JP2014097086A - Medical device packaging film and medical device package - Google Patents

Abstract

An object of the present invention is to provide a medical device packaging film capable of providing a medical device packaging body excellent in oxygen absorption, and to provide a medical device packaging body excellent in oxygen absorption.
As a result, it is not necessary to enclose an oxygen scavenger separately from the packaging material, and the medical device packaging film that can reduce the oxygen concentration in the package to the extent that it can sufficiently prevent deterioration and deterioration of the packaging material due to γ- ray sterilization And providing a medical device package.
A medical device packaging film of the present invention has a barrier layer and an oxygen absorbing layer, and the oxygen absorbing layer includes a base resin, an oxygen absorbing resin, and a reaction accelerator. Consists of things. The medical device packaging body of the present invention includes the medical device packaging film of the present invention.
[Selection] Figure 1

Description

  The present invention relates to a medical device packaging film and a medical device packaging body that are used particularly for medical applications. More specifically, the present invention relates to a medical device packaging film capable of blocking oxygen and having oxygen absorption performance, and a medical device packaging body. In particular, the medical application field relates to a hollow fiber type dialyzer package used in the hemodialysis field.

Conventionally, a plastic package or a plastic package in which an aluminum foil is laminated on a film is used as a package for storing medical devices.
For example, blood purifiers such as hemodialyzers, blood filters, leukocyte removers, blood component adsorbers, and plasma separators are generally known as medical devices through which body fluids are circulated. It has been.
Among blood purifiers, hollow fiber membrane hemodialyzers (hereinafter referred to as dialyzers) used for hemodialysis are typical examples of blood purifiers because of their use quantity and the large number of products used. . The dialyzer is loaded with a plurality of hollow fiber membrane bundles in a cylindrical casing.

When such a blood purifier is used for an artificial kidney dialyzer, complete sterilization is required before use. From the viewpoint of excellent sterilization effect and handling as a final form, it is common to sterilize after producing a package in which a medical device is packaged with a bag.
For sterilization treatment, physical treatment such as chemical treatment methods such as ethylene oxide gas (hereinafter referred to as EOG), thermal (high pressure steam) sterilization methods, or gamma (γ) rays, electron beam, and other radiation sterilization methods. Different processing methods are used, depending on the structure and material of the packaging material and contents.
Among these, the EOG sterilization method and the radiation sterilization method can be used while being processed in a packaged state, and thus require a little heating, but are generally used as preferable methods. However, in the EOG sterilization method, residual EOG becomes a problem, and it is necessary to degas enough to remove toxic EOG as a post-treatment, and the processing time is long because repeated pressurization and decompression, depending on the material There are problems such as performance changes.
For this reason, it takes time to confirm the shipment.

On the other hand, γ-ray sterilization methods typified by radiation sterilization have no problems with residual gas, packaging materials, and heat resistance of cylindrical casings, as with EOG, and the radiation power is high, so even high-density materials can be irradiated. It is possible and is very excellent as a sterilization method for blood purification devices. Moreover, since it is also possible to easily control the dose by the irradiation time, it is widely used.
Sterilization and sterilization includes direct damage and indirect damage to bacteria. Indirect damage uses oxygen radicals generated from water and oxygen, so even a small amount of water or oxygen is required. Sterilization by direct damage is possible even in the absence of water or oxygen, but a large amount of irradiation energy is required.
However, it is well known that some of the packaging materials are subject to deterioration such as chemical changes due to oxygen radicals, etc., and depending on the material of the packaging materials, gases such as ketones, aldehydes and organic acids may be generated. .

In order to prevent the deterioration and deterioration of the packaging material due to the generation of oxygen radicals as described above, an oxygen absorbent is enclosed in the package before γ-ray sterilization to reduce oxygen inside the package. (For example, Patent Documents 1 and 2).
However, there are also problems such as the trouble of filling the oxygen absorbent or the bulk in the bag, the damage of the bag due to the oxygen absorbent, the problem at the time of disposal, and in some cases accidental ingestion and accidental eating. Also, a method using vacuum packaging or the like (for example, Patent Document 3) or a method of sterilizing water after immersing water against the dead weight of the semipermeable membrane of the dialyzer and replacing the inside of the dialyzer with an inert gas (Patent Document 4) However, workability and productivity are troublesome, oxygen concentration variation, oxygen in the medical device body is gradually released, and it is advantageous in terms of concerns about the rise of oxygen in the medical device package and cost It can not be said.

JP 2005-095270 A Japanese Patent Application No. 11-504153 JP 2001-149471 A JP 2001-170167 A

  It is an object of the present invention to provide a packaging material by γ-ray sterilization without the need to enclose an oxygen scavenger separately from a film packaging material for medical device packaging, without vacuum packaging, and without being replaced with an inert gas. An object of the present invention is to provide a medical device packaging film and a medical device packaging body that can reduce the oxygen concentration in the packaging body to such an extent that deterioration and deterioration of the medical device can be sufficiently prevented.

  Such an object is achieved by the present inventions (1) to (5) below.

(1) A medical device packaging film having a barrier layer and an oxygen absorbing layer,
The medical device packaging film, wherein the oxygen absorbing layer is composed of a resin composition including a base resin, an oxygen absorbing resin, and a reaction accelerator.
(2) The film for medical device packaging according to (1), wherein in the resin composition, the oxygen-absorbing resin is contained in an amount of 1% by weight to 80% by weight with respect to the entire resin composition.
(3) The film for medical device packaging according to (1) or (2), wherein the content of the reaction accelerator in the resin composition is 100 ppm or more and 10,000 ppm or less with respect to the resin composition.
(4) The medical device packaging film according to any one of (1) to (3), wherein the medical device packaging film further has a seal layer.
(5) A medical device package comprising the medical device packaging film according to any one of (1) to (4) above as a constituent member.

  The medical device packaging film according to the present invention provides a medical device packaging film and a medical device packaging body that can reduce the oxygen concentration in the packaging body to such an extent that deterioration and deterioration of the packaging material due to γ-ray sterilization can be sufficiently prevented. can do.

  The medical device package described above can be subjected to radiation sterilization including γ-ray sterilization when the oxygen concentration inside the package is 5% or less, preferably 2% or less, more preferably 1% or less. By performing radiation sterilization at this concentration, it is possible to prevent deterioration and deterioration of the packaging material and the medical device as the contents. This oxygen concentration can be achieved from 3 days to 10 days after sealing the medical device with a medical packaging film, and radiation sterilization including γ-ray sterilization is performed after reducing the oxygen concentration during this period. Can do. By performing radiation sterilization during this period, it is possible to reduce the oxygen concentration to a level at which radiation sterilization is possible and to shorten the period from manufacture to shipment.

It is sectional drawing of the film for medical device packaging which concerns on one Embodiment of this invention. It is sectional drawing of the film for medical device packaging which concerns on one Embodiment of this invention. It is sectional drawing of the film for medical device packaging which concerns on one Embodiment of this invention. It is sectional drawing of the film for medical device packaging which concerns on one Embodiment of this invention. It is a figure of the medical device package which concerns on one Embodiment of this invention. It is a figure for demonstrating the measuring method of the oxygen absorption amount of the film for medical device packaging which concerns on this invention.

  Hereinafter, the medical device packaging film and medical device packaging body of the present invention will be described in detail.

The medical device packaging film of the present invention has a barrier layer and an oxygen absorbing layer, and the oxygen absorbing layer is composed of a resin composition containing a base resin, an oxygen absorbing resin, and a reaction accelerator. It is characterized by that.
The medical device packaging film can provide a medical device package excellent in transparency, oxygen absorption, and barrier properties by having the above-described configuration.

  Since the medical device packaging film of the present invention has a barrier layer, oxygen can be prevented from newly entering the medical device packaging body from the outside, and the oxygen absorbing property of the oxygen absorbing layer can be sufficiently exhibited. be able to. Thereby, it is possible to provide a medical device package having more excellent oxygen absorbability, and to further improve the ability to lower the oxygen concentration in the package. That is, it is possible to provide a medical device package that is more excellent in oxygen absorption.

  Moreover, the said oxygen absorption layer is comprised with the said resin composition, can provide the medical device package excellent in oxygen absorptivity, and can reduce the oxygen concentration in a package. Moreover, the transparency of an oxygen absorption layer and a medical device packaging film can be improved by using an oxygen absorbing resin, and a medical device packaging film excellent in internal visibility can be provided.

  In addition, the medical device package of the present invention can be obtained by sealing the end portion using the medical device packaging film as a sealing member.

  Hereinafter, the medical device package of the present invention will be described in detail based on the embodiments shown in the drawings.

  As shown in FIG. 1, the medical device packaging film according to the present invention includes an outer layer 110, a first adhesive layer 120, a barrier layer 130, a second adhesive layer 140, an oxygen absorbing layer 150, and a seal layer 160 in this order. The medical device packaging film 100 formed by being laminated may be mentioned. The medical device packaging film 100 is not particularly limited, but can be used for a medical device packaging body 200 as shown in FIG. Hereinafter, each structure of the medical device packaging film 100 will be described in detail.

(1) Outer layer The medical device packaging film 100 may include an outer layer 110 as shown in FIG. The outer layer preferably has a strength that can withstand external impacts and the like.

  Although it does not specifically limit as resin which comprises the outer layer 110, It is preferable that a thermoplastic resin is included. For example, polyethylene, polypropylene, polyvinyl chloride, polyvinylidene chloride, polychlorotrifluoroethylene, polystyrene, polyethylene, polyamide, polyethylene terephthalate, cyclic olefin polymer, cyclic olefin copolymer, petroleum resin, polytetrafluoroethylene, polyvinyl fluoride, polyvinyl fluoride. And fluorinated resin copolymers such as vinylidene fluoride and ethylene / tetrafluoroethylene copolymer. The material of the outer layer 110 may include a plurality of these.

  The outer layer 110 may contain an antioxidant. When the outer layer 110 contains an antioxidant, examples of the antioxidant include known antioxidants, such as hindered phenol antioxidants, phosphorus antioxidants, thioether antioxidants, ultraviolet absorbers, hindered amines. A system light stabilizer or the like is used alone or in combination of two or more for the purpose of preventing coloration of the film and preventing changes in physical properties during γ-ray irradiation.

  The outer layer 110 may be one or more layers, and may have a two-layer structure or a multilayer. Examples of the laminating method include a dry laminating method, an extrusion laminating method, a hot melt laminating method, a wet laminating method, and a thermal (thermal) laminating method. Also, a method of coating a resin having a gas barrier property, a method of depositing a thin film by depositing an inorganic oxide or metal such as aluminum metal, silicon oxide (silica) or aluminum oxide (alumina), an organic barrier layer or an organic / inorganic composite Multilayering may be performed by a coating method such as a method of coating a barrier layer. Further, a metal foil such as an aluminum foil, a biaxially stretched or biaxially stretched polyethylene terephthalate film or a polypropylene film deposited with an inorganic oxide may be used.

  The thickness of the outer layer 110 is not particularly limited, but is preferably 5 μm or more and 200 μm or less, and more preferably 20 μm or more and 150 μm or less. By being above the lower limit value, sufficient strength can be secured, and by being below the upper limit value, transparency can be secured.

(2) First Adhesive Layer The medical device packaging film 100 may include a first adhesive layer 120 as shown in FIG. The material of the first adhesive layer 120 is not particularly limited, but a known adhesive resin can be used. Especially, it is preferable to select with resin used as an adjacent layer (for example, outer layer), for example, adhesive polyolefin resin etc. are used. Specifically, as the material of the first adhesive layer 120, for example, ethylene-methacrylate-glycidyl acrylate terpolymer, or various polyolefins, monobasic unsaturated fatty acid, dibasic unsaturated fatty acid, or these An anhydride grafted (maleic acid grafted ethylene-vinyl acetate copolymer, maleic acid grafted ethylene-α-olefin copolymer, etc.) and the like are used. Examples of monobasic unsaturated fatty acids include acrylic acid and methacrylic acid. Examples of the dibasic unsaturated fatty acid include maleic acid, fumaric acid, itaconic acid and the like.

  The first adhesive layer 120 may contain an antioxidant. When the 1st contact bonding layer 120 contains antioxidant, as antioxidant, well-known antioxidant, for example, hindered phenolic antioxidant, phosphorus antioxidant, thioether antioxidant, ultraviolet absorption Agents, hindered amine light stabilizers, and the like are used alone or in admixture of two or more for the purpose of preventing coloration of the film during γ-ray irradiation and preventing changes in physical properties.

  Although the thickness of the 1st contact bonding layer 120 is not specifically limited, 3 micrometers or more and 30 micrometers or less are preferable, and 5 micrometers or more and 20 micrometers or less are preferable. When it is at least the lower limit value, sufficient adhesion can be ensured, and when it is at most the upper limit value, problems such as bleeding of the first adhesive layer can be prevented.

(3) Barrier Layer The medical device packaging film 100 includes a barrier layer 130 as shown in FIG. When the barrier layer 130 is used as a medical device package, it can restrict the permeation of oxygen entering from the outside, and thereby the oxygen concentration inside the medical device package can be rapidly reduced. This can limit, for example, the permeation of oxygen entering from the outside of the medical device package 200 as shown in FIG. 5, thereby rapidly reducing the oxygen concentration inside the medical device package 200. Can do. As a material of the barrier layer 130, a known material having an oxygen barrier property, for example, a polyvinyl alcohol resin, an ethylene-vinyl alcohol copolymer resin (hereinafter referred to as “EVOH resin”), a polyvinylidene chloride resin, or a diamine. A polyamide resin having an aromatic ring as a component, polyacrylonitrile, or the like is used. The barrier layer 130 may be a material obtained by blending an oxygen-absorbing resin with a known material having the above-described oxygen barrier property to obtain a further oxygen high barrier material. Such a material is not particularly limited. For example, an EVOH resin containing the oxygen absorbing resin A, a polyamide resin containing the oxygen absorbing resin A, a polyester resin containing the oxygen absorbing resin A, and the like can be used. .
The oxygen-absorbing resin A is not particularly limited, and for example, an unsaturated polyolefin-based oxygen-absorbing resin is used. More specifically, for example, ethylenically unsaturated hydrocarbon polymer, main chain ethylenically unsaturated hydrocarbon polymer, polyether unit polymer, copolymer of ethylene and distorted cyclic alkylene, polyamide resin, acid-modified polybutadiene, hydroxyaldehyde Polymers, polyisoprene, styrene / butadiene copolymers, styrene / isoprene copolymers, and the like can be used alone or in combination.
The barrier layer may be a multi-layer laminate of these materials, such as a medical device packaging film 100B shown in FIG. 3, such as two layers including the auxiliary barrier layer 130A. The EVOH resin is obtained, for example, by saponifying an ethylene vinyl acetate copolymer. The barrier layer 130 preferably has an oxygen permeability of 200 ml / (m ² · 24 h · atm) or less, more preferably 10 ml / (m ² · 24 h · atm) or less, and an oxygen permeability of 2 ml / More preferably (m ² · 24h · atm) or less. By being below the upper limit, a sufficient reduction in oxygen concentration can be realized when a medical device package is obtained. Such oxygen permeability is not particularly limited, but can be measured by a method of measuring in accordance with JIS K 7126B.

  The thickness of the barrier layer 130 is not particularly limited, but is preferably 3 μm or more and 100 μm or less, and more preferably 5 μm or more and 80 μm or less. By being more than the said lower limit, sufficient oxygen barrier property and the fall of oxygen concentration can be implement | achieved, and the moldability of the packaging film can be improved by being below the said upper limit.

(4) Second Adhesive Layer The medical device packaging film 100 may include a second adhesive layer 140 as shown in FIG. The material of the second adhesive layer 140 is not particularly limited, but a known adhesive resin can be used. For example, an adhesive polyolefin resin is used. Specifically, as the material of the second adhesive layer 140, for example, an ethylene-methacrylate-glycidyl acrylate terpolymer, or various polyolefins to a monobasic unsaturated fatty acid, a dibasic unsaturated fatty acid, or these An anhydride grafted (maleic acid grafted ethylene-vinyl acetate copolymer, maleic acid grafted ethylene-α-olefin copolymer, etc.) and the like are used. Examples of monobasic unsaturated fatty acids include acrylic acid and methacrylic acid. Examples of the dibasic unsaturated fatty acid include maleic acid, fumaric acid, itaconic acid and the like.

  The second adhesive layer 140 may contain an antioxidant. When the second adhesive layer 140 contains an antioxidant, examples of the antioxidant include known antioxidants such as hindered phenol-based antioxidants, phosphorus-based antioxidants, thioether-based antioxidants, and UV absorption. Agents, hindered amine light stabilizers, and the like are used alone or in admixture of two or more for the purpose of preventing coloration of the film during γ-ray irradiation and preventing changes in physical properties.

  Although the thickness of the 2nd contact bonding layer 140 is not specifically limited, 3 micrometers or more and 30 micrometers or less are preferable, and 5 micrometers or more and 20 micrometers or less are preferable. When it is at least the lower limit value, sufficient adhesion can be ensured, and when it is at most the upper limit value, problems such as bleeding of the second adhesive layer can be prevented.

(5) Oxygen Absorbing Layer The medical device packaging film 100 includes an oxygen absorbing layer 150 as shown in FIG. The oxygen absorbing layer 150 is composed of a resin composition containing a base resin, an oxygen absorbing resin B that is an oxygen absorbent, and a reaction accelerator. The oxygen-absorbing resin B is not particularly limited. For example, an unsaturated polyolefin-based oxygen absorbing resin is used. More specifically, for example, ethylenically unsaturated hydrocarbon polymer, main chain ethylenically unsaturated hydrocarbon polymer, polyether unit polymer, copolymer of ethylene and distorted cyclic alkylene, polyamide resin, acid-modified polybutadiene, hydroxyaldehyde Polymers, polyisoprene, styrene / butadiene copolymers, styrene / isoprene copolymers, and the like can be used alone or in combination.

  The content of the oxygen-absorbing resin B is not particularly limited, but is preferably 1 to 80% by weight, preferably 5 to 60% by weight, based on the resin composition. More preferably. By being above the lower limit value, sufficient oxygen absorbability can be realized, and by being below the upper limit value, an effect of internal visibility can be obtained.

  On the other hand, the reaction accelerator is not particularly limited, and examples thereof include a radical generator, a photocatalyst and a transition metal compound, and two or more of these may be used in combination. Among these, a transition metal compound is preferable, and the reactivity between oxygen and the polymer having an unsaturated bond can be further increased by including the transition metal compound. By increasing the reactivity in this manner, oxygen can be efficiently removed in a short time, and there is an effect of further improving the storage stability of the contents when the package is made. The transition metal compound is not particularly limited, and for example, zinc stearate, cobalt stearate, cobalt naphthenate, zinc naphthenate, acetylacetonate zinc, acetylacetonate cobalt or acetylacetonate copper is preferable.

The content of the reaction accelerator is not particularly limited, but is preferably 100 ppm or more and 10,000 ppm or less, more preferably 300 ppm or more and 5000 ppm or less, and more preferably 500 ppm or more and 5000 ppm or less with respect to the whole resin composition. Is more preferably 700 ppm or more and 5000 ppm or less, and further preferably 1000 ppm or more and 5000 ppm or less.
Sufficient oxygen absorptivity can be realized by being above the lower limit, and coloring by the reaction accelerator can be suppressed by being below the upper limit. Thus, adjusting the content of the reaction accelerator contained in the oxygen absorbing layer can be realized by setting the content of the reaction accelerator in the resin composition within the above range.

  Although it does not specifically limit as said base resin, The thing which does not affect the transparency of an oxygen absorption layer is preferable. For example, a polyamide-type resin, a polyethylene-type resin, a polypropylene-type resin, and a polyester-type resin are mentioned, You may use these 2 or more types together. By including such a resin, the strength of the oxygen absorption layer 150 can be increased. As a result, the strength of the medical device packaging film and the medical device packaging body can be increased, and unintentional breakage and holes that occur during the manufacture of the medical device packaging body or during packaging or transportation of the medical device packaging body. It is possible to prevent defects such as perforations.

  The content of the base resin is not particularly limited, but is preferably 20 to 99% by weight, and preferably 40 to 95% by weight with respect to the resin composition. More preferable. Dispersibility of the oxygen-absorbing resin B and the reaction accelerator is improved by being at least the lower limit, and sufficient oxygen absorbability can be obtained by being at most the upper limit.

  The oxygen absorption layer 150 may contain an antioxidant. When the oxygen absorbing layer 150 contains an antioxidant, examples of the antioxidant include known antioxidants such as hindered phenol antioxidants, phosphorus antioxidants, thioether antioxidants, and ultraviolet absorbers. Hindered amine light stabilizers and the like are used alone or in combination of two or more for the purpose of preventing coloration of the film during γ-ray irradiation and preventing changes in physical properties. The content of the antioxidant in the oxygen absorbing layer 150 is preferably 170 ppm or less, more preferably 5 ppm or more and 120 ppm or less, and more preferably 35 ppm or more and 60 ppm or less with respect to the resin composition. Further preferred. By being in the preferred range, sufficient oxygen absorbability can be realized.

  Moreover, the oxygen absorption layer 150 can contain an additive, a compatibilizing agent, etc. in the range which does not impair a physical property. Inclusion of such an additive has the effect of promoting the oxygen absorption reaction.

  The thickness of the oxygen absorbing layer 150 is not particularly limited, but is preferably 5 μm or more and 200 μm or less, and more preferably 10 μm or more and 100 μm or less. By being above the lower limit value, sufficient oxygen absorbability, when the medical device package body, it is possible to achieve a reduction in oxygen concentration inside the medical device package body, by being below the upper limit value, The moldability of the medical device packaging film can be improved.

(6) Seal Layer The medical device packaging film 100 may include a seal layer 160 as shown in FIG.
The sealing layer 160 is not particularly limited, but has a sealing function for sealing (heat sealing, ultrasonic sealing, high frequency sealing, impulse sealing, etc.), and has an adverse effect on the contents accommodated in the medical device package 200. It does not affect The material of the seal layer 160 includes low density polyethylene (LDPE) resin, linear low density polyethylene (LLDPE) resin, medium density polyethylene (MDPE) resin, high density polyethylene (HDPE) resin, polypropylene (PP) resin, ethylene -Vinyl acetate copolymer (EVA) resin, ethylene-methyl methacrylate copolymer (EMMA) resin, ethylene-ethyl acrylate copolymer (EEA) resin, ethylene-methyl acrylate copolymer (EMA) resin, ethylene-ethyl Acrylate-maleic anhydride copolymer (E-EA-MAH) resin, ethylene-acrylate copolymer (EAA) resin, ethylene-methacrylic acid copolymer (EMAA) resin, ionomer (ION) resin, etc. Or two or more types are used in combination.

  The seal layer 160 may contain an antioxidant. When the seal layer 160 contains an antioxidant, examples of the antioxidant include known antioxidants such as hindered phenol-based antioxidants, phosphorus-based antioxidants, thioether-based antioxidants, ultraviolet absorbers, A hindered amine light stabilizer or the like is used alone or in admixture of two or more for the purpose of preventing coloration of the film during γ-ray irradiation and preventing changes in physical properties.

  The seal layer 160 may include a chemical deodorant. As the chemical deodorant, a known substance that chemically adsorbs the odor-causing substance is used, and is appropriately selected according to the target odor-causing substance. Specifically, when the target odor-causing substance is an aldehyde, as the deodorant, for example, amine compound-supporting silicon dioxide, a composite of an amine organic compound and a silicate inorganic compound, an amino group between layers A layered phosphate or the like that holds is used. When the target odor-causing substance is an acid, examples of the deodorizer include hydroxyl-supported zirconium, aluminosilicate, and hydroxyl-supported zinc oxide. The chemical deodorant is added to a known binder resin by, for example, a usual master batch blending method at the time of melt extrusion. This medical device packaging film 100 has a chemical deodorant, so that the appearance (roughness of the skin and transparency) is improved as compared with a medical device packaging film having a physical deodorant.

  The thickness of the seal layer 160 is not particularly limited, but is preferably 3 μm or more and 100 μm or less, and more preferably 5 μm or more and 50 μm or less. When it is at least the lower limit, sufficient sealing properties can be secured, and when it is at most the upper limit, problems such as seepage of the seal layer can be prevented.

  Further, the medical device packaging film 100 may further include a deodorizing layer 170 containing the above deodorant as a layer different from the seal layer 160, like the medical device packaging film 100C shown in FIG. . The deodorizing layer 170 can be manufactured by using a known binder resin at the time of melt extrusion of the chemical deodorant.

  Although the thickness of the deodorizing layer 170 is not specifically limited, 3 micrometers or more and 100 micrometers or less are preferable, and 5 micrometers or more and 50 micrometers or less are preferable. By being more than the said lower limit, sufficient deodorizing effect can be acquired, and internal visibility is not inhibited by being below the said upper limit.

<Method for producing medical device packaging film>
The production method of the medical device packaging film is not particularly limited, but a coextrusion T-die method such as a feed block method or a multi-manifold method in which a raw material resin is melt-extruded by several extruders, The air-cooling type or water-cooling type co-extrusion inflation method can be mentioned, and among these, the method of forming a film by the co-extrusion T-die method is particularly preferable because the thickness control of each layer is excellent. As a subsequent process, a single layer sheet or film forming each layer is bonded using an appropriate adhesive, a dry laminating method, an extrusion laminating method, a hot melt laminating method, a wet laminating method, a thermal (thermal) laminating method, and the like. Used in combination of methods. Moreover, you may laminate | stack by the method by coating.

  The thickness of the medical device packaging film thus obtained is not particularly limited, but is preferably 30 μm or more and 300 μm or less, and more preferably 50 μm or more and 200 μm or less. By being more than the said lower limit, the effect of oxygen barrier property and oxygen absorptivity can be acquired, and the effect of favorable visibility can be acquired by being below the said upper limit.

  Further, the medical device packaging film of the present invention is not particularly limited, but the total light transmittance is preferably 70% or more, and more preferably 80% or more. By being more than the said lower limit, transparency when it is set as a medical device packaging body can fully be ensured, and the visibility inside a medical device packaging body can be improved. Here, the total light transmittance can be measured using a haze meter.

  In addition, the medical device packaging film of the present invention has a crystal nucleating agent, a petroleum resin, an elastomer, an antistatic agent, an ultraviolet absorber, a lubricant, an antioxidant, a light stabilizer, and an antiblocking agent as long as the basic performance is not impaired. An additive such as an agent, a surfactant, a dye, a pigment, a flame retardant, and a plasticizer may be added to one or more layers included in the medical device packaging film. By including such a layer, the medical device packaging film and the medical device package can include an antistatic function, an ultraviolet protection function, and the like, and further improve the storage stability of the contents of the medical device package. be able to.

<Medical device packaging>
Hereinafter, the medical device package of the present invention will be described in detail based on the embodiments shown in the drawings.

As shown in FIG. 5, the medical device packaging 200 is not particularly limited, but can be composed of the medical device packaging film 100.
The medical device packaging body 200 is formed on the medical device packaging body 200 such that the medical device packaging film 100 has the outer layer 110 on the outer side and the seal layer 160 on the inner side. The pocket 210 of the medical device package contains contents such as a medical device. After the contents are stored in the pocket, the medical device packaging film is sealed and sealed.

  When the medical device packaging film is used as one surface in the medical device packaging body, the material for the other medical device packaging film is not particularly limited. For example, Sumilite CEL-R111B or CEL-R161A (Sumitomo Bakelite) Etc.). In addition, containers made of metals such as aluminum, films manufactured by the method of depositing inorganic oxides such as silicon oxide (silica) and aluminum oxide (alumina) after forming, and coating with metal and inorganic thin films are used. May be. Moreover, you may use the film for medical device packaging of this invention. The blister pack pocket accommodates contents such as medical devices. After the contents are stored in the pocket, the medical device packaging film is sealed and sealed.

<Effect in this embodiment>
This medical device packaging film has an oxygen-absorbing layer containing an oxygen-absorbing resin, so there is no need to enclose an oxygen scavenger separately from the packaging material, and there is no need for vacuum packaging, and replacement with an inert gas. In addition, it is possible to provide a package that can remove internal oxygen and reduce the oxygen concentration to γ-ray sterilization.

Below, Examples 1-7 which concern on a medical device packaging body provided with the film for medical device packaging of this invention, and Comparative Examples 1-2 are demonstrated. In addition, this invention is not limited at all by these Examples.
In addition, evaluation of the medical device packaging film obtained in the following Examples and Comparative Examples was performed by the following method.

<Confirmation of oxygen absorption performance>
The sample 100D cut into 100 cm ² was put into a 200 ml sample bottle 620 together with a sensor chip 610 of PSt3 type for oxygen concentration measurement (manufactured by PreSens, detection limit: 0.01%), and oxygen absorption performance was confirmed.

<Measurement of oxygen absorption>
As shown in FIG. 6, oxygen concentration measurement at 25 ° C. was performed using a non-contact oxygen concentration meter 600 (manufactured by PreSens, product number: Fibox 3 LCD) and a sensor chip 610.

The oxygen absorption capacity was judged by the oxygen absorption capacity ml / cm ² , which is a unit represented by the amount of oxygen absorbed per unit area. When the oxygen absorption capacity after the start of measurement 5 days is 0.20ml / cm ² or more ◎, when is 0.20ml / cm ² less than 0.15ml / cm ² or more ○, 0.15ml / cm ² less than 0 when it .10ml / cm ² or more △, and as × when less than 0.10 ml / cm ^2.

Example 1
<Production of film>
As a resin constituting the outer layer, a polypropylene resin (manufactured by Prime Polymer Co., Ltd., product number: E122V) and an elastomer propylene copolymer (manufactured by Mitsui Chemicals, Inc., product number: XM7080) were prepared. An adhesive polyolefin resin (manufactured by Nippon Polyolefin Co., Ltd., product number: ER313E-1) was prepared as a resin constituting the first adhesive layer. As a resin constituting the barrier layer, an EVOH resin containing oxygen absorbing resin (manufactured by Kuraray Co., Ltd., product number: AP931) was prepared. An adhesive polyolefin resin (manufactured by Mitsui Chemicals, product number: LF308) was prepared as a resin constituting the second adhesive layer. Resin in which metallocene LLDPE resin (manufactured by Ube Maruzen Polyethylene Co., Ltd., product number: 125FN) is mixed as a base resin in a proportion of 80% by weight and unsaturated polyolefin oxygen-absorbing resin in a proportion of 20% by weight as a resin constituting the oxygen absorbing layer A composition was prepared. As a resin constituting the seal layer, a metallocene PP resin (manufactured by Nippon Polypro Co., Ltd., product number: WFX4) was prepared.

  Furthermore, as the resin constituting the oxygen absorbing layer, the resin composition in which the base resin and the unsaturated polyolefin oxygen absorbing resin are mixed is reacted so that the content is 1000 ppm by weight with respect to the resin composition. An accelerator, cobalt stearate, was added.

  The metallocene PP resin constituting the sealing layer, the resin composition constituting the oxygen absorbing layer, the adhesive polyolefin resin constituting the second adhesive layer, the EVOH resin constituting the barrier layer, and the first adhesive layer The adhesive polyolefin resin and the polypropylene resin constituting the outer layer were coextruded in this order to produce a medical device packaging film (see FIG. 1). In the obtained medical device packaging film, the thickness of the seal layer is 20 μm, the thickness of the oxygen absorption layer is 30 μm, the thickness of the second adhesive layer is 5 μm, the thickness of the barrier layer is 20 μm, and the thickness of the first adhesive layer The thickness was 5 μm, the thickness of the outer layer was 20 μm, and the total thickness of the film was 100 μm.

The oxygen concentration after 5 days was 14.9%, and the oxygen absorption capacity was 0.17 ml / cm ² .

(Example 2)
Materials other than the following were prepared in the same manner as in Example 1 to prepare a medical device packaging film material. Polypropylene resin as the resin constituting the outer layer (product number: FH3471M, manufactured by Sumitomo Chemical Co., Ltd.) As the resin constituting the oxygen absorbing layer, 80% by weight of the base resin and 20% by weight of the unsaturated polyolefin-based oxygen absorbing resin What was mixed in was prepared. As a resin constituting the deodorant layer, LLDPE resin (manufactured by Prime Polymer Co., Ltd., product number: 0248Z) and 2% by weight of a chemical deodorant, amine-based compound-supported silicon dioxide (Toa Gosei Co., Ltd.) Manufactured, product number: Kesmon NS-241). As a resin constituting the seal layer, an LLDPE resin (manufactured by Prime Polymer Co., Ltd., product number: 0248Z) was prepared.

  Furthermore, the resin composition in which the base resin and the unsaturated polyolefin-based oxygen-absorbing resin are mixed as the resin constituting the oxygen-absorbing layer is reacted so that the content is 2000 ppm by weight with respect to the resin composition. An accelerator, cobalt stearate, was added.

  LLDPE resin constituting the sealing layer, deodorant and base resin constituting the deodorizing layer, resin composition constituting the oxygen absorbing layer, adhesive polyolefin resin constituting the second adhesive layer, and barrier layer The EVOH resin containing the oxygen-absorbing resin constituting the film, the adhesive polyolefin resin constituting the first adhesive layer, and the polypropylene resin constituting the outer layer were coextruded in this order to produce a medical device packaging film ( (See FIG. 4). In the obtained medical device packaging film, the thickness of the sealing layer is 5 μm, the thickness of the deodorizing layer is 10 μm, the thickness of the oxygen absorbing layer is 20 μm, the thickness of the second adhesive layer is 5 μm, and the thickness of the barrier layer The thickness of the first adhesive layer was 5 μm, the thickness of the outer layer was 20 μm, and the total thickness of the film was 90 μm.

The oxygen concentration after 5 days was 9.6%, and the oxygen absorption capacity was 0.30 ml / cm ² .

(Example 3)
The medical device packaging film produced in Example 2 was laminated with a 23 μm-thick polychlorotrifluoroethylene on the outer layer side to obtain a medical device packaging film (see FIG. 2).

The oxygen concentration after 5 days was 9.2%, and the oxygen absorption capacity was 0.31 ml / cm ² .

(Example 4)
Materials other than the following were prepared in the same manner as in Example 1 to prepare a medical device packaging film material. A copolymer polyester resin (manufactured by Eastman Chemical Japan Co., Ltd., product number: GN071) was prepared as a resin constituting the outer layer, and an EVOH resin (manufactured by Kuraray Co., Ltd., product number: J171B) was prepared as a resin constituting the barrier layer. As the resin constituting the oxygen absorbing layer, a resin composition was prepared in which 90% by weight of the base resin and 10% by weight of the unsaturated polyolefin oxygen absorbing resin were mixed.

  Further, the resin composition in which the base resin and the unsaturated polyolefin-based oxygen-absorbing resin are mixed as the resin constituting the oxygen-absorbing layer is reacted so that the content is 4000 ppm by weight with respect to the resin composition. An accelerator, cobalt stearate, was added.

  The metallocene PP resin constituting the sealing layer, the resin composition constituting the oxygen absorbing layer, the adhesive polyolefin resin constituting the second adhesive layer, the EVOH resin constituting the barrier layer, and the first adhesive layer The adhesive polyolefin resin and the copolymer polyester resin constituting the outer layer were coextruded in this order to produce a medical device film (see FIG. 4). In the obtained medical device packaging film, the seal layer has a thickness of 15 μm, the oxygen absorption layer has a thickness of 60 μm, the second adhesive layer has a thickness of 4 μm, the barrier layer has a thickness of 20 μm, and the first adhesive layer has a thickness of The thickness was 4 μm, the thickness of the outer layer was 40 μm, and the total thickness of the film was 143 μm.

The oxygen concentration after 5 days was 15.6%, and the oxygen absorption capacity was 0.15 ml / cm ² .

(Example 5)
<Production of sheet>
A polypropylene resin (manufactured by Prime Polymer Co., Ltd., product number: E122V) was prepared as a resin constituting the outer layer. An adhesive polyolefin resin (manufactured by Nippon Polyolefin Co., Ltd., product number: ER313E-1) was prepared as a resin constituting the first adhesive layer. An EVOH resin (manufactured by Kuraray Co., Ltd., product number: J171B) was prepared as a resin constituting the barrier layer. Also, polyamide resin (Mitsubishi Gas Chemical Co., Ltd., product number: S6007) is used as the resin constituting the auxiliary barrier layer, and adhesive polyolefin resin (Mitsui Chemicals Co., Ltd., product number: LF308) is used as the resin constituting the second adhesive layer. ) Was prepared. As the resin constituting the oxygen absorbing layer, a mixture of 50% by weight of the base resin and 15% by weight of the unsaturated polyolefin-based oxygen absorbing resin was prepared. As a resin constituting the deodorizing layer, LLDPE resin (manufactured by Prime Polymer Co., Ltd., product number: 0248Z) and 5% by weight of amine-based compound-supporting silicon dioxide (Toagosei Co., Ltd.) as a chemical deodorant Manufactured, product number: Kesmon NS-241). As a resin constituting the seal layer, an LLDPE resin (manufactured by Prime Polymer Co., Ltd., product number: 0248Z) was prepared.

  Further, the resin composition obtained by mixing the base resin of the oxygen absorbing layer and the unsaturated polyolefin oxygen absorbing resin is stearin as a reaction accelerator so that the content is 1500 ppm by weight with respect to the resin composition. Cobalt acid was added.

  LLDPE resin constituting the sealing layer, deodorant and base resin constituting the deodorizing layer, resin composition constituting the oxygen absorbing layer, adhesive polyolefin resin constituting the second adhesive layer, and auxiliary barrier A film for medical device packaging, coextruded in this order with a polyamide resin constituting a layer, an EVOH resin constituting a barrier layer, an adhesive polyolefin resin constituting a first adhesive layer, and a polypropylene resin constituting an outer layer (See FIG. 3). In the obtained medical device packaging film, the thickness of the sealing layer is 10 μm, the thickness of the deodorizing layer is 10 μm, the thickness of the oxygen absorbing layer is 30 μm, the thickness of the second adhesive layer is 5 μm, The thickness was 10 μm, the thickness of the barrier layer was 20 μm, the thickness of the first adhesive layer was 5 μm, the thickness of the outer layer was 25 μm, and the total thickness of the film was 115 μm.

The oxygen concentration after 5 days was 12.9%, and the oxygen absorption capacity was 0.22 ml / cm ² .

(Comparative Example 1)
A medical device packaging film was obtained in the same manner as in Example 1 except that no oxygen-absorbing resin was used.

Since the oxygen concentration after 5 days was 20.7% and the oxygen absorption capacity was 0.01 ml / cm ^2, it was evaluated as x.

(Comparative Example 2)
A medical device packaging film was obtained in the same manner as in Example 1 except that no reaction accelerator was added.

The oxygen concentration after 5 days was 20.3%, and the oxygen absorption capacity was 0.02 ml / cm ² .

  As is clear in Table 1, the medical device packaging film according to the present invention is excellent in oxygen absorbability.

  Since the medical device packaging film and the medical device package according to the present invention are excellent in oxygen absorbability, they can be suitably used for the medical device package.

100, 100A, 100B, 100C Medical device packaging film 100D Cut sample 110 Outer layer 110A Auxiliary outer layer 120 First adhesive layer 130 Barrier layer 130A Auxiliary barrier layer 140 Second adhesive layer 150 Oxygen absorbing layer 160 Seal layer 170 Deodorant layer 200 Medical Equipment package 210 Pocket 300 Medical instrument 600 Non-contact oxygen analyzer 610 Sensor chip for measuring oxygen concentration 620 Sample bottle

In order to prevent the deterioration and deterioration of the packaging material due to the generation of oxygen radicals as described above, an oxygen absorbent is enclosed in the package before γ-ray sterilization to reduce oxygen inside the package. (For example, Patent Documents 1 and 2).
However, there are also problems such as the trouble of filling the oxygen absorbent or the bulk in the bag, the damage of the bag due to the oxygen absorbent, the problem at the time of disposal, and in some cases accidental ingestion and accidental eating .

JP 2005-095270 A Japanese Patent Application No. 11-504153

The purpose of the present invention is to eliminate the need for an oxygen scavenger separately from the film packaging material for medical device packaging, and to reduce the oxygen concentration in the package so as to sufficiently prevent deterioration and deterioration of the packaging material due to γ- ray sterilization. An object of the present invention is to provide a medical device packaging film and a medical device packaging body that can be reduced.

<Medical device packaging Sokarada>
Hereinafter, the medical device package of the present invention will be described in detail based on the embodiments shown in the drawings.

<Effect in this embodiment>
The medical device packaging film, by having an oxygen-absorbing layer containing an oxygen-absorbing resin, it is not necessary to encapsulate separately from the oxygen scavenger is a packaging material, it can be removed of oxygen internal, gamma ray sterilization It is possible to provide a package body that can be reduced to a possible oxygen concentration.

Claims (5)

A medical device packaging film having a barrier layer and an oxygen absorbing layer,
The medical device packaging film, wherein the oxygen absorbing layer is composed of a resin composition including a base resin, an oxygen absorbing resin, and a reaction accelerator. The film for medical device packaging according to claim 1, wherein the oxygen-absorbing resin is contained in the resin composition in an amount of 1 wt% or more and 80 wt% or less based on the entire resin composition. The film for medical device packaging according to claim 1 or 2, wherein a content of the reaction accelerator in the resin composition is 100 ppm or more and 10,000 ppm or less with respect to the resin composition. The medical device packaging film according to any one of claims 1 to 3, wherein the medical device packaging film further has a seal layer. The medical device package which uses the medical device packaging film of any one of Claims 1 thru | or 4 as a structural member.