DE102019122359A1 - Safety cap for securing a lid, head or closure on a pharmaceutical vessel - Google Patents

Abstract

A safety cap (10) is proposed 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) running around the axial direction (z) in the circumferential direction ) and 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 is, wherein the side wall (12) has a first wall section (15), the end section (13) of the side wall (12) - The insertion opening (14) is completely encircled and - is intended to be attached to a cylindrical section of a pharmaceutical vessel or object, the securing cap (10) being designed to be attachable to pharmaceutical vessels or objects with an outer diameter of different sizes due to tolerances by the first wall section (15) of the side wall (12) is designed to be expandable in the radial direction.

Description

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

There are aids 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 the purpose of forgery, for example in order to protect the vessel contents and / or to imitate, modify or otherwise manipulate its identification (usually on a label); for example, in order to put unauthorized drugs into circulation undetected.

In order to prevent this misuse, 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.

The tolerance-related deviations in the dimensions that occur in practice, in particular the outer diameter of such pharmaceutical vessels and objects, give rise to the problem that the inner 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, which causes the side wall of the safety cap to fold at the latest when the label is glued throws, which limits the protection against unauthorized manipulation and its detectability.

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 securing caps is that the undesired drapery and its adverse effects on the security against manipulation cannot be avoided as soon as such a securing 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 the security against manipulation, the dimensions of which are standardized and / or based on setpoints, but actually in practice often deviate from these standards or setpoints.

Regardless of these manufacturing tolerances, the safety cap according to the application should be easily attachable at least within a tolerance range, without the tolerance-related deviations in the vessel dimensions leading 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.

• - einen stirnseitigen Kappenabschnitt, insbesondere in Form einer Stirnfläche, zum zumindest bereichsweisen Überdecken eines an einem pharmazeutischen Gefäß oder Gegenstand montierten Deckels, Kopfes oder Verschlusses in einer axialen Richtung,
• - eine um die axiale Richtung in Umfangsrichtung verlaufende Seitenwand und
• - einen Endabschnitt der Seitenwand mit einer Einführöffnung, durch die hindurch beim Aufschieben der Sicherungskappe das Gefäß oder der Gegenstand mit dem Deckel, Kopf oder Verschluss voran in die Sicherungskappe einführbar ist.

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 partially 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 is designed to be attachable to pharmaceutical vessels or objects with outside diameters of different sizes due to tolerances by designing the first wall section of the side wall to be expandable in the radial direction.

• 1 ein Vial als Beispiel eines pharmazeutischen Gefäßes, das mit einer Sicherungskappe zu versehen ist,
• 1A eine Sicherungskappe mit veränderter Geometrie für das Vial aus 1,
• 2 das Vial aus 1, überdeckt mit der Sicherungskappe aus 1A,
• 3 eine perspektivische Ansicht einer Sicherungskappe, dargestellt in leichter Untersicht,
• 4 einige exemplarische Formgestaltungen von Schwächungselemente bzw. Dehnungsöffnungen für den ersten Wandabschnitt der Sicherungskappe,
• 5 ein exemplarisches Ausführungsbeispiel des ersten Wandabschnitts, in welchem Schwächungselemente bzw. Dehnungsöffnungen in Form von Schnitten oder Schlitzen vorgesehen sind, und
• 6 ein alternatives Ausführungsbeispiel mit Schwächungselementen bzw. Dehnungsöffnungen, die nicht die gesamte Wandstärke des ersten Wandabschnitts durchschneiden, und
• 7 eine gegenüber den 1 bis 3 detailliertere Querschnittsansicht hinsichtlich der Bestandteile des Gefäßverschlusses, insbesondere des Vials.

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

• 1 a vial as an example of a pharmaceutical vessel that is to be provided with a safety cap,
• 1A a safety cap with a modified geometry for the vial 1 ,
• 2 the vial 1 , covered with the safety cap 1A ,
• 3 a perspective view of a safety cap, shown in a slight bottom view,
• 4th some exemplary shapes of weakening elements or expansion openings for the first wall section of the safety cap,
• 5 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
• 6th an alternative embodiment with weakening elements or expansion openings which do not cut through the entire wall thickness of the first wall section, and
• 7th one opposite the 1 to 3 detailed cross-sectional view 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 produce folds as soon as the outside diameter of a specific pharmaceutical vessel (e.g. a certain vial or vial) is smaller than the inside diameter of the safety cap, there are no more folds in the safety cap according to the application. 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 a 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 larger , but 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 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 the safety cap, which would also be at the expense of security against 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, is in the radial direction Designed to be expandable, as a result of which the securing cap, which is often too narrow at the beginning, remains intact even during and after attachment to the pharmaceutical 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, on the closed vessel. In the latter cases, circumferential internal screw threads that are locally interrupted in the circumferential direction can be provided on the safety cap, or many screw-thread sections which, despite the variable internal diameter of the cap, act together like a screw thread 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 described treated explicitly; 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 (and also pre-shrunk) by the action of heat, 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 vessel diameter), which 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 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 application, 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 have some other value that for example between 25 µm and 300 µm, preferably between 50 µm and 100 µm.

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

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

The safety cap comprises, for example, a side wall 12 and a lid (or end cap section) 11 or. 19th ; 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 cover can be glued onto the edge (for example from above) or connected to or attached to it in some other way.

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

The securing caps according to the application are not any stretchable and deformable casings, in particular no tubular casings or other flat or tubular structures, but three-dimensionally preformed molded parts; in particular plastic caps or capsules, which are preferably in one piece, non-flat and not merely 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 value of the tolerance range for the standardized vessel diameter or between such a lower limit value of the tolerance range and the standardized mean value or . Setpoint of the vessel diameter is.

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 non-deformable 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 consist of a plastic material that has no rubber-like stretchability, but can only be stretched up to a yield point. In particular, the securing cap can consist of a plastic material that has a non-rubber-like elasticity up to a yield point that 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 is 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 weakening 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 the head, closure or for this specific shoulder or collar area) would be nominal, ie at be exactly 46 mm in accordance 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 around 46 mm and not only to vials, but to any other pharmaceutical vessels and 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 symbols in the following sections of the description are necessarily shown in all figures with explicit reference symbols. Instead, the respective reference symbols of the elements or features in the following text refer to all figures of this application across all figures.

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

The vial 1 in 1 includes the actual vessel body 2 , the circumferential wall of which has an outside circumferential surface, the diameter of which is also the outer 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 over the total height 1 be. The outer wall of the vascular abdomen or at least part of it thus forms a cylindrical vessel section 4th , which has a constant, i.e. uniform outer diameter over its height extension, which for example is not conical or conical, but rather cylindrical and in particular circular-cylindrical over its height extension (alternatively, the vial could, instead of at the level of the vessel belly, the cylindrical vessel section 4th also have above the vascular abdomen).

The cylindrical vessel section 4th 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 furthermore comprises a lid, head or other closure 3 showing the vascular body 2 locked, but must also be protected against manipulation, etc., with the help of the safety cap 10 that as a special molding 20th is trained. The closure to be secured by the safety cap 3 of the vessel is in the 1 and 2 shown in simplified form; shows a more detailed representation of the vial closure 7th .

The safety cap 10 can according to all embodiments of this application, in particular according to the figures of 1 to 7th optionally be formed in one piece or in several parts; in particular, it does not necessarily have to consist of just a single (molded) part.

• - eine Wandung bzw. einen Mantel 12 und
• - einen Deckel 11.

Preferably, the safety cap 10 Include the following:

• - a wall or a jacket 12 and
• - a lid 11 .

• - einen (optionalen) Aufreissstreifen in der Wandung, beispielsweise im zylindrischen Wandungsabschnitt und/oder
• - eine (optionale) Aufreissperforation in der Wandung, beispielsweise im zylindrischen Wandungsabschnitt.

These can be connected or attached to each other in any way, be glued together, for example. In addition, the safety cap 10 still 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 wall section.

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

In 1 is finally an adhesive label 50 shown schematically, the outer peripheral surfaces of the vessel 1 , 2 and safety cap 10 , 20th (after they at the vessel 1 attached, for example pushed on or put on etc .; so) pasted over and thus connected to one another in a tamper-proof manner 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 surrounds at least a large part of the circumference of the vessel 1 and cap 10 (Incidentally, whenever the application refers to a diameter, the radius or the circumference can also be considered).

The safety cap 10 possesses, for example, the features and / or properties already explained above or below (possibly with reference to further figures or claims), possibly also in combination with one another. In particular, it is available as a one-piece molded plastic part 20th realized, e.g. injection molded.

As also in 1 can be seen and in 1A (there with a slightly changed shape of the safety cap alone) is denoted by reference numerals, the safety cap 10 an end cap section 11 on, preferably in the form of a circular disk-shaped (or, unlike shown, alternatively also circular ring-shaped or otherwise the closure 3 at least partially upwardly securing) end face 19th . The peripheral surface, ie the side wall 12 the cap 10 can optionally upwards (in the axial direction z , which can optionally also be an axis of symmetry of the safety cap and / or vessel) the end face 11 , 19th protrude, making the face 11 , 19th from her T-shaped, can be branched off concentrically inwards. Because of the clasp 3 as intended, completely or at least partially overlapping and thus securing end face 11 , 19th the securing cap is not just a cover, in particular not a tubular cover made of flat material, but a three-dimensionally preformed, non-flat molded part 20th . The cap 10 needs the lock 3 not to touch the neck of the vessel or conical surfaces near the neck.

The side wall 12 the safety cap 10 does not need to be cylindrical over its entire height (along z), ie with a constant diameter. But at least in a lower section, namely a lower, first wall section 15th , owns the side wall 12 one (over the height of the first wall section 15th ) constant diameter, in particular inner diameter Di, the one for attaching around the standardized or actual outer diameter Da of the standardized vessel 1 around, to protect it the fuse cap 10 is intended, is intended. The one with constant diameter can also be a cylindrical section 16 his height extension is greater than that of the first wall section 15th ; in particular, the cylindrical section 16 the first wall section 15th include. But at least the first wall section 15th , which is a lower wall section or comprises one, has a uniform diameter along its height, in particular inner diameter Di. However, according to this application, this can be changed, namely radially expandable, for which weakening elements explained later 5 or expansion openings 25th in the first wall section 15th (and preferably only there) are formed that form the first wall section 15th eg interrupt locally. The remaining side wall areas 12 and 16 (as far above the first wall section 15th running further), but are dimensionally stable and not with weakening elements 5 , at least not with expansion openings 25th provided for radial expansion.

The side wall 12 the cap 10 has a (lowermost) end section 13 that has an insertion opening 14th surrounds, through which the vessel 1 with its head, lid or other closure 3 can be introduced first. The cylindrical section should 4th of the vessel itself (namely an upper part of the outer surface of the circumferential wall of the vessel belly) with the inner surface of the first wall section 15th the safety cap 10 come into contact; 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 each other in a clamping or press fit, but again manually separable. The one around the cylindrical vessel section 4th inside surface of the first wall section to be clamped around 15th comprises at least the lowermost end portion 13 around the insertion opening 14th around; also a more or less high section of the side wall 12 or at least part of its cylindrical section 16 .

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

1A shows a geometrically slightly modified variant of the safety cap 10 out 1 ; to be used for the same vial 1 . To illustrate the lower end section 13 around the insertion opening 14th around and the first wall section 15th is a cylindrical, lower wall section 16 the side wall 12 pulled up further upwards, ie extends further upwards in the direction z . The total height of the cap 10 can still remain unchanged as in 1 so that there is still enough abdominal area uncovered by the safety cap 10 remains to go through the label 50 to be taped.

In 1A it becomes clearer that the first wall section which is to be adapted to the outer diameter Da of the vessel or vessel belly with regard to its own internal diameter Di 15th only a lower part of the cylindrical wall section 16 the side wall 12 needs to be. Thus the cylindrical wall portion is 16 the side wall 12 only in a lower section, namely the first wall section 15th , radially expandable, whereas the remaining upper part of the cylindrical wall section 16 and also the rest of the side wall 12 (as well as the face 11 , 19th ) dimensionally stable, ie not radially expandable, but non-deformable.

2 shows the vial 1 out 1 with the safety cap 10 out 1A ; again are the diameters Da, Di of the cylindrical circumferential surface 4th (on the outside of the vessel 1 ) and 16 (inside on the safety cap 10 ) to coordinate with each other in order to achieve a tight fit or at least a positive connection with each other.

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

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

The label can either partially or completely cover the vessel. The label can also be glued onto itself so that it overlaps, i.e. it can be an all-round label.

In all of the 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 in each case preferably only glues around the expandable or expanded first wall section 15th and in any case also part of the outer wall of the vessel.

Any folds can be avoided when using the safety cap suggested here 10 , 20th only as a result of the inevitable difference in the outer radii of the vessel 1 and cap 10 arise that the cap must always have a certain wall thickness, but no longer as a result of wrinkles or compression of the side wall occurring in the circumferential direction 12 itself or its cylindrical wall section 16 , not even at the level of the first wall section 15th .

The reason for this is that the inner diameter Di of the first wall section 15th to an actual outer diameter that is smaller than conventional, in particular smaller than the standard dimension, since the vessel is adapted, that is to say it is likely to be almost always stretched when it is put on or should actually tear. However, the first wall section is as proposed here 15th radially expandable, as will be explained in more detail with reference to the following figures; these are attenuation elements 5 , especially expansion openings 25th in the first wall section 15th intended.

Incidentally, the side wall needs 12 above the first wall section 15th generally no further upwardly continued part of the or the same cylindrical wall section 16 to have, and also the conical reduction of the radius is not absolutely necessary; the first wall section 15th can extend (almost) to the end face of the head 11 extend. Only at the transition between the side wall 12 and head-sided Face 11 can the side wall 11 not be expandable, but must have a non-expandable diameter. Otherwise, the shown shape variations are the cap 10 , also when used for a vial, only as an example.

3 shows a perspective view of the fuse cap 10 with a slight view from below of the insertion opening 14th . In 3 is the first wall section 15th relatively low; it only includes the lower end portion 13 the side wall or its (lower and, for example, larger) cylindrical wall section 16 .

To widen the first wall section 15th is preferably a plurality of weakening elements distributed in the circumferential direction 5 , especially expansion openings 25th in the first wall section 15th intended. The first wall section 15th is thus locally weakened or interrupted; the perforated or at least weakened first wall section 15th is thus expandable, ie radially expandable, although the cap 10 outside the first wall section 15th remains dimensionally stable.

In 3 are the weakening elements 5 or expansion openings 25th as introduced or preformed slots 18th shown; alternatively, however, they can also, for example, have recesses 6th be. The first wall section 15th has an arrangement 35 such weakening elements distributed over its circumference and height 5 or expansion openings 25th on. When the fuse cap 10 on a pharmaceutical vessel or object with a larger outer diameter Da than the preformed inner diameter Di of the first wall section 15th is attached, enables the arrangement 35 the weakening elements 5 or expansion openings 25th a radial expansion of the first wall section 15th . As a result, its preformed, originally mostly intentionally dimensioned somewhat too small internal diameter Di is reduced to the actual, mostly larger external diameter Da of the overlaid vessel 1 widened; the cap then sits firmly on the vessel without the creased folds of the flared cap wall 15th can arise.

4th shows an example of some forms of attenuation elements 5 or expansion openings 25th , each shown as a cut or slot contour 18th or contour of a recess 6th in the first wall section 15th the safety cap 10 . The cutting or punching lines preferably run 18th the respective attenuation elements 5 or expansion openings 25th perpendicular to the surface of the first wall section 15th and each extend through the entire wall thickness.

Alternatively, as in 6th in the circumferential plane perpendicular to the axial direction z , ie in a plan view of the end, ie underside, cap edge surface 17th is shown, also towards z running punchings or sufficiently deep cuts in the first wall section 15th be introduced, which only penetrate its wall thickness to 70 to 95%. These cuts 18th or other weakening elements 5 or expansion openings 25th are then in the circumferential direction u alternately from the outside 15a of the first wall section 15th from here and from the inside 15i of the first wall section 15th are introduced into this, whereby a radial expandability can also be realized. Preferably, however, the entire wall thickness penetrating weakening elements 5 or expansion openings 25th as in 4th or the other figures.

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

As in the lower two arrangements 35 of attenuation elements 5 or expansion openings 25th in 4th and more detailed in 5 (for there H-shaped design, mainly in the direction of z extending cuts or slits 18th as weakening elements 5 or expansion openings 25th ) is shown, the arrangement 35 especially a variety of groups 7th or (preferably horizontally circumferential) rows of weakening elements 5 or expansion openings 25th include their associated attenuation elements 5 or expansion openings 25th each (when belonging to different groups 7th or rows) at different heights and / or with different heights H1 , H2 , H3 , H4 in the first wall section 15th are introduced so that between the weakening elements 5 or expansion openings 25th of the different groups or rows 7th (in particular between those two adjacent ones, in the direction z rows offset to one another) each time there is a height offset, as in 5 shown.

In addition, it is preferably provided that the weakening elements 5 or expansion openings 25th of the different groups 7th or rows in direction z overlap or overlap in their respective height extension so that in each case height overlaps or overlaps of the respective height extensions h1 , h2 , h3 (in the direction z ) between the attenuation elements 5 or expansion openings 25th two adjacent groups or rows of attenuation elements 5 or expansion openings 25th consist.

The weakening elements 5 or expansion openings 25th the first, ie bottom row or group 7th extend to the lower edge of the cap 17th of the first wall section 15th (and thus also the end section 13 ).

When expanding the first wall section 15th generate the weakening elements 5 or expansion openings 25th preferably shear areas 30th in the first wall section 15th , as in 5 is shown. In the shear areas 30th is the plastic material of the first wall section 15th because of the attacking forces 31 sheared, bent and / or bent, bent or elastically deformed in any other way as soon as the safety cap 10 over a vessel 1 with a slightly larger diameter Da (than Di) has been slipped over. The material of the wall section remaining between the perforations or weakening elements is in the shear regions 15th so deformed that the facing edges of the cuts 18th or other weakening elements 5 , 25th can be pulled apart. This is the radius or diameter and / or circumference of the first wall section 15th larger than originally (when the molded part was manufactured 10 , 20th ) preformed.

The wall thickness of the fuse cap 10 , their plastic material and the size, shape and / or positioning of the weakening elements 5 , 25th can be coordinated or adapted to one another in such a way that between the attenuation elements or

Expansion openings 5 , 25th the shear areas 30th or other wall areas of the first wall section 15th 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 remain, ie only partially from its peripheral surface or its vessel belly 2 take off.

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

We in 7th can be seen, includes the closure 3 of the vial 1 , 2 a sealing plug 3a , preferably made of rubber. A cover plate is placed on it 3b , ie a plastic disc to be placed on the stopper 3a . The cover panel 3b has an indentation in its peripheral surface. A locking ring, for example in the form of a crimp cap 3c , which can consist of aluminum, for example, engages with its upper edge in the indentation of the cover plate 3b on. In addition, the locking ring engages under 3c with its lower edge 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. This holds the locking ring, ie the crimp cap 3c the stopper 3a and the cover plate 3b secure to the vessel body 2 firmly.

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

Regardless of the exemplary embodiments of these figures, the safety cap 10 , 20th can also be used for all other pharmaceutical vessels.

List of reference symbols

1

pharmaceutical vessel or object

2

Vascular body

3

Clasp

3a

Sealing plug

3c

Crimp cap

3b

Support washer

4th

cylindrical section

5

Weakening element

6th

Recess

7th

Group of weakening elements

10

Safety cap

11

end cap section

12

Side wall

13

End section

14th

Insertion opening

15th

first wall section

15a

Exterior surface

15i

Inner surface

16

cylindrical wall section

17th

end cap edge surface

18th

slot

19th

Face

20th

Molding

25th

Expansion opening

30th

Shear area

31

Bending force

35

arrangement

50

label

h1, h2, h3

Height overlap

H1, H2, H3, H4

Height extension

r

radial direction

u

Circumferential direction

z

axial direction

Claims (15)

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 - Is intended to be attached to a cylindrical section of a pharmaceutical vessel or object, the securing cap (10) being designed to be attachable to pharmaceutical vessels or objects with outer diameters of different sizes due to tolerances by the first wall section (15) of the side wall (12) in the radial direction is designed expandable. Safety cap Claim 1 , characterized in that the securing cap (10) is or comprises a three-dimensional molded part (20), in particular a preformed three-dimensional molded part (20) made of a plastic material that can be shrunk by the action of heat. Safety cap Claim 1 or 2 , characterized in that the securing cap (10) is or comprises a pre-shrunk molded part (20) made of a plastic material which can be shrunk by the action of heat, the side wall (12), the first wall section (15) or at least the end section (13) of the side wall (12 ) has already been pre-shrunk to a predetermined diameter, in particular to a predetermined diameter for the insertion opening (14). Safety cap according to one of the Claims 1 to 3 , characterized in that the securing cap (10) is shaped such 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 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 inner diameter which corresponds to a lower limit value of the tolerance range, and the first wall section (15) can be expanded by expanding to a value of the inside diameter which corresponds to an upper limit value of the tolerance range. Safety cap according to one of the Claims 1 to 4th , characterized in that the securing cap (10) is shaped so that the first wall section (15) in the unexpanded state has an inner diameter (Di) which is smaller than a nominal and / or standardized target 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 standardized target value (Ds) of the outer diameter (Da) of the pharmaceutical by being attached to the pharmaceutical vessel or object as intended Vessel or object. Safety cap according to one of the Claims 1 to 5 , characterized in that the first wall section (15) has a plurality of circumferentially distributed weakening elements (5) serving for the radial expansion of the first wall section (15) of the side wall (12), through which the first wall section (15) is interrupted, perforated, excepted and / or otherwise locally weakened. Safety cap according to one of the Claims 1 to 6th , 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 made of the same plastic material as the first Wall section (15) is formed, but is free of weakening elements, is designed to be non-deformable and, in particular, non-expandable. Safety cap according to one of the Claims 1 to 7th , 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 (H1, H2, H3, H4) are introduced into the first wall section (15), and that the height extensions (H1, H2, H3, H4) of the respective associated weakening elements (5) of different groups (7), in particular those weakening elements (5), each two axially Direction (z) of mutually adjacent groups (7) of weakening elements (5), intersect and / or overlap (hl, h2, h3) in direction (z). Safety cap according to one of the Claims 1 to 8th , characterized in that the weakening elements (5) are expansion openings (25) through which the first wall section (15) is locally interrupted, perforated or recessed. Safety cap according to one of the Claims 1 to 9 , characterized in that the expansion openings (5) are introduced or preformed slots (18) in the first wall section (15). Safety cap according to one of the Claims 1 to 10 , characterized in that the expansion openings (25) are made or preformed recesses (6) in the first wall section (15). Safety cap according to one of the Claims 1 to 11 , characterized in that the first wall section (15) has an arrangement (35) of weakening elements (5) and / or expansion openings (25) distributed over the circumference and / or the height of the first wall section (15) 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 everted vessel (1 ) and, when the first wall section (15) is expanded, produce shear areas (30) in the first wall section (15) in which the plastic material of the first wall section (15) is sheared, bent or elastically deformed in some other way. Safety cap according to one of the Claims 1 to 12 , characterized in that the securing cap (10) consists of such a plastic material and is designed with such a wall thickness that the securing cap (10) arises in the event of a widening caused by attachment to a pharmaceutical vessel or object to be protected by the securing cap (10) as intended remains undeformed outside of the first wall section (15) or at least outside of shear regions (30) of the first wall section (15). Safety cap according to one of the Claims 1 to 13 , characterized in 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 securing cap (10), adjoins the side wall (12) and Is formed circular disk-shaped or circular ring. Safety cap according to one of the Claims 1 to 14th , characterized in that the safety cap (10) is a safety cap for a vial, an ampoule, a vial or for an infusion bottle.

Images