EP2614011B1 - Closure stopper for pharmaceutical uses - Google Patents

Description

The invention relates to a sealing plug for pharmaceutical applications, in particular for sealingly closing a container containing a pharmaceutical agent, for example for closing an ampoule containing a medicament, with a sealing flange for sealing seating on an end face of a closure mouth of the container, wherein the sealing flange has a lower sealing surface and a limiting plane adjacent to a downwardly projecting portion extending perpendicular to a central axis of the sealing plug, an engaging portion extending below the sealing flange and having a smaller radial extent than the sealing flange, and, preferably, a handling portion; which extends above the sealing flange, wherein further on the engagement portion, a circumferential sealing projection is formed, which is opposite to a first below the sealing flange, ei NEN section radius having axial portion of the engaging portion protrudes by a radial dimension.

Such plugs have already become known in various embodiments. It is, for example, on the WO 2009/002991 A1 , the WO 2009/051282 A1 , the US 2010/0050575 A1 , the WO 2008/129144 A1 ( CA 2677408 A1 ) and the WO 2005/000703 A2 directed. The sealing plugs can consist of various materials. First, they may, as a rule, as a base material with suitable additives, for example of natural rubber or rubber material, continue from a relatively soft plastic material, such as, for example, a thermoplastic elastomer. In addition, however, they may also, in terms of a modification of the thermoplastic elastomer, consist of a material, such as, for example, from of the US 2002/0113033 A1 is known. Also, the production of such a closure plug described in the aforementioned document is a possible production in the context of the present application. You can also, at least partially, be covered with a film, including, for example, on the DE 10 2004 034 899 A1 to refer. The materials mentioned can all be used in the context of the present application. The details of the above-mentioned documents with regard to the materials and methods of preparation described therein are therefore hereby also incorporated in full in the disclosure of the present application, also for the purpose of incorporating features of these applications into claims of the present application.

US 3,695,478 discloses a sealing plug according to the preamble of claims 1 and 2, and a closure according to the preamble of claim 15.

Such sealing plugs find use, inter alia, in freeze-drying processes. In particular, in such freeze-drying method, but also in general, there is a need to be able to apply the closure plug with good sealing performance advantageous.

These sealing plugs are generally formed rotationally symmetrical to a central axis.

On this basis, the invention has the object to provide a sealing plug for pharmaceutical applications, which is advantageously designed with respect to the application to a corresponding container and the achievement of the closed position.

A possible solution to the problem is given according to claim 1 in an object having the features that the sealing projection vertically at least with respect to its foot portion in Covering is formed on a return flange to the sealing flange opposite the boundary plane. It is therefore an area that is located axially higher in relation to the sealing surface than the boundary plane. This can be achieved in various ways. For example. by a weakening of the flange in this area or by a pre-arrowed in cross-section, that in cross-section, a radially outer region further protrudes downward than a radially inner region of the sealing flange, design of the sealing flange. In both cases it is achieved that in the closure state "active", ie the actual sealing acting, surface portion of the sealing surface is concentrated on a more radially outer region of the sealing flange. Since in the overlap region to the sealing projection anyway, except for a certain required to achieve the sealing effect and desired compression of the sealing projection, in the closed state, the opening cross section of the mouth of the container, a planar design of the flange in this area is not required. A further possible solution of the problem is given according to claim 2 in an object having the features that one of the outer limit of the radial dimension, by which the sealing projection protrudes from a located above the sealing projection axial portion of the engagement portion corresponding radial extent, of the based on a minimum section radius corresponding to 1.05 times or more, and that an axial dimension of the sealing projection measured along a parallels to the center line of the sealing plug, wherein the parallel upper and / or lower side of the sealing projection is a tangent forms to the adjacent region of the axial section or to a region of a possibly underside of the sealing projection extending lower portion of the engagement portion, on the Area, or possibly both, to which, coming from radially outward, initially the tangential system results, which corresponds to 0.5 times or more of the difference of the radial dimension to the lowest section radius.

This design is characterized by a comparatively radially far projecting sealing projection and corresponding to this largest radial dimension of the sealing projection receding axial portion. As a result, a comparatively strong load, in the closed state, is achieved at the sealing projection and thus with respect to the sealing projection a high sealing effect.

Further features of the invention are described below, also in the figure description and the drawing, often in their preferred assignment to the already explained above claim concepts or illustrated, but they can also be assigned to only one or more individual features described here or are represented graphically, or in another overall concept or independently of importance.

First, it is possible in the context of the invention that both feature complexes already described above are realized in a summarized manner on such a closure plug.

In the case of a sealing plug described here, it is also preferred that the sealing effect, insofar as to be referred to as the total sealing effect, results both axially and radially.

With regard to an end face of an orifice, in particular of a mouth of a bead closed with the stopper, results an axial sealing effect. With regard to the sealing projection, also where appropriate, if this partially or predominantly acts as a sliding projection, as further supplemented below, results in a sealing effect in the radial direction, within the mouth.

In the case of all sealing plugs, an indentation can also be formed on the upper side of the sealing flange, preferably vertically opposite to the lower recessed region. As a result, an even greater flexibility of the sealing flange is achieved. The return area is also referred to as (lower) indentation in the context of the application.

In this respect, it is further preferred that a cross-sectional line representing a lower surface of the sealing flange, based on a cross-sectional representation of the sealing plug, has an indentation. The lower surface of the sealing flange may coincide with the boundary plane over a larger radial area. However, it can also coincide with the boundary plane only in one, preferably outer, radial region or point of the sealing flange-furthermore with reference to the mentioned cross-sectional representation. The lower surface of the sealing flange can be seen in particular different from the boundary plane when the boundary plane coincides with the lower surface of the sealing flange only in a radially narrow area, or just in a punctiform manner, based on a cross-sectional view. In particular, the boundary plane need not run at right angles to the central axis. But it can run at right angles to this.

Said indentation leads to a weakening of the flange cross-section, if, which is basically possible but not preferred in the context of the invention, does not correspond to a corresponding bulge in the flange cross-section on the upper side of this indentation. In the preferred within the scope of the invention Design results in an advantageous weakening of the sealing flange in its root portion (radially innermost section). An elastic deformation in this area in the closed state allows the securing of a sealing system according to certain bias in the closed state.

This desired weakening can be supplemented and reinforced by the above-mentioned, circumferential recess of the sealing flange, a top-side indentation.

Furthermore, it is preferred that the indentation is formed at a transition of the sealing flange in the engagement portion. It is so close to the center, near the central region of the sealing plug formed.

The cross-sectional line, which reproduces the edge line of the indentation in cross-section, is formed in the region of the indentation running at least partially in the shape of a circle segment. This makes it possible to achieve good crack resistance while forming the indentation to the desired extent.

The cross-sectional line may extend at least partially at right angles to the center line in the region of the indentation. This, for example, in such a case in which the indentation is groove-like, with a straight groove bottom formed. However, the groove base can also be formed obliquely in cross-section, in which case a relevant subregion of the cross-sectional line runs at an acute angle to the central axis. The cross-sectional line may accordingly also have an area which runs straight, ie at right angles to a further area. The region extending at an acute angle with the central axis may be swept up or down.

Furthermore, it can be provided that the indentation merges axially downwards directly into the smallest section diameter of the engagement section. In this case, however, this engagement section does not necessarily have to be located below an orifice plane of the container in the closed state. Basically, this is only addressed that it extends below the flange training.

The said indentation is also a return area, as initially described. However, in the context of the invention, such a return region is preferably referred to as indentation, which results as a deviation from the cross-sectional line.

Furthermore, it is also preferable that two or more sealing protrusions are formed axially spaced at the engaging portion. In particular, this makes it possible to achieve that the sealing effect is concentrated on the two or more sealing projections.

Additionally or alternatively, a sealing projection, or two or more, or the two or more sealing projections, also - supplementarily or alternatively - act as a sliding projection, as described in more detail below.

In such an embodiment, it is further preferred that at least two sealing projections have different radial dimensions. This means that a sealing projection is easier to insert than the other sealing projection.

Furthermore, it is then preferable for an upper sealing projection, seen from the sealing flange, to have a greater radial dimension than a lower sealing projection. The closure plug can thus be relatively easily drive into a first position in the opening of the container and then with respect to the second sealing projection then with a slightly larger force.

With regard to the design of the sealing plug, it is further preferred that a central recess is formed in the region of the insertion section. The recess may have a cylindrical wall section in the region of the sealing projection or possibly at least in the region of a first sealing projection. Furthermore, in the region of the sealing projection, at least in the region of a possibly provided second sealing projection, the recess may have a wall region which widens radially outward.

It is also preferred that the insertion section below the possibly first sealing projection has a widening outer contour. In this way, it is possible for example to counteract a tilting tendency, for example.

The invention also relates to a closure for a container, for example an ampoule, in which a medicament is preferably received, with a closure cap and a closure stopper which is accommodated in the closure and has a sealing flange, latching formations being formed on the closure cap for latching the closure the ampoule.

Such closures are already widely known. In addition to the documents mentioned above is in this context on the US 5,314,084 A directed.

In the known closures, the closure caps of the closures are first placed on the container in a first position in which drying of the medicament received in the container can be carried out, for example, in a freeze-drying chamber via air passages to the interior of the container. After completion of the freeze-drying, the closure caps are then moved to a second position in which they are latched to a mouth edge of the container, and in which the sealing plug received in the closure cap sealingly seated with a sealing flange on an end face of the container.

In this context, the invention deals with the technical problem of achieving a permanent and secure seal as possible.

This technical problem is solved by an article according to claim 15, which is based on the fact that the radially outwardly sloping sealing flange is raised in the closed position by cooperation with a mouth edge of the container. The uninfluenced sealing plug, which in particular is not yet in a sealing closure position, accordingly has a design of the sealing flange swept forward in the direction of seating on the container. Notwithstanding a (in cross-section) continuous sweep, starting at a central region, said deflection can also be achieved by a radially outwardly on the underside of the sealing flange, for example circumferential shoulder. A thus sitting on the container closure plug has a corresponding permanent elastic bias in the sealing position. The deflection is different depending on the degree of the decrease of the sealing flange radially outward. In a strictly swept training, the deflection is correspondingly the largest radially outward and then decreases toward the middle. In addition to the effect of permanent elastic bias in the sealing position is given in such a closure plug also an enhanced sealing effect in the engaging in the containers sealing projection. It is (further) biased by said deformation in its sealing position.

In particular, it may be a two-part closure. More preferably, the closure on a sliding part, which can be displaced relative to a fixed cap from an open position in which, for example, a freeze-drying can be performed in a closed position.

In the closed position, the sliding part is movable relative to the closure cap down. In particular, it is preferred that the sliding part is locked in the closed position relative to the closure cap.

Fig. 1

eine Seitenansicht eines Verschlussstopfens erster Ausführungsform;

Fig. 2

eine Darstellung gemäß Figur 1, in einer Perspektive von schräg unten;

Fig. 3

einen Querschnitt durch den Gegenstand gemäß Figur 1 bzw. Figur 2, geschnitten in der Ebene E1-E1 in Figur 2;

Fig. 4

eine Darstellung gemäß Figur 2 einer zweiten Ausführungsform;

Fig. 5

einen Querschnitt durch den Gegenstand gemäß Figur 4, geschnitten entlang einer Ebene E2-E2 in Figur 4;

Fig. 6

eine Darstellung gemäß Figur 2 eines Gegenstandes dritter Ausführungsform;

Fig. 7

einen Querschnitt durch den Gegenstand gemäß Figur 6, geschnitten entlang einer Ebene E3-E3 in Figur 6;

Fig. 8

eine Darstellung gemäß Figur 2 einer vierten Ausführungsform;

Fig. 9

eine Querschnittsdarstellung des Gegenstandes gemäß Figur 8, geschnitten entlang der Ebene E4-E4 in Figur 8;

Fig. 10

eine Darstellung gemäß Figur 2 einer fünften Ausführungsform;

Fig. 11

eine Querschnittsdarstellung des Gegenstandes gemäß Figur 10, geschnitten entlang der Ebene E6-E6 in Figur 10

Fig. 12

eine Querschnittsdarstellung eines Einsatzes eines Verschlussstopfens in der Ausführungsform der Figuren 1 bis 3 in einem zur Gefriertrocknung verwendeten Verschluss, im Öffnungszustand;

Fig. 13

eine Darstellung gemäß Figur 12, im Verschlusszustand

The invention will be further explained below with reference to the accompanying drawings, which, however, illustrate only exemplary embodiments. Hereby shows:

Fig. 1

a side view of a sealing plug of the first embodiment;

Fig. 2

a representation according to FIG. 1 in a perspective from diagonally below;

Fig. 3

a cross section through the article according to FIG. 1 or Figure 2, cut in the plane E1-E1 in FIG. 2 ;

Fig. 4

a representation according to FIG. 2 a second embodiment;

Fig. 5

a cross section through the article according to FIG. 4 , cut along a plane E2-E2 in FIG. 4 ;

Fig. 6

a representation according to FIG. 2 an article of third embodiment;

Fig. 7

a cross section through the article according to FIG. 6 , cut along a plane E3-E3 in FIG. 6 ;

Fig. 8

a representation according to FIG. 2 a fourth embodiment;

Fig. 9

a cross-sectional view of the article according to FIG. 8 , cut along the plane E4-E4 in FIG. 8 ;

Fig. 10

a representation according to FIG. 2 a fifth embodiment;

Fig. 11

a cross-sectional view of the article according to FIG. 10 , cut along the plane E6-E6 in FIG. 10

Fig. 12

a cross-sectional view of an insert of a sealing plug in the embodiment of FIGS. 1 to 3 in a closure used for freeze-drying, in the open state;

Fig. 13

a representation according to FIG. 12 , in the locked state

Shown and described are sealing plugs 1, which serve to seal containers in which pharmaceutical agents, ie in particular medicines, are contained. They serve for the sealing closure of such a container, for example an ampoule. In particular, the illustrated and described sealing plugs 1 may also be for use in a closure suitable for carrying out a freeze-drying process.

The sealing plug 1 with reference first of all to the embodiment of the FIGS. 1 to 3 Specifically, it has a handling portion 2 which is preferable and formed as a cylinder body in the embodiment. Further, a sealing flange 3 is formed, which begins at the lower end of the handling section 2. In addition, an engagement portion 4 is formed, which extends below the sealing flange 3.

The sealing plug 1 has a central axis A. In the exemplary embodiment and also preferably, the sealing plug 1 is rotationally symmetrical with respect to the central axis A.

The engagement portion 4 has a smaller radial extent r, starting from the central axis A, than the sealing flange 3, which has a radial extent R on the other hand. This applies to the largest radial extent r of the engagement section 4 to that extent.

At the engaging portion 4 and this with forming a circumferential sealing projection 5 is formed. The sealing projection 5 is, as in particular about FIG. 3 results, compared to a first below the sealing flange 3 adjoining the sealing plug 1 axial section 6 formed radially projecting. Namely, by a radial dimension R1, which is connected to a smallest section radius D1- with respect to an outer surface of the engagement section 4 - radially outward (R1 corresponds to the difference of r and D1).

The sealing projection 5, as well as a sealing flange 3, can be formed swept down. Such a sweep is given in particular when a lower boundary line of the sealing projection 5 and / or the sealing flange 3 - based on a cross-sectional view - at least over a partial section from the outside inwards rising. In particular, with respect to a sealing projection 5, a sweep can be given by a falling from outside to inside the lower boundary line. It is preferred that an upper boundary line runs parallel or at least also rising or falling (from outside to inside) at least over a corresponding area. In particular, with respect to the sealing projection 5, the upper and lower boundary line can also run in opposite directions, ie, for example, the lower boundary line sloping from outside to inside and at the same time increasing the outer boundary line from outside to inside. As a result, a wedge-shaped in cross section configuration is given.

The swept as well as the unswept sealing flange 3 and / or the swept or unswept sealing projection 5 preferably, as well as from the cross-sectional views, for example, the Figures 3 . 5 . 7 . 9 and 11 can be seen, a peripheral edge, which runs vertically relative to the representation. Sometimes, in particular If it is a punched out area, the marginal edge may indeed be generally vertical, but in detail also irregular, for example, with slightly curved sections run.

The sealing flange 3 has a contact plane E5 on the underside. The contact plane E5 extends at right angles to the central axis A and is defined by the plane which is in first contact with the latter at an imaginary approach from below to the sealing flange 3. As can be seen, in the embodiment of the FIGS. 1 to 3 the system is given in a radially outer region 7 of the sealing flange 3. Above the contact plane E5, a return region R _{b is} formed on the sealing flange 3. In the recess region R _b , the underside contour line L of the sealing flange 3 deviates upward with respect to the contact plane E5.

In the exemplary embodiment and also preferably, said diameter D1 results within the or in vertical projection to the return area R _b .

In the embodiments of the FIGS. 1 to 3 and 8 to 11 is the sealing projection 5 completely in registration, ie in vertical projection, seen from below, to the recess area R _b .

A radial extent r corresponding to the outer limit of the radial dimension R1 corresponds to 1.05 times or more with respect to the smallest segment radius D1, up to, for example, 2 times.

Furthermore, the sealing projection 5 has an axial dimension Ax. The axial dimension Ax becomes along a parallels P to the center axis A of the sealing plug 1 measured. The parallel P extends at such a radial distance from the central axis A, in which it, coming from the outside, for the first time forms a tangent to the axial region of the engagement section adjoining the sealing projection 5. The plant of the tangent can be given here on the underside or top side or bottom and top of the sealing projection 5. In the embodiment of the FIGS. 1 to 3 this system is evident given the upper side of the sealing projection 5. In the embodiment of the FIGS. 1 to 3 the parallel P coincides with the boundary line of the section radius D1.

The points of intersection or points of contact (in the case of the tangent), or an intersection and a point of contact, of the contour line of the sealing projection 5 with the parallels P, measured in the vertical direction on the parallels P, gives said axial dimension Ax. This axial dimension Ax corresponds to 0.5 times or more the difference of the radial dimension r to the section radius D1. In the embodiment about twice. It can for example match up to 4 times. With regard to the graphic representation in Fig. 3 For example, the difference of the radial dimension r (22 mm) to the section radius D1 (18 mm) is 4 mm, so that the axial dimension Ax, which can be read from the drawing at 10 mm, is more than 0.5 times (2 mm) corresponds to the difference between r and D1. The axial dimension Ax can correspond to a value up to four times the said difference. In the embodiment, this would be up to an extension of 16 mm. For the sake of simplicity, the dimensions that can be taken directly from the drawing have been used here. In fact, such a plug is usually smaller than shown. The actual dimensions therefore correspond, for example, a quarter to an eighth of the dimensions, as can be seen from the drawing.

In the embodiment of FIGS. 4 and 5 is under the sealing projection 5, a second projection 21, here referred to as a sliding projection provided. When inserting the sealing plug 1 into a corresponding container, the sliding projection can serve to push back liquid or to guide it into the central region of the sealing plug 1. The projections 5 and 21 are axially spaced. The sliding projection is therefore preferably formed radially outward, in terms of a cooperation with an inner surface of the mouth of a vessel into which it is to be inserted, in the sense of a wiper lip.

Identical or mutatis mutandis, the same reference numerals (for example, D1, E2, etc.) mean the same elements in all embodiments, which then apply in principle to the relevant above explanations.

A distance Z between the projections 5 and 21 in the direction of the center axis A preferably corresponds to about one twentieth to one-fold of the section radius D1. In the embodiment of FIGS. 4 and 5 The dimension Z corresponds to approximately 0.72 times the section radius D1. The dimension Z can be seen at the intersections of horizontal through the projections 5, 21 with their (relative to the cross-sectional view) radially outermost points removed. If no radially outermost point but a radially outermost line is given in this context, for example, then the dimension Z should be removed in each case on the middle of a vertical extension of this radially outermost line, which is then correspondingly a vertical.

It can also be seen that, as also preferred, the radial dimensions R1 and R2 are different. In addition, the axial dimensions Ax1 and Ax2 are also differently. Preferably, the radial dimension R2 of the lower protrusion 21 is smaller than the radial dimension R1 of the upper sealing protrusion 5. It is also preferable that the dimension r is determined by the upper sealing protrusion 5. More preferably, the axial dimension Ax2 is smaller than the axial dimension Ax1.

These mentioned differences are also preferably significant. In any case, in the range of 1 to 20%.

In the embodiment of FIGS. 6 and 7 is the return area R _{b formed} in the contour line L by a circular section shape. In addition, the sealing flange 3, which in total, relative to a central axis MX extends at right angles to the central axis A, a portion B, which is formed without return area R _b . The portion B is formed radially outward with respect to the recess portion R _b . The section B has a length which preferably corresponds to half to 4 times the dimension R1.

The sealing projection 5 exceeds radially with respect to its dimension R1 a corresponding dimension of the return area R _b .

In the embodiment of FIGS. 8 and 9 With regard to the return area R _{b is} basically a comparable design to the embodiment of FIGS. 6 and 7 given. Here, however, the groove bottom N of the return area R _{b is formed} with respect to the contour line L as a straight line. In addition, in the embodiment in the form of a straight line, which also extends at right angles to the central axis A. The sealing projection 5 is formed here only in the form of a sliding projection 21. The sliding projection 21, as described in the context of this application, does not have in addition to a Sealing projection 5 may be provided, it may also be provided alone or instead of a sealing projection 5.

A return area R _b , which results from a deviation of the contour line L from a straight line, cf. the embodiments of FIGS. 6 to 9 , in the context of this application also referred to as (lower) indentation.

The maximum radial extension of the recess R _b in this embodiment (again) exceeds the dimension D1 plus the dimension R1.

In the embodiment of FIGS. 10 and 11 are in turn two projections 5, 21 formed axially with each other, corresponding approximately to the embodiment of FIGS. 4 and 5 , However, the axial distance Z is much lower. Also, the difference of the largest radial extent R is larger in proportion to the dimension D1 plus R1.

The particular features of the individual embodiments have significance not only in connection with the respective embodiment. Thus, the comparatively large axial dimension Ax of the embodiments of FIGS. 1 to 3 also be provided in the sealing projections 5 of the embodiments 4, 5 or 8, 9. The design of the area R _b according to the embodiment of the FIG. 6 can also in the embodiment of FIGS. 1 to 3 . 4 . 5 . 8, 9 or 10.11 be provided. Conversely, the design of the area R _b according to the embodiment of the FIGS. 6, 7 also in the embodiment of FIGS. 1 to 3 . 4 . 5 . 8th . 9 or 10.11 be provided. In the same way, the straight running design of the sealing flange 3, as basically from the embodiments of FIGS. 6, 7 or 8, 9 is known, even in the embodiments of FIGS. 1 to 3 . 4 . 5 or 10, 11 be realized.

As far as two projections 5, 21 are realized, applies to one or both of the projections that they also, as further described above with respect to the sealing projection 5 in detail, can be formed swept down.

Due to the design of the sealing flange 3 on the one hand and a sealing projection 5, if necessary also in the form of a sliding projection 21, on the other hand, a total sealing effect is achieved in the closed state, resulting from the sum of an axial sealing effect (by the sealing flange 3) and a radial sealing effect (by the sealing projection 5 possibly also several thereof, and / or a sliding projection 21) results.

All illustrated plugs are rotationally symmetrical with respect to the central axis A.

The areas of relative or percentage dimensions mentioned above also include all intermediate values with regard to the disclosure content, in particular in one-tenth increments, especially, for example, in one-tenths of a percent increments, ie on the one hand to delimit the stated range boundaries from below and / or above, alternatively or additionally but also with regard to the disclosure of one or more singular values from the respective area.

It should also be noted that it is apparent in all embodiments that the closure stopper has a central first cavity 8 extending from its lower end and / or a further central cavity 9 extending from its upper end.

The cavity 8 and / or the cavity 9 may initially, in their initial region, have a cylindrical configuration and subsequently a curved in the contour line termination design. For example. in the form of a circle.

It is also preferred that the cavity 8 extends from below to extend into the region of the sealing flange 3 and more preferably beyond.

For example, the embodiment of the FIGS. 8 and 9 and, although less pronounced, the embodiment of FIG FIGS. 10 and 11 shows, at the beginning of the cavity 8 and / or 9, a tapered portion may be formed. Overall, then results in a cross-sectional line that corresponds to a bell shape.

The aforementioned cavity configurations are in turn not limited to one of the embodiments mentioned. The fact that they are shown in each case specifically combined with only one embodiment drawn in combination, has only exemplary character. They can be provided in the same way in the other embodiments.

Regarding the Figures 12 and 13 the application is shown in a freeze-drying closure.

It is a closure 11, which is placed on a medical ampoule 12. In the ampoule 12 is, preferably initially in liquid form, a drug. By lyophilization, this drug is then more preferably transferred in powder form.

The closure 11 consists in detail of a closure cap 13 and a sliding part 14 which is formed in the embodiment partially protruding from above with respect to the cap 13. With the sliding part 14 is also a cover - not shown here - in the embodiment preferably integrally connected via a connection 20.

As further from the cross-sectional representations of Figures 12 and 13 shows, the sealing plug 1 is received in the interior of the cap 13 and the sliding part 14. The handling section 2 is received with respect to a possible sliding in a corresponding enclosure for the handling section 2 resulting annular part 15 of the cap 13. The ring member 15 is correspondingly formed on a smaller radius dimension, but also centrally with respect to a central axis, on the closure cap 13 as an outer wall of the closure cap 13.

The cap 13 further has latching formations 16 with which it engages under a muzzle bead 17 of the ampoule 12 in the latching state.

The latching formations 16 are formed on elastically bendable latching feet 18, which can resiliently spring out accordingly when placing the closure cap 13 onto the ampoule 12 and can run over said bead 17 of the ampoule 12 in this way.

As further from a comparison of Figures 12 and 13 results, the closure plug 1 by means of the sliding part 14, namely concretely by means thereof formed Aufsetzfüßen 19 relative to the closure cap 13 from an open position according to FIG. 12 in which a freeze-drying is carried out can, in a closed position according to FIG. 13 added. In the closed position, the sliding part 14 is moved relative to the closure cap 13 down. Due to the resulting elastic deformations of the sealing flange 3 of the sealing plug 1 is almost flat on the corresponding end face of the mouth bead 17 of the ampoule 12 and the sealing projection 5 is deformed so that in any case results in the representation of a uniform outer periphery of the insertion. The male portion is cylindrically shaped by deformation and compression over a substantial portion of its height. It can also be a certain undercut, which corresponds to the measure D1, see further ahead, remain.

In the Figures 3 . 5 . 7 . 9 and 11 is also indicated in each case by the reference numeral 10, that also on the upper side on the sealing flange 3, a circumferential recess 10 may be provided which is preferably, but not necessarily, provided vertically opposite to the recess region R _b on the underside of the sealing flange 3. It is further preferred that an inner boundary line of such a recess 10 merges into the cylindrical surface of the handling section 2. LIST OF REFERENCE NUMBERS 1 sealing plug E1-4 level 2 handling section E5 limiting plane 3 sealing flange E6 level 4 engaging portion D1 section radius 5 sealing projection R1 radial 6 axial R2 radial 7 Area R _b Return area 8th cavity Ax axial dimension 9 cavity P parallel 10 indentation A center line 11 shutter L Section line 12 ampoule Z distance 13 cap R extending size 14 sliding part B section 15 ring part r radial 16 latching recesses 17 Mündungswulst 18 Rest feet 19 Aufsetzfüße 20 connection 21 Sealing projection or sliding projection

Claims (15)

1. Closure stopper (1) for pharmaceutical applications, in particular for the sealing closure of a container containing a pharmaceutical agent, for example for the closure of an ampoule (12) containing a medicament, having a sealing flange (3) for seating in a sealing manner on an end face of a closure mouth of the container, the sealing flange (3) having a lower sealing surface and a boundary plane (E5) which contacts an area protruding farthest downwardly and extends perpendicularly with respect to a centre axis of the closure stopper (1), an engagement portion which extends below the sealing flange (3) and which is formed with a smaller radial extent than the sealing flange (3), and preferably a handling portion (2) which extends above the sealing flange (3), characterized in that a circumferential sealing projection (5) is also formed on the engagement portion (4) and protrudes by a radial dimension (R1) with respect to an axial portion of the engagement portion (4) initially adjoining the sealing flange (3) from underneath and having a portion-radius (D1), and in that the sealing projection (5), at least with respect to its base portion, vertically overlaps a set-back region (R_b) which is formed on the sealing flange and is set back with respect to the boundary plane (E5).
2. Closure stopper (1) for pharmaceutical applications, in particular for the sealing closure of a container containing a pharmaceutical agent, for example for the closure of an ampoule (12) containing a medicament, having a sealing flange (3) for seating in a sealing manner on an end face of a closure mouth of the container, the sealing flange (3) having a lower sealing surface and a boundary plane (E5) which contacts an area protruding farthest downwardly and extends perpendicularly with respect to a centre axis of the closure stopper (1), an engagement portion which extends below the sealing flange (3) and which is formed with a smaller radial extent than the sealing flange (3), and preferably a handling portion (2) which extends above the sealing flange (3), characterized in that a circumferential sealing projection (5) is also formed on the engagement portion (4) and protrudes by a radial dimension (R1) with respect to an axial portion of the engagement portion (4) initially adjoining the sealing flange (3) from underneath and having a portion-radius (D1), in that a radial extent r of the closure stopper corresponding to the radial dimension (R1) corresponds to 1.05 times or more of a smallest portion-radius (D1), and in that an axial dimension (Ax) of the sealing projection, measured along a line (P) parallel to a centre line (A) of the closure stopper (1), corresponds to 0.5 times or more of the difference between the radial dimension (R1) and the smallest portion-radius (D1), the parallel line (P) on the top and/or bottom side of the sealing projection (5) forming a tangent with respect to the adjoining area of the axial portion or with respect to an area of a subportion of the engagement portion (4) optionally extending on the bottom side of the sealing projection, in particular at the area, or optionally at both areas, at which, starting from the radially outward side, the tangential contact initially results, and optionally, in that the sealing projection (5), at least with respect to its base portion, vertically overlaps a set-back region (Rb) which is formed on the sealing flange and is set back with respect to the boundary plane (5).
3. Closure stopper according to Claim 1 or 2, characterized in that a lower surface of the sealing flange (3) coincides with the boundary plane (5) over a fairly large radial portion, or coincides with the boundary plane (E) only in an outer radial portion of the sealing flange (3).
4. Closure stopper according to any of the preceding claims, characterized by a handling portion (2), the sealing flange (3) beginning at the lower end of the handling portion (2).
5. Closure stopper according to any of the preceding claims, characterized in that the set-back region is formed so that a cross-sectional line (L) with respect to a cross-sectional illustration of the closure stopper, representing the lower surface of the sealing flange (3), has a concave curvature (R_b), the concave curvature (R_b) preferably extending, at least in part, in a circular segment shape, and/or the cross-sectional line (L) extending, at least in part, at right angles to the centre line (A) in the region of the concave curvature (R_b), and/or the cross-sectional line (L) extending, at least in part, in a straight line or defining an acute angle with respect to the centre line (A).
6. Closure stopper according to Claim 5, characterized in that the concave curvature (R_b) merges directly into the portion having the smallest portion-radius (D1).
7. Closure stopper according to any of the preceding claims, characterized in that a further projection (21) is formed on the engagement portion (4) at an axial distance beneath the sealing projection (5).
8. Closure stopper according to Claim 7, characterized in that in any case two projections (5, 21) have different radial dimensions (R1, R2).
9. Closure stopper according to either of Claims 7 and 8, characterized in that an upper projection (5), viewed from the sealing flange (3), has a larger radial dimension (R1) than a lower projection (21, radial dimension R2).
10. Closure stopper according to any of the preceding claims, characterized in that the closure stopper (1) has a central recess (8) in the region of the insertion portion (4).
11. Closure stopper according to Claim 10, characterized in that the recess (8) has a cylindrical wall portion in the region of the sealing projection (5).
12. Closure stopper according to either of Claims 10 and 11, characterized in that the recess (8) has a radially outwardly widening wall portion in the region of the sealing projection (5), at least in the region of an optionally provided second projection (21).
13. Closure stopper according to any of the preceding claims, characterized in that the insertion portion (4) has a widening outer contour beneath the projection (5, 21), optionally the first projection.
14. Closure stopper according to any of the preceding claims, characterized in that a sealing effect is achievable with regard to an end-face seal of a vessel which is closable by the closure stopper, and, with regard to an overall sealing effect, also at least in part in the radial direction.
15. Closure (11) for a container, for example an ampoule (12), in which a medicament is preferably accommodated, which has a closure cap (13) and a closure stopper (1) that has a sealing flange (3) and is accommodated in the closure (11), characterized in that detent moldings (16) are formed on the closure cap (13) for the detent mounting of the closure (11) on the ampoule (12), in that the closure stopper (1) has an engagement portion (4) with a circumferential sealing projection (5), and in that the radially outwardly downwardly sloping sealing flange (3) in the closed position is (radially outwardly) raised by interaction with a mouth edge of the container, the deflection being greater radially outward and reducing towards the center.

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