DE102008060457A1 - Closure manufacturing method for sterile medicament container, involves introducing sealing element into closure body, bringing annular- and grid shaped regions in contact with each other, cooling and connecting regions - Google Patents

Abstract

The method involves outwardly accessing a portion of a sealing element (3) in a use position of a closure (1). A closure body (2) and the sealing element are partially melted in annular- and grid shaped regions (12, 13), which rest nearby a tunnel opening (11) in the use position, where the sealing element closes the tunnel opening. The sealing element is introduced into the closure body. The regions are brought in contact with each other, are cooled, and are connected with each other, where the regions surround the closure body and the sealing element in a closed form.

Description

The The invention relates to a method for producing a closure for a preferably sterile medicament container, wherein the closure of a prefabricated, cup-shaped Closure body and in this used, prefabricated, elastic-soft sealing element is assembled, wherein the closure body at least one puncture opening on the bottom side of its pot shape which is closed by the sealing element, wherein a part of the sealing element in the use position of the closure is accessible from the outside.

Such closures are for example from the DE 38 35 720 A1 known, wherein the closures described therein are made by first a closure body is made in the form of a cap and in a further manufacturing step in the same tool or a part thereof, the elastic-soft sealing element is injected into the cap, and have proven themselves.

The Injection of the sealing element guaranteed in the prefabricated cap Although one, for example, for a sterile medication container necessary tight seal between sealing element and cap, requires however, expensive tool in the manufacturing process.

Of the Invention is based on the object, a production process to provide a closure of the type mentioned, which causes low production costs.

to Solution to the problem is in the method of the initially described Art provided that in a first step, the closure body and the sealing element in areas close in the position of use the at least one puncture opening are and these Surrounded in closed form, to be melted and that in one second step, the sealing element in the closure body is used, wherein the fused areas with each other brought into contact, cooled and thereby with each other get connected.

By the mutual contact of the melted areas becomes an inseparable, tight connection between the closure body and created the sealing element. Because of the molten areas the puncture opening is surrounded in the use position is a tight closure of the lock interior in the use position reached at the puncture opening, which is an application for especially sterile medication containers allowed. The For example, puncture opening allows the implementation a cannula for withdrawing medication from the medicament container through the sealing element. The arrangement of the connection of Sealing element and closure body near the puncture opening causes the necessary mechanical stability of the closure against damage during the puncture process.

The required cooling of the melted areas, by the one cohesive connection between the sealing element and closure body is made can be accelerated by the closure body and / or the sealing element in thermal contact with coolants is / are made. For many applications, however, is the cooling effect the holding device for the sealing element or the closure body already sufficient.

The Sealing element can in the use position of the closure from the outside or be inserted from the inside into a receptacle of the closure body. Is the sealing element inserted from the outside, so is even a larger part of the sealing element from the outside accessible, as dictated by the size of the sealing opening is. The sealing opening or the sealing element can be protected by an additional cover, which is removed before first use.

For example can be provided that the area on the closure body and / or the area on the sealing element with a laser light beam is melted / become. The advantage here is that almost any Melting temperatures can be achieved.

alternative can be provided that the area on the closure body and / or the area on the sealing element with a welding mirror is melted / become. Under a welding mirror is Generally understood a heated tool, which is based on a Temperature above the melting temperature of a to be processed Workpiece is heated and then in the manner of a punch placed on the workpiece or pressed which, in the contact areas between the workpiece and welding mirror melted the workpiece becomes. Due to the shape of the welding mirror leaves the shape of the fused area on the workpiece exactly ben. Welding mirror make a cost-effective Means for melting materials in specified areas represents.

A particularly advantageous combination can provide that the area on the closure body is melted with a welding mirror and that the area is melted at the sealing element with a laser light beam. Thus, the sealing element can be made of a material, whose melting temperature is above the maximum permissible or maximum achievable operating temperature of the welding mirror.

Especially It is favorable if the area on the closure body ring-shaped or circular is formed. Thus, a Deformation of the puncture opening due to melting avoided. They are any shapes, such as polygonal, oval or circular ring shapes, usable.

Around the externally accessible in use position Part of the sealing element can not destroy the area on the closure body and / or the area on the sealing element ring or circular formed. Again, here are any shapes, such as polygonal, oval or circular ring shapes, usable. The ring shape encloses that part, the accessible in use position from the outside is and saves it.

to Formation of the shape of the fused area may be provided be that a laser light beam with a ring or circular cross-section for melting the area on the closure body and / or the area is used on the sealing element. Thus, the entire Be melted area simultaneously. The shape of the cross section can be by beam shaping or by shading with a mask To be defined.

alternative can be provided that a laser light beam with a punctiform Cross section is used and the laser light beam to melt the area at the closure body and / or area on the sealing element and along the melted area or the melted areas is performed. Thus, will the area to be melted in a period of time in the manner of a Scans overlined.

Especially It is favorable when the closure body and the sealing element in the first step before the melting of the areas be brought into a pre-assembly, the insertion of the sealing element in the closure body by a one-dimensional, rectilinear Movement allows. The insertion and connection can thus be carried out immediately after melting. It This will prevent the molten areas from prematurely to freeze again.

to Achieving short production times can be provided that the Area on the closure body and the area on the sealing element be melted in the first step at the same time.

short Travels and travel times between the melting position and the mounting position are reached when the laser light beam for melting with a mirror effect on the areas on the closure body and / or is directed to the sealing element in pre-assembly. The Distance between the positions in which the melting of the sealing element and the closure body on the one hand and the assembly of the Seal element and the closure body on the other hand, is therefore not by the dimensions of the Laserlichtstrahlgenera sector limited to the bottom.

According to one Embodiment of the invention can be provided that for the closure body and / or for the sealing element an optically and / or for the laser light beam not transparent material is used. It is thus avoided when using the closure on the medicament container accumulating in the closure Liquid quantities are visible from the outside.

A design suitable for many practical applications provides that the closure body has at least two puncture openings. In this case it can be provided that the closure body in two areas, which lie in the position of use close to each of a puncture opening and these are surrounded, at the same time melted. Alternatively or In addition, it can be provided that the sealing element in two areas, which in use position close to each one piercing opening lie and surround it, at the same time melted. hereby This results in particularly short production times, and it becomes the danger premature solidification of the melted areas, through which the connection of the sealing element with the closure body impaired.

at An embodiment may provide that the Sealing element with a bias, in particular a radially in Regarding puncture-oriented bias, is inserted into the closure body. By the bias in the sealing element, a in the sealing element with a Needle, cannula or the like inserted puncture hole after removing this needle, cannula or the like again close automatically. It becomes a denser one Completion of the medicine container even after use reached.

A particularly resistant outer shape results, if by the sealing element inserted into the closure body in the position of use, the puncture opening or the puncture openings on the closure body at least partially, in particular completely, is / are completed.

at The method may have a disk-shaped sealing element to be used with advantage.

Especially It is favorable if a sealing element with a front and a back is used, with the front and the back formed with matching shape are. It therefore does not have to when using the sealing element To check whether the sealing element in the correct orientation is arranged, since the sealing element in both orientations alike can be used.

Around to prevent the molten areas on the welding mirror attach or stick, it can be provided that a welding mirror is used with an anti-stick coating. This can be provided be that uses a material for the sealing element is, whose melting temperature is above the temperature, up to which the non-stick coating can be used non-destructively is. In this case, the melting of the sealing element, for example done by laser light irradiation.

The inventive method can be advantageous for Production of a closure for a preferably sterile Medicament container be used.

at the method of the invention, the use of laser light beams for melting areas on a sealing element and / or be provided on a closure body.

Of the Closure body is preferably made of a fusible Plastic, so a thermoplastic manufactured.

The Sealing element is preferably made of a thermoplastic elastomer (TPE) made.

The Invention will now be described with reference to exemplary embodiments, but is not limited to the embodiments. Further embodiments result from combination the features of the claims with each other and / or with features of the embodiments.

It shows:

1 a closure in a perspective sectional view,

2 the closure according to 1 in a two-dimensional sectional view,

3 the use of a welding mirror on a closure body,

4 melted areas on a closure body,

5 the use of laser light beams on a closure body,

6 the use of laser light beams on a sealing element,

7 melted areas on a sealing element and

8th the use of a welding mirror on a sealing element.

1 shows you as a whole 1 designated closure for a sterile medication container.

The closure 1 is from a prefabricated closure body 2 made of a thermoplastic material and a sealing element 3 composed of a TPE material.

The closure body 2 has a floor 4 and a wall 5 on and thus forms a pot shape. On Wall 5 closes over a shoulder 6 another wall 7 at. While the wall 5 has an oval basic shape, has the wall 7 a cylindrical basic shape. Total form wall 5 . 7 and soil 3 So a pot shape, the opening of this pot is placed in use on an opening of the drug container.

The sealing element 3 is disc-shaped and has a front 8th and a back 9 , In the 1 and 2 is the sealing element 3 so inserted into the closure body that the front 8th in touching contact with the ground 3 brought is.

Both at the front 8th as well as at the back 9 of the sealing element 3 are cylindrical protuberances 10 formed into two cylindrical puncture openings 11 in the ground 4 of the closure body 2 fit and fill in these. The outer surfaces of the protuberances 10 then close flush with the ground 4 from.

The sealing element 3 is thus symmetrical and can in two orientations, namely with the front 8th or with the back 9 to the ground 4 , be mounted as the front 8th and the back 9 are formed with matching shape.

Due to the symmetrical, central arrangement of the two puncture openings 11 can the sealing element 3 also in two orientations with the front side 8th to the ground 4 be mounted, the orientations by rotation of the sealing element 3 180 ° around an axis perpendicular to the front 8th stands, can be converted into each other.

The same applies to the back 9 so that a total of four orientations for a possible attachment of the sealing element 3 on the closure body 2 result.

In 2 it can be seen that the sealing element 3 cohesive with closure body 2 connected is.

For this purpose, in the embodiment, the sealing element 3 and the ground 4 in areas 12 . 13 fused, brought into contact with each other under a contact pressure, cooled and thereby joined together materially.

3 shows a way to the areas 12 on the closure body 2 melt, that is the closure body 2 in the fields of 12 about the critical temperature for the transition of the material from which the closure body 2 consists of heating in a deformable, in particular pasty or liquid, state.

For this purpose, a welding mirror 14 used, which serves as a heat reservoir metal block 15 and molded contact elements 16 having.

The contact elements 16 are annular and thus give the shape of the areas to be melted 12 in front. The hot contact elements 16 melt the material of the closure body 2 in the fields of 12 in which the contact elements 16 the closure body 2 touch, on.

The contact elements 16 are provided with an anti-adhesion coating, which is an adhesion of the molten material in the areas 12 when removing the welding mirror 14 from the closure body 2 prevented.

After removing the welding mirror 14 the result is the 4 shown situation. They are annular around each puncture opening 11 areas 12 formed, in which the material of the closure body 2 has melted.

5 shows another way, the melted areas 12 in the ground 4 of the closure body 2 train.

For this purpose, a laser light beam 17 on the ground 4 of the closure body 2 directed. The wavelength of the laser light used is so on the material of the closure body 2 matched that the laser light well in the closure body 2 is absorbed. The absorption leads to a heating of the material of the closure body 2 at the point of impact of the laser light beam 17 and thus to a melting.

The laser light beam 17 is now performed so that in time, the area 12 is swept over and that the area 12 thus after the action of the laser light beam 17 on the ground 4 has melted.

In the embodiment shown, even two laser light beams 17 parallel and at the same time on the ground 4 directed and guided, each laser beam 17 an annular area 12 with melted material on the floor 4 formed.

It results after switching off the laser light beams 17 thus likewise the situation according to 4 ,

Instead of too 5 described scanning process, the melting can also be performed with a laser light beam, the cross section is not as in 6 is approximately punctiform shaped, but whose cross-section is annular, wherein by the ring shape, the dimension and shape depending on one of the annular regions 12 is determined. Again, two parallel laser light beams can be used, the two areas simultaneously 12 to melt.

6 shows one way, the melted areas 13 in the sealing element 3 train.

On the sealing element 3 becomes a laser light beam 17 directed, whose wavelength is so on the material of the sealing element 3 is tuned that the sealing element 3 at the point of impact of the laser light beam 17 is melted well.

It is thus in the embodiment according to 6 a laser light beam 17 used with a point-shaped cross-section. This laser light beam 17 becomes the melting of the area 13 on the sealing element 3 and along the melted area 13 conducted in a grid-shaped or scanning motion.

There are two parallel laser light beams 17 provided, each one area 13 on a protuberance 10 to melt. The laser light rays 17 are synchronized.

The laser light rays 17 are guided so that the later used in the closure body sealing element 3 outer surface of the protuberance 10 not attacked.

It results after use of the laser light beams in 7 shown situation. The melted areas 13 surround the protuberances 10 each annular and save them from. The Material of the sealing element 3 is so on the protuberances 10 essentially not fused to the pierceability of the sealing element 3 with a needle, cannula or the like in the region of the puncture openings 11 not to interfere.

Alternatively, the melted areas 13 also with a welding mirror 14 be trained as in 8th is shown. The welding mirror 14 is like to 3 described trained; it can even be the same welding mirror 14 as in 3 used when the for melting of the sealing element 3 in the fields of 13 required operating temperature with the welding mirror 14 according to 3 can be achieved.

Alternatively, the melted areas 13 also be formed with laser light beams having an annular cross-section, as above for the formation of the areas 12 on the closure body 2 has been described. Here, the same laser light beam generator as for melting the areas 12 on the closure body 2 where appropriate, where appropriate, the wavelength of the laser light used for the sealing element 3 is set.

Instead of the front 8th of the sealing element 3 can in the same way in the described method, the back 9 of the sealing element 3 used as both sides 8th . 9 have a matching shape.

The closure body 2 and the sealing element 3 be before the melting of the respective areas 12 respectively. 13 brought into a pre-assembly, the insertion of the sealing element 3 in the closure body 2 through a one-dimensional, straight-line movement. In particular, so the front 8th of the sealing element 3 where the areas 13 be formed as described, parallel to the ground 4 aligned and this floor 4 facing. The protuberances 10 on the front side 8th are on the puncture openings 11 aligned.

The area 12 on the closure body 2 will now be simultaneously with the area 13 on the sealing element 3 melted.

Thus, the sealing element 3 after the melting of the areas 12 respectively. 13 directly into the closure body 2 be used. The sealing element 3 comes with a contact pressure against the closure body 2 applied until the melted areas 12 . 13 have cooled so far that the in 2 shown cohesive connection of the sealing element 3 with the closure body 2 results.

The sealing element 3 is here with a radial with respect to puncture openings 11 aligned bias in the closure body 2 used.

The welding mirrors 14 are usually used with an anti-stick coating to prevent the melted area from sticking 12 respectively. 13 at the contact elements 16 to prevent.

In one embodiment, the melting temperature of the material of the sealing element is 3 however, so high that they are compatible with the welding mirror 14 is unreachable without the anti-adhesion coating would be damaged, especially destroyed or burned.

Therefore, for the training of the areas 12 on the sealing element 3 Laser light beams 17 used, with which the high melting temperatures can be achieved.

The laser light rays 17 are generated in the described method in a generator, not shown. Subsequently, the desired beam cross section is formed in a beam former, and finally the laser light beams become 17 through a mirror system on the areas 12 respectively. 13 directed and optionally in these as described.

In the method of making a closure 1 for a sterile medication container is provided that in a non-elastic closure body 2 , the at least one puncture opening 11 comprises, an elastic sealing element 3 is used, which this at least one puncture opening 11 sealing closes. The sealing element 3 is with the closure body 2 cohesively connected by on the sealing element 3 and the closure body 2 matching areas 12 . 13 be melted before insertion, with the molten areas 12 . 13 when inserting the sealing element 3 be brought into contact with each other, cool down and connect.

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• - DE 3835720 A1 [0002]

Claims (19)

Method for producing a closure ( 1 ) for a preferably sterile medicament container, wherein the closure ( 1 ) from a prefabricated, cup-shaped closure body ( 2 ) and in this used, prefabricated, elastic-soft sealing element ( 3 ), wherein the closure body ( 2 ) has on the bottom side of its pot shape at least one puncture opening, which through the sealing element ( 3 ) is closed, wherein a part of the sealing element ( 3 ) in the use position of the closure ( 1 ) is accessible from the outside, characterized in that in a first step the closure body ( 2 ) and the sealing element ( 3 ) in areas (12) which, in the position of use, are close to the at least one puncture opening (11). 11 ) and these are surrounded in closed form, are melted and that in a second step, the sealing element ( 3 ) in the closure body ( 2 ), the molten areas ( 12 . 13 ) are brought into contact with each other, cooled and thereby connected to each other. Method according to claim 1, characterized in that the area ( 12 ) on the closure body ( 2 ) and / or the area ( 13 ) on the sealing element ( 3 ) with a laser light beam ( 17 ) is melted / become. Method according to claim 1 or 2, characterized in that the area ( 12 ) on the closure body ( 2 ) and / or the area ( 13 ) on the sealing element ( 3 ) with a welding mirror ( 14 ) is melted / become. Method according to one of claims 1 to 3, characterized in that the area ( 12 ) on the closure body ( 2 ) with a welding mirror ( 14 ) and that the area ( 13 ) on the sealing element ( 3 ) with a laser light beam ( 17 ) is melted. Method according to one of claims 1 to 4, characterized in that the area ( 12 ) on the closure body ( 2 ) and / or the area ( 13 ) on the sealing element ( 3 ) is annular or circular is / are formed. Method according to one of claims 1 to 5, characterized in that a laser light beam ( 17 ) having a ring or circular cross-section for melting the region ( 12 ) on the closure body ( 2 ) and / or area ( 13 ) on the sealing element ( 3 ) is used. Method according to one of claims 1 to 6, characterized in that a laser light beam ( 17 ) is used with a point-shaped cross-section and the laser light beam ( 17 ) for melting the area ( 12 ) on the closure body ( 2 ) and / or area ( 13 ) on the sealing element ( 3 ) and along the region to be melted ( 12 . 13 ) or the areas to be merged ( 12 . 13 ) to be led. Method according to one of claims 1 to 7, characterized in that the closure body ( 2 ) and the sealing element ( 3 ) before the melting of the areas ( 12 . 13 ) are brought into a pre-assembly position, the insertion of the sealing element ( 3 ) in the closure body ( 2 ) by a one-dimensional, straight-line movement. Method according to one of claims 1 to 8, characterized in that the area ( 12 ) on the closure body ( 2 ) and the area ( 13 ) on the sealing element ( 3 ) are melted at the same time. Method according to one of claims 1 to 9, characterized in that the laser light beam ( 17 ) for melting with a mirror optics on the areas ( 12 . 13 ) on the closure body ( 2 ) and / or on the sealing element ( 3 ) is directed in pre-assembly position. Method according to one of claims 1 to 10, characterized in that for the closure body ( 2 ) and / or for the sealing element ( 3 ) an optically and / or for the laser light beam ( 17 ) non-transparent material is used. Method according to one of claims 1 to 11, characterized in that the closure body ( 2 ) at least two puncture openings ( 11 ), and that the closure body ( 2 ) and / or the sealing element ( 3 ) in two areas ( 12 . 13 ), which in use position close to each of a puncture opening ( 11 ) and surround them, at the same time being melted. Method according to one of claims 1 to 12, characterized in that the sealing element ( 3 ) with a bias, in particular a radial with respect to puncture opening ( 11 ) biased bias, in the closure body ( 2 ) is used. Method according to one of claims 1 to 13, characterized in that by the in the closure body ( 2 ) used sealing element ( 3 ) in the position of use the puncture opening ( 11 ) or the puncture openings ( 11 ) on the closure body ( 2 ) at least partially, in particular completely, is / are completed. Method according to one of claims 1 to 14, characterized in that a disc-shaped sealing element ( 3 ) is used. Method according to one of claims 1 to 15, characterized in that a sealing element ( 3 ) with a front side ( 8th ) and a back ( 9 ), the front side ( 8th ) and the back ( 9 ) are formed with matching shape. Method according to one of claims 1 to 16, characterized in that a welding mirror ( 14 ) is used with an anti-adhesion coating and that for the sealing element ( 3 ) a material is used whose melting temperature is above the temperature to which the anti-adhesion coating is non-destructively usable. Closure for a preferably sterile Medication container, characterized in that the Closure with a method according to one of the claims 1 to 17 is made. Use of laser light beams ( 17 ) for melting areas on a sealing element ( 3 ) and / or on a closure body ( 2 ) in a method according to one of claims 1 to 17.