WO2020074226A1

WO2020074226A1 - Sealing arrangement with assigned container and a sealant

Info

Publication number: WO2020074226A1
Application number: PCT/EP2019/074946
Authority: WO
Inventors: Michael Spallek; Johannes Geser; Michel Karrasch
Original assignee: Kocher-Plastik Maschinenbau Gmbh
Priority date: 2018-10-08
Filing date: 2019-09-18
Publication date: 2020-04-16
Also published as: DE102018007993A1

Abstract

1. Sealing arrangement with assigned container and a sealant. 2. The invention relates to a sealing arrangement, consisting of at least one container (2, 6, 10) and a sealant (18), which is assigned with a sealing face (22) to a wall area (10) of an outside of the container (2, 6, 10) facing the environment, wherein the inside of the container (2, 6, 10) accommodates a fill material, in particular in the form of a fluid filled under sterile conditions, which fluid can be removed from the container (2, 6, 10) by means of a removal device, such as a cannula or syringe needle, which, for this purpose, penetrates the sealant (18), which serves at least partially to seal an injection point formed on the wall region (10) for a removal process and which is produced separately from the container (2, 6, 10) and is designed in the form of a block or disc-like body, characterized in that a transition layer (12) is arranged between the sealant and the wall region (10) of the container forming the injection point, which layer lies with one contact surface (14) on the wall region (10) and with an opposing contact surface (16) on the sealant (18), and which is permanently connected at least to the wall region (10) by the one contact surface (14) thereof and covers at least the sealing surface (22) of the sealing body (18) adjacent thereto with the other contact surface (16).

Description

Sealing arrangement with assigned container and a sealant

The invention relates to a sealing arrangement consisting of at least one container and a sealant, which is assigned with a sealing surface to a wall area of an outside of the container facing the surroundings, the interior of the container receiving a

Filling material, in particular in the form of a low-germ filled fluid, is used, which can be removed from the container by means of a removal device, such as a cannula or a hollow mandrel, the sealant being penetrated, which at least partially seals a puncture point formed on the wall area for a removal process serves and which is made separately from the container and is in the form of a block or disc-like body. Furthermore, the invention relates to a method for

Manufacture of such a sealing arrangement.

A sealing arrangement of this type is disclosed in document EP 2 914 507 B1. Such sealing arrangements are used in particular for medical purposes, for example in the form of ampoules or

Infusion bottles, widely used. Such containers, which are made of plastic using the blow-fill-seal process, that is to say the well-known bottelpack ^® process, are for medical use

Applications are particularly suitable because the product only comes into contact with a polymer. These containers therefore offer a high level of security against microbial contamination, even with longer ones Storage times under unfavorable environmental conditions. Such

Plastic products are also disclosed, for example, in documents US 5,897,008 A, DE 10201 3012809 A1 or EP 2 269 558 A1.

In the sealing arrangement of the type mentioned at the beginning, which is known from EP 2 914 507 B1, the block-shaped thermoplastic sealant with the assigned wall area of the container is by means of a thermal

Joining process connected, in which the two joining elements

Temperatures are welded that are adapted to their softening behavior, for example at temperatures in the range of 200 ° C.

The fluid connection of the sealant to the wall area of the container avoids the risk of a gap forming on the contact surface of the sealant. The danger of one

Microbiological contamination through the penetration of germs, possibly supported by capillary action along a gap, is thereby avoided. However, in the case of thermolabile filling goods, there is a risk that the temperature load during the joining process can lead to a degradation of the filling material.

Starting from this prior art, the object of the invention is to provide a sealing arrangement of the type mentioned at the outset which, while maintaining the advantages achieved in the prior art, is distinguished by further improved properties.

According to the invention, this object is achieved by a sealing arrangement which has the features of patent claim 1 in its entirety.

According to the characterizing part of claim 1, an essential feature of the invention is that between the

Sealant and the wall area of the container forming the puncture point, a transition layer is arranged, which with a contact surface on Wall area and with an opposite contact surface on

Sealant is present, which is firmly connected via its one contact surface at least to the wall region and which partially or completely covers with its other contact surface at least the sealing surface of the sealing body arranged adjacent to it. Due to the fact that instead of the voluminous sealant body the thinner transition layer comes into contact with the puncture point on the wall area of the container, the input of thermal energy during application is considerably less than in the direct joining process known from EP 2 914 507 B1

Sealant body and wall area. The restriction to semi-crystalline - and therefore only slightly transparent - container materials, such as low or high density polyethylene (LDPE, HDPE) or polypropylene (PP), is no longer applicable, so that amorphous - and therefore highly transparent - materials can also be used include, for example, amorphous, aromatic polyesters, polyethylene terephthalate (PET), poly (ethylene 2,5-furandicarboxylate) (PEF), glycol-modified polyethylene terephthalate (PETG), as well as amorphous polyolefins, for example cycloolefin-containing polymers with low glass transition temperatures, such as

Cycloolefin polymers COP or cycloolefin copolymers COC and their blends. Thus, instead of being limited to translucent

Container materials can also be used with highly transparent container materials, which is a major advantage for the inspectability of the container contents. With transparent container materials, any particulate contamination or precipitation can be detected much faster and easier. The additional between sealant and

The transition layer lying on the wall surprisingly also improves the re-sealing after piercing with a needle or hollow mandrel for the first time, so that the containers are not only suitable for single use in medical use. The transition layer is advantageously applied in liquid form to the wall area of the container and / or the wall area of the sealant and then solidifies with the entry of a solid, materially bonded layer

Connection with the two contact surfaces of the container and sealant. The low viscosity of the transition layer material during application enables an efficient and targeted reduction of possible microbial contaminants (such as germs, spores, bacteria) on the surfaces to be joined by encapsulation. Thus, according to the invention, there is an additional basic mechanism of

Germ count reduction is available, which in most cases makes the use of antimicrobial additives, for example silver, unnecessary, which in turn leads to cost advantages. Furthermore, it is possible to treat or sterilize the material of the transition layer before it melts using known methods, such as irradiation with UV, gamma or beta radiation (E-beam radiation), EtO fumigation and the like, to reduce the number of bacteria.

The transition layer can advantageously be at least partially made of a thermoplastic, preferably a thermoplastic elastomer (TPE), particularly preferably a TPE with an elastic phase made of styrene-ethylene-butylene-styrene (SEBS), which has a hardness of less than 60 Shore A , has, be formed.

The transition layer is at least partially formed from a thermoplastic, whose melt mass flow rate according to ISO 1133 at a test temperature of 230 ° C. and a test mass of 5 kg is more than 10 g / 10 min, preferably more than 15 g / 10 min, is particularly preferably more than 20 g / 10 min.

To strengthen the adhesion of the transition layer to the contact surfaces of the container or sealant - and advantageously for additional Germ count reduction - these can be subjected to a plasma, corona or electron beam pretreatment before the joining process.

Particularly suitable for this is the use of so-called cold atmospheric plasmas, the sterilizing effect of which is detailed in the article by J. Ehlbeck, Low temperature atmospheric pressure plasma sources for microbial decontamination, Journal of Physics D: Applied Physics IOP Publishing, 201 1, 44 (1) , pp. 1 3002.

The sealant advantageously consists of a weldable plastic, preferably a thermoplastic elastomer (TPE), particularly preferably of a material of the same material class as that

Transition layer, for example a TPE with an elastic phase made of styrene-ethylene-butylene-styrene (SEBS). In particularly advantageous exemplary embodiments, the sealant is covered on its side opposite the sealing surface by a removable protective film.

The protective film to be removed before the first piercing can be used as

Serve tamper evidence. Alternatively, a tear-off tab - shown by way of example in FIG. 15a of DE 10201 3012809 A1 - can serve as a tamper-evident seal.

In preferred exemplary embodiments, the average die ratio of transition layer to sealant is 0.2 to 1.5, preferably 0.2 to 1.0, particularly preferably 0.2 to 0.8. The

average thickness of the transition layer can be in the range from 0.5 mm to 2 mm.

In particularly advantageous exemplary embodiments, the block-like sealant body has a double cylinder geometry, the larger diameter of which is connected to the transition layer. This results in a T-shaped longitudinal sectional area, the transverse bar of the Ts being connected to the transition layer. The arrangement can be made with particular advantage such that at least a part of the sealant body with a smaller diameter is placed under a predeterminable compressive prestress. This can be done by

Compression of at least a portion of the longitudinal bar of the Ts, preferably a portion facing away from the container head, of the sealant.

In particularly advantageous exemplary embodiments, the container is at least partially covered by a cap in the region of the sealant.

Advantageously, the arrangement can be such that the above-described compressive prestress is exerted on the sealant by means of the cap.

In advantageous exemplary embodiments, the container is at least partially formed from an amorphous polyolefin with a glass transition temperature of less than 130 ° C., preferably less than 100 ° C., the material at least partially from a cycloolefin polymer and / or cycloolefin copolymer and / or their blends is formed.

With particular advantage, the container can be formed at least partially from a material that is modified with an aromatic polyester, preferably polyethylene terephthalate, polyethylene furanoate, glycol

Contains polyethylene terephthalate and / or their copolymers and / or their blends. Compared to polyethylene terephthalate (PET), polyethylene furanoate (PEF) has better barrier properties against volatile flavors such as terpenes (e.g. limonene) and is less susceptible to cracking than PET.

The contents of the container for medical purposes are, preferably for parenteral applications, over the wall area with the puncture site removable. For this purpose, the container can be, for example, an ampoule, an infusion bottle or an infusion bag. Head designs for the latter are explained in detail in DE 10 201 3 012809 A1, in particular the head designs and cap designs shown there in FIGS. 1 to 1 3 (FIGS. 14 to 16 b) are suitable in principle and only have to be adapted slightly, for example by bulges.

According to claim 1 6, the subject of the invention is also a method for producing a sealing arrangement according to one of claims 1 to 1 5, the method being characterized in that the material of the transition layer, preferably low in germs, to a temperature between 120 ° C and 270 ° C, preferably between 1 60 ° C and 250 ° C, particularly preferably between 1 70 ° C and 230 ° C, heated and at a pressure of less than 30 bar, preferably less than 20 bar, particularly preferably less than 10 bar, is liquefied and applied without pressure to the sealant body and / or to a wall area of the container which has a puncture point for a removal device such as a cannula or a hollow mandrel. An inseparable, integral connection between the transition layer and the sealant body made of a plastic, preferably a thermoplastic elastomer (TPE), and / or the wall area of the container, as the elements to be connected, is formed by a connection process in which at least one of their contact surfaces on a Temperature of at least 50 ° C, preferably at least 70 ° C, particularly preferably at least 100 ° C and / or pretreated by means of plasma, corona or electron beam pretreatment before the

Transition layer is applied and the sealant body and container are pressed together. For this purpose, the cap is advantageously designed such that it engages with the container head and forms a positive connection to the container. The invention is explained in more detail below on the basis of exemplary embodiments illustrated in the drawing.

1 shows a compared to a practical embodiment in

Longitudinal section drawn on a larger scale only of the area adjacent to the container head of an embodiment of the invention

Seal arrangement provided container;

Fig. 2 is a representation corresponding to Fig. 1 of a second

Embodiment of the invention

Sealing arrangement, and Fig. 3a, b, c is a perspective oblique view and a side view of a head design of an infusion bottle or bag without or with the inventive sealing arrangement (Fig. 3c).

The invention is explained below on the basis of exemplary embodiments with containers of the type shown in the mentioned document EP 2 914 507 B1. In such containers, the contents can be removed by directly inserting a cannula. The containers of the

Embodiments, of which only the upper area of their main container part 2 is shown in the figures, are made of one Manufactured plastic material that is suitable for the blow-fill-seal process, for example according to the well-known bottelpack ^® system. The main part 2 is followed, along the longitudinal axis 4 of the container, by a narrowed, cylindrical neck part 6, which in the further course merges into a bulge 8 which widens the diameter and, in the example shown in FIG. 1, has the shape of a convex curvature. The

Bulge 8 in turn merges into a container wall area 10, which forms the upper end of the container. The wall area 10 has the shape of an upwardly slightly curved head membrane which can be pierced for removal. On the outside of the wall region 10 there is a transition layer 12, which covers the major part of the outer surface of the wall region 10 between the bulges 8 with a contact surface 14. At the upper contact surface 16 of the transition layer 12 opposite this contact surface 14, a sealant 18 is connected to the transition layer 12, which essentially covers the entire surface area of the contact surface 16. In the example of FIG. 1, the transition layer 12 has an average layer thickness that is similar to the wall thickness of the container wall region 10. In the example of FIG. 1, the sealant 18 has the shape of a round, disk-like body, the upper side 20 of which has the same curvature as the lower side, with which it bears as the contact surface 22 on the transition layer 12, so that the body of the sealant 18 is continuous has almost the same thickness measured in the axial direction. The thickness ratio of transition layer 12 to sealant 18 is approximately 0.3 in the example of FIG. 1. On the top 20 of the sealant 18, a protective film 24 made of a plastic-metal laminate is releasably attached as a tamper-evident seal, which can be removed by means of a laterally protruding handle 26 before the container is used for the first time.

The exemplary embodiment shown in FIG. 2 differs from the example from FIG. 1 in that the sealant 18 has a block-like body in FIG Form of a double cylinder is formed, which has a T-shape in longitudinal section. The longitudinal bar 28 of the T-shape has a diameter which corresponds approximately to half the diameter of the crossbar 30 of the T-shape. The crossbar 30 forms with its underside

Contact surface 22 with which it bears on the contact surface 16 of the transition layer 12, the cross bar 30 covering almost the entire surface area of the contact surface 22. The axial length of the longitudinal beam 28 is approximately one third of the total diameter of the T-shape, which is due to the

Outside diameter of the crossbar 30 is formed. The thickness of the crossbar 30 measured in the axial direction corresponds approximately to twice the layer thickness of the transition layer 12 in the latter

Central area. Since the contact surface 16 of the transition layer 12 follows the planar contact surface 22 of the crossbar 30, while the contact surface 14 of the transition layer 12 abuts the curved container wall region 10, the layer thickness of the transition layer 12 outside the central region is greater than in the central region.

Another difference between the exemplary embodiment of FIG. 2 and the example of FIG. 1 is that the container in the head region is covered by a cap 32 in the form of a plastic injection molded part. Starting from an upper part 34, which comprises the longitudinal bar 28 of the sealant 18, the cap 32 has a ring from the neck part 6

surrounding, resilient holding fingers 36, each of which forms fixing parts 38 with its free end region. These have, starting from the end edge 40, a radially inward and upward inclined surface 42, at the end of which there is a holding surface 44 which is angled from the inclined surface 42 such that the surfaces 42 and 44 form a latching hook 46 with which the bulge 8 of the neck part 6

is reachable. When putting the cap 32 overflow

Inclined surfaces 42 the bulge 8, the holding fingers 36 being deflected elastically until, after the bulge 8 has overflowed, they move into the in FIG Fig. 2 spring back latching or hooked position shown, in which they engage behind the bulge 8, so that the cap 32 is positively connected to the neck part 6. In its upper part 34, the cap 32 forms a pressure surface 52 with a cylindrical pressure body 48 resting on the cylindrical surface of the longitudinal beam 28, which pressure surface rests on the upper side of the cross beam 30. The axial length of the pressure body 48 is dimensioned such that, in the fixing position of the cap 32 shown in FIG. 2, the pressure beam 48 acts on the longitudinal beam 28 of the sealant 18 with a prestress. At the upper end of the upper part 34, the cap 32 has an annular edge 54 which projects beyond the pressure body 48 and forms a border for the upper end surface 56 of the pressure body 48 and the upper end surface 58 of the longitudinal beam 28. The protective film 24, which is attached to the end surface 56, extends with its handle 26 outwards over a lateral support surface 60 in the upper part 34.

3a and 3b and 3c respectively show a perspective oblique view and a side view of a head piece 7 of an infusion container without or with a sealing arrangement according to the invention (FIG. 3c).

3a and 3b are known from DE 10 201 3 012 809 A1 and are only described in summary below. They have a bulge 8 and a head surface 51, which spans the transition region 53, from which two nipple-shaped bumps 50 'protrude. The bumps 50 'lie at a distance from one another on a line running diametrically on the head surface 51 and each form a round, easily penetrable wall region 10 at their front end. This has an extremely slight curvature, ie it runs almost parallel to the main plane of the head surface 51 . A side wall 54 with a concave curvature connects the wall area 10 to the surrounding head surface 51. Fig. 3c - similar to Fig. 1 5c from DE 10 201 3 012 809 A1 - shows a cap 32 placed on the container head piece 7 described above, which is locked in an analogous manner to the inclined surfaces 42 on the bulge 8 as shown in Fig. 2. On each of the two bumps 50 'there is a sealing arrangement with a transition layer 12, which on

Wall area 10 with the contact surface 14 and on the disc-shaped sealing body 18 with the contact surface 22. The pressure body 48 places the sealing body 18 under a pressure prestress. The sealing body 18 is covered by a tear-off tab 99, which can serve as an originality indicator.

The sealing arrangements located on the two bumps 50 ′ can differ in the form and / or materials of the sealant 18 and / or transition layer 12 and / or the prestress of the sealant 18, for example different sealants 18 can be used to meet special requirements such as high retention forces the removal by a hollow mandrel.

In an analogous manner, sealing arrangements according to the invention can be applied to head and cap designs as shown in WO2014 / 1 69929A1 Fig. 4.

For containers provided with the sealing arrangement according to the invention and manufactured according to the BFS process, fully transparent plastic materials are advantageously provided as container material, in particular

aromatic polyester materials, preferably polyethylene terephthalate, polyethylene furanoate, glycol-modified polyethylene terephthalate and / or their copolymers and / or their blends. Likewise, an amorphous polyolefin, such as cycloolefin polymers and / or cycloolefin copolymers, is advantageously used as the fully transparent container material Glass transition temperatures are less than 1 50 ° C, preferably less than 100 ° C, and / or their blends. Due to the application of the thin transition layer 12, which is liquid during the application, a great adhesive force is achieved in the sealing arrangement according to the invention

Connection of the sealant 18 to the container wall area 10 can be realized with a low input of thermal energy. A thermoplastic elastomer with a high MFR value according to ISO 1133 of more than 10 g / 10 min can be applied without having to heat the container wall area 10 and the sealant 18 above 100 ° C., and if at all only superficially. When applying, the material has the

Transition layer 12 typically has a temperature of approximately 70 ° C to 230 ° C and a viscosity similar to that of honey. The transition layer material is advantageously applied by means of a simple extrusion system with very low pressures of less than 30 bar compared to an injection molding process. The low viscosity of the

Transition layer material during application enables an efficient and targeted reduction of possible microbial contaminants, such as germs, spores, bacteria, on the surfaces to be connected by encapsulating them in the transition layer. Furthermore, in the invention it is optionally additionally possible to treat or sterilize the transition layer material prior to melting it using known methods, such as radiation sterilization, EtO fumigation and the like, to reduce the number of bacteria. To strengthen liability and additional

The number of bacteria on the surfaces can also be reduced by the surfaces of the sealant 18 and / or the container wall area 10

Be subjected to pretreatment, for example by plasma, corona or electron beam processes.

The joining process for realizing the exemplary embodiment of FIG. 2 can advantageously be carried out in such a way that the material of the

Transition layer 12 extruded and at a temperature of For example, 250 ° C. is metered onto the container wall area 10. Immediately thereafter, the cap 32 with the sealant 18 mounted therein, which is partially under compressive stress, is placed on the

Pressed container head and locked in the holding position by means of the locking hook 46.

To further explain some of the following

Exemplary embodiments reproduced: ampoules with a head design according to FIG. 2 were produced from several materials. A BFS plant from Rommelag of the type Bottelpack bp460 with 20-cavity molds was used for this; The following polymers PETG (MB0022 from Eastman), COC polymer (Topas 8007S, from Topas) and a polypropylene (SB81 5MO, from Borealis) were used. The sealant had a double cylinder geometry corresponding to FIG. 2.

1 . A sealant material was used for the PET-G containers

thermoplastic polymer from Kraiburg type TF3FMS with a hardness of 34 Shore A and a density of 1.1 g / cm ³ . When

The transition layer material was a maleated styrene-ethylene-butylene-styrene polymer from Kraton Polymers US LLC type FG 1901 G with a hardness of 17 Shore A, a density of 0.91 g / cm ³ and an MFI of 22 g / 10 min like. ISO 1 1 33 (test temperature 230 ° C, test weight 5 kg) is used. The transition layer material was extruded at a pressure of 8.2 bar and a temperature of 21 5 ° C., metered onto the sealant and immediately pressed onto the container head. The average thickness of the

Transition layer was in the range of 0.5 mm to 2 mm. A thermoplastic polymer with an elastic phase made of SEBS (styrene-ethylene-butylene-styrene) from Kraiburg type TF2CGT with a hardness of 18 Shore A and a density of 0.88 g / was used as the sealant material for the containers made of COC or polypropylene. cm ³ used. A SEBS elastomer was used as the transition layer material

Wittenburg (Zeewolde, NL) type Cawiton PR1 31610 with a hardness of 10 Shore A, a density of 0.90 kg / dm ³ and an MFI of 12 g / 10 min. ISO 1 1 33 (test temperature 230 ° C, test weight 5 kg) is used. The transition layer material was extruded at a pressure of 6.3 bar and a temperature of 185 ° C

The container head is dosed and immediately afterwards the cap with the pre-tensioned sealant is pressed onto the container head. The average thickness of the transition layer ranged from 0.8 mm to 2.2 mm.

Claims

Patent claims

Sealing arrangement, comprising at least one container (2, 6, 10) and a sealant (18), which is assigned a contact area (22) to a wall area (10) of an outside of the container (2, 6, 10) facing the environment, wherein the interior of the container (2, 6, 10) serves to hold a filling material, in particular in the form of a low-germ fluid, which is removed by means of a removal device, such as a cannula or a

Hollow mandrel can be removed from the container (2, 6, 10) while penetrating the wall area (10) of the container (2, 6, 10) and the sealant (18), the sealant (18) for sealing during and after the removal process and which is produced separately from the container (2, 6, 10), characterized in that a transition layer (12) is arranged between the sealant (18) and the wall area (10) of the container (2, 6, 10) forming the puncture point is with a contact surface (14) on

Wall area (10) and with an opposite

Contact surface (22) at least partially abuts the sealant (18) and is at least partially firmly connected.

Sealing arrangement according to claim 1, characterized in that the transition layer (12) in liquid form on the

Wall area (10) and / or is applied to the sealant (18), and then solidifies to form a solid

Connection to the wall area (10) and the sealant (18).

Sealing arrangement according to claim 1 or 2, characterized

characterized in that the transition layer (12) is at least partially made of a thermoplastic, preferably a thermoplastic elastomer, particularly preferably a thermoplastic elastomer with an elastic phase made of styrene-ethylene-butylene-styrene (SEBS). 4. Sealing arrangement according to one of the preceding claims, characterized in that the transition layer (12) consists at least partially of a plastic which has a hardness of less than 80 Shore A, preferably less than 60 Shore A, particularly preferably less than 50 Shore A.

5. Sealing arrangement according to one of the preceding claims, characterized in that the transition layer (12) is at least partially formed from a thermoplastic, the melt mass flow rate according to ISO 1 1 33 at a test temperature of 230 ° C and a test mass of 5 kg more is more than 10 g / 10 min, preferably more than 15 g / 10 min, particularly preferably more than 20 g / 10 min.

6. Sealing arrangement according to one of the preceding claims, characterized in that the sealant (18) is at least partially formed from a thermoplastic, preferably a thermoplastic elastomer (TPE), particularly preferably from a material of the same material class as the transition layer.

7. Sealing arrangement according to one of the preceding claims, characterized in that the sealant (18) on its side opposite the contact surface (22) from a

removable protective film (24) or a tear-off tab (99) is covered.

8. Sealing arrangement according to one of the preceding claims, characterized in that the average thickness Ratio of transition layer (12) to sealant (18) is 0.2 to 1.5, preferably 0.2 to 1.0, particularly preferably 0.2 to 0.8.

9. Sealing arrangement according to one of the preceding claims, characterized in that the sealant (18) has a T-shaped longitudinal sectional surface and that its crossbar (30) is connected to the transition layer (12).

10. Sealing arrangement according to one of the preceding claims, characterized in that the sealant (18) has a T-shaped longitudinal sectional surface and that the longitudinal bar (28) is at least partially placed under a predeterminable compressive stress.

1 1. Sealing arrangement according to one of the preceding claims, characterized in that the container in the region of the sealant (18) and the transition layer (12) is at least partially covered by a cap (32).

12. Sealing arrangement according to one of the preceding claims, characterized in that by means of the cap (32)

Pretensioning is exerted on at least part of the sealant (18), preferably on its longitudinal bar (28) in contact with parts (48) of the cap (32).

1 3. Sealing arrangement according to one of the preceding claims, characterized in that the container (2, 6, 10) from a transparent, preferably at least partially from a

predominantly amorphous polyolefin with a

Glass transition temperature of less than 1 50 ° C, preferably less than 100 ° C, is preferably formed at least partially a cycloolefin polymer and / or a cycloolefin copolymer and / or their copolymers and / or blends.

14. Sealing arrangement according to one of the preceding claims, characterized in that the container (2, 6, 10) is at least partially formed from a material which preferably at least one transparent aromatic polyester

Contains polyethylene terephthalate, polyethylene furanoate, glycol-modified polyethylene terephthalate and / or their copolymers and / or their blends.

1 5. Sealing arrangement according to one of the preceding claims, characterized in that the content of the container (2, 6, 10) for medical purposes, preferably for parenteral application, can be removed via the wall area (10) with the puncture site.

1 6. A method for producing a sealing arrangement according to one of the preceding claims, characterized in that the material of the transition layer (12), low in germs,

preferably sterilized, heated to a temperature between 120 ° C and 270 ° C, preferably between 1 60 ° C and 250 ° C, particularly preferably between 1 70 ° C and 230 ° C and with a pressure of less than 30 bar less than 20 bar, particularly preferably less than 10 bar, is liquefied and applied without pressure to the sealant (18) and / or to a wall area (10) of the container (2, 6, 10).

1 7. The method according to claim 16, characterized in that an insoluble integral connection between the

Transition layer (12) and the sealant (18) from one

Plastic, preferably a thermoplastic elastomer (TPE) and / or the wall area (10) of the container (2, 6, 10), as elements to be connected by a connection process is formed, in which at least one of its contact surfaces (14, 22) is heated to a temperature of at least 50 ° C, preferably at least 70 ° C, particularly preferably at least 100 ° C and / or by means of a plasma, and / or

Corona discharge and / or an electron beam is treated before the transition layer (12) is applied.