Device, apparatus and method for shaping the opening of a hollow body-shaped preform made of glass

By designing a floating installation structure with a movable core shaft and compensation elements, the problem of large opening tolerances in pharmaceutical glass vials is solved, high-precision opening molding is achieved, and the container closure integrity and quality standards are ensured to be met.

CN113415980BActive Publication Date: 2025-09-16SCHOTT PHARMA AG GMBH & CO KG +1
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Patent Information

Application Number
CN202110149077.5
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2020-03-03
Filing Date
2021-02-03
Publication Date
2025-09-16
Estimated Expiration
2041-02-03

AI Technical Summary

Technical Problem

In the prior art, the openings of pharmaceutical glass vials have large tolerances, resulting in incomplete closure of the container, which may cause drug contamination or leakage and fail to meet strict quality requirements.

Method used

A device has been designed in which the mandrel is movable in three directions relative to the base element. Precise alignment is achieved through floating mounting. In combination with movable compensation elements and connecting structures, this ensures that the mandrel can be accurately introduced into the opening of the preform, reducing tolerances.

Benefits of technology

Achieve extremely small tolerances on the inner and outer diameters of glass vial openings, meeting stringent quality standards and ensuring container closure integrity to avoid drug contamination and leakage.

✦ Generated by Eureka AI based on patent content.

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Abstract

A device for shaping the inner wall of an opening (2) of a hollow glass preform (4), in particular a device for producing pharmaceutical glass vials (1), comprising a mandrel (8) and a mounting element (10), wherein the mandrel (8) is inserted into the opening (2) of the preform (4) in a first direction (9) and the mandrel (8) is arranged on the mounting element (10), characterized in that the mounting element (10) comprises a base element (11) and the mandrel (8) is movable relative to the base element (11) in a second direction (12). Furthermore, a device and a method for shaping such a preform (4) and a plurality of pharmaceutical glass vials (1) are described.
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Description

Technical Field

[0001] The present invention relates to a device for shaping the inner wall of an opening of a hollow body-shaped preform made of glass, in particular to a device for manufacturing pharmaceutical glass vials, the device comprising a core shaft and a mounting member, the core shaft being used to be introduced into the opening of the preform along a first direction, wherein the core shaft is arranged on the mounting member.

[0002] The present invention also relates to a device for processing a hollow body-shaped preform made of glass, in particular to a device for manufacturing a pharmaceutical glass vial, the device having at least one chuck for clamping the preform, a heating device and an external forming device for forming the open outer wall of the preform.

[0003] The invention also relates to a method for shaping the opening of a hollow body-shaped preform made of glass, in particular a pharmaceutical glass vial, using the device.

[0004] The invention finally relates to a plurality of glass vials for pharmaceutical use. Background Art

[0005] The teachings described herein relate in particular to the production of pharmaceutical vials. Forming the opening according to the present invention represents an essential processing step in the production of glass vials. Methods and devices for forming such an opening are described, for example, in DE 10 2015 111 993 A1 and DE 10 2015 117 422 A1.

[0006] To this end, several glass tubes, each with a diameter corresponding to the product requirements and representing a suitable glass preform, are typically clamped vertically in a chuck. The chuck rotates at a specific speed and is fixed to a plate in a circular shape. Processing stations that perform various functions are located at fixed positions below the plate on which the chucks are located. The plate on which the chucks are located is indexed from one processing station to the next by a rotational movement. For processing, the plate on which the chucks are located remains stationary for a specified period of time. Due to the plate's indexing, each chuck repeatedly passes through the same processing station and, therefore, the forming system for forming the opening. The precise radial and tangential positioning of the individual chucks on the pitch circle is associated with significant engineering challenges. Therefore, for standard chucks, machine manufacturers provide a position tolerance of approximately ±0.2 mm.

[0007] When the glass tube, now clamped in the chuck, is transferred to the forming system, a mandrel (spike) is inserted into the tube. The diameter of this mandrel corresponds to the product size. The heated, soft glass tube in the opening area is pressed against the mandrel by the spring force of the forming rollers, which are moved toward the tube from the outside. The tube is then rotated by the driven chuck. This creates the inner diameter of the opening. In the optimal case, especially when the center axis of the mandrel is precisely aligned with the center axis of the rotating glass tube, the inner diameter of the opening of the glass vial corresponds to the diameter of the mandrel.

[0008] Due to positional tolerances in the chuck assembly on the plate, the center axis of the mandrel deviates from the center axis of the glass vial. This results in a varying inner diameter of the opening. Because the externally applied pressure on the forming rollers is typically only subject to spring force, variations in the inner diameter of the opening result in variations in the outer diameter.

[0009] Therefore, the devices and methods known in the prior art for forming the openings of pharmaceutical glass vials generally suffer from the following problem: the openings of the glass vials have large tolerances. Since these glass vials are typically used to store vaccine formulations, they must meet requirements for deviations from specified nominal values, which must be as small as possible. Any deviation from the nominal values ​​can result in the crimping edge not being able to fit snugly against the container, making it impossible to adequately seal the container—in other words, failing to ensure container closure integrity (CCI). This can lead to contamination, leakage, or premature failure of the pharmaceutical ingredients. Summary of the Invention

[0010] The present invention is therefore based on the object of designing and improving a device and a method of the type mentioned at the outset so that, by means of a simple construction, the openings of glass preforms, in particular glass vials, can be produced more precisely.

[0011] With respect to the apparatus, the aforementioned objectives are achieved by the features of the first aspect of the present invention. Accordingly, a device for shaping the inner wall of an opening of a hollow glass preform, particularly a device for manufacturing pharmaceutical glass vials, comprises a mandrel and a mounting element. The mandrel is inserted into the opening of the preform in a first direction, the mandrel being mounted on the mounting element. The mounting element is characterized in that the mounting element comprises a base element, and the mandrel is movable relative to the base element in a second direction.

[0012] It has been recognized that this basic object can be achieved in a particularly effective manner if the mandrel can be precisely aligned with the opening of the preform and, therefore, with the chuck holding the preform. To this end, the mandrel is designed to be movable relative to the base element, thereby enabling precise alignment of the mandrel, in particular by pressing or pushing it into the desired position, respectively, when the mandrel is introduced into the opening of the preform. This results in a floating mounting of the mandrel, which allows automatic alignment of the mandrel with the preform.

[0013] In the context of the present disclosure, the term “hollow body-shaped glass preform” is to be understood as meaning, for example, a glass tube with which pharmaceutical primary packaging, in particular pharmaceutical glass vials, can be produced.

[0014] In the context of the present disclosure, the term "pharmaceutical glass vial" is understood as meaning that this is a pharmaceutical primary packaging made of glass, such as, in particular, a vaccine container or vial for storing vaccine preparations.

[0015] In the context of this disclosure, the term "opening" describes the open end of the final product made from the preform. For pharmaceutical glass vials, this opening is also referred to as a crimp or neck closure. The inner wall of this opening can be smooth, as in the so-called "no blowback" style; or can be configured with protrusions or beads, as in the so-called "Euro blowback" style; or can be configured with grooves, as in the so-called "American blowback" style.

[0016] In the context of the present disclosure, the term "a plurality of pharmaceutical glass vials" describes a sales or packaging unit of pharmaceutical glass vials. The packaging unit is stored so that it is separated by space, for example, or it is placed in a receiving device, in particular in a nest or tray, so that the glass vials do not touch each other. Usually (but not necessarily), the plurality of pharmaceutical glass vials is at least partially surrounded by a film and is preferably sterilized. Such a packaging unit consists of more than 10 glass vials, for example: 10 to 1000 glass vials, in particular 20 to 500 glass vials, preferably 40 to 250 glass vials. Examples of such packaging units include iQ TM Platforms, such as the ready-to-use platform adaptiQ from SCHOTT AG ® .

[0017] Advantageously, the mandrel is movable relative to the base element in a third direction. Because the mandrel is movable relative to the base element in three directions, it can be aligned more precisely with the opening of the preform when it is introduced into the opening or into the preform. This allows for extremely fine tolerances during the shaping of the opening.

[0018] Particularly advantageously, the first, second and third directions each extend so as to remain perpendicular to one another. Thus, a floating mounting is implemented and the movement directions extend in a manner similar to a Cartesian coordinate system, making it possible to position the mandrel in space in a particularly precise manner.

[0019] In particular, it is conceivable that the mandrel can be displaced by 0.1 mm to 1.0 mm, in particular 0.2 mm to 0.8 mm, preferably 0.3 mm to 0.7 mm relative to the base element in the second direction and / or in the third direction. This design embodiment has the following advantages: on the one hand, the engineering complexity of implementing this design embodiment is relatively low; on the other hand, it ensures that the mandrel has sufficient "play" to compensate for tolerances of the chuck.

[0020] According to another advantageous embodiment, the mounting element comprises at least one compensating element connected to the base element, wherein the compensating element is movable relative to the base element in the second direction and / or in the third direction, wherein the mandrel is preferably immovably arranged on the compensating element. The compensating element enables the mandrel to be guided and thus precisely moved.

[0021] In another advantageous embodiment, the base element and / or the compensating element has at least one channel for accommodating the connecting element, and the at least one channel is dimensioned such that the connecting element can be arranged therein with clearance, thereby allowing movement in the second direction and / or in the third direction. This design measure, for example, allows for a particularly simple connection and guidance between the base element and the compensating element, thereby preventing the mandrel from tilting.

[0022] Particularly advantageously, the mounting element may comprise a first compensating element and a second compensating element, wherein the first compensating element is connected to the base element and the second compensating element is connected to the first compensating element, wherein the first compensating element and / or the second compensating element are movable relative to the base element in the second direction and / or in the third direction, and wherein the mandrel is preferably immovably mounted on the second compensating element. The arrangement of two compensating elements is advantageous, wherein each compensating element can be moved in one direction in each case, because the compensating elements guide the mandrel very precisely in the second and third directions. This effectively prevents the mandrel from tilting when external forces act on it, in particular when forming the opening of the preform. This significantly improves the tolerances of the resulting pharmaceutical glass vials, for example.

[0023] In order to achieve a simple connection while precisely guiding the movement of the core shaft, the base element and / or the first compensation element and / or the second compensation element may have at least one channel for accommodating the connecting element, and, wherein, the size of the channel is designed so that the connecting element is arranged in the channel with a gap, thereby allowing movement in the second direction and / or in the third direction.

[0024] According to an advantageous design embodiment, the connecting element can be configured as a pin. Due to this structure, a simple and reliable connection can be achieved.

[0025] Advantageously, the base element can be designed as a base plate and / or at least one compensation element can be designed as a compensation plate. The advantage of a plate-shaped embodiment is that the connection between the individual elements is formed over a larger area, which prevents the mandrel from tilting.

[0026] The mandrel can be particularly advantageously designed as an expansion mandrel. For example, an expansion mandrel can be used to produce a "European backflush" and / or an "American backflush." ​​Alternatively, it is conceivable that the mandrel can be used to produce openings without backflush (e.g., a one-piece opening) or openings without movable elements.

[0027] Furthermore, this basic object is achieved by an apparatus according to a second aspect of the present invention. Accordingly, an apparatus for processing hollow glass preforms, in particular an apparatus for producing pharmaceutical glass vials, comprising at least one chuck for holding the preform, a heating device, and an external shaping device for shaping the outer wall of the opening of the preform, is provided. The apparatus is characterized in that a device according to the present invention is provided.

[0028] The advantage of this device is that the preform can be machined precisely, in particular openings can be produced with extremely small tolerances.

[0029] According to an advantageous design embodiment, a rotatable processing plate with multiple chucks can be provided, and the chucks can be designed to be rotatable in each case. This has the advantage that the preform to be processed can be indexed and moved. Alternatively or additionally, the external forming device can have two movable forming rollers. This allows for simple processing or forming of the outer wall of the preform opening. Advantageously, the forming rollers can be subjected to a force in the direction of the outer wall of the preform.

[0030] Furthermore, the basic object is achieved by a method for shaping the opening of a hollow body-shaped preform made of glass, in particular by a method for producing a pharmaceutical glass vial having a device according to the invention, comprising the following method steps:

[0031] - heating at least the opening of the preform;

[0032] - The mandrel is introduced into the opening of the preform and the forming roller is pressed from the outside onto the opening of the rotating preform.

[0033] A corresponding method is distinguished in that a preform with an opening of particularly precise shape can be produced in a short time using less complex equipment.

[0034] The present invention also relates to a plurality of pharmaceutical glass vials, in particular a plurality of pharmaceutical glass vials produced using the device according to the present invention and / or using the apparatus according to the present invention and / or using the method according to the present invention, wherein the plurality of pharmaceutical glass vials comprises at least 10 glass vials, for example, 10 to 1000 glass vials, in particular 20 to 500 glass vials, preferably 40 to 250 glass vials, wherein the inner diameter of the opening of each glass vial deviates from the nominal inner diameter by less than 0.20 mm, in particular less than 0.15 mm, preferably less than 0.1 mm, particularly preferably less than 0.05 mm, and / or wherein the outer diameter of the opening of each glass vial deviates from the nominal outer diameter by less than 0.20 mm, in particular less than 0.15 mm, preferably less than 0.10 mm, particularly preferably less than 0.05 mm.

[0035] The advantage of the plurality of pharmaceutical glass vials is that they meet the most stringent quality standards, which advantage can be achieved in particular by using the above-described device and / or by using the above-described apparatus and / or by using the above-described method.

[0036] Advantageously, the inner diameter may be nominally 7 mm or 12.6 mm, and / or the outer diameter may be nominally 13 mm or 20 mm.

[0037] The present disclosure further relates to an apparatus for processing a hollow body-shaped preform made of glass, in particular to an apparatus for producing pharmaceutical glass vials, the apparatus comprising at least one chuck for clamping the preform, a heating device, and an external forming device for forming the outer wall of the opening of the preform; and the present disclosure relates to an apparatus for forming the inner wall of the opening of a preform made of glass, in particular to an apparatus according to the present invention, comprising a mandrel and a mounting part, the mandrel being for being introduced into the opening of the preform in a first direction, wherein the mandrel is arranged on the mounting part, wherein the apparatus is configured to form the opening of a pharmaceutical glass vial, wherein the inner diameter of the opening of the glass vial deviates from the nominal inner diameter by less than 0.20 mm, in particular less than 0.15 mm, preferably less than 0.1 mm, particularly preferably less than 0.05 mm, and / or wherein the outer diameter of the opening of each glass vial deviates from the nominal outer diameter by less than 0.20 mm, in particular less than 0.15 mm, preferably less than 0.10 mm, particularly preferably less than 0.05 mm. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Advantageously, the teachings of the present invention can be designed and improved in various ways. For this purpose, reference is made to the following description of preferred exemplary embodiments of the present invention with the aid of the accompanying drawings. In general, preferred design embodiments and improvements of the present invention are also described in conjunction with the description of preferred exemplary embodiments of the present invention with the aid of the accompanying drawings. In the drawings:

[0039] Figure 1a A schematic partial cross-sectional side view of a portion of a pharmaceutical glass vial is shown;

[0040] Figure 1b Shown Figure 1a A schematic partial cross-sectional side view of an enlarged detail of a pharmaceutical glass vial;

[0041] Figure 2a A schematic side view, partially in section, of a portion of another pharmaceutical glass vial is shown;

[0042] Figure 2b Shown Figure 2a A schematic partial cross-sectional side view of an enlarged detail of a pharmaceutical glass vial;

[0043] Figure 3a A schematic diagram shows a portion of an apparatus for processing a hollow body-shaped preform in a first operating position;

[0044] Figure 3b a schematic diagram showing a portion of an apparatus for processing a hollow body-shaped preform in another operating position;

[0045] Figure 4 shows a schematic cross-sectional side view of an exemplary embodiment of a device according to the present invention;

[0046] Figure 5 shows a schematic cross-sectional side view of another exemplary embodiment of an apparatus according to the present invention;

[0047] Figure 6a Shown according to Figure 5 A schematic plan view of a portion of the apparatus shown in a first position;

[0048] Figure 6b Shown according to Figure 5 a schematic plan view of a portion of the apparatus shown in another position;

[0049] Figure 7 A schematic perspective view of a mandrel is shown;

[0050] Figure 8 A perspective schematic diagram of another mandrel is shown;

[0051] Figure 9 A schematic plan view showing an exemplary embodiment of an apparatus according to the present invention; and

[0052] Figure 10 Shown is a block diagram for visualizing one embodiment of a method according to the invention. DETAILED DESCRIPTION

[0053] Figures 1a to 2b Detailed Description of the Preferred Embodiments A pharmaceutical glass vial 1 which can be produced using the teachings of the present invention and an opening 2 of the pharmaceutical glass vial 1 are shown in FIG.

[0054] Figure 1a and Figure 1b An exemplary embodiment of a pharmaceutical glass vial 1 is shown, which has an opening 2 on the inner wall with radially extending surrounding beads 3. This is thus an opening 2 with a so-called "Euro-style backflush".

[0055] Figure 2a and Figure 2b Another exemplary embodiment of a pharmaceutical glass vial 1 is shown, wherein the opening 2 on the inner wall of the pharmaceutical glass vial 1 is designed to be flat. This is therefore a so-called "backflush-free" opening 2.

[0056] Figure 3a and Figure 3b An apparatus for processing a hollow glass preform 4 is shown. The apparatus has a chuck 5 for holding the preform 4. To shape the opening 2 of the preform 4, it is heated to the desired temperature by a heating device (not shown). Furthermore, an external shaping device 6 is shown, which has two shaping rollers 7. The shaping rollers 7 can be moved toward the preform 4 along the arrows indicated by the shaping rollers 7.

[0057] Furthermore, a mandrel 8 is provided for introduction into the opening 2 in a first direction 9. The diameter of the mandrel 8 corresponds to the opening inner diameter 26 of the opening 2 to be formed. For example, a shaping roller 7, which is moved from the outside toward the preform 4, presses the soft preform 4, which is heated in the opening region, against the mandrel 8 by means of spring force. The shaping roller 7 is moved toward the preform 4 from the outside. Here, the preform 4 is rotated by means of a driven chuck 5, thereby forming the opening inner diameter.

[0058] Furthermore, it can be seen that the mandrel 8 is arranged on the mounting part 10. The mounting part 10 has a base element 11 and a first compensation element 13, which can be moved together with the base element 11 in the second direction 12. The mandrel 8 is fixedly arranged on the first compensation element 13, which is designed as a compensation plate 14. When the mandrel 8 together with the first compensation element 13 is introduced into the opening 2 or is subjected to the force of the forming roller 7, the mandrel 8 is moved or displaced in the second direction 12 to an optimal alignment position. It is also conceivable here that the first compensation element 13, or optionally a further compensation element, is also movable relative to the base element 11 in a third direction 15, which in the exemplary embodiment shown here is marked by "x" and is perpendicular to the Figure 3a and Figure 3b In this way, the mandrel 8 can be aligned even more precisely with the opening 2 . In the exemplary embodiment of the invention shown, the base element 11 is designed as a base plate 16 .

[0059] Figure 4 A schematic cross-sectional side view of an exemplary embodiment of an apparatus according to the present invention is shown. The apparatus comprises a mandrel 8 for introduction into an opening of a preform (not shown) in a first direction 9. Mandrel 8 is mounted on a mounting element 10. Mounting element 10 comprises a base element 11, a first compensating element 13, and a second compensating element 13'. First compensating element 13 is movable relative to base element 11 in a second direction 12, and second compensating element 13' is movable relative to base element 11 in a third direction 15. Third direction 15, here designated "x," extends perpendicular to the plane of the drawing.

[0060] The base element 11, the first compensating element 13, and the second compensating element 13' each have a channel 17, in which a connecting element 18 configured as a pin is arranged. The channel 17 is dimensioned such that the first compensating element 13 and the second compensating element 13' are movable in the second direction 12 or in the third direction 15, respectively.

[0061] Figure 5Another exemplary embodiment of a device for forming the inner wall of an opening in a hollow preform is shown. The device comprises a mounting element 10 and a first compensating element 13. The mounting element 10 has a base element 11, relative to which the first compensating element 13 is movable. A base plate 16 and the first compensating element 13 are connected to each other via a connecting element 18, embodied as a pin. A channel 17 for accommodating the pin is configured such that the first compensating element 13 is movable relative to the base element 11 in a second direction 12 and a third direction 15. The mandrel (not shown) of the device is configured as an expansion mandrel, which is actuated by two expansion arms 19, 19'. To this end, a movable conical element 20 is provided, which actuates the preloaded expansion arms 19, 19', each supporting one element of the expansion mandrel.

[0062] The conical element 20 and the expansion arms 19, 19' are as follows Figure 6a and Figure 6b Here, Figure 6a An operating position is shown in which the conical element 20 is moved in the direction of the expansion arms 19 , 19 ′ so that the elements of the expansion mandrel are separated in such a way that the desired size of the opening diameter is achieved. Figure 6b The rest position is shown, in which the expansion arms 19 , 19 ′ and the elements of the expansion mandrel are brought closer to one another, so that the expansion mandrel can be retracted from the formed opening.

[0063] Figure 7 A schematic perspective view of a mandrel 8 is shown. The mandrel 8 is designed as a single component and serves to form a “blowback-free” opening.

[0064] Figure 8 A schematic perspective view of a mandrel 8 designed as an expansion mandrel is shown. The mandrel 8 comprises two elements 21 , 21 ′, each having a groove 22 , so that an opening with “Euro-type blowback” can be formed.

[0065] Figure 9A schematic plan view of an exemplary embodiment of an apparatus according to the present invention is shown. The apparatus comprises a processing plate 23 having a plurality of chucks 5 for accommodating preforms, a heating device, and an external forming device 6. The device according to the present invention for forming the inner wall of an opening of a hollow product is arranged below the external forming device 6 and is therefore not visible. The processing plate 23 with the chucks 5 is transferred from one processing station to the next by a rotational movement. For processing, the processing plate 23 with the chucks 5 remains stationary for a specified period of time. In this example, there are a total of 18 processing stations. Due to the transfer of the processing plate 23, each of the chucks 5 repeatedly passes through a processing station and thereby also repeatedly passes through the device for forming the inner wall of an opening of a hollow product. The pitch diameter of the chucks 5 on the plate can be, for example, between 100 cm and 200 cm, which diameter varies depending on the respective machine model.

[0066] Figure 10 A block diagram illustrating an exemplary embodiment of the method according to the present invention is shown. In a first step 24, at least the opening of the preform is heated to soften it sufficiently for forming. In a next step 24, the mandrel of the device according to the present invention is introduced into the opening of the rotating preform, and a forming roller is pressed against the opening from the outside.

[0067] It should be noted here that other method steps may be performed before, between or after the first step 24 and the second step 25 .

[0068] The following table lists the opening inner diameter 26 and the opening outer diameter 27 (refer to Figure 1a ) from their respective nominal values.

[0069]

[0070] It is clear from the table that, in particular at those diameter values, the production is significantly more stable, wherein the other opening dimensions also become more stable due to the better shaping of the opening, thereby reducing operator intervention.

[0071] With regard to further advantageous design embodiments according to the invention, reference is made to the main part of the description and to the appended claims in order to avoid repetitions.

[0072] Finally, it should be explicitly pointed out that the exemplary embodiments of the subject matter according to the present invention described above are only used to discuss the teachings claimed, but the teachings claimed are not limited to the exemplary embodiments.

[0073] Reference Signs List

[0074]

Claims

1. A device for shaping the inner wall of an opening (2) of a hollow body-shaped preform (4) made of glass, the device comprising a mandrel (8) and a mounting element (10), the mandrel (8) being introduced into the opening (2) of the preform (4) in a first direction (9), wherein: The core shaft (8) is arranged on the mounting member (10), The invention is characterized in that: the mounting member (10) has a base element (11), and the core shaft (8) is movable relative to the base element (11) along a second direction (12), the mounting member (10) has a first compensation element (13) and a second compensation element (13'), wherein the first compensation element (13) is connected to the base element (11); and the second compensation element (13') is connected to the first compensation element (13), wherein the first compensation element (13) and / or the second compensation element (13') are movable relative to the base element (11) along the second direction (12) and / or along a third direction (15), and the base element (11) is movable relative to the base element (11) along the second direction (12) and / or along a third direction (15), and the base element (11) is movable relative to the base element (11) along the second direction (12) and / or along a third direction (15). The element (11) and / or the first compensating element (13) and / or the second compensating element (13') have at least one channel (17) for accommodating a connecting element (18); and the size of the channel (17) is designed so that the connecting element (18) is arranged in the channel (17) with a gap, thereby allowing the first compensating element (13) and / or the second compensating element (13') to move along the second direction (12) and / or along the third direction (15), wherein the core shaft (8) can move 0.1 mm to 1.0 mm relative to the base element (11) along the second direction (12) and / or along the third direction (15).

2. The device according to claim 1, characterized in that: The device is used for manufacturing pharmaceutical glass vials (1).

3. The device according to claim 1, characterized in that: The core shaft (8) is movable relative to the base element (11) by 0.2 mm to 0.8 mm along the second direction (12) and / or along the third direction (15).

4. The device according to claim 1, characterized in that: The core shaft (8) is movable relative to the base element (11) by 0.3 mm to 0.7 mm along the second direction (12) and / or along the third direction (15).

5. The device according to any one of claims 1 to 4, characterized in that: The core shaft (8) is movable relative to the base element (11) along the third direction (15).

6. The device according to any one of claims 1 to 4, characterized in that: The first direction (9) and the second direction (12) or the third direction (15) extend in each case so as to remain perpendicular to each other, or the first direction (9) and the second direction (12) and the third direction (15) extend in each case so as to remain perpendicular to each other.

7. The device according to any one of claims 1 to 4, characterized in that: The mandrel (8) is immovably arranged on the second compensating element (13').

8. The device according to claim 7, characterized in that: The connecting element (18) is designed as a pin.

9. The device according to any one of claims 1 to 4, characterized in that: The base element (11) is configured as a base plate (16); and / or the at least one compensation element (13, 13') is configured as a compensation plate (14); and / or the mandrel (8) is configured as an expansion mandrel.

10. A device for processing a hollow body-shaped preform (4) made of glass, said device comprising at least one chuck (5) for holding said preform (4), a heating device and an external shaping device for shaping the outer wall of an opening (2) of said preform (4), characterized in that: An apparatus according to any one of claims 1 to 9 is provided.

11. The device according to claim 10, characterized in that: The device is used to manufacture pharmaceutical glass vials (1).

12. The device according to claim 10 or 11, characterized in that: A rotatable processing plate (23) having a plurality of chucks (5) is provided; and the chucks (5) are in each case configured to be rotatable.

13. The device according to claim 10 or 11, characterized in that: The external shaping device (6) has two movable shaping rollers (7).

14. The device according to claim 13, characterized in that: The shaping roller (7) can be subjected to a force in the direction of the outer wall of the preform (4).

15. A method for shaping an opening of a hollow body-shaped preform (4) made of glass, said method using an apparatus according to claim 13 or 14, said method comprising the following method steps: - heating at least the opening (2) of the preform (4); - A mandrel (8) is introduced into the opening (2) of the preform (4) and a forming roller (7) is pressed from the outside onto the opening (2) of the rotating preform (4).

16. The method according to claim 15, characterized in that: The method is used to manufacture pharmaceutical glass vials (1).

17. A plurality of pharmaceutical glass vials (1), said plurality of pharmaceutical glass vials (1) being manufactured using the apparatus according to any one of claims 1 to 9, and / or using the device according to any one of claims 10 to 14, and / or using the method according to claim 15 or 16, said plurality of pharmaceutical glass vials (1) having at least 10 glass vials (1), wherein: The inner diameter (26) of the opening (2) of each of the glass vials (1) deviates from the nominal inner diameter by less than 0.20 mm, and / or wherein, The deviation of the opening outer diameter (27) of the opening (2) of each of the glass vials (1) from the nominal outer diameter is less than 0.20 mm.

18. A plurality of pharmaceutical glass vials (1) according to claim 17, characterized in that: The plurality of pharmaceutical glass vials (1) has 10 to 1000 glass vials (1).

19. A plurality of pharmaceutical glass vials (1) according to claim 17, characterized in that: The plurality of pharmaceutical glass vials (1) has 20 to 500 glass vials (1).

20. The plurality of pharmaceutical glass vials (1) according to claim 17, characterized in that: The plurality of pharmaceutical glass vials (1) has 40 to 250 glass vials (1).

21. A plurality of pharmaceutical glass vials (1) according to any one of claims 17 to 20, characterized in that: The deviation of the opening inner diameter (26) of the opening (2) of each of the glass vials (1) from the nominal inner diameter is less than 0.15 mm.

22. A plurality of pharmaceutical glass vials (1) according to any one of claims 17 to 20, characterized in that: The deviation of the opening inner diameter (26) of the opening (2) of each of the glass vials (1) from the nominal inner diameter is less than 0.1 mm.

23. A plurality of pharmaceutical glass vials (1) according to any one of claims 17 to 20, characterized in that: The deviation of the opening inner diameter (26) of the opening (2) of each of the glass vials (1) from the nominal inner diameter is less than 0.05 mm.

24. A plurality of pharmaceutical glass vials (1) according to any one of claims 17 to 20, characterized in that: The deviation of the opening outer diameter (27) of the opening (2) of each of the glass vials (1) from the nominal outer diameter is less than 0.15 mm.

25. A plurality of pharmaceutical glass vials (1) according to any one of claims 17 to 20, characterized in that: The deviation of the opening outer diameter (27) of the opening (2) of each of the glass vials (1) from the nominal outer diameter is less than 0.1 mm.

26. A plurality of pharmaceutical glass vials (1) according to any one of claims 17 to 20, characterized in that: The deviation of the opening outer diameter (27) of the opening (2) of each of the glass vials (1) from the nominal outer diameter is less than 0.05 mm.

27. A plurality of pharmaceutical glass vials (1) according to any one of claims 17 to 20, characterized in that: The nominal value of the inner diameter is 7 mm or 12.6 mm, and / or the nominal value of the outer diameter is 13 mm or 20 mm.

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