HU220975B1 - Dispenser unit, process for manufacturing the same - Google Patents

Description

EXTRACT

The present invention relates to a dispensing unit comprising a flexible polymer bag, a connector portion and a non-flexible hard portion (20), wherein the connection portion comprises an inner layer (11) welded to the hard portion and an outer polymer layer (11) welded to the inner material of the flexible bag. 10) wherein, according to the invention, the inner material (30) of the flexible bag and the outer material of the connector portion (10) are identical and are heat sterilized together, wherein the flexible bag is made of PVC and / or polyethylene, polypropylene, polyamide and films containing thermoplastic elastomers, in particular SEBS mixtures thereof, or composite multilayer films such as PE / EVA, PA / PE, PP / SEBS and the like.

In the process of the invention, the multilayer bag material is extruded together, the multilayer connector portion is extruded together, the bag material is sealed, the multilayer connector portion is sealed, and the hard portion is sealed.

HU 220 975 B1

The scope of the description is 8 pages (including 1 page figure)

HU 220 975 Bl

BACKGROUND OF THE INVENTION The present invention relates to a dispensing unit comprising a flexible bag of polymer, a connector portion and a non-flexible hard portion, wherein the connector portion has an inner layer welded to the hard portion and an outer layer of polymer welded to the inner material of the flexible bag. The present invention also relates to a process for making a metering unit.

Dosing units of this type are intended for the storage and dispensing of liquids and are particularly designed as physiologically harmless heat sterilizing bags made of transparent polymers such as polyolefin and containing at least one hard part which is sterile bonded through the piece connecting the bag material. , i.e., the welded joint between the bag and the hard part can withstand a sterilization temperature (with water vapor) of at least 125 ° C. The bag must be transparent so that changes in the contents of the fluid, such as precipitation, turbidity, etc., are immediately recognizable. Such bags are used, for example, in medicine as blood bags, for dialysis fluids, for plasma, etc. They are used as sachets, but they can also be used for other aqueous solutions, such as beverages.

Similar flexible containers are often used and are generally made of soft PVC. PVC is advantageous because it also forms a flexible film that is tightly bonded and transparent with the material commonly used for hard parts, polycarbonate. However, for various reasons, PVC has not proved to be appropriate in the meantime. PVC should contain a plasticizer to provide the desired physical properties of flexibility. These plasticizers, such as diisoctyl phthalate, tend to be precipitated from PVC and migrate into the liquid in the bag. Thus, during the course of the use of such PVC bags, a patient who has been permanently dialyzed may be exposed to a few grams of plasticizer, which is physiologically quite risky and may result in permanent damage to the patient. Apart from this, PVC also poses a problem during the waste disposal process due to the chlorine compounds produced during incineration and is already trying to replace PVC with non-halogenated compounds. So far, however, it has proved problematic to achieve the advantageous properties of PVC, namely excellent weldability and transparency, with excellent fluid tightness and water vapor barrier properties, at an economically acceptable cost with other materials.

For example, DE 32 47 294 A1 discloses a solution in which a pouch made of polyolefin, for example polyethylene, is coupled by means of a tubular connection piece, for example a hard part made of polycarbonate, and is then crosslinked by irradiation, whereby the bond between the polyethylene of the bag and the polyethylene of the attachment part becomes solid against sterilization. Polyethylene crosslinked with vinyl acetate, when crosslinked, becomes fluid at the sterilization temperature, so it is necessary to crosslink the entire arrangement containing this material.

By first forming a weld seam between the joint portion and the polycarbonate portion and then crosslinking the vinyl acetate / polyethylene copolymer to make the bond resistant to high sterilization temperatures, the bag becomes resistant to sterilization. Irradiated cross-linked cross-linking requires a considerable amount of effort, since all complete dosing units must be transported and handled to a suitable source of radiation.

In addition, the choice of material for the bag is severely limited, since the inner material of the bag should always be a polyolefin that can be welded with an EVA-containing polyolefin, otherwise connection to the PC portion and the inside of the bag cannot be ensured.

A similar arrangement is described in DE A 33 05 365. This specification describes PVC-free sterilizable bags comprising an outer layer of polyamide, mostly PA 66, an adhesive, and an inner layer of medium density polyethylene.

These bags are physiologically harmless since polyethylene does not contain a plasticizer and is at least equivalent in value to PVC bags, but it is expensive to produce and the medium density polyethylene (MD-polyethylene) used is expensive.

EP 380 270 discloses a hose material for transferring a patient attachment or accessory material into a flexible bag, optionally welded to a hard part made of polycarbonate, which has become known as a three-layer hose material which can be externally polycarbonate or ultrasound, microheated.

This sterilizing hose is provided with an outer layer containing polycarbonate-sealable polypropylene, ethylene-propylene copolymer or ethylene-propylene copolymer modified with a thermoplastic elastomer, while the interconnecting layer is made of a very low density propylene -Vinyl acetate copolymers, modified or unmodified ethylene methyl acrylate copolymers, polyvinylidene chloride, ethyl vinyl acetate and modified ethylene methyl acrylate copolymers, ethyl vinyl acetate and very low density it may consist of a mixture of very low density propylene or modified ethyl vinyl acetate; and the inner layer should preferably contain a thermoplastic polymer material such as a copolyester, polypropylene, ethylene propylene copolymers, polyurethane, PVC or a mixture of a copolyester and ethyl vinyl acetate.

Preferred material for the hose is that it has already been cross-linked by chemical crosslinkers to improve the temperature resistance (sterilization) of the welded joint during co-extrusion, or that it can subsequently be irradiated by irradiation, otherwise it will not retain its properties under sterilization conditions.

EN 220 975 B1 and flows. This known connector part is designed to form an external bond with polycarbonate and has a complicated structure. In this case, it is not a connection part, but a fluid hose to be connected to the polycarbonate part, which must of course be autoclavable.

To solve the problem of bonding between a flexible bag and a hard part made of polycarbonate, EP A 56 42 31 discloses a co-extruded connector part which uses a polyolefinic polymer material having a melt flow index of about 12 as the outer layer.

In this case, the inner layer is interconnected with an intermediate layer, which lends flexibility to, for example, SBS, and is formed as an attachment layer containing ethyl vinyl acetate for attachment to the polycarbonate. This arrangement also requires the usual measure of cross-linking the bag after welding the connection portion, for example by irradiation, which ensures sterilization of the arrangement.

DE 44 72 175 (COSTER) discloses a solution in which an outer layer is made of a flexible polypropylene or polyethylene outer socket with a polyethylene, polyester or polyester layer and a flexible polypropylene or polyethylene or polypropylene inner layer made of polyethylene, because polyethylene and polypropylene can be welded only by themselves or with each other. Polyacetate is recommended as the hard part to which the inner layer of the coupling part is welded.

However, this arrangement has the disadvantage that it cannot be sterilized by heat.

WO 93/23108 (BAXTER) relates to a connector portion for a flexible bag containing PVC, wherein the connector portion is extruded in a triple layer and a polypropylene copolymer-styrene-ethylene-butylene-styrene copolymer blend as an outer layer. contain. However, the use of PVC is generally undesirable for the reasons described above.

SUMMARY OF THE INVENTION It is an object of the present invention to provide a dispensing unit which solves the problem of attaching a multilayer bag with an inner layer of polyolefin to a hard portion, whereby these bags can be further sterilized and production is greatly simplified.

In order to solve this problem, a dispensing unit is provided in which, according to the invention, the inner material of the flexible bag and the outer material of the coupling part are thermally sterilized, wherein the flexible bag is made of PVC and / or polyethylene, polypropylene, polyamide and their thermoplastic elastomers. or mixtures of composite multilayer films such as PE / EVA, PA / PE, PP / SEBS and the like.

Preferably, the liquid to be dispensed is a water containing liquid for human or veterinary or food industry.

The invention further relates to a process for making a dispensing unit according to the invention, comprising the following steps: extruding the multilayer bag material together, extruding the multilayer connector portion, sealing the bag material, sealing the multilayer connector portion.

It is preferred that the joint-extruded joint portion containing high EVA-containing polyethylene as an inner layer is crosslinked by irradiation alone prior to sealing.

Preferably, the hard part is made of a polymer such as polycarbonate, polyacetal or polyethylene.

By making the inner layer of the connector part suitable for attachment to the hard part, where in the case of frequently used polycarbonate the corresponding connector olefin should generally be crosslinked, in particular by irradiation, it is possible to subject only the connector parts to a high cost. while the bag itself can be made from cheap, thermally relatively stable polyolefins.

Thus, it is not necessary that bags already provided with an attachment portion containing high EVA-containing polyethylene as the interior material of the bag and the outer layer of the connection portion are used on public roads, railways, etc. delivered to the irradiation plant, but only to the connector parts, which additionally reduces production costs and the use of the environment.

By using the multilayer hoses of the invention as connecting parts, it has become possible to use the preferred polypropylene as a bag material, which is inherently characterized by a high melting point (140-160 ° C). In this way, significantly higher sterilization temperatures can be used, in particular the sterilization of the bags with water vapor is trouble-free, which also allows for shortening sterilization times.

Particularly preferred are multi-layer polypropylene bags such as those described in particular in DE A 1 964 00 38.4, which are incorporated herein by reference in their entirety to avoid duplicates.

Thanks to steam sterilization, the internal surfaces can be prevented from sticking together, which is a precondition for safer heat sterilization.

In order to prevent sticking of the inner surfaces of the PVC or polyethylene used as the liner of the bag, this has to be roughened with the polyethylene or PVC used hitherto, whereas in the present invention due to the use of higher melting temperature plastics which do not need polycarbonate to be connected - the roughening operation el3

EN 220 975 B1 can be left open and the bag thus produced is also characterized by improved transparency.

It may be necessary to add an additional barrier layer to the bag foil. The barrier layer is ethylene vinyl alcohol (EVOH), which provides excellent sealing against oxygen, nitrogen, CO ₂ and other gases.

In addition, thin film technology can be used to coat an additional layer (e.g., polyethylene) with SiOx or alumina. Of course, as is known in the art, polyamide / polyethylene composite films may be used as sachets, but the selection of the connector portions in combination with other materials of the present invention will again avoid irradiating the entire sachet.

It may be advantageous for the flexible bag to comprise PVC, polyethylene, polypropylene, polyamide and mixtures thereof, in particular mixtures thereof with thermoplastic elastomers such as SEBS mixtures thereof or composite multilayer films thereof such as polyethylene / ethylene vinyl acetate. , PA / polyethylene, polypropylene / SEBS, etc. It is preferred that the bag be made, for example, by co-extrusion, although any of the methods known to those skilled in the art may be used.

Preferably, the attachment portion is a heat-sterilizing bonding inner layer, such as a crosslinked polyethylene having a high ethyl vinyl acetate content, or an inner layer that is substantially in contact with the material or liquid in the bag and where it is merely a bonding material. contains relatively problem-free PVC.

The dispensing unit according to the invention can be made by co-extruding a sterile polymeric bag, for example in a multilayer bag, and independently by forming a multilayer connector in a tubular form, for example by co-extruding the outer material of the bag, and having an inner layer weldable to the outer material of the hard portion, wherein said connector portion may optionally be crosslinked by irradiation to render it sterile resistant, and a hard portion of a material that can be welded to the inner portion of the connector portion; welding to form a welding joint that is suitable for high temperatures, such as normal sterilization temperatures resists.

Such dosage units are particularly suitable for storing medical fluids such as dialysis fluids, artificial nutrition fluids, blood, plasma, and the like.

By using the combination of bag, connector portion and hard portion according to the invention, the special case of sterile dispensing units with hard portion avoids the need to cure the entire bag by high irradiation to render the polyolefin used for attachment to the hard portion resistant to sterilization temperatures. to crosslink the joint as this only contains the high ethyl vinylacetate crosslinked polyethylene layer which is required for a secure connection with the polycarbonate.

Furthermore, it is possible to avoid using special expensive MD polyethylene / polyethylene foils with multi-layer foil which can withstand a sterilization temperature of 121 ° C, but according to the invention, as the outer layer of the connection part and the inner layer of the bag a more resistant polyolefin may be used.

Preferably, the flexible bag comprises PVC, polyethylene, polypropylene, polyamide and mixtures thereof, or multi-layer composite films thereof, such as polyethylene / ethyl vinyl acetate, polyamide / polyethylene.

The multilayer polymer tube of the connection portion may be provided, for example, with an outer layer of polyethylene, PVC, where the multilayer polymer tube and the flexible bag are bonded together (welded).

The present invention will now be described in more detail with reference to the accompanying drawings, in which the invention is not limited thereto.

Figure 1 is a longitudinal sectional view of the connector portion, the hard portion, and the attachment region of the bag, a

FIG. 2 is a cross-sectional view of the connection region of FIG

Figure 3 shows a complete bag made according to the invention.

As shown in Figure 1, a preferred embodiment of the dispensing unit according to the invention comprises a multilayer foil pouch which is weldable as an inner layer and comprises, at sterilization temperature, a polyolefin which is dense, weldable, such as polypropylene or polyethylene, polypropylene compound or the like.

The connector portion, which in the example illustrated is formed as a bilayer polymer hose, comprises a polyolefin, such as polypropylene or polyethylene, polypropylene blend or the like, weldable to the inner layer 30 of the bag and is welded to the inner layer 30 of the sachet.

The inner layer 11 of the coupling part comprises a high content ethylene vinyl acetate-containing compounded polyethylene copolymer which can be welded together by irradiation cross-linking with polycarbonate 20 to provide sterilization-resistant, fluid-tight sealing and sealing, .

The polycarbonate tube is welded into the irradiated cross-section.

Example 1

0.45 mm thick with CRATON compounded polyethylene outer layer and 0.5 mm thick high ethyl vinyl acetate polyethylene4

Bimetallic hoses of 8 mm diameter having an inner layer having a thickness of 9700 B1 are known in the art to form joint parts by co-extrusion (coextrusion). The hose material thus produced is then crosslinked by irradiation with irradiation, whereby the material of the inner layer is sufficiently resistant to temperatures above about 160 ° C.

Co-extruded double layer bags comprising an outer layer of polypropylene and an inner layer of propylene mixed with the same elastomer as the thermoplastic elastomer in the outer layer of the connection portion are then joined by cross-linked connection hose by high-frequency welding. Subsequently, the hard part of the tubular polycarbonate is inserted into the connection part in a manner known per se and welded thereto. In this case, the high ethyl vinyl acetate-containing cross-linked polyethylene forms a solid and durable weld seam under the thermal conditions of water vapor sterilization.

Example 2

The outer layer of polyethylene having a thickness of about 0.5 mm and an inner layer of polyethylene having a high ethyl vinyl acetate content of about 0.5 mm and having an outer diameter of 6 mm are produced by co-extrusion in a manner known per se. Subsequently, the resulting hose material is crosslinked by irradiation to form crosslinks, thereby providing the material with appropriate heat resistance up to a temperature greater than about 160 ° C.

Subsequently, the co-extruded double layer bags comprising an outer layer of polyethylene and an inner layer of elastomer-compounded polyethylene are bonded by high-frequency welding to a cross-linked cross-linked hose containing polyethylene-bonded polyethylene on its outer side and cross-linked polyethylene on its inner side. The polycarbonate portion is then inserted and welded in a manner known per se.

EXAMPLE 3 Double Layer Tubes of Outer Diameter of mm and 6mm of Internal Diameter with a 0.45mm Outer Layer of Ethyl Vinyl Acetate Polypropylene and a 0.5mm Thickness Layer of Polyethylene with High Ethyl Vinyl Acetate - extruding together in a manner known per se. The hose material thus produced is then crosslinked by irradiation to form a heat-resistant material up to a temperature in excess of about 160 ° C.

200 μm outer layer of polypropylene, 200 μm intermediate layer of propylene compounded with thermoplastic elastomer (CAWITON, available from Wittenburg / Bissum-The Netherlands), and 250 μl of polypropylene inner layer of thermoplastic elastomer (CAWITON) combined with 250 μm inner layer of polypropylene which are made by extruding into a water bath - the co-extruded three-layer bags are then joined by high-frequency welding with cross-linked cross-linked connecting hoses, which on the outside of the hose contain thermoplastic elastomer (CAWITON) -combined polypropylene crosslinked polypropylene . Subsequently, the polycarbonate part is inserted and welded in a manner known per se. For example, such bags may be filled with dialysis solutions, such as solutions for continuous ambulatory peritoneal dialysis (CAPD), and sterilized and stored with water vapor.

The invention is not limited to the above-mentioned embodiments, but one of ordinary skill in the art may implement several other embodiments within the scope of the claims.

Claims (11)

PATENT CLAIMS A dispensing unit for dispensing a liquid having a flexible polymeric bag having an inner layer (30), an attachment portion and a non-flexible hard portion (20), wherein the flexible polymeric bag is at least one polymer selected from the group consisting of PVC, polyethylene, polypropylene and polyamide. the hard portion (20) comprising a polymer and the connecting portion having an inner layer (11) welded to the non-flexible hard portion and an outer layer (10) welded to the inner layer (30) of the flexible polymeric bag, characterized in that the outer layer (10) and the inner layer (30) of the flexible polymer bag contain at least partially identical polymers. A dispensing unit according to claim 1, characterized in that the flexible polymer bag is made of at least one polymer and a thermoplastic elastomer. The dosing unit according to claim 2, wherein the thermoplastic elastomer is SEBS. 4. A dispensing unit according to any one of claims 1 to 3, characterized in that the flexible polymeric bag comprises a multilayer film selected from the group consisting of polyethylene / ethyl vinyl acetate, polyamide / polyethylene and polypropylene / SEBS. 5. A dosing unit according to any one of claims 1 to 3, characterized in that the non-flexible hard portion (20) comprises a polymer selected from the group consisting of polycarbonate, polyethylene and polyacetate. 6. A dispensing unit according to any one of claims 1 to 3, characterized in that the inner layer (11) of the connection part comprises a copolymer of crosslinked polyethylene containing from 15 to 30% by weight of ethylene-vinyl acetate. Dosing unit according to Claim 1, characterized in that the inner layer (11) of the connection part comprises PVC. HU 220 975 Bl A dispensing unit according to claim 1, characterized in that the flexible polymer bag is provided with an outer layer (31) of polypropylene and an inner layer (30) of a mixture of thermoplastic elastomeric material and propylene, and an outer layer (10) of thermoplastic elastomer-compounded polypropylene, while the inner layer (11) of the coupling part comprises cross-linked cross-linked polyethylene or PVC containing 15-30% ethyl vinyl acetate and the non-flexible hard portion (20) contains polycarbonate. A dosing unit according to any one of claims 1 to 8, characterized in that the fluid to be dispensed is a water-containing liquid for human or veterinary or food industry. A process for producing a liquid dispensing unit according to claim 1, comprising the steps of: a) co-extruding the multilayer bag material, B) extruding the multilayer connector portion together, c) sealing the multilayer bag material, d) sealing the multilayer connector, e) sealing the hard part. 11. The process of claim 10, wherein the multilayer connector portion is provided with an inner layer of polyethylene containing 15 to 30% by weight of ethyl vinyl acetate and crosslinked prior to closure. HU 220 975 Bl Int Cl ⁷ : A61 J 1/00