Vials with optimized neck for improved side compression performance

Abstract

The present invention relates to a glass container comprising: i) a glass tube having a first end and another end, wherein the glass tube has a longitudinal axis L tube and comprising: ia) a top region at the first end of the glass tube, the top region having an outer diameter d t ib) adjacent to the top region of the joining area; ic) adjacent to the neck region of the joining area, the outer diameter of the neck region is d n , d n <d t , and the minimum thickness of the glass in the neck area is l n id) adjacent to the neck region of the shoulder region; and ie) adjacent to the shoulder region and extending to the other end of the body region of the glass tube, the thickness of the glass body region is l b And the outer diameter of the body area is d b , d b >d t ii) a glass bottom, closing the other end of the glass tube; the joining region has an outer surface, the outer surface of the neck region is generally arc-shaped at the end, and its outer radius is r s , and the outer contour of the transition area between the top area and the neck area of the glass container is 2×[l n / l b ]×r s A minimum value limit.

Description

Technical Field

[0001] The present invention relates to a glass container comprising as container components: i) a glass tube having a first end and another end, wherein the glass tube is characterized by a longitudinal axis L tube And the direction from top to bottom includes: ia) a top region located at a first end of the glass tube; ib) a joining region adjacent to the top region; ic) a neck region adjacent to the joining region; id) a shoulder region adjacent to the neck region; and ie) a body region adjacent to the shoulder region and extending to the other end of the glass tube; and ii) a glass bottom that closes the other end of the glass tube.

[0002] Furthermore, the present invention relates to a plurality of glass containers, to a process for producing glass containers, to a glass container obtainable by the process, to a process for producing closed glass containers, to a closed glass container obtainable by the process, and to the use of glass containers for packaging pharmaceutical compositions. Background Art

[0003] In the pharmaceutical industry, containers are used as the primary packaging for pharmaceuticals. Traditionally, glass containers have been the most widely used material due to their stability, visibility, durability, rigidity, moisture resistance, ease of sealing, and affordability. Glass containers currently on the market for medical purposes include glass containers made from glass tubing and blown glass containers. The manufacturing methods for tubing-based and blown glass containers are well known. Tubular glass containers are formed from prefabricated glass tubing (mother tube) through forming and separation. In a typical manufacturing process, a glass tube is loaded into the head of a rotating machine. As the tube rotates about its main axis, one end of the tube is heated to the softening point of the glass to form the top region, which together define the neck and shoulder regions of the glass container's top. After the top region is formed, the tube is heated again to its softening point at a defined location above the thus-formed top region. The tube is then pulled along its main axis to stretch and expand the heat-softened portion, thereby creating and shaping the desired container base. Blown glass containers are produced by directly shaping a glass melt through a blown or press-blown process. Blown glass containers include, for example, spray bottles and infusion bottles (such as those described in DE 196 22 550 A1). However, blown glass containers typically have higher wall thickness tolerances, including local portions with greater wall thickness and smaller wall thickness. Due to the refraction of light, they are generally not suitable for optical inspection of filled containers through the glass wall, which makes blown glass containers unsuitable for use in many pharmaceutical applications.

[0004] Glass vials used for pharmaceutical packaging must pass numerous mechanical tests. For example, if the glass vials are used in automated sampling machines in scientific laboratories or medical institutions, as well as during stoppering, shipping, and storage, high axial loads, as measured by the so-called "vertical compression test," may be required. In addition to a certain resistance to axial loads, glass containers should also possess a sufficiently high burst strength, as measured by the so-called "burst pressure test." For example, if a pharmaceutical formulation is freeze-dried after being filled into a glass container, a burst pressure test is appropriate to identify the weakest point on the inner or outer surface of the container.

[0005] Another mechanical test that is often used to determine the mechanical strength of glass vials is the so-called "lateral compression test". This test is used, for example, to determine the effect that a certain back pressure may have on a glass vial during transport in a deheating tunnel or generally during transport on a filling line. In this test, the glass vial is placed between the upper and lower parts of a test tool (e.g. Figure 1 ), where a defined load is applied directly to the body area of the glass vial.

[0006] Because glass vials used in the pharmaceutical industry are subject to only a very low probability of failure when subjected to mechanical stress, glass vials used to fill pharmaceutical preparations should feature sufficiently high strength, particularly the ability to withstand the pressures in the aforementioned lateral compression test. While ISO vials already meet these requirements for increased stability, their strength can be further improved. For example, to increase the strength of glass containers, the glass surface of the container can be tempered by chemical treatment, such as disclosed in WO 1981 / 002572 A1 or EP 0495936 A1. However, this tempering process requires additional process steps in the manufacture of the glass container, and in the case of chemical treatment, modification of the glass surface is also necessary. Therefore, chemically strengthening the glass surface often requires new approvals for the glass container. Summary of the Invention

[0007] In general, the present invention aims to at least partially overcome the drawbacks of the prior art. Another object of the present invention is to provide a glass container, preferably a glass vial, for pharmaceutical packaging, which has improved strength in a side compression test in which a load is applied directly to the body of the glass container (particularly compared to ISO vials known in the prior art). Another object of the present invention is to provide a glass container, preferably a glass vial, for pharmaceutical packaging, which has improved strength in a side compression test in which a load is applied directly to the body of the glass container (particularly compared to ISO vials known in the prior art), and which is produced using a process 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 process for producing a glass container, preferably a glass vial, for pharmaceutical packaging, which has improved strength in a side compression test in which a load is applied directly to the body of the glass container (particularly compared to ISO vials known in the prior art), and which is produced from a prefabricated glass tube by forming and separating, without requiring additional process steps (such as modifying the glass surface).

[0008] The independent claims at least partially achieve at least one of the above objects, preferably more than one of the objects. The dependent claims provide preferred embodiments that help to at least partially achieve at least one of the objects.

[0009] At least one of the objects according to the present invention is achieved by an embodiment 1 of a glass container 1 comprising as container parts:

[0010] i) A glass tube having a first end and another end, wherein the glass tube is characterized by a longitudinal axis L tube And in the direction from top to bottom inclusive:

[0011] ia) a top region located at the first end of the glass tube, wherein the outer diameter of the top region is d t ;

[0012] ib) a joining region immediately adjacent to the top region;

[0013] ic) a neck region adjacent to the joining region, wherein the outer diameter of the neck region is d n , d n <d t , and the minimum thickness of the glass in the neck region is l n ;

[0014] id) a shoulder region immediately adjacent to the neck region; and

[0015] ie) a body region adjacent to the shoulder region and extending to the other end of the glass tube, wherein the thickness of the glass in the body region is 1 b And wherein the outer diameter of the body region is d b , d b >d t ;

[0016] ii) a glass bottom, the glass bottom sealing the other end of the glass tube;

[0017] The joining area has an outer surface which is substantially arc-shaped at the end where the joining area merges into the neck area, and the outer radius of the substantially arc-shaped area is r s , and the following conditions are met:

[0018] 2×[l n / l b ]×r s ≥0.9mm;

[0019] Preferably 2×[l n / l b ]×r s ≥1.0mm;

[0020] More preferably 2×[l n / l b ]×r s ≥1.1mm;

[0021] Even more preferably 2×[l n / l b ]×r s ≥1.2mm;

[0022] Even more preferably 2×[l n / l b ]×r s ≥1.3mm;

[0023] Even more preferably 2×[l n / l b ]×r s ≥1.4mm;

[0024] Even more preferably 2×[l n / l b ]×r s ≥1.5mm;

[0025] Even more preferably 2×[l n / l b ]×r s ≥1.7mm;

[0026] Even more preferably 2×[l n / l b ]×r s ≥2.0mm;

[0027] Most preferably 2×[l n / l b ]×r s ≥2.5mm.

[0028] At least one of the objects according to the present invention is also achieved by an embodiment 1 of a plurality of glass containers 1, each glass container comprising as container parts:

[0029] i) A glass tube having a first end and another end, wherein the glass tube is characterized by a longitudinal axis L tube And the directions from top to bottom include:

[0030] ia) a top region located at the first end of the glass tube, wherein the outer diameter of the top region is d t ;

[0031] ib) a joining region immediately adjacent to the top region;

[0032] ic) a neck region adjacent to the joining region, wherein the outer diameter of the neck region is d n , d n <d t ;

[0033] id) a shoulder region immediately adjacent to the neck region; and

[0034] ie) a body region adjacent to the shoulder region and extending to the other end of the glass tube, wherein the thickness of the glass in the body region is 1 b And wherein the outer diameter of the body region is d b , d b >d t ;

[0035] ii) a glass bottom, the glass bottom sealing the other end of the glass tube;

[0036] wherein 50% of the glass containers (100) comprised in the plurality of glass containers (100) have a breaking load in a neck crush test as described herein of at least 1100 N, preferably at least 1200 N, more preferably at least 1300 N, even more preferably at least 1400 N, even more preferably at least 1500 N, even more preferably at least 1600 N, even more preferably at least 1800 N, even more preferably at least 2000 N, even more preferably at least 2500 N and most preferably at least 3000 N.

[0037] In embodiment 2 of the plurality of glass containers 1, the plurality of glass containers 1 are designed according to embodiment 1 thereof, wherein:

[0038] ib) wherein the joining region has an outer surface which is substantially arcuate at the end where the joining region merges into the neck region, the outer radius of the substantially arcuate region being r s ;

[0039] ic) The minimum thickness of the glass in the neck area is l n ;and

[0040] For at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, the following conditions are met:

[0041] 2×[l n / l b ]×r s ≥0.9mm;

[0042] Preferably 2×[l n / l b ]×r s ≥1.0mm;

[0043] More preferably 2×[l n / l b ]×r s ≥1.1mm;

[0044] Even more preferably 2×[l n / l b ]×r s ≥1.2mm;

[0045] Even more preferably 2×[l n / l b ]×r s ≥1.3mm;

[0046] Even more preferably 2×[l n / l b ]×r s ≥1.4mm;

[0047] Even more preferably 2×[l n / l b ]×r s ≥1.5mm;

[0048] Even more preferably 2×[l n / l b ]×r s ≥1.7mm;

[0049] Even more preferably 2×[ln / l b ]×r s ≥2.0mm;

[0050] Most preferably 2×[l n / l b ]×r s ≥2.5mm.

[0051] According to the present invention, a "plurality of glass containers" preferably comprises at least 10 glass containers, preferably at least 25 glass containers, more preferably at least 50 glass containers, even more preferably at least 75 glass containers, and most preferably at least 100 glass containers. Furthermore, the plurality of glass containers is preferably randomly collected and, in particular, has not been selected for any particular properties. For example, the plurality of glass containers may be a group of containers packaged together on a typical shipping pallet.

[0052] Surprisingly, it has been found that by controlling the area of the glass container including the joining area and the neck area (ie, Figure 1 As shown, the outer contour of the glass container (in the areas not in contact with the upper and lower parts of the test tool used to apply the desired load in the side compression test known in the prior art) can significantly improve the mechanical strength of the glass container in the side compression test known in the prior art (i.e., a static load test in which the load is applied directly to the body area of the glass container). It was also discovered that the glass containers that passed the neck side compression test as described herein are also characterized by improved mechanical strength in the side compression test known in the prior art. This is again surprising because, in the side compression test known in the prior art, the load is applied directly to the body area of the glass container, not to the neck area. One skilled in the art would not therefore expect that the improved mechanical strength to laterally applied loads in the neck area would also improve the mechanical strength to loads in the body area.

[0053] In embodiment 2 of the glass container 1 according to the present invention or in embodiment 3 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 1 thereof or the plurality of glass containers 1 are designed according to embodiment 1 or embodiment 2 thereof, wherein for the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, the following conditions are satisfied:

[0054] If the glass container is placed on a flat horizontal substrate on which the outer surface of the body region lies, then the longitudinal axis L of the glass tube is located centrally in the glass container and includes the tubeIn any given cross-section of the glass container in the plane of the glass container, f(x) defines the vertical distance between the substrate and the outer surface of the glass container at a given position x, and l(x) defines the thickness of the glass at a given position x, wherein the vertical distance is perpendicular to the longitudinal axis L. tube Measure the thickness of the glass l(x) in the direction of

[0055] k(x)=|f”(x) / [1+f'(x) 2 ] 3 / 2 Defines the absolute value of the curvature of f(x) at a given position x; and in the interval between x=P1 and x=P2, for any concave curvature in the interval, [l(x) / l b ] 3 The minimum value of / k(x) is at least 0.35 mm, preferably at least 0.5 mm, more preferably at least 0.7 mm, even more preferably at least 0.9 mm, even more preferably at least 1.1 mm, even more preferably at least 1.3 mm, even more preferably at least 1.5 mm, even more preferably at least 1.7 mm, even more preferably at least 2.0 mm and most preferably at least 2.5 mm, wherein P2 defines f(x) as 1 / 2×d b –1 / 4×d t –1 / 4×d n And P1 limits f(x) to P2–d t / 2+d n / 2 of the x position.

[0056] In Example 3 of the glass container 1 according to the present invention or in Example 4 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to Example 1 or Example 2 thereof, or the plurality of glass containers 1 are designed according to any one of Examples 1 to 3 thereof, wherein the minimum thickness of the glass in the neck region is 1. n , and wherein for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1 and most preferably each glass container, the following conditions are met:

[0057] l n / l b ≥1.3;

[0058] Preferably n / l b ≥1.4;

[0059] More preferably n / l b ≥1.45;

[0060] Even more preferably n / l b ≥1.5;

[0061] Most preferably n / l b ≥1.6.

[0062] In embodiment 4 of the glass container 1 according to the present invention or in embodiment 5 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 3 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 4 thereof, wherein, for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1 and most preferably each glass container, d t In the range of 12 mm to 14 mm, preferably in the range of 12.5 mm to 13.5 mm and more preferably in the range of 12.7 mm to 13.2 mm or d t In the range of 19 mm to 21 mm, preferably in the range of 19.5 mm to 20.5 mm and more preferably in the range of 19.7 mm to 20.2 mm.

[0063] In Example 5 of the glass container 1 according to the present invention or in Example 6 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of Examples 1 to 4 thereof, or the plurality of glass containers 1 are designed according to any one of Examples 1 to 5 thereof, wherein for the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, one of the following conditions is satisfied:

[0064] -Fill volume is in the range of 1ml to 8ml, and d n within the range of 9 mm to 12 mm, preferably within the range of 9.5 mm to 10.5 mm, more preferably within the range of 9.7 mm to 10.3 mm, even more preferably within the range of 9.8 mm to 10.3 mm and most preferably within the range of 9.9 mm to 10.3 mm;

[0065] - Fill volume is in the range of 8.5ml to 22ml, and d n within the range of 14.5 mm to 18 mm, preferably within the range of 15.2 mm to 16.5 mm, more preferably within the range of 15.5 mm to 16.3 mm, even more preferably within the range of 15.7 mm to 16.3 mm and most preferably within the range of 15.9 mm to 16.3 mm; or

[0066] - Fill volume is in the range of 22.5ml to 150ml, and d nIn the range of 15.0 mm to 20 mm, preferably in the range of 16.0 mm to 17.5 mm, more preferably in the range of 16.5 mm to 17.3 mm, even more preferably in the range of 16.7 mm to 17.3 mm and most preferably in the range of 16.9 mm to 17.3 mm.

[0067] In embodiment 6 of the glass container 1 according to the present invention or in embodiment 7 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 5 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 6 thereof, wherein, for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1 and most preferably for each glass container, d b In the range of 14mm to 60mm, preferably in the range of 15mm to 32mm, more preferably in the range of 15mm to 25mm, even more preferably in the range of 15mm to 23mm and most preferably in the range of 15mm to 17mm.

[0068] In embodiment 7 of the glass container 1 according to the present invention or in embodiment 8 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 6 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 7 thereof, wherein, for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1 and most preferably for each glass container, d t -d n In the range of 1.5 mm to 6 mm, preferably in the range of 2 mm to 5 mm, more preferably in the range of 2.5 mm to 4.5 mm, even more preferably in the range of 2.5 mm to 4 mm and most preferably in the range of 2.5 mm to 3.5 mm.

[0069] In embodiment 8 of the glass container 1 according to the present invention or in embodiment 9 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 7 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 8 thereof, wherein, for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1 and most preferably each glass container, d b -d n In the range of 4 mm to 35 mm, preferably in the range of 4 mm to 15 mm, more preferably in the range of 5 mm to 13 mm, even more preferably in the range of 5 mm to 8 mm and most preferably in the range of 5 mm to 6 mm.

[0070] In embodiment 9 of the glass container 1 according to the present invention or in embodiment 10 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 8 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 9 thereof, wherein the shoulder of the shoulder region is characterized by a shoulder angle α, and wherein for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1 and most preferably each glass container, α is in the range of 10° to 70°, preferably in the range of 25° to 60°, more preferably in the range of 33° to 55°, even more preferably in the range of 37° to 50° and most preferably in the range of 38° to 45°.

[0071] In embodiment 10 of the glass container 1 according to the present invention or in embodiment 11 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 9 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 10 thereof, wherein for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1 and most preferably each glass container, the container parts from the glass bottom to the top area are rotationally symmetric around a longitudinal axis that passes perpendicularly through the center of the glass bottom.

[0072] In embodiment 11 of the glass container 1 according to the present invention or in embodiment 12 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 10 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 11 thereof, wherein for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers comprised in the plurality of glass containers 1 and most preferably each glass container, throughout the body region, the wall thickness n of the glass tube is in each case the mean value of the wall thickness of the body region. b Within the range of ±0.2 mm, preferably within the range of ±0.1 mm, more preferably within the range of ±0.08 mm and most preferably within the range of ±0.05 mm.

[0073] In embodiment 12 of the glass container 1 according to the present invention or in embodiment 13 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 11 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 12 thereof, wherein the glass container has a glass mass m g and internal volume V i , and wherein for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1 and most preferably each glass container, the following conditions are met:

[0074] m g / V i 0.75 <2.0;

[0075] Preferably m g / V i 0.75 <1.75.

[0076] In embodiment 13 of the glass container 1 according to the present invention or in embodiment 14 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 12 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 13 thereof, wherein the glass container has an inner volume V i , and wherein for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1 and most preferably for each glass container, V i In the range of 2 ml to 150 ml, preferably in the range of 3 ml to 100 ml, more preferably in the range of 3 ml to 50 ml, even more preferably in the range of 3 ml to 15 ml, most preferably in the range of 3 ml to 7 ml.

[0077] In embodiment 14 of the glass container 1 according to the present invention or embodiment 15 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 13 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 14 thereof, wherein the glass container has a height h c , and wherein for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1 and most preferably for each glass container, h c In the range of 15mm to 100mm, preferably in the range of 20mm to 60mm, more preferably in the range of 25mm to 55mm, even more preferably in the range of 30mm to 50mm and most preferably in the range of 34mm to 46mm.

[0078] In Example 15 of the glass container 1 according to the present invention, or in Example 16 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any of Examples 1 to 14 thereof, or the plurality of glass containers 1 is designed according to any of Examples 1 to 15 thereof, wherein the glass container 1, or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, is a packaging container for a medical or pharmaceutical packaging article, or a medical and pharmaceutical packaging article. Preferred pharmaceutical packaging articles are pharmaceutical compositions. Preferably, the glass container 1, or the glass containers contained in the plurality of glass containers 1, is suitable for packaging parenteral drugs according to Section 3.2.1 of the 7th edition of the European Pharmacopoeia, effective 2011.

[0079] In embodiment 16 of the glass container 1 according to the present invention or in embodiment 17 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 15 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 16 thereof, wherein the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1 and most preferably each glass container is a vial.

[0080] In embodiment 17 of the glass container 1 according to the present invention or in embodiment 18 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 16 thereof, or the plurality of glass containers 1 are designed according to any one of embodiments 2 to 17 thereof, wherein the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, is a vial with an internal volume of 1 to 8 ml, and wherein the following conditions are met:

[0081] d n ≥9.5mm;

[0082] r s ≥0.5mm.

[0083] In embodiment 18 of the glass container 1 according to the present invention or in embodiment 19 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 17 thereof or the plurality of glass containers 1 are designed according to embodiment 18 thereof, wherein for the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, the following conditions are satisfied:

[0084] d n ≥9.5mm;

[0085] Preferably dn ≥9.6mm;

[0086] More preferably d n ≥9.7mm;

[0087] Even more preferably d n ≥9.8mm;

[0088] The most preferred n ≥9.9mm.

[0089] In embodiment 19 of the glass container 1 according to the present invention or in embodiment 20 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 17 or 18 thereof, or the plurality of glass containers 1 are designed according to embodiment 18 or 19 thereof, wherein for the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, the following conditions are met:

[0090] r s ≥0.5mm;

[0091] Preferably s ≥0.55mm;

[0092] More preferably s ≥0.6mm;

[0093] Even more preferably s ≥0.7mm;

[0094] Most preferably r s ≥0.8mm.

[0095] In embodiment 20 of the glass container 1 according to the present invention or in embodiment 21 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 17 to 19 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 18 to 20 thereof, wherein the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, is a vial with a size setting of "2R" or "4R" according to DIN EN ISO 8362-1:2016-06.

[0096] In embodiment 21 of the glass container 1 according to the present invention or in embodiment 22 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 16 thereof, or the plurality of glass containers 1 are designed according to any one of embodiments 2 to 17 thereof, wherein the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, is a vial with an internal volume of 8.5 to 22 ml, and wherein the following conditions are met:

[0097] d n ≥15.5mm;

[0098] r s ≥0.5mm.

[0099] In embodiment 22 of the glass container 1 according to the present invention or in embodiment 23 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 21 thereof or the plurality of glass containers 1 are designed according to embodiment 22 thereof, wherein for the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, the following conditions are met:

[0100] d n ≥15.5mm;

[0101] Preferably d n ≥15.6mm;

[0102] More preferably d n ≥15.7mm;

[0103] Even more preferably d n ≥15.8mm;

[0104] The most preferred n ≥15.9mm.

[0105] In embodiment 23 of the glass container 1 according to the present invention or in embodiment 24 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 21 or 22 thereof, or the plurality of glass containers 1 are designed according to embodiment 22 or 23 thereof, wherein for the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, the following conditions are met:

[0106] r s ≥0.5mm;

[0107] Preferably s ≥0.55mm;

[0108] More preferably s ≥0.6mm;

[0109] Even more preferably s ≥0.7mm;

[0110] Most preferably r s ≥0.8mm.

[0111] In embodiment 24 of the glass container 1 according to the present invention or in embodiment 25 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 21 to 23 thereof or the plurality of glass containers 1 is designed according to any one of embodiments 22 to 24 thereof, wherein the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, is a vial with a size setting of "6R", "8R" or "10R" according to DIN EN ISO 8362-1:2016-06.

[0112] In embodiment 25 of the glass container 1 according to the present invention or in embodiment 26 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 16 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 2 to 17 thereof, wherein the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, is a vial with an internal volume of 22.5 to 150 ml, and wherein the following conditions are met:

[0113] d n ≥16.5mm;

[0114] r s ≥0.5mm.

[0115] In embodiment 26 of the glass container 1 according to the present invention or in embodiment 27 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 25 thereof or the plurality of glass containers 1 are designed according to embodiment 26 thereof, wherein for the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, the following conditions are met:

[0116] d n ≥16.5mm;

[0117] Preferably d n ≥16.6mm;

[0118] More preferably d n ≥16.7mm;

[0119] Even more preferably d n ≥16.8mm;

[0120] The most preferred n ≥16.9mm.

[0121] In embodiment 27 of the glass container 1 according to the present invention or in embodiment 28 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 25 or 26 thereof, or the plurality of glass containers 1 is designed according to embodiment 26 or 27 thereof, wherein for the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, the following conditions are met:

[0122] r s ≥0.5mm;

[0123] Preferably s ≥0.55mm;

[0124] More preferably s ≥0.6mm;

[0125] Even more preferably s ≥0.7mm;

[0126] Most preferably r s ≥0.8mm.

[0127] In embodiment 28 of the glass container 1 according to the present invention or in embodiment 29 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 25 to 27 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 26 to 28 thereof, wherein the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers contained in the plurality of glass containers 1, and most preferably each glass container, is a vial with a size setting of "20R", "25R", "30R", "50R" or "100R" according to DIN EN ISO 8362-1:2016-06.

[0128] In Example 29 of the glass container 1 according to the present invention or in Example 30 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any of Examples 1 to 28 thereof, or the plurality of glass containers 1 are designed according to any of Examples 1 to 29 thereof, wherein the glass is selected from borosilicate glass, aluminosilicate glass, soda-lime glass, and fused silica. The "soda-lime glass" according to the present invention is an alkali glass / alkaline earth metal glass / silicate glass according to Table 1 of ISO 12775 (first edition 1997-10-15).

[0129] In embodiment 30 of the glass container 1 according to the present invention or in embodiment 31 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 29 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 30 thereof, wherein the glass container includes a coating that at least partially overlaps the outer surface, the inner surface, or both the outer surface and the inner surface of the glass tube.

[0130] In embodiment 31 of the glass container 1 according to the present invention or embodiment 32 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 30 thereof or the plurality of glass containers 1 is designed according to embodiment 31 thereof, wherein the coating comprises a silicone resin, a silane, or a mixture thereof, wherein the silicone resin or silane may be cross-linked or non-cross-linked. For example, US 2011 / 0006028 A1, US 4,420,578, or WO 2014 / 105350 A3 disclose suitable silanes and silicone resins for treating the surface of glass containers.

[0131] In embodiment 32 of the glass container 1 according to the present invention or in embodiment 33 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 30 thereof or the plurality of glass containers 1 is designed according to embodiment 31 thereof, wherein the coating preferably comprises a coating on the outer surface of the glass tube (i.e., in the direction toward the inner volume V of the glass container). i The coating is preferably a coating as described in US 2013 / 171456 A1.

[0132] In embodiment 33 of the glass container 1 according to the present invention or embodiment 34 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 32 thereof or the plurality of glass containers 1 are designed according to embodiment 33 thereof, wherein the coating further comprises an interface layer located between the coupling agent layer and the polymer layer, and the interface layer comprises one or more chemical compositions of the polymer layer bonded to one or more chemical compositions of the coupling agent layer.

[0133] In embodiment 34 of the glass container 1 according to the present invention or in embodiment 35 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 32 or 33 thereof or the plurality of glass containers 1 are designed according to embodiment 33 or 34 thereof, wherein the coupling agent comprises at least one of the following: a first silane chemical composition, a hydrolyzate or an oligomer thereof; and a chemical composition formed by oligomerization of at least the first silane chemical composition and the second silane chemical composition, wherein the first silane chemical composition and the second silane chemical composition are different chemical compositions.

[0134] In embodiment 35 of the glass container 1 according to the present invention or in embodiment 36 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 34 thereof or the plurality of glass containers 1 are designed according to embodiment 35 thereof, wherein the first silane chemical composition is an aromatic silane chemical composition.

[0135] In embodiment 36 of the glass container 1 according to the present invention or in embodiment 37 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 32 thereof or the plurality of glass containers 1 are designed according to embodiment 33 thereof, wherein the coupling agent comprises a silsesquioxane chemical composition comprising an aromatic portion and an amino-containing portion.

[0136] In embodiment 37 of the glass container 1 according to the present invention or in embodiment 38 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 32 thereof or the plurality of glass containers 1 are designed according to embodiment 33 thereof, wherein the coupling agent comprises at least one of: a mixture of a first silane chemical composition and a second silane chemical composition; and a chemical composition formed by oligomerization of at least the first silane chemical composition and the second silane chemical composition, wherein the first silane chemical composition and the second silane chemical composition are different chemical compositions.

[0137] In embodiment 38 of the glass container 1 according to the present invention or in embodiment 39 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to embodiment 37 thereof or the plurality of glass containers 1 are designed according to embodiment 38 thereof, wherein the first silane chemical composition is an aromatic silane chemical composition.

[0138] In embodiment 39 of the glass container 1 according to the present invention or in embodiment 40 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 32 to 39 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 33 to 39 thereof, wherein the polymer chemical composition is a polyimide chemical composition.

[0139] In embodiment 40 of the glass container 1 according to the present invention or embodiment 41 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 39 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 40 thereof, wherein the internal volume V of the glass container i Containing a pharmaceutical composition.

[0140] In embodiment 41 of the glass container 1 according to the present invention or in embodiment 42 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 40 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 41 thereof, wherein the glass container 1 comprises a closure, preferably a lid, on the top of the glass container 1 .

[0141] In Example 42 of the glass container 1 according to the present invention or in Example 43 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of Examples 1 to 41 thereof or the plurality of glass containers 1 are designed according to any one of Examples 1 to 42 thereof, wherein the glass container 1 has not yet been heat tempered.

[0142] In embodiment 43 of the glass container 1 according to the present invention or in embodiment 44 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 42 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 43 thereof, wherein the glass of at least the neck region of the glass container 1 is characterized in that sodium is present in the thickness n of the glass. b Basically evenly distributed.

[0143] In embodiment 44 of the glass container 1 according to the present invention or in embodiment 45 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 43 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 44 thereof, wherein the glass of at least the neck region of the glass container 1 is characterized in that potassium is present in the glass thickness n b Basically evenly distributed.

[0144] In embodiment 45 of the glass container 1 according to the present invention or in embodiment 46 of the plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 1 to 44 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 45 thereof, wherein the glass of at least the neck region of the glass container 1 is characterized in that the compressive stress (CS) of the outer surface area of the neck region is less than 500 MPa, preferably less than 300 MPa, even more preferably less than 170 MPa, even more preferably less than 80 MPa, even more preferably less than 30 MPa, and most preferably less than 15 MPa. For example, the compressive stress can be measured using a polarimeter suitable for the vial geometry.

[0145] At least one of the objects according to the present invention is achieved by embodiment 1 of a process 1 for producing an article, preferably a glass container, more preferably a glass container 1 according to the present invention or a glass container comprised in a plurality of glass containers 1 according to the present invention, the process comprising as process steps the following steps:

[0146] I) Providing a glass tube having a first end and another end, wherein the glass tube is characterized by a longitudinal axis L tube , outer diameter d b and glass thickness n b ;

[0147] 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 rotates about its main axis;

[0148] III) while the heated glass tube is rotated about its main axis, shaping the outer contour of the first end portion so as to obtain:

[0149] ia) a top region located at the first end of the glass tube, wherein the outer diameter of the top region is d t , d t <d b ;

[0150] ib) a joining region immediately adjacent to the top region;

[0151] ic) a neck region adjacent to the joining region, wherein the outer diameter of the neck region is d n , d n <d t , and the minimum thickness of the glass in the neck region is l n ;as well as

[0152] id) the shoulder region immediately adjacent to the neck region;

[0153] The joining area has an outer surface which is substantially arc-shaped at the end where the joining area merges into the neck area, and the outer radius of the substantially arc-shaped area is r s , and wherein the shaping in process step III) is such that the outer contour c of the first end portion of the glass tube is obtained outer , and the following conditions are met:

[0154] 2×[l n / l b ]×r s ≥0.9mm;

[0155] Preferably 2×[l n / l b ]×r s ≥1.0mm;

[0156] More preferably 2×[l n / l b ]×r s ≥1.1mm;

[0157] Even more preferably 2×[l n / l b ]×r s ≥1.2mm;

[0158] Even more preferably 2×[l n / l b ]×r s ≥1.3mm;

[0159] Even more preferably 2×[l n / l b ]×r s ≥1.4mm;

[0160] Even more preferably 2×[l n / l b ]×r s ≥1.5mm;

[0161] Even more preferably 2×[l n / l b ]×r s ≥1.7mm;

[0162] Even more preferably 2×[l n / l b ]×r s ≥2.0mm;

[0163] Most preferably 2×[l n / l b ]×r s ≥2.5mm.

[0164] The "softening temperature" of a glass is the temperature at which the viscosity of the glass (determined according to ISO 7884-6:1987) is 10 7.6 Temperature at dPa×sec.

[0165] In Example 2 of Process 1 according to the present invention, Process 1 is designed according to its Example 1, wherein the process comprises the following additional process steps:

[0166] IV) heating the glass tube at a defined location above the first end formed in process step III) 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 main axis;

[0167] V) pulling the heated glass tube while the glass tube is rotated about its major axis to stretch it and create a container closure;

[0168] VI) While the heated glass tube is rotated about its major axis, preferably when the temperature is elevated above its glass transition temperature, preferably above its softening temperature, the container closure is formed to obtain a body region adjacent to the shoulder region and a glass bottom.

[0169] In embodiment 3 of process 1 according to the present invention, process 1 is designed according to embodiment 1 or 2 thereof, wherein in process step III), the outer contours c of the joining region and the neck region are formed using one or more forming tools, preferably one or more forming rollers, acting on predetermined positions of the outer surfaces of the heated joining region and the heated neck region. outer .

[0170] In Example 4 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 3 thereof, wherein the shaping in Process Step III) is such that an outer contour c of the first end portion of the glass tube having the following characteristics is obtained: outer :

[0171] If the glass container is placed on a flat horizontal substrate on which the outer surface of the body region lies, then the longitudinal axis L of the glass tube is located centrally in the glass container and includes the tube In any given cross-section of the glass container in the plane of the glass container, f(x) defines the vertical distance between the substrate and the outer surface of the glass container at a given position x, and l(x) defines the thickness of the glass at a given position x, wherein the vertical distance is perpendicular to the longitudinal axis L. tube Measure the thickness of the glass l(x) in the direction of

[0172] k(x)=|f”(x) / [1+f'(x) 2 ] 3 / 2Defines the absolute value of the curvature of f(x) at a given position x; and in the interval between x=P1 and x=P2, for any concave curvature in the interval, [l(x) / l b ] 3 The minimum value of / k(x) is at least 0.35 mm, preferably at least 0.5 mm, more preferably at least 0.7 mm, even more preferably at least 0.9 mm, even more preferably at least 1.1 mm, even more preferably at least 1.3 mm, even more preferably at least 1.5 mm, even more preferably at least 1.7 mm, even more preferably at least 2.0 mm and most preferably at least 2.5 mm, wherein P2 defines f(x) as 1 / 2×d b –1 / 4×d t –1 / 4×d n x position and P1 defines f(x) to be P2–d t / 2+d n / 2 of the x position.

[0173] In Example 5 of Process 1 according to the present invention, Process 1 is designed according to any one of its Examples 1 to 4, wherein the shaping in the process step III) is such that when the minimum thickness of the glass in the neck region is l n When the following conditions are met:

[0174] l n / l b ≥1.3;

[0175] Preferably n / l b ≥1.4;

[0176] More preferably n / l b ≥1.45;

[0177] Even more preferably n / l b ≥1.5;

[0178] Most preferably n / l b ≥1.6.

[0179] In Example 6 of Process 1 according to the present invention, Process 1 is designed according to any one of its Examples 1 to 5, wherein the shaping in process step III) is such that d t In the range of 12 mm to 14 mm, preferably in the range of 12.5 mm to 13.5 mm and more preferably in the range of 12.7 mm to 13.2 mm or d tIn the range of 19 mm to 21 mm, preferably in the range of 19.5 mm to 20.5 mm and more preferably in the range of 19.7 mm to 20.2 mm.

[0180] In Example 7 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 6 thereof, wherein the shaping in process step III) is such that:

[0181] -Filling volume ranges from 1ml to 8ml, d n in the range of 9 mm to 12 mm, preferably, in the range of 9.5 mm to 10.5 mm, more preferably in the range of 9.7 mm to 10.3 mm, even more preferably in the range of 9.8 mm to 10.3 mm and most preferably in the range of 9.9 mm to 10.3 mm;

[0182] -Fill volume ranges from 8.5ml to 22ml, d n within the range of 14.5 mm to 18 mm, preferably within the range of 15.2 mm to 16.5 mm, more preferably within the range of 15.5 mm to 16.3 mm, even more preferably within the range of 15.7 mm to 16.3 mm and most preferably within the range of 15.9 mm to 16.3 mm; or

[0183] -Fill volume ranges from 22.5ml to 150ml, d n In the range of 15.0 mm to 20 mm, preferably in the range of 16.0 mm to 17.5 mm, more preferably in the range of 16.5 mm to 17.3 mm, even more preferably in the range of 16.7 mm to 17.3 mm and most preferably in the range of 16.9 mm to 17.3 mm.

[0184] In Example 8 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 7 thereof, wherein the shaping in process step III) is such that d t In the range of 14mm to 60mm, preferably in the range of 15mm to 32mm, more preferably in the range of 15mm to 25mm, even more preferably in the range of 15mm to 23mm and most preferably in the range of 15mm to 17mm.

[0185] In Example 9 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 8 thereof, wherein the shaping in process step III) is such that d t –d nIn the range of 1.5 mm to 6 mm, preferably in the range of 2 mm to 5 mm, more preferably in the range of 2.5 mm to 4.5 mm, even more preferably in the range of 2.5 mm to 4 mm and most preferably in the range of 2.5 mm to 3.5 mm.

[0186] In Example 10 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 9 thereof, wherein the shaping in Process Step III) is such that d b –d n In the range of 4 mm to 35 mm, preferably in the range of 4 mm to 15 mm, more preferably in the range of 5 mm to 13 mm, even more preferably in the range of 5 mm to 8 mm and most preferably in the range of 5 mm to 6 mm.

[0187] In embodiment 11 of process 1 according to the present invention, process 1 is designed according to any one of embodiments 1 to 10 thereof, wherein the shaping in process step III) is such that the shoulder of the shoulder region is characterized by a shoulder angle α, and wherein α is in the range of 10° to 70°, preferably in the range of 25° to 60°, more preferably in the range of 33° to 55°, even more preferably in the range of 37° to 50° and most preferably in the range of 38° to 45°.

[0188] In Example 12 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 11 thereof, wherein the forming in process step III) is such that the container parts of the glass container from the top area above the glass bottom are rotationally symmetrical around a longitudinal axis perpendicularly passing through the center of the glass bottom.

[0189] In embodiment 13 of process 1 according to the invention, process 1 is designed according to any one of embodiments 1 to 12 thereof, wherein the wall thickness n of the glass tube is in each case the mean value of this wall thickness of the glass tube. b Within the range of ±0.2 mm, preferably within the range of ±0.1 mm, more preferably within the range of ±0.08 mm and most preferably within the range of ±0.05 mm.

[0190] In Example 14 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 13 thereof, wherein the glass container is a vial with an internal volume of 1 to 8 ml, and wherein the shaping in process step III) is such that the following conditions are satisfied:

[0191] d n ≥9.5mm;

[0192] r s ≥0.5mm.

[0193] In Example 15 of Process 1 according to the present invention, Process 1 is designed according to Example 14 thereof, wherein the shaping in process step III) is such that the following conditions are met:

[0194] d n ≥9.5mm;

[0195] Preferably d n ≥9.6mm;

[0196] More preferably d n ≥9.7mm;

[0197] Even more preferably d n ≥9.8mm;

[0198] The most preferred n ≥9.9mm.

[0199] In Example 16 of Process 1 according to the present invention, Process 1 is designed according to Example 14 or 15 thereof, wherein the shaping in process step III) is such that the following conditions are met:

[0200] r s ≥0.5mm;

[0201] Preferably s ≥0.55mm;

[0202] More preferably s ≥0.6mm;

[0203] Even more preferably s ≥0.7mm;

[0204] Most preferably r s ≥0.8mm.

[0205] In Example 17 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 13 thereof, wherein the glass container is a vial having an internal volume of 8.5 to 22 ml, and wherein the shaping in process step III) is such that the following conditions are satisfied:

[0206] d n ≥15.5mm;

[0207] r s ≥0.5mm.

[0208] In Example 18 of Process 1 according to the present invention, Process 1 is designed according to Example 17 thereof, wherein the shaping in process step III) is such that the following conditions are met:

[0209] d n ≥15.5mm;

[0210] Preferably d n ≥15.6mm;

[0211] More preferably d n ≥15.7mm;

[0212] Even more preferably d n ≥15.8mm;

[0213] The most preferred n ≥15.9mm.

[0214] In Example 19 of Process 1 according to the present invention, Process 1 is designed according to Example 17 or 18 thereof, wherein the shaping in process step III) is such that the following conditions are met:

[0215] r s ≥0.5mm;

[0216] Preferably s ≥0.55mm;

[0217] More preferably s ≥0.6mm;

[0218] Even more preferably s ≥0.7mm;

[0219] Most preferably r s ≥0.8mm.

[0220] In Example 20 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 13 thereof, wherein the glass container is a vial having an internal volume of 22.5 to 150 ml, and wherein the shaping in process step III) is such that the following conditions are satisfied:

[0221] d n ≥16.5mm;

[0222] r s ≥0.5mm.

[0223] In Example 21 of Process 1 according to the present invention, Process 1 is designed according to Example 20 thereof, wherein the shaping in process step III) is such that the following conditions are met:

[0224] d n ≥16.5mm;

[0225] Preferably d n ≥16.6mm;

[0226] More preferably d n ≥16.7mm;

[0227] Even more preferably d n ≥16.8mm;

[0228] The most preferred n ≥16.9mm.

[0229] In Example 22 of Process 1 according to the present invention, Process 1 is designed according to Example 20 or 21 thereof, wherein the shaping in process step III) is such that the following conditions are met:

[0230] r s ≥0.5mm;

[0231] Preferably s ≥0.55mm;

[0232] More preferably s ≥0.6mm;

[0233] Even more preferably s ≥0.7mm;

[0234] Most preferably r s ≥0.8mm.

[0235] In Example 23 of Process 1 according to the present invention, Process 1 is designed according to its Examples 1 to 22, wherein the glass of the glass tube provided in step I) is selected from borosilicate glass, aluminosilicate glass, soda-lime glass and fused silica.

[0236] In Example 24 of Process 1 according to the present invention, Process 1 is designed according to Examples 1 to 23 thereof, wherein the glass container has not yet been thermally tempered.

[0237] In embodiment 25 of process 1 according to the present invention, process 1 is designed according to any one of embodiments 1 to 24 thereof, wherein the glass of at least the neck region of the glass container is characterized in that sodium is present in the thickness n of the glass. b Basically evenly distributed.

[0238] In embodiment 26 of process 1 according to the present invention, process 1 is designed according to any one of embodiments 1 to 25 thereof, wherein the glass of at least the neck region of the glass container is characterized in that potassium is present in the thickness n of the glass. b Basically evenly distributed.

[0239] In Example 27 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 27 thereof, wherein the glass of at least the neck region of the glass container is characterized in that the compressive stress (CS) of the outer surface area of the neck region is less than 500 MPa, preferably less than 300 MPa, even more preferably less than 170 MPa, even more preferably less than 80 MPa, even more preferably less than 30 MPa, and most preferably less than 15 MPa. For example, the compressive stress can be measured using a polarimeter suitable for the vial geometry.

[0240] At least one of the objects of the present invention is achieved by embodiment 1 of a glass container 2 obtainable by the process 1 of the present invention according to any one of its embodiments 1 to 27. In a preferred embodiment of the glass container 2, the glass container 2 has the technical features of the glass container 1 of the present invention according to any one of its embodiments, as well as the technical features of each glass container included in the plurality of glass containers 1 according to the present invention.

[0241] At least one of the objects according to the present invention is achieved by embodiment 1 of process 2, which comprises the following steps as process steps:

[0242] a) providing a glass container 1 according to any one of its preferred embodiments, a plurality of glass containers 1 according to any one of its preferred embodiments, or a glass container 2 according to any one of its preferred embodiments;

[0243] b) Filling the pharmaceutical composition into the inner volume V of the glass container i in; and

[0244] c) Closing the glass container.

[0245] The sealing in process step c) preferably includes contacting the glass container with a closure, preferably a lid, preferably covering the opening of the glass container with the closure, and connecting the closure to the hollow body. The connection preferably includes forming a positive fit between the glass container, preferably a flange of the glass container, and the closure. The positive fit is preferably achieved by a crimping step. Process 2 is preferably a process for packaging pharmaceutical compositions.

[0246] At least one of the objects according to the invention is achieved by embodiment 1 of a closed glass container obtainable by process 2 of the invention according to any one of its embodiments.

[0247] At least one of the objects according to the present invention is achieved by embodiment 1 of process 3, which comprises the following steps as process steps:

[0248] A) providing a glass container 1 according to any one of its preferred embodiments, a plurality of glass containers 1 according to any one of its preferred embodiments, or a glass container 2 according to any one of its preferred embodiments; and

[0249] B) administering the pharmaceutical composition to a patient.

[0250] At least one of the objects of the present invention is achieved by embodiment 1 of a use 1 of a glass container 1 according to any of its preferred embodiments, a plurality of glass containers 1 according to any of its preferred embodiments, or a glass container 2 according to any of its preferred embodiments for packaging a pharmaceutical composition. The packaging preferably comprises: placing the pharmaceutical composition into the inner volume of the glass container; and closing the glass container.

[0251] glass container

[0252] The glass container according to the present invention or the glass container contained in a plurality of glass containers according to the present invention can have any size or shape that a person skilled in the art considers suitable in the context of the present invention. Preferably, the top area of the glass container includes an opening that enables the pharmaceutical composition to be loaded into the inner volume of the glass container. The glass container comprises a glass tube and a glass bottom as container parts, the glass tube having a first end and another end, the glass bottom sealing the other end of the glass tube. Preferably, the glass container adopts an integrated design, which is prepared by the following steps: providing a glass tube and shaping one end of the glass tube (i.e. the end that will become the opening of the glass container) to obtain a top area, a joining area, a neck area and a shoulder area; then, shaping the other end of the glass tube to obtain a closed glass bottom. Preferred glass containers are pharmaceutical glass containers, more preferably one selected from a vial, an ampoule or a combination thereof, particularly preferably a vial.

[0253] For the purposes of this paper, the internal volume V i The internal volume of a glass container is the total volume of the interior. This volume can be determined by filling the interior of the glass container to the brim with water and measuring the volume of water that can be accommodated to the brim. Therefore, the internal volume as used herein is not the nominal volume as often referred to in the pharmaceutical technology field. For example, the nominal volume can be approximately 0.5 times smaller than the internal volume.

[0254] Glass

[0255] The glass of the container can be any type of glass and can consist of any material or combination of materials deemed suitable by a skilled artisan in the context of the present invention. Preferably, the glass is suitable for pharmaceutical packaging. Particularly preferably, the glass is of type I, more preferably type Ib, according to the definition of glass types in Section 3.2.1 of the 7th edition of the European Pharmacopoeia, effective 2011. Alternatively or additionally, and preferably compared to the aforementioned, the glass is selected from borosilicate glass, aluminosilicate glass, soda-lime glass, and fused silica, or a combination of at least two thereof. For purposes herein, aluminosilicate glass is a glass having an Al2O3 content of greater than 8% by weight, preferably greater than 9% by weight, and 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, and particularly preferably in the range of 0 to 7% by weight, based on the total weight of the glass. For the purposes of this document, 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, and 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.

[0256] Further preferred glasses according to the present invention contain substantially no B. "Substantially no B" means that the glass contains no B that has been added to the glass composition for some purpose. This means that B may still be present as an impurity, but preferably in an amount not exceeding 0.1 wt. %, more preferably not exceeding 0.05 wt. %, in each case based on the weight of the glass.

[0257] Outer contour of the joint area

[0258] An important factor for the glass container 1 according to the present invention, for a glass container included in a plurality of glass containers 1 according to the present invention, and for the glass container 2 according to the present invention is the mechanical strength of the neck region to the load applied to the neck region in the neck side compression test as described in the "Measurement Methods" section. This mechanical strength can be achieved, for example, by a very specific outer profile c of the junction region (i.e., the transition region between the top region and the neck region) of the glass container. outer To achieve this, the outer contour c outer By 2×[l n / lb ]×r s ≥0.9mm to characterize a minimum value, where l n Minimum thickness of glass corresponding to the neck area (mm), l b The thickness of the glass corresponding to the body area (mm) and r s Corresponds to the outer radius (mm) of the generally circular arc-shaped outer surface at the end where the joining region merges into the neck region.

[0259] Pharmaceutical composition

[0260] In the context of the present invention, it is contemplated that the skilled person thinks that suitable each pharmaceutical composition. A pharmaceutical composition is a composition comprising at least one active ingredient. A preferred active ingredient is a vaccine. The pharmaceutical composition can be a fluid or a solid or a fluid and a solid, wherein particularly preferred in this article is a fluid composition. A preferred solid composition is a granular composition, such as a powder, various tablets or various capsules. Another preferred pharmaceutical composition is a parenteral pharmaceutical composition, i.e. a composition administered by a parenteral route, which can be any non-enteral route. Parenteral administration can be by injection (e.g., using a needle (typically a hypodermic needle) and a syringe) or by inserting an indwelling catheter.

[0261] According to a first preferred embodiment of the glass container 1 according to the present invention, the glass container is a vial with an overflow capacity equal to or greater than 1 ml and a maximum of 5 ml, preferably a vial with a size setting of "2R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is met, preferably all of the conditions are met:

[0262] i)r s in the range of 0.5 mm to 1.0 mm, more preferably in the range of 0.6 mm to 0.95 mm and even more preferably in the range of 0.75 mm to 0.9 mm;

[0263] ii)d t in the range of 9.5 mm to 16.5 mm, more preferably in the range of 11 mm to 15 mm and even more preferably in the range of 12.5 mm to 13.5 mm;

[0264] iii)d n in the range of 8 mm to 13 mm, more preferably in the range of 9 mm to 12 mm and even more preferably in the range of 10 mm to 11 mm;

[0265] iv)d bin the range of 14 mm to 18 mm, more preferably in the range of 15 mm to 17 mm and even more preferably in the range of 15.5 mm to 16.5 mm;

[0266] v)l b in the range of 0.4 mm to 2 mm, more preferably in the range of 0.8 mm to 1.3 mm and even more preferably in the range of 0.9 mm to 1.15 mm;

[0267] vi)[l(x) / l b ] 3 The minimum value of / k(x) is ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0268] vii)2×[l n / l b ]×r s ≥0.9 mm, preferably ≥1.5 mm and more preferably ≥2.0 mm;

[0269] viii)h c within the range of 32 mm to 38 mm, more preferably within the range of 33.5 mm to 36.5 mm and even more preferably within the range of 34.5 mm to 35.5 mm;

[0270] ix)h b in the range of 12 mm to 32 mm, more preferably in the range of 17 mm to 27 mm and even more preferably in the range of 21 mm to 23 mm;

[0271] x)h t-n In the range of 6 mm to 10 mm, more preferably in the range of 7 mm to 9 mm and even more preferably in the range of 7.5 mm to 8.5 mm.

[0272] According to a second preferred embodiment of the glass container 1 according to the present invention, the glass container is a vial with an overflow capacity greater than 4 ml and a maximum of 8 ml, preferably a vial with a size setting of "4R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is met, preferably all of the conditions are met:

[0273] i)r s in the range of 0.5 mm to 1.0 mm, more preferably in the range of 0.6 mm to 0.95 mm and even more preferably in the range of 0.75 mm to 0.9 mm;

[0274] ii)d tin the range of 9.5 mm to 16.5 mm, more preferably in the range of 11 mm to 15 mm and even more preferably in the range of 12.5 mm to 13.5 mm;

[0275] iii)d n in the range of 8 mm to 13 mm, more preferably in the range of 9 mm to 12 mm and even more preferably in the range of 10 mm to 11 mm;

[0276] iv)d b in the range of 14 mm to 18 mm, more preferably in the range of 15 mm to 17 mm and even more preferably in the range of 15.5 mm to 16.5 mm;

[0277] v)l b in the range of 0.4 mm to 2 mm, more preferably in the range of 0.8 mm to 1.3 mm and even more preferably in the range of 0.9 mm to 1.15 mm;

[0278] vi)[l(x) / l b ] 3 The minimum value of / k(x) is ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0279] vii)2×[l n / l b ]×r s ≥0.9 mm, preferably ≥1.5 mm and more preferably ≥2.0 mm;

[0280] viii)h c within the range of 42 mm to 48 mm, more preferably within the range of 43.5 mm to 46.5 mm and even more preferably within the range of 44.5 mm to 45.5 mm;

[0281] ix)h b within the range of 22 mm to 42 mm, more preferably within the range of 27 mm to 37 mm and even more preferably within the range of 31 mm to 33 mm;

[0282] x)h t-n In the range of 6 mm to 10 mm, more preferably in the range of 7 mm to 9 mm and even more preferably in the range of 7.5 mm to 8.5 mm.

[0283] According to a third preferred embodiment of the glass container 1 according to the present invention, the glass container is a vial with an overflow capacity greater than 8 ml and a maximum of 10.75 ml, preferably a vial with a size setting of "6R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is met, preferably all of the conditions are met:

[0284] i)r s in the range of 0.5 mm to 1.0 mm, more preferably in the range of 0.6 mm to 0.95 mm and even more preferably in the range of 0.75 mm to 0.9 mm;

[0285] ii)d t in the range of 17.5 mm to 23.0 mm, more preferably in the range of 18.5 mm to 22.0 mm and even more preferably in the range of 19.5 mm to 20.5 mm;

[0286] iii)d n in the range of 14 mm to 19 mm, more preferably in the range of 15 mm to 18 mm and even more preferably in the range of 16 mm to 17 mm;

[0287] iv)d b within the range of 19.5 mm to 24.5 mm, more preferably within the range of 20.5 mm to 23.5 mm and even more preferably within the range of 21.5 mm to 22.5 mm;

[0288] v)l b in the range of 0.4 mm to 2 mm, more preferably in the range of 0.8 mm to 1.3 mm and even more preferably in the range of 0.9 mm to 1.15 mm;

[0289] vi)[l(x) / l b ] 3 The minimum value of / k(x) is ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0290] vii)2×[l n / l b ]×r s ≥0.9 mm, preferably ≥1.5 mm and more preferably ≥2.0 mm;

[0291] viii)h c within the range of 37 mm to 43 mm, more preferably within the range of 38.5 mm to 41.5 mm and even more preferably within the range of 39.5 mm to 40.5 mm;

[0292] ix)h b in the range of 16 mm to 36 mm, more preferably in the range of 21 mm to 31 mm and even more preferably in the range of 25 mm to 27 mm;

[0293] x)h t-n In the range of 6.5 mm to 10.5 mm, more preferably in the range of 7.5 mm to 9.5 mm and even more preferably in the range of 8 mm to 9 mm.

[0294] According to a fourth preferred embodiment of the glass container 1 according to the present invention, the glass container is a vial with an overflow capacity greater than 10.75 ml and a maximum of 12.5 ml, preferably a vial with a size setting of "8R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is met, preferably all of the conditions are met:

[0295] i)r s in the range of 0.5 mm to 1.0 mm, more preferably in the range of 0.6 mm to 0.95 mm and even more preferably in the range of 0.75 mm to 0.9 mm;

[0296] ii)d t in the range of 17.5 mm to 23.0 mm, more preferably in the range of 18.5 mm to 22.0 mm and even more preferably in the range of 19.5 mm to 20.5 mm;

[0297] iii)d n in the range of 14 mm to 19 mm, more preferably in the range of 15 mm to 18 mm and even more preferably in the range of 16 mm to 17 mm;

[0298] iv)d b within the range of 19.5 mm to 24.5 mm, more preferably within the range of 20.5 mm to 23.5 mm and even more preferably within the range of 21.5 mm to 22.5 mm;

[0299] v)l b in the range of 0.4 mm to 2 mm, more preferably in the range of 0.8 mm to 1.3 mm and even more preferably in the range of 0.9 mm to 1.15 mm;

[0300] vi)[l(x) / l b ] 3 The minimum value of / k(x) is ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0301] vii)2×[ln / l b ]×r s ≥0.9 mm, preferably ≥1.5 mm and more preferably ≥2.0 mm;

[0302] viii)h c within the range of 42 mm to 47 mm, more preferably within the range of 43.5 mm to 46.5 mm and even more preferably within the range of 44.5 mm to 45.5 mm;

[0303] ix)h b in the range of 21 mm to 41 mm, more preferably in the range of 26 mm to 36 mm and even more preferably in the range of 30 mm to 32 mm;

[0304] x)h t-n In the range of 6.5 mm to 10.5 mm, more preferably in the range of 7.5 mm to 9.5 mm and even more preferably in the range of 8 mm to 9 mm.

[0305] According to a fifth preferred embodiment of the glass container 1 according to the present invention, the glass container is a vial with an overflow capacity greater than 12.5 ml and a maximum of 16.25 ml, preferably a vial with a size setting of "10R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is met, preferably all of the conditions are met:

[0306] i)r s in the range of 0.5 mm to 1.0 mm, more preferably in the range of 0.6 mm to 0.95 mm and even more preferably in the range of 0.75 mm to 0.9 mm;

[0307] ii)d t in the range of 17.5 mm to 23.0 mm, more preferably in the range of 18.5 mm to 22.0 mm and even more preferably in the range of 19.5 mm to 20.5 mm;

[0308] iii)d n in the range of 14 mm to 19 mm, more preferably in the range of 15 mm to 18 mm and even more preferably in the range of 16 mm to 17 mm;

[0309] iv)d b in the range of 21 mm to 27 mm, more preferably in the range of 22 mm to 26 mm and even more preferably in the range of 23.5 mm to 24.5 mm;

[0310] v)l bin the range of 0.4 mm to 2 mm, more preferably in the range of 0.8 mm to 1.3 mm and even more preferably in the range of 0.9 mm to 1.15 mm;

[0311] vi)[l(x) / l b ] 3 The minimum value of / k(x) is ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0312] vii)2×[l n / l b ]×r s ≥0.9 mm, preferably ≥1.5 mm and more preferably ≥2.0 mm;

[0313] viii)h c within the range of 42 mm to 47 mm, more preferably within the range of 43.5 mm to 46.5 mm and even more preferably within the range of 44.5 mm to 45.5 mm;

[0314] ix)h b in the range of 20 mm to 40 mm, more preferably in the range of 25 mm to 35 mm and even more preferably in the range of 29 mm to 31 mm;

[0315] x)h t-n In the range of 7 mm to 11 mm, more preferably in the range of 8 mm to 10 mm and even more preferably in the range of 8.5 mm to 9.5 mm.

[0316] According to a sixth preferred embodiment of the glass container 1 according to the present invention, the glass container is a vial with an overflow capacity greater than 16.25 ml and a maximum of 22.5 ml, preferably a vial with a size setting of "15R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is met, preferably all of the conditions are met:

[0317] i)r s in the range of 0.5 mm to 1.0 mm, more preferably in the range of 0.6 mm to 0.95 mm and even more preferably in the range of 0.75 mm to 0.9 mm;

[0318] ii)d t in the range of 17.5 mm to 23.0 mm, more preferably in the range of 18.5 mm to 22.0 mm and even more preferably in the range of 19.5 mm to 20.5 mm;

[0319] iii)d nin the range of 14 mm to 19 mm, more preferably in the range of 15 mm to 18 mm and even more preferably in the range of 16 mm to 17 mm;

[0320] iv)d b in the range of 21 mm to 27 mm, more preferably in the range of 22 mm to 26 mm and even more preferably in the range of 23.5 mm to 24.5 mm;

[0321] v)l b in the range of 0.4 mm to 2 mm, more preferably in the range of 0.8 mm to 1.3 mm and even more preferably in the range of 0.9 mm to 1.15 mm;

[0322] vi)[l(x) / l b ] 3 The minimum value of / k(x) is ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0323] vii)2×[l n / l b ]×r s ≥0.9 mm, preferably ≥1.5 mm and more preferably ≥2.0 mm;

[0324] viii)h c within the range of 56 mm to 64 mm, more preferably within the range of 58 mm to 62 mm and even more preferably within the range of 59.5 mm to 60.5 mm;

[0325] ix)h b in the range of 35 mm to 55 mm, more preferably in the range of 40 mm to 50 mm and even more preferably in the range of 44 mm to 46 mm;

[0326] x)h t-n In the range of 7 mm to 11 mm, more preferably in the range of 8 mm to 10 mm and even more preferably in the range of 8.5 mm to 9.5 mm.

[0327] According to a seventh preferred embodiment of the glass container 1 according to the present invention, the glass container is a vial with an overflow capacity greater than 22.5 ml and a maximum of 29.25 ml, preferably a vial with a size setting of "20R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is met, preferably all of the conditions are met:

[0328] i)r sin the range of 0.5 mm to 1.0 mm, more preferably in the range of 0.6 mm to 0.95 mm and even more preferably in the range of 0.75 mm to 0.9 mm;

[0329] ii)d t in the range of 17.5 mm to 23.0 mm, more preferably in the range of 18.5 mm to 22.0 mm and even more preferably in the range of 19.5 mm to 20.5 mm;

[0330] iii)d n in the range of 15 mm to 20 mm, more preferably in the range of 16 mm to 19 mm and even more preferably in the range of 17 mm to 18 mm;

[0331] iv)d b within the range of 27 mm to 33 mm, more preferably within the range of 28 mm to 32 mm and even more preferably within the range of 29.5 mm to 30.5 mm;

[0332] v)l b in the range of 0.5 mm to 2.5 mm, more preferably in the range of 0.7 mm to 2 mm, even more preferably in the range of 0.9 mm to 1.6 mm and most preferably in the range of 1.15 mm to 1.25 mm;

[0333] vi)[l(x) / l b ] 3 The minimum value of / k(x) is ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0334] vii)2×[l n / l b ]×rs≥0.9mm, preferably ≥1.5mm and more preferably ≥2.0mm;

[0335] viii)h c within the range of 51 mm to 59 mm, more preferably within the range of 53 mm to 57 mm and even more preferably within the range of 54.5 mm to 55.5 mm;

[0336] ix)h b In the range of 15 mm to 55 mm, more preferably in the range of 25 mm to 45 mm,

[0337] Even more preferably in the range of 30 mm to 40 mm and most preferably in the range of 34 mm to 36 mm;

[0338] x)h t-nIn the range of 7 mm to 13 mm, more preferably in the range of 8.5 mm to 11.5 mm and even more preferably in the range of 9.25 mm to 10.75 mm.

[0339] According to an eighth preferred embodiment of the glass container 1 according to the present invention, the glass container is a vial with an overflow capacity greater than 29.25 ml and a maximum of 35 ml, preferably a vial with a size setting of "25R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is met, preferably all of the conditions are met:

[0340] i)r s in the range of 0.5 mm to 1.0 mm, more preferably in the range of 0.6 mm to 0.95 mm and even more preferably in the range of 0.75 mm to 0.9 mm;

[0341] ii)d t in the range of 17.5 mm to 23.0 mm, more preferably in the range of 18.5 mm to 22.0 mm and even more preferably in the range of 19.5 mm to 20.5 mm;

[0342] iii)d n in the range of 15 mm to 20 mm, more preferably in the range of 16 mm to 19 mm and even more preferably in the range of 17 mm to 18 mm;

[0343] iv)d b within the range of 27 mm to 33 mm, more preferably within the range of 28 mm to 32 mm and even more preferably within the range of 29.5 mm to 30.5 mm;

[0344] v)l b in the range of 0.5 mm to 2.5 mm, more preferably in the range of 0.7 mm to 2 mm, even more preferably in the range of 0.9 mm to 1.6 mm and most preferably in the range of 1.15 mm to 1.25 mm;

[0345] vi)[l(x) / l b ] 3 The minimum value of / k(x) is ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0346] vii)2×[l n / l b ]×r s ≥0.9 mm, preferably ≥1.5 mm and more preferably ≥2.0 mm;

[0347] viii)h c within the range of 61 mm to 69 mm, more preferably within the range of 63 mm to 67 mm and even more preferably within the range of 64.5 mm to 65.5 mm;

[0348] ix)h b within the range of 25 mm to 65 mm, more preferably within the range of 35 mm to 55 mm, even more preferably within the range of 40 mm to 50 mm and most preferably within the range of 44 mm to 46 mm;

[0349] x)h t-n In the range of 7 mm to 13 mm, more preferably in the range of 8.5 mm to 11.5 mm and even more preferably in the range of 9.25 mm to 10.75 mm.

[0350] According to a ninth preferred embodiment of the glass container 1 according to the present invention, the glass container is a vial with an overflow capacity greater than 35 ml and a maximum of 49.75 ml, preferably a vial with a size setting of "30R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is met, preferably all of the conditions are met:

[0351] i)r s in the range of 0.5 mm to 1.0 mm, more preferably in the range of 0.6 mm to 0.95 mm and even more preferably in the range of 0.75 mm to 0.9 mm;

[0352] ii)d t in the range of 17.5 mm to 23.0 mm, more preferably in the range of 18.5 mm to 22.0 mm and even more preferably in the range of 19.5 mm to 20.5 mm;

[0353] iii)d n in the range of 15 mm to 20 mm, more preferably in the range of 16 mm to 19 mm and even more preferably in the range of 17 mm to 18 mm;

[0354] iv)d b within the range of 27 mm to 33 mm, more preferably within the range of 28 mm to 32 mm and even more preferably within the range of 29.5 mm to 30.5 mm;

[0355] v)l b in the range of 0.5 mm to 2.5 mm, more preferably in the range of 0.7 mm to 2 mm, even more preferably in the range of 0.9 mm to 1.6 mm and most preferably in the range of 1.15 mm to 1.25 mm;

[0356] vi)[l(x) / l b ] 3 The minimum value of / k(x) is ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0357] vii)2×[l n / l b ]×r s ≥0.9 mm, preferably ≥1.5 mm and more preferably ≥2.0 mm;

[0358] viii)h c within the range of 71 mm to 79 mm, more preferably within the range of 73 mm to 77 mm and even more preferably within the range of 74.5 mm to 75.5 mm;

[0359] ix)h b within the range of 35 mm to 75 mm, more preferably within the range of 45 mm to 65 mm, even more preferably within the range of 50 mm to 60 mm and most preferably within the range of 54 mm to 56 mm;

[0360] x)h t-n In the range of 7 mm to 13 mm, more preferably in the range of 8.5 mm to 11.5 mm and even more preferably in the range of 9.25 mm to 10.75 mm.

[0361] According to a tenth preferred embodiment of the glass container 1 according to the present invention, the glass container is a vial with an overflow capacity greater than 49.75 ml and a maximum of 92.5 ml, preferably a vial with a size setting of "50R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is met, preferably all of the conditions are met:

[0362] i)r s in the range of 0.5 mm to 1.0 mm, more preferably in the range of 0.6 mm to 0.95 mm and even more preferably in the range of 0.75 mm to 0.9 mm;

[0363] ii)d t in the range of 17.5 mm to 23.0 mm, more preferably in the range of 18.5 mm to 22.0 mm and even more preferably in the range of 19.5 mm to 20.5 mm;

[0364] iii)d n in the range of 15 mm to 20 mm, more preferably in the range of 16 mm to 19 mm and even more preferably in the range of 17 mm to 18 mm;

[0365] iv)d b within the range of 37 mm to 43 mm, more preferably within the range of 38 mm to 42 mm and even more preferably within the range of 39.5 mm to 40.5 mm;

[0366] v)l b in the range of 0.5 mm to 2.5 mm, more preferably in the range of 0.7 mm to 2 mm, even more preferably in the range of 0.9 mm to 1.6 mm and most preferably in the range of 1.15 mm to 1.25 mm;

[0367] vi)[l(x) / l b ] 3 The minimum value of / k(x) is ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0368] vii)2×[l n / l b ]×r s ≥0.9 mm, preferably ≥1.5 mm and more preferably ≥2.0 mm;

[0369] viii)h c within the range of 69 mm to 77 mm, more preferably within the range of 71 mm to 75 mm and even more preferably within the range of 72.5 mm to 73.5 mm;

[0370] ix)h b within the range of 29 mm to 69 mm, more preferably within the range of 39 mm to 59 mm, even more preferably within the range of 44 mm to 54 mm and most preferably within the range of 48 mm to 50 mm;

[0371] x)h t-n In the range of 7 mm to 13 mm, more preferably in the range of 8.5 mm to 11.5 mm and even more preferably in the range of 9.25 mm to 10.75 mm.

[0372] According to an eleventh preferred embodiment of the glass container 1 according to the present invention, the glass container is a vial with an overflow capacity greater than 92.5 ml and a maximum of 150 ml, preferably a vial with a size setting of "100R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is met, preferably all of the conditions are met:

[0373] i)r sin the range of 0.5 mm to 1.0 mm, more preferably in the range of 0.6 mm to 0.95 mm and even more preferably in the range of 0.75 mm to 0.9 mm;

[0374] ii)d t in the range of 17.5 mm to 23.0 mm, more preferably in the range of 18.5 mm to 22.0 mm and even more preferably in the range of 19.5 mm to 20.5 mm;

[0375] iii)d n in the range of 15 mm to 20 mm, more preferably in the range of 16 mm to 19 mm and even more preferably in the range of 17 mm to 18 mm;

[0376] iv)d b within the range of 43 mm to 51 mm, more preferably within the range of 45 mm to 49 mm and even more preferably within the range of 46.5 mm to 47.5 mm;

[0377] v)l b in the range of 0.5 mm to 2.5 mm, more preferably in the range of 0.7 mm to 2 mm, even more preferably in the range of 0.9 mm to 1.6 mm and most preferably in the range of 1.15 mm to 1.25 mm;

[0378] vi)[l(x) / l b ] 3 The minimum value of / k(x) is ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0379] vii)2×[l n / l b ]×r s ≥0.9 mm, preferably ≥1.5 mm and more preferably ≥2.0 mm;

[0380] viii)h c within the range of 96 mm to 103 mm, more preferably within the range of 98 mm to 101 mm and even more preferably within the range of 99.5 mm to 100.5 mm;

[0381] ix)h b within the range of 55 mm to 95 mm, more preferably within the range of 65 mm to 85 mm, even more preferably within the range of 70 mm to 80 mm and most preferably within the range of 74 mm to 76 mm;

[0382] x)h t-nIn the range of 7 mm to 13 mm, more preferably in the range of 8.5 mm to 11.5 mm and even more preferably in the range of 9.25 mm to 10.75 mm.

[0383] Measurement method

[0384] The following measurement methods will be used in the context of the present invention: Unless otherwise stated, measurements have to be carried out at an ambient temperature of 23° C., an ambient pressure of 100 kPa (0.986 atm) and a relative atmospheric humidity of 50%.

[0385] Determination of local curvature k(x) and local glass thickness l(x)

[0386] The outer contour c of the glass in the joining region (ie the transition region between the top region and the neck region), defined by the function f(x), can be determined in a non-destructive manner using a profile projector. outer The local curvature k(x) and local thickness l(x) of the glass container are determined. This method is particularly suitable for glass containers that have been chemically and / or thermally toughened and are therefore not easily cut in half without cracking or bursting. In order to determine the local curvature k(x) in a non-destructive manner, a Mitutoyo Pj-3000 profile projector is used to visualize the outer contour of the glass container. The profile projector has a 10X magnification and is operated under transmitted light. The vial is placed in a glass bowl. BHB (butyl octyl salicylate available from Hallstar Corporation, Chicago, USA). The BHB is used to visualize the outer contour of the vial. Ensure that the cross section of the glass container that is inspected in the contour projector corresponds to a cross section that is centrally located in the glass container and includes the longitudinal axis L of the glass container. tube (i.e., a plane perpendicular to the axis passing through the center of the base) (see Figure 5A and 5B ).

[0387] – To improve the measurement accuracy, the outer contour of the glass in the transition area between the top area and the neck area can also be determined based on a physical cross-section parallel to the longitudinal axis of the container. outer and local thickness l(x) (again, ensuring that the cross section of the glass container corresponds to a plane located centrally within the glass container and including the longitudinal axis of the glass container, as shown in FIG5 ). For preparation without breakage, the glass container can be embedded in a transparent two-component epoxy resin (e.g., STRUERS GmbH, EpoFix resin) or other suitable material. After the epoxy resin has cured, cross-sectional cuts parallel to the container axis can be obtained by mechanical sawing, mechanical grinding, and mechanical polishing. The geometric features of the container can then be determined (measured) by capturing undistorted images and using geometric analysis software tools.

[0388] - From these images, the position perpendicular to the longitudinal axis L can be determined with the aid of an electronic ruler and using any suitable image analysis software tool. tube The thickness of the glass measured in the direction of l(x).

[0389] - Based on the images obtained by the above two methods, the relevant outer contour c of the outer surface of the transition area between the top area and the neck area of the glass container can be extracted outer And its value is estimated. In order to extract the relevant contours of the outer surface, the image processing steps implemented in Python [https: / / www.python.org / ] are performed on the image based on the image processing library OpenCV [https: / / opencv.org / ].

[0390] 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 estimated using a 5th-order univariate spline. The radius of curvature R(x) is then obtained from the formula

[0391]

[0392] Where R(x)=1 / k(x).

[0393] Determination of r s

[0394] In order to determine the outer radius r of the substantially circular arc-shaped region at the end where the joining region merges into the neck region, s , in the images obtained by means of the above two methods, determine the point A on the outer surface of the joint area, at which the slope β of the tangent line reaches its maximum value (see Figure 6 ). In the case of the linear region where the slope β of the tangent line reaches a maximum, A is defined as the point closest to the neck region. In a second step, line b is defined as the extension of the substantially non-curved outer surface of the neck region. In this case, the largest possible circle is formed, which is adjacent to point A, coincides with the gradient (= slope circle), and only touches line b (at point B), but does not cross line b (see again Figure 6 ). The radius of this circle corresponds to r s .

[0395] Wall thickness and diameter

[0396] The wall thickness of the glass container at a given location and the inner or outer diameter of the glass container at a given location are determined in accordance with DIN ISO 8362-1.

[0397] Neck compression test

[0398] The mechanical resistance of the bottle neck region to diametrical compression is determined using a radial load strength test conducted in accordance with DIN EN ISO 8113 ("Glass containers – Resistance to vertical loads – Test methods"). Compressive forces are applied in the diametric (radial) direction at two opposing locations on the bottle neck's outer surface geometry. Using a universal testing machine, the compressive force is increased at a constant load rate of 2000 N / min until the container breaks (breakage can be detected as a sudden drop in the force-time diagram F(t)). The radial load is applied by two opposing uniaxial concave steel surfaces, between which the bottle neck is positioned parallel to the axis. One of the concave surfaces is designed as a self-aligning concave surface to compensate for geometric irregularities. The concavity radius of both steel surfaces is 25% greater than the radius of the neck's outer diameter, so that the load is applied along two opposing lines. The width of the concave steel surfaces is selected to be slightly smaller than the height of the bottle neck.

[0399] Side compression test

[0400] The mechanical resistance of the vial body area to diametrical compression is determined using a radial load strength test conducted in accordance with DIN EN ISO 8113 ("Glass containers – Resistance to vertical loads – Test methods"). Compressive forces are applied in the diametric (radial) direction at two opposing locations on the outer surface geometry of the vial body. Using a universal testing machine, the compressive force is increased at a constant load rate of 1500 N / min until the container fails (failure can again be detected as a sudden drop in the force-time diagram F(t)). The radial load is applied by two opposing uniaxial concave steel surfaces, between which the vial body is positioned parallel to the axis. One of the concave surfaces is designed as a self-aligning concave surface to compensate for geometric irregularities. The concavity radius of both steel surfaces is 25% greater than the radius of the body's outer diameter, so that the load is applied along two opposing lines. The width of the concave steel surface is selected to be greater than the height of the vial body.

[0401] Example

[0402] The outer diameter is 16mm and the wall thickness is l b A glass tube made of borosilicate glass with a thickness of 1 mm is loaded into the head of the rotating machine. While the glass tube rotates about its main axis, the bottom end of the glass tube is heated to its softening point using a flame, and the heated end is shaped to form the top area, the joint area, the neck area, and the shoulder area. In order to form these areas of the desired shape in the rotating machine, the glass tube is placed in a Figure 8By using support rollers with the desired outer shape, it is ensured that the transition area between the top area and the neck area is always achieved. s The required value of d t -d n d n , and l n The desired value of , forming the outer contour c of the top area, the joint area, the neck area and the shoulder area outer Additional information on these areas of glass vial formation can also be found at:

[0403] "https: / / www.schott.com / pharmaceutical_packaging / german / about_us / videos.html".

[0404] In the next step, a flame is used to heat the glass tube above the previously formed first end to its softening point while the glass tube is rotated about its major axis, and the heated glass tube is pulled along its major axis to stretch it and create the container closure.

[0405] By means of the above process, by changing the shape of the support rollers, glass containers with a size setting of "10R" according to DIN EN ISO 8362-1:2016-06 were produced, and the outer contour c of the joining area (i.e., the transition area between the top area and the neck area) of these glass containers was outer The shapes are different.

[0406] At least 50 glass containers of each shape were produced in a rotary machine. The outer contour of the transition area between the top area and the neck area c outer The shape of one of them corresponds to the shape of this region of a glass container known in the prior art (Comparative Example 1).

[0407]

[0408] Table 1

[0409] 1) The above table gives [l(x) / l b ] 3 / The minimum value of k(x) in the interval between points P1 and P2.

[0410] Evaluate

[0411] For the glass containers described above, the resistance to load in a neck crush test and in a side compression test has been determined. For each shape of the outer contour c of the transition region between the top region and the neck region outer50 vials were tested. The load determined corresponds to the pressure at which 10% of the vials break. Table 2 shows the results, where the corresponding load values of the lateral compression test are normalized to the values determined for the reference vials of the comparative example.

[0412]

[0413] Table 2

[0414] From the results shown in Table 2, it can be seen that by adjusting the outer contour c of the transition area between the top area and the neck area outer And by adjusting the resistance in the neck crush test, the resistance to load in the side compression test can be significantly increased. BRIEF DESCRIPTION OF THE DRAWINGS

[0415] Unless otherwise stated in the instructions or specific drawings:

[0416] Figure 1 shows the setup for a lateral compression test known from the prior art;

[0417] Figure 2 shows cross-sectional views of different regions of a glass container 100 according to the present invention;

[0418] Figure 3 shows an enlarged cross-sectional view of a top region 104, a joining region 105, a neck region 106, and a shoulder region 107 of a glass container 100 according to the present invention;

[0419] Figure 4A The outer contour c of the top region 104, the joint region 105, the neck region 106 and the shoulder region 107 of the glass container 100 according to the present invention is shown. outer An enlarged cross-sectional view of;

[0420] Figure 4B The curve of the function f(x) in the range of P1 to P2 is shown, and the function f(x) represents the outer contour c of the transition area between the top area and the neck area. outer ;

[0421] Figure 5A A side view showing the position of a plane 111 for determining the local curvature of the function f(x) and the glass thickness l(x) in the range from P1 to P2;

[0422] Figure 5B A top view showing the position of a plane 111 for determining the local curvature of the function f(x) and the glass thickness l(x) in the range from P1 to P2;

[0423] Figure 6Shows the s Determination of

[0424] Figure 7 is a cross-sectional view of another glass container 100 according to the present invention, illustrating a shoulder angle α;

[0425] Figure 8 A process 1 for preparing a glass container according to the present invention is shown;

[0426] Figure 9 shows a flow chart of process 2 for packaging a pharmaceutical composition according to the present invention;

[0427] Figure 10 The setup for the neck crush test is shown;

[0428] Figure 11A is a schematic side view of a neck compression test; and

[0429] Figure 11B is a schematic front view of the neck compression test. DETAILED DESCRIPTION

[0430] Figure 1 The following shows the setup for a side compression test known from the prior art. As can be seen, a glass container 100 with a glass bottom 109 is placed in a horizontal position between two steel plates 117, 118, by means of which a compressive force is applied in the diametrical (radial) direction to two opposite locations of the outer surface geometry of the vial body. Using a universal testing machine, the compressive force is increased at a constant load rate of 1500 N / min until the container breaks. The radial load is applied by two opposing uniaxial concave steel surfaces 117, 118, between which the body area 109 of the vial 100 is placed parallel to the axis L. tube One of the concave surfaces 117 is configured as a self-adjusting concave surface so as to be able to compensate for geometric irregularities. The concavity radius of the two steel surfaces 117, 118 is greater than the outer diameter d of the body region. b The radius of the concave steel surface is 25% larger, so that the load is applied along two opposite lines. The width of the concave steel surface is selected to be greater than the height of the bottle body area 108. Figure 1 It can also be seen that due to d t (diameter of the top region 104) and d n (diameter of the neck region 106) is less than d b (diameter of the body region 108 ), so that the top region 104 , the engagement region 105 and the neck region 106 are not in contact with the clamping jaws 117 , 118 .

[0431] Figure 21 shows cross-sectional views of different regions of a glass container 100 according to the present invention. The glass container 100 comprises a glass tube 101 as a container component, the glass tube 101 having a first end 102 and another end 103, and a glass bottom 109 closing the other end 103 of the glass tube. The glass tube 101 is characterized by a longitudinal axis L tube The direction from top to bottom includes: a top region 104 located at the first end 102 of the glass tube 101, wherein the outer diameter of the top region is d t The joining region 105 is adjacent to the top region 104; the neck region 106 is adjacent to the joining region 105, wherein the outer diameter of the neck region is d n , d n <d t A shoulder region 107 adjacent to the neck region 106; and a body region 108 adjacent to the shoulder region 107 and extending to the other end portion 103 of the glass tube 101, wherein the thickness of the glass body region is l b And wherein the outer diameter of the body region is d b , d b >d t The joining region 105 corresponds to the transition region between the top region 104 and the neck region 106. n is the minimum thickness of the glass in the neck region 106. The neck region 106 is defined by a substantially linear and nearly horizontal curve of the function f(x), which defines the outer contour c of the glass container 100. couter (See Figure 4B ). Therefore, the beginning and end of the neck region 106 are defined by the points where the curve of the function f(x) is no longer linear and horizontal. The beginning and end of the neck region 106 are defined by x1 and x2 and Figure 4B express.

[0432] Figure 3 An enlarged cross-sectional view of the top region 104, the joining region 105, the neck region 106, and the shoulder region 107 of a glass container 100 according to the present invention is shown (the body region 108 immediately adjacent to the shoulder region 109 is not shown in this figure). Figure 3 In the embodiment, the joining region 105 has an outer surface that is substantially arcuate at the end where the joining region 105 merges into the neck region 106, the substantially arcuate region having an outer radius r s .

[0433] Figure 4A FIG. 1 shows the outer contours of the top region 104, the joint region 105, the neck region 106 and the shoulder region 107 of the glass container 100 according to the present invention determined based on an image of the glass container 100 obtained using the method described in the “Test Methods” section herein.outer These images are arranged as follows: The glass container 100 is placed on a flat horizontal substrate 110 with the outer surface of the body region 108 on it. Then, k(x) and l(x) are measured between points P1 and P2, as also described in the "Test Methods" section. s corresponds to (d t -d n ) / 2, s / 2 corresponds to (d t -d n ) / 4, which means that P2 is f(x) is (d b -d t ) / 2+s / 2=(d b -d t ) / 2+(d t -d n ) / 4=1 / 2×d b –1 / 4×d t –1 / 4×d n The x position of . Then P1 is P2–s=P2–d t / 2+d n / 2 of the x position. Figure 4B The curve of function f(x) is shown. Function f(x) represents the outer contour c between point P1 and point P2. outer Point x1 and point x2 represent the beginning and end of the neck region 106 .

[0434] Figure 5A and Figure 5B The side view and the top view respectively show the position of the flat surface 111 of the glass container 100, which is used to Figure 4A and Figure 4B The method shown in determines the local curvature of the function f(x) in the range from P1 to P2 and the glass thickness l(x). The plane 111 corresponds to the plane located centrally in the glass container and including the longitudinal axis L of the glass container. tube (See Figure 2 )(exist Figure 5A The longitudinal axis is the axis perpendicular to the center of the bottom 109 ( Figure 5B ).

[0435] Figure 6 Shows the s To determine the outer radius r of the substantially circular arc-shaped region at the end where the joining region 105 merges into the neck region 106 s, in the images of the plane 111 obtained by means of the two methods described in the "Test Methods" section of this document, a point A is determined on the outer surface of the joint region 105 at which the slope β of the tangent line 112 reaches its maximum. In the case of a linear region where the slope β of the tangent line 112 reaches its maximum, A is defined as the point closest to the neck region 106. In a second step, the line b 113 is defined as the extension of the substantially non-curved outer surface of the neck region 106. In this case, the largest possible circle 114 is formed, which is adjacent to point A, coincides with the gradient (= slope circle), and only touches the line b 113 (at point B), but does not cross the line b 113 (see again). Figure 6 ). The radius of this circle corresponds to r s .

[0436] Figure 7 is the height h according to the present invention c A cross-sectional view of another glass container 100. c corresponds to the length of the body region 108, h t-n corresponds to the total length of the top region 104, the joining region 105 and the neck region 106. The glass container 100 comprises a shoulder region 107 connecting the body region 108 and the neck region 106, wherein the shoulder region 107 is characterized by a shoulder angle α.

[0437] Figure 8 The process for forming the top region 104, the joining region 105, the neck region 106 and the shoulder region 107 of the glass container 100 according to the present invention is shown. b is 16mm and the glass thickness (wall thickness) is l b A glass tube 101 made of borosilicate glass with a thickness of 1 mm is loaded into the head of the rotating machine. While the glass tube 101 is rotating about its main axis, the bottom end of the glass tube 101 is heated to its softening point using a flame 116, and the heated end is shaped to form a top region 104, a joint region 105, a neck region 106, and a shoulder region 107. In order to form these regions of the desired shape in the rotating machine, the glass tube 101 is placed in a position such as Figure 8 The upward position shown. By using a forming roller 115 with the desired outer shape, it is ensured that the desired maximum curvature of the transition area between the top area 104 and the neck area 106 is always achieved, and the outer contours of the top area 104, the joining area 105, the neck area 106 and the shoulder area 107 are formed. outer .

[0438] Figure 9Flowchart showing a process 200 for packaging a pharmaceutical composition according to the present invention. Process step a) 201, providing a glass container 100 according to the present invention. Process step b) 202, filling the inner volume V of the glass container 100 with a pharmaceutical composition. i and process step c) 203, closing the opening 112 of the glass container 100, thereby obtaining a closed glass container 121.

[0439] Figure 10 The present invention shows a test for determining the mechanical resistance of the neck region 106 of a vial to diametrical compression. This resistance is determined by means of a radial load strength test according to DIN EN ISO 8113 ("Glass containers - Resistance to vertical loads - Test methods"), wherein a compressive force is applied to the outer surface of the neck region 106 at two opposite locations in the diametrical (radial) direction. Using a universal testing machine, the compressive force is increased at a constant load rate of 2000 N / min until the vial 100 breaks (breakage can be detected as a sudden drop in the force-time diagram F(t)). The radial load is applied by two opposing uniaxial concave steel plates 119, 120, between which the neck region 106 of the vial 100 is placed parallel to the axis L. tube One of the concave steel plates 119 is configured as a self-adjusting concave steel plate so as to be able to compensate for geometric irregularities. The concavity radius of the two steel surfaces is greater than the outer diameter d of the neck region 106. n The radius of the concave steel surface is 25% larger, so that the load is applied along two opposite lines. The width of the concave steel surface is selected to be slightly smaller than the height of the small bottleneck area 104.

[0440] Figure 11A and Figure 11B A schematic side view and a schematic front view of a neck compression test are shown.

[0441] Reference Signs List

[0442] 100 Glass container according to the present invention

[0443] 101 Glass Tube

[0444] 102 First end of the glass tube 101

[0445] 103 The other end of the glass tube 101

[0446] 104 Top Area

[0447] 105 junction area

[0448] 106 Neck area

[0449] 107 shoulder area

[0450] 108 Main body area

[0451] 109 Glass Bottom

[0452] 110 flat horizontal base

[0453] 111 Cross-sectional plane in the middle of the glass container 100

[0454] 112 Tangent line with maximum slope β

[0455] 113 Extension of the substantially non-curved outer surface of the neck region 105 (line b)

[0456] 114 The largest possible circle

[0457] 115 forming roller

[0458] 116 Heating element, preferably a flame

[0459] 117 Self-adjusting steel plate

[0460] 118 rigid steel plate

[0461] 119 Self-adjusting steel plate

[0462] 120 rigid steel plate

[0463] 200 Process for packaging a pharmaceutical composition according to the present invention

[0464] 201 Process step a)

[0465] 202 process step b)

[0466] 203 process step c)

Claims

1. A glass container (100), comprising the following as container components: i) A glass tube (101) having a first end (102) and another end (103), wherein the glass tube (101) is characterized by a longitudinal axis L tube And the directions from top to bottom include: ia) is located at the top region (104) of the first end (102) of the glass tube (101), wherein the outer diameter of the top region is d t ; ib) a joining region (105) immediately adjacent to said top region (104); ic) a neck region (106) adjacent to the joining region (105), wherein the outer diameter of the neck region is d n , d n <d t , and wherein the minimum thickness of the glass in the neck region (106) is l n ; id) a shoulder region (107) proximate to said neck region (106); and ie) a body region (108) adjacent to the shoulder region (107) and extending to the other end (103) of the glass tube (101), wherein the thickness of the glass in the body region is l b , and wherein the outer diameter of the body region is d b , d b >d t ; ii) a glass bottom (109), the glass bottom (109) sealing the other end (103) of the glass tube (101); The joining region (105) has an outer surface, and the outer surface is substantially arc-shaped at the end where the joining region (105) merges into the neck region (106), and the outer radius of the substantially arc-shaped region is r s , and the following conditions are met: 2×[l n / l b ]×r s ≥0.9mm。 2. The glass container (100) according to claim 1, wherein the glass container (100) is a pharmaceutical glass container.

3. The glass container (100) according to claim 1, wherein 2×[l n / l b ]×r s ≥1.0mm。 4. The glass container (100) according to claim 1, wherein 2×[l n / l b ]×r s ≥1.1mm.

5. The glass container (100) according to claim 1, wherein 2×[l n / L b ]×r s ≥1.2mm.

6. The glass container (100) according to claim 1, wherein 2×[l n / l b ]×r s ≥1.3mm。 7. The glass container (100) according to claim 1, wherein 2×[l n / l b ]×r s ≥1.4mm。 8. The glass container (100) according to claim 1, wherein 2×[l n / L b ]×r s ≥1.5mm.

9. The glass container (100) according to claim 1, wherein 2×[l n / L b ]×r s ≥1.7mm.

10. The glass container (100) according to claim 1, wherein 2×[l n / l b ]×r s ≥2.0mm。 11. The glass container (100) according to claim 1, wherein 2×[l n / L b ]×r s ≥2.5mm.

12. The glass container (100) according to claim 3, wherein the following conditions are met: If the glass container (100) is placed on a flat horizontal substrate (110) on which the outer surface of the body region (108) is located, the longitudinal axis L located centrally in the glass container (100) and including the glass tube (101) tube In any given cross section of the glass container (100) within the plane (111) of the glass container (100), f(x) defines the vertical distance between the substrate (110) and the outer surface of the glass container (100) at a given position x, and l(x) defines the thickness of the glass at a given position x, wherein the distance is perpendicular to the longitudinal axis L. tube The thickness l(x) of the glass is measured in the direction of k(x)=|f”(x) / [1+f'(x) 2 ] 3 / 2 | defines the absolute value of the curvature of f(x) at a given position x; and In the interval between x=P1 and x=P2, for any concave curvature in the interval, [l(x) / l b ] 3 The minimum value of / k(x) is at least 0.35 mm, where P2 defines f(x) to be 1 / 2×d b –1 / 4×d t –1 / 4×d n x position and P1 defines f(x) to be P2–d t / 2+d n / 2 of the x position.

13. The glass container (100) according to claim 12, wherein: [l(x) / l b ] 3 / k(x) is at least 0.5 mm.

14. The glass container (100) according to claim 12, wherein: [l(x) / l b ] 3 / k(x) is at least 0.7 mm.

15. The glass container (100) according to claim 12, wherein [l(x) / l b ] 3 / k(x) is at least 0.9 mm.

16. The glass container (100) according to claim 12, wherein [l(x) / l b ] 3 / k(x) is at least 1.1 mm.

17. The glass container (100) according to claim 12, wherein: [l(x) / l b ] 3 / k(x) is at least 1.3 mm.

18. The glass container (100) according to claim 12, wherein [l(x) / l b ] 3 / k(x) is at least 1.5 mm.

19. The glass container (100) according to claim 12, wherein: [l(x) / l b ] 3 / k(x) is at least 1.7 mm.

20. The glass container (100) according to claim 12, wherein [l(x) / l b ] 3 / k(x) is at least 2.0 mm.

21. The glass container (100) according to claim 12, wherein [l(x) / l b ] 3 / k(x) is at least 2.5 mm.

22. The glass container (100) according to any one of claims 1 to 11, wherein the glass container (100) is a vial with an internal volume of 1 to 8 ml, and wherein the following conditions are met: d n ≥9.7mm; r s ≥0.5mm。 23. The glass container (100) according to claim 22, wherein the glass container (100) is a vial with a size setting of "2R" or "4R" according to DIN EN ISO 8362-1:2016-06.

24. The glass container (100) according to any one of claims 1 to 11, wherein the glass container (100) is a vial with an internal volume of 8.5 to 22 ml, and wherein the following conditions are met: d n ≥15.5mm; r s ≥0.5mm。 25. The glass container (100) according to claim 24, wherein the glass container (100) is a vial having a size setting of "6R", "8R", or "10R" according to DIN EN ISO 8362-1:2016-06.

26. The glass container (100) according to any one of claims 1 to 11, wherein the glass container 100 is a vial with an internal volume of 22.5 to 150 ml, and wherein the following conditions are met: d n ≥16.5mm; r s ≥0.5mm。 27. The glass container (100) according to claim 26, wherein the glass container (100) is a vial having a size setting of "20R", "25R", "30R", "50R" or "100R" according to DIN EN ISO 8362-1:2016-06.

28. The glass container (100) according to any one of claims 1 to 11, wherein the following conditions are met: l n / l b ≥1.3。 29. The glass container (100) according to any one of claims 1 to 11, wherein the following conditions are met: l n / l b ≥1.4。 30. The glass container (100) according to any one of claims 1 to 11, wherein the following conditions are met: l n / l b ≥1.45。 31. The glass container (100) according to any one of claims 1 to 11, wherein the following conditions are met: l n / l b ≥1.5。 32. The glass container (100) according to any one of claims 1 to 11, wherein the following conditions are met: l n / l b ≥1.6。 33. The glass container (100) according to any one of claims 1 to 11, wherein the following conditions are met: L n ×r s / L b ≥0.7mm.

34. The glass container (100) according to any one of claims 1 to 11, wherein the following conditions are met: d b In the range of 14mm to 60mm; and / or d t -d n in the range of 1.5 mm to 6 mm; and / or d b -d n In the range of 4mm to 35mm.

35. The glass container (100) according to any one of claims 1 to 11, wherein the following conditions are met: d b In the range of 15mm to 32mm; and / or d t -d n in the range of 2 mm to 5 mm; and / or d b -d n In the range of 4mm to 15mm.

36. The glass container (100) according to any one of claims 1 to 11, wherein the following conditions are met: d b In the range of 15mm to 25mm; and / or d t -d n in the range of 2.5 mm to 4.5 mm; and / or d b -d n In the range of 5mm to 13mm.

37. The glass container (100) according to any one of claims 1 to 11, wherein the following conditions are met: d b In the range of 15mm to 23mm; and / or d t -d n in the range of 2.5 mm to 4 mm; and / or d b -d n In the range of 5mm to 8mm.

38. The glass container (100) according to any one of claims 1 to 11, wherein the following conditions are met: d b In the range of 15mm to 17mm; and / or d t -d n in the range of 2.5 mm to 3.5 mm; and / or d b -d n In the range of 5mm to 6mm.

39. The glass container (100) according to any one of claims 1 to 11, wherein the glass container has a glass mass m g and internal volume V i , and the following conditions are met: m g / V i 0.75 <2.0。 40. The glass container (100) according to any one of claims 1 to 11, wherein the glass container has a glass mass m g and internal volume V i , and the following conditions are met: m g / V i 0.75 <1.75。 41. The glass container (100) according to claim 39, wherein V i In the range of 2ml to 150ml.

42. The glass container (100) according to claim 39, wherein V i In the range of 3ml to 100ml.

43. The glass container (100) according to claim 39, wherein V i In the range of 3ml to 50ml.

44. The glass container (100) according to claim 39, wherein V i In the range of 3ml to 15ml.

45. The glass container (100) according to claim 39, wherein V i In the range of 3ml to 7ml.

46. A plurality of glass containers (100), each glass container (100) comprising as container components: i) A glass tube (101) having a first end (102) and another end (103), wherein the glass tube (101) is characterized by a longitudinal axis L tube And the directions from top to bottom include: ia) is located at the top region (104) of the first end (102) of the glass tube (101), wherein the outer diameter of the top region is d t ; ib) a joining region (105) immediately adjacent to said top region (104); ic) a neck region (106) adjacent to the joining region (105), wherein the outer diameter of the neck region is d n , d n <d t ; id) a shoulder region (107) proximate to said neck region (106); and ie) a body region (108) adjacent to the shoulder region (107) and extending to the other end (103) of the glass tube (101), wherein the thickness of the glass in the body region is l b And wherein the outer diameter of the body region is d b , d b >d t ; ii) a glass bottom (109), the glass bottom (109) sealing the other end (103) of the glass tube (101); wherein 50% of the glass containers (100) contained in the plurality of glass containers (100) break at a load of at least 1100 N in a neck crush test, in: ib) the joining region (105) has an outer surface, the outer surface is substantially arc-shaped at the end where the joining region (105) merges into the neck region (106), and the outer radius of the substantially arc-shaped region is r s ; ic) The minimum thickness of the glass in the neck region (106) is l n ; And wherein for at least 75% of the glass containers (100) contained in the plurality of glass containers (100), the following conditions are satisfied: 2×[l n / l b ]×r s ≥0.9mm。 47. A plurality of glass containers (100) according to claim 46, wherein 2×[l n / l b ]×r s ≥1.0mm.

48. A plurality of glass containers (100) according to claim 46, wherein 2×[l n / l b ]×r s ≥1.1mm.

49. A plurality of glass containers (100) according to claim 46, wherein 2×[l n / l b ]×r s ≥1.2mm.

50. A plurality of glass containers (100) according to claim 46, wherein 2×[l n / l b ]×r s ≥1.3mm.

51. A plurality of glass containers (100) according to claim 46, wherein 2×[l n / l b ]×r s ≥1.4mm.

52. A plurality of glass containers (100) according to claim 46, wherein 2×[l n / l b ]×r s ≥1.5mm.

53. A plurality of glass containers (100) according to claim 46, wherein 2×[l n / l b ]×r s ≥1.7mm.

54. A plurality of glass containers (100) according to claim 46, wherein 2×[l n / l b ]×r s ≥2.0mm.

55. A plurality of glass containers (100) according to claim 46, wherein 2×[l n / l b ]×r s ≥2.5mm.

56. The plurality of glass containers (100) of claim 47, wherein the load is at least 1200N.

57. The plurality of glass containers (100) of claim 47, wherein the load is at least 1300N.

58. The plurality of glass containers (100) of claim 47, wherein the load is at least 1400N.

59. The plurality of glass containers (100) of claim 47, wherein the load is at least 1500N.

60. The plurality of glass containers (100) of claim 47, wherein the load is at least 1600N.

61. The plurality of glass containers (100) of claim 47, wherein the load is at least 1800N.

62. The plurality of glass containers (100) of claim 47, wherein the load is at least 2000N.

63. The plurality of glass containers (100) of claim 47, wherein the load is at least 2500N.

64. The plurality of glass containers (100) of claim 47, wherein the load is at least 3000N.

65. The plurality of glass containers (100) according to any one of claims 56 to 64, wherein for at least 75% of the glass containers (100) contained in the plurality of glass containers (100), the following conditions are met: If the glass container (100) is placed on a flat horizontal substrate (110) on which the outer surface of the body region (108) is located, the longitudinal axis L located centrally in the glass container (100) and including the glass tube (101) tube In any given cross section of the glass container (100) within the plane (111) of the glass container (100), f(x) defines the vertical distance between the substrate (110) and the outer surface of the glass container (100) at a given position x, and l(x) defines the thickness of the glass at a given position x, wherein the distance is perpendicular to the longitudinal axis L. tube The thickness l(x) of the glass is measured in the direction of k(x)=|f”(x) / [1+f'(x) 2 ] 3 / 2 defines the absolute value of the curvature of f(x) at a given location x; and In the interval between x=P1 and x=P2, for any concave curvature in the interval, [l(x) / l b ] 3 The minimum value of / k(x) is at least 0.35 mm, where P2 defines f(x) to be 1 / 2×d b –1 / 4×d t –1 / 4×d n x position and P1 defines f(x) to be P2–d t / 2+d n / 2 of the x position.

66. A plurality of glass containers (100) according to claim 65, wherein [l(x) / l b ] 3 / k(x) is at least 0.5 mm.

67. A plurality of glass containers (100) according to claim 65, wherein [l(x) / l b ] 3 / k(x) is at least 0.7 mm.

68. A plurality of glass containers (100) according to claim 65, wherein [l(x) / l b ] 3 / k(x) is at least 0.9 mm.

69. A plurality of glass containers (100) according to claim 65, wherein [l(x) / l b ] 3 / k(x) is at least 1.1 mm.

70. A plurality of glass containers (100) according to claim 65, wherein [l(x) / l b ] 3 / k(x) is at least 1.3 mm.

71. A plurality of glass containers (100) according to claim 65, wherein [l(x) / l b ] 3 / k(x) is at least 1.5 mm.

72. A plurality of glass containers (100) according to claim 65, wherein [l(x) / l b ] 3 / k(x) is at least 1.7 mm.

73. A plurality of glass containers (100) according to claim 65, wherein [l(x) / l b ] 3 / k(x) is at least 2.0 mm.

74. A plurality of glass containers (100) according to claim 65, wherein [l(x) / l b ] 3 / k(x) is at least 2.5 mm.

75. A process for preparing a closed glass container (100), comprising as process steps the following steps: a) providing a glass container (100) according to any one of claims 1 to 45 or a plurality of glass containers (100) according to any one of claims 46 to 74; b) filling the pharmaceutical composition into the inner volume Vi of the glass container (100); and c) Closing the glass container (100).

76. A closed glass container (100) obtainable by the process according to claim 75.

77. Use of the glass container (100) of any one of claims 1 to 45 or a plurality of glass containers (100) according to any one of claims 46 to 74 for packaging a pharmaceutical composition.

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