Multi-layer co-extrusion film and disposable biological process bag

Abstract

The utility model provides a multi-layer co-extrusion film and a disposable biological process bag, and relates to the field of film materials for bioreactors. The multi-layer co-extrusion film sequentially comprises a liquid contact layer, a secondary inner layer, a first bonding layer, a blocking layer, a second bonding layer and a protective outer layer from inside to outside, the liquid contact layer and the secondary inner layer are both ethylene-vinyl acetate copolymers, and the blocking layer is of a double-layer structure composed of an ethylene-vinyl alcohol copolymer layer and a nylon layer. Wherein the nylon layer is attached to the second bonding layer. The multi-layer co-extrusion film designed by the utility model has good biocompatibility, gas barrier property, bending resistance and puncture resistance, and can meet various use scenes.

Description

Technical Field

[0001] The utility model relates to the technical field of membrane materials for bioreactors, in particular to a multi-layer co-extruded film and a disposable bioprocess bag. Background Art

[0002] Disposable bioprocessing bags can be made into liquid storage bags, mixing bags, bioreactor bags, weighing bags and feeding bags, etc. They are widely used in the research and development and production of various types of cell suspension culture, recombinant proteins and other bioengineering products. Their no need for cleaning, disposable, high barrier properties and biocompatibility not only greatly improve work efficiency, but also avoid cross contamination between some process flows.

[0003] Disposable bioprocessing bags are made of multi-layer co-extruded films, and their basic structure is "liquid contact layer / adhesive layer / gas barrier layer / adhesive layer / protective outer layer". Among them, the liquid contact layer must have good biocompatibility, and no small molecules can be precipitated during use to pollute the original liquid. The gas barrier layer provides isolation functions for gases such as oxygen, water vapor, and carbon dioxide. The protective outer layer provides a certain strength and thermal welding function for the film material. As a film layer that provides overlap, butt joints, etc. for the film material itself, the protective outer layer needs to meet high-frequency welding and direct thermal welding requirements, and provide sufficient flexural strength.

[0004] Traditional disposable bioprocessing bags whose liquid contact layer is made of ultra-low-density polyethylene co-extruded film sometimes leak or even become intolerant to the raw liquid of biopharmaceutical companies, thereby changing the properties of the liquid and causing economic losses to biopharmaceutical companies. Utility Model Content

[0005] In view of the deficiencies in the prior art, the utility model provides a multi-layer co-extruded film and a disposable bioprocess bag to better ensure the safety of the stock solution of biopharmaceutical companies.

[0006] The utility model provides a multi-layer co-extruded film, which comprises a liquid contact layer, a sub-inner layer, a first adhesive layer, a barrier layer, a second adhesive layer and a protective outer layer from the inside to the outside, wherein the liquid contact layer and the sub-inner layer are both ethylene-vinyl acetate copolymers, and the barrier layer is composed of a double-layer structure of an ethylene-vinyl alcohol copolymer layer and a nylon layer, wherein the nylon layer is bonded to the second adhesive layer.

[0007] According to the multi-layer co-extruded film provided by the utility model, the thickness of the liquid contact layer is 115 to 135 microns.

[0008] According to the multi-layer co-extruded film provided by the utility model, the thickness of the sub-inner layer is 115-135 microns.

[0009] According to the multi-layer co-extruded film provided by the utility model, the thickness of the ethylene-vinyl alcohol copolymer layer is 15 to 25 microns.

[0010] According to the multi-layer co-extruded film provided by the utility model, the thickness of the nylon layer is 10 to 20 microns.

[0011] According to the multi-layer co-extruded film provided by the utility model, the protective outer layer is high-density polyethylene, and the thickness thereof is 40 to 60 microns.

[0012] According to the multi-layer co-extruded film provided by the utility model, the first adhesive layer and the second adhesive layer are ethylene-acrylic acid copolymer or ethylene-methacrylic acid copolymer.

[0013] According to the multi-layer co-extruded film provided by the utility model, the thickness of the first adhesive layer is 20 to 30 microns.

[0014] According to the multi-layer co-extruded film provided by the utility model, the thickness of the second adhesive layer is 35 to 45 microns.

[0015] The utility model also provides a disposable bioprocess bag, which comprises a liquid storage bag made of the multi-layer co-extruded film, a connector and a pipeline.

[0016] The utility model provides a multi-layer co-extruded film and a disposable bioprocess bag. The liquid contact layer and the sub-inner layer of the multi-layer co-extruded film are both made of ethylene-vinyl acetate copolymer (EVA), which can be used in total parenteral nutrition bags (TPN) for treatment, providing stable and lasting protection for the liquid medicine, and the liquid contact layer and the sub-inner layer are designed as two layers, which helps to enhance the physical properties. The multi-layer co-extruded film designed by the utility model has good biocompatibility, gas barrier performance, anti-bending performance and anti-puncture performance, and can meet a variety of usage scenarios. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the present invention or the prior art, a brief introduction will be given below to the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0018] Figure 1 It is a schematic diagram of the structure of the multi-layer co-extruded film provided by the utility model;

[0019] Reference numerals:

[0020] 1: liquid contact layer; 2: sub-inner layer; 3: first adhesive layer; 4: barrier layer; 41: ethylene-vinyl alcohol copolymer layer; 42: nylon layer; 5: second adhesive layer; 6: protective outer layer. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical solution and advantages of the utility model clearer, the technical solution of the utility model will be described clearly and completely below. Obviously, the described embodiments are part of the embodiments of the utility model, not all of them. Based on the embodiments of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0022] The term "first" or "second" in the specification and claims of the utility model may explicitly or implicitly include one or more of the features. In the description of the utility model, unless otherwise specified, "multiple" means two or more. In addition, "and / or" in the specification and claims means at least one of the connected objects, and the character " / " generally means that the related objects are in an "or" relationship.

[0023] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0024] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0025] Combine the following Figure 1 The multilayer coextruded film of the present invention is described.

[0026] The utility model embodiment provides a multi-layer co-extruded film, such as Figure 1As shown, the multilayer co-extruded film comprises, from inside to outside, a liquid contact layer 1, a sub-inner layer 2, a first adhesive layer 3, a barrier layer 4, a second adhesive layer 5 and a protective outer layer 6, wherein the liquid contact layer 1 and the sub-inner layer 2 are both ethylene-vinyl acetate copolymers, and the barrier layer 4 is composed of a double-layer structure of an ethylene-vinyl alcohol copolymer layer 41 and a nylon layer 42, wherein the nylon layer 42 is bonded to the second adhesive layer 5.

[0027] Ethylene-vinyl acetate copolymer, referred to as EVA in English, is a common thermoplastic elastomer. It is produced by free radical polymerization or ionic polymerization of ethylene and vinyl acetate under high temperature or high pressure.

[0028] In this embodiment, the liquid contact layer 1 and the sub-inner layer 2 are both made of medical-grade ethylene-vinyl acetate copolymer (EVA), which can be used in total parenteral nutrition bags (TPN) for treatment, providing stable and lasting protection for the liquid medicine, and the liquid contact layer 1 and the sub-inner layer 2 are designed as two layers instead of being combined into one layer, which helps to enhance the physical properties. The multi-layer co-extruded film designed by the utility model has good biocompatibility, gas barrier properties, anti-bending properties and anti-puncture properties, and can meet a variety of usage scenarios.

[0029] In the above technical solution, the thickness of the liquid contact layer 1 can be 115-135 microns. In one embodiment, the thickness of the liquid contact layer 1 is 125 microns.

[0030] In the above technical solution, the thickness of the sub-inner layer 2 can be 115-135 microns. In one embodiment, the thickness of the sub-inner layer 2 is 125 microns.

[0031] In the embodiment of the utility model, the barrier layer 4 is composed of a double-layer structure of an ethylene-vinyl alcohol copolymer layer 41 and a nylon layer 42 , wherein the nylon layer 42 is bonded to the second adhesive layer 5 .

[0032] In the above technical solution, ethylene-vinyl alcohol copolymer, referred to as EVOH in English, is copolymerized by ethylene and vinyl alcohol under the action of a catalyst. It has good oxygen and carbon dioxide gas barrier properties, while improving the transparency, glossiness and mechanical strength of the product, and can withstand 1,000 times of rubbing.

[0033] Nylon is referred to as PA. The structure of nylon is mainly composed of thermoplastic resin containing repeated amide groups —[NHCO]— on the main chain of the molecule. Nylon has excellent mechanical properties, chemical resistance, heat resistance, electrical insulation, wear resistance, flame retardancy, etc. The utility model adds a nylon layer 42 between the protective outer layer 6 (and the second adhesive layer 5) and the ethylene-vinyl alcohol copolymer layer 41, which improves the physical properties of the film material, such as tensile strength, puncture resistance, etc., and provides a guarantee for the reliability of the disposable bioprocess bag in use.

[0034] The utility model designs the liquid contact layer 1 and the sub-inner layer 2 of EVA material as two layers, so that the barrier layer only adopts a two-layer structure to meet the use needs of customers and achieve the corresponding strength requirements. Compared with the gas barrier layer of the PA / EVOH / PA three-layer film composite commonly used in the prior art, the structure is simpler.

[0035] In the above technical solution, the thickness of the ethylene-vinyl alcohol copolymer layer 41 can be 15-25 microns. In one embodiment, the thickness of the ethylene-vinyl alcohol copolymer layer 41 is 20 microns.

[0036] In the above technical solution, the thickness of the nylon layer 42 can be 10 to 20 microns. In one embodiment, the thickness of the nylon layer 42 is 15 microns.

[0037] In the utility model, the protective outer layer 6 is made of high-density polyethylene (HDPE) material without any additives, which can effectively protect against adhesion during the bag making and welding process. The product has a wide welding temperature range and can still maintain a certain toughness under low temperature conditions, thereby improving the scratch resistance of the protective outer layer 6.

[0038] In the above technical solution, the thickness of the protective outer layer 6 can be 40 to 60 microns. In one embodiment, the thickness of the protective outer layer 6 is 50 microns.

[0039] In one embodiment, the first adhesive layer 3 and the second adhesive layer 5 are ethylene-acrylic acid copolymer or ethylene-methacrylic acid copolymer.

[0040] Ethylene-acrylic acid copolymer, referred to as EEA in English, is a carboxyl-containing ethylene copolymer formed by copolymerization of ethylene monomer and acrylic acid monomer under the action of an initiator. It has good bonding properties and can bond rubber, plastic, metal and glass, and can be used as an adhesive between composite film layers.

[0041] Ethylene-methacrylic acid copolymer, referred to as EMA in English, is a copolymer of ethylene and methacrylic acid under the action of a catalyst. Because its molecular chain contains methacrylic acid groups, the substance has good flexibility, impact resistance, chemical resistance and weather resistance. The substance can be used to produce various plastic products, such as films, plates, pipes, profiles, etc., and can also be used as adhesives, coatings, inks and other materials.

[0042] In the above technical solution, the thickness of the first adhesive layer 3 can be 20-30 micrometers. In one embodiment, the thickness of the first adhesive layer 3 is 25 micrometers.

[0043] In the above technical solution, the thickness of the second adhesive layer 5 can be 35-45 micrometers. In one embodiment, the thickness of the second adhesive layer 5 is 40 micrometers.

[0044] The thickness of each layer of the multi-layer co-extruded film of the utility model is controlled within the above range, so that each layer of the film material can be better fitted and has better adhesion, and is not easy to be delaminated during use.

[0045] The multi-layer co-extruded film of the utility model is prepared by a conventional co-extrusion method. In some embodiments, the following steps can be adopted: (1) adding the raw materials of each layer into an extruder respectively; (2) melting, co-extrusion blow molding or casting at a die head temperature of 120-220°C to obtain the film.

[0046] The utility model also provides a disposable bioprocess bag, which comprises a liquid storage bag made of the multi-layer co-extruded film, a connector and a pipeline.

[0047] The utility model uses welding equipment, joints and pipelines to make a disposable bioprocess bag from a multilayer co-extruded film. The disposable bioprocess bag can be used as a disposable liquid storage bag, a disposable mixing bag or a disposable freeze-thaw bag, and is used in biopharmaceutical companies to store, mix, freeze-thaw and other operations on liquid feed.

[0048] The disposable bioprocess bag made by the utility model was subjected to a pressure test and no leakage was found; and no problem was found when the bag was repeatedly frozen and thawed at -80°C for three times.

[0049] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the utility model, rather than to limit it. Although the utility model has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the utility model.

Claims

1. A multi-layer co-extruded film, characterized in that: From the inside to the outside, there are a liquid contact layer, a sub-inner layer, a first adhesive layer, a barrier layer, a second adhesive layer and a protective outer layer. The liquid contact layer and the sub-inner layer are both ethylene-vinyl acetate copolymers. The barrier layer is composed of a double-layer structure of an ethylene-vinyl alcohol copolymer layer and a nylon layer, wherein the nylon layer is bonded to the second adhesive layer.

2. The multi-layer co-extruded film according to claim 1, characterized in that: The thickness of the liquid contact layer is 115 to 135 microns.

3. The multi-layer co-extruded film according to claim 1, characterized in that: The thickness of the sub-inner layer is 115-135 microns.

4. The multi-layer co-extruded film according to claim 1, characterized in that: The thickness of the ethylene-vinyl alcohol copolymer layer is 15 to 25 microns.

5. The multi-layer co-extruded film according to claim 1, characterized in that: The thickness of the nylon layer is 10 to 20 microns.

6. The multi-layer co-extruded film according to claim 1, characterized in that: The protective outer layer is high-density polyethylene with a thickness of 40 to 60 microns.

7. The multi-layer co-extruded film according to claim 1, characterized in that: The first adhesive layer and the second adhesive layer are ethylene-acrylic acid copolymer or ethylene-methacrylic acid copolymer.

8. The multi-layer co-extruded film according to claim 7, characterized in that: The thickness of the first adhesive layer is 20 to 30 micrometers.

9. The multi-layer co-extruded film according to claim 7, characterized in that: The thickness of the second adhesive layer is 35-45 microns.

10. A disposable bioprocessing bag, characterized in that: The invention comprises a liquid storage bag, a joint and a pipeline made of the multi-layer co-extruded film according to any one of claims 1 to 9.

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