Vial having an 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 an opposite end, wherein the glass tube has a longitudinal axis L tube and the direction from the top to the bottom includes: ia) a top region located at the first end of the glass tube, wherein the outer diameter of the top region is d t ; ib) a joining region adjacent to the top region; ic) a neck region adjacent to the joining region, wherein the outer diameter of the neck region is d n , d n < d t ; id) a shoulder region adjacent to the neck region; and ie) a body region adjacent to the shoulder region and extending to the opposite end of the glass tube, the thickness of the glass in the body region being l b and the outer diameter of the body region is d b , d b > d t ; ii) a glass bottom closing the opposite end of the glass tube; wherein the outer contour of the transition region between the top region and the neck region of the glass container is defined by a certain minimum value of the radius of curvature.

Description

Field of the Invention

[0001] The present invention relates to a glass container, which glass container comprises the following as container parts: i) a glass tube having a first end and an opposite end, wherein the glass tube is characterized by a longitudinal axis L tube and the direction from top to bottom comprises: ia) a top region located at the 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 opposite end of the glass tube; and ii) a glass bottom closing the opposite 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 this process, to a process for producing a closed glass container, to a closed glass container obtainable by this process, and to the use of glass containers for encapsulating pharmaceutical compositions. Background Art

[0003] In the pharmaceutical industry, containers are used for the primary packaging of pharmaceuticals. Among them, the most commonly used material traditionally is glass containers, because glass containers ensure stability, visibility, durability, rigidity, moisture resistance, ease of capping and economy. Glass containers for medical purposes currently on the market include glass containers made from glass tubing and blow-molded glass containers. The manufacturing methods for tubing-based glass containers and blow-molded glass containers are well known. Tubing-based glass containers are made from preformed glass tubing (mother tubes) by shaping and separating. In a typical manufacturing process, the glass tube is loaded into the head of a rotary machine, and then, while the glass tube rotates about its main axis, one end of the glass tube is heated to the softening point of the glass to form the top region, namely the neck region and the shoulder that together characterize the final form of the top of the glass container. After the top region is formed, the glass tube is heated again to its softening point at a defined position above the top region so formed, and then the glass tube is pulled along its main axis to stretch and expand the already thermally softened part, thereby generating and shaping the bottom of the required container. Blow-molded glass containers are formed directly from a glass melt by a blowing process or a press-blowing process. Blow-molded glass containers include, for example, spray bottles and infusion bottles (such as those described in DE 196 22 550 A1). However, blow-molded glass containers generally have higher tolerances with respect to the wall thickness, including local parts with a larger wall thickness and a smaller wall thickness. Due to the refraction of light they are generally not suitable for optical inspection of the filled container through the glass wall, which results in blow-molded glass containers not being suitable for use in many pharmaceutical applications.

[0004] Glass vials for pharmaceutical packaging must pass numerous mechanical tests. For example, if glass vials are used in an automatic sampling machine in a scientific laboratory or medical institution and during the stoppering, shipping, and storage of the glass vials, a high axial load determined in the so-called "vertical compression test" may be required. In addition to having a certain resistance to axial load, the glass container should also have a high enough burst strength as determined in the so-called "burst pressure test". For example, if a pharmaceutical preparation is loaded into the glass container and then lyophilized to find the weakest point on the inner or outer surface of the container, it is appropriate to conduct the burst pressure test.

[0005] Another mechanical test commonly used to determine the mechanical strength of glass vials is the so-called "lateral compression test". For example, this test is used to determine the effect that a certain back pressure may have on the glass vials when they are transported in a heat source removal tunnel or generally on a filling line. In this test, the glass vial is placed between the upper and lower components of the test tool (as Figure 1 shown), where a defined load is directly applied to the body area of the glass vial.

[0006] Since in the pharmaceutical industry, when using glass vials, only a very low probability of breakage is allowed when the glass vials are subjected to mechanical stress, glass vials for filling pharmaceutical preparations should be characterized by a high enough strength, especially a high enough ability to withstand a certain pressure in the above-mentioned lateral compression test. Although ISO-vials already meet these requirements for increased stability, the strength of the glass vials can still be further improved. For example, to increase the strength of the glass container, the glass surface of the container can be tempered by a chemical treatment method disclosed in, for example, 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, the glass surface also needs to be modified. Therefore, chemically strengthening the glass surface usually requires new approval of the glass container. Summary of the Invention

[0007] Generally, the object of the present invention is to overcome at least in part 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 certain load is directly applied to the body portion of the glass container (especially compared with the 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 certain load is directly applied to the body portion of the glass container (especially compared with the ISO vials known in the prior art), and which is prepared by as simple a process as possible, preferably prepared from a preformed glass tube by shaping and separation. Another object of the present invention is to provide a process for preparing a glass container, preferably a glass vial, for pharmaceutical packaging, which has improved strength in a side compression test in which a certain load is directly applied to the body portion of the glass container (especially compared with the ISO vials known in the prior art), and which is prepared from a preformed glass tube by shaping and separation, wherein no additional process steps (such as modifying the glass surface) are required.

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

[0009] At least one of the objects according to the present invention is achieved by Embodiment 1 of the glass container 1, which glass container comprises, as container components, the following:

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

[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 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 ;

[0014] id) a shoulder region 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 l band the outer diameter of the body region is d b , d b > d t ;

[0016] ii) a glass bottom that closes the other end of the glass tube;

[0017] wherein, if the glass container is placed on a flat horizontal base on which the outer surface of the body region lies, then in any given cross-section of the glass container in the plane that is centered in the glass container and includes the longitudinal axis L tube of the glass container, f(x) defines the vertical distance between the base and the outer surface of the glass container at a given position x, and l(x) defines the thickness of the glass at the given position x, where the thickness l(x) of the glass is measured in a direction perpendicular to the longitudinal axis L tube ;

[0018] where 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

[0019] wherein in the interval between x = P1 and x = P2, for any concave curvature within this interval, the minimum value of [l(x) / l b 3 / 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, where P2 defines the x-position where f(x) is 1 / 2 × d b – 1 / 4 × d t – 1 / 4 × d n and P1 defines the x-position where f(x) is P2 – d t / 2 + d n / 2;

[0020] At least one of the objects according to the invention is also achieved by Embodiment 1 of a plurality of glass containers 1, each glass container comprising, as container parts, the following:

[0021] i) a glass tube having a first end and an other end, wherein the glass tube is characterized by a longitudinal axis L tube and comprising, in the direction from top to bottom:

[0022] ia) a top region located at the first end of the glass tube, wherein the outer diameter of the top region is d​​t ;

[0023] ib) The joint region adjacent to the top region;

[0024] ic) The neck region adjacent to the joint region, wherein the outer diameter of the neck region is d n , d n < d t ;

[0025] id) The shoulder region adjacent to the neck region; and

[0026] ie) The 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 l b and wherein the outer diameter of the body region is d b , d b > d t ;

[0027] ii) The glass bottom, which closes the other end of the glass tube;

[0028] Among them, 50% of the glass containers (100) included in the plurality of glass containers have a rupture load in the neck extrusion 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.

[0029] In Example 2 of the plurality of glass containers 1, the plurality of glass containers 1 are designed according to Example 1 thereof, wherein for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers included in the plurality of glass containers 1 and most preferably each glass container satisfies the following conditions:

[0030] If the glass container is placed on a flat horizontal base with the outer surface of the body region thereon, then in any given cross-section of the glass container in the plane that is centered in the glass container and includes the longitudinal axis L tube of the glass container, f(x) defines the vertical distance between the base and the outer surface of the glass container at a given position x, and l(x) defines the thickness of the glass at the given position x, wherein the thickness l(x) of the glass is measured in a direction perpendicular to the longitudinal axis L tube ;

[0031] 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

[0032] In the interval between x = P1 and x = P2, for any concave curvature within this interval, [l(x) / l b 3 / k(x) has a minimum value of 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, where P2 defines the x position where f(x) is 1 / 2 × d b – 1 / 4 × d t – 1 / 4 × d n and P1 defines the x position where f(x) is P2 – d t / 2 + d n / 2.

[0033] According to the present invention, "a plurality of glass containers" preferably includes 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. In addition, the plurality of glass containers is preferably randomly collected and, in particular, has not been selected for any property. For example, the plurality of glass containers can be a set of containers that are commonly packaged in a typical shipping pallet.

[0034] Surprisingly, it has been found that by controlling the local curvature of the outer contour of the region of the glass container including the joint region and the neck region (i.e., the region that does not come into contact with the upper and lower parts of the test tool for applying the desired load in the side compression test known from the prior art, as shown Figure 1 ), the mechanical strength of the glass container in the side compression test known from the prior art (i.e., a static load test in which a load is directly applied to the body region of the glass container) can be significantly improved. It has also been found that the characteristics of the glass container passing the neck side compression test as described herein are also characterized by improved mechanical strength in the side compression test known from the prior art. This is again surprising because in the side compression test known from the prior art, the load is directly applied to the body region of the glass container, rather than to the neck region. A person skilled in the art cannot therefore expect that an improvement in the mechanical strength of the laterally applied load in the neck region will also improve the mechanical strength of the load in the body region.

[0035] ​In embodiment 2 of the glass container 1 according to the present invention or in embodiment 3 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to its embodiment 1 or the plurality of glass containers 1 are designed according to its embodiment 1 or embodiment 2.

[0036] ib) wherein the joint region has an outer surface which at the end where the joint region merges into the neck region

[0037] is substantially circular-arc shaped, and the outer radius of this substantially circular-arc shaped region is r s ;

[0038] ic) the minimum thickness of the glass in the neck region (106) is l n , and

[0039] wherein for at least 75%, preferably at least 85%,

[0040] more preferably at least 95% and most preferably each glass container of the glass container 1 or included in the plurality of glass containers 1 satisfies the following condition:

[0041] 2 × [l n / l b × r s ≥ 0.9 mm;

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

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

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

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

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

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

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

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

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

[0051] In Example 3 of the glass container 1 according to the present invention or in Example 4 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to its Example 1 or Example 2 or the plurality of glass containers 1 are designed according to any one of its Examples 1 to 3, wherein the minimum thickness of the glass in the neck region is l 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 comprised in the plurality of glass containers 1 and most preferably for each glass container the following conditions are satisfied:

[0052] l n / l b ≥ 1.3;

[0053] Preferably l n / l b ≥ 1.4;

[0054] More preferably l n / l b ≥ 1.45;

[0055] Even more preferably l n / l b ≥ 1.5;

[0056] Most preferably l n / l b ≥ 1.6.

[0057] In Example 4 of the glass container 1 according to the present invention or in Example 5 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of its Examples 1 to 3 or the plurality of glass containers 1 are designed according to any one of its Examples 1 to 4, 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 for each glass container, d tIn 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.

[0058] In embodiment 5 of the glass container 1 according to the invention or in embodiment 6 of a plurality of glass containers 1 according to the invention, the glass container 1 is designed according to any one of its embodiments 1 to 4 or the plurality of glass containers 1 are designed according to any one of its embodiments 1 to 5, 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 for each glass container, one of the following conditions is met:

[0059] - The filling volume is in the range of 1 ml to 8 ml, and 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;

[0060] - The filling volume is in the range of 8.5 ml to 22 ml, and d n In the range of 14.5 mm to 18 mm, preferably in the range of 15.2 mm to 16.5 mm, more preferably in the range of 15.5 mm to 16.3 mm, even more preferably in the range of 15.7 mm to 16.3 mm and most preferably in the range of 15.9 mm to 16.3 mm; or

[0061] - The filling volume is in the range of 22.5 ml to 150 ml, and 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.

[0062] In embodiment 6 of the glass container 1 according to the invention or in embodiment 7 of a plurality of glass containers 1 according to the invention, the glass container 1 is designed according to any one of its embodiments 1 to 5 or the plurality of glass containers 1 are designed according to any one of its embodiments 1 to 6, 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 for each glass container, db In the range of 14 mm to 60 mm, preferably in the range of 15 mm to 32 mm, more preferably in the range of 15 mm to 25 mm, even more preferably in the range of 15 mm to 23 mm, and most preferably in the range of 15 mm to 17 mm.

[0063] In Example 7 of the glass container 1 according to the present invention or in Example 8 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of Examples 1 to 6 thereof or the plurality of glass containers 1 are designed according to any one of Examples 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 included 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.

[0064] In Example 8 of the glass container 1 according to the present invention or in Example 9 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of Examples 1 to 7 thereof or the plurality of glass containers 1 are designed according to any one of Examples 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 included in the plurality of glass containers 1 and most preferably for 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.

[0065] In Example 9 of the glass container 1 according to the present invention or in Example 10 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of Examples 1 to 8 thereof or the plurality of glass containers 1 are designed according to any one of Examples 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 included in the plurality of glass containers 1 and most preferably for 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°.

[0066] In embodiment 10 of glass container 1 according to the present invention or in embodiment 11 of a plurality of glass containers 1 according to the present invention, glass container 1 is designed according to any one of embodiments 1 to 9 thereof or a plurality of glass containers 1 are designed according to any one of embodiments 1 to 10 thereof, wherein for glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% and most preferably each glass container included in the plurality of glass containers 1, the container part from the glass bottom up to the top region is rotationally symmetric about a longitudinal axis vertically passing through the center of the glass bottom.

[0067] In embodiment 11 of glass container 1 according to the present invention or in embodiment 12 of a plurality of glass containers 1 according to the present invention, glass container 1 is designed according to any one of embodiments 1 to 10 thereof or a plurality of glass containers 1 are designed according to any one of embodiments 1 to 11 thereof, wherein for glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% and most preferably each glass container included in the plurality of glass containers 1, throughout the body region, in each case based on the mean value of the wall thickness of the body region, the wall thickness n of the glass tube b is in the range of ±0.2 mm, preferably in the range of ±0.1 mm, more preferably in the range of ±0.08 mm and most preferably in the range of ±0.05 mm.

[0068] In embodiment 12 of glass container 1 according to the present invention or in embodiment 13 of a plurality of glass containers 1 according to the present invention, glass container 1 is designed according to any one of embodiments 1 to 11 thereof or a 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 an internal volume V i , and wherein for glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% and most preferably each glass container included in the plurality of glass containers 1, the following condition is satisfied:

[0069] m g / V i 0.75 <2.0;

[0070] Preferably m g / V i 0.75 <1.75.

[0071] In embodiment 13 of glass container 1 according to the present invention or in embodiment 14 of a plurality of glass containers 1 according to the present invention, glass container 1 is designed according to any one of embodiments 1 to 12 thereof or a plurality of glass containers 1 are designed according to any one of embodiments 1 to 13 thereof, wherein the glass container has an internal volume Vi and wherein for the glass container 1 or for at least 75%, preferably at least 85%, more preferably at least 95% and most preferably each of the glass containers comprised in a plurality of glass containers 1, V i is in the range of from 2 ml to 150 ml, preferably in the range of from 3 ml to 100 ml, more preferably in the range of from 3 ml to 50 ml, even more preferably in the range of from 3 ml to 15 ml and most preferably in the range of from 3 ml to 7 ml.

[0072] In embodiment 14 of the glass container 1 according to the invention or in embodiment 15 of a plurality of glass containers 1 according to the 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% and most preferably each of the glass containers comprised in a plurality of glass containers 1, h c is in the range of from 15 mm to 100 mm, preferably in the range of from 20 mm to 60 mm, more preferably in the range of from 25 mm to 55 mm, even more preferably in the range of from 30 mm to 50 mm and most preferably in the range of from 34 mm to 46 mm.

[0073] In embodiment 15 of the glass container 1 according to the invention or in embodiment 16 of a plurality of glass containers 1 according to the invention, the glass container 1 is designed according to any one of embodiments 1 to 14 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 1 to 15 thereof, wherein the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% and most preferably each of the glass containers comprised in a plurality of glass containers 1 is a packaging container for medical or pharmaceutical packaging articles or medical and pharmaceutical packaging articles. Preferred pharmaceutical packaging articles are pharmaceutical compositions. Preferably, according to the provisions of section 3.2.1 of the 7th edition of the European Pharmacopoeia in force in 2011, the glass container 1 or the glass containers comprised in a plurality of glass containers 1 are suitable for packaging parenteral pharmaceuticals.

[0074] In embodiment 16 of the glass container 1 according to the invention or in embodiment 17 of a plurality of glass containers 1 according to the 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% and most preferably each of the glass containers comprised in a plurality of glass containers 1 is a vial.

[0075] In embodiment 17 of glass container 1 according to the present invention or in embodiment 18 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of embodiments 2 to 16 thereof or the plurality of glass containers 1 are designed according to any one of embodiments 3 to 17 thereof, wherein at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers 1 or the glass containers included 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 the following conditions are satisfied:

[0076] d n ≥9.5 mm;

[0077] r s ≥0.5 mm.

[0078] In embodiment 18 of glass container 1 according to the present invention or in embodiment 19 of a 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 at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers 1 or the glass containers included in the plurality of glass containers 1 and most preferably each glass container, the following conditions are satisfied:

[0079] d n ≥9.5 mm;

[0080] Preferably d n ≥9.6 mm;

[0081] More preferably d n ≥9.7 mm;

[0082] Even more preferably d n ≥9.8 mm;

[0083] Most preferably d n ≥9.9 mm.

[0084] In embodiment 19 of glass container 1 according to the present invention or in embodiment 20 of a 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 embodiment 19 thereof, wherein for at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers 1 or the glass containers included in the plurality of glass containers 1 and most preferably each glass container, the following conditions are satisfied:

[0085] r s ≥0.5 mm;

[0086] Preferably r s ≥0.55 mm;

[0087] More preferably, r s ≥0.6 mm;

[0088] Even more preferably, r s ≥0.7 mm;

[0089] Most preferably, r s ≥0.8 mm.

[0090] In embodiment 20 of glass container 1 according to the invention or in embodiment 21 of a plurality of glass containers 1 according to the invention, glass container 1 is designed according to any one of embodiments 17 to 19 thereof or a plurality of glass containers 1 are designed according to any one of embodiments 18 to 20 thereof, wherein glass container 1 or 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 is a vial sized "2R" or "4R" according to DIN EN ISO8362-1:2016-06.

[0091] In embodiment 21 of glass container 1 according to the invention or in embodiment 22 of a plurality of glass containers 1 according to the invention, glass container 1 is designed according to any one of embodiments 2 to 16 thereof or a plurality of glass containers 1 are designed according to any one of embodiments 3 to 17 thereof, wherein glass container 1 or 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 is a vial having an internal volume of 8.5 to 22 ml, and wherein the following conditions are met:

[0092] d n ≥15.5 mm;

[0093] r s ≥0.5 mm.

[0094] In embodiment 22 of glass container 1 according to the invention or in embodiment 23 of a plurality of glass containers 1 according to the invention, glass container 1 is designed according to embodiment 21 thereof or a plurality of glass containers 1 are designed according to embodiment 22 thereof, wherein for glass container 1 or 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, the following conditions are met:

[0095] d n ≥15.5 mm;

[0096] Preferably, d n ≥15.6 mm;

[0097] More preferably, d n ≥15.7 mm;

[0098] Even more preferably d n ≥15.8 mm;

[0099] Most preferably d n ≥15.9 mm.

[0100] In Example 23 of the glass container 1 according to the invention or in Example 24 of a plurality of glass containers 1 according to the invention, the glass container 1 is designed according to its Example 21 or 22 or a plurality of glass containers 1 are designed according to its Example 22 or 23, wherein for the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers comprised in a plurality of glass containers 1 and most preferably for each glass container, the following conditions are met:

[0101] r s ≥0.5 mm;

[0102] Preferably r s ≥0.55 mm;

[0103] More preferably r s ≥0.6 mm;

[0104] Even more preferably r s ≥0.7 mm;

[0105] Most preferably r s ≥0.8 mm.

[0106] In Example 24 of the glass container 1 according to the invention or in Example 25 of a plurality of glass containers 1 according to the invention, the glass container 1 is designed according to any one of its Examples 21 to 23 or a plurality of glass containers 1 are designed according to any one of its Examples 22 to 24, wherein the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers comprised in a plurality of glass containers 1 and most preferably each glass container is a vial sized "6R", "8R" or "10R" according to DIN EN ISO8362-1:2016-06.

[0107] In Example 25 of the glass container 1 according to the invention or in Example 26 of a plurality of glass containers 1 according to the invention, the glass container 1 is designed according to any one of its Examples 2 to 16 or a plurality of glass containers 1 are designed according to any one of its Examples 3 to 17, wherein the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% of the glass containers comprised in a plurality of glass containers 1 and most preferably each glass container is a vial having an internal volume of 22.5 to 150 ml, and wherein the following conditions are met:

[0108] d n≥16.5 mm;

[0109] r s ≥0.5 mm.

[0110] In embodiment 26 of the glass container 1 according to the invention or in embodiment 27 of a plurality of glass containers 1 according to the invention, the glass container 1 is designed according to its embodiment 25 or the plurality of glass containers 1 are designed according to their embodiment 26, wherein for the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% and most preferably each of the glass containers comprised in the plurality of glass containers 1, the following conditions are met:

[0111] d n ≥16.5 mm;

[0112] Preferably d n ≥16.6 mm;

[0113] More preferably d n ≥16.7 mm;

[0114] Even more preferably d n ≥16.8 mm;

[0115] Most preferably d n ≥16.9 mm.

[0116] In embodiment 27 of the glass container 1 according to the invention or in embodiment 28 of a plurality of glass containers 1 according to the invention, the glass container 1 is designed according to its embodiment 25 or 26 or the plurality of glass containers 1 are designed according to their embodiment 26 or 27, wherein for the glass container 1 or at least 75%, preferably at least 85%, more preferably at least 95% and most preferably each of the glass containers comprised in the plurality of glass containers 1, the following conditions are met:

[0117] r s ≥0.5 mm;

[0118] Preferably r s ≥0.55 mm;

[0119] More preferably r s ≥0.6 mm;

[0120] Even more preferably r s ≥0.7 mm;

[0121] Most preferably r s ≥0.8 mm.

[0122] In Embodiment 28 of glass container 1 according to the invention or in Embodiment 29 of a plurality of glass containers 1 according to the invention, glass container 1 is designed according to any one of Embodiments 25 to 27 thereof or a plurality of glass containers 1 are designed according to any one of Embodiments 26 to 28 thereof, wherein glass container 1 or 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 is a vial sized "20R", "25R", "30R", "50R" or "100R" according to DIN EN ISO8362-1:2016-06.

[0123] In Embodiment 29 of glass container 1 according to the invention or in Embodiment 30 of a plurality of glass containers 1 according to the invention, glass container 1 is designed according to any one of Embodiments 1 to 28 thereof or a plurality of glass containers 1 are designed according to any one of Embodiments 1 to 29 thereof, wherein the glass is selected from borosilicate glass, aluminosilicate glass, calcium sodium glass and fused silica. "Calcium sodium glass" according to the invention is an alkali glass / alkaline earth metal glass / silicate glass according to Table 1 of ISO 12775 (First Edition 1997-10-15).

[0124] In Embodiment 30 of glass container 1 according to the invention or in Embodiment 31 of a plurality of glass containers 1 according to the invention, glass container 1 is designed according to any one of Embodiments 1 to 29 thereof or a plurality of glass containers 1 are designed according to any one of Embodiments 1 to 30 thereof, wherein the glass container comprises a coating that at least partially overlaps with the outer surface, inner surface, or both the outer and inner surfaces of the glass tube.

[0125] In Embodiment 31 of glass container 1 according to the invention or in Embodiment 32 of a plurality of glass containers 1 according to the invention, glass container 1 is designed according to Embodiment 30 thereof or a plurality of glass containers 1 are designed according to Embodiment 31 thereof, wherein the coating comprises a silicone, silane or a mixture thereof, wherein the silicone or silane can be crosslinked or non-crosslinked. For example, suitable silanes and silicones for treating the surface of glass containers are disclosed in US 2011 / 0006028 A1, US 4,420,578 or WO 2014 / 105350 A3.

[0126] In Embodiment 32 of glass container 1 according to the invention or in Embodiment 33 of a plurality of glass containers 1 according to the invention, glass container 1 is designed according to Embodiment 30 thereof or a plurality of glass containers 1 are designed according to Embodiment 31 thereof, wherein the coating preferably comprises a coating located on the outer surface of the glass tube (i.e., facing the internal volume V of the glass container) ia coupling agent layer on a surface opposite the inner surface) and a polymer layer on the coupling agent layer, the coupling agent layer comprising a coupling agent and the polymer layer comprising a polymer chemical composition. Preferably, the coating is the coating described in US 2013 / 171456 A1.

[0127] In Example 33 of the glass container 1 according to the present invention or in Example 34 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to its Example 32 or a plurality of glass containers 1 are designed according to its Example 33, wherein the coating further comprises an interface layer between the coupling agent layer and the polymer layer, and the interface layer comprises one or more chemical compositions of the polymer layer combined with one or more chemical compositions of the coupling agent layer.

[0128] In Example 34 of the glass container 1 according to the present invention or in Example 35 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to its Example 32 or 33 or a plurality of glass containers 1 are designed according to its Example 33 or Example 34, wherein the coupling agent comprises at least one of the following: a first silane chemical composition, its hydrolysis product or oligomer; and a chemical composition formed by oligomerization of at least a first silane chemical composition and a second silane chemical composition, wherein the first silane chemical composition and the second silane chemical composition are different chemical compositions.

[0129] In Example 35 of the glass container 1 according to the present invention or in Example 36 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to its Example 34 or a plurality of glass containers 1 are designed according to its Example 35, wherein the first silane chemical composition is an aromatic silane chemical composition.

[0130] In Example 36 of the glass container 1 according to the present invention or in Example 37 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to its Example 32 or a plurality of glass containers 1 are designed according to its Example 33, wherein the coupling agent comprises a silsesquioxane chemical composition, the silsesquioxane chemical composition comprising an aromatic moiety and an ammonia-containing moiety.

[0131] In Example 37 of the glass container 1 according to the present invention or in Example 38 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to its Example 32 or a plurality of glass containers 1 are designed according to its Example 33, wherein the coupling agent comprises at least one of the following: a mixture of a first silane chemical composition and a second silane chemical composition; and a chemical composition formed by oligomerization of at least a first silane chemical composition and a second silane chemical composition, wherein the first silane chemical composition and the second silane chemical composition are different chemical compositions.

[0132] In embodiment 38 of glass container 1 according to the present invention or in embodiment 39 of a plurality of glass containers 1 according to the present invention, glass container 1 is designed according to its embodiment 37 or a plurality of glass containers 1 are designed according to its embodiment 38, wherein the first silane chemical composition is an aromatic silane chemical composition.

[0133] In embodiment 39 of glass container 1 according to the present invention or in embodiment 40 of a plurality of glass containers 1 according to the present invention, glass container 1 is designed according to any one of its embodiments 32 to 39 or a plurality of glass containers 1 are designed according to any one of its embodiments 33 to 39, wherein the polymer chemical composition is a polyimide chemical composition.

[0134] In embodiment 40 of glass container 1 according to the present invention or in embodiment 41 of a plurality of glass containers 1 according to the present invention, glass container 1 is designed according to any one of its embodiments 1 to 39 or a plurality of glass containers 1 are designed according to any one of its embodiments 1 to 40, wherein the internal volume V of the glass container i contains a pharmaceutical composition.

[0135] In embodiment 41 of glass container 1 according to the present invention or in embodiment 42 of a plurality of glass containers 1 according to the present invention, glass container 1 is designed according to any one of its embodiments 1 to 40 or a plurality of glass containers 1 are designed according to any one of its embodiments 1 to 41, wherein glass container 1 includes a closure at the top of glass container 1, preferably a lid.

[0136] In embodiment 42 of glass container 1 according to the present invention or in embodiment 43 of a plurality of glass containers 1 according to the present invention, glass container 1 is designed according to any one of its embodiments 1 to 41 or a plurality of glass containers 1 are designed according to any one of its embodiments 1 to 42, wherein glass container 1 has not been thermally tempered.

[0137] In embodiment 43 of glass container 1 according to the present invention or in embodiment 44 of a plurality of glass containers 1 according to the present invention, glass container 1 is designed according to any one of its embodiments 1 to 42 or a plurality of glass containers 1 are designed according to any one of its embodiments 1 to 43, wherein the glass of at least the neck region of glass container 1 is characterized in that sodium is substantially uniformly distributed over the thickness n of the glass b thereon.

[0138] In embodiment 44 of glass container 1 according to the present invention or in embodiment 45 of a plurality of glass containers 1 according to the present invention, glass container 1 is designed according to any one of its embodiments 1 to 43 or a plurality of glass containers 1 are designed according to any one of its embodiments 1 to 44, wherein the glass of at least the neck region of glass container 1 is characterized in that potassium is in the thickness n of the glassb Be evenly distributed basically on it.

[0139] In Example 45 of the glass container 1 according to the present invention or in Example 46 of a plurality of glass containers 1 according to the present invention, the glass container 1 is designed according to any one of Examples 1 to 44 thereof or the plurality of glass containers 1 are designed according to any one of Examples 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 region 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, a polarimeter suitable for the vial geometry can be used to measure the compressive stress.

[0140] At least one of the objects according to the present invention is achieved by Example 1 of Process 1 for manufacturing an article, preferably a glass container, more preferably the glass container 1 according to the present invention or a glass container included in a plurality of glass containers 1 according to the present invention, the process comprising the following steps as process steps:

[0141] I) Provide a glass tube having a first end and another end, wherein the glass tube is characterized by a longitudinal axis L tube and an outer diameter d b and a glass thickness n b ;

[0142] II) While the glass tube is rotating about its main axis, heat the first end of the glass tube to a temperature above its glass transition temperature, preferably to a temperature above its softening temperature, with a heating element, preferably with a flame;

[0143] III) While the heated glass tube is rotating about its main axis, shape the outer contour of the first end in order to obtain:

[0144] 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 ;

[0145] ib) A joint region adjacent to the top region;

[0146] ic) A neck region adjacent to the joint region, wherein the outer diameter of the neck region is d n , d n < d t ; and

[0147] id) A shoulder region adjacent to the neck region;

[0148] wherein the shaping in process step III) is such that an outer contour c of the first end portion of the glass tube is obtained with the following characteristics outer :

[0149] If the glass container is placed on a flat horizontal base on which the outer surface of the body region lies, then in any given cross-section of the glass container in the plane that is centered within the glass container and includes the longitudinal axis L tube of the glass container, f(x) defines the vertical distance between the base and the outer surface of the glass container at a given position x, and l(x) defines the thickness of the glass at the given position x, where the thickness l(x) of the glass is measured in a direction perpendicular to the longitudinal axis L tube ;

[0150] where 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

[0151] where, in the interval between x = P1 and x = P2, for any concave curvature within the interval, the minimum value of [l(x) / l b 3 / 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, where P2 defines the x-position at which f(x) is 1 / 2 × d b – 1 / 4 × d t – 1 / 4 × d n and P1 defines the x-position at which f(x) is P2 – d t / 2 + d n / 2;

[0152] The "softening temperature" of the glass means the temperature at which the viscosity of the glass (determined according to ISO 7884-6:1987) is 10 7.6 dPa×sec.

[0153] In Example 2 of Process 1 according to the present invention, Process 1 is designed according to its Example 1, wherein the process includes additional process steps:

[0154] IV) While the glass tube is rotating about its main axis, heating a defined position above the first end portion of the glass tube shaped in process step III) to a temperature above its glass transition temperature, preferably to a temperature above its softening temperature, with a heating element, preferably with a flame;​​

[0155] V) While the glass tube is rotating about its main axis, the heated glass tube is pulled to effect stretching and produce a container closure;

[0156] VI) While the heated glass tube is rotating about its main axis, preferably when the temperature is 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.

[0157] In Example 3 of Process 1 according to the present invention, Process 1 is designed according to its Example 1 or 2, wherein in Process Step III), one or more forming tools acting on predetermined positions on the outer surfaces of the heated joint region and the heated neck region, preferably one or more forming rollers, are used to form the outer contour c of the joint region and the neck region outer .

[0158] In Example 4 of Process 1 according to the present invention, Process 1 is designed according to any one of its Examples 1 to 3, wherein the forming in Process Step III) is carried out in the following manner:

[0159] ib) The joint region has an outer surface that is substantially circular-arc-shaped at the end where the joint region merges into the neck region, and this substantially circular-arc-shaped region has an outer radius r s ;

[0160] ic) The minimum thickness of the glass in the neck region is l n ;

[0161] Wherein, the following conditions are satisfied:

[0162] 2 × [l n / l b × r s ≥ 0.9 mm;

[0163] Preferably 2 × [l n / l b × r s ≥ 1.0 mm;

[0164] More preferably 2 × [l n / l b × r s ≥ 1.1 mm;

[0165] Even more preferably 2 × [l n / l b × r s ≥ 1.2 mm;

[0166] Even more preferably 2 × [l n / l b × rs ≥1.3 mm;

[0167] Even more preferably, 2 × [l n / l b × r s ≥1.4 mm;

[0168] Even most preferably, 2 × [l n / l b × r s ≥1.5 mm;

[0169] Even more preferably, 2 × [l n / l b × r s ≥1.7 mm;

[0170] Even more preferably, 2 × [l n / l b × r s ≥2.0 mm;

[0171] Most preferably, 2 × [l n / l b × r s ≥2.5 mm.

[0172] In Example 5 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 4 thereof, wherein the shaping in Process Step III) is carried out in such a manner that when the minimum thickness of the glass in the neck region is l n , the following conditions are satisfied:

[0173] l n / l b ≥1.3;

[0174] Preferably, l n / l b ≥1.4;

[0175] More preferably, l n / l b ≥1.45;

[0176] Even more preferably, l n / l b ≥1.5;

[0177] Most preferably, l n / l b ≥1.6.

[0178] In Example 6 of Process 1 according to the present invention, Process 1 is designed according to any one of Examples 1 to 5 thereof, wherein the shaping in Process Step III) is such that d tIn 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.

[0179] 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:

[0180] - The filling volume is in the range of 1 ml to 8 ml, 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;

[0181] - The filling volume is in the range of 8.5 ml to 22 ml, d n In the range of 14.5 mm to 18 mm, preferably in the range of 15.2 mm to 16.5 mm, more preferably in the range of 15.5 mm to 16.3 mm, even more preferably in the range of 15.7 mm to 16.3 mm, and most preferably in the range of 15.9 mm to 16.3 mm; or

[0182] - The filling volume is in the range of 22.5 ml to 150 ml, 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.

[0183] 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 14 mm to 60 mm, preferably in the range of 15 mm to 32 mm, more preferably in the range of 15 mm to 25 mm, even more preferably in the range of 15 mm to 23 mm, and most preferably in the range of 15 mm to 17 mm.

[0184] 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 –dn 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.

[0185] In Example 10 of Process 1 according to the 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 is 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.

[0186] In Example 11 of Process 1 according to the invention, Process 1 is designed according to any one of Examples 1 to 10 thereof, wherein the shaping in Process Step III) is such that the shoulder in 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°.

[0187] In Example 12 of Process 1 according to the invention, Process 1 is designed according to any one of Examples 1 to 11 thereof, wherein the shaping in Process Step III) is such that the container part of the glass container from the glass bottom to the top region is rotationally symmetric about a longitudinal axis passing vertically through the center of the glass bottom.

[0188] In Example 13 of Process 1 according to the invention, Process 1 is designed according to any one of Examples 1 to 12 thereof, wherein, in each case based on the mean value of the wall thickness of the glass tube, the wall thickness n of the glass tube b is in the range of ±0.2 mm, preferably in the range of ±0.1 mm, more preferably in the range of ±0.08 mm and most preferably in the range of ±0.05 mm.

[0189] In Example 14 of Process 1 according to the invention, Process 1 is designed according to any one of Examples 4 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 met:

[0190] d n ≥9.5 mm;

[0191] r s ≥0.5 mm.

[0192] In Example 15 of Process 1 according to the present invention, Process 1 is designed according to its Example 14, wherein the shaping in Process Step III) is such that the following conditions are met:

[0193] d n ≥9.5 mm;

[0194] Preferably d n ≥9.6 mm;

[0195] More preferably d n ≥9.7 mm;

[0196] Even more preferably d n ≥9.8 mm;

[0197] Most preferably d n ≥9.9 mm.

[0198] In Example 16 of Process 1 according to the present invention, Process 1 is designed according to its Example 14 or 15, wherein the shaping in Process Step III) is such that the following conditions are met:

[0199] r s ≥0.5 mm;

[0200] Preferably r s ≥0.55 mm;

[0201] More preferably r s ≥0.6 mm;

[0202] Even more preferably r s ≥0.7 mm;

[0203] Most preferably r s ≥0.8 mm.

[0204] In Example 17 of Process 1 according to the present invention, Process 1 is designed according to any one of its Examples 4 to 13, wherein the glass container is a vial with an internal volume of 8.5 to 22 ml, and wherein the shaping in Process Step III) is such that the following conditions are met:

[0205] d n ≥15.5 mm;

[0206] r s ≥0.5 mm.

[0207] In Example 18 of Process 1 according to the present invention, Process 1 is designed according to its Example 17, wherein the shaping in Process Step III) is such that the following conditions are met:

[0208] d n≥15.5 mm;

[0209] Preferably d n ≥15.6 mm;

[0210] More preferably d n ≥15.7 mm;

[0211] Even more preferably d n ≥15.8 mm;

[0212] Most preferably d n ≥15.9 mm.

[0213] In Example 19 of Process 1 according to the present invention, Process 1 is designed according to its Example 17 or 18, wherein the shaping in Process Step III) is such that the following conditions are met:

[0214] r s ≥0.5 mm;

[0215] Preferably r s ≥0.55 mm;

[0216] More preferably r s ≥0.6 mm;

[0217] Even more preferably r s ≥0.7 mm;

[0218] Most preferably r s ≥0.8 mm.

[0219] In Example 20 of Process 1 according to the present invention, Process 1 is designed according to any one of its Examples 4 to 13, wherein the glass container is a vial with an internal volume of 22.5 to 150 ml, and wherein the shaping in Process Step III) is such that the following conditions are met:

[0220] d n ≥16.5 mm;

[0221] r s ≥0.5 mm.

[0222] In Example 21 of Process 1 according to the present invention, Process 1 is designed according to its Example 20, wherein the shaping in Process Step III) is such that the following conditions are met:

[0223] d n ≥16.5 mm;

[0224] Preferably d n ≥16.6 mm;

[0225] More preferably d n≥16.7 mm;

[0226] Even more preferably d n ≥16.8 mm;

[0227] Most preferably d n ≥16.9 mm.

[0228] In Example 22 of Process 1 according to the invention, Process 1 is designed according to its Example 20 or 21, wherein the shaping in Process Step III) is such that the following conditions are met:

[0229] r s ≥0.5 mm;

[0230] Preferably r s ≥0.55 mm;

[0231] More preferably r s ≥0.6 mm;

[0232] Even more preferably r s ≥0.7 mm;

[0233] Most preferably r s ≥0.8 mm.

[0234] In Example 23 of Process 1 according to the 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, calcium-sodium glass and fused silica.

[0235] In Example 24 of Process 1 according to the invention, Process 1 is designed according to its Examples 1 to 23, wherein the glass container has not been thermally tempered.

[0236] In Example 25 of Process 1 according to the invention, Process 1 is designed according to any one of its Examples 1 to 24, wherein the glass of at least the neck region of the glass container is characterized in that sodium is substantially uniformly distributed in the thickness n of the glass. b over the thickness.

[0237] In Example 26 of Process 1 according to the invention, Process 1 is designed according to any one of its Examples 1 to 25, wherein the glass of at least the neck region of the glass container is characterized in that potassium is substantially uniformly distributed in the thickness n of the glass. b over the thickness.

[0238] 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 region 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, a polarimeter suitable for the vial geometry can be used to measure the compressive stress.

[0239] At least one of the objects according to the present invention is achieved by Example 1 of the glass container 2 obtainable by Process 1 of the present invention according to any one of Examples 1 to 27 thereof. 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 the examples thereof and the technical features of each glass container included in a plurality of glass containers 1 according to the present invention.

[0240] At least one of the objects according to the present invention is achieved by Example 1 of Process 2, which process 2 comprises the following steps as process steps:

[0241] a) providing a glass container 1 according to any preferred embodiment of its preferred embodiments, a plurality of glass containers 1 according to any preferred embodiment of its preferred embodiments, or a glass container 2 according to any preferred embodiment of its preferred embodiments;

[0242] b) filling the internal volume V of the glass container with the pharmaceutical composition i therein; and

[0243] c) closing the glass container.

[0244] The closing in process step c) preferably comprises bringing the glass container into contact with a closure, preferably with a lid, preferably covering the opening of the glass container with the closure, and connecting the closure and the hollow body. The connection preferably comprises a form-fit between the glass container, preferably the flange of the glass container, and the closure. The form-fit is preferably formed by a crimping step. Process 2 is preferably a process for packaging a pharmaceutical composition.

[0245] At least one of the objects according to the present invention is achieved by Example 1 of the closed glass container obtainable by Process 2 of the present invention according to any one of the examples thereof.

[0246] At least one of the objects according to the present invention is achieved by Example 1 of Process 3, which process 3 comprises the following steps as process steps:

[0247] 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

[0248] B) administering the pharmaceutical composition to a patient.

[0249] An embodiment 1 of use 1 of 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 for packaging a pharmaceutical composition realizes at least one of the objects of the present invention. The packaging preferably comprises: filling the internal volume of the glass container with the pharmaceutical composition; and closing the glass container.

[0250] Glass container

[0251] The glass container according to the present invention or the glass containers comprised in a plurality of glass containers according to the present invention can have any size or shape considered suitable by a person skilled in the art in the context of the present invention. Preferably, the top region of the glass container comprises an opening which enables the filling of the internal volume of the glass container with the pharmaceutical composition. The glass container comprises a glass tube and a glass bottom as container parts, the glass tube having a first end and an opposite end, and the glass bottom closing the opposite end of the glass tube. Preferably, the glass container has an integral design and is prepared by the following steps: providing the glass tube and shaping one end of the glass tube (i.e., the end which will become the opening of the glass container) to obtain a top region, a junction region, a neck region and a shoulder region; and then, shaping the opposite end of the glass tube to obtain a closed glass bottom. Preferred glass containers are pharmaceutical glass containers, more preferably one selected from vials, ampoules or combinations thereof, and particularly preferably vials.

[0252] For use herein, the internal volume V i represents the total volume inside the glass container. This volume can be determined by filling the interior of the glass container with water up to the rim and measuring the volume of water that can be accommodated inside up to the rim. Thus, the internal volume as used herein is not the nominal volume as often mentioned in the pharmaceutical art. For example, the nominal volume can be about 0.5 times smaller than the internal volume.

[0253] Glass

[0254] The glass of the container can be any type of glass and can consist of any material or combination of materials considered suitable by a person skilled in the art in the context of the present invention. Preferably, the glass is suitable for pharmaceutical packaging. Particularly preferably, according to the definition of the type of glass in section 3.2.1 of the 7th edition of the European Pharmacopoeia in force in 2011, the type of glass is type I, and more preferably type I b. Alternatively or additionally, compared to the foregoing preference, the glass is selected from borosilicate glass, aluminosilicate glass, calcium sodium glass, and fused silica; or a combination of at least two of them. For use herein, aluminosilicate glass is glass in which the content of Al2O3 is greater than 8 wt%, preferably greater than 9 wt%, and particularly preferably in the range of 9 wt% to 20 wt% in each case based on the total weight of the glass. In each case based on the total weight of the glass, the content of B2O3 in the preferred aluminosilicate glass is less than 8 wt%, preferably at most 7 wt%, and particularly preferably in the range of 0 to 7 wt%. For use herein, borosilicate glass is glass in which the content of B2O3 is at least 1 wt%, preferably at least 2 wt%, more preferably at least 3 wt%, more preferably at least 4 wt%, even more preferably at least 5 wt%, and particularly preferably in the range of 5 wt% to 15 wt% in each case based on the total weight of the glass. In each case based on the total weight of the glass, the content of Al2O3 in the preferred borosilicate glass is less than 7.5 wt%, preferably less than 6.5 wt%, and particularly preferably in the range of 0 to 5.5 wt%. On the other hand, in each case based on the total weight of the glass, the content of Al2O3 in the borosilicate glass is in the range of 3 wt% to 7.5 wt%, preferably in the range of 4 wt% to 6 wt%.

[0255] A further preferred glass according to the present invention substantially does not contain B. Herein, "substantially does not contain B" means that the glass does not contain B that has been added to the glass composition for some purpose. This means that B can still be present as an impurity, but in each case based on the weight of the glass, preferably its content does not exceed 0.1 wt%, more preferably does not exceed 0.05 wt%.

[0256] Outer contour of the joint area

[0257] An important factor for the glass container 1 according to the present invention, the glass container included in a plurality of glass containers 1 according to the present invention, and the glass container 2 according to the present invention is the mechanical strength of the neck region against the load that is applied to the neck region in the neck-side compression test as described in the "Measurement Method" section. Wherein the mechanical strength can be achieved, for example, by a very special outer contour c of the joint region of the glass container (i.e., the transition region between the top region and the neck region). outer implemented, and the outer contour c outer is characterized by a certain minimum value of the curvature of this region.

[0258] To determine this minimum value of the curvature angle of this region, the glass container is placed on a flat horizontal base on which the outer surface of the body region lies. Centrally located within the glass container and including the longitudinal axis L of the glass tube tube In any given cross-section of the glass container, within the plane that includes the longitudinal axis L of the glass tube, f(x) defines the vertical distance (mm) between the base and the outer surface of the glass container at a given position x (whereby f(x) represents the outer contour c of the glass container outer ), and l(x) defines the thickness (mm) of the glass at a given position x, where the thickness l(x) of the glass is measured in a direction perpendicular to the longitudinal axis L tube . The local curvature k(x) can be determined from f(x) in the following manner:

[0259] k(x) = |f”(x) / [1 + f'(x) 2 3 / 2 |.

[0260] At this time, the outer contour c of the glass container according to the present invention outer is characterized in that, within the interval between x = P1 and x = P2, for any concave curvature within this interval, [l(x) / l b 3 / k(x) has a minimum value of 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, where P2 defines that f(x) is 1 / 2 × d b –1 / 4 × d t –1 / 4 × d n and P1 is the x position of P2 – d t / 2 + d n / 2.

[0261] Pharmaceutical composition

[0262] ​​In the context of the present invention, every pharmaceutical composition considered suitable by the person skilled in the art is contemplated. A pharmaceutical composition is a composition comprising at least one active ingredient. A preferred active ingredient is a vaccine. The pharmaceutical composition can be fluid or solid or a combination of fluid and solid, with fluid compositions being particularly preferred herein. Preferred solid compositions are granular, such as powders, 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 (usually a hypodermic syringe needle) and a syringe) or by insertion of an indwelling catheter.

[0263] According to a first preferred embodiment of the glass container 1 of the present invention, the glass container is a vial with an overflow volume equal to or greater than 1 ml and at most 5 ml, preferably a vial sized "2R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is satisfied, preferably all conditions are satisfied:

[0264] i) r s is 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;

[0265] ii) d t is 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;

[0266] iii) d n is 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;

[0267] iv) d b is 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;

[0268] v) l b is 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;

[0269] vi) [l(x) / l b 3 / k(x) has a minimum value ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;​

[0270] vii) 2×[l n / l b ×r s ≥0.9 mm, preferably ≥1.5 mm and more preferably ≥2.0 mm;

[0271] viii) h c in the range of 32 mm to 38 mm, more preferably in the range of 33.5 mm to 36.5 mm and even more preferably in the range of 34.5 mm to 35.5 mm;

[0272] 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;

[0273] 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.

[0274] 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 at most 8 ml, preferably a vial sized "4R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is satisfied, preferably all conditions are satisfied:

[0275] 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;

[0276] 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;

[0277] 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;

[0278] 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;

[0279] v) l bin the range from 0.4 mm to 2 mm, more preferably in the range from 0.8 mm to 1.3 mm and even more preferably in the range from 0.9 mm to 1.15 mm;

[0280] vi) [l(x) / l b 3 / k(x) has a minimum value ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0281] vii) 2 × [l n / l b × r s ≥ 0.9 mm, preferably ≥ 1.5 mm and more preferably ≥ 2.0 mm;

[0282] viii) h c in the range from 42 mm to 48 mm, more preferably in the range from 43.5 mm to 46.5 mm and even more preferably in the range from 44.5 mm to 45.5 mm;

[0283] ix) h b in the range from 22 mm to 42 mm, more preferably in the range from 27 mm to 37 mm and even more preferably in the range from 31 mm to 33 mm;

[0284] x) h t-n in the range from 6 mm to 10 mm, more preferably in the range from 7 mm to 9 mm and even more preferably in the range from 7.5 mm to 8.5 mm.

[0285] According to a third preferred embodiment of the glass container 1 according to the invention, the glass container is a vial with an overflow volume greater than 8 ml and at most 10.75 ml, preferably a vial sized "6R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is satisfied, preferably all conditions are satisfied:

[0286] i) r s in the range from 0.5 mm to 1.0 mm, more preferably in the range from 0.6 mm to 0.95 mm and even more preferably in the range from 0.75 mm to 0.9 mm;

[0287] ii) d t in the range from 17.5 mm to 23.0 mm, more preferably in the range from 18.5 mm to 22.0 mm and even more preferably in the range from 19.5 mm to 20.5 mm;

[0288] 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;

[0289] iv) d b in the range of 19.5 mm to 24.5 mm, more preferably in the range of 20.5 mm to 23.5 mm and even more preferably in the range of 21.5 mm to 22.5 mm;

[0290] 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;

[0291] vi) [l(x) / l b 3 / k(x) has a minimum value ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0292] vii) 2 × [l n / l b × r s ≥ 0.9 mm, preferably ≥ 1.5 mm and more preferably ≥ 2.0 mm;

[0293] viii) h c in the range of 37 mm to 43 mm, more preferably in the range of 38.5 mm to 41.5 mm and even more preferably in the range of 39.5 mm to 40.5 mm;

[0294] 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;

[0295] 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.

[0296] According to a fourth preferred embodiment of the glass container 1 according to the invention, the glass container is a vial with an overflow capacity greater than 10.75 ml and at most 12.5 ml, preferably a vial sized "8R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is satisfied, preferably all conditions are satisfied:

[0297] 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;

[0298] 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;

[0299] 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;

[0300] iv)d b in the range of 19.5 mm to 24.5 mm, more preferably in the range of 20.5 mm to 23.5 mm, and even more preferably in the range of 21.5 mm to 22.5 mm;

[0301] 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;

[0302] vi)[l(x) / l b 3 / k(x) has a minimum value ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm, and even more preferably ≥ 2.1 mm;

[0303] vii)2×[l n / l b ×r s ≥ 0.9 mm, preferably ≥ 1.5 mm, and more preferably ≥ 2.0 mm;

[0304] viii)h c in the range of 42 mm to 47 mm, more preferably in the range of 43.5 mm to 46.5 mm, and even more preferably in the range of 44.5 mm to 45.5 mm;

[0305] 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;

[0306] 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.​

[0307] 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 volume greater than 12.5 ml and at most 16.25 ml, preferably a vial sized "10R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is satisfied, preferably all conditions are satisfied:

[0308] i) r s is in the range from 0.5 mm to 1.0 mm, more preferably in the range from 0.6 mm to 0.95 mm and even more preferably in the range from 0.75 mm to 0.9 mm;

[0309] ii) d t is in the range from 17.5 mm to 23.0 mm, more preferably in the range from 18.5 mm to 22.0 mm and even more preferably in the range from 19.5 mm to 20.5 mm;

[0310] iii) d n is in the range from 14 mm to 19 mm, more preferably in the range from 15 mm to 18 mm and even more preferably in the range from 16 mm to 17 mm;

[0311] iv) d b is in the range from 21 mm to 27 mm, more preferably in the range from 22 mm to 26 mm and even more preferably in the range from 23.5 mm to 24.5 mm;

[0312] v) l b is in the range from 0.4 mm to 2 mm, more preferably in the range from 0.8 mm to 1.3 mm and even more preferably in the range from 0.9 mm to 1.15 mm;

[0313] vi) [l(x) / l b 3 The minimum value of / k(x) ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0314] vii) 2 × [l n / l b × r s ≥ 0.9 mm, preferably ≥ 1.5 mm and more preferably ≥ 2.0 mm;

[0315] viii) h c is in the range from 42 mm to 47 mm, more preferably in the range from 43.5 mm to 46.5 mm and even more preferably in the range from 44.5 mm to 45.5 mm;​

[0316] 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;

[0317] 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.

[0318] According to a sixth preferred embodiment of the glass container 1 according to the invention, the glass container is a vial with an overflow volume greater than 16.25 ml and at most 22.5 ml, preferably a vial sized "15R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is satisfied, preferably all conditions are satisfied:

[0319] 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;

[0320] 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;

[0321] 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;

[0322] 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;

[0323] 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;

[0324] vi)[l(x) / l b 3 The minimum value of / k(x) ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0325] ​vii) 2 × [l n / l b × r s ≥ 0.9 mm, preferably ≥ 1.5 mm and more preferably ≥ 2.0 mm;

[0326] 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;

[0327] ix) h b within the range of 35 mm to 55 mm, more preferably within the range of 40 mm to 50 mm and even more preferably within the range of 44 mm to 46 mm;

[0328] x) h t-n within the range of 7 mm to 11 mm, more preferably within the range of 8 mm to 10 mm and even more preferably within the range of 8.5 mm to 9.5 mm.

[0329] According to the 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 at most 29.25 ml, preferably a vial sized "20R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is satisfied, preferably all conditions are satisfied:

[0330] i) r s within the range of 0.5 mm to 1.0 mm, more preferably within the range of 0.6 mm to 0.95 mm and even more preferably within the range of 0.75 mm to 0.9 mm;

[0331] ii) d t within the range of 17.5 mm to 23.0 mm, more preferably within the range of 18.5 mm to 22.0 mm and even more preferably within the range of 19.5 mm to 20.5 mm;

[0332] iii) d n within the range of 15 mm to 20 mm, more preferably within the range of 16 mm to 19 mm and even more preferably within the range of 17 mm to 18 mm;

[0333] 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;

[0334] v) l bIn 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;

[0335] vi) [l(x) / l b 3 / k(x) has a minimum value ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0336] vii) 2 × [l n / l b × r s ≥ 0.9 mm, preferably ≥ 1.5 mm and more preferably ≥ 2.0 mm;

[0337] viii) h c is in the range of 51 mm to 59 mm, more preferably in the range of 53 mm to 57 mm and even more preferably in the range of 54.5 mm to 55.5 mm;

[0338] ix) h b is in the range of 15 mm to 55 mm, more preferably in the range of 25 mm to 45 mm, even more preferably in the range of 30 mm to 40 mm and most preferably in the range of 34 mm to 36 mm;

[0339] x) h t-n is 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.

[0340] According to an eighth preferred embodiment of the glass container 1 according to the invention, the glass container is a vial with an overflow capacity greater than 29.25 ml and at most 35 ml, preferably a vial sized "25R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is satisfied, preferably all conditions are satisfied:

[0341] i) r s is 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;

[0342] ii) d t is 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; ​

[0343] 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;

[0344] iv) d b in the range of 27 mm to 33 mm, more preferably in the range of 28 mm to 32 mm, and even more preferably in the range of 29.5 mm to 30.5 mm;

[0345] 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;

[0346] vi) [l(x) / l b 3 / k(x) has a minimum value ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm, and even more preferably ≥ 2.1 mm;

[0347] vii) 2 × [l n / l b × r s ≥ 0.9 mm, preferably ≥ 1.5 mm, and more preferably ≥ 2.0 mm;

[0348] viii) h c in the range of 61 mm to 69 mm, more preferably in the range of 63 mm to 67 mm, and even more preferably in the range of 64.5 mm to 65.5 mm;

[0349] ix) h b in the range of 25 mm to 65 mm, more preferably in the range of 35 mm to 55 mm, even more preferably in the range of 40 mm to 50 mm, and most preferably in the range of 44 mm to 46 mm;

[0350] 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.

[0351] ​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 at most 49.75 ml, preferably a vial sized "30R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is satisfied, preferably all conditions are satisfied:

[0352] i) r s is in the range from 0.5 mm to 1.0 mm, more preferably in the range from 0.6 mm to 0.95 mm and even more preferably in the range from 0.75 mm to 0.9 mm;

[0353] ii) d t is in the range from 17.5 mm to 23.0 mm, more preferably in the range from 18.5 mm to 22.0 mm and even more preferably in the range from 19.5 mm to 20.5 mm;

[0354] iii) d n is in the range from 15 mm to 20 mm, more preferably in the range from 16 mm to 19 mm and even more preferably in the range from 17 mm to 18 mm;

[0355] iv) d b is in the range from 27 mm to 33 mm, more preferably in the range from 28 mm to 32 mm and even more preferably in the range from 29.5 mm to 30.5 mm;

[0356] v) l b is in the range from 0.5 mm to 2.5 mm, more preferably in the range from 0.7 mm to 2 mm, even more preferably in the range from 0.9 mm to 1.6 mm and most preferably in the range from 1.15 mm to 1.25 mm;

[0357] vi) [l(x) / l b 3 / k(x) has a minimum value ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0358] vii) 2 × [l n / l b × r s ≥ 0.9 mm, preferably ≥ 1.5 mm and more preferably ≥ 2.0 mm;

[0359] viii) h c is in the range from 71 mm to 79 mm, more preferably in the range from 73 mm to 77 mm and even more preferably in the range from 74.5 mm to 75.5 mm; ​

[0360] ix) h b in the range of 35 mm to 75 mm, more preferably in the range of 45 mm to 65 mm, even more preferably in the range of 50 mm to 60 mm and most preferably in the range of 54 mm to 56 mm;

[0361] 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.

[0362] According to a tenth preferred embodiment of the glass container 1 according to the invention, the glass container is a vial with an overflow volume greater than 49.75 ml and at most 92.5 ml, preferably a vial dimensioned as "50R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is satisfied, preferably all conditions are satisfied:

[0363] 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;

[0364] 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;

[0365] 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;

[0366] iv) d b in the range of 37 mm to 43 mm, more preferably in the range of 38 mm to 42 mm and even more preferably in the range of 39.5 mm to 40.5 mm;

[0367] 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;

[0368] vi) [l(x) / l b 3 ​The minimum value of / k(x) ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0369] vii) 2 × [l n / l b × r s ≥ 0.9 mm, preferably ≥ 1.5 mm and more preferably ≥ 2.0 mm;

[0370] viii) h c is in the range of 69 mm to 77 mm, more preferably in the range of 71 mm to 75 mm and even more preferably in the range of 72.5 mm to 73.5 mm;

[0371] ix) h b is in the range of 29 mm to 69 mm, more preferably in the range of 39 mm to 59 mm, even more preferably in the range of 44 mm to 54 mm and most preferably in the range of 48 mm to 50 mm;

[0372] x) h t-n is 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.

[0373] According to the 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 at most 150 ml, preferably a vial sized "100R" according to DIN EN ISO 8362-1:2016-06, wherein further preferably, at least one of the following conditions i) to x) is satisfied, preferably all conditions are satisfied:

[0374] i) r s is 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;

[0375] ii) d t is 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;

[0376] iii) d n is 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;

[0377] iv) d bin the range of 43 mm to 51 mm, more preferably in the range of 45 mm to 49 mm and even more preferably in the range of 46.5 mm to 47.5 mm;

[0378] 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;

[0379] vi)[l(x) / l b 3 / k(x) has a minimum value ≥ 0.35 mm, preferably ≥ 1.5 mm, more preferably ≥ 1.8 mm and even more preferably ≥ 2.1 mm;

[0380] vii)2×[l n / l b ×r s ≥ 0.9 mm, preferably ≥ 1.5 mm and more preferably ≥ 2.0 mm;

[0381] viii)h c in the range of 96 mm to 103 mm, more preferably in the range of 98 mm to 101 mm and even more preferably in the range of 99.5 mm to 100.5 mm;

[0382] ix)h b in the range of 55 mm to 95 mm, more preferably in the range of 65 mm to 85 mm, even more preferably in the range of 70 mm to 80 mm and most preferably in the range of 74 mm to 76 mm;

[0383] 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.

[0384] Measurement method

[0385] The following measurement methods will be used in the context of the present invention. Unless otherwise stated, the measurements must be carried out at an ambient temperature of 23 °C, an ambient air pressure of 100 kPa (0.986 atm) and a relative atmospheric humidity of 50%.

[0386] Determine the local curvature k(x) and the local glass thickness l(x)

[0387] – The outer contour c of the glass in the bonding area (i.e., the transition area between the top area and the neck area) 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 the local thickness l(x). This method is particularly applicable to glass containers that have been chemically tempered and / or thermally tempered and are thus not easily cut in half without cracking or bursting. To non-destructively determine the local curvature k(x), 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 operates under transmitted light illumination. The vial is placed in BHB (butyl octyl salicylate available from Hallstar Company, Chicago, USA). BHB is used to visualize the outer contour of the vial. Ensure that the cross-section of the glass container inspected in the profile projector corresponds to a plane that is centered within the glass container and includes the longitudinal axis L tube (i.e., the axis passing vertically through the bottom center) (see Figure 5A and 5B ).

[0388] – To improve the measurement accuracy, the outer contour c of the glass in the transition region between the top region and the neck region can also be determined based on a physical cross-sectional cut parallel to the longitudinal axis of the container outer and the local thickness l(x) (again ensuring that the cross-section of the glass container corresponds to a plane that is centered within the glass container and includes the longitudinal axis of the glass container, as shown in Figure 5). To prepare without breakage, the glass container can be embedded in a transparent two-component epoxy resin (e.g., STRUERS GmbH, EpoFix resin) or other suitable materials. After the epoxy resin cures, a cross-sectional cut 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 distortion-free images and geometric analysis software tools.

[0389] – The thickness l(x) of the glass measured in the direction perpendicular to the longitudinal axis L tube can be determined based on these images with the help of an electronic ruler and using any suitable image analysis software tool.

[0390] – Based on the images obtained by the above two methods, the relevant outer contour c of the outer surface of the transition region between the top region and the neck region of the glass container can be extracted outer and its value can be estimated. To extract the relevant contour of the outer surface, image processing steps implemented in Python [https: / / www.python.org / ] are performed on the images based on the image processing library OpenCV [https: / / opencv.org / ].

[0391] First, a median filter is used to denoise the image. Then, an edge detection algorithm based on the Sobel filter is used to process the denoised image, where the contours are identified by thresholding the gradient image. To calculate the slope and curvature, a fifth-order univariate spline is used to numerically estimate the extracted contours. Subsequently, the radius of curvature R(x) is obtained from the formula

[0392]

[0393] where R(x) = 1 / k(x).

[0394] Determine r s

[0395] To determine the outer radius r of the substantially circular arc region at the end of the neck region incorporated into the joint region s , in the image obtained by means of the above two methods, a point A on the outer surface of the joint region is determined, where the slope β of the tangent reaches its maximum value (see Figure 6 ). In the case of the linear region where the slope β of the tangent reaches its maximum value, A is defined as the point closest to the neck region. In the second step, a line b is defined as the extension of the substantially non-curved outer surface of the neck region. At this time, the largest possible circle is formed, which is adjacent to point A, coincides with the gradient (= bevel circle), and touches only the line b (at point B), but does not cross the line b (see again Figure 6 ). The radius of this circle corresponds to r s .

[0396] Wall thickness and diameter

[0397] The wall thickness of the glass container at a given position and the inner or outer diameter of the glass container at a given position are determined in accordance with DIN ISO 8362-1.

[0398] Neck extrusion test

[0399] The mechanical resistance of the vial neck region to diametral compression is determined by means of a radial load strength test carried out in accordance with DIN EN ISO 8113 (“Glass containers – Resistance to vertical load – Test method”), in which compressive forces are applied in the diametrical (radial) direction to two opposite positions of the outer surface geometry of the vial neck. A universal testing machine is used to increase the compressive force at a constant load rate of 2000 N / min until the container breaks (the break can be detected by a sudden drop in the force-time graph F(t)). The radial load is applied by two opposite uniaxially concave steel surfaces between which the neck portion of the vial is placed parallel to the axis. One of the concave surfaces is configured as a self-adjusting concave surface in order to be able to compensate for irregularities in the geometry. The radius of concavity of the two steel surfaces is 25% larger than the radius of the outer diameter of the neck portion, so that the load is applied along two opposite lines. The width of the concave steel surfaces is chosen to be slightly less than the height of the vial neck portion.

[0400] Side compression test

[0401] The mechanical resistance of the vial body region to diametral compression is determined by means of a radial load strength test carried out in accordance with DIN EN ISO 8113 (“Glass containers – Resistance to vertical load – Test method”), in which compressive forces are applied in the diametrical (radial) direction to two opposite positions of the outer surface geometry of the vial body. A universal testing machine is used to increase the compressive force at a constant load rate of 1500 N / min until the container breaks (the break can again be detected by a sudden drop in the force-time graph F(t)). The radial load is applied by two opposite uniaxially concave steel surfaces between which the body portion of the vial is placed parallel to the axis. One of the concave surfaces is configured as a self-adjusting concave surface in order to be able to compensate for irregularities in the geometry. The radius of concavity of the two steel surfaces is 25% larger than the radius of the outer diameter of the body portion, so that the load is applied along two opposite lines. The width of the concave steel surfaces is chosen to be greater than the height of the vial body portion.

[0402] Example

[0403] A glass tube made of borosilicate glass with an outer diameter of 16 mm and a wall thickness l b of 1 mm is inserted into the head of a rotary machine. While the glass tube is rotating 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 in order to form a top region, a joining region, a neck region and a shoulder region. In order to form these regions of the desired shape in the rotary machine, the glass tube is placed in the upward position as Figure 8 shown. By using support rollers with the desired external shape, the required maximum curvature of the transition region between the top region and the neck region and dt -d n 、d n 、and l n to the required values and form the outer contour c of the top region, the joint region, the neck region, and the shoulder region outer 。Additional information on the formation of these regions of the glass vial can also be found at the following address:

[0404] “https: / / www.schott.com / pharmaceutical_packaging / german / about_us / videos.html”.

[0405] In the next step, while the glass tube is rotating about its main axis, the position above the previously formed first end of the glass tube is heated to its softening point using a flame, and the heated glass tube is pulled along its main axis in order to stretch and shape the container closure.

[0406] By means of the above process, glass containers dimensioned according to DIN EN ISO 8362-1:2016-06 with a size designation of “10R” are produced by changing the shape of the support rollers, and the outer contour c of the joint region (i.e., the transition region between the top region and the neck region) of these glass containers outer has a different shape.

[0407] At least 50 glass containers of each shape are produced in a rotary machine. The outer contour c of the transition region between the top region and the neck region outer of one of them corresponds to the shape of this region of a glass container known from the prior art (comparative example 1).

[0408]

[0409] Table 1

[0410] 1) . The above table gives the minimum value of [l(x) / l b 3 / k(x) in the interval between point P1 and point P2.

[0411] Evaluation

[0412] For the above glass containers, the resistance to loads in the neck extrusion test as well as in the 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 outer ​, 50 vials have been tested. The load that has been determined corresponds to the pressure at which 10% of the vials are broken. Table 2 shows the results, where the corresponding load values for the side compression test are normalized to the values determined for the reference vial of the comparative example.

[0413]

[0414] Table 2

[0415] As can be seen from the results shown in Table 2, by adjusting the outer contour c of the transition region between the top region and the neck region outer and by adjusting the resistance in the neck squeeze test, the resistance to load in the side compression test can be significantly increased. Description of the Drawings

[0416] Unless otherwise specified in the specification or in a particular figure:

[0417] Figure 1 shows the setup of the side compression test known from the prior art;

[0418] Figure 2 shows a cross-sectional view of different regions of the glass container 100 according to the present invention;

[0419] Figure 3 shows an enlarged cross-sectional view of the top region 104, the engagement region 105, the neck region 106, and the shoulder region 107 of the glass container 100 according to the present invention;

[0420] Figure 4A shows an enlarged cross-sectional view for determining the outer contour c of the top region 104, the engagement region 105, the neck region 106, and the shoulder region 107 of the glass container 100 according to the present invention outer ;

[0421] Figure 4B shows the curve of the function f(x) in the range from P1 to P2, where the function f(x) represents the outer contour c of the transition region between the top region and the neck region outer ;

[0422] Figure 5A shows a side view of the position of the 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 5B shows a top view of the position of the 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;

[0424] Figure 6Shows the determination of r s ;

[0425] Figure 7 is a cross-sectional view of another glass container 100 according to the present invention, showing the shoulder angle α;

[0426] Figure 8 Displays process 1 for preparing a glass container according to the present invention;

[0427] Figure 9 Shows a flowchart of process 2 for packaging a pharmaceutical composition according to the present invention;

[0428] Figure 10 Shows the setup of a neck extrusion test;

[0429] Figure 11A is a schematic side view of a neck extrusion test; and

[0430] Figure 11B is a schematic front view of a neck extrusion test. Detailed Description

[0431] Figure 1 Shows the setup of a side compression test known from the prior art. As can be seen, a glass container 100 having a glass bottom 109 is placed in a horizontal position sandwiched between two steel plates 117, 118, and a compressive force is applied to two opposite positions of the outer surface geometry of the vial body in the diameter (radius) direction by means of the two steel plates 117, 118. A universal testing machine is used to increase the compressive force at a constant load rate of 1500 N / min until the container breaks. The radial load is applied by two opposite uniaxial concave steel surfaces 117, 118, between which the body region 109 of the vial 100 is placed parallel to the axis L tube . One of the concave surfaces, the concave surface 117, is configured as a self-adjusting concave surface in order to be able to compensate for irregularities in the geometry. The concave radius of the two steel surfaces 117, 118 is 25% larger than the outer diameter d b of the body region, thereby applying the load along two opposite lines. The width of the concave steel surface is selected to be greater than the height of the vial body region 108. As can also be seen from Figure 1 , since d t (the diameter of the top region 104) and d n (the diameter of the neck region 106) are smaller than d b (the diameter of the body region 108), the top region 104, the joint region 105, and the neck region 106 do not come into contact with the clamping jaws 117, 118.

[0432] Figure 2A cross-sectional view of different regions of a glass container 100 according to the present invention is shown. The glass container 100 includes a glass tube 101 and a glass bottom 109 as container components. The glass tube 101 has a first end 102 and another end 103, and the glass bottom 109 closes the another end 103 of the glass tube. The glass tube 101 is characterized by a longitudinal axis L tube And the direction from the top to the bottom includes: a top region 104 located at the first end 102 of the glass tube 101, where the outer diameter of the top region is d t ; a joining region 105 adjacent to the top region 104; a neck region 106 adjacent to the joining region 105, where 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 another end 103 of the glass tube 101, where 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 . The joining region 105 corresponds to the transition region between the top region 104 and the neck region 106. l 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 a function f(x), and the function f(x) defines the outer contour c couter (See Figure 4B ). Therefore, the starting part and the ending part of the neck region 106 are defined by those points where the curve of the function f(x) is no longer linear and horizontal. The starting part and the ending part of the neck region 106 are represented by x1 and x2 and Figure 4B .

[0433] 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 the glass container 100 according to the present invention is shown (the body region 108 adjacent to the shoulder region 109 is not shown in this figure). In Figure 3 , the joining region 105 has an outer surface that is substantially circular arc-shaped at the end where the joining region 105 merges into the neck region 106, and the substantially circular arc-shaped region has an outer radius r s .

[0434] Figure 4A Shows the outer contour c of 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 determined based on an image of the glass container 100 obtained by using the method described in the "Test Method" section hereinouter Magnified cross-sectional view. These images are placed as follows: The glass container 100 is placed on a flat horizontal base 110 on which the outer surface of the body region 108 lies. Then, as also described in the "Test Method" section, k(x) and l(x) are measured between point P1 and point P2. s corresponds to (d t -d n ) / 2, and s / 2 corresponds to (d t -d n ) / 4, meaning that P2 is at the x-position where 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 . Then P1 is at the x-position of P2 – s = P2 – d t / 2 + d n / 2. Figure 4B Shows the curve of the function f(x), which represents the outer contour c outer between point P1 and point P2. Points x1 and x2 represent the start and end of the neck region 106.

[0435] Figure 5A and Figure 5B show a side view and a top view, respectively, of the position of the plane 111 of the glass container 100, which is used to determine the local curvature of the function f(x) in the range from P1 to P2 and the glass thickness l(x) by the method shown in Figure 4A and Figure 4B . The plane 111 corresponds to a plane that is centered in the glass container and includes the longitudinal axis L tube (see Figure 2 )(shown by a dashed line in Figure 5A ), the longitudinal axis being the axis that vertically passes through the center of the bottom 109 ( Figure 5B ).

[0436] Figure 6 shows the determination of r s . To determine the outer radius r of the substantially circular arc region at the end where the joining region 105 merges into the neck region 106 s, in the image of the plane 111 obtained by means of the two methods described in the "Test Method" section of this article, determine the point A on the outer surface of the joint region 105 where the slope β of the tangent line 112 reaches its maximum value. In the case of the linear region where the slope β of the tangent line 112 reaches its maximum value, A is defined as the point closest to the neck region 106. In the second step, the line b 113 is defined as the extension of the substantially non-curved outer surface of the neck region 106. At this time, the largest possible circle 114 is formed, which is adjacent to the point A, coincides with the gradient ( = bevel circle), and only touches the line b 113 (at the point B), but does not cross the line b 113 (see again Figure 6 ). The radius of this circle corresponds to r s .

[0437] Figure 7 is a cross-sectional view of another glass container 100 with a height of h c according to the present invention. h c corresponds to the length of the body region 108, and h t-n corresponds to the total length of the top region 104, the joint region 105, and the neck region 106. The glass container 100 includes a shoulder region 107 connecting the body region 108 and the neck region 106, and the shoulder region 107 is characterized by a shoulder angle α.

[0438] Figure 8 shows the process for forming 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. A glass tube 101 made of borosilicate glass with an outer diameter d b of 16 mm and a glass thickness (wall thickness) l b of 1 mm is loaded into the head of a rotary machine. While the glass tube 101 rotates 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 the top region 104, the joint region 105, the neck region 106, and the shoulder region 107. In order to form these regions with the desired shape in the rotary machine, the glass tube 101 is placed in the upward position as shown in Figure 8 . By using a forming roller 115 with the desired external shape, the required maximum curvature of the transition region between the top region 104 and the neck region 106 is always achieved, and the outer contour c outer of the top region 104, the joint region 105, the neck region 106, and the shoulder region 107 is formed.

[0439] Figure 9Shows a flow chart of process 200 for packaging a pharmaceutical composition according to the present invention. Process step a) 201, provides a glass container 100 according to the present invention. Process step b) 202, loads the pharmaceutical composition into the internal volume V of the glass container 100 i ; and process step c) 203, closes the opening 112 of the glass container 100, thereby obtaining a closed glass container 121.

[0440] Figure 10 Shows a test for determining the mechanical resistance of the neck region 106 of the vial to diametral compression. This resistance is determined by means of a radial load strength test carried out in accordance with DIN EN ISO 8113 (“Glass containers – Resistance to vertical load – Test methods”), in which compressive forces are applied to two opposite positions on the outer surface of the neck region 106 in the diameter (radius) direction. A universal testing machine is used to increase the compressive force at a constant load rate of 2000 N / min until the vial 100 breaks (the break can be detected as a sudden drop in the force-time graph F(t)). The radial load is applied by two opposite 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 in order to be able to compensate for geometric irregularities. The radius of concavity of the two steel surfaces is 25% larger than the radius of the outer diameter d of the neck region 106 n , so that the load is applied along two opposite lines. The width of the concave steel surface is chosen to be slightly less than the height of the vial neck region 104.

[0441] Figure 11A and Figure 11B Shows a schematic side view and a schematic front view of the neck extrusion test.

[0442] List of reference numerals

[0443] 100 Glass container according to the present invention

[0444] 101 Glass tube

[0445] 102 First end of the glass tube 101

[0446] 103 Other end of the glass tube 101

[0447] 104 Top region

[0448] 105 Joint region

[0449] 106 Neck region

[0450] 107 Shoulder region

[0451] 108 body region

[0452] 109 glass bottom

[0453] 110 flat horizontal base

[0454] 111 cross-sectional plane in the middle of the glass container 100

[0455] 112 tangent line with the maximum slope β

[0456] 113 extension (line b) of the substantially non-curved outer surface of the neck region 105

[0457] 114 possible maximum circle

[0458] 115 forming roller

[0459] 116 heating element, preferably a flame

[0460] 117 self-regulating steel plate

[0461] 118 rigid steel plate

[0462] 119 self-regulating steel plate

[0463] 120 rigid steel plate

[0464] 200 Process for packaging a pharmaceutical composition according to the present invention

[0465] 201 Process step a)

[0466] 202 Process step b)

[0467] 203 Process step c)

Claims

1. A glass container (100) comprising, as container parts, the following: 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 direction from top to bottom includes: ia) 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 area (105) adjacent to said top area (104); (ic) a neck region (106) adjacent to the bonding region (105), wherein an outer diameter of the neck region is d n , d n < d t ; id) A shoulder area (107) adjacent to said neck area (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 of 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) that closes said other end (103) of said glass tube (101); Wherein, if the glass container (100) is placed on a planar horizontal substrate (110) on which the outer surface of the body region (108) lies, then in any given cross-section of the glass container (100) within the plane (111) that is centered within the glass container (100) and includes the longitudinal axis L of the glass tube (101), 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 the given position x, wherein the thickness l(x) of the glass is measured in a direction perpendicular to the longitudinal axis L tube ; and in the plane (111), for any given cross-section 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 the given position x, where the thickness l(x) of the glass is measured in a direction perpendicular to the longitudinal axis L tube of the glass; where 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​ Wherein, in the interval between x = P1 and x = P2, for any concave curvature within the interval, the minimum value of [l(x) / l b 3 / k(x) is at least 0.35 mm, where P2 defines the x position at which f(x) is 1 / 2 × d b – 1 / 4 × d t – 1 / 4 × d n and P1 defines the x position at which f(x) is P2 – d t / 2 + d n / 2.​ 2. The glass container (100) according to claim 1, wherein said glass container (100) is a pharmaceutical glass container.

3. The glass container (100) according to claim 1, wherein [l(x) / l b 3 / k(x) is at least 0.5 mm.​ 4. The glass container (100) according to claim 1, wherein [l(x) / l b 3 / k(x) is at least 0.7 mm.​ 5. The glass container (100) according to claim 1, wherein [l(x) / l b 3 / k(x) is at least 0.9 mm.​ 6. The glass container (100) according to claim 1, wherein [l(x) / l b 3 / k(x) is at least 1.1 mm.​ 7. The glass container (100) according to claim 1, wherein [l(x) / l b 3 / k(x) is at least 1.3 mm.​ 8. The glass container (100) according to claim 1, wherein [l(x) / l b 3 / k(x) is at least 1.5 mm.​ 9. The glass container (100) according to claim 1, wherein [l(x) / l b 3 / k(x) is at least 1.7 mm.​ 10. The glass container (100) according to claim 1, wherein [l(x) / l b 3 / k(x) is at least 2.0 mm.​ 11. The glass container (100) according to claim 1, wherein [l(x) / l b 3 / k(x) is at least 2.5 mm.​ 12. The glass container (100) according to claim 1, wherein ib) The joint region (105) has an outer surface which is substantially circularly arcuate at the end where the joint region (105) merges into the neck region (106), and the outer radius of the substantially circularly arcuate region is r s ; ic) The minimum thickness of the glass in the neck region (106) is l n and Among them, The following conditions are met: 2×[l n / l b ×r s ≥0.9 mm.

13. The glass container (100) according to claim 12, wherein 2 × [l n / l b × r s ≥ 1.1 mm.

14. The glass container (100) according to claim 12, wherein 2 × [l n / l b × r s ≥ 1.2 mm.

15. The glass container (100) according to claim 12, wherein 2 × [l n / l b × r s ≥ 1.3 mm.

16. The glass container (100) according to claim 12, wherein 2 × [l n / l b × r s ≥ 1.4 mm.

17. The glass container (100) according to claim 12, wherein 2 × [l n / l b × r s ≥ 1.5 mm.

18. The glass container (100) according to claim 12, wherein 2×[l n / l b ×r s ≥1.7 mm.

19. The glass container (100) according to claim 12, wherein 2×[l n / l b ×r s ≥2.0 mm.

20. The glass container (100) according to claim 12, wherein 2 × [l n / l b × r s ≥ 2.5 mm.

21. The glass container (100) according to any one of claims 12 to 20, wherein said glass container (100) is a vial with an internal volume of 1 to 8 ml, and wherein the following conditions are met: d n ≥ 9.7 mm; r s ≥0.5 mm.

22. The glass container (100) according to claim 21, wherein said glass container (100) is a vial sized "2R" or "4R" according to DIN EN ISO 8362-1:2016-06.

23. The glass container (100) according to any one of claims 12 to 20, wherein said 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 ≥ 15.5 mm; r s ≥ 0.5 mm.

24. The glass container (100) according to claim 23, wherein said glass container (100) is a vial sized "6R", "8R", or "10R" according to DIN EN ISO 8362-1:2016-06.

25. The glass container (100) according to any one of claims 12 to 20, wherein said glass container is a vial with an internal volume of 22.5 to 150 ml, and wherein the following conditions are met: d n ≥ 16.5 mm; r s ≥ 0.5 mm.

26. The glass container (100) according to claim 25, wherein said glass container (100) is a vial sized "20R", "25R", "30R", "50R", or "100R" according to DIN EN ISO 8362-1:2016-06.

27. The glass container (100) according to any one of claims 12 to 20, wherein the following conditions are met: l n / l b ≥1.3。 28. The glass container (100) according to any one of claims 12 to 20, wherein the following conditions are met: l n / l b ≥1.4。 29. The glass container (100) according to any one of claims 12 to 20, wherein the following conditions are satisfied: l n / l b ≥1.45。 30. The glass container (100) according to any one of claims 12 to 20, wherein the following conditions are satisfied: l n / l b ≥1.5。 31. The glass container (100) according to any one of claims 12 to 20, wherein the following conditions are satisfied: l n / l b ≥1.6。 32. The glass container (100) according to any one of claims 12 to 20, wherein the following conditions are satisfied: l n ×r s / l b ≥0.7 mm.

33. The glass container (100) according to any one of claims 1 to 20, wherein the following conditions are satisfied: d b in the range of 14 mm to 60 mm; 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 4 mm to 35 mm.

34. The glass container (100) according to any one of claims 1 to 20, wherein the following conditions are satisfied: d b in the range of 15 mm to 32 mm; 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 4 mm to 15 mm.

35. The glass container (100) according to any one of claims 1 to 20, wherein the following conditions are satisfied: d b in the range of 15 mm to 25 mm; 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 5 mm to 13 mm.

36. The glass container (100) according to any one of claims 1 to 20, wherein the following conditions are satisfied: d b in the range of 15 mm to 23 mm; 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 5 mm to 8 mm.

37. The glass container (100) according to any one of claims 1 to 20, wherein the following conditions are satisfied: d b in the range of 15 mm to 17 mm; 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 5 mm to 6 mm.

38. The glass container (100) according to any one of claims 1 to 20, wherein the glass container has a glass mass m g and an internal volume V i , and satisfies the following conditions: m g / V i 0.75 <2.0。 39. The glass container (100) according to any one of claims 1 to 20, wherein the glass container has a glass mass m g and an internal volume V i , and satisfies the following conditions: m g / V i 0.75 <1.75。 40. The glass container (100) according to claim 38, wherein V i is in the range of 2 ml to 150 ml.

41. The glass container (100) according to claim 38, wherein V i is in the range of 3 ml to 100 ml.

42. The glass container (100) according to claim 38, wherein V i is in the range of 3 ml to 50 ml.

43. The glass container (100) according to claim 38, wherein V i is in the range of 3 ml to 15 ml.

44. The glass container (100) according to claim 38, wherein V i is in the range of 3 ml to 7 ml.

45. A plurality of glass containers (100), each glass container (100) comprising the following as container components: i) A glass tube (101) having a first end (102) and an opposite end (103), wherein the glass tube (101) is characterized by a longitudinal axis L tube and the direction from top to bottom includes: ia) 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 bonding area (105) adjacent to the top area (104); (ic) A neck region (106) adjacent to the bonding region (105), wherein the outer diameter of the neck region is d n , d n < d t ; id) A shoulder area (107) adjacent to the neck area (106); and (ie) a body region (108) adjacent to said shoulder region (107) and extending to said other end (103) of said glass tube (101), wherein the thickness of the glass of said body region is l b and wherein the outer diameter of said body region is d b , d b > d t ; ii) A glass bottom (109) that closes the other end (103) of the glass tube (101); wherein, for 50% of the glass containers (100) included in the plurality of glass containers (100), the load at which the glass container (100) breaks in a neck extrusion test is at least 1100 N; wherein for at least 75% of the glass containers (100) included in the plurality of glass containers (100), the following conditions are satisfied: If the glass container (100) is placed on a planar horizontal substrate (110) on which the outer surface of the body region (108) lies, then in any given cross-section of the glass container (100) within the plane (111) that is centered within the glass container (100) and includes the longitudinal axis L of the glass tube (101), 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 the given position x, where the thickness l(x) of the glass is measured in a direction perpendicular to the longitudinal axis L tube of the glass container (100), and l(x) defines the thickness of the glass at the given position x, where the thickness l(x) of the glass is measured in a direction perpendicular to the longitudinal axis L tube of the glass; 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 within the said interval, the minimum value of [l(x) / l b 3 / k(x) is at least 0.35 mm, where P2 defines the x position where f(x) is 1 / 2 × d b – 1 / 4 × d t – 1 / 4 × d n and P1 defines the x position where f(x) is P2 – d t / 2 + d n / 2.​ 46. The plurality of glass containers (100) according to claim 45, wherein the minimum value of [l(x) / l b 3 / k(x) is at least 0.5 mm.​ 47. The plurality of glass containers (100) according to claim 45, wherein the minimum value of [l(x) / l b 3 / k(x) is at least 0.7 mm.​ 48. The plurality of glass containers (100) according to claim 45, wherein the minimum value of [l(x) / l b 3 / k(x) is at least 0.9 mm.​ 49. The plurality of glass containers (100) according to claim 45, wherein the minimum value of [l(x) / l b 3 / k(x) is at least 1.1 mm.​ 50. The plurality of glass containers (100) according to claim 45, wherein the minimum value of [l(x) / l b 3 / k(x) is at least 1.3 mm.​ 51. The plurality of glass containers (100) according to claim 45, wherein the minimum value of [l(x) / l b 3 / k(x) is at least 1.5 mm.​ 52. The plurality of glass containers (100) according to claim 45, wherein the minimum value of [l(x) / l b 3 / k(x) is at least 1.7 mm.​ 53. The plurality of glass containers (100) according to claim 45, wherein the minimum value of [l(x) / l b 3 / k(x) is at least 2.0 mm.​ 54. The plurality of glass containers (100) according to claim 45, wherein the minimum value of [l(x) / l b 3 / k(x) is at least 2.5 mm.​ 55. The plurality of glass containers (100) according to claim 45, wherein the load is at least 1200 N.

56. The plurality of glass containers (100) according to claim 45, wherein the load is at least 1300 N.

57. The plurality of glass containers (100) according to claim 45, wherein the load is at least 1400 N.

58. The plurality of glass containers (100) according to claim 45, wherein the load is at least 1500 N.

59. The plurality of glass containers (100) according to claim 45, wherein the load is at least 1600 N.

60. The plurality of glass containers (100) according to claim 45, wherein the load is at least 1800 N.

61. The plurality of glass containers (100) according to claim 45, wherein the load is at least 2000 N.

62. The plurality of glass containers (100) according to claim 45, wherein the load is at least 2500 N.

63. The plurality of glass containers (100) according to claim 45, wherein the load is at least 3000 N.

64. A plurality of glass containers (100) according to any one of claims 55 to 63, wherein for at least 75% of the glass containers (100) comprised in the plurality of glass containers (100), the following condition is met: ib) The bonding region (105) has an outer surface which is substantially circular-arc-shaped at the end where the bonding region (105) merges into the neck region (106), and the outer radius of the substantially circular-arc-shaped region is r s ; ic) The minimum thickness of the glass in the neck region (106) is l n and 2×[l n / l b ×r s ≥0.9 mm.

65. The plurality of glass containers (100) according to claim 64, wherein 2×[l n / l b ×r s ≥1.1 mm.

66. The plurality of glass containers (100) according to claim 64, wherein 2×[l n / l b ×r s ≥1.2 mm.

67. The plurality of glass containers (100) according to claim 64, wherein 2×[l n / l b ×r s ≥1.3 mm.

68. The plurality of glass containers (100) according to claim 64, wherein 2×[l n / l b ×r s ≥ 1.4 mm.

69. The plurality of glass containers (100) according to claim 64, wherein 2×[l n / l b ×r s ≥1.5 mm.

70. The plurality of glass containers (100) according to claim 64, wherein 2 × [l n / l b × r s ≥ 1.7 mm.

71. The plurality of glass containers (100) according to claim 64, wherein 2×[l n / l b ×r s ≥2.0 mm.

72. The plurality of glass containers (100) according to claim 64, wherein 2×[l n / l b ×r s ≥2.5 mm.

73. A process for preparing a closed glass container (100), comprising the following steps as process steps: a) providing a glass container (100) according to any one of claims 1 to 44 or a plurality of glass containers (100) according to any one of claims 45 to 72; b) filling a pharmaceutical composition into the internal volume Vi of the glass container (100); and c) closing the glass container (100).

74. A closed glass container (100) obtainable by the process according to claim 73.

75. Use of a glass container (100) according to any one of claims 1 to 44 or a plurality of glass containers (100) according to any one of claims 45 to 72 for packaging a pharmaceutical composition.

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