FLEXIBLE MULTI-LAYERED FILM HAVING UV AND VISIBLE LIGHT BARRIER LAYER FOR MEDICAL PACKAGING

Abstract

The invention relates to flexible multilayer films comprising a first polymer layer (A), a second polymer layer (B), and a central polymer layer (C), wherein the central polymer layer (C) is situated between the first polymer layer (A) and the second polymer layer (B), and wherein the central polymer layer (C) comprises at least one UV absorber and at least one colorant that, in combination, absorb light in the 175 nm to 525 nm wavelength range. The multilayer film is suitable for producing medical bags having UV and light protection.

Claims

1. A heat-sterilizable multilayer film comprising: a) a first polymer layer (A), b) a second polymer layer (B), and c) a central polymer layer (C), wherein the central polymer layer (C) is situated between the first polymer layer (A) and the second polymer layer (B), wherein each of the three polymer layers (A), (B), and (C) comprises at least one aliphatic polyolefin, wherein the central polymer layer (C) comprises at least one UV absorber and at least one colorant from inorganic pigments selected from the group consisting of: a) iron oxides, b) zinc ferrite color pigments, c) iron-oxide-coated mica, and d) mixed-phase oxide pigments, wherein the combination of at least one UV absorber and at least one colorant absorbs radiation in the 175 nm to 525 nm wavelength range, and wherein: the first polymer layer (A) comprises at least one polypropylene homopolymer modified with at least one impact modifier, the second polymer layer (B) comprises at least one polypropylene terpolymer and/or polypropylene bipolymer modified with at least one impact modifier, the central polymer layer (C) comprises at least one polypropylene terpolymer modified with at least one impact modifier, and the central polymer layer has a mass fraction of 70% to 90% by weight of the total multilayer film.

2. The heat-sterilizable multilayer film of claim 1, wherein the central polymer layer (C) comprises at least one UV absorber selected from the group consisting of: a) organic UV absorbers, b) inorganic UV absorbers, c) polymeric UV absorbers, d) HALS (hindered amine light stabilizers) UV absorbers, and e) combination of two or more UV absorbers from groups a) to d).

3. The heat-sterilizable multilayer film of claim 1, wherein the at least one impact modifier is selected from the group consisting of styrene block copolymers, polyethylene copolymers, and polyethylene elastomers.

4. The heat-sterilizable multilayer film of claim 1, wherein the total thickness of the multilayer film is between 50 μm and 500 μm.

5. The heat-sterilizable multilayer film of claim 1, wherein the multilayer film is a flat or tubular film.

6. The heat-sterilizable multilayer film of claim 1, wherein at least the second polymer layer (B), is free from chemical modifiers, plasticizers, and adhesion promoters.

7. The heat-sterilizable multilayer film of claim 1, consisting of polymer layers (A), (B), and (C).

8. A process for producing a heat-sterilizable multilayer film of claim 1, comprising a step in which the first polymer layer (A), the central polymer layer (C), and the second polymer layer (B) are coextruded.

9. (canceled)

10. A medical packaging comprising a heat-sterilizable multilayer film of claim 1.

11. A container for at least one medicament comprising the medical packaging of claim 10.

12. A process for producing a medical packaging comprising the steps of: a) providing at least one heat-sterilizable multilayer film of claim 1; b) optionally providing one or more port elements and/or tubing units; c) forming a medical packaging from the at least one heat-sterilizable multilayer film, such that the second polymer layer (B) forms the inner surface of the medical packaging and the first polymer layer (A) forms the outer surface of the medical packaging; d) optionally positioning the port elements and/or tubing units between the inner surfaces at the edges of the medical packaging; e) bringing the inner surfaces at the edges of the medical packaging into contact with one another and with port elements and/or tubing units optionally positioned therebetween; and f) welding the inner surfaces at the edges of the medical packaging to one another and to port elements and/or tubing units optionally positioned therebetween.

13. The heat-sterilizable multilayer film of claim 1, wherein the iron oxides a) are yellow or red iron(III) oxide.

14. The heat-sterilizable multilayer film of claim 1, wherein the mixed-phase oxide pigments are chromium antimony titanate and/or nickel antimony titanate.

15. The heat-sterilizable multilayer film of claim 2, wherein the organic UV absorbers are benzophenones, benzotriazoles, oxalanilides, and/or phenyltriazines.

16. The heat-sterilizable multilayer film of claim 2, wherein the inorganic UV absorbers are titanium dioxide, iron oxide pigments, silicon dioxide, and/or zinc oxide.

17. The heat-sterilizable multilayer film of claim 2, wherein the polymeric UV absorbers are PMMA microspheres (polymethyl methacrylate).

18. The heat-sterilizable multilayer film of claim 2, wherein the HALS UV absorbers are 2,2,6,6-tetramethylpiperidine derivatives.

19. The medical packaging of claim 10, wherein the medical packaging is a medical multi-chamber bag.

20. The medical packaging of claim 10, wherein the medical packaging is subdivided into chambers.

21. The container of claim 11, wherein the at least one medicament is sensitive to light in the 175 nm to 525 nm wavelength range.

Description

[0133] The invention is elucidated in more detail hereinbelow with reference to examples, without being limiting thereto.

EXAMPLE 1

[0134] First Polymer Layer (A): [0135] 97% by weight of PP 41 E4 cs278 from Huntsman Corp., USA, polypropylene homopolymer [0136] 3% by weight of Tuftec H1062 from Asahi, Japan, styrene-ethylene/butylene block copolymer

[0137] The above formulation was mixed in the molten state in a separate compounding step and granulated for further use.

[0138] Second Polymer Layer (B): [0139] 85% by weight of TD 120 BF, Borealis, Austria, terpolymer [0140] 15% by weight of Tuftec H1062 from Asahi, Japan, styrene-ethylene/butylene block copolymer

[0141] The above formulation was mixed in the molten state in a separate compounding step and granulated for further use.

[0142] Central Polymer Layer (C): [0143] 68% by weight of TD 120 BF, Borealis, Austria, terpolymer [0144] 20% by weight of Tuftec H1062 from Asahi, Japan, styrene-ethylene/butylene block copolymer [0145] 5% by weight of Engage 8003, Dow, USA, polyethylene elastomer [0146] 4% by weight of Luvobatch PP UV5082, Lehmann & Voss, Germany, UV absorber [0147] 3% by weight of yellow iron(III) oxide, product 2233, Caesar & Loretz GmbH, Germany, colorant

[0148] The above formulation was mixed in the molten state in a separate compounding step and granulated for further use.

[0149] The film was coextruded on a blown-film line with water cooling using process parameters customary for polypropylene.

[0150] The film was produced with a total thickness of 200 μm, the first polymer layer (A) and second polymer layer (B) each having a thickness of 15 μm and the central polymer layer (C) having a thickness of 170 μm. The film produced can be sterilized with hot steam and is already capable of being firmly welded with welding tools heated to a temperature of 125° C.

EXAMPLE 2

[0151] First Polymer Layer (A): [0152] 97% by weight of PP 41 E4 cs278 from Huntsman Corp., USA, polypropylene homopolymer [0153] 3% by weight of Tuftec H1062 from Asahi, Japan, styrene-ethylene/butylene block copolymer

[0154] The above formulation was mixed in the molten state in a separate compounding step and granulated for further use.

[0155] Second Polymer Layer (B): [0156] 75% by weight of TD 120 BF, Borealis, Austria, terpolymer [0157] 20% by weight of Tuftec H1062 from Asahi, Japan, styrene-ethylene/butylene block copolymer [0158] 5% by weight of Engage 8003, Dow, USA, polyethylene elastomer

[0159] The above formulation was mixed in the molten state in a separate compounding step and granulated for further use.

[0160] Central Polymer Layer (C): [0161] 67% by weight of TD 120 BF, Borealis, Austria, terpolymer [0162] 20% by weight of Tuftec H1062 from Asahi, Japan, styrene-ethylene/butylene block copolymer [0163] 5% by weight of Engage 8003, Dow, USA, polyethylene elastomer [0164] 4% by weight of CopoBeads PMMA microspheres (5 μm diameter), Coating Products OHZ eK, Germany, polymeric UV absorber [0165] 4% by weight of red iron(III) oxide, product 2337, Caesar & Loretz GmbH, Germany, colorant

[0166] The above formulation was mixed in the molten state in a separate compounding step and granulated for further use.

[0167] The film was coextruded on a blown-film line with water cooling using process parameters customary for polypropylene.

[0168] The film was produced with a total thickness of 200 μm, the first polymer layer (A) and second polymer layer (B) each having a thickness of 15 μm and the central polymer layer (C) having a thickness of 170 μm. The film produced can be sterilized with hot steam and is already capable of being firmly welded with welding tools heated to a temperature of 125° C.