WO2021032799A1

WO2021032799A1 - Securing cap for securing a lid, top or closure on a pharmaceutical vessel

Info

Publication number: WO2021032799A1
Application number: PCT/EP2020/073244
Authority: WO
Inventors: Gerhard Ross
Original assignee: Schreiner Group Gmbh & Co. Kg
Priority date: 2019-08-20
Filing date: 2020-08-19
Publication date: 2021-02-25
Also published as: DE102019122359A1

Abstract

The invention relates to a securing cap (10) for securing a lid, top or other closure on a pharmaceutical vessel or object against unauthorised opening, removal or other tampering, the securing cap (10) having at least the following: - an end-side cap section (11), in particular in the form of an end face (19), for covering, at least in some regions, a lid, top or closure mounted on a pharmaceutical vessel or object in an axial direction (z), - a side wall (12) running in the circumferential direction around the axial direction (z), and - an end section (13) of the side wall (12), having an introduction opening (14) through which the vessel or the object can be introduced with the lid, top or closure first into the securing cap (10) when the securing cap (10) is pushed on, wherein the side wall (12) has a first wall section (15), which - comprises the end section (13) of the side wall (12), - completely encircles the introduction opening (14), and - is intended for attachment to a cylindrical section of a pharmaceutical vessel or object, the securing cap (10) being designed to be attachable to pharmaceutical vessels or objects having different outer diameters resulting from tolerances by way of a design of the first wall section (15) of the side wall (12) such that said first wall section is widened in the radial direction.

Description

description

Safety cap for securing a lid, head or closure on a pharmaceutical container

The application relates to a safety cap for securing a lid, head or other closure on a pharmaceutical vessel or object against unauthorized opening, removal or other manipulation.

For many pharmaceutical vessels and objects, such as vials, ampoules, vials or infusion bottles, etc. there are predefined, standardized setpoints for their dimensions; in particular standardized setpoints for their outer diameter. In practice, however, such pharmaceutical vessels often deviate from the standardized target values for the dimensions, in particular for the outer diameter, with the actual tolerance ranges depending on the type of pharmaceutical vessel being able to reach or even exceed one millimeter.

There are tools for securing ready-made pharmaceutical vessels that have already been closed by means of a lid, head or other closure, in particular against unauthorized opening or removal of the closure or against other manipulations, in particular against manipulations (tampering) that can be carried out for counterfeiting purposes, for example To imitate, modify or otherwise manipulate the contents of the vessel and / or its marking (usually located on a label); for example, in order to put unauthorized drugs into circulation undetected.

In order to prevent this abuse, the lid, head or other closure is sometimes covered by an additional outer (secondary) lid, which is connected to the actual vessel by a label. Such an outer additional cover serves as a safety cap in order to prevent unauthorized, unnoticed manipulation of the inner cover or closure.

Due to the tolerance-related deviations in the dimensions that occur in practice, in particular the outer diameter of such pharmaceutical vessels and objects the problem arises that the inside diameter of a safety cap often cannot be dimensioned appropriately. Depending on how large the outer diameter of the vessel or object is, the safety cap is either not wide enough so that it tears or is damaged when it is attached to the vessel, or too large, so that the side wall of the safety cap is then at the latest when glued by the The label throws creases, which limits the protection against unauthorized manipulation and their recognizability.

It is known to make a "bead" in a safety cap, ie an indentation running in a ring on the inside of the safety cap, which is close to a likewise annular contact surface for a vessel edge (such as the upper edge of a container; similar to a glass or a bottle ) is arranged, but has a slightly smaller diameter. As a result, a closure provided with a bead can also be placed on vessels whose edge or other diameter is slightly smaller than expected. This opens up a certain range of tolerance towards smaller vessel dimensions, albeit within narrow limits, and in any case only affects the closure itself.

The disadvantage of conventional safety caps is that the undesired drapery and its adverse effects on the tamper-evident security cannot be avoided as soon as such a safety cap is to be glued by a label to a pharmaceutical vessel that is too small in diameter.

It is the object of the present application to provide a safety cap that can be attached to pharmaceutical vessels or objects better and in particular without folds or other adverse consequences for manipulation safety, the dimensions of which are standardized and / or based on setpoints, but actually in the Practice often deviate from these standards or setpoints.

Regardless of these manufacturing tolerances, the safety cap according to the application should be able to be attached without any problems at least within a tolerance range without the to- Tolerance-related deviations in the vessel dimensions lead to problems in the tamper-proof packaging of filled or filled pharmaceutical vessels or objects.

This object is achieved by the safety cap according to claim 1.

According to claim 1, the safety cap has at least the following:

- an end cap section, in particular in the form of an end face, for at least regionally covering a lid, head or closure mounted on a pharmaceutical vessel or object in an axial direction,

- A side wall extending around the axial direction in the circumferential direction and

- An end portion of the side wall with an insertion opening through which at

Sliding on the safety cap, the vessel or the object with the lid, head or closure first can be introduced into the safety cap.

The side wall furthermore has a first wall section which comprises the end section of the side wall, completely surrounds the insertion opening and is intended for attachment to a cylindrical section of a pharmaceutical vessel or object.

According to this application, the securing cap on pharmaceutical vessels or objects with different outer diameters due to tolerances can be attached by the first wall section of the side wall being expandable in the radial direction.

Some exemplary embodiments are described below with reference to the figures. Show it:

FIG. 1 shows a vial as an example of a pharmaceutical vessel that is to be provided with a safety cap,

FIG. 1 A shows a safety cap with a modified geometry for the vial from FIG. 1,

FIG. 2 the vial from FIG. 1, covered with the securing cap from FIG. 1A, Figure 3 is a perspective view of a safety cap, shown in a slight bottom view,

FIG. 4 shows some exemplary shapes of weakening elements or expansion openings for the first wall section of the safety cap,

FIG. 5 shows an exemplary embodiment of the first wall section in which weakening elements or expansion openings are provided in the form of cuts or slits, and FIG

FIG. 6 shows an alternative exemplary embodiment with weakening elements or expansion openings which do not cut through the entire wall thickness of the first wall section, and FIG

FIG. 7 shows a cross-sectional view which is more detailed than FIGS. 1 to 3 with regard to the components of the vessel closure, in particular the vial.

As explained above, it is provided that the attachment of the securing cap to pharmaceutical vessels or objects of different sizes outside diameters is made possible in that the first wall section of the side wall is designed to be expandable in the radial direction.

While conventional safety caps almost always drape as soon as the outside diameter of a specific pharmaceutical vessel (e.g. a certain vial or vial) turns out to be smaller than the inside diameter of the safety cap, the safety cap according to the application no longer drags. The reason for this is that the inner diameter of the safety cap according to the application is not adapted to the largest possible, tolerance-related still tolerable or expected vessel diameter, but conversely corresponds to the smallest possible, tolerance-related still tolerable or expected vessel diameter or at least corresponds to a value of an expected vessel diameter that is not bigger but is only just as large, preferably even smaller, than the standardized or empirical target value of the outer diameter of the pharmaceutical vessel.

Because the inner diameter of the securing cap, which is preformed as a result of the manufacturing process, now corresponds to a lower limit for the range of expected vessel diameters, the inner diameter of the securing cap can at best be too narrow, but no longer too wide. Accordingly, the proposed securing cap can be mounted on a pharmaceutical vessel, in particular with a press fit or press fit.

On the other hand, in order to avoid tearing of the safety cap, which would also reduce the security of manipulation, according to the application the side wall of the safety cap, more precisely a first wall section of this side wall, which is intended to be attached to a cylindrical section of a pharmaceutical vessel or object, Designed to be expandable in the radial direction, as a result of which the safety cap, which is often too tight at the beginning, remains intact even during and after attachment to the pharmaceutical's vessel or the pharmaceutical object.

Regardless of the other features and embodiments, the securing cap can be attached, for example, in that the securing cap can be placed, in particular pushed on or pressed on, or alternatively rotated, in particular screwed on, the closed vessel. In the latter cases, circumferential, locally interrupted inside screw thread on the safety cap can be provided or many screw thread sections that act together as a screw thread despite the variable inner diameter of the cap and engage in a corresponding screw thread of the vessel, if provided there. In the following explanations, for the sake of brevity, only attachable, in particular slide-on or clip-on safety caps are explicitly dealt with; nevertheless, they can each also be designed to be rotatable.

According to the exemplary embodiments of this application, the securing cap can be, for example, a three-dimensional molded part, in particular a preformed three-dimensional molded part made of a plastic material that can be shrunk by the action of heat (and also pre-shrunk), or at least comprise such a molded part. For example, the side wall, the first wall section and / or at least the end section of the side wall can already be pre-shrunk to a predetermined diameter, in particular to a predetermined diameter for the insertion opening. This diameter (inner diameter), to which the side wall or at least a lower part of it is pre-shrunk, can, for example, correspond to a lower value for the vessel diameter (outer diameter of the vessel), which corresponds to a lower limit of the tolerance range for the standardized vessel diameter or between such the lower limit of the tolerance range and the standardized mean value or target value for the vessel diameter. The vessel attachment is therefore pre-shrunk in such a way that it can be pressed or placed onto the pharmaceutical vessel without further heat treatment, the first wall section being expanded radially. Whenever a safety cap made of shrinkable or pre-shrunk plastic material is mentioned in this registration, the wall thickness or layer thickness of the safety cap, in particular its side wall, its end section and / or its first wall section, can be, for example, 70 μm or some other value , for example between 25 pm and 300 pm, preferably between 50 pm and 100 pm.

As an alternative to vessel attachments made of or with pre-shrunk plastic material (as described, for example, below), vessel attachments made by injection molding or other techniques are also conceivable.

The vessel attachment can for example be formed from a uniformly or homogeneously composed or homogeneously distributed plastic material or at least comprise such a material. For example, at least the end section 13 and / or the first wall section 15 of the securing cap is cast or shaped from this homogeneous material.

The safety cap comprises, for example, a side wall 12 and a cover (or end cap section) 11 or 19; these can also be formed as different parts, in particular also from different materials. The side wall 12 can, for example, have an (upper, narrow) edge towards the cover which can be angled and / or can lie in the cover surface. The lid can (for example, from above) to be glued to the edge or connected to it or attached to it in some other way.

The cover 11 or the face or plate (face plate 19) can be a film, for example; in particular a film made of plastic or aluminum or some other metallic material. The cover 11, 19 can, for example, be formed from a non-shrinkable (plastic) film, whereas the wall section (be it the entire side wall 12 or only its end section 13 and / or its first wall section 13) is made of a shrinkable material thus is shrinkable.

The securing caps according to the application are not any stretchable and deformable sheaths, in particular no tubular sheaths or other flat or tubular structures, but three-dimensionally preformed molded parts; in particular plastic caps or capsules, which are preferably one-piece, non-flat and not le diglich tubular.

The plastic material of the safety cap is preferably a non-shrinkable, already pre-shrunk plastic, whereby the diameter of the insertion opening in the unexpanded state corresponds to a value that either corresponds to a lower limit of the tolerance range for the standardized vessel diameter or between such a lower limit of the tolerance range and the standardized mean or target value of the vessel diameter.

Furthermore, the plastic material of the safety cap has no rubber-like elasticity, but is dimensionally stable to the extent that uninterrupted or non-weakened wall areas of the safety cap are dimensionally stable, i.e. if the safety cap is properly attached to a vessel that is too wide in diameter, they are or remain undeformed.

The plastic material of the cap has, for example, a yield point that limits its elasticity to one or a few percent. This enables the cap to be attached or applied in a secure, clearly defined press fit and / or press fit on the vessel. For example, the safety cap can be made of a plastic material that does not Has rubber-like stretchability, but is only stretchable up to a yield point. In particular, the securing cap can consist of a plastic material that does not have a rubber-like elasticity up to a yield point which is, for example, at most 5%, preferably at most 2%, in particular at most 1%. Of course, other plastic materials can also be used; especially those that do not have extensive elastic extensibility, ie that are not rubbery.

For example, the plastic material of the securing cap, the wall thickness of the securing cap (in particular its side wall and / or its first wall section) and the weakening elements and / or expansion openings (explained later) can be coordinated with one another in such a way that the safety cap on the vessel or the Object resulting expansion of the first wall section not achieved by a rubber-like or other elastic expansion of full-surface wall sections of the plastic material, as would be the case with rubber sleeves, but by reversible deformations of local areas of the wall sections in the vicinity of the Schwächungsele elements.

Apart from these above, previously explained optional additional features, the following explanations are also, for the sake of brevity, exemplarily based on a safety cap for a vial, i.e. for an ampoule bottle, regardless of all otherwise conceivable pharmaceutical vessels or objects.

Using the example of a vial for a liquid content of 50 ml, the outer diameter of the vial, more precisely the outer wall or cylindrical peripheral wall of the actual vial glass body (not of the head, closure or for this certain shoulder or collar area) would be nominal, ie exactly 46 mm with perfect compliance with the standard. In practice, however, this standardized diameter is only adhered to with a certain tolerance range, which can be up to 1.0 mm upwards or downwards (corresponding to vial diameters occurring in practice, for example between 45 mm and 47 mm). Of course, the embodiments proposed in this application apply not only to vessel diameters of around 46 mm and not only to vials, but to any other pharmaceutical vessels and to any vessel diameter. The exemplary embodiments of the figures are specifically explained below. For the sake of clarity, not all elements or features mentioned with reference characters in the following sections of the description are necessarily shown in all figures with explicit reference characters. Instead, the respective reference characters of the elements or features in the following text refer to all figures of this application across all figures.

Figure 1 shows a vial as an example of a pharmaceutical vessel 1 which is to be provided with a safety cap 10 or is already provided. This securing cap 10 can be designed to be radially expandable according to the exemplary embodiments of this application in order to avoid the conventionally disadvantageous folds.

The vial 1 in FIG. 1 comprises the actual vessel body 2, the circumferential wall of which has an outside circumferential surface, the diameter of which is also the outside diameter Da of the vial 1 or other pharmaceutical vessel or object. This outer diameter Da can also be the maximum outer diameter of the vial 1 over the total height. Thus, the outer wall of the vessel belly or at least a part of it forms a cylindrical vessel section 4, which has a constant, ie uniform outer diameter over its height, which for example is not conical or conical, but rather cylindrical and in particular circularly cylindrical over its height (As an alternative, instead of at the level of the vessel belly, the vial could also have the cylindrical vessel section 4 above the vessel belly).

The cylindrical vessel section 4 is, for example, the circumferential wall of the vessel belly or an upper, ring-shaped part of it, which should have a standardized outer diameter Da, but can deviate from it in practice due to manufacturing tolerances (see above or below).

The vial 1 also includes a lid, head or other closure 3, which closes the vessel body 2, but must also be protected against manipulation, etc., with the help of the safety cap 10, which is designed as a special molded part 20. Of the The closure 3 of the vessel to be secured by the safety cap is shown in simplified form in FIGS. 1 and 2; FIG. 7 shows a more detailed illustration of the vial closure.

In accordance with all the embodiments of this application, in particular in accordance with the figures in FIGS. 1 to 7, the securing cap 10 can optionally be configured in one piece or in several pieces; in particular, it does not necessarily have to consist of just a single (molded) part.

Preferably, the securing cap 10 can comprise:

- A wall or a jacket 12 and

- a lid 11.

These can be connected to one another or attached to one another in any way, for example glued together. In addition, the safety cap 10 can also have the following:

an (optional) tear strip in the wall, for example in the cylindrical wall section and / or

- An (optional) tear-open perforation in the wall, for example in the cylindrical W andungsab cut.

The above statements apply in connection with all figures; not exclusively in connection with Figure 1.

In Figure 1, finally, an adhesive label 50 is shown schematically, which sticks over the outer peripheral surfaces of the vessel 1, 2 and safety cap 10, 20 (after it has been attached to the vessel 1, for example pushed or put on etc .; see above) and thus tamper-proof connects with each other; in particular to irretrievably and permanently indicate a later attempt at first opening; for example in the form of irreversible damage to the label 50. The label 50 is, for example, an all-round label or encircles at least a large part of the circumference of the vessel 1 and cap 10 (by the way, whenever the application refers to a diameter, likewise the radius or the scope can be considered). The securing cap 10 has, for example, the features and / or properties already explained above or below (possibly with the aid of further figures or claims), possibly also in combination with one another. In particular, it is implemented as a one-piece plastic molded part 20, for example injection molded.

As can also be seen in Figure 1 and in Figure 1A (there with a slightly different shape of the safety cap alone) is denoted by reference numerals, the safety cap 10 has an end cap portion 11, preferably in the form of a circular disk (or, differently than shown , alternatively also circular or otherwise securing the closure 3 at least partially upwards) end surface 19. The circumferential surface, ie the side wall 12 of the cap 10 can optionally upwards (in the axial direction z, which is optionally also an axis of symmetry of the safety cap and / or can be a vessel) protrude beyond the end face 11, 19, whereby the end face 11, 19 can branch off from it in a T-shaped manner, concentrically inward. Due to the end face 11, 19 that completely or at least partially covers the closure 3 as intended and thereby secures the end face 11, 19, the safety cap is not just a sleeve, in particular not a tubular sleeve made of flat material, but a three-dimensional, pre-formed, non-flat molded part 20. The cap 10 requires not to touch the closure 3, the neck of the vessel or conical surfaces near the neck.

The side wall 12 of the securing cap 10 does not need to be cylindrical, ie shaped with a constant diameter, over its entire height (along z). But at least in a lower section, namely a lower, first wall section 15, the Be tenwand 12 has a constant diameter (over the height extension of the first wall section 15), in particular the inner diameter Di, which is required to attach to the nor mized or actual outer diameter Da des standardized vessel 1 around, the protection cap 10 is provided for the sen protection is intended. The constant diameter can also be a cylindrical section 16, the height extension of which is greater than that of the first wall section 15; In particular, the cylindrical section 16 can include the first wall section 15. However, at least the first wall section 15, which is a lower wall section or comprises one, has a uniform diameter along its height, in particular the inner diameter Di. However, according to this application, this can be changed, namely radially expandable, for which later Weakening elements 5 or expansion openings 25 explained below are formed in the first wall section 15 (and preferably only there), which interrupt the first wall section 15, for example locally. The remaining side wall areas 12 and 16 (as far above the first wall section 15 running further), however, are dimensionally stable and not provided with weakening elements 5, at least not with expansion openings 25 for radial expansion.

The side wall 12 of the cap 10 has a (lowermost) end section 13 which surrounds an insertion opening 14 through which the vessel 1 can be inserted with its head, lid or other closure 3 first. The cylindrical portion 4 of the vessel itself (namely an upper part of the outer surface of the peripheral wall of the vessel belly) should come into contact with the inner surface of the first wall portion 15 of the safety cap 10; both should ideally have the same diameter Da or Di or at least with almost identical diameters Da, Di be more or less firmly clamped around one another in a clamping or press fit, but again manually separable. The inner surface of the first wall section 15 to be clamped around the cylindrical vessel section 4 comprises at least the lowermost end section 13 around the insertion opening 14; furthermore a more or less high section of the side wall 12 or at least a section of its cylindrical section 16.

In the extreme case, the side wall can also be cylindrical over its entire height, in particular up to the underside of the end face 11, 19, i.e. with a uniformly large diameter (especially inner diameter) or circumference or radius, regardless of height; so that the first wall section 15 can reach up to the end face 11, 19 depending on the type of vessel.

Figure 1A shows a geometrically slightly modified variant of the safety cap 10 from Figure 1; to use for the same vial 1. To clarify the lower Endab section 13 around the insertion opening 14 and the first wall section 15 is a zy-cylindrical, lower wall section 16 of the side wall 12 is pulled up further, ie extends further up in the direction z. The total height of the cap 10 can nevertheless be unchanged as in FIG. 1, so that there is still sufficient vascular abdominal area uncovered by the securing cap 10 to be glued around by the label 50. In FIG. 1A it becomes clearer that the first wall section 15 to be adapted to the outer diameter Da of the vessel or vessel bulge with regard to its own internal diameter Di only needs to be a lower part of the cylindrical wall section 16 of the side wall 12. Thus, the cylindrical wall section 16 of the side wall 12 is only radially expandable in a lower section, namely the first wall section 15, whereas the remaining upper part of the cylindrical wall section 16 and also the remaining part of the side wall 12 (as well as the end face 11, 19) dimensionally stable, ie not radially expandable, but non-deformable.

FIG. 2 shows the vial 1 from FIG. 1 with the securing cap 10 from FIG. 1A; Again, the diameters Da, Di of the cylindrical circumferential surface 4 (on the outside of the vessel 1) and 16 (on the inside of the safety cap 10) are to be matched to one another in order to achieve a tight fit on one another or at least a positive connection with one another.

Due to the design of the securing cap 10 according to FIG. 1A, the cylindrical wall section 16 of the cap 10 protrudes further upwards than the circumferential surface of the vessel and can, for example, serve to enlarge the labelable area of the label 50 (compared to FIG. 1).

For example, it can be provided that the first wall section 15 without the remaining, upper part of the cylindrical wall section 16 of the cap 10 is designed to be tunable, in particular expandable, to the radius Da of the vessel. Depending on the design, only this expandable first wall section 15 is then, for example, pasted over by means of the label 50 together with the vessel 1, ie the label 50 pasted or pasted over only a part of the vessel belly and the expandable first wall section 15. Alternatively, however the label 50 can also partially cover or glue around the remaining, upper part of the cylindrical wall section 16 of the cap 10.

The label can either partially cover the vessel or completely cover it. In addition, the label can also be glued onto itself in an overlapping manner, ie it can be an all-round label. In all figures and other embodiments of this application, the label can have any additional functions or configurations. For example, it can be designed as a hanging label, wrap-around label, multi-layer label and / or provided with a booklet or with removable parts or the like.

The label 50 preferably glues around only the expandable or expanded first wall section 15 and in each case also a part of the outer wall of the vessel.

Any wrinkles can occur when using the backup cap 10, 20 proposed here only as a result of the inevitable difference in the outer radii of the vessel 1 and cap 10, which the cap must always have a certain wall thickness, but no longer due to wrinkles occurring in the circumferential direction or Damming of the side wall 12 itself or its cylindrical wall section 16, not even at the level of the first wall section 15.

The reason for this lies in the fact that the inner diameter Di of the first wall section 15 is adapted to an actual outer diameter Da of the vessel, which is smaller than conventional, in particular smaller than the standard dimensioned, so it is likely to almost always have to be stretched or actually tore when it is put on. However, as proposed here, the first wall section 15 can be expanded radially, as will be explained in more detail with reference to the following figures; for this purpose, weakening elements 5, in particular expansion openings 25, are provided in the first wall section 15.

Incidentally, the side wall 12 above the first wall section 15 generally does not have to have any further upward part of the or the same cylindrical Wandab section 16, and the conical reduction in the radius is not necessarily required; the first wall section 15 can extend (almost) to the end face 11 on the head side. Only at the transition between the side wall 12 and head-side face 11 can the side wall 11 not be expandable, but must have a non-expandable diameter. Otherwise, the illustrated variations in shape of the cap 10, even when used for a vial, are merely exemplary. FIG. 3 shows a perspective view of the securing cap 10 in a slight underside view of the insertion opening 14. In FIG. 3, the first wall section 15 is relatively low; it comprises only the lower end section 13 of the side wall or its (lower and eg larger) cylindrical wall section 16.

To expand the first wall section 15, a plurality of weakening elements 5 distributed in the circumferential direction, in particular expansion openings 25, are preferably provided in the first wall section 15. The first wall section 15 is so locally weakened or interrupted; the perforated or at least weakened first wall section 15 is thus expandable, i.e. radially expandable, although the cap 10 remains dimensionally stable outside the first wall section 15.

In FIG. 3, the weakening elements 5 or expansion openings 25 are shown as introduced or preformed slots 18; Alternatively, however, they can also be recesses 6, for example. The first wall section 15 has an arrangement 35 of such weakening elements 5 or expansion openings 25 distributed over its circumference and its height. If the securing cap 10 is attached to a pharmaceutical vessel or object with a larger outer diameter Da than the preformed inner diameter Di of the first wall section 15, the arrangement 35 of the Schwächungsele elements 5 or expansion openings 25 allows the first wall section 15 to expand radially , originally mostly intentionally a little too small dimensioned inside diameter Di expanded to the actual, mostly larger outside diameter Da of the overlaid vessel 1; the cap then sits firmly on the vessel without the possibility of folds in the expanded cap wall 15.

Figure 4 shows an example of some forms of the weakening elements 5 or Dehnungsöff openings 25, each shown as a cut or slot contour 18 or contour of a recess 6 in the first wall section 15 of the safety cap 10. The cut or punch lines 18 of the respective Weakening elements 5 or expansion openings 25 perpendicular to the surface of the first wall section 15 and each extend through the entire wall thickness. Alternatively, as shown in FIG. 6 in the circumferential plane perpendicular to the axial direction z, ie in a plan view of the end-side, ie underside, cap edge surface 17, punchings running in direction z or sufficiently deep incisions can also be made in the first wall section 15, which only penetrate its wall thickness to 70 to 95%. These cuts 18 or other weakening elements 5 or expansion openings 25 are then made in the circumferential direction u alternately from the outside 15a of the first wall section 15 and from the inside 15i of the first wall section 15, whereby a radial expandability is also possible . Preferably, however, the entire wall thickness penetrating weakening elements 5 or expansion openings 25 as shown in Figure 4 or the other figures.

According to Figure 4, the weakening elements 5 or expansion openings 25 of the respective arrangement 35 can, for example, straight, curved, branching or other cut lines 18 oriented anywhere within the base of the first wall section 15 (e.g. angular or also wave-shaped) or alternatively recesses in Be in the form of rectangles, polygons, circles, ellipses or other outline contours. However, incisions, i.e. cutting lines, are preferred, since these - with the same force from the inside when the securing cap 10 is slipped over the vessel 1 - widen the first wall section 15 to a greater extent than if only flat pieces are punched out.

As in the lower two arrangements 35 of weakening elements 5 or expansion openings 25 in Figure 4 and in more detail in Figure 5 (for there H-shaped cuts or slits 18 extending mainly in the direction z as Schwächungsele elements 5 or expansion openings 25) is shown, the arrangement 35 can in particular comprise a plurality of groups 7 or (preferably horizontally circumferential) rows of weakening elements 5 or expansion openings 25, the associated weakening elements 5 or expansion openings 25 each (if they belong to different groups 7 or rows) in different heights and / or with different height extensions Hl, H2, H3, H4 are introduced into the first wall section 15, so that between the weakening elements 5 or expansion openings 25 of the different In each of the groups or rows 7 (in particular between those two adjacent rows offset from one another in the direction z) there is a height offset, as shown in FIG.

In addition, it is preferably provided that the weakening elements 5 or expansion openings 25 of the various groups 7 or rows in the z direction intersect or overlap in their respective height extension, so that each height overlap or overlap of the respective height extension hl, h2, h3 (in direction z) between the weakening elements 5 or expansion openings 25 each two adjacent groups or rows of weakening elements 5 or expansion openings 25 exist.

The weakening elements 5 or expansion openings 25 of the first, i.e. bottom row or group 7 each extend as far as the lower cap edge surface 17 of the first wall section 15 (and thus also of the end section 13).

When the first wall section 15 is expanded, the weakening elements 5 or expansion openings 25 preferably produce shear regions 30 in the first wall section 15, as shown in FIG. In the shear areas 30, the plastic material of the first wall section 15 is sheared, bent and / or bent, bent or elastically deformed in some other way due to the applied beige forces 31 as soon as the safety cap 10 is over a vessel 1 with a slightly larger diameter Da (than Di) has (been) slipped over. In the shear areas, the material of the wall section 15 remaining between the perforations or weakening elements is thus deformed such that the mutually facing edges of the cuts 18 or other weakening elements 5, 25 can be pulled apart. As a result, the radius or diameter and / or circumference of the first wall section 15 is preformed larger than originally Lich (when the molded part 10, 20 is produced).

The wall thickness of the securing cap 10, its plastic material and the size, shape and / or positioning of the weakening elements 5, 25 can be coordinated or adapted to one another in such a way that between the weakening elements or Expansion openings 5, 25, the shear areas 30 or other wall areas of the first wall section 15, when they are sheared, bent and / or deformed, with their inner surface 15i in at least partial, for example punctiform or partial contact with the peripheral surface 2 of the pharmaceutical vessel 1 or The object remained, that is to say only partially stand out from its circumferential surface or its vessel belly 2.

FIG. 7 shows, on an enlarged scale, a cross-sectional view which is more detailed than FIGS. 1 to 3 with regard to the components of the vessel closure, in particular the vial, and specifically as a partial view only in the immediate vicinity of the closure. The vessel neck of the vessel body 1; 2 is only partially shown, namely in the region of the vessel opening which is to be closed with the closure 3 (and which is also closed before the vessel attachment 10; 20 proposed in this application is attached).

As can be seen in FIG. 7, the closure 3 of the vial 1, 2 comprises a closure stopper 3a, preferably made of rubber. A cover disk 3b, i.e. a plastic disk to be placed on the stopper 3a, is placed thereon. The cover plate 3b has an indentation in its peripheral surface. A locking ring, for example in the form of a Bör delkappe 3c, which can for example consist of aluminum, engages with its upper edge in the indentation of the cover plate 3b. In addition, the lower edge of the securing ring 3c engages under an outer bulge or a bulge of the vessel 1 or the wall of the vessel body 2, which surrounds the vessel opening on the outside. As a result, the locking ring, i.e. the crimp cap 3c, holds the stopper 3a and the cover disk 3b securely on the vessel body 2.

The safety cap 10 surrounds this entire Ge vascular closure 3 in its upper, tapered area; 3a, 3b, 3c; the actual side wall of the safety cap 10 is located outside the partial view shown in FIG. 7, namely lower at the level of the vessel belly (not shown in FIG. 7).

Independently of the exemplary embodiments in these figures, the safety cap 10, 20 can also be provided for all other pharmaceutical vessels. List of reference symbols

1 pharmaceutical vessel or object

2 vessel bodies

3 closure

3a sealing plug

3c crimp cap

3b washer

4 cylindrical section

5 weakening element

6 recess 7 group of weakening elements 10 safety cap 11 end cap section 12 side wall

13 end section

14 insertion opening

15 first wall section 15a outer surface 15i inner surface

16 cylindrical wall section

17 end cap edge surface

18 slot

19 face

20 molded part 25 expansion opening

30 shear area

31 Bending force 35 Arrangement 50 Label hl, h2, h3 Height adjustment Hl, H2, H3, H4 Height extension, radial direction u circumferential direction z axial direction

Claims

1. Safety cap (10) for securing a lid, head or other closure on a pharmaceutical vessel or object against unauthorized opening, removal or other manipulation, the safety cap (10) having at least the following:

- an end cap section (11), in particular in the form of an end face (19), for at least regionally covering a lid, head or closure mounted on a pharmaceutical vessel or object in an axial direction (z),

- A side wall (12) and extending in the circumferential direction about the axial direction (z)

- An end section (13) of the side wall (12) with an insertion opening (14) through which the vessel or object can be inserted into the safety cap (10) with the lid, head or closure first when the safety cap (10) is pushed on, wherein the side wall (12) has a first wall portion (15) which

- the end portion (13) of the side wall (12) comprises,

- The insertion opening (14) completely encircles and

- For attachment to a cylindrical section of a pharmaceutical vessel or

Object is determined, the securing cap (10) being designed to be attachable to pharmaceutical vessels or objects with outside diameters of different sizes due to tolerance, in that the first wall section (15) of the side wall (12) is designed to be expandable in the radial direction.

2. Safety cap according to claim 1, characterized in that the safety cap (10) is or comprises a three-dimensional molded part (20), in particular a pre-formed three-dimensional molded part (20) made of a plastic material that shrinks by the action of heat.

3. Safety cap according to claim 1 or 2, characterized in that that the securing cap (10) is or comprises a pre-shrunk molded part (20) made of a heat-shrinkable plastic material, the side wall (12), the first wall section (15) or at least the end section (13) of the side wall (12) already on is pre-shrunk to a predetermined diameter, in particular to a predetermined diameter for the insertion opening (14).

4. Safety cap according to one of claims 1 to 3, characterized in that the safety cap (10) is shaped so that the inner diameter (Di) of the first wall section (15) is within a tolerance range for a mean value of the inner diameter (Di), in particular can be varied within a tolerance range of a maximum of ± 2.0 mm, preferably a maximum of ± 1.0 mm around this mean value or a value smaller than this mean value, the first wall section (15) in the unexpanded state having a value of the inside diameter that corresponds to a lower limit value of the tolerance range, and wherein the first wall section (15) can be expanded by expanding to a value of the inner diameter which corresponds to an upper limit value of the tolerance range.

5. Safety cap according to one of claims 1 to 4, characterized in that the safety cap (10) is shaped such that the first wall section (15) in the unexpanded state has an inner diameter (Di) which is smaller than a nominal and / or standardized nominal value (Ds) of the outer diameter (Da) of a pharmaceutical vessel or object, and that the first wall section (15) can be expanded at least to the extent that it is larger than the nominal and / or by being attached to the pharmaceutical vessel or object as intended Standardized target value (Ds) of the outer diameter (Da) of the pharmaceutical container or object.

6. Safety cap according to one of claims 1 to 5, characterized in that that the first wall section (15) has a plurality of circumferentially distributed, for the radial expansion of the first wall section (15) of the side wall (12) serving weakening elements (5), through which the first wall section (15) interrupted, pierced, excluded and / or is weakened locally in some other way.

7. Safety cap according to one of claims 1 to 6, characterized in that only the first wall section (15) of the side wall (12) is designed to be expandable in the radial direction, whereas the end cap section (11) and / or a remaining part of the side wall ( 12), which is formed from the same plastic material as the first wall section (15), but is free of weakening elements, is designed to be non-deformable and in particular non-expandable.

8. Safety cap according to one of claims 1 to 7, characterized in that the first wall section (15) has a plurality of rows and / or groups (7) of weakening elements (5), the associated weakening elements (5) each at different heights and / or with different height extensions (Hl, H2, H3, H4) are introduced into the first wall section (15), and that the height extensions (Hl, H2, H3, H4) of the respectively associated weakening elements (5) of different groups (7) , in particular those Schwächungsele elements (5) of two groups (7) of weakening elements (5) adjacent to one another in the axial direction (z), intersect and / or overlap one another in direction (z) (hl, h2, h3).

9. Securing cap according to one of claims 1 to 8, characterized in that the weakening elements (5) are expansion openings (25) through which the first wall section (15) is locally interrupted, perforated or recessed.

10. Safety cap according to one of claims 1 to 9, characterized in that that the expansion openings (5) in the first wall section (15) are introduced or formed in front of slots (18).

11. Securing cap according to one of claims 1 to 10, characterized in that the expansion openings (25) in the first wall section (15) are introduced or formed in front of recesses (6).

12. Safety cap according to one of claims 1 to 11, characterized in that the first wall section (15) is an arrangement (35) over the circumference and / or the height of the first wall section (15) of weakening elements (5) and / or expansion openings (25) which, when the securing cap (10) is attached to a pharmaceutical vessel or object with a larger outer diameter than the preformed inner diameter (Di) of the first wall section (15), a radial expansion of the first wall section (15) up to the actual, larger outer diameter (Da) of the overlaid vessel (1) and when the first wall section (15) is expanded, it creates shear areas (30) in the first wall section (15) in which the plastic material of the first wall section (15) is sheared, bent or otherwise elastically deformed.

13. Securing cap according to one of claims 1 to 12, characterized in that the securing cap (10) consists of such a plastic material and is designed in such a wall thickness that the securing cap (10) when attached to the one intended by the securing cap (10) the widening to be protected pharmaceutical vessel or object outside of the first wall section (15) or at least outside of shear regions (30) of the first wall section (15) remains undeformed.

14. Securing cap according to one of claims 1 to 13, characterized in that that the end cap section (11) is or comprises an end face (19) which runs in the direction perpendicular to an axial direction (z) and / or direction of symmetry of the fuse cap (10), adjoins the side wall (12) and is circular disk-shaped or circular is trained.

15. Safety cap according to one of claims 1 to 14, characterized in that the safety cap (10) is a safety cap for a vial, an ampoule, a phi ole or for an infusion bottle.