WO2008046164A2 - Method for manufacturing a multi-layered film and film manufactured by said method - Google Patents

Method for manufacturing a multi-layered film and film manufactured by said method Download PDF

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Publication number
WO2008046164A2
WO2008046164A2 PCT/BE2006/000116 BE2006000116W WO2008046164A2 WO 2008046164 A2 WO2008046164 A2 WO 2008046164A2 BE 2006000116 W BE2006000116 W BE 2006000116W WO 2008046164 A2 WO2008046164 A2 WO 2008046164A2
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WO
WIPO (PCT)
Prior art keywords
polypropylene
film
homopolymer
layered film
copolymer
Prior art date
Application number
PCT/BE2006/000116
Other languages
French (fr)
Other versions
WO2008046164A3 (en
Inventor
Johan Willy Declerck
Original Assignee
Tekni-Plex Europe, Naamloze Vennootschap
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 Tekni-Plex Europe, Naamloze Vennootschap filed Critical Tekni-Plex Europe, Naamloze Vennootschap
Priority to EP06804574A priority Critical patent/EP2102003A2/en
Priority to BRPI0622108-4A priority patent/BRPI0622108A2/en
Priority to US12/311,909 priority patent/US20100030180A1/en
Priority to PCT/BE2006/000116 priority patent/WO2008046164A2/en
Publication of WO2008046164A2 publication Critical patent/WO2008046164A2/en
Publication of WO2008046164A3 publication Critical patent/WO2008046164A3/en

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Classifications

    • 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
    • B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/08—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the cooling method
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/07—Flat, e.g. panels
    • B29C48/08—Flat, e.g. panels flexible, e.g. films
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/16—Articles comprising two or more components, e.g. co-extruded layers
    • B29C48/18—Articles comprising two or more components, e.g. co-extruded layers the components being layers
    • B29C48/21—Articles comprising two or more components, e.g. co-extruded layers the components being layers the layers being joined at their surfaces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/911—Cooling
    • B29C48/9135—Cooling of flat articles, e.g. using specially adapted supporting means
    • B29C48/9145—Endless cooling belts
    • 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
    • B32B25/00—Layered products comprising a layer of natural or synthetic rubber
    • B32B25/04—Layered products comprising a layer of natural or synthetic rubber comprising rubber as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B25/08—Layered products comprising a layer of natural or synthetic rubber comprising rubber 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
    • B32B27/06—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
    • B32B27/32—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
    • B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/10—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the pressing technique, e.g. using action of vacuum or fluid pressure
    • B32B37/1027—Pressing using at least one press band
    • B32B37/1036—Pressing between one press band and a cylinder
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/911—Cooling
    • B29C48/9135—Cooling of flat articles, e.g. using specially adapted supporting means
    • B29C48/914—Cooling of flat articles, e.g. using specially adapted supporting means cooling drums
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
    • B29K2023/10—Polymers of propylene
    • B29K2023/12—PP, i.e. polypropylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2009/00—Layered products
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/712—Containers; Packaging elements or accessories, Packages
    • B29L2031/7148—Blood bags, medical 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
    • 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
    • B32B2309/00—Parameters for the laminating or treatment process; Apparatus details
    • B32B2309/08—Dimensions, e.g. volume
    • B32B2309/10—Dimensions, e.g. volume linear, e.g. length, distance, width
    • B32B2309/105—Thickness
    • 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
    • B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/14—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers
    • B32B37/15—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers with at least one layer being manufactured and immediately laminated before reaching its stable state, e.g. in which a layer is extruded and laminated while in semi-molten state
    • B32B37/153—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers with at least one layer being manufactured and immediately laminated before reaching its stable state, e.g. in which a layer is extruded and laminated while in semi-molten state at least one layer is extruded and immediately laminated while in semi-molten state
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]

Definitions

  • the transparency ' requirement is very important as medical fluids for intravenous application need to be absolutely clear and particle free and visual inspection will allow to determine whether or not contamination has taken place and to check for the turbidity of the solution.
  • IV-bags intravenous bags
  • Other important requirements for a film used for manufacturing intravenous bags (IV-bags) for the containment of medical fluids are heat sealability, flexibility, puncture resistance,- the ability to withstand sterilisation and barrier properties.
  • the flexibility of the film is important for the drainage of IV-bags, so that patients receive exact solution quantities as intended.
  • PVC polyvinyl chloride
  • a known alternative film for manufacturing IV- bags consists of at least three layers, namely an outer layer and an inner layer with an intermediate layer provided in between.
  • inner and outer layer is based on the position of said layers in a finished IV-bag, more specifically, the inner layer is meant to be situated at the inside of the bag and will be in contact with the product contained therein, while the outer surface constitutes the outer surface of the IV-bag.
  • At least the inner layer and the intermediate layer comprise a mixture of a polypropylene homopolymer or copolymer and a thermoplastic elastomer (TPE) .
  • TPE thermoplastic elastomer
  • the present invention concerns a multi-layered film consisting of at least an inner layer and an outer layer, with an intermediate layer provided in between, whereby at least the inner and the outer layer consist of a homopolymer of polypropylene and/or a copolymer of polypropylene, and whereby the intermediate layer contains at least a mixture of a homopolymer of polypropylene and/or a copolymer of polypropylene with a thermoplastic elastomer, characterized in that the film has a haze of 5% or less.
  • the present invention also relates to a method for manufacturing such a high transparent multi-layered film.
  • Lamination however has the inconvenience that additional adhesives have to be used to laminate the different layers, which not only implies an additional production cost but which also implies that due care should be taken when selecting convenient adhesives since migration of the adhesives or residual solvents out of the film should be prevented.
  • a second known method is to co-extrude the layers and to subsequently chill the film in between two chill rolls.
  • a third known method consists of co-extruding the layers and to subsequently quench the film in a water bath.
  • the invention concerns a method for manufacturing a multi-layered film consisting of at least an inner layer and an outer layer, with an intermediate layer provided in between, whereby at least the inner and the outer layer consist of a homopolymer of polypropylene and/or a copolymer of polypropylene, and whereby the intermediate layer contains at least a mixture of a homopolymer of propylene and/or a copolymer of polypropylene with a thermoplastic elastomer, characterised in that the method at least comprises the steps of co-extruding said layers to create a film and subsequently chill said film between at least one rotating endless belt and a chill roll that extend complementary to each other over at least a part of their course.
  • the method according to the invention allows to manufacture highly transparent multi-layered films comprising at least one layer containing a mixture of a homopolymer of propylene and/or a copolymer of polypropylene with a thermoplastic elastomer such as, for example, polyisobutylene (PIB) orstyrene-ethylene-butylene-styrene (SEBS), or the like.
  • PIB polyisobutylene
  • SEBS styrene-ethylene-butylene-styrene
  • Figure 1 represents a cross section of a film according to the invention
  • Figure 2 schematically represents a method for manufacturing a film according to the invention
  • Figure 3 represents a container manufactured with a film according to the invention
  • Figure 4 represents, on a larger scale, a cross section according to line IV-IV in figure 3.
  • Figure 1 represents a multi-layered film 1 according to the invention consisting of at least three layers, in particular an outer layer 2, an inner layer 3 and an intermediate layer 4 provided in between the inner layer 3 and the outer layer 2.
  • the outer layer 2 and the inner layer 3 both comprise a homopolymer of polypropylene and/or a copolymer of polypropylene.
  • Both layers 2 and 3 may also comprise a thermoplastic elastomer (TPE) such as, for example, polyisobutylene, styrene-ethylene-butylene-styrene (SEBS) , or the like.
  • TPE thermoplastic elastomer
  • SEBS styrene-ethylene-butylene-styrene
  • the inner layer 3 preferably has a melting temperature inferior to the melting temperature of the outer layer 2, whereto the inner layer 3 preferably consists of a copolymer of polypropylene, while the outer layer preferably consists of a homopolymer of polypropylene. This type of construction enhances the heat sealing characteristics .
  • the intermediate layer 4 comprises a mixture of at least (a) an homopolymer of polypropylene and/or a copolymer of polypropylene, and (b) a thermoplastic elastomer (TPE) , such as PIB and/or SEBS or the like.
  • TPE thermoplastic elastomer
  • the TPE that is used in at least the intermediate layer 4 of the film preferably is a compound containing styrene- ethylene-butylene-styrene (SEBS) next to polypropylene.
  • SEBS styrene- ethylene-butylene-styrene
  • TPE in the intermediate layer 4 provides a good flexibility that is required for a film used for the manufacturing of medical solution bags.
  • the film is further autoclavable .
  • the thickness of the film is typically between 100 and 300 ⁇ m, whereby the outer layer is preferably in the range of 30 ⁇ m, the thickness of the inner layer 3 is preferably in the range of 50 ⁇ m and the thickness of the intermediate layer 4 is preferably in the range of 100 ⁇ m.
  • the random copolymer of polypropylene can be for example Borealis ® RD 204 CF, Borealis ® RD 208 CF or Borealis ® TD 109 CF.
  • the homopolymer of polypropylene can be for example Borealis ® DM 55 or Borealis ® HD 601 CF.
  • the haze of the film is less than or equal to 5%, preferably even less than 3,5% and more preferably even less than 2,5% when measured by the following standard test method: ASTM D 1003.
  • the method for manufacturing the above film 1 at least comprises the steps of co- extruding the at least three layers 2, 3 and 4 through a die 5 in order to create a film 1.
  • the co-extruded film 1 subsequently is chilled between at least one rotating endless belt 7 and a chill roll 6 that extend complementary to each other over at least a part of their course.
  • the endless belt 7 consists of a metal sheet that is guided over at least two guiding rolls 8 and 9.
  • the roll 6 and the endless belt 7 are driven in an inverse direction and are chilled, such that the film 1 is transported in between said roll 6 and endless belt 7 and is cooled at its both surfaces during an extended period dependent on the drive speed of the roll and endless belt.
  • the method according to the invention offers the advantage that the chilling of the film can be performed adequately, such that the growth of crystals in the film can be prevented or at least stopped before the crystals reach dimensions equal to or greater than the wavelength of visible light, thereby resulting in a highly transparent film with a haze that is equal to or less than 5% and preferably even less than 3,5%.
  • polypropylene materials are carefully selected so that they cannot recrystallize at temperatures typically applied for the thermal sterilization of containers. This enables to keep the transparency very high even after autoclaving.
  • films according to the invention have shown an increase in haze from an initial value of approximately 3,5% prior to the sterilisation to approximately 5% after the sterilisation.
  • the film 1 according to the present invention is especially suited for the manufacturing of medical solution bags 10.
  • Figures 3 and 4 represent a medical solution bag 10 and in particular an intravenous bag (IV bag) that is manufactured by providing two sheets of a film 1, according to the invention, with their inner layers 3 facing each other and by sealing both films 1 together at their edges 11.
  • IV bag intravenous bag

Abstract

Multi-layered film consisting of at least an inner layer (3) and an outer layer (2), with an intermediate layer (4) provided in between, whereby at least the inner and the outer layers (2-3) consist of a homopolymer of polypropylene and/or a copolymer of polypropylene, and whereby the intermediate layer (4) contains at least a mixture of a homopolymer of polypropylene and/or a copolymer of polypropylene with a thermoplastic elastomer, characterized in that the film (1) has a haze of 5% or less.

Description

Method for manufacturing a multi-layered film and film manufactured by said method.
It is generally accepted that a film used for the containment- of medical fluids needs to. present highly transparent, in order to allow visual inspection of their content .
The transparency ' requirement is very important as medical fluids for intravenous application need to be absolutely clear and particle free and visual inspection will allow to determine whether or not contamination has taken place and to check for the turbidity of the solution.
Other important requirements for a film used for manufacturing intravenous bags (IV-bags) for the containment of medical fluids are heat sealability, flexibility, puncture resistance,- the ability to withstand sterilisation and barrier properties.
The flexibility of the film is important for the drainage of IV-bags, so that patients receive exact solution quantities as intended.
It is clear that ideally the transparency and flexibility of the film are not affected by autoclave sterilisation at high temperature, humidity and pressure, nor during low temperature storing.
Currently medical bags are typically made from films based on polyvinyl chloride (PVC) . However, such PVC films are
i not free of low molecular weight additives, such as plasticizers, which can migrate from the IV-bag into the medical fluid contained therein. Therefore it is recommended for several applications to replace PVC by inert materials such as for instance polyolefin materials.
Alternative films have been designed and tested in industry. A known alternative film for manufacturing IV- bags consists of at least three layers, namely an outer layer and an inner layer with an intermediate layer provided in between.
The use of the terms inner and outer layer is based on the position of said layers in a finished IV-bag, more specifically, the inner layer is meant to be situated at the inside of the bag and will be in contact with the product contained therein, while the outer surface constitutes the outer surface of the IV-bag.
In said alternative film, at least the inner layer and the intermediate layer comprise a mixture of a polypropylene homopolymer or copolymer and a thermoplastic elastomer (TPE) .
An inconvenience of such film, produced by a conventional method, is that the haze of such films comprising one or more layers of a mixture of polypropylene and a thermoplastic elastomer, usually around -β %, is rather high.
The goal of the present invention is to provide a solution for the above inconveniences. Therefore the present invention concerns a multi-layered film consisting of at least an inner layer and an outer layer, with an intermediate layer provided in between, whereby at least the inner and the outer layer consist of a homopolymer of polypropylene and/or a copolymer of polypropylene, and whereby the intermediate layer contains at least a mixture of a homopolymer of polypropylene and/or a copolymer of polypropylene with a thermoplastic elastomer, characterized in that the film has a haze of 5% or less.
The present invention also relates to a method for manufacturing such a high transparent multi-layered film.
Up to now, there are known three major methods for manufacturing such a film, the first is by extrusion of the several layers and a subsequent lamination step.
Lamination however has the inconvenience that additional adhesives have to be used to laminate the different layers, which not only implies an additional production cost but which also implies that due care should be taken when selecting convenient adhesives since migration of the adhesives or residual solvents out of the film should be prevented.
A second known method is to co-extrude the layers and to subsequently chill the film in between two chill rolls.
An inconvenience is that this method cannot sufficiently prevent the growth of crystals in the film with dimensions superior to the wavelength of light, thereby reducing the transparency of the film. Also by this cooling method, the two sides of the film are unevenly cooled. This results in building in stress in the film and induces curl and shrink during thermal handling.
A third known method consists of co-extruding the layers and to subsequently quench the film in a water bath.
Although this method allows producing a very amorphous and clear film, the quenching results in a film with a somewhat wavy surface that increases the haze to around 6 %.
Thereto the invention concerns a method for manufacturing a multi-layered film consisting of at least an inner layer and an outer layer, with an intermediate layer provided in between, whereby at least the inner and the outer layer consist of a homopolymer of polypropylene and/or a copolymer of polypropylene, and whereby the intermediate layer contains at least a mixture of a homopolymer of propylene and/or a copolymer of polypropylene with a thermoplastic elastomer, characterised in that the method at least comprises the steps of co-extruding said layers to create a film and subsequently chill said film between at least one rotating endless belt and a chill roll that extend complementary to each other over at least a part of their course.
Extended research and tests have shown that the method according to the invention allows to manufacture highly transparent multi-layered films comprising at least one layer containing a mixture of a homopolymer of propylene and/or a copolymer of polypropylene with a thermoplastic elastomer such as, for example, polyisobutylene (PIB) orstyrene-ethylene-butylene-styrene (SEBS), or the like.
With the intention of better showing the features of the present invention, hereafter, as an example without any limitative character, several preferred forms of embodiments are described, with reference to the accompanying drawings, wherein:
Figure 1 represents a cross section of a film according to the invention; Figure 2 schematically represents a method for manufacturing a film according to the invention; Figure 3 represents a container manufactured with a film according to the invention; Figure 4 represents, on a larger scale, a cross section according to line IV-IV in figure 3.
Figure 1 represents a multi-layered film 1 according to the invention consisting of at least three layers, in particular an outer layer 2, an inner layer 3 and an intermediate layer 4 provided in between the inner layer 3 and the outer layer 2.
According to the invention the outer layer 2 and the inner layer 3 both comprise a homopolymer of polypropylene and/or a copolymer of polypropylene. Both layers 2 and 3 may also comprise a thermoplastic elastomer (TPE) such as, for example, polyisobutylene, styrene-ethylene-butylene-styrene (SEBS) , or the like. The inner layer 3 preferably has a melting temperature inferior to the melting temperature of the outer layer 2, whereto the inner layer 3 preferably consists of a copolymer of polypropylene, while the outer layer preferably consists of a homopolymer of polypropylene. This type of construction enhances the heat sealing characteristics .
Also according to the invention, the intermediate layer 4 comprises a mixture of at least (a) an homopolymer of polypropylene and/or a copolymer of polypropylene, and (b) a thermoplastic elastomer (TPE) , such as PIB and/or SEBS or the like.
The TPE that is used in at least the intermediate layer 4 of the film preferably is a compound containing styrene- ethylene-butylene-styrene (SEBS) next to polypropylene.
Providing TPE in the intermediate layer 4 provides a good flexibility that is required for a film used for the manufacturing of medical solution bags. The film is further autoclavable .
Preferably, no nucleating agents or low molecular weight additives, such as plasticizers, are present in the film.
The thickness of the film is typically between 100 and 300 μm, whereby the outer layer is preferably in the range of 30 μm, the thickness of the inner layer 3 is preferably in the range of 50 μm and the thickness of the intermediate layer 4 is preferably in the range of 100 μm. The random copolymer of polypropylene can be for example Borealis® RD 204 CF, Borealis® RD 208 CF or Borealis® TD 109 CF. The homopolymer of polypropylene can be for example Borealis® DM 55 or Borealis® HD 601 CF.' For a mixture of polypropylene and thermoplastic elastomer, for instance Meliflex® XS 141, Meliflex® XS 167, Meliflex® XS 140-3, Cellene® 06-121-08, Cellene® 06-121-09 or Cellene® 06-121- 12 can be chosen.
According to the invention the haze of the film is less than or equal to 5%, preferably even less than 3,5% and more preferably even less than 2,5% when measured by the following standard test method: ASTM D 1003.
As represented in figure 2, the method for manufacturing the above film 1 at least comprises the steps of co- extruding the at least three layers 2, 3 and 4 through a die 5 in order to create a film 1. The co-extruded film 1 subsequently is chilled between at least one rotating endless belt 7 and a chill roll 6 that extend complementary to each other over at least a part of their course.
In this case the endless belt 7 consists of a metal sheet that is guided over at least two guiding rolls 8 and 9.
The roll 6 and the endless belt 7 are driven in an inverse direction and are chilled, such that the film 1 is transported in between said roll 6 and endless belt 7 and is cooled at its both surfaces during an extended period dependent on the drive speed of the roll and endless belt. The method according to the invention offers the advantage that the chilling of the film can be performed adequately, such that the growth of crystals in the film can be prevented or at least stopped before the crystals reach dimensions equal to or greater than the wavelength of visible light, thereby resulting in a highly transparent film with a haze that is equal to or less than 5% and preferably even less than 3,5%.
In addition the polypropylene materials are carefully selected so that they cannot recrystallize at temperatures typically applied for the thermal sterilization of containers. This enables to keep the transparency very high even after autoclaving.
Essays have shown that a film according to the invention can resist an autoclave sterilisation cycle of 20 minutes at 121°C, with only a slight loss of transparency.
Indeed, films according to the invention have shown an increase in haze from an initial value of approximately 3,5% prior to the sterilisation to approximately 5% after the sterilisation.
In addition it is proven to be able to increase the polypropylene content in the outer layer 2 and inner layer 3, or even eliminate the TPE content in said layers, hence reducing the raw material cost of the co-extruded film.
The film 1 according to the present invention is especially suited for the manufacturing of medical solution bags 10. Figures 3 and 4 represent a medical solution bag 10 and in particular an intravenous bag (IV bag) that is manufactured by providing two sheets of a film 1, according to the invention, with their inner layers 3 facing each other and by sealing both films 1 together at their edges 11.
It is of course also possible to fold one sheet of a film according to the invention with the inner layer 3 facing the inside and by sealing the three free edges 11 to form the desired IV bag 11.
The present invention is by no means limited to the above described embodiments, on the contrary many alternatives of the film and method according to the invention may be realised without departing from the scope of the invention.

Claims

Claims
1. Multi-layered film consisting of at least an inner layer (3) and an outer layer (2), with an intermediate layer (4) provided in between, whereby at least the inner and the outer layers (2-3) consist of a homopolymer of polypropylene and/or a copolymer of polypropylene, and whereby the intermediate layer (4) contains at least a mixture of a homopolymer of polypropylene and/or a copolymer of polypropylene with a thermoplastic elastomer, characterized in that the film (1) has a haze of 5% or less .
2. Multi-layered film according to claim 1, characterized in that the film (1) has a haze of less that 3,5% and preferably less than 2,5%.
3. Multi-layered film according to claims 1 or 2, characterized in that it is free of nucleating agents or low molecular weight additives.
4. Multi-layered film according to claim 1, characterised in that both the inner layer (3) and outer layer (2) comprise a mixture of a homopolymer of polypropylene and/or a copolymer of polypropylene with a thermoplastic elastomer.
5. Multi-layered film a-ccording to claim 1, characterised in that the outer layer (2) comprises a homopolymer of polypropylene and that the inner layer (3) compris-es a homopolymer or a copolymer of polypropylene.
6. Multi-layered film according to any of claims 1 to 5, characterised in that the thermoplastic elastomer is a compound of polypropylene and styrene-ethylene-butylene- styrene (SEBS) and/or polyisobutylene (PIB) .
7. Multi-layered film according to any of the preceding claims, characterised in that the film is autoclavabl-e .
8. Method for manufacturing a multi-layered film according to any of claims 1 to 7, consisting of at least an inner layer (3) and an outer layer (2), with an intermediate layer (4) provided in between, characterised in that the method at least comprises the steps of co-extruding said layers (2, 3 and 4) to create a film (1) and subsequently chill said film (1) between at least one rotating endless belt (7) and a chill roll (6) that extend complementary to each other over at least a part of their course.
9. Medical solution bag manufactured from one or more multi-layered films (1) according to any of claims 1 to 7.
10. Medical solution bag according to claim 9, characterised in that it is an intravenous bag.
11. Use of a multi-layered film according to any of claims 1 to 7 for the manufacture of a medical solution bag, in particular an intravenous bag.
PCT/BE2006/000116 2006-10-18 2006-10-18 Method for manufacturing a multi-layered film and film manufactured by said method WO2008046164A2 (en)

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EP06804574A EP2102003A2 (en) 2006-10-18 2006-10-18 Method for manufacturing a multi-layered film and film manufactured by said method
BRPI0622108-4A BRPI0622108A2 (en) 2006-10-18 2006-10-18 Method of producing a multilayer film and film produced by said method
US12/311,909 US20100030180A1 (en) 2006-10-18 2006-10-18 Method for manufacturing a multi-layered film and film manufactured by said method
PCT/BE2006/000116 WO2008046164A2 (en) 2006-10-18 2006-10-18 Method for manufacturing a multi-layered film and film manufactured by said method

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WO2008046164A3 (en) 2009-05-07
BRPI0622108A2 (en) 2011-12-27
EP2102003A2 (en) 2009-09-23

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