EP3840719A1 - Infusionsbeutel - Google Patents

Infusionsbeutel

Info

Publication number
EP3840719A1
EP3840719A1 EP19752630.4A EP19752630A EP3840719A1 EP 3840719 A1 EP3840719 A1 EP 3840719A1 EP 19752630 A EP19752630 A EP 19752630A EP 3840719 A1 EP3840719 A1 EP 3840719A1
Authority
EP
European Patent Office
Prior art keywords
styrene
matrix
polymer
ethylene
layer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19752630.4A
Other languages
German (de)
English (en)
French (fr)
Inventor
Torsten Brandenburger
Beatrix Heuel-Hoemmen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of EP3840719A1 publication Critical patent/EP3840719A1/de
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1431—Permanent type, e.g. welded or glued
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1462—Containers with provisions for hanging, e.g. integral adaptations of the container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/302—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising aromatic vinyl (co)polymers, e.g. styrenic (co)polymers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B3/00—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form
    • B32B3/02—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by features of form at particular places, e.g. in edge regions
    • B32B3/08—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by features of form at particular places, e.g. in edge regions characterised by added members at particular parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00—Layers arrangement
    • B32B2250/03—3 layers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00—Layers arrangement
    • B32B2250/24—All layers being polymeric
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2250/00—Layers arrangement
    • B32B2250/24—All layers being polymeric
    • B32B2250/246—All polymers belonging to those covered by groups B32B27/32 and B32B27/30
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2270/00—Resin or rubber layer containing a blend of at least two different polymers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2274/00—Thermoplastic elastomer material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/40—Properties of the layers or laminate having particular optical properties
    • B32B2307/412—Transparent
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B32B2307/51—Elastic
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B32B2307/536—Hardness
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B32B2307/54—Yield strength; Tensile strength
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B32B2307/558—Impact strength, toughness
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/50—Properties of the layers or laminate having particular mechanical properties
    • B32B2307/582—Tearability
    • B32B2307/5825—Tear resistant
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/70—Other properties
    • B32B2307/732—Dimensional properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/40—Closed containers
    • B32B2439/46—Bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/80—Medical packaging

Definitions

  • the invention relates to a medical packaging designed as an infusion bag, which consists of multilayer, welded foils, and which with a
  • 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.
  • Multi-layer films made of PP 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.
  • Films have a high mechanical stability with regard to tearing a film, since the film is mechanical
  • PP films can be improved by providing a matrix phase polymer system.
  • 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.
  • Multi-layer PP films with SEBS are also described in the two patent applications WO 2011/128185 A1 and KR 2003 046120 A.
  • the invention has for its object the mechanical properties of an infusion bag
  • Infusion bag made of a multi-layer PP film
  • Weld seams have a high degree of elasticity without the weld seam tearing open.
  • the invention is generally described by an as
  • Infusion bag made of medical packaging which is made of a multi-layer film welded together
  • weld seam preferably longitudinal and transverse weld seams, and with one
  • 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
  • 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),
  • SEBS styrene-ethylene / butylene-styrene block copolymer
  • 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.
  • 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,
  • SEBS styrene-ethylene / butylene-styrene block copolymer
  • 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
  • SEBS styrene-ethylene / butylene-styrene block copolymer
  • the middle layer styrene-ethylene / butylene-styrene block copolymer has a S / EB M styrene-ethylene / butylene ratio
  • the outer layer styrene-ethylene / butylene-styrene block copolymer has a styrene-ethylene / butylene ratio S / EBA, where S / EB ⁇ > S / EB M.
  • the medical packaging which is designed as an infusion bag, is made of a multilayer film that is welded together
  • the packaging comprises two longitudinal and two
  • 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
  • a needle, a spike or a Luer lock connector can be connected to the connector.
  • 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.
  • 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
  • the outer layer represents the surface of the as
  • Infusion bags are designed medical packaging.
  • 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.
  • the matrix consists of a polypropylene.
  • 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 styrene-ethylene / butylene-styrene block copolymer
  • SEBS is a block polymer composed of styrene, butylene and ethylene sections, which comprises a hydrogenated butadiene section, to which are attached
  • 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
  • S / EB A > S / EB M.
  • the middle layer therefore has a higher proportion of butylene / ethylene than the outer layer.
  • 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 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%.
  • 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.
  • 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.
  • S / EBi styrene-ethylene / butylene ratio
  • S / EB A ⁇ 2.0 S / EB M and / or S / EBi ⁇ 2.0 S / EBM
  • the SEBS used for the middle layer is softer than the SEBS used for the inner and / or outer layer.
  • 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
  • this includes
  • Phase polymer of the matrix-phase-polymer system of the middle layer additionally a styrene-isoprene-styrene block copolymer (SIS).
  • SIS styrene-isoprene-styrene block copolymer
  • SEBS styrene-ethylene / butylene-styrene block copolymer
  • SIS styrene-isoprene-styrene block polymer
  • GMP2 styrene-isoprene-styrene block polymer
  • the matrix polymer of the middle layer is a polypropylene random copolymer. This goes well with that
  • SEBS SEBS with the high butylene / ethylene content and contributes to a soft middle layer.
  • 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
  • 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
  • the polypropylene of the outer layer has a temperature of at least 10 ° C
  • 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
  • the PP polymer used for the outer layer is preferably harder than at least the PP polymer used for the middle layer.
  • 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
  • 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.
  • the matrix polymer preferably has a weight fraction G A M and the phase polymer one
  • 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.
  • 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.
  • 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.
  • Phase polymer increases in the outer layer, wherein GMPI + 2> 3 G A P and / or GMPI + 2 ⁇ 5 G A P.
  • 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.
  • GMP preferably at least, is composed of GMPI and GMP2.
  • 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.
  • SEBS styrene-ethylene / butylene-styrene block copolymer
  • 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.
  • the inner layer has a thickness Di
  • the middle layer has a thickness D M
  • 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
  • the inner and / or the outer layer of the multilayer film preferably has a thickness of more than 15 ⁇ m, particularly preferably more than 25 ⁇ m and / or less than 45 ⁇ m, particularly preferably less than 35 ⁇ m.
  • the middle layer preferably has a thickness of more than 100 ⁇ m, particularly preferably more than 120 ⁇ m and / or less than 170 ⁇ m, particularly preferably less than 150 ⁇ m, in particular from 125 ⁇ m to 145 ⁇ m,
  • the medical packaging is designed as an infusion bag filled with a medical liquid.
  • the medical fluid is one
  • the medical fluid is therefore an infusion solution.
  • infusion solutions include
  • Salt solutions in particular solutions with NaCl, KCl, CaCl and / or Mg;
  • Solutions with carbohydrates in particular glucose solutions
  • Colloid solutions especially for blood replacement therapy (e.g. Voluven®); and or
  • premixed systems in which an active ingredient has already been added to the medical fluid, e.g.
  • 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.
  • the infusion bag can also have a total capacity of up to 3000 ml.
  • 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.
  • Nutritional composition will divide this inner
  • the seams are torn open and the components are mixed together.
  • 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
  • the invention can also be described by a
  • the film is a multi-layer film
  • 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
  • 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 middle layer styrene-ethylene / butylene-styrene block copolymer has a S / EB M styrene-ethylene / butylene ratio
  • the outer layer styrene-ethylene / butylene-styrene block copolymer has a styrene-ethylene / butylene ratio S / EBA, where S / EB ⁇ > S / EB M.
  • the film is processed using a welding process
  • 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
  • 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 middle layer styrene-ethylene / butylene-styrene block copolymer has a S / EB M styrene-ethylene / butylene ratio
  • the outer layer styrene-ethylene / butylene-styrene block copolymer has a styrene-ethylene / butylene ratio S / EBA, where S / EB ⁇ > S / EB M.
  • 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.
  • Fig. 2 is a schematic sectional view of the for
  • Infusion bags used multi-layer PP film.
  • the infusion bag 1 consists of two together
  • 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
  • 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.
  • 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
  • reclosable elastomer element that can be pierced with a spike and / or also with a needle in order to remove or supply liquid.
  • 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.
  • the layers 9a, 9b, 9c become molten. Doing so
  • 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 ⁇ m thick.
  • the middle layer 9b has a thickness of 125-145 ⁇ m.
  • 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.
  • thermoplastic elastomers ie SEBS and optionally SIS
  • the proportion by weight of thermoplastic elastomers is higher in the middle layer 9b than in the inner and outer layers 9a, 9c.
  • 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 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
  • 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

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Laminated Bodies (AREA)
EP19752630.4A 2018-08-21 2019-08-20 Infusionsbeutel Pending EP3840719A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18189930 2018-08-21
PCT/EP2019/072263 WO2020038941A1 (de) 2018-08-21 2019-08-20 Infusionsbeutel

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EP3840719A1 true EP3840719A1 (de) 2021-06-30

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EP (1) EP3840719A1 (ko)
JP (1) JP2021533851A (ko)
KR (1) KR20210044203A (ko)
CN (1) CN112584815A (ko)
AU (1) AU2019323653A1 (ko)
BR (1) BR112020025267A2 (ko)
CA (1) CA3109725A1 (ko)
CL (1) CL2021000364A1 (ko)
MX (1) MX2021001959A (ko)
WO (1) WO2020038941A1 (ko)
ZA (1) ZA202100527B (ko)

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WO2022187332A1 (en) * 2021-03-02 2022-09-09 West Pharmaceutical Services, Inc. Container for a pharmaceutical composition

Family Cites Families (14)

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Publication number Priority date Publication date Assignee Title
DE4447626C5 (de) * 1994-03-29 2007-01-25 Fresenius Ag Medizinischer Mehrkammerbeutel
DE19515254C2 (de) * 1995-04-26 1998-06-04 Fresenius Ag PVC-freie Mehrschichtfolie, Verfahren zur Herstellung derselben und deren Verwendung
EP0892830B1 (de) * 1996-03-21 2003-08-13 Kobusch-Sengewald GmbH & Co.KG Mehrlagenfolie, verfahren zu ihrer herstellung und ihre verwendung
SE9601348D0 (sv) * 1996-04-10 1996-04-10 Pharmacia Ab Improved containers for parenteral fluids
DE19746402A1 (de) 1997-10-21 1999-04-22 Fresenius Medical Care De Gmbh Verfahren und Vorrichtung zum Verschweißen von Kunststoffolien, vorzugsweise von Polyolefin-Folien
JP4086421B2 (ja) * 1999-07-19 2008-05-14 郡是高分子工業株式会社 樹脂積層体
DE10060523A1 (de) * 1999-12-11 2001-06-13 Fresenius Kabi De Gmbh Autoklavierbare, PVC-freie Mehrschichtfolie, insbesondere für die Verpackung von flüssigen, medizinischen Produkten, Verfahren zur Herstellung sowie Verwendung
KR100422761B1 (ko) * 2001-12-05 2004-03-16 호남석유화학 주식회사 다층 필름 및 다층 필름용 수지 조성물
CN1666856A (zh) * 2004-03-11 2005-09-14 德国玻利西尼公司 可加热杀菌的多层膜
JP4613037B2 (ja) * 2004-07-15 2011-01-12 ベスパック株式会社 ポリプロピレン系樹脂製複室袋
ES2717616T3 (es) * 2007-12-24 2019-06-24 Choongwae Corp Utilización de una película multicapa para recipiente de disolución médica y recipiente que comprende la misma
US8901249B2 (en) * 2008-08-06 2014-12-02 Borealis Ag Composition based on polypropylene compounds with styrenic based elastomers
KR101091527B1 (ko) * 2009-04-06 2011-12-13 제이더블유생명과학 주식회사 의료용 다층 필름, 및 이의 용도
DE102010014785A1 (de) 2010-04-13 2011-10-13 Fresenius Medical Care Deutschland Gmbh Mehrschichtfolie, Verwendung einer Mehrschichtfolie und Verfahren zur Herstellung einer Mehrschichtfolie

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BR112020025267A2 (pt) 2021-03-09
AU2019323653A1 (en) 2021-01-14
CA3109725A1 (en) 2020-02-27
WO2020038941A1 (de) 2020-02-27
CN112584815A (zh) 2021-03-30
JP2021533851A (ja) 2021-12-09
CL2021000364A1 (es) 2021-06-18
US20210169739A1 (en) 2021-06-10
ZA202100527B (en) 2022-08-31
KR20210044203A (ko) 2021-04-22

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