WO2003064522A1

WO2003064522A1 - Non-rigid material

Info

Publication number: WO2003064522A1
Application number: PCT/EP2003/000981
Authority: WO
Inventors: Jean-Luc Dewez
Original assignee: Baxter International Inc.
Priority date: 2002-01-30
Filing date: 2003-01-30
Publication date: 2003-08-07
Also published as: BE1014593A5

Abstract

The present invention provides a non-rigid or flexible material which is suitable to be placed in contact with a biological and/or therapeutic material, and which is sterilisable using steam at a temperature of at least 121 °C and/or by irradiation, wherein the material comprises: a) a polypropylene having a melting temperature below 145 °C and a modulus in flexure (Emod) of from 25 to 800 MPa and/or a propylene copolymer having a melting temperature below 145 °C and a modulus in flexure (Emod) of from 25 to 800 MPa and; b) optionally at least one plastomer comprising at least one statistical copolymer of ethylene and at least one C3 to C10 alpha-olefin having a density of from 0.8 to 0.9 g/cm3 and is substantially free of slip agents and anti-blocking agents.

Description

Non-rigid Material

The present invention relates to a non-rigid or flexible material which is suitable to be placed in contact with a biological and/or therapeutic material.

From WOO 1/0282 non-rigid compositions based on propylene polymers are known which contain no elastomeric fractions and include a statistical copolymer of propylene and at least one comonomer, and a plastomer comprising a statistical copolymer of ethylene and at least one C3 to CIO alpha-olefin.

In the operation of mixing the copolymer with the plastomer, WOO 1/02482 refers to the addition of conventional additives such as antioxidants, stabilisers, filler, etc. The examples describe the addition of around 0.3% antioxidants and antacid (neutraliser). In an industrial application the person skilled in the art will conventionally add to the composition one or a plurality of slip agents and one or more anti-blocking agents in order to make said composition easy for the manufacturing machinery to process.

EP-A-0850756 discloses a receptacle or film comprising a series of polypropylene layers. The surface polypropylene layer and the intermediate layer are layers of polypropylene and copolymer of propylene with an alpha- olefin. In all the examples of this document, 0.3% antioxidants and neutralisers are added to the mixes, which is equivalent to saying that given the presence of antioxidants and of neutralising agent (upwards of 0.3% by weight) in the commercial propylene polymer or copolymer, the content of antioxidants and neutraliser in the mixes must be more than 0.6% by weight.

This document specifically refers to the presence of other compounds conventionally added along with polyolefins. These documents do not describe the possibility of producing films or thin parts that conform to the pharmaceutical norms without a slip agent (such as erucamide) and/or anti-blocking agent (such as silicon dioxide).

It is conventional to add one or more slip agents and/or one or more antiblocking agents to compositions which are intended to be converted into articles such as non-rigid pouches. The addition of these agents makes it easier for manufacturing machinery to process the composition.

Although in the pharmaceutical and food sectors, and in particular in the pharmaceutical industry, the presence of additives in films and other moulded, injected or extruded parts is not recommended, and may even be proscribed, in order to prevent particles from passing into the pharmaceutical or food composition, films for use with pharmaceuticals or food have to date been prepared from thermoplastic material containing one or more slip agents, one or more anti-blocking agents, one or more antioxidants, one or more neutralisers, etc., in order to ensure that they can be used and converted on existing equipment such as machines for manufacturing non-rigid pouches.

It has now been observed that it is possible to obtain films, in particular monolayer films, or thin parts that are non-rigid, stable and resistant to medical sterilising operations, and that can be produced and converted on existing machines, from a composition containing a copolymer of propylene and/or polypropylene in the absence of any slip agent or anti-blocking agent. The absence of these agents makes it possible to avoid transfer or migration of particles or molecules of slip agent or anti-blocking agent into a pharmaceutical or biological composition in contact with such a film.

The person skilled in the art would not have expected that despite the absence of slip agent and anti-blocking agent it would be possible to obtain polypropylene or propylene copolymer materials (in particular monolayer film or parts) that are stable and sterilisable on existing machines such as machines for manufacturing non-rigid pouches.

The present invention provides a non-rigid or flexible material which is suitable to be placed in contact with a biological and/or therapeutic material, and which is sterilisable using steam at a temperature of at least 121°C and/or by irradiation, wherein the material comprises at least one of a polypropylene having a melting temperature below 145°C and a modulus in flexure (Emod) of from 25 to 800 MPa and a propylene copolymer having a melting temperature below 145°C and a modulus in flexure (Emod) of from 25 to 800 MPa and optionally at least one plastomer comprising at least one statistical copolymer of ethylene and at least one C3 to CIO alpha-olefin having a density of from 0.8 to 0.9 g/cm and is substantially free of slip agents and anti-blocking agents.

The modulus in flexure of the polypropylene and propylene copolymer is determined according to ASTM D790 standard.

Suitable techniques for sterilisation by irradiation include the use of gamma radiation, electron beam and/or ion beam, for example by means of cyclotrons or accelerators marketed by IB A of Belgium.

The term "plastomer" as used herein is intended to refer to compositions comprising or consisting of at least one statistical copolymer of ethylene and at least one C3 to CIO alpha-olefin.

Advantageously, the material of the present invention may consist essentially of a polypropylene and/or propylene copolymer as defined above and optionally a plastomer as defined above.

As used herein, the term "consists essentially of means that the material does not contain any other components in amounts that may alter the properties of the material. A material that consists essentially of a polypropylene and/or a propylene copolymer and optionally plastomer will typically comprise more than 99% by weight, preferably more than 99.5% by weight, and especially more than 99.7% by weight, of a polypropylene and/or copolymer of propylene and optionally a plastomer.

The material may contain one or a plurality of polypropylenes and/or one or a plurality of propylene based copolymers. For example, it may contain a mix of polypropylene(s) with one or more propylene based copolymers.

Examples of suitable polypropylenes include isotactic, syndiotactic or atactic, homostereoblock, stereoblock, high molecular mass atactic or high molecular mass amorphous homopolymers or copolymers. The term high molecular mass here advantageously denotes a molecular mass greater than 100,000, and preferably greater than 200,000. The use of steroblock polypropylenes is preferred.

Suitable copolymers include, but are not limited, to copolymers (advantageously statistical copolymers) of propylene and at least one comonomer selected from ethylene and C4 to C8 alpha-olefins. An example of a suitable statistical copolymer is a copolymer containing from 0.5 to 6% by weight of monomeric units derived from ethylene and/or from 5 to 20% by weight of monomeric units derived from butene.

Examples of polypropylenes suitable for use in the present invention include (but are not limited to): stereoblock polypropylenes alternately comprising sequences or blocks selected from isotactic sequences or blocks, atactic sequences or blocks, and syndiotactic sequences or blocks. A preferred stereoblock polypropylene is constituted by alternating isotactic and atactic diastereosequences, or isotactic and syndiotactic diastereosequences, or syndiotactic and atactic diastereosequences. Isotactic or substantially isotactic polypropylenes (for example with an isotacticity index [total number of isotactic chain links/total number of chain links] of more than 95%>, in particular more than 99%) in respect of which substantially all the methyl groups are in one position in relation to the plane of symmetry of the polypropylene molecular chain without the methyl groups; Syndiotactic or substantially syndiotactic polypropylenes (for example with a syndiotacticity index [total number of syndiotactic chain links/total number of chain links] of more than 95%, in particular more than 99%) in respect of which substantially all the methyl groups are alternately situated on either side of the plane of symmetry of the polypropylene molecular chain without the methyl groups; - Atactic or substantially atactic polypropylenes (random or substantially random position of the methyl group in relation to the plane of symmetry of the molecular chain without the methyl groups; Mixtures of such polypropylenes .

The polypropylene used in the present invention may be prepared by the processes described in the prior art. In particular, the methods outlined in EP-A-1083188, EP-A-910591, EP-A-1010709, US 5,594,080, WO99/52950, W099/52955 and WO98/54230 are suitable for producing polypropylenes for use in the present invention. When the polypropylene or the propylene based copolymer is produced in the presence of at least one catalyst, the polypropylene or copolymer advantageously contains less than 0.5% by weight of catalyst, preferably less than 0.2% by weight, more especially less than 0.1% by weight, or even less, such as for example less than 0.05% by weight. The catalyst or catalytic system used advantageously contains a metallocene catalyst.

In one preferred aspect of the present invention, the material of the invention comprises at least one statistical copolymer of ethylene and at least one C3 to CIO alpha-olefin having a density of from 0.8 to 0.9 g/cm .

Copolymers of ethylene suitable for use as plastomers in the present invention include those commonly referred to as very low density polethylene (VLDPE) or ultra low density polyethylene (ULDPE). The copolymers of ethylene used in the present invention can be obtained using single site catalyst methods known in the art such as those described in US Patent Nos 5783638 and 5272236. Suitable copolymers of ethylene are commercially available, for example from Exxon.

In one aspect, the present invention provides a material comprising from 50 to 99% by weight of a polypropylene and/or copolymer of propylene as defined above and from 1 to 50% by weight of a plastomer as defined above. The copolymer of ethylene may be present in an amount of greater than 40% by weight, for example from 41 to 50% by weight for example approximately 45% by weight.

One prefened material of the invention comprises a propylene copolymer, a stereoblock polypropylene and a plastomer.

In a preferred aspect of the invention the weight ratio of the polypropylene and/or propylene copolymer to the copolymer of ethylene is from 30:70 to 70:30, more preferably from 40:60 to 60:40 and most preferably around 50:50.

Advantageously, materials of the invention comprise less than 0.5% by weight, advantageously less than 0.4% by weight, of antioxidising agent and catalyst neutralising agent. The material preferably comprises less than 0.3% by weight, advantageously less than 0.25% by weight, preferably less than 0.2% of antioxidising agent and catalyst neutralising agent. The low content of antioxidant and neutraliser, or even the substantially total absence of these compounds, makes it possible to reduce or even totally avoid the migration of these compounds to the biological and/or therapeutic material, and accordingly reduces any risk of contaminating said materials.

The material of the present invention is substantially free of slip agents and anti-blocking agents. Preferably, the material of the invention is also substantially free of elastomeric fractions.

By substantially free, we mean that the material comprises less than 0.1% by weight, preferably less than 0.05% by weight and most preferably around 0% of these substances.

In a prefened aspect of the invention, the material contains less than 1250 ppm, advantageously less than 1000 ppm, and preferably less than 700 ppm, of C12 to C54 oligomers.

In a preferred aspect, the material of the present invention has a haze transparency index of less than 10% and a gloss brightness index of more than 80%, and these characteristics are preferably preserved even after steam sterilisation at a temperature of at least 121°C. The haze transparency index and the gloss brightness index as used herein were measured using the ASTM D1003 standard. These indexes can be measured on Haze-Gard Plus equipment from Gardner Instruments.

The material of the invention preferably exhibits a modulus in flexure of from 20 to 700 MPa, in particular below 500 MPa. The modulus in flexure is for example less than 300 MPa, advantageously less than 200 MPa, or even less than or equal to around 100 MPa. Materials having a modulus in flexure of less than or equal to about 100 MPa are particularly prefened. The modulus in flexure as used herein is measured according to the ASTMD D790 standard. The modulus in flexure can be measured using machines such as a Zwick 1455 testing machine.

A material of the invention can, for example, be obtained from mixture of polypropylene and/or copolymer of propylene and plastomer(s) defining a polyethylene phase dispersed in a substantially continuous polypropylene and/or propylene copolymer phase. In the mixture, the weight ratio of polypropylene and or copolymer of propylene to plastomer is typically from 30/70 to 70/30, advantageously from 40/60 to 60/40, and preferably around 50/50.

The material of the invention is suitable to be contracted with a biological and/or therapeutic material. This is thought to be because the material of the invention is substantially free of slip agents and anti-blocking agents. In this regard, it is advantageous if the material also has a low antioxidant and neutralising agent content or is free of such compounds.

The present invention also provides a film comprising a material as defined above. The films of the invention may consist essentially of a material as defined above. Alternatively, they may comprise a multilayer film comprising a layer of a material as defined above joined to one or more other layers. These multilayer films can be obtained by co-extrusion. In other words, the films ofthe invention may be a single layer or have two or more layers.

Advantageously the films (including monolayer and multilayer films) of the invention has a thickness of from 100 μm to 1000 μm, advantageously from 125 μm to 500 μm, and preferably from 150 μm to 300 μm.

A preferred film of the invention comprises monolayer film of a material as defined above. By "monolayer film" we mean a film consisting of a single layer of a material ofthe invention only.

The film may consist only of a monolayer film of a material as defined above or may contain such a monolayer film in combination with another film such as, for example a multilayer film as defined above or a propylene copolymer or polypropylene film.

An example of one film of the invention is a film which is non-rigid or flexible and is suitable to be placed in contact with a biological and/or therapeutic material and which is sterilisable using steam at a temperature of at least 121°C and/or by irradiation, which film comprises a monolayer film comprising: a) a propylene based copolymer having a melting temperature below

145°C and a modulus in flexure (Emod) of from 25 to 800 MPa and/or a stereoblock polypropylene having a melting temperature below 145°C and a modulus in flexure (Emod) of from 25 to 800

MPa; and b) at least one plastomer comprising at least one statistical copolymer of ethylene and at least one C3 to CIO alpha-olefin having a density of from 0.8 to 0.9 g/cm³ ; in which more than 99.5% by weight of the monolayer film consists of the propylene based copolymer and/or the polypropylene and the plastomer, the weight ratio of the propylene based copolymer and/or the polypropylene to the plastomer is from 30:70 to 70:30 and the monolayer film is substantially free of slip agents and anti-blocking agents.

The present invention also provides articles comprising a film or material as defined above. The materials and films of the invention are particularly suitable for use in articles suitable for holding, storing, guiding, transporting or transferring biological or therapeutic materials. For example, they can be used to produce containers, bags, pouches, conduits and tubing suitable for such uses. Articles of this type may be made from the material of the invention alone or in combination with any suitable and compatible material.

The articles of the invention can, for example, be obtained by welding one or more films as defined above to another film of the same or different composition. The films of the invention can be welded to other films ofthe invention or to other films.

It is preferably that an article made from or comprising a material or film of the invention is designed or adapted so that the material or film of the invention at least in part contacts the biological or therapeutic materials when the article is used.

An article of the invention may consist essentially of a monolayer film of a material as defined above. In one aspect of the invention the material, film or article preferably contains at least one amorphous polypropylene of high molecular weight or has been produced substantially essentially from an amorphous polypropylene of high molecular weight.

Articles comprising the materials and films ofthe invention are suitable for: holding a therapeutic fluid, notably one that can be administered parenterally or peritoneally, fonning a conduit or tube guiding a therapeutic fluid, notably one than can be administered parenterally or peritoneally; holding and/or storing and/or guiding blood or a constituent thereof or a biological tissue or drugs, proteins or peptides, for example monoclonal antibodies; collecting a biological fluid or material, more particularly as a drainage bag.

Other uses will be readily apparent to the person of skill in the art.

The film or an article containing the film may be sterilised before and/or after it has been formed into an article such as a bag or tube and before and/or after it has been filled, if applicable, for example using water vapour at 121 °C and/or by irradiation. Sterilisation after the filling stage is advantageous because it allows the container and its contents to be sterilised.

The material or film or article comprising a material of the invention may be extruded in a specially shaped die, such as for forming a tube or conduit or poured or injected into a mould.

The filling of articles according to the invention with therapeutic or biological solutions (blood, etc.) is advantageously carried out under aseptic conditions, for instance in a clean room or pressurised chamber.

It is possible to prepare preforms, for example monolayer preforms, adapted to be hot-blown into a mould in order to form an article according to the invention.

Where films are being manufactured, these may be drawn in one, two or three (advantageously orthogonal) directions, as required.

Where the material is in the form of an article such as a pouch, the article is advantageously equipped with one or more means of accessing the interior of the article. Suitable means of access include resealable openings, ports through which tubes may be passed, ports to which tubes may be attached and/or sealed, for example ports between two films that fonn walls of the article, ports suitable for receiving needles, such as those which allow direct penetration of the needle into the article, for example a Belly Med port. Other appropriate means of access will be readily apparent to the person of ordinary skill in the art. The terms "doors" is used hereinafter to refer to any suitable type of access means. These doors may be made from a material compatible with the materials of the invention, for example they may be produced from polyolefm or from a mix containing one or more polyolefins. However, these doors are preferably produced from a propylene copolymer and/or polypropylene or a mix containing a propylene copolymer and/or polypropylene, in particular a composition similar to that used to make the material of the invention. Preferably the material used to form the door is substantially free of slip agents and anti-blocking agents and is optionally adapted to be sterilised by steam and/or radiation.

The present invention also provides a process for manufacturing materials, films and articles according to the invention.

The materials, films and articles of the invention can be produced on standard and conventional machinery. For instance, pouches, perfusion or transfusion pouches, etc., can be produced on conventional machinery featuring for example one or more welding units (thermal, ultrasonic, laser, for example of the "form fill seal" type with vertical/horizontal orientation) and/or filling unit(s).

For instance, a material of the invention in the form of a film may be produced by calendering or by extrusion, for example by means of a flat extrusion die, bubble die, etc., with or without a cooling stage (water cooling, air cooling, roller cooling, etc.) and with or without drawing or tensile load (tube load) and with or without blowing. The film may be subjected to various treatments such as corona treatment, surface treatment, laminating, coating, post-curing, drawing (unidimensional, two-dimensional or three-dimensional), abrupt cooling, etc., for example to improve printing on the films using conventional inks for polypropylene.

Films may also be prepared using cast extrusion equipment, for example monolayer cast extrusion equipment. The extruder is fed with a dry blend of the components of the material in the required proportions. Such dry blends can be prepared using gravimetric dosage and mixing equipment. Alternatively, compounds containing the components of the material may be obtained by co-rotating twin screw compounding extrusion followed by pelletising. The pelletised material can then be extruded.

Articles such as bags and pouches may be manufactured from films by any suitable method known in the art. One particularly suitable method is vertical Form-Fill Seal derived from the Clear-Flex technology (US-A- 4656813).

In the Form-Fill Seal Technology, both a film suitable for making the article and a liquid to be contained within the article are fed into the machine. An article such as a bag or pouch in which the liquid is sealed is produced.

Preferably materials, films and articles of the present invention are manufactured in a manner that allows complete recycling of the materials, films and articles. In particular, it is advantageous to recycle any materials that do not have the required properties during the manufacturing process.

As described below the Form-Fill Seal based technology can be used in combination with a recycle procedure.

Materials and films can be manufactured continuously by extrusion. - An article can be manufactured using Form-Fill Seal based technology

Materials, films or articles that do not have the required properties can be identified using conventional methods of medical device quality control. The identified materials and films can be ground into a powder using standard techniques, if necessary following an operation for washing and drying.

The powder so produced can be converted into granules or pellets. The pellets or granules can then be recycled to make films or articles according to the invention or otherwise, but preferably according to the invention.

The grinding operation, with a washing or drying stage if necessary, is advantageously carried out at the production site itself, but could also very well be performed at a location remote from the production site, for example in a hospital, etc. It is preferred that when articles of the invention comprise one or more doors that these doors are made from polypropylene. This facilitates the recycling operation since the articles and the door or doors thereof are made of materials that are conventional and compatible, materials comprising a high proportion of polypropylene.

The following non-limiting examples illustrate the invention.

Example 1

Monolayer non-rigid pouches were prepared using a composition made up of 55% by weight propylene/ethylene statistical copolymer containing approximately 4.3% by weight of ethylene (prepared as in Example 1 of US 5,204,305), 44.85% by weight of a plastomer whose production involved a metallocene catalyst (EXACT 8201® (Exxon), a copolymer of ethylene and octene), 0.1% antioxidant (irganox) and 0.05% neutraliser (calcium stearate).

The propylene/ethylene copolymer exhibits the following characteristics: melting temperature: approx. 132°C melt liquidity index (230°C, 2.16 kg - ASTM standard D1238, 1986): 4.5 g/10 minutes ratio of C2x3 (chain monomer)/C2x5+ (chain oligomer): 35/8

The plastomer exhibits the following characteristics: density: 0.882 g/cm3 melt liquidity index (190°C, 2.16 kg - ASTM standard D1238, 1986): 1 g/10 minutes - MW/Mn ratio: approx. 2.4 less than 0.05% metallocene content

A dry blend of these components was prepared using gravimetric dosage and mixing equipment.

The composition comprising these components had a melting temperature close to 132°C and a softening temperature of around 80°C. The composition was free from erucamide (slip agent) and anti-blocking agent (Si0₂).

A film approximately 180 μm thick was extruded from the dry blend of this composition using mono-layer cast extrusion equipment. The oligomer content ofthe film composition (determined by thermal desorption) was less than 600 ppm. The film had a tensile strength (ASTM D 638M) of around 20.5 MPa and an elongation at break greater than 600% (ASTM D 638M).

The film was transparent.

This film was washed using an aqueous solution (if appropriate containing one or a plurality of chemical agents such as a peroxide) and was then vapour-sterilised at 121°C. Following sterilisation this film was still transparent (haze index less than 9%, brightness index higher than 85% measured according to ASTM D1003 using Haze-Gard Plus Equipment from Gardner Instrument).

This film was then processed in a conventional machine using vertical Form-Fill Seal technology derived from the Clear-Flex technology (US 4656813) to produce separate non-rigid pouches by heat-sealing together portions of the film. Before closing the pouch by heat-sealing, the pouch was aseptically filled with a solution or fluid. The solutions or fluids or materials that were put into the pouches were: blood; platelet-enriched plasma; - saline solutions for parenteral administration; glucose solutions for parenteral administration; antibiotic solutions for parenteral administration; peptide solutions; protein solutions; - glucose-enriched saline solutions; solutions containing an anti-clotting agent (aspirin, citrate); etc.

It was found that these solutions were preserved and that there was no detectable transfer of antioxidant agent, slip agent, anti-blocking agent, neutralising agent and catalyst residue from the film to the solution, even after the solutions had been in the pouches for more than a fortnight (for example for a period of more than 3 months, in particular more than 6 months, such as for a period of more than 15 months at room temperature).

Example 2

Example 1 was repeated, except that the antioxidants used in Example 1 were replaced by vitamin E, tetrakis(methylene-3-(3',5'-di-t-butyl-4'- hydroxyphenyl)-proprionate)methane, tris(2,4-di-t-butylphenyl)phosphite, hydrotalcite, and mixtures thereof with irganox at the rate of 0.1 to 0.2% by weight ofthe composition. Example 3

The composition of Example 1 was extruded into tubes with an external diameter of 3 mm and a thickness of the order of 300μm. These transparent tubes were vapour-sterilised at 121 °C. These tubes were used for parenteral administration of solutions. It was found that it was a straightforward matter to weld together two adjacent tubes prepared as in this Example, using a cutting and welding device equipped with a heating blade.

Example 4

Example 1 was repeated, except that the proportions of the components were adjusted so that the composition contained 60% by weight of propylene and ethylene copolymer.

Example 5

Example 1 was repeated except that the proportions of the components were adjusted so that the composition contained 50% by weight of propylene and ethylene copolymer.

Example 6

Example 1 was repeated and the pouches were equipped with a tube at a weld seam, said tube exhibiting one extremity closed by, for example, a weld seam. Before using the pouch, said tube is advantageously welded to another tube (perfusion tube), for instance by means of a device with a cutting and heating blade. Example 7

A composition prepared according to Example 1 was coextruded with a polypropylene to produce a film comprising a layer of the composition of Example 1 and a polypropylene layer.

When the layered material was formed into pouches the layer of the composition of Example 1 formed the interior surface ofthe pouches.

Example 8

Example 1 was repeated, apart from the fact that bags or pouches for collecting urine, dialysis fluids, faeces, medical waste, etc. were manufactured.

Example 9

Example 1 was repeated, except that a composition containing substantially only stereoblock polypropylene was used, such as a polypropylene produced by the Waymout method (US 5,594,080) or by a method as outlined in EP 1083188 or WO 98/02469 or WO 99/52955 or employing a catalyst according to WO 99/52950.

Example 10

Example 1 was repeated, except that the composition was extruded into a non-rigid tube with an external diameter of 2.5 mm and an internal diameter of 2 mm.

This non-rigid tube was joined to a non-rigid pouch made by heat-sealing a film from Example 1. Accordingly the film and the tube (door or means of access to the interior of the non-rigid pouch) are produced from identical material, thereby facilitating recycling of the product, for example in the event of a defect in the pouch, a defect in the tube, or defective attachment of the tube to the pouch.

Example 11

Example 10 was repeated, except that non-rigid pouches with their tubes that did not conform to pharmaceutical standards were ground, washed, dried and extruded into granules before being remixed with granules of first use material. The quantity of granules recycled in the composition used to form the film and the tube may vary between, for example, 0.1% by weight and 50% by weight, or even more, but is advantageously between 5 and 25% by weight, for example 10%o by weight, 15% by weight, or 20% by weight.

Examples 12 to 18

Non-rigid pouches similar to the one in Example 1 were prepared using the following compositions, compositions which contain no slip agent or antiblocking agent.

Claims

1. Non-rigid or flexible material which is suitable to be placed in contact with a biological and/or therapeutic material, and which is sterilisable using steam at a temperature of at least 121°C and/or by irradiation, wherein the material comprises: a) a polypropylene having a melting temperature below 145°C and a modulus in flexure (Emod) of from 25 to 800 MPa and/or a propylene copolymer having a melting temperature below 145°C and a modulus in flexure (Emod) of from 25 to 800 MPa; and b) optionally at least one plastomer comprising at least one statistical copolymer of ethylene and at least one C3 to CIO alpha-olefin having a density of from 0.8 to 0.9 g/cm and is substantially free of slip agents and anti-blocking agents.

2. A material according to claim 1 consisting essentially of a polypropylene as defined in claim 1 and/or a propylene copolymer as defined in claim 1 and optionally a plastomer as defined in claim 1.

3. A material according to claim 1 or 2 comprising at least one plastomer as defined in claim 1.

4. A material according to any one of the preceding claims comprising from 50 to 99% by weight of the polypropylene and/or copolymer of propylene and from 1 to 50% by weight ofthe plastomer.

5. A material according to any one of the preceding claims wherein the weight ratio of the polypropylene and/or propylene copolymer to the plastomer is from 30:70 to 70:30.

6. A material according to any one of the preceding claims comprising a stereoblock polypropylene.

7. A material according to any one ofthe preceding claims comprising a statistical copolymer of propylene which comprises from 0.5 to 6% by weight of monomeric units derived from ethylene and/or from 5 to 20% by weight of monomeric units derived from butene.

8. A material according to any one of the preceding claims that is substantially free of elastomeric fractions.

9. A material according to any one of the preceding claims comprising less than 0.3% by weight of antioxidant and catalyst neutralising agents.

10. A material according to any one of the preceding claims, containing less than 1250 ppm of C12 to C54 oligomers.

11. A material according to any of the preceding claims, having a haze transparency index of less than 10% and a gloss brightness index of more than 80%.

12. A material according to any of the preceding claims, having a modulus in flexure of from 20 to 700 MPa.

13. A film comprising a material as defined in any one of the preceding claims.

14. A film according to claim 13 consisting essentially of a material according to any one of claims 1 to 12.

15. A film according to claims 13 or 14, which has a thickness of from lOO μm to lOOO μm.

16. A film according to any one of claims 13 to 15 which comprises a monolayer film of a material according to any one of claims 1 to 12.

17. A film according to claim 16 which is non-rigid or flexible and is suitable to be placed in contact with a biological and/or therapeutic material and which is sterilisable using steam at a temperature of at least 121°C and/or by inadiation, which film comprises a monolayer film comprising: a) a propylene based copolymer having a melting temperature below 145°C and a modulus in flexure (Emod) of from 25 to 800 MPa and/or a stereoblock polypropylene having a melting temperature below 145°C and a modulus in flexure (Emod) of from 25 to 800 MPa; and b) at least one plastomer comprising at least one statistical copolymer of ethylene and at least one C3 to CIO alpha-olefin having a density of from 0.8 to 0.9 g/cm ; in which the monolayer film consists essentially of the propylene based copolymer and/or the polypropylene and the plastomer, the weight ratio of the propylene based copolymer and/or the polypropylene to the plastomer is from 30:70 to 70:30 and the monolayer film is substantially free of slip agents and anti-blocking agents.

18. A film according to any one of claims 13 to 17, which comprises a multi-layer film comprising at least one layer of material as defined in any one of claims 1 to 12 joined to one or more other layers.

19. A film according to claim 18, wherein the multilayer film has been obtained by co-extrusion.

20. An article comprising a film or material as defined in any one of the preceding claims.

21. An article according to claim 20 in the form of a container, bag, pouch, conduit or tube suitable for holding, storing and/or guiding a biological or therapeutic material.

22. An article according to claim 20 or 21 formed by welding one or more films as defined in any one of claims 13 to 18 to another film having the same composition or a different composition.

23. An article according to any one claims 20 to 22 adapted so that in use the material or film as defined in any one of claim 1 to 19 contacts the biological or therapeutic material.

24. An article according to any one of claims 20 to 23 comprising at least one door.

25. An article according to claim 24, wherein at least one door has been formed from a propylene copolymer or polypropylene based composition.

26. An article according to claim 25, wherein at least one door has been produced from a polypropylene based composition which is substantially free of slip agents and anti-blocking agents and which is optionally adapted to be sterilised by steam and/or inadiation.

27. An article according to any of claims 20 to 26, consisting essentially of a monolayer film as defined in any one of claims 13 to 17 and optionally one or more doors as defined in any one of claims 24 to 26.

28. A material, film or article according to any one of the preceding claims which contains at least one amorphous polypropylene of high molecular weight or has been produced substantially essentially from an amorphous polypropylene of high molecular weight.

29. Use of an article according to any one of claims 20 to 28 for holding a therapeutic fluid.

30. Use according to claim 29, wherein the fluid is adapted to be administered by the parenteral or peritoneal route.

31. Use of a material or film according to any one of claims 1 to 19 to form a conduit or tube suitable for guiding a therapeutic fluid.

32. Use according to claim 31, wherein the conduit or tube is suitable for administering a fluid by the parenteral or peritoneal route.

33. Use of an article according to any of claims 20 to 28 for holding and/or storing and/or guiding blood or one of the constituents thereof or another biological material.

34. Use of an article according to any of claims 20 to 28 for collecting a biological fluid or material.

35. Use according to claim 34 as a drainage bag.

36. Method for manufacturing an article according to any of claims 20 to 28, in which: - a material or film as defined in any one of claims 1 to 19 is manufactured continuously by extrusion; the article is manufactured using Form-Fill Seal based technology; materials, films, or articles that do not have the required properties are identified and ground into a powder, if necessary following an operation for washing and drying them; the thus produced powder is converted into granules or pellets; and the pellets or granules are recycled to manufacture a film or article as defined in any one of claims 13 to 28.

37. The use of a method according to claim 36 in the manufacture of an article comprise one or more doors made from polypropylene.