EP3687474A1

EP3687474A1 - Container, connection and production device

Info

Publication number: EP3687474A1
Application number: EP18773973.5A
Authority: EP
Inventors: Johannes Geser; Roland Sauter; Daniel BOJBIC; Sven Schneider; Torsten Giebeler
Original assignee: Kocher Plastik Maschinenbau GmbH
Current assignee: Kocher Plastik Maschinenbau GmbH
Priority date: 2017-09-26
Filing date: 2018-09-18
Publication date: 2020-08-05
Also published as: US11324660B2; JP2020534926A; CN111132647B; DE102017009012A1; CN111132647A; JP2023052333A; WO2019063346A1; US20200276081A1

Abstract

A container, more particularly an ampule, made of plastic material, having a container part (10) for receiving a container content (14), which can be dispensed through a container opening (12) which is closed by a head part (18) that can be separated along a separating point (16), on which head part a neck part (20) abuts, said neck part having a plurality of different functional surfaces on the inner circumference side, a support functional surface (44) of said functional surfaces being provided for sealing with respect to a removal body (32), which is provided for removing the container content (14) when the container opening (12) is opened, wherein in addition to the available functional surfaces, a front surface (50) is provided as an additional functional surface on the inner side (40) of the neck part, said front surface differing geometrically from the contact functional surface (44), is characterised in that the front surface (50) seamlessly transitions into the contact functional surface (44), and that the front surface (50) and the contact functional surface (44) are accommodated in the neck part (20) between the other functional surfaces.

Description

Container and connection and manufacture lvorrichtung

The invention relates to a container, in particular Ampul le, consisting of plastic material comprising a container part for receiving a dispensable via a container opening container contents, which is closed by a Trennstel le separable headboard to which a neck part is connected, the inner peripheral side a variety of different Functional surfaces, of which a plant-functional surface is used to seal against a removal body, which is provided with released container opening for removal of the container contents, which zusl addition to the existing functional surfaces for safe removal and production-safe production a further functional area in the form of a Front surface is provided on the neck part inside, which differs geometrically in at least one property of the property of a plant-functional area. A pertinent container is regularly used for medical purposes, which can be connected for example by means of a conical connection with a removal body of a removal device, such as a syringe. The conical connection may be lockable (ISO 80369-7: 201 6, for example a LuerLock connection) or non-lockable (ISO 80369-7: 201 6, for example a Luer-slip connection). These and other connecting devices used for geometries and their variants, for example for enteral (ENFit, ISO 80369-3: 2016) application or neuraxial (NRFit, ISO 80369-6: 201 6) application, are described in detail in the standards listed. For parenteral purposes - for example, hypodermic syringes - preferred connections with a cone connection with a cone ratio of 6%, which corresponds to a cone angle of 3.43 degrees, are also referred to in technical language as Luer connections. These known connection geometries use relatively large sealing surfaces which produce the required secure seal between the elements to be connected over a relatively long conical area. For this very good surface qualities are necessary in order to ensure the desired secure seal, for example between injection syringe and injection needle can. This can easily be achieved with injection-molded components using rigid and semi-rigid materials, for example using plastics such as polycarbonate (PC), styrene acrylonitrile (SAN), polystyrene (PS), etc. This also results in low "joining forces" for the users, whereas the connection of injection syringes as a removal device with filled drug containers is particularly demanding.

If a container in cost-effective manner in the context of large quantities and with other plastic materials (polypropylene, polyethylene) as described above, for example in the context of blow molding, are produced, including preferably the blow molding, filling and closing process belongs, are occurring leaks respectively leaks in the removal process from the container by means of the sampling device is not always safe to exclude, which may be associated with an adverse risk to the patient. It is therefore important to ensure that the extraction connection is sufficiently leak-tight on the one hand against the entry of possibly contaminated air into the interior of the container. on the other hand to ensure an unwanted escape of fluid from the container out.

With regard to the requirements explained above, in a container according to the invention according to US 201 6/0200484 A1, it has already been proposed, in addition to the large conical primary sealing surface over the entire neck region (FIGS. 6 to 8), to provide an additional secondary seal in axial distance provide the type of sealing lip, which opens after separation of the head part releasing the container opening into the environment and abuts the removal body of the removal device as soon as the removal body engages the container.

Between the additional, upper-lying sealing lip and the spaced-down conical sealing surface, two further functional surfaces are arranged, of which the one, third functional surface merges into the conical-sealing surface via a conical inner shoulder along a separating seam (FIG. 4). The further fourth functional surface adjoins this third functional surface, merges into the sealing lip and forms a cylindrical peripheral surface on the inner circumference side of the neck part, which is penetrated by the removal body for a removal process. This fourth functional surface, in conjunction with the adjacently outer wall parts of the neck part, forms two widened, rectangular fixing webs, on the underside of which, when the container is in place, an additional container peripheral wall is present and forms a fastening possibility for the removal system from the outside. The third and fourth functional surfaces, which hold the primary and secondary seals (conical sealing surface and sealing lip) axially at a distance from one another, comprise the removal body engaging in the container at a radial distance and insofar do not perform a sealing function. The realization of a reproducible sealing lip as a secure secondary seal, however, appears difficult, since the thin sealing lip is formed only by the removal of the cap part by the user. As a result, user-specific and handling-related irregularities of the sealing lip can not be reliably ruled out and thus question their reproducible sealing function.

By virtue of the additional secondary seal which is necessary, an additional friction naturally arises between the removal body and the container to be dispensed and / or dispensed in the region of its neck, which leads to increased actuating or joining forces in the production of the fluid-conducting connection, resulting in overall handling difficult, especially if the operator for hygiene reasons out wearing appropriate gloves. In order to be able to safely absorb such increased handling and connecting forces, in particular when the removal body is introduced, the neck wall in the region of the contact surface is made particularly thick-walled by its wall thickness so as to avoid kinking of the neck portion in this area; alone, increased actuation forces are again necessary in order to be able to insert the conical removal body in this area of the neck portion with increased wall thickness by corresponding expansion along the contact surface area.

Also, the two to the longitudinal axis of the container diametrically opposed Festlegestege form on the outer circumference of the neck portion the possibility to clamp the removal device with the removal body with an open container to form a LuerLock connection accordingly; Alone it comes through the disadvantageous arrangement of the two Festlegestege in a common plane transverse to the longitudinal axis of the container easily to over-rotation of the locking thread of the removal device, which I clearly confuse the user, as he must assume a defect in the container.

Based on this state of the art, the invention is based on the object of providing a container which is improved over the known container and of providing a device of manufacture with which the container according to the invention can be produced in a secure and cost-effective manner. This object is achieved by a container with the features of claim 1 in its entirety and a manufac turing lvorrichtung with the features of claim 1 7. Further vortei l haften embodiments of the inventive solutions according to the respective main claims are the subject of the dependent claims.

The container according to the invention is characterized in that, in the manner of an additional functional surface, a pre-surface merges seamlessly into the functional surface and that the pre-surface and the functional surface are received in the neck region between the other functional surfaces. The container according to the invention is further distinguished by the fact that the wall thickness in the region of the pre-area, but especially in the area of the functional area, is lower than the average wall thickness in the neck portion. This results in a decisive for the safe sealing low rad iale rigidity of the sealing area (Tei lfläche the on-position functional area depending on the detai ll ierten geometry of the removal body), since its expansion through the removal body only small forces are necessary. Advantageously in accordance with the invention, a short design of the functional surface is possible in order to ensure that the ampule has sufficient torsional stability. This, in turn, is important for opening the ampule at the intended separation point takes place and not in the area of the plant functional area, which would make the container unusable. Moreover, the short design of the plant-functional surface avoids a buckling or buckling of the container in the neck area during insertion of the removal body. The term "front surface" is intended to clarify that it lies in the direction of the insertion of the removal body into the container part in front of the installation functional surface , which has become known in the professional world under the brand bottelpack ^® .

The inventive reduction of the plant-functional surface in length by the head side seamlessly adjacent front surface ermögl icht surprisingly a secure seal and at the same time a small amount of force for the produc- tion of the connection between the removal body and container. Also for reasons of production-safe manufacture ment of the blow-molded Ampul len, the inventively achieved Kurzflächen- squeeze with increased sealing force effect of the known surface pressure is preferable, since geometric tolerances in the container neck are inherently compensated by the connection process. Thus, within a predefinable tolerance field, due to geometric deviations or deviations in the material structure, an effective seal between the inner sides of the container neck part and the removal body arises at high local pressing force, but overall reduced total forces due to the reduction of the effective total sealing surface.

In a preferred embodiment of the container according to the invention, it is provided that the mentioned differences in the properties between contact functional surface and front surface to improve the insertion force of the removal body and the sealing force effect in the - longitudinal extent and / or Wall thickness in connection with adjoining outer wall parts of the neck part and / or

- surface inclination

you can see.

In this way, an actual sealing surface (part of the abutment functional surface depending on the geometry of the removal body) of small width can be realized, which does not impair the stability of the neck part as a whole. Also, due to the small width and the low rigidity of the actual sealing area, the requirements for the angular tolerance of the contact surface function are much lower, which in particular when using soft materials such as polypropylene (PP) or polyethylene (H DPE, LDPE), to a improved mass production capacity. It is thus achieved that the container according to the invention can be inexpensively produced in large quantities in the context of a conventional blow molding, filling and closing method without further ado.

A radially elastic design of the container opening in the sealing surface area is achieved, in particular, by including the adjacent outer wall parts to the individual functional surfaces, the average wall thickness of the front surface and / or contact functional surface over the average wall thickness of the other functional surfaces by about 20% -50 %, preferably 20% -30%, is reduced. That is, it comes to an overall wall thickness reduction in quasi-Eigenl quasi-Dichtl inienbereich yet sufficient axial stiffness to avoid buckling, so that with low operating forces a secure connection for a container contents removal between removal body and container is hergestel lt. In a particularly preferred embodiment of the container according to the invention, the contact functional surface forms a contact cone which relative to the longitudinal axis of the container has an opening angle of 3.43 G rad (cone angle) or greater, wherein the corresponding Erm ermettelte opening angle of the present invention surface 30 G rad, respectively, has an oblique inclination of 1 5 degrees, ie half an opening angle. In particular, if the cone angle of the container in the region of its Entnahmestel le greater 3.43 G rad compared to a cone angle of the removal body, for example in the form of a syringe, m with a male Konustei l of 3.43 G rad or 6% according to ISO 80369 -7: 201 6 gewäh lt is a hemmn isfreier connection process for the removal body at low operating forces and at the same time achieved very good Flu id-Abd sealing. This also contributes to the fact that the opening angle of the additional conical front surface is 30 G rad; a value which, on the one hand, ensures a high linear pressure between the functional surface and the removal body and, on the other hand, an additional insertion guide in the sense of a conical enlargement for the free end face of the removal body, in order in this respect to start the insertion process in the direction the plant functional area further facilitate.

In a further preferred embodiment of the container according to the invention, it is provided with further functional surfaces on the inside of the Halstei les to further stiffen the Halstei l, wherein one of the other functional surfaces on its adjoining outside l th Wandtei l a lock ungsmögl ichkeit for Has removal body, preferably in the form of a threaded section, ie, preferably formed of two partial threads. With the dahmöven invention Befestigungsmögl probability is sichergestel lt that it can not be unintentionally when unscrewing the removal device with the removal body to overspeeding, so that in each case Fal l a safe threaded engagement is real isiert, in which the sealing cone of a lockable connection in the counter seat is pressed in a sealing manner. In a further preferred embodiment with the possibility of locking (for example LuerLock connection), an increased distance between the head-side end of the contact functional surface and the opening of more than 3 mm, preferably more than 4 mm, particularly preferably more than 5 mm is provided. This ensures that the connection process is first intervened in the partial thread before the sealing pressure is generated. This greatly improves handling for the user.

In order to be able to safely use removal devices with removal bodies of different lengths (only the minimum length of which is specified in the standard), it is also advantageous if, after complete connection, the upper edge of the opened container does not abut axially on the removal device. This is achieved - in contrast to the arrangement shown in US 2016/0200484 A1 - in that the distance from the head end of the partial thread to the separation point (the upper edge of the opened ampoule) is very small and not more than 2 mm, preferably less than 1 mm.

In a preferred embodiment of the container according to the invention it is provided that the abutment-functional surface and the pre-surface are overlapped at their adjacent outer wall portions of at least two webs, preferably diametrically opposite the longitudinal axis of the container opposite each other, at their free ends respectively in the adjacent, outer Wall regions of the third and fourth functional surface pass and thus substantially axially stiffen the relevant sealing area in the middle of the neck portion, and increase its Torsionswidermomentomoment against unwanted opening in the sealing area, but not significantly increase its radial stiffness. Furthermore, it is the subject of the invention, an apparatus for producing such a container or such a connecting device to be provided, wherein in the context of a molding plastic manufacturing lverfahren a forming mandrel is used, which forms at least two functional surfaces as a positive shape in the form of investment functional surface and in the form of the subsequent additional functional surface, as set forth above.

It is particularly preferred in a manufacturing lvorrichtung provided that the forming mandrel in the manufacture ment of a container, as stated above, is used in the context of a blow molding, filling and Schl ießverfahrens. H herefor the forming mandrel is designed as a hollow mandrel.

In the following, the solutions according to the invention are explained in more detail by means of exemplary embodiments according to the drawing. In principle, they show the notion of principle and not of scale

Fig. 1 in an end view of a filled befül container in the manner of an ampoule;

Fig. 2a-c in an enlarged presen- tation an upper part of the container of FIG. 1 before (Fig. 2a) and schematically in section dargestel after opening (Fig. 2b) by removing the head part of the Trennstel le (1 6th ), and (Fig. 2c) in a partially enlarged view;

FIG. 3 shows a side view of the container according to FIG. 1; FIG.

Fig. 4 in the manner of a partial longitudinal section of the invention

Connecting portion of the container connected to a lockable conical connection; and

Fig. 5 and 6 once in view, once in a longitudinal section, in sections, a filler ldorn for the manufacture len of a neck portion and Befül len a container of FIGS. 1 to 4. Fig. 1 shows as a whole a one-piece prior to its opening container in the form of a Ampul le plastic material consisting of a container part 1 0 for receiving a dispensable via a container opening 1 2 liquid or semi-solid container contents 14 for medical purposes or the like. The addressed container opening 1 2 is closed along a separation point 1 6 of a detachable head part 1 8, to which a neck portion 20 connects, which merges into the eigentl Ike container part 1 0. The head part 1 8 has a handle 22 with which the head part 1 8 at the Trennstel le 1 6 with low operating torques can turn off the neck part 20 by releasing the container opening 12. An exposed container opening 12 after detachment of the head part 1 8 by means of the handle 22 is schematically in section exemplified in Fig. 2b dargestel lt. Outer peripheral side is in the upper part of the neck portion 20, a portion of a threaded section 24 in the manner of a Aufschraubgewindes shown in the vorl 1 is formed from two partial thread sections 26, 28, of which a partial thread section 26 extends on the front side of the neck section 20 according to FIGS. 1 and 2a and a partial thread section 28 at the rear according to the illustration of the side view according to FIG Fig. 3. The two partial thread sections 26, 28 conclude with their mean thread courses in the region of their rear meeting in accordance with the illustration of FIG. 3 at an angle of 70 to 80 degrees with the container longitudinal axis 34 a. The said threaded section 24 on the outer circumference of the neck portion 20 is used for locking with a

Extraction device 30 with a tapered removal body 32, as is partially dargestel in part in Fig. 4 dar.

Such a removal device 30 is for example part of a syringe, the removal body 32 serves to remove the container contents 14 from the container part 1 0 with the container opening 1 2 released. As further shown in FIGS. 2a-c and 4, a plurality of different functional surfaces are provided on the inner side 40 of the neck part 18, the neck part 20 adjoining a transitional bend 42 on the upper side of the container part 10 and extending therefrom extends between the container part 10 to the separation point 16, to which the head part 18 connects. One of said functional surfaces forms a contact functional surface 44. One of the respective detail geometry of the removal body 32 dependent part of this investment-functional surface 44 is used to seal against the removal body 32 of the respective removal device 30. Extending the peripheral investment function surface 44 fictitious downwards, these extensions 46 close a cone angle of 3.43 Degree with each other and form so far a preferred connection with a 6% cone ratio. As far as the sampling device 30 is introduced with konusförmigem sampling body 32 completely along the neck portion 20 (see Fig. 4), a part of the outer wall 48 in sealing contact with at least As shown in FIG. 4, the removal device 30 is completely connected and an internal thread 38 of the removal device 30 is locked on the neck part 20 via the partial threads 26, 28. Between the head-side end of the neck part 20 and the removal device 30 remains a free length tolerance compensation distance 61 which allows the use of removal devices 30 with removal bodies 58 of different lengths to be used safely. This is inventively achieved in that the distance C of the head-side end of the partial thread of the separation point (the upper edge of the opened ampoule) is made very low and not more than 2 mm, preferably less than 1 mm. Seen in the direction of FIG. 4, an additional functional surface, the front surface 50, is formed on the inner side 40 of the neck part 20 above the abutment-functional surface 44. This additional functional surface 50 merges seamlessly into the abutment-functional surface 44, wherein the front surface 50 and the abutment-functional surface 44 are received between the other functional surfaces in the neck portion 20, which will be explained in more detail below. In particular, the front surface 50 differs in at least one property from the container functional side seamlessly adjoining system functional surface 44th

In any case, it should be ensured that the respectively existing difference in the properties between contact functional surface 44 and additional front surface 50 serves to ensure that when the removal body 32 is received, it can simultaneously act on it with an increased sealing pressure with a reduced sealing surface. On the one hand, provision is made in particular for the contactor functional surface 44 to be designed with a small width B (see FIG. 4, but not in a scale), where B is less than 3 mm, preferably less than 2 mm, particularly preferably less than 1 mm.

Furthermore, it is provided that, taking into account the adjacent rotationally symmetrical outer wall part 54 of contact functional surface 44 and outer wall part 56 of additional functional surface 50, the average wall thickness at least in a partial area of the contact surface 44 and / or a portion of the front surface 50 with respect to the middle

Wall thickness in the range of the other functional surfaces 66, 70 by about 20% - 50%, preferably about 20% -30%, is reduced. Here, in each case assume a mean wall thickness, since at least the functional surfaces 44 and 50 have a corresponding inclination, whereas in particular according to the illustrations according to FIGS. 1 to 3, the outer circumference of the outer wall parts 54, 56 is substantially cylindrical. The average wall thickness in the already mentioned sealing area with the inclusion of the two functional surfaces 44, 50 is thus less than 4 mm, preferably less than 3 mm, more preferably less than 2 mm. This results in a very favorable elastic design of the container or ampoule opening in said sealing area in the radial direction, by corresponding reduction in wall thickness. Thus, seen in the axial longitudinal extent of the container body 10, in the neck portion 20 a high axial stiffness to avoid the indentation during insertion / connection with the removal body 32 is achieved.

In a particularly preferred embodiment, however, provision is made for the correspondingly determined opening angle alpha of the additional front surface to be approximately 10 to 50 degrees, preferably 20-40 degrees, particularly preferably 30 degrees, relative to the contact cone of the peripheral contact surface 44. As a result, a tilt-safe insertion is possible, which can be done with little force and without the formation of abrasion particles. This is over the prior art

(US 201 6/0200484 A1), which has to install a sealing lip mandatory for improved sealing at the free end of the neck portion, very beneficial.

Accordingly, with the solution according to the invention, a high local pressure, a quasi-line pressure, leads to an improved sealing, wherein altogether lower total forces are required by a reduced sealing surface in order to move the removal device 30 with the removal body 32 into the final removal position in FIG Spend the neck portion 20 of the container or ampoule. This has no equivalent in the prior art. In a further preferred embodiment with the possibility of locking (for example LuerLock connection), there is an increased distance D (see Fig. 4) between the opening 12 and the head-side end of the abutment-functional surface 44 of more than 3 mm, preferably more than 4 mm, more preferably more than 5 mm provided. This ensures that the connecting process is first intervened in the partial thread before the sealing pressure between a part of the plant-functional surface 44 and the removal body is generated. This considerably facilitates the connection between the removal device and the container.

For an improved sealing and an improved insertion of the removal body 32, it may moreover be provided that in particular the

Plant functional surface 44 forms a contact cone, which has over the container longitudinal axis 34 an opening angle of more than 3.43 degrees (corresponding to 6% cone ratio according to ISO 80369-7: 201 6). Surprisingly, it has been shown that, despite different cone angles, the seal between the cone of the removal body 32 and the container 10 according to the invention, which conforms to the standard of 3.43 degrees, results in a reliable seal.

The radially elastic functional regions 44 and 50, which are embodied in a small width B, provide a quasi-linear sealing region which is largely insensitive to geometric tolerances, surface damage and the like, and thus enables an overpressure-proof use of the container. 4, as a further third functional surface 60 on the inner side 40 of the neck portion 20 there is a transition surface which opens into the container part 10 and, starting from the contact surface 44, an outwardly projecting transition cone 62 having. Seen in the direction of FIG. 4 downwards, the transition cone 62 is in a cylindrical transition piece 64 on, in the context of the transitional arc 42 and as part of the neck portion 20 integrally merges into the container part 10, which forms a recording option within the framework of a predeterminable hollow volume for the container contents 14. The pertinent transition piece 64 is on the outside and inside circumference side each formed as a circular or oval hollow cylinder piece.

Seen in the direction of view of FIG. 4, as a further fourth functional surface 66, adjacent to the further functional surface 50, a further transition cone 68 is provided, with opposite to a transition cone 62 opposite direction of inclination, i. the further transition cone 68 widens upward in the opposite direction. The pertinent fourth functional surface 66 passes on the inner peripheral side in the direction of the connected head portion 18 or in the direction of the released container opening 12 in a fifth functional surface 70 on its adjacent outer wall portion 72 a possibility for locking the removal device 30 in the form of at least one threaded section 24 (Fig. 1, 2 and 3) and shown in Fig. 4 only schematically.

As not visible in the view of FIG. 4, but shown in FIG. 2a, the abutment-functional surface 44 and the additional front surface 50 are overlapped at their adjacent outer wall portions or outer wall portions 54, 56 by at least two webs 76 at their free ends Ends in one piece integrally formed in the adjacent outer wall portions in the form of the respective transition cone 62, 68 in the associated area of the third and fourth functional surface 60 and 66 pass. The webs 76 are used for axial stiffening and stiffening in the circumferential direction and are, as shown in Fig. 2, to the longitudinal axis 34 of the container diametrically opposite to each other on the outside of the neck portion 20 is present. For ease of illustration, the pertinent webs 76 have been omitted in Fig. 1. As the Fig. 3 further shows that reproduces the container part 10 without container contents 14, can in a vertical plane with the webs 76 further stiffening webs 78 may be disposed on the outside of the container part 1 0. About such webs 78 is the respective container or the Ampul le in the context of a üblen card composite in the manufacture ment, before any separation, with other containers respectively Ampul len of a type in a row and lying in a common plane or orientation as a commodity interconnected (not shown).

A further solution according to the invention is directed to providing a device for the manufacture of a container according to FIGS. 1 to 4 or a connecting device, which uses a forming mandrel 80 as part of a shaping plastic manufacturing process, which serves as a positive mold according to the diagram 5 and 6 forms at least two mutually different shaping surfaces 82, 84, which in the context of the shaping process later correspond in terms of their design to the abutment-functional surface 44 or the adjoining functional surface 50. In particular, the forming mandrel 80 can be in the herstel lung of a container according to the embodiment of FIGS. 1 to 4 as part of a Übl l- cozy blow molding, fuel and ießverfahrens use sleeps (BFS or bottel- pack ^® process), the is described in more detail by way of example with reference to an inventive manufacturing device according to DE 1 0 2014 001 446 A1.

As shown particularly in FIG. 6, the forming mandrel 80 is formed as a hollow mandrel and has on its underside the forming surface 82, which later produces the 3.43 degree cone angle for the conical abutment functional surface 44. In addition, the forming surface 82 is arranged on the outer circumference of the forming mandrel 80, which seen in the longitudinal axis 86 of the mandrel 80, with this a preferred cone angle of 30 degrees or in the manner of a preferred 1 5 degrees bevel included. Above the molding surface 84 are in a superposition further mold surfaces 88 as a third type of Formflä- Chen arranged with different diameters, which serve the manufacture ment further functional surfaces 66, 70 in the neck portion 20; if necessary ls also for mitformen the head part 1 8 are used. The solution according to the invention has been explained in detail essentially by means of lockable and non-lockable conical connections according to ISO803669-7: 201 6, however, in a simple and analogous manner also on removal devices / removal bodies of other geometries, such as those for enteral (ISO 80369-3 : 201 6) or neuraxial (ISO 80369-6: 201 6, including, inter alia, spinal or epidural anesthesia and intrathecal chemotherapy).

With the solution according to the invention, a container or a Ampul le with a special len connecting device or other connection device is created, which can be produced in a cost-effective and production-safe manufacture in the context of a blow-Fül l-Verschließ- procedure, the BFS method. With low handling forces respectively handling torques, the corresponding connections for a fluid transfer, based on a standardized removal body, can be manufactured safely under- and over-pressure-tight, whereby soft plastic materials such as polypropylene (PP) or polyethylene (cf. HDPE, LDPE).

Claims

P a n t a n s p r e c h e

, Container, in particular Ampul le, consisting of plastic material with a container part (10) for receiving a container opening (12) deliverable container contents (14) of a along a Trennstel le (1 6) separable head part (18) is closed to a neck part (20) is connected, which has a plurality of different functional surfaces on the inner peripheral side, of which a contact functional surface (44) serves to seal against a removal body (32) which, when the container opening (12) is released, takes the container contents ( 14) is provided, in addition to the existing functional surfaces as a further functional surface a front surface (50) on the neck part inside (40) is provided, which is geometrically different from the plant functional surface (44), characterized in that the front surface ( 50) seamlessly merges into the abutment functional surface (44), and that the pre-surface (50) and the abutment functional surface (44) are received between the other functional surfaces in the neck portion (20). 2. Container according to claim 1, characterized in that the differences in the geometric properties between the abutment functional surface (44) and the pre-surface (50) in the

Longitudinal extension and / or

- Wall thickness in connection with adjacent external walls

Wall parts of the neck part and / or

surface slope

you can see.

Container according to claim 1 or 2, characterized in that at least a part of the abutment functional surface (44) is received when Menem removal body (32) at the same time exerts an increased sealing pressure on this with reduced sealing surface.

Container according to one of the preceding claims, characterized in that a sealing effect between the container and an over the released container opening (1 2) inserted removal body (32) ausschliessl only on the contact surface (44) of the neck portion (20) is achieved by the system-functional surface (44) in the removal position of the removal body (32) in the neck portion (20) on the outer surface of the removal body (32) at least partially comes to rest with the formation of a sealing surface.

Container according to one of the preceding claims, characterized in that, taking into account the adjacent outer wall parts (54, 56) to the individual functional surfaces (44, 50), the average wall thickness in the region of the front surface (50) and / or the abutment functional surface (44). compared to the average wall thickness of the other functional surfaces (66,70) by about 20% -50%, preferably about 20% - 30%, is reduced.

Container according to one of the preceding claims, characterized in that the abutment-functional surface (44) has a contact cone with an opening angle of 0 to 1 0 degrees, preferably 2-5 degrees, particularly preferably 3 to 4 degrees.

Container according to one of the preceding claims, characterized in that the opening angle (a) of the additional, in the form of a cone formed front surface (50) 10-40 degrees, preferably 20- 40 degrees, particularly preferably 25-35 degrees.

Container according to one of the preceding claims, characterized in that the distance (C) of the head end of the part wind (26) from the opening (12) is not more than 2 mm, preferably less than 1 mm.

9. Container according to one of the preceding claims, characterized in that the distance (D) of the head-side end of the abutment functional surface (44) and the opening (1 2) more than 3 mm, preferably more than 4 mm, particularly preferred more than 5 mm.

1 0. A container according to any one of the preceding claims, characterized in that as a further third functional surface (60) on the inside of the neck part (20) serves a transitional surface which opens into the container part (1 0) and starting from the functional Contact surface (44) has a transition cone (62). 1 1. Container according to one of the preceding claims, characterized in that a further transition cone (68) is provided as a further fourth functional surface (66) adjacent to the additional functional surface (50) with a direction of inclination opposite to that of a transition cone (62).

1 2. A container according to any one of the preceding claims, characterized in that the fourth functional surface (66) merges in the direction of the head part (18) in a fifth functional surface (70), on its adjacent, outlying wall part (72) a Befestigungsmög- LIkeit (74) for the removal device (30).

1 3. A container according to any one of the preceding claims, characterized in that the Befestigungsmögl probability (74) on the outside of the neck portion (20) for the removal device (30) from at least one threaded section (24) is formed in the manner of a Aufschraubgewindes and that Preferably, the threaded section (24) is formed from at least two partial thread sections (26, 28) whose middle layer Thread profiles at an angle of about 70 to 80 degrees with the container longitudinal axis (34) include.

14. Container according to one of the preceding claims, characterized in that the abutment-functional surface (44) and the pre-surface (50) at its adjoining außenl constricting wall areas (54, 56) of at least two webs (76) are overlapped, which at their free ends in each of the adjacent outer wall portions (54, 56) of the third and fourth functional surface (60, 66) merge.

1 5. A container according to any one of the preceding claims, characterized in that it is used for packaging of fluids for enteral application.

1 6. A container according to any one of the preceding claims, characterized in that it is used for packaging of fluids for parenteral application.

1 7. A container according to any one of the preceding claims, characterized in that it is used for packaging fluids for neuraxial use.

1 8. An apparatus for producing a container according to one of claims 1 to 1 7, characterized in that in the context of a shaping plastic manufacturing lverfahrens a forming mandrel (80) is used, which forms at least two molding surfaces (82, 84) as a positive shape in Form of the plant-functional surface (44) and in the form of the adjoining front surface (50).

1 9. Apparatus according to claim 1 8, characterized in that the forming mandrel (84) in the manufacture ment of a container according to one of claims 1 to 1 7 in the context of a blow-mold, filling and closing method is used.