LABELLING ARRANGEMENT FOR A MULTI-PART CONTAINER, SYSTEM AND METHOD FOR APPLYING A LABELLING ARRANGEMENT TO A MULTI-PART CONTAINER
20220081176 · 2022-03-17
Assignee
- Schreiner Group GmbH & Co. KG (Oberschleissheim, DE)
- Bausch+Stroebel Maschinenfabrik Ilshofen GmbH + Co, KG (Ilshofen, DE)
Inventors
- Andreas HOFENAUER (Germering, DE)
- Stefan KRAUSS (Muenchen, DE)
- Tanja MESSMER (Renningen, DE)
- Robert UNGLERT (Muenchen, DE)
- Harald REBER (Wolpertshausen, DE)
Cpc classification
B65C3/24
PERFORMING OPERATIONS; TRANSPORTING
B65D41/46
PERFORMING OPERATIONS; TRANSPORTING
B65D51/18
PERFORMING OPERATIONS; TRANSPORTING
B65D55/0818
PERFORMING OPERATIONS; TRANSPORTING
A61J1/05
HUMAN NECESSITIES
International classification
B65D55/08
PERFORMING OPERATIONS; TRANSPORTING
B65C3/24
PERFORMING OPERATIONS; TRANSPORTING
B65D41/46
PERFORMING OPERATIONS; TRANSPORTING
Abstract
A labelling arrangement for a multi-part container includes a sleeve-shaped cap element having an interlocking structure adapted to be applied to a first part of the container and coupled to the first part by the interlocking structure. The labelling arrangement further includes a sealing label adapted to be attached to a second part of the container by a second label portion and to surround the applied cap element by a first label portion. The labelling arrangement further includes at least one severing region so that, when the container applied with the labelling arrangement is opened, the labelling arrangement is severable in the severing region and at least a part of the cap element is removable together with the first part of the container from the second part of the container.
Claims
1: A labelling arrangement (1) for a multi-part container (30) comprising: a sleeve-shaped cap element (10) having an interlocking structure (13) on an inner surface (11) and configured to be applied to a first part (31) of the container (30) and coupled to an outer surface (34) of the first part (31) by means of the interlocking structure (13), and a sealing label (20) having a first label portion (21) and a second label portion (22) adjacent to the first label portion (21), the second label portion (22) is configured to be attached to a second part (32) of the container (30), and the first label portion (21) is configured, with respect to a state of the sealing label (20) is applied to the container (30), to surround the applied cap element (10) with respect to a longitudinal axis (L), wherein the labelling arrangement (1) further comprises at least one severing area (14, 24), so that when the container (30) applied with the labelling arrangement (1) is opened, the labelling arrangement (1) is severable in the severing area (14, 24) and at least a part (17) of the cap element (10) is removable together with the first part (31) of the container (30) from the second part (32) of the container (30).
2: The labelling arrangement (1) according to claim 1, wherein the first label portion (21) of the sealing label (20) is configured to be attached to the applied cap element (10) with respect to a state of the sealing label (20) applied to the container (30), so that the sealing label (20) couples the cap element (10) to the second part (32) of the container (30).
3: The labelling arrangement (1) according to claim 1, wherein the sealing label (20) comprises a severing area (24) disposed between the first and second label portions (21, 22), so that, when the container (30) applied with the labelling arrangement (1) is opened, the sealing label (20) is severable in a predetermined manner in the severing area (24) of the sealing label (20) and the first label portion (21) is removable together with the at least one part (17) of the cap element (10) and the first part (31) of the container (30) from the second label portion (22) and the second part (32) of the container (30).
4: The labelling arrangement (1) according to claim 1, wherein the cap element (10) is formed in two parts and has a severing area (14), the cap element (10) having a first cap section (17) and a second cap section (18) with respect to the longitudinal axis (L) of the cap element (10), and the severing area (14) of the cap element (10) is formed between the first and second cap sections (17, 18), so that when the container (30) applied with the labelling arrangement (1) is opened, the cap element (10) is predeterminedly severable in the severing area (14) of the cap element (10) and the first cap section (17) is removable together with the first part (31) of the container (30) from the lower cap section (18) and the second part (32) of the container (30).
5: The labelling arrangement (1) according to claim 1, wherein the cap element (10) has on the inner surface (11) a contour which comprises the interlocking structure (13) and which is preformed in coordination with a contour on the outer surface (34) of the first part (31) of the container (30).
6: The labelling arrangement (1) according to claim 5, wherein, with respect to the longitudinal axis (L) of the cap element (10), the cap element (10) has, on the inner surface (11), a circumferential contour which forms a negative shape with respect to a circumferential contour on the outer surface (34) of the first part (31) of the container (30).
7: The labelling arrangement (1) according to claim 1, wherein the interlocking structure (13) has at least one toothed element (131) which is configured to engage in a recess on the outer surface (34) of the first part (31) of the container (30) when the cap element (10) is fitted to the first part (31) of the container (30) and to couple the cap element (10) to the first part (31) of the container (30).
8: The labelling arrangement (1) according to claim 6, wherein the toothed element (131) is in the form of a snap-in hook (16), which is configured to form a positive-locking connection with the first part (31) of the container (30), so that with respect to the longitudinal axis (L) of the cap element (10) a holding force is established between the cap element (10) and the first part (31) in the direction of the longitudinal axis (L).
9: The labelling arrangement (1) according to claim 6, wherein the toothed element (131) is configured to form of a web or pin with respect to the longitudinal axis (L) of the cap element (10) and to form a positive-locking connection with the first part (31) of the container (30), so that with respect to the longitudinal axis (L) of the cap element (10) a retaining force is provided in a radial direction between the cap element (10) and the first part (31).
10: The labelling arrangement (1) according to claim 1, wherein the cap element (10) has a recess (19) which penetrates a wall of the cap element (10), so that a fluid exchange can be formed between an inner space and an outer space of the cap element (10).
11: The labelling arrangement (1) according to claim 1, comprising: an adhesive layer arranged on an underside of the sealing label (20) so that the sealing label (20) is attachable to the container (30) by means of adhesion, wherein the sealing label (20) has an adhesive-free surface in the separation area (14, 24).
12: The labelling arrangement (1) according to claim 1, wherein the respective severing area (14, 24) is formed in coordination with the container (30) in a region of the cap element (10) and/or of the sealing label (20) which, with respect to an applied state of the labelling arrangement (1) on the container (30), is associated with a transition (33) between the first part (31) and the second part (32) of the container (30).
13: The labelling arrangement (1) according to claim 1, wherein a severing element (171, 25) is provided in the severing area (14, 24).
14: The labelling arrangement (1) according to claim 1, comprising: an opening detection element (172, 26) that is arranged in the severing area (14, 24) of the cap element (10) and/or the sealing label (20) and that is configured to indicate a removal of at least a part (17) of the cap element (10) and/or the first label portion (21) together with the first part (31) of the container (30) from the second part (32) of the container (30).
15: Use of a labelling arrangement (1) according to claim 1 for a container (30) that is divisible into several parts.
16: A system comprising: a container (30) divisible into a plurality of parts comprising a first part (31) and a second part (32), and the labelling arrangement (1) according to claim 1, which is applied to the container (30) such that the second label portion (22) of the sealing label (20) is attached to the second part (32) of the container (30) and the first label portion (21) of the sealing label (20) is attached to the cap element (10) applied to the first part (31) of the container (30).
17: A method for applying a labelling arrangement (1) to a multi-part container (30), comprising: providing a container (30) divisible into multiple parts comprising a first part (31) and a second part (32), providing a sleeve-shaped cap element (10) having an interlocking structure (13) on an inner surface (11) thereof, providing a sealing label (20) having a first label portion (21) and a second label portion (22) adjacent to the first label portion (21), the cap element (10) and the sealing label (20) forming the labelling arrangement (1) which has at least one severing area (14, 24), placing the cap element (10) on the first part (31) of the container (30) and coupling the interlocking structure (13) of the cap element (10) to an outer surface (34) of the first part (31) of the container (30), and attaching the sealing label (20) to the container (30) by attaching the second label portion (22) to the second part (32) of the container (30) and surrounding the attached cap element (10) with the first label portion (21) with respect to a longitudinal axis (L) of the cap element (10), so that, when the container (30) applied with the labelling arrangement (1) is opened, the labelling arrangement (1) is severable in the severing area (14, 24) and at least a part (17) of the cap element (10) together with the first part (31) of the container (30) is removable from the second part (32) of the container (30).
18: The method of claim 17, wherein attaching the sealing label (20) to the container (30) comprises: attaching the first label portion (21) to the attached cap element (10) such that the sealing label (20) couples the cap element (10) to the second part (32) of the container (30).
19: The method of claim 16, wherein placing and coupling the cap element (10) to the first portion (31) of the container (30) comprises: attaching the cap element (10) to the first part (31) of the container (30) so that a toothed element (131) of the interlocking structure (13) engages a recess on an outer surface (34) of the first part (31).
20: The method according to claim 16, wherein placing and coupling the cap element (10) to the first part (31) of the container (30) comprises: aligning the cap element (10) relative to the first part (31) of the container (30) with respect to the longitudinal axis (L) of the cap element (10), sliding the cap element (10) onto the first part (31) of the container (30) so that a toothed element (131, 16) of the interlocking structure (13) engages in a recess on an outer surface (34) of the first part (31), and rotating the cap element (10) relative to the first part (31) of the container (30) with respect to the longitudinal axis (L) of the cap element (10) so that a toothed element (131) of the interlocking structure (13) engages in a recess on an outer surface (34) of the first part (31).
Description
[0089] In the following, embodiments of the described labelling arrangement are explained with reference to schematic drawings. They show:
[0090]
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[0099] Elements of the same construction and function are marked with the same reference signs across the figures. For reasons of clarity, not all of the elements shown in all of the figures may be identified with the corresponding reference signs.
[0100]
[0101] The labelling arrangement 1 comprises a cap element 10 and a sealing label 20.
[0102] The sealing label 20 comprises a first label portion 21 and a second label portion 22 adjacent the first label portion 21, the second label portion 22 is configured to be attached to a second part 32 of the container 30 (see, for example,
[0103] The labelling arrangement 1 further comprises at least one severing portion 14, 24 (see, for example,
[0104] By means of the described labelling arrangement 1, a reliable and cost-effective sealing solution for syringes can be realised, among other things. The labelling arrangement 1 enables a secure sealing of, for example, primary packaging in the pharmaceutical field, such as injection vials or vials, whereby an intactness of a medicament packaging can be guaranteed or at least clearly indicated. The labelling arrangement 1 prevents unintentional reuse of a suitably labelled primary packaging after use and clearly visibly and reliably indicates an initial opening of the primary packaging. Thus, by means of the labelling arrangement 1, tampering with the primary packaging is also counteracted or indicated by a first-opening proof.
[0105] The container 30 can be designed as a glass syringe or plastic syringe, as an injection vial, as a vial or other receptacle, which has a removable head for opening, which is arranged on or at a body of the container 30. In the context of this description, terms such as “top” and “bottom” refer to an operational arrangement or application or orientation of the labelling arrangement 1 and the container 30. This also applies to terms such as “head” and “body”, where the head is usually to be arranged at the top and the body usually at the bottom. The first part 31 of the container 30 forms, for example, as an upper part, a head of a syringe, and comprises, for example, a cap, a lid or a primary closure or primary cap which is removed to open the container 30. The second part 32 of the container 30 then forms, for example as a lower part, a body of the syringe, which realises a receptacle for receiving and storing a predetermined content.
[0106] The first label portion 21 of the sealing label 20 is associated with the upper, first part 31 of the container 30 and may therefore also be referred to as the upper label portion 21. The second label portion 22 of the sealing label 20 is associated with the lower, second part 32 of the container 30 and remains on the body or receptacle of the container 30 after opening and can therefore also be referred to as the lower label portion 22.
[0107] The container 30 thus forms a primary vessel to which the labelling arrangement 1 is predefined to be attached as a secondary component. The cap element 10 may therefore also be referred to as the secondary cap 10, which is attached to the primary cap 31 of the container 30. In the following, the labelling arrangement 1 is described predominantly in cooperation with a syringe as the container 30, which has a syringe head and a syringe body. However, the principle is also applicable to other pharmaceutical packaging, such as injection vials or vials.
[0108] The syringe head comprises, for example, a primary cap 31 of the syringe 30, for example in the form of a removable primary cap 31, which is specifically covered with the cap element 10 as a further cap or secondary cap 10. The secondary cap 10 is attached to the syringe 30, in particular to the syringe body 32, by means of the sealing label 20 and connects the secondary cap 10 to the syringe body 32. In this way, a reliable and secure seal can be set up for the primary container 30, which counteracts unauthorised manipulation of the contents of the container and clearly indicates a first use or an opening that has already taken place. The sealing label 20 can therefore also be referred to as a security label 20, as it contributes to security of the container contents or the container condition.
[0109]
[0110] The cap element 10 can be fitted or pushed onto the first part 31 of the container 30 by means of tolerable contact pressure, so that the two components lock together. In addition, the cap element 10 may have a recess, slot and/or indentations which provide a degree of resilience such that the cap element 10 can deform elastically when placed on the primary cap 31.
[0111] The cap element 10 may be of one-piece or multi-piece configuration. It has a first upper cap section 17 and a second lower cap section 18 relative to a longitudinal axis L of the cap element 10. The longitudinal axis L represents, for example, a central centre axis with respect to which the container 30 and the cap element 10 are substantially rotationally symmetrical. The longitudinal axis L can therefore also be regarded as the longitudinal axis of the labelling arrangement 1 and/or of the container 30.
[0112] Preferably, the interlocking structure 13 comprises at least one interlocking element 131 configured to engage a recess on the outer surface 34 of the first part 31 of the container 30 when the cap element 10 is attached to the first part 31 of the container 30 and to couple the cap element 10 to the first part 31 of the container 30 (see
[0113] When applied to the container 30, the cap element 10 is placed on the primary cap 31 and preferably extends up to the second part 32 of the container 30 so that a homogeneous, in particular flush, outer surface is formed. For example, the lower cap section 18 covers a neck of the syringe, which is a transition 33 between the first and second parts 31 and 32 of the container 30 (see e.g.
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[0115]
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[0118] The sealing label 20 has been pre-determinedly cut through, leaving the first label portion 21 on the cap element 10 and the second label portion 22 on the second part 32 of the container 30. Furthermore, an opening detection element 26 is illustrated, which represents a clearly recognisable indication in the form of a lettering that the container 30 has been opened or that an initial opening has already taken place. The opening detection element 26 may be provided by an at least partial double or multilayer of the sealing label 20. For example, the second label section 22 is double-layered and has “OPEN” written on a lower label layer facing the container body 32 in the severing area 24.
[0119] The first label portion 21 then extends, for example, onto the second label portion 22 or at least onto the lower label layer of the second label portion 22 and covers the lettering in a non-opened state of the labelling arrangement 1, so that the opening detection element 26 is not yet visible from the outside. When opened, the first label portion 21 is removed together with the cap element 10. Thus, the overlap area between the first label portion 21 and the lower label layer of the second label portion 22 is separated and the opening detection element 26 is exposed.
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[0128]
[0129] The upper cap section 17 of the cap element 10 forms a portion of the secondary cap which can be slid over the primary cap 31 of the container 30. Also shown are bevelled engagement hooks 16, which also function as interlocking elements 131. The bevel is designed to taper in the direction of an open end 101 of the cap element 10 and allows the secondary cap 10 to be pushed onto the container 30 from above in a simple and guided manner Several spaced-apart engagement hooks 16 can be formed, or a circumferential engagement ring can be formed with respect to the longitudinal axis L. The one or more latching hooks 16 snap into a recess of the syringe below a Luer-Lock thread, which is formed as an annular groove, for example, between the Luer-Lock thread and a shoulder of the syringe body 32.
[0130] In addition, further toothed elements 131 are arranged on an inner surface 11 which extend substantially vertically or in the direction of the longitudinal axis L and form bevelled contact pressure spring elements. The upwardly formed bevel of the toothed elements 131 again allows the cap element 10 to be easily pushed onto the syringe or container 30 from above. The toothed elements 131 then press from the inside against the outer surface 34 of the Luer-Lock thread 31. Preferably, an undercut is thereby avoided. For example, the toothed elements 131 are arcuate and provide a degree of flexibility during placement. Should one or more of the toothed elements 131 directly encounter a protrusion of the first part 31 of the container 30 during push-on, the pressure spring element or the toothed element 131 can bend away to one side and nestle in a suitable position against the outer contour of the first part 31. As a result, even non-directional sliding of the cap element 10 allows reliable attachment of the secondary cap to the container 30.
[0131] The upper and lower cap sections 17 and 18 are also connected to each other by frangible connecting webs 171. When the container 30 or the syringe provided with the labelling arrangement 1 is turned open, the connecting webs 171 break through (see also
[0132] A lower edge of the upper cap section 17 preferably has a bevelled bulge 15, which also allows the cap element 10 to be pushed on easily from above. The bulge 15 may further contribute to a stable and secure fit of the cap element 10 to the primary cap 31 by sliding the bulge over or onto a bead on the primary cap 31 of the container 30.
[0133] A wall thickness of the cap element 10 is preferably designed to match any difference in diameter between the first part 31 and the second part 32 of the container 30. In this way, the cap element 10 can form a geometry compensation between the Luer-Lock adapter 31 and the syringe barrel 32 as an adapter.
[0134] The lower cap section 18 may also be formed separately from the upper cap section 17 and be fitted onto the container 30. One or more recesses may be provided to allow easy sliding on (see
[0135]
[0136]
[0137] The adapter or secondary cap 10 has mechanical structures with the interlocking structure 13 in an inner area, which fulfil two functions. On the one hand, a toothed element 131 in the form of a snap-in hook 16, which forms an internal mechanical projection of the secondary cap 10, snaps into a horizontal notch of the primary cap 31, for example. On the other hand, the toothed elements 131 interlock, for example as vertical inner structures in the form of flexible webs or according to a negative form of an outer primary cap structure, with the outer structures of the primary cap 31. These two functions mean that when the secondary cap 10 is rotated, it can be unscrewed from the syringe 30 together with the primary cap 31 and then remains with the primary cap 31 and can be disposed of together. In the case of Luer-Lock glass syringes, the secondary cap 10 is preferably made in two parts, whereby the two cap sections 17 and 18 can be connected to each other by connecting webs 171. The lower cap section 18 of the secondary cap 10 snaps with a protrusion, for example in the form of one or more engagement hooks 16, into or onto the lower edge of the Luer-Lock thread, while the upper cap section 17 snaps with its internal interlocking structure 13 into one or more notches of the primary cap 31 and can interlock with the outer structure of the primary cap 31.
[0138] According to a further embodiment, the labelling arrangement 1 may also be configured such that the first label portion 21 of the sealing label 20 surrounds the first part 31 of the container 30 in a sleeve-like manner without being adhesively coupled to or with the first part 31 of the container 30. The first label portion 21 can thus enclose the secondary cap or the cap element 10 all around without contact or without adhesion with respect to the longitudinal axis L. The first label portion 21 then forms a label sleeve which is open at the top with respect to the longitudinal axis L. When the container 30 is opened, the first label portion 21 is pressed against the outer surface 12 of the cap element 10 and is separated from the second label portion 22 by pulling and/or turning and is removed together with the secondary cap 10 from the second part 32 of the container 30.
[0139] According to such an embodiment, the sealing label 20 also has a severing area 24 in which, for example, a perforation is formed as a severing element 25, which enables a predetermined tearing of the sealing label 20. Alternatively or additionally, a tear strip can also be arranged in the severing area 24 in order to enable controlled tearing of the sealing label 20. Alternatively, a film element, such as an acetate film, may be provided as a tear-through element, which has a low tear resistance. The foil element tears through when the first label portion 21 and the cap element 10 are twisted and/or pulled, so that an initial opening is clearly visible. Such a foil element thus allows the sealing label 20 to be torn through without the need for a perforation or a tear strip.
[0140] Even if the first label portion 21 according to such an embodiment does not make adhesive contact with the cap element 10, reliable tamper-resistance of the labelling arrangement 1 can be achieved. The first label portion 21 is preferably designed in such a way that there is only a narrow gap or space between the attached cap element 10 and the surrounding first label portion 21. Manipulation or an attempt to open the label by reaching into the narrow gap leads to tearing or crumpling of the first label portion 21, so that such an operation leaves recognisable traces.
[0141]
[0142] The cap sections 17, 18 of the cap element 10 then cover, as adapter parts, the areas of the primary closure 31 that have a smaller diameter than the syringe body 32 and the bead 35 of the primary closure 31. This also contributes to a uniform diameter progression or circumferential uniformity of the container 30 and thus to improved labelling capability. If the primary closure 31 has a bulbous shape, as indicated in
[0143] Furthermore, the cap element 10 can also be formed in two parts without connecting webs. The two separate cap sections are then arranged, for example, spaced apart from each other on the primary cap of the container 30. Such a design is suitable, for example, if an area of the primary part of the container to be arranged between the cap sections 17, 18 is wider than the areas adjoining it at the top and bottom. The primary closure 31 has, for example, a bead which realises the widest part of the first part of the container 30 transversely to the longitudinal axis.
[0144] For example, the syringe body 32 has a diameter of 10.85 mm, while the bead 35 on the syringe head 31 has a diameter of 10.95 mm. When the cap element 10 is fitted, for example, the annular lower cap section 18 can then be slid over the bead 35. The lower cap section 18 is preferably slotted and has an expansion joint or recess which allows it to be slipped over the bead 35 (see
[0145] Another way of arranging the cap element 10 on the first part 31 of the container 30 with the bead 35 is that the annular lower cap section 10 is placed on the container head 31 prior to the primary closure, and subsequently the primary closure is attached to the container head 31. With respect to a Luer threaded syringe 30, the primary closure is then threaded into the thread provided on the container head 31. The lower annular cap section 18 does not then require, for example, a slit to provide expandability. The upper cap section 17 can then be fitted. Over-labelling of the existing gap and the bead 35 arranged therein is easily and reliably possible.
[0146]
[0147] In a step S1, the secondary cap 10 is first placed on the primary cap 31 of the syringe 30. This preferably comprises aligning the primary and secondary caps 31 and 10 relative to each other. Such alignment may in particular comprise rotating the cap element 10 until a functionally correct alignment of the cap element 10 with respect to the outer structure of the first part 31 of the container 30 is achieved. Subsequently, the cap element 10 is placed or pushed onto the primary cap 31 and pushed in the direction of the container body 32 until the cap element 10 engages and locks into a recess of the primary cap 31 by means of a snap-in hook 16. In this way, a vertical holding force of the primary and secondary caps 31 and 10 against each other can be established.
[0148] In a step S3, the secondary cap 10 may be rotated relative to the primary cap 31 to form a stable and secure interlocking of the interlocking structure 13 of the secondary cap 10 with the outer surface 34 of the primary cap 31. In this way, a horizontal holding force of the primary and secondary caps 31 and 10 against each other can be established.
[0149] In a further step S5, the sealing label 20 is then applied to the syringe body 32 and the secondary cap 10 to seal the container or syringe 30.
[0150] The sealing label 20 and/or the cap element 10 comprise a severing area 24 and/or 14, preferably formed or arranged to be located in the transition portion 33 between the syringe body 32 and the secondary cap 10 and the syringe head 31 respectively. When the secondary cap 10 is rotated, the sealing label 20 and/or the cap element 10 is predeterminedly destroyed along the severing area 24 and/or 14 and the secondary cap 10 can be unscrewed and/or removed from the syringe 30 together with the primary cap 31. The primary cap 31 remains fixed inside the secondary cap 10.
REFERENCE SIGNS
[0151] 1 labelling arrangement [0152] 10 cap element/secondary cap [0153] 101 open end of the cap element [0154] 11 inner surface of the cap element [0155] 12 outer surface of the cap element [0156] 121 surface structure of the outer surface [0157] 13 interlocking structure of the cap element [0158] 131 toothed element of the interlocking structure [0159] 14 severing area of the cap element [0160] 15 bevelled protrusion of the cap element [0161] 16 bevelled snap-in hook of the cap element [0162] 17 upper cap section of the cap member [0163] 171 connecting web between the cap sections [0164] 172 portion of connecting web [0165] 18 lower cap section of the cap element [0166] 19 recess of the cap element [0167] 20 sealing label [0168] 21 first label portion of the sealing label [0169] 22 second label portion of the sealing label [0170] 24 severing area of the sealing label [0171] 25 severing element/perforation/film element [0172] 26 opening detection element [0173] 261 first partial element of the opening detection element [0174] 262 second partial element of the opening detection element [0175] 30 container/syringe [0176] 31 first part of the container/primary cap [0177] 32 second part of the container/syringe body [0178] 33 transition between the first and the second part [0179] 34 outer surface of the first part [0180] 35 bead of the first part [0181] L longitudinal axis [0182] S(i) step of a method for applying a labelling arrangement