top view of the bottom portion 104 with the centre 107. FIG. 6C shows a cross-sectional view of the circular bottom portion 104. As shown in this figure, the thickness of the material in the bottom portion 104 can vary with the area from the centre 107 towards the outer region 106. In the bottom portion 104 shown in FIG. 6C the thickness reaches its lowest point d.sub.b,min at the centre 107 of the bottom portion 104. As a consequence of the above described nature of the process of forming a bottom portion 104 and the curved heel 105 from a mother tube 101 the exterior surface of the bottom portion is not necessarily flat, but often has a concave indentation 108 as shown in FIG. 6C.
[0127] FIG. 7 shows a cross sectional view of the container 100. The hollow cylindrical body 101 of the container 100 has an inner diameter D.sub.I and an outer diameter D.sub.o, wherein D.sub.o>D.sub.I. The dotted circles at the bottom show the curved heel 105 of the container 100. The section covered by the dotted circles is shown in an enlarged view in FIG. 8. The circular bottom portion 104 is characterized by a bottom diameter D.sub.bottom, wherein D.sub.bottom=D.sub.O2r.sub.o (D.sub.O corresponds to the outer diameter of the hollow cylindrical body 101 and r.sub.o is the outer radius of the curved heel 105 measured by means of the approach shown in FIG. 12A).
[0128] FIG. 8 shows an enlarged view of the curved heel 105 of container 100 according to the invention, in which the inner and outer contour of the heel 105 are substantially arc-shaped. As can be seen, the structure of the curved heel 105 deviates from the structure of the heel in prior art containers as shown in FIG. 2. In the configuration of the embodiment according to the invention, the thickness dh of the material in the area of the curved heel 105 has been increased and the outer radius r.sub.o has been reduced to ensure that a certain minimum value for the term d.sub.h.sup.3/(r.sub.od.sub.w) is reached. Furthermore, the inner radius r.sub.i also has been increased.
[0129] FIG. 9 shows an enlarged view of a further curved heel 105 in a container 100 embodiment according to the invention, in which the inner and outer contour of the heel 105 are substantially arc-shaped, but in whichcontrary to the curved heel shown in FIG. 8the length of the circular arc at the outer surface of the curved heel is smaller than 2r.sub.o/4. In this case r.sub.o does not correspond to the outer radius of the curved heel, but to width of the material overhang in the area of the curved heel that is defined by the distance between points C and D (for the determination of r.sub.o see again FIG. 12A).
[0130] FIGS. 10A and 10B show in a side view and in a top view the localization of plane 113 in the container 100 that is used to determined r.sub.o, r.sub.i and d.sub.h by means of the approaches that are shown in FIGS. 11A, 11B, 11C, 12A and 12B. Plane 113 corresponds to the plane that is centrically located in the container 100 and that comprises the longitudinal axis of the container (indicated by the dashed line in FIG. 10A), i. e. the axis that goes perpendicular through the centre 107 of the bottom (see FIG. 10B).
[0131] FIG. 11A illustrates the determination of dh in a curved heel 105 in plane 113. For the determination of d.sub.h a tangent 116 that confines an angle of 45 with the ground-level bearing surface 115 is placed at the exterior surface of the curved heel 105. The point of the exterior surface of the curved heel 105 that comes into contact with the 45-tangent 116 is designated as A (see the lower circle in FIG. 11A). Next, a straight line 117 orthogonal to 45-tangent 116 is guided through point A. The position at which this straight orthogonal line 117 breaks through the interior side of the curved heel 105 is designated as B (see the upper circle FIG. 11A). d.sub.h corresponds to the distance between points A and B.
[0132] FIGS. 11B-11C show curved heels 105 having a shape such that there are more than only one point of exterior surface of the curved heel 105 that comes into contact with the 45-tangent 116. In such a case point A corresponds to the point that is nearest to the outer surface of hollow cylindrical body 101 of the container 100.
[0133] FIG. 12A illustrates the determination of r.sub.o in a curved heel 105 in plane 113. For the determination of r.sub.o the intersection point of a first straight line 118 that forms an elongation of the exterior side of the hollow cylindrical body 101 and the ground-level bearing surface 115 is determined. This intersection point is designated as C (see the left circle in FIG. 12A). Next, the point of the exterior surface of the container 100 that contacts the ground-level bearing surface 115 and that is closest to point C is determined. This intersection point is designated as D (see the right circle in FIG. 12A). r.sub.o corresponds to the distance between points C and D.
[0134] FIG. 12B illustrates the determination of r.sub.i in a curved heel 105 in plane 113. For the determination of r.sub.i a tangent 119 that confines and angle of 45 with the ground-level bearing surface 115 is placed at the interior surface of the curved heel 105. The point of the interior surface of the curved heel 105 that comes into contact with the 45-tangent 119 is designated as E (see the small circle in FIG. 12B). Next, the largest quarter circle 120 is determined that can be properly positioned on the inner contour of the curved heel 105, that comprises point E in the middle of the quarter circle and the ends of which do not extend into the mass of glass. r.sub.i corresponds to the radius of the largest quarter circle 120
[0135] If there are more than only one point of interior surface of the curved heel 105 that comes into contact with the 45-tangent 119, point E corresponds to the geometric centre between points P1 and P2, wherein point P1 is the point on the 45-tangent 119 that comes into contact with the interior surface of the curved heel and that is located nearest to the hollow cylindrical body 101 and point P2 is the point on the 45-tangent 119 that comes into contact with the interior surface of the curved heel 105 and that is located nearest to the bottom portion 104.
[0136] FIG. 13 illustrates a first process for the preparation of a glass container 100 according to the invention. FIG. 13A illustrates process steps I), II) and III), wherein in process step I) a glass tube 101 with a first 102 and a further end 103 is provided, the glass tube having a wall thickness of d.sub.w (not shown in FIG. 13A). In process step II), the glass tube is heated, while rotating around its major axis, to its softening point with a heating element (indicated by the candle flames shown on the left in FIG. 13A), preferably with a flame 122. In process step III) the heated glass tube is pulled along its major axis for stretching as shown on the right in FIG. 13A, thereby creating a container closure 123. In process step IV), depicted in FIG. 13B, container closure 123 is shaped to form a glass bottom portion 104 and a curved glass heel 105 (not shown in FIG. 13B) via which the glass bottom portion 104 is connected to the glass tube/the hollow cylindrical body portion 101.
[0137] FIG. 14A illustrates a sub-step in the formation of the desired shape of the curved glass heel 105 in glass container 100 according to the present invention. For the formation of the desired shape of the curved glass heel 105 a glass container 100 that is fixed in an fixing element 126 of a rotary machine and that is continuously rotated around its longitudinal axis as shown in FIG. 14A is brought in an upward position with the glass bottom showing to the top. In a first sub-step, the glass bottom is heated with a burner 122 in which the peripheral zone (as indicated by the arrows at the top of FIG. 14A) is heated to a larger extend compared to the middle section so that the area in the peripheral zone of the glass bottom 104 (i.e. in an area indicated by the circles in FIG. 14A that comprises the curved glass heel and the part of the hollow cylindrical body 101 that is in contact with the curved glass heel 105) are particularly heated. As a result, a melting of the bottom portion 104 even into the wall of the hitherto hollow cylindrical body 101 occurs so that the glass contracts slightly under the surface tension and the bottom slightly sinks (see l in FIG. 14A). This leads to an increased accumulation of glass in the peripheral zone 127 of the bottom portion 104 (indicated by the circles in FIG. 14A), compared to a prior art process in which the surface of the glass floor is heated evenly and only to such a degree as necessary to enable bottom forming. The additional mass of glass in the peripheral zone 127 of the glass bottom 104 thus arises from the hitherto cylindrical wall of the hollow cylindrical body 101 which is adjacent to the curved heel 105.
[0138] FIG. 14B illustrates a further sub-step in the formation of the shape of the curved glass heel 105 in the glass container 100 according to the present invention. In this sub-step the glass container 100 is still continuously rotated around its longitudinal axis and the glass bottom 101 is concavely pushed inward by a die 124, while at the same time an air flow from below pushes the bottom portion 104 of the container 100 against the die 124 so that it does not sink under gravity. At the same time a molding roller 125 is provided which predetermines the outer shape of the curved glass heel 105 and which prevents the glass mass accumulated in the peripheral zone 127 from escaping to the outside. Simultaneously, the air flow and the die 124 cause the bottom portion 104 and the peripheral zone 127 to cool down quickly until it these areas are no longer shapeable.
[0139] FIG. 15 shows a flow chart of a process 300 for packaging a pharmaceutical composition. In a process step a) 301, the container 100 according to one of the embodiments of the invention is provided. In a process step b) 302, a pharmaceutical composition is filled into the interior volume V.sub.i of the container 100, and in a process step c) 303 the open end 103 of the container 100 is closed by a plunger 60.
TABLE-US-00004 LIST OF REFERENCE SIGNS P pharmaceutical composition L length 50 container assembly D.sub.O outer diameter 60 plunger D.sub.I inner diameter 100 container D.sub.bottom bottom diameter 101 hollow cylindrical body r.sub.O outer radius of curved heel 102 dead end 103 open end r.sub.I inner radius of curved heel 104 bottom portion 105 curved heel d.sub.W wall thickness 106 outer region of the bottom portion d.sub.h thickness in the center of curved heel 107 center of the bottom portion 108 concave indentation l.sub.O length of circular arc 113 plane d.sub.cgb thickness at center of the bottom 115 ground-level bearing surface 116 45-tangent at the exterior surface of the d.sub.b, min minimum thickness of the bottom curved heel 200 medical device 117 straight line orthogonal to 45-tangent 202 hollow device body (device housing) 118 straight line forming an elongation of the 204 tube hollow cylindrical body 206 actuation mechanism 119 45-tangent at the interior surface of the 208 spring curved heel 210 trigger 120 largest quarter circle 300 process 122 heating element, preferably a flame 301 process step a) 123 container closure 302 process step b) 124 die 303 process step c) 125 molding roller 10 container assembly (prior art) 126 fixing element of a rotary machine 127 peripheral zone of the bottom in which 12 container (prior art) material accumulates 14 open end (prior art) 140 plunger actuation 14 curved heel (prior art) 160 fluidic connection (cannula) 16 closed end (prior art) 160A first end of the cannula 18 neck portion (prior art) 160B second end of the cannula 20 crimp (prior art) A overall volume reduction 22 plunger (prior art) 24 plunger actuation (prior art) 26 fluidic connection (prior art)
