Apparatus for forming a cone for accommodating a needle on a syringe, method for making a cone for accommodating a needle on a syringe, and syringes relating thereto

Abstract

The forming device (4) for the receiving cone (8) of a needle in the syringe body (12) of a glass syringe includes a forming tool (16) shaped to create a hole (20) for producing the receiving cone (8) and a lubricant / coolant injection device (24). The forming tool (16) includes a gripping portion (28), a tip (32), and a tip body (36) disposed between the tip (32) and the gripping portion (28) and configured to create the hole (20). The gripping portion (28), tip body (36), and tip (32) are integral and aligned along a major axis (XX). With respect to a cross section perpendicular to the major axis (XX), the tip body (36) has a non-circular cross section, and in the cross section perpendicular to the major axis (XX), the non-circular cross section is inscribed in a maximum circle (40) whose radius is the maximum distance between a point (P) on the cross section and the major axis (XX).

Description

[Technical Field]

[0001] The present invention relates to an apparatus for forming a cone for accommodating a needle on a syringe, a method for making a cone for accommodating a needle on a syringe, and the syringes obtained thereby. [Background technology]

[0002] As is known, glass syringes, which have a hollow cylindrical syringe body capable of containing a medical substance to be injected in the form of a solid, suspension, or solution, are widely used in the medical industry. The injection is performed through a front delivery end via an attached needle, which is itself hollow and fluidly connected to a cavity in the syringe body.

[0003] A piston or plunger is contained within the cavity and is depressed by the user or by an automatic or semi-automatic system to allow injection of the medical fluid in a known manner.

[0004] The formation of a cone on the syringe body, designed to hold the needle, represents a crucial step, in which the tip of the tool is attached to the syringe body just before the rollers are closed and the glass is shaped by them. Therefore, the channel that accommodates the part of the needle attached to the syringe body must remain open, i.e. transparent, at a stage when the glass is very hot and malleable. This step is important because there is a risk that the hole intended to accommodate the needle will close easily.

[0005] Indeed, this shaping must be done in a precise and controlled manner, since cracks may form in the particularly fragile glass body, resulting in a loss of mechanical strength. Furthermore, the hole for accommodating the needle must be shaped very precisely to avoid residual or broken glass and / or sharp edges that could subsequently cause cracks caused by the insertion of the needle into the desired position or seat.

[0006] Furthermore, it should be noted that the operation of forming the cone for receiving the needle in the syringe must also be as fast as possible, since tens or hundreds of thousands of parts must be processed. Obviously, increasing the forming speed poses a greater risk of defects.

[0007] To maintain the transparency of the receiving holes, a known solution involves the use of forming tips containing tungsten, which is in fact a particularly hard material and is resistant to high temperatures as well as the considerable wear that occurs on the tip when it comes into contact with the glass to be formed.

[0008] While tungsten solves the wear / temperature resistance problem by allowing for fairly rapid molding, it can become a contaminant of the syringe glass. That is, small amounts of tungsten are released from the tip onto the glass as a result of spalling and redeposition of its salts and oxides caused by the high glass molding temperatures. These tungsten derivatives may be incompatible with the drugs or formulations contained in the syringe body and may alter therapeutic efficacy over time.

[0009] For this reason, in molding processes that use tungsten tips, the tips are used for a limited time (ranging from 2 to 4 hours) to minimize the release of tungsten compounds into the syringe body, after which the tip must be replaced.

[0010] It is also known to use a gas (typically nitrogen) blown in during the forming step to avoid or limit as much as possible the formation of tungsten oxide due to the oxidizing action of the oxygen contained in the air.

[0011] However, these solutions are complex and increase the overall process cost.

[0012] Alternative tungsten-free forming tips are also known, which prevent the problem of tungsten compound formation, such as oxides and salts, upstream. Tips containing silicon nitride are known to be used for this purpose. However, these solutions have several drawbacks and disadvantages.

[0013] Indeed, silicon nitride tips are hard and resistant to moderate to high temperatures, but cannot match the speeds and operating temperatures achieved by comparable tungsten tips (in terms of size and shape).

[0014] To at least partially overcome this high temperature resistance limitation, it is known to provide an appropriate flow of lubricating cooling fluid at the contact point between the glass and the forming tip to reduce its operating temperature.

[0015] In any event, the absolute size, i.e. thickness, of the chip is so small that the lubricating / cooling fluid does not always penetrate effectively to lubricate and cool the chip.

[0016] As a result, such prior art tips cannot meet or exceed the production performance of comparable tungsten tips. Summary of the Invention

[0017] Therefore, there is a need to address the deficiencies and limitations discussed above with reference to the prior art.

[0018] In particular, there is a need to provide a molded tip for a receiving cone of a syringe needle that can be molded accurately, quickly, and reliably without the costly and complicated use of a controlled atmosphere (e.g., an inert gas such as nitrogen), has a functional life comparable to that of a tungsten tip, and ensures that compound segregation (release) from the syringe body is completely eliminated or significantly reduced.

[0019] This need is met by a molding device according to claim 1 and a method according to claim 19 for making a cone for accommodating a needle in a syringe. [Brief explanation of the drawings]

[0020] Further features and advantages of the present invention will be more readily apparent from the following description of preferred, non-limiting examples.

[0021] [Figure 1a] 1 shows a side view of a molding apparatus according to one embodiment of the present invention. [Figure 1b] 1 shows a cross-sectional view of a syringe body molded in accordance with the present invention. [Figure 2a] 1 shows a side view of a forming tool according to an embodiment of the present invention. [Figure 2b] 3 shows another side view of the molding tool. [Figure 2c] 1 shows a plan view of the molding tool as seen from the chip side. [Figure 3a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 3b] 3 shows another side view of the molding tool. [Figure 3c] 1 shows a plan view of the molding tool as seen from the chip side. [Figure 4a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 4b] 3 shows another side view of the molding tool. [Figure 4c] 1 shows a plan view of the molding tool as seen from the chip side. [Figure 5a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 5b] 3 shows another side view of the molding tool. [Figure 5c] 1 shows a plan view of the molding tool as seen from the chip side. [Figure 6a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 6b] 3 shows another side view of the molding tool. [Figure 6c]1 shows a plan view of the molding tool as seen from the chip side. [Figure 7a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 7b] 3 shows another side view of the molding tool. [Figure 7c] 1 shows a plan view of the molding tool as seen from the chip side. [Figure 8a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 8b] 3 shows another side view of the molding tool. [Figure 8c] 1 shows a plan view of the molding tool as seen from the chip side. [Figure 9a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 9b] 3 shows another side view of the molding tool. [Figure 9c] 1 shows a plan view of the molding tool as seen from the chip side. [Figure 10a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 10b] 3 shows another side view of the molding tool. [Figure 10c] 1 shows a plan view of the molding tool as seen from the chip side. [Figure 11a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 11b] 3 shows another side view of the molding tool. [Figure 11c] 1 shows a plan view of the molding tool as seen from the chip side. [Figure 12a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 12b] 3 shows another side view of the molding tool. [Figure 12c] 1 shows a plan view of the molding tool as seen from the chip side. [Figure 13a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 13b] 3 shows another side view of the molding tool. [Figure 13c]1 shows a plan view of the molding tool as seen from the chip side. [Figure 14a] 10 shows a side view of a forming tool according to another embodiment of the present invention. [Figure 14b] 3 shows another side view of the molding tool. [Figure 14c] 1 shows a plan view of the molding tool as seen from the chip side.

[0022] Elements or element parts that are common in the embodiments described below are designated by the same reference numerals. DETAILED DESCRIPTION OF THE INVENTION

[0023] With reference to the aforementioned figures, the reference numeral 4 is used to generally refer to an apparatus for forming a needle housing cone 8 in a syringe body 12 of a glass syringe for medical substances. The syringe body 12 has a main axis (principal axis of elongation or longitudinal axis) XX.

[0024] The apparatus 4 includes a forming tool 16. The forming tool 16 is shaped to create a hole 20 in the glass syringe body 12 for creating the containment cone 8.

[0025] In other words, the receiving cone 8 is obtained in a series of steps by shaping the wall of the glass syringe body 12. The syringe body 12 is contracted around the forming tool 16, preferably by using a pair of rollers 22. The forming tool 16 thus functions as a male plug or pin, while the side wall 23 of the syringe body 12 is contracted onto the forming tool 16 by said rollers 22 moving along a radial direction RR perpendicular to the main axis (main extension axis) XX. When the forming tool 16 is removed, a hole 20 is left behind to accommodate the syringe needle.

[0026] The molding apparatus 4 also includes a lubricating / cooling liquid dispenser 24 at the tip 32 of the molding tool 16 and / or at the contact area between the molding tool 16 and the glass syringe body 12. The dispenser 24 may include one or more dispense nozzles 25 for the lubricating / cooling liquid.

[0027] For purposes of the present invention, the type of dosing device 24 and the type of lubricating / cooling fluid used are irrelevant.

[0028] The forming tool 16 comprises a gripping portion (shank portion) 28 suitable for gripping by an associated drive means (motor means). The drive means may translate, rotate, or translate with rotation along a major axis XX of the forming tool 16 relative to the syringe body 12. Alternatively, the forming tool 16 may be held stationary while the syringe body 12 is translated, rotated, and / or translated with rotation along the major axis XX. The forming tool 16 further comprises a tip 32 suitable for forming the syringe body 12, and a tip body 36 inserted between the tip 32 and the gripping portion 28 and suitable for machining the hole 20 in the glass.

[0029] The gripping portion 28, tip body 36, and tip 32 are preferably integrally formed with one another and aligned along the main axis (axis of rotation) XX of the forming tool 16.

[0030] Advantageously, the tip body 36 has a non-circular cross section, relative to a cross section perpendicular to the major axis XX, which is inscribed in a maximum circle 40 having as its radius the maximum distance between any point on the cross section and the major axis XX, said maximum distance being measured on the cross section perpendicular to the major axis XX.

[0031] In other words, with respect to a cross section perpendicular to the main axis XX, the maximum radius or maximum distance from the same main axis is considered to define the radius and diameter of the hole 20 that can be formed in the syringe body 12 after rotating the molding tool about the main axis (axis of rotation) XX.

[0032] This means that, with respect to a cross section perpendicular to the main axis XX, the cross section of the tip body 36 is always smaller than the cross section, i.e., the area, of the maximum circle 40. The maximum circle 40 is a circle having a radius equal to the radius of the hole 20 to be made. In other words, the tip body 36 has one or more transverse excavations (recesses) relative to the maximum circle 40.

[0033] Preferably, the tip body 36 has, at its largest cross section on the major axis XX, a cross section that is less than 85% of the cross section of the largest circle 40 .

[0034] According to a further embodiment, the tip body 36 has, at its largest cross section on the main axis XX, a cross section that is less than 70% of the cross section of the largest circle 40 .

[0035] The ratio of the cross section of the tip body 36 to the maximum circle 40 may be further reduced so that the required mechanical torsional strength (and bending strength) of the tip body 36 is always guaranteed.

[0036] In particular, the cross section of the tip body 36 defines, relative to the maximum circle 40, at least one recess 44 adapted to allow the passage of a lubricating coolant fluid.

[0037] In other words, with respect to the theoretical maximum size of the tip body 36 given by the maximum circle 40, it is envisioned to use a shape that is not circular, but instead has at least one recess 44 that defines a cavity that forms a passage for the lubricating / cooling fluid.

[0038] According to one embodiment, the tip body 36 has, in cross section on the main axis XX, a plurality of recesses 44 fluidly connected to one another to form a continuous channel for the passage of a lubricating / cooling liquid.

[0039] Preferably, the recesses 44 in the tip body 36 are fluidly connected to one another along the major axis XX to form a continuous channel for the passage of lubricating / cooling fluid along the tip body 36 .

[0040] The cross section of the tip body 36 is preferably constant along the major axis, in other words, the tip body 36 is cylindrical, i.e., it is made up of straight lines all parallel to the major axis, but has a cross section that differs from a circular cross section (in particular, a cross section that is smaller than the maximum circle 40 due to the presence of at least one recess 44).

[0041] Of course, for purposes of mechanical strength and durability / reliability of the molding tool 16, it is preferred that the cross section of the syringe body 12 (tip body 36) be as symmetrical as possible.

[0042] The cross section of the tip body 36 may vary along the major axis XX.

[0043] For example, according to one possible embodiment, the cross section of the tip body 36 may taper from the grip portion (shank portion) 28 towards the tip 32 along the main axis XX.

[0044] There are many possible shapes for the tip body 36.

[0045] For example, the cross section of tip body 36 may be any regular polygon inscribed in circle 40, such as a triangle, square, rhombus, pentagon, or hexagon.

[0046] The cross section of tip body 36 may be a closed polyline inscribed in a circle 40 at most, such as a rectangle, a trapezoid, or any closed shape.

[0047] The cross section of tip body 36 may be formed by a curve that is inscribed in maximum circle 40. This cross section may have straight sides and / or curved sides, etc.

[0048] 2 to 14 show some of the above possible embodiments of the present invention.

[0049] By way of example, Figures 2-14 illustrate some of the possible shapes of tip body 36 according to various embodiments of the present invention.

[0050] For example, in FIGS. 2 a - 2 c , a triangular cross-sectional shape is envisaged, in particular according to an equilateral triangle inscribed in the largest circle 40 .

[0051] 3a to 3c show a square cross-sectional shape, FIGS. 4a to 4c show a rectangular cross-sectional shape, and FIGS. 5a to 5c show a diamond cross-sectional shape.

[0052] 6a to 6c assume a pentagonal cross-sectional shape, and FIGS. 7a to 7c assume a hexagonal cross-sectional shape.

[0053] 8a-8c show a star-shaped cross-sectional shape, while FIGS. 9a-9c assume a cross-sectional shape of a cross section with two equal, perpendicular arms whose length is equal to the diameter of the largest circle 40.

[0054] 10a-10c assume a partially circular cross-sectional shape with a facet (flat portion) on one side 56. Preferably, but not exclusively, facet 56 has a length that is less than the diameter of the remainder of the circular cross-section.

[0055] 11a-11c, an elliptical cross-sectional shape is assumed, with the major axis of the ellipse equal to the diameter of the largest circle 40. In FIG.

[0056] In Figures 12a to 12c, a partially circular cross-sectional shape is assumed, with a pair of facets (flat surfaces) 56 preferably arranged symmetrically on either side of the main axis XX.

[0057] 13a to 13c show a circular cross-sectional shape having a diameter equal to that of the largest circle 40, with a pair of recesses 44 having a substantially parabolic shape arranged on either side of the main axis XX.

[0058] Finally, FIGS. 14a-14c show a circular cross-sectional shape having a diameter smaller than that of the maximum circle 40, with an arc 60 being substantially tangent to the maximum circle 40. FIG.

[0059] The arc 60 corresponds to a thread 64 that is threaded helically around said circular shape along a major axis XX.

[0060] Tip 32 preferably tapers from the point where it connects to tip body 36 .

[0061] Preferably, the tip 32 has the same shape as the tip body 36 in a cross section perpendicular to the main axis XX.

[0062] For example, if tip body 36 has a square cross section, tip 32 also has a square cross section but is tapered, ie, has smaller sides.

[0063] The end (point) 48 of the tip 32 need not be sharp.

[0064] For example, the tip 32 may have a flat end (end face) 48 contained in a plane perpendicular to the major axis XX.

[0065] The tip 32 may be provided with a conical, pyramidal, or frustoconical end 48 .

[0066] According to one embodiment, a step (neck-in portion) 52 is provided in the area for connecting the grip portion (shank portion) 28 to the tip body 36 with respect to a cross section perpendicular to the main axis XX.

[0067] The gripping portion (shank portion) 28 may have any cross section. The gripping portion (shank portion) 28 may have a circular cross section equal to the maximum circle 40.

[0068] The function of the gripping portion (shank portion) 28 is to allow grasping and / or movement of the forming tool 16 about the main axis XX, but does not have the function of removing material from the syringe body 12 .

[0069] Preferably, the gripping portion (shank portion) 28, tip 32, and tip body 36 are made of metallic, ceramic, and / or non-metallic materials and are tungsten-free.

[0070] Of course, the present invention may be applied to tips that consist entirely or partly of tungsten.

[0071] As mentioned above, the particular geometry of forming tool 16 and tip 32 allows for lubrication and temperature containment at the receiving cone 8. This reduces contamination of the cone 8 with tungsten compounds (which can easily create the high temperatures achieved with conventional tips) and allows for the use of ceramic tips, which provide some degree of breakage resistance.

[0072] However, it has been found that the use of a ceramic material doped with yttrium compounds results in a forming tool 16 having a high strength tip 32. In particular, this ceramic material doped with yttrium compounds, in combination with the previously described shapes of the forming tool 16 and tip 32, allows for the avoidance of the use of a tungsten tip without losing the high temperature resistance properties typical of tungsten tips.

[0073] In a preferred embodiment, the ceramic material used is silicon nitride (Si3N4) doped with yttrium oxide (YO3), more preferably in an amount between 3% and 7% by weight, or between 4% and 6% by weight. In certain embodiments, the silicon nitride contains yttrium oxide and alumina (Al2O3) in a combined amount between 7% and 13% by weight, or between 8% and 12% by weight.

[0074] The analytical detection method described below was developed to assess the residual amount of yttrium present in the syringe cone after it has been molded using a molding tool 16 made of a ceramic material to which an yttrium compound has been added.

[0075] The analytical method for detecting yttrium is as follows. [measurement] Element Y, which can be removed from syringe cones by extraction in a heated ultrasonic bath using 2% nitric acid (HNO3) as the extraction solvent. [Analysis technology] Inductively coupled plasma mass spectrometry (ICP-MS) [Test items] Type I Neutral Borosilicate Glass (USP <660> Bulk syringes (without needles attached and without internal coating) in Type I neutral borosilicate glass as defined in IEC 61001-2, with two types of cone shapes (Stake Needle (SN) and Luer Lock (LLC)). [Quantitative range] 0.1 to 200 μg / L [Extraction method] (a) Insert each syringe into a screw-cap test tube. (b) Fill the syringe with 1 ml of 2% nitric acid and close the test tube with a cap. (c) Immerse in a preheated ultrasonic bath at 75°C for 1 hour. (d) Shake (using a vortex shaker) the test tube containing the syringe. (e) Cool to room temperature. (f) Remove the syringe from the test tube, being careful to empty all of the liquid from the test tube. (g) Take 0.3 ml of the extraction solution and transfer it to a new clean test tube, and dilute the extract 10-fold by adding 2.7 ml of internal standard solution (iridium 56 μg / L in 2% nitric acid). (h) Shake the solution to homogenize it. [Device Settings] Sample volume submitted for analysis: 3 mL (obtained by dilution as in step (g)) Internal standard used: iridium, final concentration 50 μg / L Acquisition mode: Standard The instrument is adjusted with 2% nitric acid and calibrated with a calibration curve for element Y in the range of 0.1 to 200 μg / L. Atomic weight: 193Ir, 89Y [Calculation of Y extraction volume per syringe (considering 1 mL extraction volume)] Y (nanograms / syringe) = C × FD where: C: Concentration of the diluted extract (μg / L) returned by the software FD: Dilution factor (equal to 10)

[0076] A second method for extracting yttrium from cones 8 is described below.

[0077] [measurement] Element Y present in the syringe cone can be quantified following complete mineralization / decomposition of the glass matrix (cone region fragment only) using hydrofluoric acid or other solvents that promote mineralization.

[0078] [Analysis technology] Inductively coupled plasma mass spectrometry (ICP-MS)

[0079] [Test items] Type I Neutral Borosilicate Glass (USP <660> Bulk syringes (without needles attached and without internal coating) in Type I neutral borosilicate glass as defined in IEC 61001-2, with two types of cone shapes (Stake Needle (SN) and Luer Lock (LLC)).

[0080] A third method for extracting yttrium from cones 8 is described below.

[0081] [measurement] Element Y present in the syringe cone, identifiable by fragmentation of the syringe cone region, which was subjected to laser ablation for sampling and subsequent determination by ICP-MS without the need for pretreatment or derivatization.

[0082] [Analysis technology] Laser ablation, inductively coupled plasma mass spectrometry (LA-ICP-MS)

[0083] [Test items] Type I Neutral Borosilicate Glass (USP <660> Bulk syringes (without needles attached and without internal coating) in Type I neutral borosilicate glass as defined in IEC 61001-2, with two types of cone shapes (Stake Needle (SN) and Luer Lock (LLC)).

[0084] Using the method described above, the yttrium content in the cone of a syringe molded with a tip according to the method of the present invention was determined to be between 0.5 nanograms and 1 nanogram.

[0085] The forming apparatus 4 may comprise at least one second forming tool shaped to complete the hole 20 created by the forming tool 16 .

[0086] In other words, the forming device 4 often includes multiple forming tools 16 that function to create the shape of the needle receiving cone 8 in a series of stages (series of steps). The first stage (first step) consists of forming the base, i.e., forming the main hole, and subsequent stages (steps) are used to define the details. The multiple forming tools 16 used may have the characteristics described above. The multiple forming tools 16 may have the same shape but different sizes, or may have different outlines, surface shapes, and materials. The multiple forming tools 16 constitute a set of forming tools 16.

[0087] Next, the operation or method of forming a cone for accommodating a needle in a syringe according to the present invention will be described.

[0088] In particular, the forming tool 16 is attached via a gripping portion (shank portion) 28 to a suitable drive means.

[0089] The syringe body 12 is then rotated about the main axis (axis of rotation) XX, taking care to effect a flow of lubricating / cooling fluid in the area of ​​the tip 32 and / or tip body 36 .

[0090] The shape of the tip body 36, which assumes a cross section smaller than that of the maximum circle 40, allows the glass of the syringe body 12 to be machined while creating the hole 20, while at the same time allowing an adequate flow of lubricating coolant to pass through to avoid overheating and therefore premature wear of the forming tool 16.

[0091] Needless to say, the centre of the hole 20 (to be made) in the syringe body 12 must be aligned with the centre of the main axis XX.

[0092] After creating the hole 20, the forming tool 16 is removed and finishing of the surface of the hole 20 continues as described above using at least a second forming tool.

[0093] As can be seen from the above description, the device for shaping a cone for accommodating a needle in a syringe according to the present invention makes it possible to overcome the drawbacks present in the prior art.

[0094] In particular, the present invention contemplates the use of a molded tip that may not contain any tungsten, thereby making it possible to avoid or significantly reduce the separation (release) of tungsten compounds into the glass syringe body.

[0095] Thus, the present invention allows for a transition from glass syringes with low tungsten content (as per prior art solutions utilizing tungsten tips and employing techniques to contain the segregation (release) of tungsten on the glass body) to glass syringes that are completely free of tungsten, or that contain negligible amounts of tungsten compounds, completely less than in the prior art.

[0096] Despite the absence of tungsten, the forming tip of the present invention is able to achieve the same forming accuracy and forming speed as with a tungsten tip without the use of any controlled atmosphere.

[0097] In fact, the absence of tungsten prevents the formation of associated tungsten compounds, while the special shape of the tip body allows the use of a generous flow of lubricating cooling fluid so that the tip heating temperature can be effectively controlled and suppressed.

[0098] This shape allows for adequate cross-sectional passages for the lubricating and cooling fluid to effectively reach the most stressed areas from a mechanical and thermal point of view, thereby avoiding both excessive heating and processing defects that could lead to future cracks in the glass. For example, the suboptimal flow of coolant makes it possible to eliminate the so-called "screwing" of the syringe cone surface, typical of prior art methods. This phenomenon is manifested by irregular shapes, especially wavy shapes, of the inner syringe contour at the cone. In the case of conventional tips, this phenomenon can actually be reduced, but not eliminated, by simply slowing down the rotation speed, resulting in slower processing.

[0099] Furthermore, the mechanical wear of the forming tip of the present invention can be advantageously monitored and controlled because the tip is constantly and effectively lubricated and cooled during the mechanical processing of the glass body. Thus, even when using a material less resistant than tungsten, such as silicon nitride, the tip never reaches a critical temperature due to the presence of effective cooling and lubrication during the machining of glass, thereby reducing tip consumption and ensuring high processing accuracy.

[0100] In particular, when using a forming tool 16 made of a ceramic material doped with yttrium compounds, it is possible to obtain syringes that are completely free of tungsten (and have an irrelevant residual yttrium content) while optimizing the production process, i.e., providing the tip 32 with high strength and durability that is not possible with ceramic tips of conventional shapes and compositions.

[0101] These syringes may contain, for example, tocilizumab, darbepoetin alfa, bevacizumab, interferon beta-1a, interferon beta-1b, onabotulinumtoxinA, exenatide, imiglucerase, certolizumab pegol, glatiramer acetate, secukinumab, triptorelin, dupilumab, etanercept, epoetin, cetuximab, aflibercept, follitropin beta, teriparatide, papillomavirus vaccine, glucagon, follicle-stimulating hormone (FSH), trastuzumab, insulin lispro, insulin, adalimumab, dibotermin alfa, interferon alfa-2a, paliperidone, pembrolizumab, anakinra, antihemophilia Factor VIII, insulin glargine, enoxaparin, ranibizumab, alemtuzumab, rituximab, tenecteplase, botulinum toxin type A, epoetin beta, pegfilgrastim, filgrastim, somatropin, insulin aspart, activated heptagonist alfa, romiplostim, pegaspargase, nivolumab, abatacept, chorionic gonadotropin alfa, pegylated interferon alfa-2a, pertuzumab, pegylated interferon beta-1a, pneumococcal vaccine, denosumab, infliximab, alteplase, golimumab, basiliximab, eculizumab, ustekinumab, palivizumab, atezolizumab, insulin It is particularly suited to certain active agents that are sensitive to the presence of tungsten, such as degludec, ibalizumab, liraglutide, and omalizumab.

[0102] A further subject of the present invention is therefore that the syringe filled with one of the aforementioned active substances is characterized in that it is free of tungsten and contains a residual amount of yttrium of between 0.5 and 1 nanogram.

[0103] Those skilled in the art may make many modifications and variations to the molding apparatus described above to meet their foreseeable and particular needs, and all of these modifications and variations are within the scope of the present invention as defined in the claims.

Claims

1. A molding device (4) for a needle receiving cone (8) in a syringe body (12) of a glass syringe for medical substances, comprising: a molding tool (16) shaped to create a hole (20) for creating the receiving cone (8) in the syringe body (12); and at least one injection device (24) for injecting a lubricating / cooling liquid into the contact area between the molding tool (16) and the syringe body (12); The forming tool (16) a gripping part (28) that is grasped and moved by a corresponding driving means; a tip (32) for forming the hole (20) on the syringe body (12); a tip body (36) provided between the tip (32) and the grip portion (28) for creating the hole (20); the grip portion (28), the tip body (36), and the tip (32) are integrally connected and arranged along a main axis (X-X) that is a rotation axis of the syringe body (12) and / or the molding tool (16); With respect to a cross section perpendicular to the major axis (X-X), the tip body (36) has a non-circular cross section; In a cross section perpendicular to the major axis (X-X), the non-circular cross section is inscribed in a maximum circle (40) whose radius is the maximum distance between a point (P) on the cross section and the major axis (X-X); A molding device characterized in that the overall cross section of the tip body (36) is smaller than the cross section of the largest circle (40).

2. 2. A molding device according to claim 1, wherein the tip body (36) has, at its largest cross section on the major axis (X-X), a cross section that is less than 85% of the cross section of the largest circle (40).

3. A forming device according to claim 1 or claim 2, wherein the tip body (36) has, at its largest cross section on the major axis (X-X), a cross section that is less than 70% of the cross section of the largest circle (40).

4. 4. The molding device of claim 1, wherein the cross section of the tip body (36) defines, relative to the maximum circle (40), at least one recess (44) that allows the passage of the lubricating / cooling liquid.

5. 5. The molding apparatus of claim 4, wherein the tip body (36), in cross section along the major axis (X-X), exhibits a plurality of the recesses (44) fluidly connected to one another to create a continuous channel for the passage of the lubricating / cooling liquid.

6. 6. A molding apparatus according to claim 4 or claim 5, wherein the recesses (44) in the tip body (36) are connected to one another along the major axis (X-X) to create a continuous channel for the passage of the lubricating / cooling liquid along the tip body (36).

7. A forming device according to any one of claims 1 to 6, wherein the cross section of the tip body (36) varies along the major axis (X-X).

8. 8. A forming apparatus according to any one of claims 1 to 7, wherein the cross section of the tip body (36) tapers along the major axis (X-X) from the gripping portion (28) towards the tip (32).

9. 9. The forming apparatus of any one of claims 1 to 8, wherein the tip (32) and tip body (36) are made of a tungsten-free metallic, non-metallic, and / or ceramic material.

10. 9. A forming apparatus according to any one of claims 1 to 8, wherein the tip (32) and the tip body (36) are made entirely or at least partially of tungsten.

11. 11. The molding device according to claim 1, wherein the cross section of the tip body (36) is a regular polygon inscribed in the largest circle (40).

12. 11. The molding apparatus of any one of claims 1 to 10, wherein the cross section of the tip body (36) is a closed polyline inscribed in the largest circle (40).

13. 11. The molding device according to claim 1, wherein the cross section of the tip body (36) is a curve inscribed in the largest circle (40).

14. 14. A forming apparatus according to any one of claims 1 to 13, wherein the tip (32) tapers from the connection to the tip body (36).

15. A forming device according to any one of claims 1 to 14, wherein in a cross section perpendicular to the main axis (XX), the tip (32) has the same shape as the tip body (36).

16. A molding tool (16) having a shape to create a hole (20) for creating a receiving cone (8) in a syringe body (12) of a glass syringe, The forming tool (16) is as claimed in any one of claims 1 to 9 or any one of claims 11 to 15.

17. 17. The mold tool of claim 16, wherein the tip (32) and the tip body (36) of the mold tool (16) are made of a ceramic material doped with a yttrium compound.

18. The ceramic material is yttrium oxide (Y ２ O ３ Silicon nitride (Si) ３ N ４ ) and The yttrium oxide is present in the silicon nitride in an amount between 3% and 7% by weight, or between 4% and 6% by weight, or The ceramic material is a mixture of yttrium oxide and alumina (Al ２ O ３ 18. The mold tool of claim 17, wherein the silicon nitride comprises SiO 2 and SiO 3 , in an amount of between 7% and 13% by weight, or between 8% and 12% by weight.

19. A method for making a glass syringe for medical substances provided with a needle receiving cone (8), comprising: providing a syringe body (12) of a glass syringe provided with a side wall (23) intended to delimit a hole (20) in said receiving cone (8); Providing a forming device (4) according to any one of claims 1 to 15; rotating the syringe body (12) and / or the molding tool (16) about the main axis (X-X); and aligning the main axis (X-X) of the molding tool (16) with the axis of symmetry (S-S) of the hole (20) to be created, and then molding the side wall (23) of the syringe body (12).

20. A method for producing a syringe using a molding tool (16) according to claim 17 or claim 18, comprising: A method of producing a syringe, wherein the syringe contains no tungsten and a residual amount of yttrium between 0.5 nanograms and 1 nanogram.

21. Tocilizumab, darbepoetin alfa, bevacizumab, interferon beta-1a, interferon beta-1b, onabotulinumtoxinA, exenatide, imiglucerase, certolizumab pegol, glatiramer acetate, secukinumab, triptorelin, dupilumab, etanercept, epoetin, cetuximab, aflibercept, follitropin beta, teriparatide, papillomavirus vaccine, glucagon, follicle-stimulating hormone (FSH), trastuzumab, insulin lispro, insulin, adalimumab, dibotermin alfa, interferon alfa-2a, paliperidone, pembrolizumab, anakinra, antihemophilic factor VII I factor), insulin glargine, enoxaparin, ranibizumab, alemtuzumab, rituximab, tenecteplase, botulinum toxin type A, epoetin beta, pegfilgrastim, filgrastim, somatropin, insulin aspart, activated heptagonist alfa, romiplostim, pegaspargase, nivolumab, abatacept, chorionic gonadotropin alfa, pegylated interferon alfa-2a, pertuzumab, pegylated interferon beta-1a, pneumococcal vaccine, denosumab, infliximab, alteplase, golimumab, basiliximab, eculizumab, ustekinumab, palivizumab, atezolizumab, insulin 21. The method for producing a syringe according to claim 20, wherein the syringe is filled with any one of the active substances degludec, ibalizumab, liraglutide, and omalizumab.

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