DE8200215U1 - Physiologically safe pouch that can be sterilized above 110 ° C - Google Patents

Description

Physiologically harmless pouch that can be sterilized ^{above HO 0 C}

The invention relates to a physiologically harmless ^{bag which can be sterilized above HO 0} C and is made of a thermoplastic polymer for receiving liquids and has at least one tubular outlet opening.

Bags of the type mentioned at the beginning are used millions of times in medicine. They serve for example for receiving blood or infusion solutions to be administered parenterally and must above 100 ⁰ C hitzesteriiLsierbar.sein, to meet the usual hygiene requirements.

On the one hand, they must be easy and automated to manufacture and, on the other hand, due to their low value, they must be disposable be. The material used to manufacture these bags should continue to be flexible and collapsible and be so highly transparent when processed that changes in the liquid contained in the bag are immediate can be noticed.

OFFICE 6370 OBERURSPL "LINDENSTRASSE 10 TEL. 06171/56849 TELEX 4186343 real d

OFFICE ί050 FREISING 'BRANCH OFFICE 8390 PASSAU

SCHNEGGSTRASSE 3-5 LUDWIGSTRASSE 2

TEL. 08161/62091 TEL.-0851/36616

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Α ± ξ some polymer that largely meets these requirements fulfilled, polyvinyl chloride (PVC) has been used, which is usually used to improve the elastic properties Contains plasticizers. Such plasticizers, such as diisooctyl phthalate, are not, however completely enclosed in the voids between the polymeric molecules, but can also be caused by the The polymer migrates and diffuses into the liquid contained in the bag. This fact has been increasing in the last few years in an ever increasing need for a hygienic A flawless bag that can be heat-sterilized and no more hygienically questionable plasticizers having.

Attempts to solve this problem failed, however, because the substances used either have too high a vapor permeability exhibited, which led to an undesirable increase in the solution concentration, and on the other hand either were not hygienically perfect, i.e. they also released leachable components or were insufficient were solid, so that they broke or were damaged when subjected to excessive mechanical stress.

In the CH-PS 444 382 a plastic bag is described, which can be used for therapeutic fluids to be used parenterally. With this plastic bag the wall consists of a plastic laminate that on the outside, i.e. the side facing away from the liquid a PVC layer and on the inside a polyhalohydrocarbon synthetic resin layer having. This latter layer does not have any pharmacologically inadmissible ingredients that could be caused by dissolving in those in the pouch contained solution could pass over. However, the polyhalohydrocarbons used have the disadvantage that they are very expensive to produce and process and inadequate at the weld seams fuse so that there is still direct contact with the PVC. This contact also exists

gene also at the outlet opening, which is usually made entirely of PVC and with further PVC connecting hoses can be connected. Furthermore, such a disposable bag places a burden on the environment, as the incineration of these bags leads to highly aggressive hydrogen halides.

Another bag is described in US-PS 41 40 162, which consists of a plastic mass with three components. These components are a polyolefin that is used in the consists essentially of propylene units, a block copolymer and optionally a plasticizer, which can also be a polymer. Furthermore, this bag Have antioxidants that are certainly not hygienically harmless.

From the above listing of the components it is already apparent that both the components themselves as The processing of these components are also costly and a bag made from them differs from the usual PVC bags are unlikely to prevail for both manufacturing and cost reasons.

This has led to the fact that the same applicant has registered another plastic compound for the production of connecting elements between PVC hoses on the one hand and polyolefin bags on the other hand in DE-OS 3,026,974. This plastic compound in turn consists of several polymeric components, for the manufacture and price of which the statements made above apply. Furthermore, this connecting member must be welded both to the polyolefin bag and to the PVC hose, which usually creates process engineering difficulties and is also costly.
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It should be noted in particular that all the proposed solutions work with PVC connecting hoses that naturally have plasticizers and insofar as

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are dubious to look at.

It should also be taken into account that it has long been in the food industry, of course, in plastic bags There are packaged, cookable and freezable foods, but these plastic bags have no exit openings, which are highly elastic at normal temperature and can also be sterilized.

Accordingly, the invention has for its object to provide a To create according to the type mentioned, which is made of a commonly used, inexpensive plastic material and which has at least one highly elastic opening nozzle which is integral with the bag is welded *

This object is achieved by the invention in that the bag consists of a polyolefin and the a copolymer of a polyolefin with vinyl acetate existing tubular outlet opening after welding is cross-linked to the pouch.

According to the invention, a bag is now obtained, which under Use of very inexpensive plastic materials, such as polyethylene. Can be produced. The usual extrusion processes for production can be used for this purpose of films or tubular films are used, which do not present any significant problems for the expert place.

The hose that is used to produce the hose-shaped outlet opening is also very inexpensive Polyolefin raw materials made with

a certain proportion of vinyl acetate are copolymerized. 35

This copolymer leaves with increasing VAc content The rebound elasticity increases by leaps and bounds, which is a measure of the elasticity of the hose. Polyolefin tubing

alone have the disadvantage compared to this copolymer that they are not sufficiently elastic and do not fit tightly with connection elements such as couplings and the like can be provided, which is an "imperative for the medical field Use of PVC hoses that have these very good elasticity properties have - as explained above - a mandatory requirement.

If, for example, a copolymer of polyethylene and vinyl acetate (EVA) is used, it is found that, although the rebound elasticity increases with increasing VAC content, on the other hand the melting temperature in the VAC range of interest ^{falls to values below ICO 0} C, so that a sterilization of a bag with such a hose connector is no longer possible.

It is now known that hoses based on VAC-containing polyolefins can be thermally crosslinked can be stabilized and even in their elasticity behavior can be improved, but on the other hand, however, the person skilled in the art is also familiar with the fact that these are crosslinked Hoses can no longer be welded to the starting polyolefin alone, so that no connection between the polyolefin and the cross-linked copolymer of polyolefin and VAC comes about.

According to the invention it has now surprisingly been found that a polyolefin bag and a not yet cross-linked tube made of a copolymer made of polyolefin and VAC welded together and after the cross-linking of the copolymer these Connection on the one hand is not canceled and on the other hand withstands the usual mechanical loads.

In addition to these properties, there are of course the high elasticity values and the favorable temperature behavior of such a cross-linked hose added, so that overall a sterilizable bag for medical

Purposes obtained whose properties are similar to those of a conventional PVC bag in mechanical Respect are at least equivalent.

On usable polyolefins which are used as a polymer for producing the bag according to the invention can include polyethylene, polypropylene, polybutadiene, rubbers or their! copolymers and mixed polymers with other vinyl compounds, such as ethylene / propylene, s plastics, poly-ethylene / vinyl acetate), acrylonitrile / Butadiene / styrene polymers and the like.

According to the invention, polyolefins are products that are optionally substituted by the vinyl polymerization of Ethylene are produced. These products can also have small amounts of other polymers added do not substantially disrupt or change the structure of these polyolefins. For example, small Additions of styrene or polyacrylonitrile-substituted ethylene compounds are added. The resulting Polyolefin products are considered to belong to the aforementioned polyolefins.

According to the invention, the polyolefin used is preferably polyethylene as the material for the bag, which can optionally contain small amounts of vinyl acetate in the form of the copolymer of ethylene and vinyl acetate. In such a case, for example, the vinyl acetate i

be up to 10 wt .-%.
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In particular, a medium or high density polyethylene (MDA and HDA) is used, which is usually produced by low pressure polymerisation. The density is in a range from 0.9 to 0.94, in particular around 0.935 g / cm ³ .

In any case, however, it must be ensured that such polyolefins do not have a melting point,

which is below the Sterilisationstemper-ature of 11 5-120 ⁰ C. In the case of the above-mentioned EVA polymer (copolymer of ethylene and vinyl acetate), the melting point falls with increasing vinyl acetate content, so that such products must be subjected to a crosslinking treatment, which is described below, before the sterilization treatment.

The water vapor permeability of the aforementioned polyolefins can be a problem with such bags, that are kept for a long time. To fix it this problem can advantageously be caused by the bag film be coated on its outside with a layer which lowers this water vapor permeability, for example a metal foil or another polymer. As a polymer are particularly suitable because of their high mechanical strength polyamide or PVC, by means of a laminating adhesive, such as polyvinylidene chloride, in a special embodiment on the polyolefin film be glued on. In terms of production technology, the polyolefin can be extruded in the form of a tube and then extruded be glued with an outer lamination.

If PVC is used as the outer film, the polyolefin film according to the invention is used ensures that plasticizers in the PVC cannot get through the laminating adhesive and the polyolefin film diffuse into the solution in the bag.

Such laminates have a temperature of about 23 ° C and a relative humidity of 85% in the Usually a water vapor permeability according to DIN 53122 of> 1, while it is otherwise with the pure polyolefin film is above 20 g / m d. Such values apply to standard films with a thickness of 50-100, in particular about 75 / um for the polyolefin film and 20-100, in particular 30-70 / um for the polymeric liner, such as Polyamide. Such films are, for example, under the name "Flexovac V 7144" from Sengewald,

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Ig 1 Halle / Westphalia and are so / ohl from the BGA as

| ⁵ also by the FDA because of their physiological harmless-

I have been admitted.

5 As already mentioned above, the polyolefin film facing the liquid in the bag has

I do not contain any plasticizers or additives that may be

I am physiologically questionable and above all in that

If aqueous solution could diffuse. Furthermore, the

I 10 polyolefin film, optionally provided with an organic lamination film, is clear and transparent and ice

these properties also after sterilization.

} ^; As a material for the hose-like outlet opening

15 a copolymer of an olefin with vinyl acetate is used. As the polyolefins produced from this olefin, those already mentioned above for the production of the bag mentioned olefins in question. Such olefins have one

₄ vinyl acetate content in the copolymer of 5-40, preferably

\ 20 8-35, in particular 20-32% by weight. As already explained above, the melting point of polyethylene falls with it.

; increasing vinyl acetate content from about HO ⁰ C to about 70 ⁰ C

when the VAC content is 30% by weight. Such a tube will melt at a naturally Sterili-25 sation level above 100 ⁰ C together, and is therefore unusable. On the other hand, the required rebound elasticity of these hoses increases with increasing VAC content from 35 to 55% at 30% VAC content.

30 can also be such a tubular

Weld material with a VAC content to the material of the bag without problems, provided that essentially the ; the same polyolefin materials are used. Of the

ι Use of essentially the same polyolefin materials

Γ 35 is for the tubular connection piece and the bag therefore preferred.

The embodiment in which the

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Polyethylene bag and the tubular connector from a copolymer of polyethylene and vinyl acetate (EVA) with the above-mentioned vinyl acetate contents exist. EVA is, for example, from Höchst AG under the name "Hostälen LD / EVA" and Von der ICI under the names "Evatane" and "Alkathene EVA" manufactured.

The bag materials are manufactured and processed using the methods customary in plastics technology, For example, as explained above, the bags can be made from a coextrusion of tubular films Cutting of the foils and subsequent edge sealing are made * These bags ·, in which the edge provided for the connection opening is not welded remains, is then welded to a piece of hose, which with the help of a mandrel into the opened Bag is inserted. This is followed by the heat sealing of the entire not yet welded edge with the Hose connector. If several hose connectors are provided, one leads of course at the same time this processing step, whereby, of course, appropriate sealing tools are used.

The pouches produced in this way have essentially the same properties as a PVC pouch with the exception that the connection hose made of EVA melts together during sterilization above approx. 80 ^° C. and thus heat sterilization of this pouch is not possible. On the other hand, the weld seam that is formed between the bag and the hose connection piece is so strong that only a forcible removal of this piece is possible.

In order to make the hose connector sterilizable, the hose made of EVA must be cross-linked as a result of which the melting point of the hose and its elasticity increase considerably. Through this cross connection

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iistzungsbehandlung it is thus possible that the thus treated finished bag may be sterilized at temperatures up to about 120 ⁰ C, furthermore, the crosslinked tube has considerably better elastic Eigenschäften as a PVC tube,

It has now been found according to the invention that this Crosslinking does not cancel out the aforementioned weld seam, which would have been suspected because crosslinking Hoses with the polyolefin material alone, for example with polyethylene, are not welded can.

The crosslinking can be carried out after the crosslinking treatments of EVA *, which are known per se. It can be achieved, for example, by irradiation with high-energy radiation, for example with accelerated electrons, Q (~ and ß-rays with an energy above 2.5 Mrad

be performed. Preferably, depending on the material used and its thickness, values work from 5-10 Mrad. * and polyethylene

This treatment has the advantage that the already sealed and essentially pyrogen-free bag through this high-energy radiation is sterilized, so that hereby the filling of an already sterilized Solution is possible, so heat treatment in the autoclave can be dispensed with. Furthermore, this radiation

treatment has the advantage that even a polymerization that has not been completely carried out in polyethylene or a § Pouch film made with a low EVA content is cross-linked and has mechanical strength be improved.

Another method of crosslinking is treatment with peroxides, for example cumene peroxide and the like., which disintegrate during the heat treatment and

start a radical cross-linking. In this case, of course, the production of the EVA hoses, which usually takes place in the heat, can be combined with the bag production, otherwise the EVA materials are cross-linked and then no longer welded to the polyethylene used as the bag material can be.

Another cross-linking process, also based on the addition and decomposition of chemical compounds consists in the use of organosilicon compounds which, when decomposed, become hot and humid Cross-link the atmosphere with the EVA, forming Si bridges. An example of this Si cross-linking represents the so-called "Sioplas process" from ICI, in which the organosilicon compounds are incorporated into the EVA granules are incorporated and the product obtained is extruded into the desired films or tubes. Here, too, the cross-linking takes place within hours to days, depending on the selected degree of humidity and the temperature. The cross-linking can be carried out within about 1 hour, if it is carried out at temperatures above 80 ° and a relative humidity of 100%.

Of course, this process also requires joint production of the film and tubular products and their further processing into the bag according to the invention.

Of these above-mentioned crosslinking methods, irradiation with high-energy radiation and treatment with organosilicon crosslinking compounds are preferred.
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It should be emphasized, however, that each 'crosslinking process can be used, with which a not yet cross-linked and already linked to the bag material

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welded polyolefin hose with a certain VAC content can be cross-linked after welding.

Show it

Fig. 1 shows a bag for infusion purposes schematically in plan view and

i | 2 shows a section through the bag along the line H-II.

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I, The bag 10 consists essentially of the chamber 12,

i-'i which is enclosed on all sides by a welding edge 14, where-

["'■ in this bag 10 has two outlet openings 16 and 18, each of which is connected to a hose extension piece 20 and 22. About these hose extensions

20 and 22 is the liquid to be stored, for example. wise an infusion solution, into the chamber 12 of the bag

10 initiated, with one or both extensions

{ can be used as an inlet nozzle. This hose

• ^; 20 attachments are after filling with the stopper 24; and 26 locked.

Since the bags are usually hung with the hose extensions 20, 22 down, so that the filled Solution can flow out without difficulty, the edge 14 opposite these hose extension pieces has an opening 28, which od a hook-shaped holding part of a tripod. The like. For fastening and holding the bag 10 can be introduced.

According to the preferred embodiment, which can be seen in enlarged form in FIG. 2, the bag material consists from a laminate 30, which is formed in the form of a film. This laminate 30 points to the one facing the solution Side on a polyethylene film, which usually has a thickness of 30-100, preferably 75 / µm. That polyethylene used is preferably a

■ * · * · * «« a ■■■■ III III

2

Material with a density of 0.935 g / cm, a melting range of 121-124 ° C and a Vicat softening temperature of about η 8 ⁰ C.

^ On this polyethylene film 32 is a polyamide film 34 glued on by means of a laminating adhesive, which usually has a diameter of about 30-70 / am. In particular a laminate 30 with the designation Flexo-

wag V7144 used by Pirma Sengewald, Halle. 10

From the i-iy. 2 it can also be seen that the polyethylene film has a weld 36 in the transition area to the hose attachment pieces 20 and 22. the one intimate connection between the film and the extension piece '^ so that these extensions can be torn out 20 and 22 from the bag 10 is only possible with destruction of the entire bag.

The material for the hose extension pieces 20 and 22 is

EVA selected with a VAC content of preferably 25-35 % By weight, with the aforementioned products "Hostalen", "Evatan" or "Alkathene" being used will.

After the crosslinking, for example by irradiation with ß-rays or by treating according to the Sioplas process, a cross-linked hose end piece 20 is obtained and Z2, which is hitzesteiilisierbar at temperatures up to 120 ⁰ C. The welding

seam 36 not repealed by a prior to crosslinking treatment lying sweat treatment has been made.

1. To s amrnenraces

Physiologically harmless pouch that can be sterilized ^{above HO 0 C}

Physiologically harmless bag (10) that can be sterilized and is made from polyolefin materials. This bag (10) consists in particular of a polyethylene film as bag material and from a copolymer of poly (ethylene / vinyl acetate) with a vinyl acetate content of preferably 20-32% by weight as the material for the hose attachment (20, 22). This made of poly (ethylene / vinyl acetate) The existing hose attachment is first welded to the bag material and then cross-linked.

Claims (11)

1. Physiologically harmless and above HO ⁰ C sterilizable bag made of a thermoplastic polymer for receiving liquids, which has at least one tubular outlet opening, characterized in that the bag (10) consists of a polyolefin and consists of a copolymer of a polyolefin with vinyl acetate Hose extension piece (20, 22) is cross-linked after welding with the bag (10). 2. Bag according to claim 1, characterized in that the polyolefins are polyethylene, polypropylene, rubbers, polybutadiene, Polystyrene, their copolymers or mixed polymers with other vinyl polymers, ethylene / Propylene rubber, poly (ethylene / vinyl acetate) or polyacrylonitrile / butadiene / styrene polymer. 3. Bag according to claim 1 or 2, characterized in that the polyolefin Polyäthy? ■ »with a density of 0.9-0.94, especially about 0.935. 4. Bag according to claim 2 or 3, characterized in that the polyolefins have a vinyl acetate content in the copolymer OFFICE 6370 OBERURSEL 'LINDENSTKASSE IO TEL. 06171/56849 TELEX 4186343 real d OFFICE 8050 FREISING * SCHNEGCSTKASSE 3-5 TEL. 08161/62091 : 'TF ^x * ⁵ . ^{26th i>} "'. ^pav ? { ^d : ■ TWO OFFICE 8390 PASSAU LUDWiCSTRASSE 2 TEL. 0851/36616 2
have up to 35, preferably 10 wt .-%. 5. Bag according to one of claims 1 to 4, characterized in that the polyolefin is present form of a film ^and is laminated with a polyamide or PVC film. 6. Bag according to claim 5, characterized in that the laminate consisting of polyolefin film and liner is up to 0.2 mm thick, the polyolefin film having a thickness of 50-100, preferably 75 and the Laminating film a thickness of 20-100, preferably 30-75 urn. 7. Bag according to one of claims 1 to 6, characterized in that that the hose extension piece (20, 22) made of a copolymer of olefin and vinyl acetate with a vinyl acetate content of 5-40, preferably Π-35, in particular 20-32 wt .-%. 8. Bag according to claim 7, characterized in that it is cross-linked by high-energy rays. 9. Bag according to claim 7, characterized in that it is cross-linked by Si bridges. 25th 10. Bag according to one of claims 1 to 9, characterized in that that for the chamber (12) facing side of the bag (10) and for the hose extension piece (2Ü, 22) the same olefin materials used will. 11. Bag according to claim 10, characterized in that the polyolefin material for the bag (10) and the Sehlauehansatzgtüek (20, 22) polyethylene is used.