EP3840719A1

EP3840719A1 - Infusion bag

Info

Publication number: EP3840719A1
Application number: EP19752630.4A
Authority: EP
Inventors: Torsten Brandenburger; Beatrix Heuel-Hoemmen
Original assignee: Fresenius Kabi Deutschland GmbH
Current assignee: Fresenius Kabi Deutschland GmbH
Priority date: 2018-08-21
Filing date: 2019-08-20
Publication date: 2021-06-30
Also published as: CA3109725A1; WO2020038941A1; CN112584815A; CL2021000364A1; KR20210044203A; MX2021001959A; US20210169739A1; JP2021533851A; BR112020025267A2; AU2019323653A1; ZA202100527B

Abstract

The invention relates to a medical package designed as an infusion bag, which medical package is made from multi-layer films that are welded to one another and is filled with a medical liquid for infusion and/or for parenteral nutrition. The invention is described by a medical package designed as an infusion bag, which is made up of a film comprising multiple layers welded to one another and has at least one weld seam, preferably longitudinal and transverse weld seams, and is filled with a medical liquid. The multi-layer film has at least one inner layer of a matrix-phase polymer system, an intermediate layer of a matrix-phase polymer system, and an outer layer of a matrix-phase polymer system. The matrix polymer of the matrix-phase polymer system of the inner layer, the intermediate layer and the outer layer in each case comprises a polypropylene polymer (PP) having defined parts by weight in the individual layers, and the phase polymer of the matrix-phase polymer system of the inner layer, the intermediate layer and the outer layer in each case comprises a styrene-ethylene/butyl-styrene block copolymer (SEBS) having defined parts by weight in the individual layers. The film is characterised in that the styrene-ethylene/butyl-styrene block copolymer (SEBS) of the intermediate layer has a styrene-ethylene/butylene ratio (S/EB_M) and the styrene-ethylene/butylene-styrene block copolymer (SEBS) of the outer layer has a styrene-ethylene/butylene ratio (S/EB_A), in which S/EB_A> S/EB_M. It has been shown that in this way the mechanical properties of the multi-layer film can be improved, in particular in the event of expansion of the multi-layer film in the region of the weld seams. The improved mechanical properties appear both at room temperature and also at lower temperatures of down to 4 °C.

Description

infusion bag

description

Field of the Invention

The invention relates to a medical packaging designed as an infusion bag, which consists of multilayer, welded foils, and which with a

medical fluid for infusion or parenteral use.

Background of the Invention

Infusion bags, which consist of multilayer, together

welded foils are known. These consist of foils welded directly to one another and comprise at least one removal port. The requirements for

Infusion bags are high. So they should withstand a high degree of mechanical loads. At the same time, the films used for this must be free of pollutants. There is also generally a requirement to be able to subject the infusion bag to thermal sterilization, typically at a temperature of 121 ° C.

Among other things, PVC films are used. Multi-layer films made of PP (polypropylene) are particularly suitable. The tensile strength in particular can be increased by different layers of PP, that is to say by providing a multi-layer PP film. Infusion bag made of multi-layer stretchy

Films have a high mechanical stability with regard to tearing a film, since the film is mechanical

Can yield loads. With stretch films, however, it is more difficult to ensure high mechanical stability in the area of the weld seams. It is also known that the mechanical properties of PP films can be improved by providing a matrix phase polymer system. For example, a thermoplastic elastomer can be distributed in a PP matrix. This increases the impact strength of the material and thus improves the tear resistance of a multi-layer composite.

For example, the patent US 5,783,269 A

(Fresenius AG) a multi-layer PP film. The layers of this film can comprise a styrene-ethylene / butylene-styrene block polymer copolymer (SEBS) or a styrene-isoprene-styrene block polymer copolymer (SIS). This can improve the stability under impact and tensile loads. Multi-layer PP films with SEBS are also described in the two patent applications WO 2011/128185 A1 and KR 2003 046120 A.

Object of the invention

The invention has for its object the mechanical properties of an infusion bag

medical packaging based on polypropylene

improve .

It is a particular object of the invention to provide a

Infusion bag made of a multi-layer PP film

to provide, in which the film in the area of

Weld seams have a high degree of elasticity without the weld seam tearing open.

Summary of the invention

The object of the invention is already achieved by a

Infusion bag trained medical packaging according to claim 1 solved. Preferred embodiments of the invention are the subject of the dependent claims, the description and the

Take drawings.

The invention is generally described by an as

Infusion bag made of medical packaging, which is made of a multi-layer film welded together

is constructed and has at least one weld seam, preferably longitudinal and transverse weld seams, and with one

medical fluid is filled,

wherein the multilayer film has at least one inner layer made of a matrix phase polymer system, a middle layer made of a matrix phase polymer system and an outer layer made of a matrix phase polymer system, wherein

the matrix polymer of the matrix phase polymer system of the inner layer, the middle layer and the outer layer each comprises a polypropylene polymer (PP) and

the phase polymer of the matrix-phase-polymer system of the inner layer, the middle layer and the outer layer each comprises a styrene-ethylene / butylene-styrene block copolymer (SEBS),

and wherein the middle layer styrene-ethylene / butylene-styrene block copolymer (SEBS) has a styrene-ethylene / butylene ratio S / EB _M and the styrene-ethylene / butylene-styrene block copolymer (SEBS) has outer layer has a styrene / ethylene / butylene ratio S / EB _A , in particular S / EBA> S / EBM.

According to claim 1, the invention is described by a medical packaging designed as an infusion bag, which is constructed from a multilayer film welded together and has at least one weld seam, and is filled with a medical fluid,

the multilayer film comprising at least one inner layer has a matrix phase polymer system, a middle layer of a matrix phase polymer system and an outer layer of a matrix phase polymer system, wherein

the matrix polymer of the matrix phase polymer system of the inner layer is a polypropylene polymer (PP) with a

Weight fraction G _IM in the range of 70-90% by weight and the phase polymer of the matrix-phase polymer system of the inner layer comprises a styrene-ethylene / butylene-styrene block copolymer (SEBS) with a weight fraction G _IP in the range comprises from 10 to 30% by weight,

the matrix polymer of the matrix phase polymer system of the middle layer is a polypropylene polymer (PP) with a

Weight fraction G _MM in the range of 40-60 wt .-% and the weight fraction G _{MP of} the phase polymer of the matrix-phase-polymer system of the middle layer (9b) is in the range of 40-60 wt .-% and styrene-ethylene / Butylene-styrene block copolymer (SEBS),

the matrix polymer of the matrix phase polymer system of the outer layer is a polypropylene polymer (PP) with a

The proportion by weight of G _AM in the range from 75 to 95% by weight and the phase polymer of the matrix-phase-polymer system of the outer layer comprise a styrene-ethylene / butylene-styrene block copolymer (SEBS) with a proportion by weight of G _{AP of} the phase polymer in the range of 5 - 25 wt .-%, wherein

the middle layer styrene-ethylene / butylene-styrene block copolymer (SEBS) has a S / EB _M styrene-ethylene / butylene ratio and the outer layer styrene-ethylene / butylene-styrene block copolymer (SEBS) has a styrene-ethylene / butylene ratio S / EBA, where S / EB _Ä > S / EB _M.

The medical packaging, which is designed as an infusion bag, is made of a multilayer film that is welded together

constructed and has at least one weld seam, preferably at least one longitudinal and at least one transverse weld seam, on which two multilayer films are welded together. In particular, the packaging comprises two longitudinal and two

Cross welds.

Furthermore, the packaging designed as an infusion bag can also comprise at least one port for removing a medical liquid. The port is welded in particular with its lower part in the weld seam or one of the weld seams, in particular in a cross weld seam. The lower part of the port can be designed, for example, in the shape of a boat. The port can be part of a connector, in which in particular a sealing element

is arranged. For example, a needle, a spike or a Luer lock connector can be connected to the connector.

Furthermore, the medical packaging can also comprise a hanger for attachment to a rack or an IV pole. The hanger can in particular be designed as a recess or incision in a transverse weld seam opposite the port.

The packaging according to the invention is filled with a medical liquid, for example with a saline solution. The packaging preferably has a capacity of 50 to 1000 ml, in particular per chamber.

The multi-layer film used for packaging is a polypropylene-based film. It is a film comprising polypropylene as a main component, which in particular, as explained below, forms a PP matrix. The film is preferably free of PVC.

The multilayer film has at least three, preferably exactly three, layers. The layers are bonded together. In particular, the layers are connected to one another in the hot state by co-extrusion and joining. The multilayer film comprises at least an inner layer made of a matrix phase polymer system, a middle layer made of a matrix phase polymer system and an outer layer made of a matrix phase polymer system.

The inner layer is in with the medical fluid

Contact. The outer layer represents the surface of the as

Infusion bags are designed medical packaging.

In a matrix-phase-polymer system, at least two different polymers are present, one polymer being separated, in particular as dispersed, solidified drops, being present in the matrix of the other polymer.

The matrix polymer of the matrix phase polymer system of the inner layer, the middle layer and the outer layer each comprises a polypropylene polymer. In particular, the matrix consists of a polypropylene.

The phase polymer of the matrix-phase-polymer system of the inner layer, the middle layer and the outer layer each comprises at least one styrene-ethylene / butylene-styrene block copolymer (SEBS) as the phase polymer.

SEBS is a block polymer composed of styrene, butylene and ethylene sections, which comprises a hydrogenated butadiene section, to which are attached

Connect styrene groups. This is particularly due to the polymerization of a styrene and butadiene monomer and

subsequent hydrogenation of the previously polymerized SBS

manufactured. The hydrated butadiene forms a soft middle block between styrene blocks. The SEBS forms a good bond with the PP matrix polymer. The middle layer styrene-ethylene / butylene-styrene block copolymer (SEBS) has a styrene-ethylene / butylene ratio S / EB _M. The styrene-ethylene / butylene-styrene block copolymer (SEBS) of the outer layer has a styrene-ethylene / butylene ratio S / EB _A. The styrene-ethylene / butylene ratio is in each case the weight fraction of styrene divided by the weight fraction of the sum of ethylene and butylene.

The weight ratio of styrene to the sum of ethylene and butylene can be determined by determining the weight of the styrene and butadiene monomer consumed for the polymerization. After polymerization, the styrene content can be determined using UV spectrometry. After extraction and dissolution of the sample, the measurement can be carried out with a UV spectrometer. The proportion of bound styrene is calculated by means of peak absorption at a

Absorbance wavelength associated with a styrene component using a calibration curve.

According to the invention, S / EB _A > S / EB _M. The middle layer therefore has a higher proportion of butylene / ethylene than the outer layer.

It has been found that this can significantly improve the mechanical properties of the multilayer film, particularly when the multilayer film is stretched in the area of the weld seams.

In particular, it was achieved that the sterile

multilayer film also in the area of their weld seams,

preferably their longitudinal weld seams can be stretched to at least 150%, preferably at least 200% of their length without the film tearing in the area of the weld seam.

The maximum elongation (elongation at break according to DIN EN ISO 527

(Version 2012-06)) of the non-sterile, unwelded multilayer Foil alone is preferably above 500%, particularly preferably above 600% and / or below 800%.

The tensile strength of the non-sterile, multilayer film alone is preferably above 20 N / mm ² and / or below 40 N / mm ² .

The multilayer non-sterile film has a measurable yield strength. The yield strength (measured according to DIN EN ISO 527) is preferably over 5 N / mm ² , particularly preferably over 6 N / mm ² , and / or under 15 N / mm ² . The elongation when the yield point is reached is preferably over 10%, particularly preferably over 15% and / or under 30%.

After thermal sterilization, no yield point can be determined on the film of the packaging designed as an infusion bag. The maximum elongation (elongation at break according to DIN EN ISO 527 (version 2012-06)) of the sterilized multilayer film alone is preferably over 400%, particularly preferably over 500% and / or under 700%. The tensile strength of the sterile, multilayer film is preferably above 20 N / mm2 and / or below 40 N / mm2. The improved mechanical properties on the sterilized bag are evident both at room temperature and at lower temperatures of up to 4 ° C.

Without being bound by theory, in addition to a softer material of the middle layer, the distribution of the SEBS in the PP matrix for the improved mechanical could

Properties to be responsible.

In one embodiment of the invention, the styrene-ethylene / butylene-styrene block polymer of the inner layer has a styrene-ethylene / butylene ratio S / EBi, where S / EBi> S / EB _M. There is also an inner layer with a low butylene / ethylene content compared to the middle layer. According to one embodiment of the invention, S / EB _A > 1.2 S / EB _M , preferably S / EB _A > 1.5 S / EB _M , and / or S / EBi> 1.2 S / EB _M , preferably S / EBi> 1.5 S / EB _M , and / or is S / EBi = S / EB _A. Preferably S / EB _A <2.0 S / EB _M and / or S / EBi <2.0 S / EBM

Preferably, the SEBS used for the middle layer is softer than the SEBS used for the inner and / or outer layer. In particular, the middle layer or the SEBS of the middle layer has a Shore A hardness (measured according to DIN EN ISO 868 (version 2003-10) and DIN ISO 7619-1 (version 2012-02)) of less than 50, preferably less than 45, and / or over 30.

The SEBS used for the inner and / or outer layer can have a Shore A hardness of more than 55, preferably more than 62, and / or less than 80.

The ratio S / EB _{M of} the middle layer in one embodiment of the invention is below 0.16, preferably below 0.14, and / or above 0.10, preferably above 0.13. A SEBS polymer with such properties is available, for example, under the trade name Asahi Tuftec® H1221.

The ratio S / EBi of the inner layer and / or the ratio S / EB _{A of} the outer layer is in one embodiment the

Invention above 0.18, preferably above 0.20, and / or below 0.28, preferably below 0.24. A SEBS polymer with such

Properties is available, for example, under the trade name Asahi Tuftec® H1062.

In a development of the invention, this includes

Phase polymer of the matrix-phase-polymer system of the middle layer additionally a styrene-isoprene-styrene block copolymer (SIS). In particular, the styrene-ethylene / butylene-styrene block copolymer (SEBS) with a part by weight of GMPI and the styrene-isoprene-styrene block polymer (SIS) with a part by weight of GMP2 is provided, GMPI> 3 GMP2 and / or GMPI <5 GMP2.

According to a further embodiment of the invention, the matrix polymer of the middle layer is a polypropylene random copolymer. This goes well with that

used SEBS with the high butylene / ethylene content and contributes to a soft middle layer.

According to one embodiment, the matrix polymer in the middle layer has a weight fraction GMM which is essentially the weight fraction GMP of the phase polymer or GMPI + 2

Corresponds to phase polymers. In particular, GMM = 0.9 - 1.1 * GMPI + 2 or GMM = 0.9 - 1.1 * GMP. GMP is in particular the sum of GMPI and GMP2 ·

The matrix polymer of the outer layer is according to one

Embodiment of the invention not a PP random copolymer, but a polypropylene homopolymer. In this way, a firm outer layer of the layer package is achieved.

The softening temperature (Vicat softening temperature A / 50 / N) of the polypropylene used for the outer layer is

preferably higher than that of the polypropylene used for the middle and / or inner layer. In particular, the polypropylene of the outer layer has a temperature of at least 10 ° C,

preferably at least 15 ° C, higher softening temperature than the middle layer polypropylene.

The Vicat softening temperature A / 50 / N of the PP of the outer layer is preferably above 140 ° C., particularly preferably above 150 ° C and / or below 170 ° C (measured according to DIN EN ISO 306 (version 2014-03)).

The film according to the invention shows good weldability and good resistance to thermal

Sterilization, especially with autoclaving.

The PP polymer used for the outer layer is preferably harder than at least the PP polymer used for the middle layer. According to one embodiment of the invention, the PP polymer used for the outer layer has a ball pressure hardness H 358/30 (according to DIN 53 505 (version 2000-08) / ISO 2039 (version

2003-06)) of over 55 MPa, preferably over 60 MPa and / or under 80 MPa. The PP used for the middle and / or inner layer can have a ball pressure hardness H 358/30 of less than 60 MPa, preferably less than 50 and / or more than 35 MPa.

In the outer layer, the matrix polymer preferably has a weight fraction G _A M and the phase polymer one

Weight fraction G _A P, where G _A M> 4 G _A P.

According to one embodiment of the invention, the matrix polymer has a weight fraction of GIM in the inner layer and the phase polymer has a weight fraction of GIP, where GIM> 3 GIP. In particular, the weight fraction GIM of the matrix polymer in the inner layer is in the range from 70 to 90% by weight and

Weight fraction GIP of the phase polymer in the range of 10-30% by weight.

The inner layer matrix polymer is preferably also a polypropylene random copolymer.

The matrix polymer has one in the outer layer

Weight fraction G _A M and the phase polymer has one

Weight fraction G _A P, preferably G _A M> 4 G _A P. In the outer layer, the weight fraction G _A M of the matrix polymer is preferably in the range from 75 to 95% by weight and

Weight fraction G _A P of the phase polymer in the range from 5 to 25% by weight.

Preferably, the weight fraction of the phase polymer GMPI + 2 in the middle layer with respect to the weight fraction of P G _A

Phase polymer increases in the outer layer, wherein GMPI + 2> 3 G _A P and / or GMPI + 2 <5 G _A P.

In the middle layer, the weight fraction GMM of the matrix polymer is preferably in the range of 40-60% by weight and / or the weight fraction GMP of the phase polymer or

Weight fraction GMPI + 2 of the phase polymers in the range of 40-60% by weight. In one embodiment, GMP, preferably at least, is composed of GMPI and GMP2.

In particular, the weight percentage GMPI of the styrene-ethylene / butylene-styrene block copolymer (SEBS) as a phase polymer is in the range from 30 to 55% by weight and / or the weight percentage GMP2 of the styrene-isoprene-styrene is -Block polymer (SIS) as a further phase polymer in the range of greater than or equal to 0-20% by weight.

According to one embodiment of the invention, the inner layer has a thickness Di, the middle layer has a thickness D _M and the outer layer has a thickness D _A , 4 Di <D _M <5 D _A and / or 4 D _A <D _M < 5 Tue is.

The multilayer film used for packaging has

preferably a total thickness of more than 150 μm, particularly preferably more than 180 μm and / or less than 250 μm, particularly preferably less than 220 μm. The inner and / or the outer layer of the multilayer film preferably has a thickness of more than 15 μm, particularly preferably more than 25 μm and / or less than 45 μm, particularly preferably less than 35 μm.

The middle layer preferably has a thickness of more than 100 μm, particularly preferably more than 120 μm and / or less than 170 μm, particularly preferably less than 150 μm, in particular from 125 μm to 145 μm,

According to the invention, the medical packaging is designed as an infusion bag filled with a medical liquid. The medical fluid is one

Liquid which is used for medical purposes and is preferably administered intravenously here. In a preferred embodiment, the medical fluid is therefore an infusion solution. Possible examples of such infusion solutions include

sterile water;

Salt solutions, in particular solutions with NaCl, KCl, CaCl and / or Mg;

Solutions with carbohydrates, in particular glucose solutions; Solutions, emulsions and / or suspensions with nutrients for parenteral nutrition, especially with lipids, amino acids and / or glucose;

Colloid solutions, especially for blood replacement therapy (e.g. Voluven®); and or

so-called premixed systems, in which an active ingredient has already been added to the medical fluid, e.g.

Paracetamol.

The medical packaging designed as an infusion bag, which is filled with a medical liquid, can also be referred to as a pharmaceutical product. The medical packaging designed as an infusion bag preferably has a volume of 50 ml to 1000 ml.

If the infusion bag is designed, for example, as a multi-chamber bag, it can also have a total capacity of up to 3000 ml. Thus, according to one embodiment, the infusion bag can be designed as a three-chamber bag for parenteral nutrition. Each chamber contains one component (lipids, amino acids or glucose). The three chambers are initially separated from one another, for example, by inner, tearable seams. Before applying the

Nutritional composition will divide this inner

The seams are torn open and the components are mixed together.

The features mentioned above in the description of the medical packaging designed as an infusion bag, which is constructed from the multilayer film which is welded to one another and has at least one weld seam, and with one

medical fluid is filled, as well as in the

Features described in patent claims are also features of the weldable film described below and / or the welding method described below.

The invention can also be described by a

sealable film, in particular for the medical packaging described above as an infusion bag. The film is a multi-layer film,

the phase polymer of the matrix phase polymer system of inner layer, the middle layer and the outer layer each comprises a styrene-ethylene / butylene-styrene block copolymer (SEBS), characterized in that

The film is processed using a welding process,

for example with a pulse welding process for

Production of a trained as an infusion bag

medical packaging from a multilayer film,

the phase polymer of the matrix-phase-polymer system of the inner layer, the middle layer and the outer layer each comprises a styrene-ethylene / butylene-styrene block copolymer (SEBS), characterized in that

The invention can provide an improved packaging made of a multilayer PP film. The film has a high degree of elasticity in the area of the weld seams, without the weld seams tearing open or in the area of the weld seams. The PP content of the multilayer film is preferably above 55% by weight, particularly preferably above 60% by weight and / or below 70% by weight, particularly preferably below 65% by weight.

Brief description of the drawings

The subject matter of the invention is to be explained in more detail below with reference to a schematically illustrated exemplary embodiment with reference to the drawings in FIGS. 1 to 4.

1 shows an infusion bag

medical packaging.

Fig. 2 is a schematic sectional view of the for

Infusion bags used multi-layer PP film.

Detailed description of the drawings

1 shows an infusion bag 1

medical packaging.

The infusion bag 1 consists of two together

weld multilayer films 8. The multilayer films 8 are connected to one another via the longitudinal weld seams 7 and the transverse weld seams 6, so that a bag is formed which is filled with a medical liquid. The bag 1 is a single-chamber bag here.

The multilayer films 8 are connected to one another, for example, by means of a pulse welding process. The foils 8 are welded with heatable sealing strips which come into contact with the foil by means of a welding tool. welded by temporarily heating the sealing strips so that the foils clamped between the sealing strips become molten at least in sections and are thus welded. Is a pulse welding process

for example in the published patent application EP 0 911 141 A2 (Fresenius Medical Care Deutschland GmbH).

The infusion bag 1 comprises at least one port, in this exemplary embodiment two ports 2a, 3a, one port 2a of which is used to fill in liquid, for example the metering of a medication, and another port 3a is used to withdraw the medical liquid.

In this exemplary embodiment, the ports 2a, 3a comprise a welding boat, with which they are welded in an area 5 of a transverse welding seam 6.

The two ports 2a and 3a each provide the lower part of a connector 2 and 3. The two connectors 2 and 3 are each formed by the two lower parts 2a and 3a and the upper parts 2b and 3b. The upper part 2b, 3b is preferably placed on the lower part 2a, 3a, in particular bounced. A sealing element (not shown here in the figures), which closes the passage in the port 2a, 3a or in the connector 2, 3 to the bag volume, is preferably form-fitting between the respective

Lower part 2a, 3a and the upper part 2b, 3b included. The sealing element mentioned is a self-closing,

reclosable elastomer element that can be pierced with a spike and / or also with a needle in order to remove or supply liquid. After this

Pulling out the spike and / or the needle closes the sealing element independently. As an elastomer material e.g. Polyisoprene can be used. The upper part also includes

2b, 3b of the connector 2, 3 each have a cover, preferably a breakable cap 2c, 3c, which covers the sealing element. The respective sealing element is therefore only accessible after the cap 2c, 3c has been removed or broken off.

The infusion bag 1 further comprises a hanger 4 on the side opposite the at least one port 2a, 3a for attaching the infusion bag to an infusion stand or a rack. The hanger 4 can be designed as a cut or punched out in the cross weld 6.

Fig. 2 is a schematic view of the for

Infusion bag 1 used multilayer film 8.

The film 8 consists of an inner layer 9c in contact with the medical fluid, a middle layer 9b and an outer layer 9a. When the foils 8 are welded together, the layers 9a, 9b, 9c become molten. Doing so

For example, during pulse welding, the entire material in the area of the weld seam is converted into a molten state.

The inner and outer layers 9c, 9a are each 25-45 µm thick. The middle layer 9b has a thickness of 125-145 μm.

The outer layer 9a consists of a PP homopolymer, to which SEBS has been added to improve the mechanical properties. The proportion by weight G _A M of the PP homopolymer is in a range from 82 to 88% by weight. The weight fraction G _A P of the SEBS is in a range of 12-18% by weight.

The inner layer 9c consists of a PP random copolymer to which SEBS has been added to improve the mechanical properties. The weight fraction GIM of the PP random copolymer is in a range of 77-83 wt%. The weight fraction GIP of the SEBS is in a range of 17-23% by weight.

The middle layer 9b is softer than at least the outer layer 9a. It is preferably also softer than the inner layer 9c. The middle layer 9b consists of a PP random copolymer which is softer than the PP of the outer layer 9a and to which SEBS and optionally SIS have been added. The weight fraction G _{MM of} the PP random copolymer is in a range from 47 to 53% by weight. The weight fraction G _{MPI of} the SEBS is in the range of 37-43% by weight. The weight fraction G _MP 2 of the second thermoplastic elastomer SIS is in the range of 7-13% by weight. The

The proportion by weight of thermoplastic elastomers (ie SEBS and optionally SIS) is higher in the middle layer 9b than in the inner and outer layers 9a, 9c.

Furthermore, the SEBS of the middle layer 9b has a higher one

Weight fraction of ethylene / butylene as the SEBS in the inner and outer layers 9a, 9c. The ratio S / EB _M in the middle layer 9b is 12/88. The ratio S / EB _A in the outer layer 9a and / or in the inner layer 9c is 18/82.

This provides a soft middle layer 9b with SEBS which is more finely distributed than the inner and outer layers 9c, 9a and which to a large extent is the mechanical one

Properties of the infusion bag, especially for

Drop tests, improved. This improved mechanical

Properties are evident both at room temperature and at lower temperatures of up to 4 ° C.

The film 8 is produced by co-extrusion of the individual layers 9a-9c. The invention allows the mechanical properties of an infusion bag 1, in particular in the

Area of welds 6, 7 and over a wide

Temperature range, can be improved.

LIST OF REFERENCE NUMBERS

1 infusion bag

2 connector for supplying an additive or medication 2a lower part or port of the connector

2b top part of the connector

2c break-off part of the upper part

3 connector for withdrawing a medical fluid

3a lower part or port of the connector

3b top part of the connector

3c break-off part of the upper part

4 hangers

5 area welding boats

6 cross weld

7 longitudinal weld

8 slide

9a outer layer

9b middle layer

9c inner layer

Claims

Claims:

1. Medical as an infusion bag (1)

Packaging that is sealed from one another

multilayer film (8) and at least one

Has weld (6, 7), and with a medical

Liquid is filled,

the multilayer film (8) comprising at least one inner layer (9c) made of a matrix phase polymer system, a middle layer (9b) made of a matrix phase polymer system and an outer layer (9a) made of a matrix phase polymer system

owns, whereby

the matrix polymer of the matrix phase polymer system of the inner layer (9c) is a polypropylene polymer (PP) with a

GIM weight fraction in the range of 70 - 90 wt .-% and the phase polymer of the matrix-phase polymer system of the inner layer (9c) is a styrene-ethylene / butylene-styrene block copolymer (SEBS) with a weight fraction of GIP im Range from 10 to 30% by weight,

the matrix polymer of the matrix phase polymer system of the middle layer (9b) comprises a polypropylene polymer (PP) with a weight fraction GMM in the range of 40-60% by weight and the weight fraction GMP of the phase polymer of the matrix phase polymer System of the middle layer (9b) is in the range from 40 to 60% by weight and comprises styrene-ethylene / butylene-styrene block copolymer (SEBS),

the matrix polymer of the matrix phase polymer system of the outer layer (9a) is a polypropylene polymer (PP) with a

The proportion by weight G _A M in the range from 75 to 95% by weight and the phase polymer of the matrix-phase-polymer system of the outer layer (9a) comprises a styrene-ethylene / butylene-styrene block copolymer (SEBS) with a proportion by weight G _A P of

Phase polymer in the range of 5 - 25 wt .-%,

in which the styrene-ethylene / butylene-styrene block copolymer (SEBS) of the middle layer (9b) has a styrene-ethylene / butylene ratio S / EB _M and the styrene-ethylene / butylene-styrene block copolymer (SEBS) the outer layer (9a) has a styrene / ethylene / butylene ratio S / EB _A , where S / EB _A > S / EB _M.

2. Medical as an infusion bag (1)

Packaging according to the preceding claim, characterized in that the styrene-ethylene / butylene-styrene block polymer of the inner layer (9c) has a styrene-ethylene / butylene ratio S / EBi, where S / EBi> S / EB _M ,

3. Medical as an infusion bag (1)

Packaging according to one of the preceding claims, characterized in that S / EB _A > 1.2 S / EB _M , preferably S / EB _A > 1.5 S / EB _M , and / or that S / EBi> 1, 2 S / EB _M is

preferably S / EBi> 1.5 S / EB _M and / or that S / EBi = S / EB _A.

4. Medical trained as an infusion bag (1)

Packaging according to one of the preceding claims, characterized in that the phase polymer of the matrix-phase-polymer system of the middle layer (9b) comprises a styrene-isoprene-styrene block copolymer (SIS).

5. Medical as an infusion bag (1)

Packaging according to the preceding claim, characterized in that in the middle layer (9b) the styrene-ethylene / butylene-styrene block copolymer (SEBS) with a proportion by weight of GMPI and the styrene-isoprene-styrene block polymer (SIS) one

Weight fraction GMP2 are provided, GMPI> 3 GMP2 and / or GMPI <5 GMP2.

6. As an infusion bag (1) designed medical packaging according to one of the two preceding claims, characterized in that the weight fraction GMPI of the styrene-ethylene / butylene-styrene block copolymer (SEBS) in one

Range of 30 - 55 wt .-% and / or that the

The weight fraction GMP2 of the styrene-isoprene-styrene block polymer (SIS) is in a range of greater than or equal to 0-20% by weight.

7. Medical infusion bag (1)

Packaging according to one of the preceding claims, characterized in that the matrix polymer of the middle layer (9b) is a polypropylene random copolymer.

8. Medical as an infusion bag (1)

Packaging according to one of the preceding claims, characterized in that in the middle layer (9b)

Matrix polymer has a weight proportion of GMM, which in

Essentially the percentage by weight GMP of the phase polymer

corresponds, where GMM = 0.9 - 1.1 * GMP.

9. Medical trained as an infusion bag (1)

Packaging according to one of the preceding claims, characterized in that the matrix polymer of the outer layer (9a) is a polypropylene homopolymer.

10. Medical infusion bag (1)

Packaging according to one of the preceding claims, characterized in that in the inner layer (9c)

The matrix polymer has a weight fraction of GIM and the phase polymer has a weight fraction of GIP, where GIM> 3 GIP.

11. Medical trained as an infusion bag (1)

Packaging according to one of the preceding claims, characterized characterized in that the matrix polymer of the inner layer (9c) is a polypropylene random copolymer.

12. Medical designed as an infusion bag (1)

Packaging according to one of the preceding claims, characterized in that in the outer layer (9a)

The matrix polymer has a proportion by weight G _A M and the phase polymer has a proportion by weight G _A P, where G _A M> 4 G _A P.

13. Medical designed as an infusion bag (1)

Packaging according to one of the preceding claims, characterized in that the weight fraction GMPI + 2 des

Phase polymer in the middle layer (9b) compared to

Weight fraction G _A P is increased the phase of polymer in the outer layer (9a), wherein GMPI + 2> 3 G _A P and / or GMPI + 2 <5 G _A P.

14. Medical as an infusion bag (1)

Packaging according to one of the preceding claims, characterized in that the inner layer (9c) has a thickness Di, the middle layer (9b) has a thickness D _M and the outer layer (9a) has a thickness D _A , 4 Di < D _M <5 D _A and 4 D _A <D _M <5 Di.