EP2614011A1

EP2614011A1 - Closure stopper for pharmaceutical uses

Info

Publication number: EP2614011A1
Application number: EP11763616.7A
Authority: EP
Inventors: Ronny Prosper Elisabeth Vrijens; Reinhard Louis Jozef Waeben
Original assignee: Datwyler Pharma Packaging International NV
Current assignee: Datwyler Pharma Packaging Belgium NV
Priority date: 2010-09-09
Filing date: 2011-09-01
Publication date: 2013-07-17
Anticipated expiration: 2031-09-01
Also published as: US10273059B2; US20130213924A1; EP2614011B1; JP2013540655A; DE102011050983A1; WO2012031969A1

Abstract

The invention relates in the first instance to a closure stopper (1) for pharmaceutical uses, in particular for leaktight closure of a receptacle containing a pharmaceutical agent, for example for closure of an ampoule (12) containing a medicament, with a sealing flange (3) for sitting sealingly on an end face of a closure mouth of the receptacle, wherein the sealing flange has a lower sealing surface and a boundary plane (E5), which lies on an area protruding farthest down and extends perpendicularly with respect to a centre axis of the closure stopper, with an engagement portion, which extends below the sealing flange and is designed with a smaller radial extent than the sealing flange, and, preferably, with a handling portion (2), which extends above the sealing flange, wherein a circumferential sealing projection (5) is also formed on the engagement portion (4) and protrudes by a radial extent (R1) beyond an axial part of the engagement portion (4) having a radius (D1) and firstly adjoining the sealing flange from underneath. To be able to fit the closure stopper advantageously in place with a good sealing action, it is proposed that the sealing projection (5) is coincident vertically, at least with respect to its foot portion, with a set-back area (R_b) formed on the sealing flange with respect to the contact plane.

Description

Closing plugs for pharmaceutical applications

The invention relates to a closure stopper 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 an engagement portion extending below the sealing flange and formed with 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, a portion radius having axial portion of the engaging portion protrudes by a radial dimension.

Such sealing plugs have already become known in various embodiments. It is, for example, to WO 2009/002991 AI, the WO

2009/051282 AI, US 2010/0050575 AI, WO 2008/129144 AI (CA

2677408 AI) and WO 2005/000703 A2. The sealing plugs can consist of various materials. First, they can, as a rule, consist of a base material with suitable additives, for example of natural rubber or rubber material, furthermore of a comparatively 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 US 2002/0113033 AI 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. They may also, at least in part, be covered with a film, to which reference should be made, for example, to DE 10 2004 034 899 A1. 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.

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 of the problem is given according to a first inventive idea in an object, which in particular has 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 the surface portion of the sealing surface which is "active" in the closed state, that is to say the actual sealing effect, is concentrated on a region of the sealing flange which is more radially outward, because in the overlapping area to the sealing projection anyway, except for a certain one The sealing effect required and desired compression of the sealing projection, in the closed state of the opening cross-section of the mouth of the container is a flat even Design of the flange in this area is not required.

A further possible solution to the problem is given according to a further inventive idea in an article, which in particular has the features that one of the outer boundary of the radial dimension, which projects beyond the sealing projection against a located above the sealing projection axial portion of the engagement portion corresponding radial extent, from the central axis, based on a smallest sectional 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 a tangent 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 forms, 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 presented, but they can also be assigned to only one or more individual features, here described or illustrated in the drawing, or be in another overall concept or independent 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 can 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, if the boundary plane coincides with the lower surface of the sealing flange only in a radially narrow area, or even point-like, 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 case of the invention preferred 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 form of a circular section. 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 area running at an acute angle with the central axis can be swept upwards or downwards. 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 below a mouth level of the container in the closed state.

Basically, this is only addressed that it extends below the flange training.

The indent mentioned is also a return area, as described first. 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 Dichtvor jumps.

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 in terms of lenthe 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, having a closure cap and a closure stopper accommodated in the closure and having a sealing flange, detent formations being formed on the closure cap for holding the stop Closure on the ampoule. Such closures are already widely known. In addition to the publications mentioned above, reference is also made to US Pat. No. 5,314,084 A in this connection. In the known closures, the closure caps of the closures are first arranged 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 airways provided 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 is 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 the case of a strictly swept formation, the deflection is correspondingly greatest 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 relative to a fixed cap from an open position in which, for example, a freeze-drying can be performed in a locked position can be offset.

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.

The invention will be further explained below with reference to the accompanying drawings, which, however, illustrate only exemplary embodiments. 1 shows a side view of a sealing plug of the first embodiment; FIG. 2 shows an illustration according to FIG. 1, in a perspective obliquely from below;

3 shows a cross section through the article according to FIG. 1 or FIG. 2, cut in the plane El-El in FIG. 2;

4 shows a representation according to FIG. 2 of a second embodiment;

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

FIG. 6 shows a representation according to FIG. 2 of an article of the third embodiment;

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

8 shows a representation according to FIG. 2 of a fourth embodiment;

FIG. 9 is a cross-sectional view of the article of FIG. 8 taken along the plane E4-E4 of FIG. 8; FIG.

10 shows a representation according to FIG. 2 of a fifth embodiment;

11 is a cross-sectional view of the article according to FIG. 10, cut along the plane E6-E6 in FIG. 10 12 is a cross-sectional view of an insert of a sealing plug in the embodiment of Figures 1 to 3 in a closure used for freeze-drying, in the open state.

Fig. 13 is a view according to Figure 12, in the closed 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 closure plug 1, with reference first of all, in particular to the embodiment of FIGS. 1 to 3, has in detail a handling section 2, which is preferred and formed in the exemplary embodiment as a cylinder body. 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. As can be seen in particular from FIG. 3, the sealing projection 5 is designed to protrude radially in relation to an axial section 6 which adjoins the sealing plug 1 initially below the sealing flange 3. Namely, by a radial dimension Rl, which is connected to a minimum section radius Dl - relative to an outer surface of the engaging portion 4 - radially outward (Rl corresponds here to the difference of r and Dl). 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 representation-extends at least over a partial section from the outside to the inside. In particular with respect to a sealing projection 5, a sweep can also be provided by a lower boundary line sloping from outside to inside. 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. Figures 3, 5, 7, 9 and 11 can be seen, a peripheral edge, based on the representation runs vertically. Sometimes, In particular, when it comes to a punched-out area, the marginal edge, although generally vertical, in detail but 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 Figures 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 is formed on the sealing flange 3. In the recess region R, the lower-side 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 D 1 results within or in vertical projection relative to the return region Rb.

In the exemplary embodiments of FIGS. 1 to 3 and 8 to 11, the sealing jump 5 is completely covered, that is to say in the case of FIGS. H. in vertical projection, seen from below, to the return area Rb.

A radial extent r corresponding to the outer boundary of the radial dimension R 1 corresponds to 1.05 times or more, up to, for example, 2 times, based on the smallest segment radius D 1.

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 Figures 1 to 3, this system is shown on the upper side of the sealing projection 5 given. In the embodiment of Figures 1 to 3, the parallel P coincides with the boundary line of the section radius Dl.

The points of intersection or points of contact (in the case of the tangent), or an intersection and a point of contact, 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 Axialmaß Ax corresponds to 0.5 times or more of the difference of the radial dimension r to the section radius Dl. In the embodiment about twice. It can for example match up to 4 times. 3, the difference between the radial dimension r (22 mm) and the section radius D 1 (18 mm) is 4 mm, for example, so that the axial dimension Ax, which can be read off the drawing at 10 mm, is more than 0.5 times (2 mm) the difference between r and Dl. 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 Figures 4 and 5, 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. Therefore, the sliding projection is preferably formed radially outward, in the sense 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.

The same or mutatis mutandis, the same reference numerals (eg. Dl, 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 central axis A preferably corresponds to approximately one twentieth to one-fold of the section radius D1. In the embodiment of FIGS. 4 and 5, the dimension Z corresponds approximately to 0.72 times the section radius D1. The dimension Z can be seen at the points of intersection of horizontal through the projections 5, 21 with their (relative to the cross-sectional representation) 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 at the center 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 are Axl and Ax2 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 Axl.

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, the return area R in the contour line L is formed by a circular section shape. In addition, the

Sealing flange 3, the total, relative to a central axis MX extends perpendicular to the central axis A, a portion B, which is formed without a return area Rb. The portion B is formed radially outward with respect to the recess portion Rb. The section B has a length which preferably corresponds to half to four times the dimension Rl.

The sealing projection 5 exceeds radially with respect to its dimension Rl a corresponding dimension of the return area Rb. In the exemplary embodiment of FIGS. 8 and 9, a comparable design to the embodiment of FIGS. 6 and 7 is basically given with regard to the return region Rb. Here, however, the groove bottom N of the return portion Rb 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, which results from a deviation of the contour line L from a straight line, cf. the embodiments of Figures 6 to 9, in the context of this application also referred to as (lower) indentation.

The maximum radial extent of the recess Rb in this embodiment exceeds (again) the dimension D1 plus the dimension R1.

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

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 can also be provided in the case of the sealing projections 5 of the embodiments 4, 5 or 8, 9. The configuration of the region Rb according to the embodiment of FIG. 6 can also be provided in the embodiment of FIGS. 1 to 3, 4, 5, 8, 9 or 10, 11. Conversely, the design of the region Rb according to the embodiment of FIGS. 6, 7 can also be provided in the embodiment of FIGS. 1 to 3, 4, 5, 8, 9 or 10, 11. In the same way, the straight design of the sealing flange 3, as it is known in principle from the embodiments of Figures 6, 7 or 8, 9, also in the embodiments of Figures 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, which is the sum of an axial sealing effect (by the sealing flange 3) and a radial sealing effect (By the sealing projection 5, if necessary, 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 is further 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, as the embodiment of Figures 8 and 9 and, although less pronounced, the embodiment of Figures 10 and 11, 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.

Referring to 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 is further apparent from the cross-sectional representations of FIGS. 12 and 13, the sealing plug 1 is accommodated in the interior of the closure cap 13 or of 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 part 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 pass over the aforementioned bulge 17 of the ampoule 12 in this way. As is further apparent from a comparison of FIGS. 12 and 13, the closure plug 1 is carried out by means of the sliding part 14, specifically by means of support feet 19 formed thereon relative to the closure cap 13, from an open position according to FIG. 12, in which freeze-drying is carried out. can, in a closed position according to FIG 13 offset. 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 may also be a certain undercut, which corresponds to the measure Dl, 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 on the upper side on the sealing flange 3, a circumferential recess 10 may be provided which preferably, but not necessarily, verti cal opposite to the recess area R is provided 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. All disclosed features are essential to the invention. The disclosure of the associated / attached priority documents (copy of the prior application) is hereby also incorporated in full in the disclosure of the application, also for the purpose of including features of these documents in claims of the present application. The subclaims characterize in their optional sibling version independent inventive development of the prior art, in particular to make on the basis of these claims divisional applications. Reference list

1 stopper El-4 level

2 handling section E5 boundary plane

3 sealing flange E6 level

4 engagement section Dl section radius

5 sealing projection Rl radial dimension

6 Axial section R2 Radial measure

7 area Rb return area

8 Cavity Ax axial dimension

9 Cavity P Parallel

10 indentation A center line

11 Closure L Cross-section line

12 ampoule Z distance

13 Cap R Extension dimension 14 Sliding section B Section

15 ring part r radial dimension

16 latching formations

17 muzzle bead

18 resting feet

19 support feet

20 connection

21 sealing projection or sliding projection

Claims

A sealing plug (1) for pharmaceutical applications, in particular for sealingly closing a container containing a pharmaceutical agent, for example for closing an ampoule (12) containing a medicament, with a sealing flange (3) for sealing seating on an end face of a closure mouth of the container in that the sealing flange (3) has a lower sealing surface and a delimiting plane (E5) extending perpendicularly to a central axis of the sealing plug (1) adjacent to a region projecting furthest downwards, an engagement section extending below the sealing flange (3) and formed with a smaller radial extent than the sealing flange (3), and, preferably, a handling portion (2) which extends above the sealing flange (3), wherein further on the engagement portion (4) a circumferential sealing projection (5) is formed , which faces one below the Dichtflansc hes (3) subsequent, a section radius (Dl) having axial portion of the engaging portion (4) by a radial dimension (Rl) protrudes, characterized in that the sealing projection (5) vertically at least with respect to its foot portion in register to one on the sealing flange relative to the Contact plane trained return area (Rb).

2. Plug according to the features of the preamble of claim 1 or claim 1 or in particular according thereto, characterized in that a radial dimension (Rl) corresponding radial extent r based on a smallest section radius (Dl) 1.05 times or more and that an axial dimension (Ax) measured along a parallels (P) to a center line (A) of the sealing plug (1), wherein the parallel (P) on the top and / or bottom of the sealing projection ( 5, 7) forms a tangent to the adjacent region of the axial section or to a region of a subsection of the engagement section (4), possibly extending below the visual projection, at the region, or possibly both, to the radial outside Coming first tangential plant results, which corresponds to 0.5 times or more of the difference of the radial dimension (Rl) to the lowest section radius (Dl).

Closure stopper according to one or more of the preceding claims or in particular according thereto, characterized in that a cross-sectional line (L) representing the lower surface of the sealing flange (3) has a recess (Rb).

Closure stopper according to one or more of the preceding claims or in particular according thereto, characterized in that the indentation (Rb) extends at least partially circular segment-shaped.

Closure stopper according to one or more of the preceding claims or in particular according thereto, characterized in that the cross-sectional line (L) extends in the region of the indentation (Rb) at least partially perpendicular to the center line (A).

Closure stopper according to one or more of the preceding claims or in particular according thereto, characterized in that the cross-sectional line (L) extends at least partially straight or under inclusion of an acute angle with the center line (A).

Closing plug according to one or more of the preceding claims or in particular according thereto, characterized in that the indentation (Rb) merges directly into the region with the smallest section radius (Dl).

Closure stopper according to one or more of the preceding claims or in particular according thereto, characterized in that below the sealing projection (5) axially spaced at the engagement portion (4), a further projection (21) is formed.

Closure stopper according to one or more of the preceding claims or in particular according thereto, characterized in that in any case two projections (5, 21) have different radial dimensions (Rl, R2).

Closure stopper according to one or more of the preceding claims or in particular according thereto, characterized in that an upper projection (5) seen from the sealing flange (3) has a greater radial dimension (R1) than a lower projection (21, radial dimension R2).

Closure stopper according to one or more of the preceding claims or in particular according thereto, characterized in that the closure stopper (1) in the region of the insertion section (4) a has central recess (8).

Closing plug according to one or more of the preceding claims or in particular according thereto, characterized in that the recess (8) in the region of the sealing projection (5) has a cylindrical wall portion.

Closure stopper according to one or more of the preceding claims or in particular according thereto, characterized in that the recess (8) in the region of the sealing projection (5), at least in the region of a possibly provided second projection (21), has a radially outwardly widening wall region ,

Closure stopper according to one or more of the preceding claims or in particular according thereto, characterized in that the insertion section (4) below the, possibly first, projection (5, 21) has a widening outer contour.

Closure stopper according to one or more of the preceding claims or in particular according thereto, characterized in that a sealing effect both in terms of a frontal sealing of a vessel which is closable with the sealing plug, as well as, at least partially, based on a total sealing effect, in the radial direction is.

Closure for a container, for example an ampoule, in which a medicament is preferably received, with a closure cap and a sealing flange accommodated in the closure having locking plug, wherein on the closure cap Rastausformungen are formed for latching the closure to the ampoule, characterized in that the radially outwardly sloping sealing flange is raised in the closed position by cooperation with a mouth edge of the container (radially outward).