Glass syringe barrels with increased cone rupture force
By designing a glass syringe barrel with specific curvature and forming, the problem of susceptibility to mechanical stress in the prior art is solved, the stability and mechanical strength of the Luer joint connection are improved, and the pressure resistance of the glass syringe barrel is enhanced.
Patent Information
- Application Number
- CN202010802234.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-08-12
- Filing Date
- 2020-08-11
- Publication Date
- 2025-08-29
- Estimated Expiration
- 2040-08-11
AI Technical Summary
Existing glass syringe barrels are susceptible to mechanical stress in the tapered area, especially during the connection and use of Luer joints, resulting in insufficient strength of the glass syringe barrel.
A glass syringe barrel is designed, including at least partially conical upper portion, prepared by forming and separating precast glass tubes, a specific curvature design of the tapered area and shoulder area, increasing the pressure resistance of the tapered area and in certain embodiments roughening or coating treatment on the outer surface to enhance strength.
The pressure resistance of the glass syringe barrel in the conical area is improved, the stability of the Luer joint connection and the mechanical strength during use are enhanced, and additional processing steps are avoided.
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Figure CN112386767B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a glass syringe barrel having an at least partially conical upper portion and having a longitudinal axis L barrel The glass syringe barrel can include a top end through which liquid is ejected and a bottom end into which a plunger stopper can be pushed. The glass syringe barrel can include, from the top end to the bottom end, 1) a tapered region, 2) a shoulder region, and 3) a body region. The present invention also relates to a plurality of glass syringe barrels and syringes including the glass syringe barrels. Background Art
[0002] To ensure the reliable use of pharmaceutical products, prefilled disposable syringes are commercially available. These syringes allow for rapid injection of the product they contain through relatively simple handling or processing. These prefilled syringes have a syringe barrel made of glass or polymer, with a syringe tip formed thereon. The syringe needle is integrated into the barrel, or the barrel has a Luer connection cone with a tapered connector, optionally with a lockable tapered connector (Luer lock). A gripping plate is attached to the other open end of the syringe barrel. This gripping plate can be integral with the syringe barrel or attached as a separate component. An elastic piston stop slides through the open end of the syringe barrel. The piston stop has a threaded blind hole into which, in various embodiments, a piston rod with a threaded front end can be screwed. The standard DIN ISO 11040 describes these disposable syringes, also known as prefabricated syringes, which have a syringe barrel made of glass. For example, this syringe barrel is described in Section 4. Section 5 describes a standard elastomeric piston stop and a standard piston rod made of a polymer with a cross-shaped cross section.
[0003] There are two types of Luer tapers: locking and slip. "Luer lock" fittings are often called "Luer locks," while "Luer slips" are often called "slip tips." Luer lock fittings are securely connected via a boss on the female fitting that screws into threads in a sleeve on the male fitting. Slip tip (Luer slip) fittings are simply conformed to the Luer taper and pressed together, remaining in place by friction (they lack threads). Glass syringes designed for Luer lock fittings are typically characterized by an at least partially conical upper portion, over which the Luer assembly is pushed, followed by a constriction. The diameter of this constriction is smaller than that of the tapered portion. The reduction in diameter in the constriction creates a notch around the conical upper portion, allowing the Luer lock adapter (a plastic sleeve containing threads) to "snap in" and thus securely hold the components to the syringe.
[0004] In glass syringe barrels that include a Luer lock or Luer slip fitting, the outer diameter of the conical upper portion is only about 4 mm, and the wall thickness of the glass in the tapered region is only about 1 to 2 mm. Consequently, such glass syringe barrels are very susceptible to mechanical stresses in the tapered region. Mechanical stresses include, for example, those generated when a Luer adapter is attached to the conical upper portion and when a needle in a Luer adapter attached to the Luer cone is inserted into human or animal tissue as part of the intended use of such a syringe, or when such a glass syringe barrel is shipped in a packaging unit containing a large number of syringes packaged in a confined space. Summary of the Invention
[0005] In general, the object of the present invention is to at least partially overcome the disadvantages arising from the prior art. Another object of the present invention is to provide a glass syringe barrel comprising an at least partially conical upper part, in particular a Luer taper designed for a Luer lock connector or a Luer slip connector, which has an improved resistance to pressure applied to the tapered area of the glass syringe barrel compared to similar glass syringe barrels known in the prior art. Another object of the present invention is to provide a glass syringe barrel comprising an at least partially conical upper part, in particular a Luer connector designed for a Luer lock connector or a Luer slip connector, which has an improved resistance to pressure applied to the tapered area of the glass syringe barrel compared to similar glass syringe barrels known in the prior art. Moreover, the glass syringe barrel has been produced by a method that is as simple as possible, preferably by forming and separating from a prefabricated glass tube. Another object of the present invention is to provide a method for producing a glass syringe barrel comprising an at least partially conical upper portion, in particular a Luer taper designed for a Luer lock or Luer slip connector, which has improved resistance to pressure applied to the tapered region of the glass syringe compared to similar glass syringe barrels known from the prior art. The glass syringe is produced from a prefabricated glass tube by forming and separating, without requiring additional processing steps, such as, for example, modifying the glass surface in the tapered and / or shoulder region or thickening the glass.
[0006] The independent claims contribute to at least partially solving at least one, preferably several, of the above objects. The dependent claims provide preferred embodiments, which contribute to at least partially solving at least one of the objects.
[0007] Embodiment 1 of a glass syringe barrel having an at least partially conical upper portion contributes to solving at least one of the objects according to the present invention. The glass syringe barrel has a longitudinal axis L barrel , and includes a top end through which liquid can be ejected and a bottom end through which a plunger stopper can be pushed in. The glass syringe barrel includes, in a direction from the top end to the bottom end:
[0008] i) a tapered region having a first end and a second end, the first end of the tapered region corresponding to the top end of the glass syringe barrel, wherein the tapered region has a length l1 and an outer diameter d1 at its second end;
[0009] iii) a shoulder region having a first end and a second end, the first end of the shoulder region being adjacent to the second end of the tapered region, wherein an outer profile of the shoulder region comprises a concave and substantially arc-shaped region c1 starting below the second end of the tapered region, and a convex and substantially arc-shaped region c2 starting above the second end of the shoulder region, the outer radius of region c1 being r1, and the outer radius of region c2 being r2;
[0010] iii) a body region having a first end and a second end, the first end of the body region being adjacent to the second end of the shoulder region, the second end of the body region corresponding to the bottom end of the glass syringe barrel, wherein the body region has an outer diameter d2 and a glass thickness n2;
[0011] Wherein, if the glass syringe barrel is placed with the outer surface of the main body region on a flat horizontal substrate, then in any given cross section of the glass syringe barrel located in the plane, f(x) is defined as the vertical distance between the substrate and the outer surface of the glass syringe barrel at a given position x; the plane is located at the center of the glass syringe barrel and includes the longitudinal axis L of the glass syringe barrel. barrel ,
[0012] Where k(x)=|f”(x) / [1+f'(x) 2 ] 3 / 2 | is defined as the absolute value of the curvature of f(x) at a given location x, and
[0013] where, in the interval between x=P1 and x=P2, for any concave curvature in this interval, (1 / k(x)) / n2 2 The minimum value is at least 0.5mm -1 , preferably at least 0.6 mm -1 , more preferably at least 0.75 mm -1 , even more preferably at least 0.85 mm -1 , most preferably at least 1.0 mm -1 Wherein, P1 is defined as the x position where the outer diameter of the glass syringe barrel is 0.95×d2, and P2 is P1+3×n2.
[0014] The embodiment 1 of a plurality of glass syringe barrels 1 also contributes to solving at least one of the objects according to the present invention. Each glass syringe barrel has an upper portion that is at least partially conical, and each glass syringe barrel has a longitudinal axis L barrel and includes a top end through which liquid can be ejected and a bottom end through which a plunger stopper can be pushed in. Each glass syringe barrel includes, in a direction from the top end to the bottom end:
[0015] i) a tapered region having a first end and a second end, the first end of the tapered region corresponding to the top end of the glass syringe barrel, wherein the tapered region has a length l1 and an outer diameter d1 at its second end;
[0016] ii) a shoulder region having a first end and a second end, the first end of the shoulder region being adjacent to the second end of the tapered region, wherein an outer profile of the shoulder region includes a concave and substantially arc-shaped region c1 starting below the second end of the tapered region, and a convex and substantially arc-shaped region c2 starting above the second end of the shoulder region, the outer radius of region c1 being r1, and the outer radius of region c2 being r2;
[0017] iii) a body region having a first end and a second end, the first end of the body region being adjacent to the second end of the shoulder region, the second end of the body region corresponding to the bottom end of the glass syringe barrel, wherein the body region has an outer diameter d2 and a glass thickness n2;
[0018] Wherein, for at least 75% of the glass syringe barrels included in the plurality of glass syringe barrels 1, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels meets the following conditions:
[0019] Wherein, if the glass syringe barrel is placed on a planar horizontal substrate having the outer surface of the main body region thereon, then in any given cross-section of the glass syringe barrel located in a plane, f(x) is defined as the vertical distance between the substrate and the outer surface of the glass syringe barrel at a given position x; the plane is located at the center of the glass syringe barrel and includes the longitudinal axis L of the glass syringe barrel barrel ,
[0020] k(x)=|f”(x) / [1+f'(x) 2 ] 3 / 2 | is defined as the absolute value of the curvature of f(x) at a given position x,
[0021] In the interval between x=P1 and x=P2, for any concave curvature in this interval, (1 / k(x)) / n2 2The minimum value is at least 0.5mm -1 , preferably at least 0.6 mm -1 , more preferably at least 0.75 mm -1 , even more preferably at least 0.85 mm -1 , most preferably at least 1.0 mm -1 Wherein, P1 is defined as the x position. At the x position, the outer diameter of the glass syringe barrel is 0.95×d2, and P2 is P1+3×n2.
[0022] The embodiment 1 of a plurality of glass syringe barrels 2 also contributes to solving at least one of the objects according to the present invention. Each glass syringe barrel has an upper portion that is at least partially conical, and each glass syringe barrel has a longitudinal axis L barrel The glass syringe barrel includes a top end through which liquid can be ejected and a bottom end into which a plunger stopper can be pushed. Each glass syringe barrel includes, in a direction from the top end to the bottom end:
[0023] i) a tapered region having a first end and a second end, the first end of the tapered region corresponding to the top end of the glass syringe barrel, and the tapered region having a length l1 and an outer diameter d1 at its second end;
[0024] ii) a shoulder region having a first end and a second end, the first end of the shoulder region being adjacent to the second end of the tapered region, wherein an outer profile of the shoulder region comprises a concave and substantially arc-shaped region c1 starting below the second end of the tapered region, and a convex and substantially arc-shaped region c2 starting above the second end of the shoulder region, the outer radius of region c1 being r1, and the outer radius of region c2 being r2;
[0025] iii) a body region having a first end and a second end, the first end of the body region being adjacent to the second end of the shoulder region, the second end of the body region corresponding to the bottom end of the glass syringe barrel, wherein the body region has an outer diameter d2 and a glass thickness n2.
[0026] in,
[0027] - the glass syringe barrels included in the plurality of glass syringe barrels have a Luer cone rupture resistance of at least 50 N, preferably at least 65 N, more preferably at least 80 N, even more preferably at least 95 N, most preferably at least 110 N at a 1% quantile; and / or,
[0028] - the glass syringe barrels comprised in said plurality of glass syringe barrels have a 50% quantile Luer cone rupture resistance of at least 145 N, preferably at least 175 N, more preferably at least 205 N, even more preferably at least 230 N, most preferably at least 270 N.
[0029] If at least 1% of the glass syringe barrels have a Luer cone rupture resistance less than or equal to 50 N, and if at least 99% of the glass syringe barrels have a Luer cone rupture resistance greater than or equal to 50 N, then the 1% quantile of the plurality of glass syringe barrels has a Luer cone rupture resistance of 50 N. If at least 50% of the glass syringe barrels have a Luer cone rupture resistance less than or equal to 145 N, and if at least 50% of the glass syringe barrels have a Luer cone rupture resistance greater than or equal to 145 N, then the 50% quantile of the plurality of glass syringe barrels has a Luer cone rupture resistance of 145 N.
[0030] In the sense of the present invention, a "plurality of glass syringes" preferably comprises at least 10 glass syringes, preferably at least 25, more preferably at least 50, even more preferably at least 100, even more preferably at least 200, and most preferably at least 400. Furthermore, the plurality of glass syringes is preferably randomly collected and not specifically selected for any property. For example, the plurality of glass syringes may be a set of syringes packed together in a typical shipping pallet.
[0031] In embodiment 2 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to embodiment 1. For the glass syringe barrel 1 or for at least 75% of the glass syringe barrels included in the plurality of glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, in the interval between x=P1 and x=P2, the first derivative f'(x) of f(x) is max The maximum value of is less than 18, even more preferably less than 15, even more preferably less than 10, and most preferably less than 5.
[0032] In embodiment 3 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to embodiment 1 or 2. For the glass syringe barrel 1 or for at least 75% of the glass syringe barrels included in the plurality of glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, r1 is in the range of 0.4 mm to 3 mm, preferably in the range of 0.5 mm to 2.5 mm, more preferably in the range of 0.6 mm to 2 mm, even more preferably in the range of 0.7 mm to 1.8 mm, and most preferably in the range of 0.8 mm to 1.5 mm.
[0033] In embodiment 4 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to any one of embodiments 1 to 3. Wherein, for the glass syringe barrel 1 or for at least 75% of the glass syringe barrels included in the plurality of glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, r2 is in the range of 1.2 mm to 3.1 mm, preferably in the range of 1.4 mm to 2.9 mm, more preferably in the range of 1.6 mm to 2.7 mm, even more preferably in the range of 1.8 mm to 2.5 mm, and most preferably in the range of 2.0 mm to 2.3 mm.
[0034] In embodiment 5 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to any one of embodiments 1 to 4, wherein the glass syringe barrel further comprises a contraction region between the tapered region and the shoulder region. The contraction region has a first end adjacent to the second end of the tapered region, a second end adjacent to the first end of the shoulder region, and an outer contour c3, wherein the length of the contraction region is l1', the minimum outer diameter d1' below the first end of the contraction region is less than d1, and the outer diameter at the second end of the contraction region is d1".
[0035] In embodiment 6 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to embodiment 5, wherein the outer contour c3 of the glass syringe barrel in the contraction area is conical, d1'<d1", and wherein at the second end of the contraction area, c3 merges into c1 without any offset.
[0036] In embodiment 7 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 are designed according to embodiment 6, wherein, in the constriction region, parallel to the longitudinal axis L barrel A first line extending parallel to c3 and a second line extending in the same plane as the first line include an angle γ between them, wherein γ is in the range of 0.3° to 2.5°, preferably in the range of 0.5° to 2.0°, and most preferably in the range of 0.7° to 1.5° for the glass syringe barrel 1 or for at least 75% of the glass syringe barrels included in the plurality of glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably for each of the glass syringe barrels.
[0037] In embodiment 8 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 1 to 7, wherein, for the glass syringe barrel 1 or for at least 75% of the glass syringe barrels included in the multiple glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably for each glass syringe barrel, l1 or the total length l1+l1' in the presence of a contraction area is in the range of 8 mm to 12 mm, preferably in the range of 8.25 mm to 10.5 mm, more preferably in the range of 8.5 mm to 10 mm, even more preferably in the range of 8.6 mm to 9.8 mm, even more preferably in the range of 8.7 mm to 9.6 mm, and most preferably in the range of 9.4 mm to 9.6 mm.
[0038] In embodiment 9 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 5 to 8, wherein, for the glass syringe barrel 1 or for at least 75% of the glass syringe barrels included in the multiple glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, l1' is in the range of 1 mm to 3 mm, preferably in the range of 1.1 mm to 2.5 mm, more preferably in the range of 1.2 mm to 2 mm, even more preferably in the range of 1.3 mm to 1.8 mm, and most preferably in the range of 1.4 mm to 1.6 mm.
[0039] In embodiment 10 of the glass syringe barrel 1 according to the present invention or a plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to any of embodiments 1 to 9, wherein for the glass syringe barrel 1 or for at least 75% of the glass syringe barrels included in the plurality of glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, d1 is in the range of 4 mm to 4.8 mm, preferably in the range of 4.2 mm to 4.6 mm, more preferably in the range of 4.3 mm to 4.5 mm, even more preferably in the range of 4.35 mm to 4.45 mm, and most preferably in the range of 4.40 mm to 4.42 mm. Preferably, d1 is the maximum outer diameter of the tapered region. Furthermore, preferably, the second end of the tapered region (or, if the tapered region includes a constriction region, the second end of the constriction region) preferably corresponds to the point where the outer diameter d1 exceeds 4.4 mm.
[0040] In embodiment 11 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 1 to 10, wherein, for the glass syringe barrel 1 or for at least 75% of the glass syringe barrels included in the multiple glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, d2 is in the range of 6 mm to 15 mm, preferably in the range of 6.5 mm to 14 mm, more preferably in the range of 7 mm to 13 mm, even more preferably in the range of 7.5 mm to 12 mm, and most preferably in the range of 8 mm to 11 mm.
[0041] In embodiment 12 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to any one of embodiments 1 to 11, wherein the outer surface of the glass syringe barrel in the tapered area is roughened or provided with a coating.
[0042] In embodiment 13 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to any one of embodiments 5 to 12, wherein, for the glass syringe barrel 1 or for at least 75% of the glass syringe barrels included in the plurality of glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, d1' is in the range of 3.4 mm to 5.2 mm, preferably in the range of 3.6 mm to 5 mm, more preferably in the range of 3.8 mm to 4.8 mm, even more preferably in the range of 4 mm to 4.6 mm, and most preferably in the range of 4.2 mm to 4.4 mm.
[0043] In embodiment 14 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 5 to 13, wherein, in the glass syringe barrel 1 or in at least 75% of the glass syringe barrels included in the multiple glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, the maximum thickness of the glass in the contraction area is in the range of 1.3 mm to 2.1 mm, preferably in the range of 1.4 mm to 2 mm, more preferably in the range of 1.5 mm to 1.9 mm, even more preferably in the range of 1.6 mm to 1.8 mm, and most preferably in the range of 1.65 mm to 1.75 mm.
[0044] In embodiment 15 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 5 to 14, wherein, in the glass syringe barrel 1 or in at least 75% of the glass syringe barrels included in the multiple glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, the minimum thickness of the glass in the contraction area is in the range of 1.1 mm to 1.9 mm, preferably in the range of 1.2 mm to 1.8 mm, more preferably in the range of 1.3 mm to 1.7 mm, even more preferably in the range of 1.4 mm to 1.6 mm, and most preferably in the range of 1.45 mm to 1.55 mm.
[0045] In embodiment 16 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 1 to 15, wherein, in the glass syringe barrel 1 or in at least 75% of the glass syringe barrels included in the multiple glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, the shoulder area is characterized by an external shoulder angle α in the range of 6° to 28°, preferably in the range of 8° to 22°, more preferably in the range of 9° to 16°, even more preferably in the range of 10° to 15°, and most preferably in the range of 11° to 14°.
[0046] In embodiment 17 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 1 to 16, wherein, in the glass syringe barrel 1 or in at least 75% of the glass syringe barrels included in the multiple glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, the shoulder area is characterized by an inner shoulder angle β in the range of 22° to 50°, preferably in the range of 25° to 40°, more preferably in the range of 26° to 35°, even more preferably in the range of 27° to 32°, and most preferably in the range of 28° to 31°.
[0047] In embodiment 18 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 are designed according to any one of embodiments 1 to 17, wherein n s is the glass thickness in the shoulder region, measured at the point on the inner shoulder surface where it first intersects the longitudinal axis L barrel Forming a 30° angle. And wherein in the glass syringe barrel 1 or in at least 75% of the glass syringe barrels included in the plurality of glass syringe barrels 1, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, n s Within the range of 1.2 mm to 2 mm, preferably within the range of 1.3 mm to 1.8 mm, more preferably within the range of 1.3 mm to 1.6 mm, even more preferably within the range of 1.35 mm to 1.5 mm, most preferably within the range of 1.35 mm to 1.45 mm.
[0048] In embodiment 19 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 1 to 18, wherein l2 is the length of the main body area, and wherein in the glass syringe barrel 1 or in at least 75% of the glass syringe barrels included in the multiple glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, l2 is in the range of 30 mm to 60 mm, preferably in the range of 35 mm to 55 mm, more preferably in the range of 38 mm to 50 mm, even more preferably in the range of 39.5 mm to 45 mm, and most preferably in the range of 39.5 mm to 41 mm.
[0049] In embodiment 20 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 1 to 19, wherein, in the glass syringe barrel 1 or in at least 75% of the glass syringe barrels included in the multiple glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, n2 is in the range of 0.6 mm to 1.6 mm, preferably in the range of 0.7 mm to 1.5 mm, more preferably in the range of 0.8 mm to 1.4 mm, even more preferably in the range of 0.9 mm to 1.3 mm, and most preferably in the range of 1 mm to 1.2 mm.
[0050] In embodiment 21 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 1 to 20, wherein the glass syringe barrel has a nominal volume V, and wherein in the glass syringe barrel 1 or in at least 75% of the glass syringe barrels included in the multiple glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels, V is in the range of 0.5 ml to 11 ml, preferably in the range of 0.5 ml to 9 ml, more preferably in the range of 0.5 ml to 7 ml, even more preferably in the range of 0.5 ml to 5 ml, and most preferably in the range of 0.5 ml to 3 ml.
[0051] In embodiment 22 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 1 to 21, wherein the glass syringe barrel has a length l3, which is measured as the distance between the top end and the bottom end, and wherein in the glass syringe barrel 1 or in at least 75% of the glass syringe barrels included in the multiple glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably in each of the glass syringe barrels, l3 is in the range of 30 mm to 100 mm, preferably in the range of 35 mm to 95 mm, more preferably in the range of 40 mm to 90 mm, even more preferably in the range of 45 mm to 86 mm, and most preferably in the range of 46 mm to 70 mm.
[0052] In embodiment 24 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to any one of embodiments 1 to 23, wherein the glass syringe barrel 1 or at least 75% of the glass syringe barrels included in the plurality of glass syringe barrels 1 or 2, preferably at least 85%, more preferably at least 95%, and most preferably each of the glass syringe barrels is circumscribed about the longitudinal axis L barrel Rotationally symmetrical, the longitudinal axis L barrel Extending parallel to the main body region and preferably passing through the center of the top end and the bottom end.
[0053] In embodiment 24 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to any one of embodiments 1 to 23, wherein the glass syringe barrel is designed for a Luer slip fitting and is sealed by an end cap attached to the at least partially conical upper part.
[0054] In embodiment 25 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to any one of embodiments 1 to 24, wherein the glass syringe barrel is designed for a Luer lock connection and comprises a Luer lock adapter attached to the at least partially conical upper part.
[0055] In embodiment 26 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to any one of embodiments 1 to 25, wherein the needle is attached to the at least partially conical upper part via a Luer connector and wherein the needle is sealed by a needle cap.
[0056] In embodiment 28 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 are designed according to any one of embodiments 1 to 27, wherein the syringe further comprises:
[0057] iv) a flange region having a first end and a second end, the first end of the flange region being adjacent to the second end of the body region, the second end of the flange region comprising a finger flange and corresponding to the bottom end of the glass syringe barrel, wherein the flange region has an outer diameter d3>d2.
[0058] In embodiment 29 of the glass syringe barrel 1 according to the present invention or the multiple glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the multiple glass syringe barrels 1 or 2 are designed according to any one of embodiments 1 to 28, wherein the glass is selected from the group consisting of borosilicate glass, aluminosilicate glass, soda-lime glass and fused quartz.
[0059] In embodiment 30 of the glass syringe barrel 1 according to the present invention or the plurality of glass syringe barrels 1 or 2 according to the present invention, the glass syringe barrel 1 or the plurality of glass syringe barrels 1 or 2 is designed according to any one of embodiments 1 to 29, wherein the glass syringe barrel includes a coating at least partially superimposed on the inner surface of the main body area.
[0060] A contribution to solving at least one of the objects according to the present invention is provided by the following method or embodiment 1 of an article of manufacture, preferably a glass syringe barrel, more preferably a glass syringe barrel according to the present invention, comprising the following process steps:
[0061] I) will have a longitudinal axis L tube (which corresponds to L in the finished glass syringe barrel Barrel ), the glass tube at the first end and the other end is loaded into a machine, preferably into a rotating machine, the glass tube having a wall thickness n2 and an outer diameter d2;
[0062] II) heating the first end of the glass tube to a temperature above its glass transition temperature, preferably above its softening temperature, with a heating element, preferably a flame, while the glass tube is rotated about its longitudinal axis;
[0063] III) while the glass tube is rotated about its longitudinal axis, shaping the heated first end using one or more shaping tools acting at the first end on a predetermined location on the outer surface of the glass tube to form:
[0064] i) a tapered region having a first end and a second end, the first end of the tapered region corresponding to the top end of the glass syringe barrel, the tapered region having a length l1 and an outer diameter d1 at its second end;
[0065] ii) a shoulder region having a first end and a second end, the first end of the shoulder region being adjacent to the second end of the tapered region, wherein an outer profile of the shoulder region comprises a concave and substantially arc-shaped region c1 starting below the second end of the tapered region and a convex and substantially arc-shaped region c2 starting above the second end of the shoulder region, the outer radius of region c1 being r1, and the outer radius of region c2 being r2;
[0066] iii) a body region having a first end and a second end, the first end of the body region being adjacent to the second end of the shoulder region, the second end of the body region preferably corresponding to the bottom end of the glass syringe barrel, wherein the body region has an outer diameter d2 and a glass thickness n2;
[0067] In this case, the shaping in method step III) is carried out to obtain an outer contour in the shoulder region, which is characterized by the following features:
[0068] If the shaped glass tube is placed with the outer surface of the body region on a flat horizontal substrate, then the glass syringe barrel is located in a plane (the plane is located in the center of the glass syringe barrel and includes the longitudinal axis L of the shaped glass tube) tube ), f(x) is defined as the vertical distance between the substrate and the outer surface of the glass syringe barrel at a given position x,
[0069] k(x)=|f”(x) / [1+f'(x) 2 ] 3 / 2 | is defined as the absolute value of the curvature of f(x) at a given location x, and
[0070] In the interval between x=P1 and x=P2, for any concave curvature in this interval, (1 / k(x)) / n2 2 The minimum value is at least 0.5mm -1 , preferably at least 0.6 mm -1 , more preferably at least 0.75 mm -1 , even more preferably at least 0.85 mm -1 , most preferably at least 1.0 mm -1, where P1 is defined as the x position at which the outer diameter of the glass syringe barrel is 0.95×d2 and P2 is P1+3×n2.
[0071] In embodiment 2 of the method 1 according to the invention, the method 1 is designed according to embodiment 1 thereof, wherein the shaping in method step III) is performed such that in the interval between x=P1 and x=P2, the first derivative f'(x) of f(x) is max The maximum value of is less than 18, even more preferably less than 15, even more preferably less than 10, and most preferably less than 5.
[0072] In embodiment 3 of method 1 according to the present invention, method 1 is designed according to embodiment 1 or 2 thereof, wherein the shaping in method step III) is carried out so that r1 is in the range of 0.4 mm to 3 mm, preferably in the range of 0.5 mm to 2.5 mm, more preferably in the range of 0.6 mm to 2 mm, even more preferably in the range of 0.7 mm to 1.8 mm, most preferably in the range of 0.8 mm to 1.5 mm.
[0073] In embodiment 4 of method 1 according to the present invention, method 1 is designed according to any one of its embodiments 1 to 3, wherein the forming in method step III) is carried out so that r2 is in the range of 1.2 mm to 3.1 mm, preferably in the range of 1.4 mm to 2.9 mm, more preferably in the range of 1.6 mm to 2.7 mm, even more preferably in the range of 1.8 mm to 2.5 mm, most preferably in the range of 2.0 mm to 2.3 mm.
[0074] In embodiment 5 of method 1 according to the present invention, method 1 is designed according to any one of its embodiments 1 to 4, wherein d2 is in the range of 6 mm to 15 mm, preferably in the range of 6.5 mm to 14 mm, more preferably in the range of 7 mm to 13 mm, even more preferably in the range of 7.5 mm to 12 mm, and most preferably in the range of 8 mm to 11 mm.
[0075] In embodiment 6 of method 1 according to the present invention, method 1 is designed according to any one of embodiments 1 to 5 thereof, wherein n2 is in the range of 0.6 mm to 1.6 mm, preferably in the range of 0.7 mm to 1.5 mm, more preferably in the range of 0.8 mm to 1.4 mm, even more preferably in the range of 0.9 mm to 1.3 mm, and most preferably in the range of 1 mm to 1.2 mm.
[0076] In embodiment 7 of method 1 according to the present invention, method 1 is designed according to any one of embodiments 1 to 6 thereof, wherein the shaping in method step III) is performed so as to form a contraction region located between the tapered region and the shoulder region, the contraction region having a first end adjacent to the second end of the tapered region, a second end adjacent to the first end of the shoulder region, and an outer contour c3, wherein the length of the contraction region is l1', the minimum outer diameter d1' below the first end of the contraction region is <d1, and the outer diameter at the second end of the contraction portion is d1".
[0077] In embodiment 8 of method 1 according to the present invention, method 1 is designed according to embodiment 7 thereof, wherein the shaping in method step III) is carried out so that the outer contour c3 of the glass syringe barrel in the contraction area is conical, and d1'<d1", and wherein at the second end of the contraction area, c3 merges into c1 without any offset.
[0078] In embodiment 9 of the method 1 according to the invention, the method 1 is designed according to embodiment 8 thereof, wherein the shaping in method step III) is performed so that in the constriction region parallel to the longitudinal axis L barrel The extending first line and a second line extending parallel to c3 and in the same plane as the first line include an angle γ between them, wherein γ is in the range of 0.3° to 2.5°, preferably in the range of 0.5° to 2.0°, and most preferably in the range of 0.7° to 1.5°.
[0079] In embodiment 10 of method 1 according to the present invention, method 1 is designed according to any one of its embodiments 1 to 9, wherein the forming in method step III) is carried out so that l1 or the total length l1+l1' (in the presence of a contraction area) is in the range of 8 mm to 12 mm, preferably in the range of 8.75 mm to 10.5 mm, more preferably in the range of 8.5 mm to 10 mm, even more preferably in the range of 8.6 mm to 9.8 mm, even more preferably in the range of 8.7 mm to 9.6 mm, most preferably in the range of 9.4 mm to 9.6 mm.
[0080] In embodiment 11 of method 1 according to the present invention, method 1 is designed according to any one of embodiments 7 to 10 thereof, wherein the shaping in method step III) is carried out so that l1' is in the range of 1 mm to 3 mm, preferably in the range of 1.1 mm to 2.5 mm, more preferably in the range of 1.2 mm to 2 mm, even more preferably in the range of 1.3 mm to 1.8 mm, most preferably in the range of 1.4 mm to 1.6 mm.
[0081] In embodiment 12 of method 1 according to the present invention, method 1 is configured according to any of embodiments 1 to 11 thereof, wherein the shaping in method step III) is performed such that d1 is in the range of 4 mm to 5 mm, preferably in the range of 4.1 mm to 4.8 mm, more preferably in the range of 4.2 mm to 4.6 mm, even more preferably in the range of 4.3 mm to 4.45 mm, and most preferably in the range of 4.40 mm to 4.42 mm. Preferably, d1 is the maximum outer diameter of the tapered region. It is further preferred that the second end of the tapered region corresponds to the point where the outer diameter d1 exceeds the value of 4.4 mm.
[0082] In embodiment 13 of method 1 according to the present invention, method 1 is designed according to any one of its embodiments 7 to 12, wherein the forming in method step III) is carried out so that d1' is in the range of 3.4 mm to 5.2 mm, preferably in the range of 3.6 mm to 5 mm, more preferably in the range of 3.8 mm to 4.8 mm, even more preferably in the range of 4 mm to 4.6 mm, most preferably in the range of 4.2 mm to 4.4 mm.
[0083] In embodiment 14 of method 1 according to the present invention, method 1 is designed according to any one of its embodiments 7 to 13, wherein the forming in method step III) is carried out so that the maximum thickness of the glass in the contraction area is in the range of 1.3 mm to 2.1 mm, preferably in the range of 1.4 mm to 2 mm, more preferably in the range of 1.5 mm to 1.9 mm, even more preferably in the range of 1.6 mm to 1.8 mm, and most preferably in the range of 1.65 mm to 1.75 mm.
[0084] In embodiment 15 of method 1 according to the present invention, method 1 is designed according to any one of its embodiments 7 to 13, wherein the forming in method step III) is carried out so that the minimum thickness of the glass in the contraction area is in the range of 1.1 mm to 1.9 mm, preferably in the range of 1.2 mm to 1.8 mm, more preferably in the range of 1.3 mm to 1.7 mm, even more preferably in the range of 1.4 mm to 1.6 mm and most preferably in the range of 1.45 mm to 1.55 mm.
[0085] In embodiment 16 of method 1 according to the invention, method 1 is designed according to any of embodiments 1 to 15 thereof, wherein the shaping in method step III) is performed such that the shoulder region is characterized by an outer shoulder angle α in the range of 6° to 28°, preferably in the range of 8° to 22°, more preferably in the range of 9° to 16°, even more preferably in the range of 10° to 15° and most preferably in the range of 11° to 14°.
[0086] In embodiment 17 of method 1 according to the invention, method 1 is designed according to any of embodiments 1 to 16 thereof, wherein the shaping in method step III) is performed such that the shoulder region is characterized by an inner shoulder angle β in the range of 22° to 50°, preferably in the range of 25° to 40°, more preferably in the range of 26° to 35°, even more preferably in the range of 27° to 32°, most preferably in the range of 28° to 31°.
[0087] In embodiment 18 of method 1 according to the invention, method 1 is designed according to any one of embodiments 1 to 17 thereof, wherein the shaping in method step III) is performed such that, if n s is the thickness of the glass in the shoulder region, measured at the point on the inner shoulder surface where it first intersects the longitudinal axis L barrel Forming a 30° angle, then n s Within the range of 1.2 mm to 2 mm, preferably within the range of 1.3 mm to 1.8 mm, more preferably within the range of 1.3 mm to 1.6 mm, even more preferably within the range of 1.35 mm to 1.5 mm, most preferably within the range of 1.35 mm to 1.45 mm.
[0088] In embodiment 19 of method 1 according to the present invention, method 1 is designed according to any one of embodiments 1 to 18 thereof, wherein the method further comprises the following steps:
[0089] IV) Roughening the outer surface of the glass syringe barrel in the tapered region or applying a coating to the outer surface of the glass syringe barrel in the tapered region.
[0090] In embodiment 20 of method 1 according to the present invention, method 1 is designed according to any one of embodiments 1 to 19 thereof, wherein the method further comprises the following steps:
[0091] V) while the glass tube is rotating about its main axis, cutting the glass tube at a predetermined position above the first end to obtain a glass tube having a length l tube A glass tube comprising a first end shaped by method steps I) to III) and a second end, wherein the cutting can be performed mechanically by a cutting device, or can be performed by flame heating, wherein the flame is used to melt the glass at the predetermined position and then break it.
[0092] VI) heating the second end of the glass tube to a temperature above its glass transition temperature, preferably above its softening temperature, using a heating element (preferably a flame) while the glass tube is rotated about its major axis;
[0093] VII) While the glass tube is being rotated about its major axis, the heated second end is formed to form the finger flange using one or more forming tools acting at the first end on a predetermined location of the outer surface of the glass tube.
[0094] In embodiment 21 of method 1 according to the present invention, method 1 is designed according to any one of embodiments 1 to 20 thereof, wherein the glass is a type selected from the group consisting of borosilicate glass, aluminosilicate glass and fused silica.
[0095] In embodiment 22 of method 1 according to the present invention, method 1 is designed according to any one of embodiments 1 to 21 thereof, wherein the method further comprises the following steps:
[0096] VIII) Covering at least a portion of the inner surface of the body region with a coating.
[0097] Embodiment 1 of the glass syringe barrel 2 obtainable by the method of the present invention according to any one of its embodiments 1 to 22 contributes to solving at least one of the objects of the present invention. In a preferred embodiment of the glass syringe barrel 2, the glass syringe barrel 2 shows the technical features of the glass syringe barrel 1 of the present invention and the technical features of each glass syringe barrel included in the plurality of glass syringe barrels 1 or 2 of the present invention according to any one of its embodiments.
[0098] A contribution to solving at least one of the objects according to the present invention is made by embodiment 1 of a syringe comprising:
[0099] A) a glass syringe barrel 1 according to any preferred embodiment thereof, a plurality of glass syringe barrels 1 or 2 according to any preferred embodiment thereof, or a glass syringe barrel 2 according to any preferred embodiment thereof;
[0100] B) A plunger stopper that has been pushed into the bottom end of a glass syringe barrel or has been pushed into the bottom end of each glass syringe barrel included in the plurality of glass syringe barrels 1 or 2 .
[0101] In embodiment 2 of the syringe according to the present invention, the syringe further comprises:
[0102] C) a pharmaceutical composition filled into at least a portion of the interior volume of the main body region.
[0103] Glass syringe barrel
[0104] In the context of the present invention, the glass syringe barrel according to the present invention may have any size or shape that a person skilled in the art considers suitable. The first end of the glass syringe barrel is an opening in the form of a channel located within the tapered region, through which the pharmaceutical composition contained in the glass syringe can be squeezed out of the glass syringe barrel and the plunger stopper can be pushed into the second end of the glass syringe barrel (preferably with a finger flange). Preferably, the glass syringe barrel is of one-piece design, which is prepared by the following steps: providing a glass tube, preferably in the form of a hollow cylinder; forming a conically shaped upper part, thereby obtaining a tapered region and a shoulder region (and an optional contraction region); and forming a finger flange at the other end of the glass tube. The preferred glass syringe barrel is a pre-filled glass syringe barrel filled with a pharmaceutical preparation. Preferably, the glass syringe barrel is shaped around the longitudinal axis L barrel Rotational symmetry, longitudinal axis L barrel Preferably it passes vertically through the center of the main body area.
[0105] Glass
[0106] In the context of the present invention, the glass of the glass syringe barrel can be any type of glass and can be composed of any material or combination of materials deemed suitable by the skilled person. Preferably, the glass is suitable for pharmaceutical packaging. According to the definition of glass types in Section 3.2.1 of the European Pharmacopoeia (7th Edition, 2011), it is particularly preferred that the glass is type I, more preferably type Ib. Additionally or optionally, it is preferred that the glass be selected from the group consisting of borosilicate glass, aluminosilicate glass, soda-lime glass, and fused quartz, or a combination of at least two thereof. For use herein, an aluminosilicate glass is a glass having an Al2O3 content greater than 8% by weight, preferably greater than 9% by weight, particularly preferably in the range of 9% to 20% by weight, based on the total weight of the glass. Preferred aluminosilicate glasses have a B2O3 content of less than 8% by weight, preferably a maximum of 7% by weight, particularly preferably 0% to 7% by weight, based on the total weight of the glass. For the purposes of this disclosure, borosilicate glass is a glass having a B2O3 content of at least 1% by weight, preferably at least 2% by weight, more preferably at least 3% by weight, more preferably at least 4% by weight, even more preferably at least 5% by weight, and particularly preferably in the range of 5% to 15% by weight, based in each case on the total weight of the glass. Preferred borosilicate glasses have an Al2O3 content of less than 7.5% by weight, preferably less than 6.5% by weight, particularly preferably in the range of 0% to 5.5% by weight, based in each case on the total weight of the glass. On the other hand, borosilicate glasses have an Al2O3 content in the range of 3% to 7.5% by weight, preferably in the range of 4% to 6% by weight, based in each case on the total weight of the glass.
[0107] Further preferred glasses according to the invention are essentially free of B. The expression "essentially free of B" refers to glasses that do not contain B that has been intentionally added to the glass composition. This means that B may still be present as an impurity, but the proportion of B is preferably not more than 0.1% by weight, more preferably not more than 0.05% by weight, based in each case on the weight of the glass.
[0108] The outer contour shape of the Luer cone in the defined area
[0109] An important element of the glass syringe barrel 1 according to the invention, an important element of the glass syringe barrels contained in the plurality of glass syringe barrels 1 according to the invention, and an important element of the glass syringe barrel 2 according to the invention is the shape of the outer contour in the shoulder region formed in method step III) of the method 1 according to the invention, in particular the outer contour in the concave and essentially circular arc-shaped region of the shoulder region. This outer contour of the shoulder region is characterized in that, in the interval between x=P1 and x=P2, for any concave curvature in this interval, (1 / k(x)) / n2 2 The minimum value is at least 0.5mm -1 , where P1 is defined as the x-position at which the outer diameter of the glass syringe barrel is 0.95×d2, and P2 is P1+3×n2. Furthermore, if the glass syringe barrel further includes a constriction region located between the tapered region and the shoulder region and characterized by an outer contour c3, then it is also preferred that the glass syringe barrel be conical in the constriction region such that the diameter of the constriction region increases toward the shoulder region. In this case, it is particularly preferred that the outer contour of the glass syringe barrel at the second end of the constriction region merges seamlessly into the outer contour of the glass syringe barrel at the first end of the shoulder region.
[0110] Pharmaceutical composition
[0111] In the context of the present invention, it is contemplated that any liquid pharmaceutical composition that one skilled in the art would consider suitable for use in a syringe is contemplated. A pharmaceutical composition is a composition comprising at least one active ingredient. A preferred active ingredient is a vaccine. Another preferred pharmaceutical composition is a parenteral medicament, i.e., a composition intended to be administered by a parenteral route, which may be any route other than parenteral. Parenteral administration can be by injection, for example, using a needle (typically a hypodermic needle) and a syringe.
[0112] Measurement method
[0113] The following measurement methods will be used in the context of the present invention: Unless otherwise stated, the measurements have to be carried out at an ambient temperature of 23° C., an ambient atmospheric pressure of 100 kPa (0.986 atm) and a relative atmospheric humidity of 50%.
[0114] Determine the local curvature k(x)
[0115] - The local curvature k(x) of the outer contour of the glass syringe barrel in the shoulder region, defined by the function f(x), can be determined in a non-destructive manner using a profile projector. This method is particularly suitable for glass syringe barrels that have been chemically and / or thermally tempered and are therefore not easily cut in half without cracking or breaking. In order to determine the local curvature k(x) in a non-destructive manner, the outer contour of the glass syringe barrel is visualized using a Mitutoyo PJ-3000 profile projector. This profile projector has a magnification of 10 times and operates under transmitted light illumination. The barrel is placed in the injection bowl of the glass syringe. BHB (which is butyloctanyl salicylate available from HallStar Corporation, Chicago, USA). BHB is used to visualize the outer contour of the barrel. It ensures that the cross section of the glass syringe barrel inspected in the profile projector corresponds to the longitudinal axis L located in the center of the glass syringe barrel and including the glass syringe barrel barrel plane, longitudinal axis L barrel That is, the axis passing vertically through the cylinder (see Figure 6A and Figure 6B ).
[0116] - In order to improve the measurement accuracy, it is also possible to use a barrel The outer contour of the glass syringe barrel in the shoulder area is determined by a physical cross-section (e.g. Figure 4 (As shown, again ensuring that this cross-section of the glass syringe barrel corresponds to a plane located in the center of the glass syringe barrel and including the longitudinal axis of the glass syringe barrel). To prevent cracking during production, the barrel can be embedded in a transparent two-component epoxy resin, such as EpoFix resin from STRUERS GmbH, or other suitable materials. After the epoxy resin has cured, a cross-section parallel to the barrel axis can be obtained by machine-supported sawing, grinding, and polishing. The barrel's geometric features can then be determined (measured) using undistorted image recording and geometric analysis software tools.
[0117] The relevant outer contour of the outer surface of the glass syringe barrel in the shoulder region can be extracted and numerically approximated from the images obtained by the two methods described above. To extract the relevant outer contour, the images were subjected to an image processing step implemented in Python [https: / / www.python.org / ] based on the image processing library OpenCV [https: / / open-cv.org / ].
[0118] First, the image is denoised using a median filter. The denoised image is then processed using an edge detection algorithm based on a Sobel filter, where contours are identified by thresholding the gradient image. To calculate the slope and curvature, the extracted contours are numerically approximated using a 5th-order univariate spline. The radius of curvature, R(x), is then given by the following formula:
[0119]
[0120] Where R(x)=1 / k(x).
[0121] Determination of r1 and r2
[0122] In the images obtained by the above two methods, r1 can be determined geometrically by applying a bevel rounding to the first inflection point IP (i.e., the first point satisfying the condition f”(x)=0) of the function f(x) (i.e., the first inflection point that occurs when entering the outer contour of the shoulder region from the top of the glass syringe barrel) and to the straight line extending along the outer contour of the tapered region, as shown in FIG. Figure 7 r2 can also be determined geometrically by applying a circle adjacent to a straight line extending along the outer contour of the main body region and gradually increasing the diameter of the circle until a maximum overlap is achieved between the outer contour of the shoulder region and a segment of the circle (again referring to Figure 7 ). The radius of the circle obtained in this way is r2.
[0123] n s Determination
[0124] In the images obtained by the above two methods, the glass thickness n in the shoulder area is s Measured at point P3 in the shoulder region where the tangent to the outer surface is first aligned with respect to the syringe axis L barrel Forming an angle of 30°, such as Figure 8 As shown. s is determined in a direction perpendicular to this line. To do this, draw a line perpendicular to the tangent at P3. The point where this perpendicular line intersects the inner surface is called P4. Draw a third line that extends parallel to the tangent and passes through P4. s Corresponds to the distance between these two parallel lines.
[0125] Determination of α and β
[0126] In the images obtained by the above two methods, the inner shoulder angle β is the angle between the inner shoulder and the syringe axis L. barrel The distance is [d c,inner +d 2,inner ) / 4, such as Figure 9 Displayed in. c,inner corresponds to the inner diameter of the channel at the top of the syringe barrel, and d 2,inner Corresponds to the inner radius of the body area. α was determined using an offline camera. A line was drawn along the longest straight section between the two radii, and the angle was then measured by applying a horizontal line.
[0127] Determination of cone rupture force
[0128] The cone rupture force was determined according to ISO 11040-4:2015 C.2, where the following parameters were selected:
[0129]
[0130] Example
[0131] Example 1 and Comparative Example 1:
[0132] A glass tube made of borosilicate glass with an outer diameter d2 of 10.85 mm and a wall thickness n2 of 1.1 mm is loaded into the head of the rotating machine. tube While rotating, heat one end of the glass tube (the end where the Luer cone is to be located) with a flame to its softening point (see Figure 11A While the glass tube is being rotated about its longitudinal axis, the heated end portion is shaped using a forming tool acting at a first end on a predetermined location on the outer surface of the glass tube to form a tapered region, which also includes a constriction region and a shoulder region. In a first step, a first forming tool is pressed at a first end against the outer surface of the glass tube to begin forming the constriction region (see Figure 11B The first end is then further heated (see Figure 11D ), then a set of second forming tools are pressed against the preformed outer surface of the glass tube at the first end to obtain the final shape of the tapered area, the contraction area and the shoulder area (see Figure 11E ). The shape of the other forming tools and the angle at which these tools are pressed against the molten tapered area ensure that the minimum radius of curvature between points P1 and P2 is maintained within the required range.
[0133] In a further process step, the glass tube is cut at a predetermined position above the first end while the glass tube is rotated about its longitudinal direction to obtain a glass tube having a length l tubeA glass tube having a tapered first end and a second end is then heated with a flame to a temperature above its glass transition temperature at the second end while the glass tube is rotated in its longitudinal direction. While the glass tube is still rotating in its longitudinal direction, the second end is shaped to form a finger flange by pressing a suitable forming tool against the outer surface of the glass tube at the second end.
[0134] 500 glass syringe barrels have been prepared in a rotary machine.The outer contour in the shoulder region of one of the glass syringe barrels corresponds to the outer contour of the shoulder region in a glass syringe barrel from the prior art (comparative example).
[0135] Comparative Example 1 Example 1 <![CDATA[r1[mm]]]> 0.4 1.5 <![CDATA[r2[mm]]]> 1.8 2.3 <![CDATA[(1 / k(x)) / n2 2 [mm -1 ]]]> 0.17 0.74 <![CDATA[f’(x) max ]]> 19 4.45 Average tip resistance [%] 100 183 Median tip resistance [N] 142 275 Median tip resistance [%] 100 194 1% quantile [N] 48.3 116.5
[0136] Unless otherwise indicated in the specification or a particular drawing:
[0137] Example 2 and Comparative Example 2:
[0138] Two glass syringe barrels (glass syringe barrels A and B) were compared, both having a body region with an outer diameter of 10.85 mm and a glass thickness of 1.4 mm. Glass syringe barrel B was defined such that the outer profile of the shoulder region between points P1 and P2 was characterized by a minimum local curvature of at least 0.67 mm. -1 (Its for the term (1 / k(x)) / n2 2 For the case of -1 ). On the other hand, the glass syringe barrel A is defined by an outer contour known from the prior art, characterized by a local curvature value between points P1 and P2 as low as 1.11 mm -1 (Its for the term (1 / k(x)) / n2 2 For the case of -1 ).
[0139] For glass syringe barrels A and B, the maximum tensile stress in the transition region between the shoulder region and the tapered region, which is generated when a force of 100 N is applied to the tapered portion of the syringe, is calculated as Figure 12 The following results have been obtained (see Figure 13A and 13B ):
[0140]
[0141] These results also show that by ensuring that the term (1 / k(x)) / n2 in the transition region between the shoulder region and the tapered region of the glass syringe barrel 2 The minimum value is at least 0.5mm -1(thus higher than the value determined in Comparative Example 1 of the present application for glass syringe barrels known from the prior art), resulting in an increased resistance to pressure applied to the tapered region of the glass syringe barrel. BRIEF DESCRIPTION OF THE DRAWINGS
[0142] Figure 1 shows a cross-sectional view of a syringe comprising a glass syringe barrel 100 according to the present invention, in which a plunger stop 104 has been introduced;
[0143] Figure 2 shows an enlarged cross-sectional view of the top end of a glass syringe barrel 100 according to the present invention, the glass syringe barrel 100 comprising a conical upper portion 101 in the form of a Luer taper;
[0144] Figure 3 An enlarged cross-sectional view of a top end 102 of another glass syringe barrel 100 according to the present invention is shown, the glass syringe barrel 100 comprising a conical upper portion 101 in the form of a Luer taper, wherein the glass syringe barrel further comprises a constricted region 108 between the tapered region 105 and the shoulder region 111;
[0145] Figure 4 The determination of the angle γ in the contraction region 108 is shown;
[0146] Figure 5A Shown Figure 3 FIG. 1 is an enlarged cross-sectional view of the top end 102 of the glass syringe barrel 100 shown in FIG. Figure 3 Instead, the glass syringe barrel 100 having the outer surface of the body region 114 is placed on the base plate 119;
[0147] Figure 5B shows the function f(x), by which the curvature k(x) of the outer contour of the glass syringe barrel in the shoulder region 111 can be determined;
[0148] Figure 6A The positioning of the plane 120 for determining the local curvature of the function f(x) in the range P1 to P2 is shown in side view;
[0149] Figure 6B The positioning of the plane 120 for determining the local curvature of the function f(x) in the range P1 to P2 is shown in a top view;
[0150] Figure 7 The determination of r1 is shown;
[0151] Figure 8 Shown s determination;
[0152] Figure 9The determination of β is shown;
[0153] Figure 10 A glass syringe barrel 100 according to the present invention is shown having an end cap 117 attached to a conical upper portion 101;
[0154] Figures 11A-11F Steps I), II) and III) of the method 1 according to the invention for producing a glass syringe barrel 100 are shown;
[0155] Figure 12 shows the mechanical load applied to the tapered portion of the glass syringe barrel when calculating the maximum tensile stress in Comparative Example 2 and Example 2;
[0156] Figure 13A and 13B Calculation results in Comparative Example 2 and Example 2 are shown. DETAILED DESCRIPTION
[0157] Figure 1 1 shows a cross-sectional view of a syringe comprising a glass syringe barrel 100 according to the present invention, in which a plunger stopper 104 has been introduced, the glass syringe barrel 100 having a length l3 and an outer diameter d2 in the body region 114. Figure 1 As shown, the syringe barrel 100 includes a top end 102 having a conical upper portion 102 and a bottom end 103 into which a plunger stopper 104 has been introduced.
[0158] Figure 2 Shown Figure 1 An enlarged cross-sectional view of the top end 102 of a glass syringe barrel 100 is shown, which includes a conical upper portion 101 ( Figure 2 The cross section of the glass syringe barrel 100 shown corresponds to Figure 1 The area enclosed by the dotted circle shown). Figure 2 As can be seen in FIG, the conical upper portion 101 of the glass syringe barrel 100 is in the form of a Luer slip fitting and is Figure 2The illustrated embodiment includes a tapered region 105 having a first end 106 and a second end 107, the first end 106 corresponding to the top end 102 of the glass syringe barrel 100, where the length of the tapered region 105 is l1 and the outer diameter at the second end 107 is d1. A shoulder region 111 is adjacent to the tapered region 105, the shoulder region 111 having a first end 112 and a second end 113 adjacent to the second end 107 of the tapered region 105, where the outer contour of the shoulder region 111 includes a concave and substantially circular arc region c1 (see the thick dashed line in the upper right of the shoulder region), whose outer radius r1 starts below the second end 110 of the constriction region 108, and includes a convex and substantially circular arc region c2 (see the thick solid line in the upper right of the shoulder region), whose outer radius r2 starts above the second end 113. Also as Figure 2 shown, the shoulder region 111 is characterized by an outer shoulder angle α and an inner shoulder angle β. A body region 114 (also see Figure 1 ) is adjacent to the shoulder region 111, and the syringe plunger 104 can be pushed into the body region 114. The body region 114 has a first end 115 adjacent to the second end 113 of the shoulder region 111 and a second end 116 corresponding to the bottom end 103 of the glass syringe barrel 100, where the glass thickness in the body region 114 is n2. The diameter d2 of the body region 114 corresponds to the diameter of the glass tube 126 used to manufacture the glass syringe barrel 100 according to the present invention (see Figures 11A-11F ).
[0159] Figure 3 A cross-sectional enlarged view of the top end 102 of another glass syringe barrel 100 according to the present invention is shown. The glass syringe barrel 100 includes a conical upper part 101 in the form of a Luer cone, where the glass syringe barrel further includes a constriction region 108 located between the tapered region 10 and the shoulder region 111. The constriction region 108 includes a first end 109 adjacent to the second end 107 of the tapered region 105, a second end 110 adjacent to the first end 112 of the shoulder region 111, and an outer contour c3. The constriction region has a length l1’, a minimum outer diameter d1’ < d1 below the first end 109 of the constriction region 108, and an outer diameter d1” at the second end 110 of the constriction region 108. In context, preferably, the outer contour c3 of the glass syringe barrel in the constriction region 108 is conical and d1’ < d1”, where c3 converges into c1 without any misalignment at the second end of the constriction region. It is also preferred that in the constriction region 108, an angle γ is included between a first line 117 extending parallel to the longitudinal axis L barrel and a second line 118 extending parallel to c3 and extending in the same plane as the first line 117, where γ is in the range of 1° to 3°. Figure 4It is shown how the angle γ in the contraction region 108 is determined, which defines the conical extension of the contraction region.
[0160] The glass syringe barrel 100 according to the invention is characterized by a well-defined outer contour in the transition region between the shoulder region 111 and the constriction region 108 (if present). Figure 5A As shown, if the glass syringe barrel 100 is placed on a flat horizontal substrate 119 with the outer surface of the body region 114, the function f(x) is defined as the vertical distance between the substrate 119 and the outer surface of the glass syringe barrel 100 at a given position x in the region, thereby defining the outer contour of the glass syringe barrel 100 (see Figure 5B ). From this function, the curvature function k(x) of the outer contour at a given position x can be calculated as:
[0161] k(x)=|f”(x) / [1+f'(x) 2 ] 3 / 2 |.
[0162] The glass syringe barrel according to the present invention is now characterized in that, in the interval between x=P1 and x=P2, for any concave curvature in this interval, (1 / k(x)) / n2 2 The minimum value is at least 0.5mm -1 , where P1 is defined as the x position where the outer diameter of the glass syringe barrel 100 is 0.95×d2, and P2 is P1+3×n2. (See Figure 5A ).
[0163] Figure 6A and Figure 6B The positioning of the flat surface 120 in the glass syringe barrel 100 is shown in side view and top view. Figure 5A and Figure 5B The method shown is used to determine the local curvature of the function f(x) in the range P1 to P2. The plane 120 corresponds to the longitudinal axis L located at the center of the glass syringe barrel 100 and including the glass syringe barrel 100. barrel plane.
[0164] Figure 7The figure shows how to determine the outer radius r1 of the concave, substantially arc-shaped region c1 of the shoulder region 111. r1 can be geometrically determined in a cross-sectional image of the glass syringe barrel 100 by applying a beveled rounding to the first inflection point IP of the function f(x) (i.e., the first point satisfying the condition f(x)=0) (i.e., the first inflection point occurring when entering the outer contour of the shoulder region 111 from the top end 102 of the glass syringe barrel 100) and to the straight line 121 extending along the outer contour of the tapered region 105. r2 can be geometrically determined by applying a circle adjacent to the straight line 122 extending along the outer contour of the main body region 114 and gradually increasing the diameter of the circle until the outer contour of the shoulder region 111 and a segment of the arc of the circle have a maximum overlap. The radius of the circle thus obtained is r2.
[0165] Figure 8 shows how to determine the glass thickness n in the shoulder region 111 s .n s Measured at point P3 in the shoulder region where the tangent to the outer surface is first aligned with respect to the syringe axis L barrel Forming an angle of 30°, such as Figure 8 As shown. s is determined in a direction perpendicular to this line. To do this, draw a line perpendicular to the tangent at P3. The point where this perpendicular line intersects the inner surface is called P4. Draw a third line that extends parallel to the tangent and passes through P4. s Corresponds to the distance between these two parallel lines.
[0166] Figure 9 How to determine the inner shoulder angle β is shown. The inner shoulder angle β is the angle between the inner shoulder and the syringe axis L. barrel The distance is [d c,inner +d 2,inner ) / 4. c,inner corresponds to the inner diameter of the passage 125 at the top end 102 of the glass syringe barrel 100, and d 2,inner Corresponds to the inner diameter of the main body region 114.
[0167] Figure 10 A glass syringe barrel 100 according to the present invention is shown having an end cap 126 attached to a conical upper portion 101 .
[0168] Figures 11A-11F Steps I), II) and III) of the method 1 according to the invention for producing a glass syringe barrel 100 according to the invention are shown. In method step I), a glass syringe barrel having a longitudinal axis L is formed. tubeA glass tube 127 having a wall thickness n2 and an outer diameter d2 is loaded into a machine, preferably a rotating machine, with a first end 129 and an other end 128. In method step II), the glass tube 127 is heated by a heating element 130 (preferably a flame 130) (by means of a heating element 130) while the glass tube 127 is rotated about its longitudinal axis. Figure 11A The glass tube 127 is heated to a temperature above its glass transition temperature, preferably above its softening temperature, as indicated by the candle flame shown on the left in the figure. In method step III), while the glass tube 127 is still rotating about its longitudinal axis, the heated first end 129 is shaped to form the conical upper portion 101 by using a shaping tool 131 that acts on the outer surface of the glass tube 127 at a predetermined position at the first end 129, as shown in FIG. Figure 11B and Figure 11E As shown. Figures 11A-11F In the process shown, the conical upper part 101 is formed in two steps: in a first step, a first set of forming tools 131 is used to form a Luer tip precursor 132 that does not have the final shape of the conical upper part 101 according to the present invention (see FIG. Figure 11B and Figure 11C ). Then Figure 11D The Luer cone precursor 132 is heated again as shown, and then Figure 11E The second set of forming tools 133 is used to perform the final shaping to obtain the finished glass tube 127 of the conical upper portion 101 (see FIG. Figure 11E The shape of the forming tools 131, 133 used in the forming process and the degree of pressure used to press the forming tools against the molten region of the glass tube 127 must ensure that the desired geometry is achieved, particularly in the transition between the shoulder region 111 and the tapered region 105 (or, if present, the contraction region 108).
[0169] In a further method step V), the glass tube with the finished conical upper part 101 is cut at a predetermined position above the first end 129 while the glass tube is rotated about its longitudinal axis to obtain a glass tube with a length l tube A glass tube comprising a first end 128 formed by method steps I) to III) and a second end. In a further method step VI), the second end of the glass tube is heated to a temperature above its glass transition temperature, preferably to a temperature above its softening temperature, by means of a heating element, preferably a flame, while the glass tube is rotated about its longitudinal axis. In a further method step VII), the heated second end is formed, for example, into a finger flange by means of one or more forming tools acting at a first end on a predetermined position of the outer surface of the glass tube while the glass tube is rotated about its longitudinal axis (method steps V) to VII) not previously performed. Figures 11A-11F shown in ).
[0170] Reference Signs List
[0171] 100 Glass syringe barrel according to the present invention
[0172] 101 Conical upper part
[0173] 102 Top
[0174] 103 bottom
[0175] 104 plunger stopper
[0176] 105 Cone Area
[0177] 106 First end of the tapered region 105 (=top end 102)
[0178] 107 Second end of the tapered region 105 (=first end 112 of the shoulder region 111 or first end 109 of the contraction region 108)
[0179] 111 Shoulder area
[0180] 112 First end of the shoulder region 111 (= second end 107 of the tapered region 105 or second end 110 of the contracted region 108)
[0181] 113 Second end of the shoulder region 111 (=first end 115 of the main body region 114)
[0182] 114 Main Area
[0183] 115 First end of the main body region 114 (= second end 113 of the shoulder region 111)
[0184] 116 Second end of the main body region 114 (= bottom end 103 )
[0185] 108 Contraction Area
[0186] 109 First end of the contraction region 108 (= second end 107 of the tapered region 105)
[0187] 110 Second end of the contraction region 108 (=first end 112 of the shoulder region 111)
[0188] 117 First Line
[0189] 118 Second Line
[0190] 119 flat horizontal substrate
[0191] 120 The middle cross-sectional plane of the glass syringe barrel 100
[0192] 121 Extension of the outer contour of the tapered region 105
[0193] 122 Extension of the outer contour of the main body area 114
[0194] 123 The outer surface of the shoulder area 111 and l barrel Tangent at a 30° angle
[0195] 124 The inner surface of the shoulder area 111 and l barrel Tangent at a 30° angle
[0196] 125 Top 102 Channel
[0197] 126 End Cap
[0198] 127 Glass Tube
[0199] 128 The other end of the glass tube
[0200] 129 First end of glass tube
[0201] 130 Heating element
[0202] 131 The first set of forming tools
[0203] 132 Luer-end precursor
[0204] 133 The second set of forming tools
[0205] 134 Glass tubing with finished Luer ends.
Claims
1. A glass syringe barrel (100) having an at least partially conical upper portion (101) and having a longitudinal axis L barrel The glass syringe barrel (100) includes a top end (102) through which liquid can be ejected, and a bottom end (103) into which a plunger stopper (104) can be pushed, and the glass syringe barrel (100) includes, in a direction from the top end (102) to the bottom end (103): i) a tapered region (105) having a first end (106) and a second end (107), the first end (106) of the tapered region (105) corresponding to the top end (102) of the glass syringe barrel (100), wherein the tapered region (105) has a length l1 and an outer diameter d1 at its second end (107); ii) a shoulder region (111) having a first end (112) and a second end (113), the first end (112) of the shoulder region (111) being adjacent to the second end (107) of the tapered region (105), wherein an outer contour of the shoulder region (111) comprises a concave and substantially arc-shaped region c1 starting below the second end (107) of the tapered region (105), and a convex and substantially arc-shaped region c2 starting above the second end (113) of the shoulder region (111), the outer radius of region c1 being r1, and the outer radius of region c2 being r2; iii) a body region (114) having a first end (115) and a second end (116), the first end (115) of the body region (114) being adjacent to the second end (113) of the shoulder region (111), the second end (116) of the body region (114) corresponding to the bottom end (103) of the glass syringe barrel (100), wherein the body region (114) has an outer diameter d2 and a glass thickness n2; Wherein, if the glass syringe barrel (100) is placed with the outer surface of the main body region (114) on a planar horizontal substrate (119), then in any given cross-section of the glass syringe barrel (100) located in a plane (120), f(x) is defined as the vertical distance between the substrate (119) and the outer surface of the glass syringe barrel (100) at a given position x; the plane (120) is located at the center of the glass syringe barrel (100) and includes the longitudinal axis L of the glass syringe barrel (100). barrel , Where k(x)=|f''(x) / [1+f'(x) 2 ] 3 / 2 | is defined as the absolute value of the curvature of f(x) at a given location x, and where, in the interval between x = P1 and x = P2, for any concave curvature in this interval, (1 / k(x)) / n2 2 The minimum value is at least 0.5mm -1 , where P1 is defined as the x position where the outer diameter of the glass syringe barrel is 0.95×d2, and P2 is P1+3×n2.
2. The glass syringe barrel (100) according to claim 1, wherein (1 / k(x)) / n2 2 The value is at least 0.6mm -1 .
3. The glass syringe barrel (100) according to claim 1, wherein (1 / k(x)) / n2 2 The value is at least 0.75mm -1 .
4. The glass syringe barrel (100) according to claim 1, wherein (1 / k(x)) / n2 2 The value is at least 0.85mm -1 .
5. The glass syringe barrel (100) according to claim 1, wherein (1 / k(x)) / n2 2 The value is at least 1.0 mm -1 .
6. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein The first derivative f'(x) of f(x) in the interval between x=P1 and x=P2 max The maximum value is less than 18.
7. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein The first derivative f'(x) of f(x) in the interval between x=P1 and x=P2 max The maximum value is less than 15.
8. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein The first derivative f'(x) of f(x) in the interval between x=P1 and x=P2 max The maximum value is less than 10.
9. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein In the interval between x = P1 and x = P2, the first derivative f'(x) of f(x) is max The maximum value is less than 5.
10. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein r1 is in the range of 0.4 mm to 3 mm.
11. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein r1 is in the range of 0.5 mm to 2.5 mm.
12. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein r1 is in the range of 0.6 mm to 2 mm.
13. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein r1 is in the range of 0.7 mm to 1.8 mm.
14. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein r1 is in the range of 0.8 mm to 1.5 mm.
15. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein r2 is in the range of 1.2mm to 3.1mm.
16. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein r2 is in the range of 1.4mm to 2.9mm.
17. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein r2 is in the range of 1.6mm to 2.7mm.
18. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein r2 is in the range of 1.8mm to 2.5mm.
19. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein r2 is in the range of 2.0 mm to 2.3 mm.
20. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein The glass syringe barrel (100) further includes a contraction region (108) located between the tapered region (105) and the shoulder region (111); the contraction region (108) has a first end (109) adjacent to the second end (107) of the tapered region (105), a second end (110) adjacent to the first end (112) of the shoulder region (111), and an outer contour c3, wherein the length of the contraction region (108) is l1', the minimum outer diameter d1' below the first end (109) of the contraction region (108) is less than d1, and the outer diameter at the second end (110) of the contraction region (108) is d1''.
21. The glass syringe barrel (100) of claim 20, wherein: The outer contour c3 of the glass syringe barrel (100) in the contraction region (108) is conical, and d1'<d1'', and at the second end (110) of the contraction region (108), c3 merges into c1 without any offset.
22. The glass syringe barrel (100) of claim 20, wherein In the contraction region (108), parallel to the longitudinal axis L barrel The angle between the first line (117) extending parallel to c3 and the second line (118) extending in the same plane as the first line (117) is included. ,in In the range of 0.3° to 2.5°.
23. The glass syringe barrel (100) of claim 22, wherein In the range of 0.5° to 2.0°.
24. The glass syringe barrel (100) of claim 22, wherein In the range of 0.7° to 1.5°.
25. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein l1 is in the range of 8mm to 12mm.
26. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein l1 is in the range of 8.25mm to 10.5mm.
27. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein l1 is in the range of 8.5mm to 10mm.
28. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein l1 is in the range of 8.6mm to 9.8mm.
29. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein l1 is in the range of 8.7mm to 9.6mm.
30. The glass syringe barrel (100) according to any one of claims 1 to 5, wherein l1 is in the range of 9.4mm to 9.6mm.
31. The glass syringe barrel (100) of claim 20, wherein l1' is in the range of 1 mm to 3 mm.
32. The glass syringe barrel (100) of claim 20, wherein l1' is in the range of 1.1 mm to 2.5 mm.
33. The glass syringe barrel (100) of claim 20, wherein l1' is in the range of 1.2 mm to 2 mm.
34. The glass syringe barrel (100) of claim 20, wherein l1' is in the range of 1.3 mm to 1.8 mm.
35. The glass syringe barrel (100) of claim 20, wherein l1' is in the range of 1.4 mm to 1.6 mm.
36. The glass syringe barrel (100) of any one of claims 1 to 5, wherein The shoulder region (111) is characterized by an outer shoulder angle In the range of 6° to 28°.
37. The glass syringe barrel (100) of claim 36, wherein The outer shoulder angle In the range of 8° to 22°.
38. The glass syringe barrel (100) of claim 36, wherein The outer shoulder angle In the range of 9° to 16°.
39. The glass syringe barrel (100) of claim 36, wherein The outer shoulder angle In the range of 10° to 15°.
40. The glass syringe barrel (100) of claim 36, wherein The outer shoulder angle In the range of 11° to 14°.
41. The glass syringe barrel (100) of any one of claims 1 to 5, wherein The shoulder region (111) is characterized by an inner shoulder angle In the range of 22° to 50°.
42. The glass syringe barrel (100) of claim 41, wherein The inner shoulder angle In the range of 25° to 40°.
43. The glass syringe barrel (100) of claim 41, wherein The inner shoulder angle In the range of 26° to 35°.
44. The glass syringe barrel (100) of claim 41, wherein The inner shoulder angle In the range of 27° to 32°.
45. The glass syringe barrel (100) of claim 41, wherein The inner shoulder angle In the range of 28° to 31°.
46. The glass syringe barrel (100) of any one of claims 1 to 5, wherein d1 is in the range of 4 mm to 4.8 mm.
47. The glass syringe barrel (100) of any one of claims 1 to 5, wherein d1 is in the range of 4.2 mm to 4.6 mm.
48. The glass syringe barrel (100) of any one of claims 1 to 5, wherein d1 is in the range of 4.3 mm to 4.5 mm.
49. The glass syringe barrel (100) of any one of claims 1 to 5, wherein d1 is in the range of 4.35 mm to 4.45 mm.
50. The glass syringe barrel (100) of any one of claims 1 to 5, wherein d1 is in the range of 4.40 mm to 4.42 mm.
51. The glass syringe barrel (100) of any one of claims 1 to 5, wherein d1 is the maximum outer diameter of the tapered region.
52. The glass syringe barrel (100) of any one of claims 1 to 5, wherein d2 is in the range of 6 mm to 15 mm.
53. The glass syringe barrel (100) of any one of claims 1 to 5, wherein d2 is in the range of 6.5 mm to 14 mm.
54. The glass syringe barrel (100) of any one of claims 1 to 5, wherein d2 is in the range of 7 mm to 13 mm.
55. The glass syringe barrel (100) of any one of claims 1 to 5, wherein d2 is in the range of 7.5 mm to 12 mm.
56. The glass syringe barrel (100) of any one of claims 1 to 5, wherein d2 is in the range of 8 mm to 11 mm.
57. The glass syringe barrel (100) of any one of claims 1 to 5, wherein n s is the thickness of the glass in the shoulder region, measured at the point of the inner shoulder surface where it first intersects the longitudinal axis L barrel Forming a 30° angle, n s In the range of 1.2mm to 2mm.
58. The glass syringe barrel (100) of claim 57, wherein n s In the range of 1.3mm to 1.8mm.
59. The glass syringe barrel (100) of claim 57, wherein n s In the range of 1.3mm to 1.6mm.
60. The glass syringe barrel (100) of claim 57, wherein n s In the range of 1.35mm to 1.5mm.
61. The glass syringe barrel (100) of claim 57, wherein n s In the range of 1.35mm to 1.45mm.
62. The glass syringe barrel (100) of any one of claims 1 to 5, wherein n2 is in the range of 0.6 mm to 1.6 mm.
63. The glass syringe barrel (100) of any one of claims 1 to 5, wherein n2 is in the range of 0.7 mm to 1.5 mm.
64. The glass syringe barrel (100) of any one of claims 1 to 5, wherein n2 is in the range of 0.8 mm to 1.4 mm.
65. The glass syringe barrel (100) of any one of claims 1 to 5, wherein n2 is in the range of 0.9 mm to 1.3 mm.
66. The glass syringe barrel (100) of any one of claims 1 to 5, wherein n2 is in the range of 1 mm to 1.2 mm.
67. The glass syringe barrel (100) of any one of claims 1 to 5, wherein The glass syringe barrel has a nominal volume V, and V is in the range of 0.5 ml to 11 ml.
68. The glass syringe barrel (100) of claim 67, wherein the nominal volume V is in the range of 0.5 ml to 9 ml.
69. The glass syringe barrel (100) of claim 67, wherein the nominal volume V is in the range of 0.5 ml to 7 ml.
70. The glass syringe barrel (100) of claim 67, wherein the nominal volume V is in the range of 0.5 ml to 5 ml.
71. The glass syringe barrel (100) of claim 67, wherein the nominal volume V is in the range of 0.5 ml to 3 ml.
72. The glass syringe barrel (100) of any one of claims 1 to 5, wherein At least a portion of the outer surface of the glass syringe barrel (100) in the tapered region (105) is roughened or provided with a coating.
73. The glass syringe barrel (100) of any one of claims 1 to 5, wherein The glass syringe barrel (100) is sealed by an end cap (126) attached to the conical upper portion (101).
74. The glass syringe barrel (100) of any one of claims 1 to 5, wherein The syringe also includes iv) a flange region having a first end and a second end, the first end of the flange region being adjacent to the second end of the body region, the second end of the flange region comprising a finger flange and corresponding to the bottom end of the glass syringe barrel, wherein the flange region has an outer diameter d3>d2.
75. A plurality of at least 100 glass syringe barrels (100), each glass syringe barrel (100) having an at least partially conical upper portion (101), each glass syringe barrel (100) having a longitudinal axis L barrel The glass syringe barrel (100) includes a top end (102) through which liquid can be ejected, and a bottom end (103) into which a plunger stopper (104) can be pushed, and each glass syringe barrel (100) includes, in a direction from the top end (102) to the bottom end (103): i) a tapered region (105) having a first end (106) and a second end (107), the first end (106) of the tapered region (105) corresponding to the top end (102) of the glass syringe barrel (100), wherein the tapered region (105) has a length l1 and an outer diameter d1 at its second end (107); ii) a shoulder region (111) having a first end (112) and a second end (113), the first end (112) of the shoulder region (111) being adjacent to the second end (107) of the tapered region (105), wherein an outer contour of the shoulder region (111) comprises a concave and substantially arc-shaped region c1 starting below the second end (107) of the tapered region (105), and a convex and substantially arc-shaped region c2 starting above the second end (113) of the shoulder region (111), the outer radius of region c1 being r1, and the outer radius of region c2 being r2; iii) a body region (114) having a first end (115) and a second end (116), the first end (115) of the body region (114) being adjacent to the second end (113) of the shoulder region (111), the second end (116) of the body region (114) corresponding to the bottom end (103) of the glass syringe barrel (100), wherein the body region (114) has an outer diameter d2 and a glass thickness n2; The glass syringe barrels included in the plurality of glass syringe barrels (100) have a 1% quantile Luer cone rupture resistance of at least 50N.
76. The plurality of at least 100 glass syringe barrels (100) of claim 75, wherein the glass syringe barrels included in the plurality of glass syringe barrels (100) have a 1% quantile Luer cone rupture resistance of at least 65N.
77. The plurality of at least 100 glass syringe barrels (100) of claim 75, wherein the glass syringe barrels included in the plurality of glass syringe barrels (100) have a 1% quantile Luer cone rupture resistance of at least 80N.
78. The plurality of at least 100 glass syringe barrels (100) of claim 75, wherein the glass syringe barrels included in the plurality of glass syringe barrels (100) have a 1% quantile Luer cone rupture resistance of at least 95N.
79. The plurality of at least 100 glass syringe barrels (100) of claim 75, wherein the glass syringe barrels included in the plurality of glass syringe barrels (100) have a 1% quantile Luer cone rupture resistance of at least 110N.
80. A syringe comprising A) A glass syringe barrel (100) according to any one of claims 1 to 74 or a plurality of glass syringe barrels (100) according to any one of claims 75 to 79; B) A plunger stopper (104) that has been pushed into the bottom end (103) of the glass syringe barrel (100) or into the bottom end (103) of each glass syringe barrel (100) included in the plurality of glass syringe barrels.
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