US20010008686A1 - Medical multilayer sealant films and methods for producing the same - Google Patents

Medical multilayer sealant films and methods for producing the same Download PDF

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Publication number
US20010008686A1
US20010008686A1 US08/796,755 US79675597A US2001008686A1 US 20010008686 A1 US20010008686 A1 US 20010008686A1 US 79675597 A US79675597 A US 79675597A US 2001008686 A1 US2001008686 A1 US 2001008686A1
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United States
Prior art keywords
layer
film
sealant film
density polyethylene
resin
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Abandoned
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US08/796,755
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English (en)
Inventor
Fujio Inoue
Masamitsu Izumi
Shigetoshi Kashiyama
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Otsuka Pharmaceutical Co Ltd
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Otsuka Pharmaceutical Co Ltd
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Publication date
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Priority to US08/796,755 priority Critical patent/US20010008686A1/en
Assigned to OTSUKA PHARMACEUTICAL FACTORY, INC. reassignment OTSUKA PHARMACEUTICAL FACTORY, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: INOUE, FUJIO, IZUMI, MASAMITSU, KASHIYAMA, SHIGETOSHI
Publication of US20010008686A1 publication Critical patent/US20010008686A1/en
Priority to US10/330,050 priority patent/US6773775B2/en
Abandoned legal-status Critical Current

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/18—Layered products comprising a layer of synthetic resin characterised by the use of special additives
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/306—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising vinyl acetate or vinyl alcohol (co)polymers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04—Interconnection of layers
    • B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2024—Separating means having peelable seals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2309/00—Parameters for the laminating or treatment process; Apparatus details
    • B32B2309/08—Dimensions, e.g. volume
    • B32B2309/10—Dimensions, e.g. volume linear, e.g. length, distance, width
    • B32B2309/105—Thickness
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2323/00—Polyalkenes
    • B32B2323/04—Polyethylene
    • B32B2323/046—LDPE, i.e. low density polyethylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/80—Medical packaging
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
    • Y10T428/1341—Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/1379—Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit
    • Y10T428/1383—Vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit is sandwiched between layers [continuous layer]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/24—Structurally defined web or sheet [e.g., overall dimension, etc.]
    • Y10T428/24942—Structurally defined web or sheet [e.g., overall dimension, etc.] including components having same physical characteristic in differing degree
    • Y10T428/2495—Thickness [relative or absolute]
    • Y10T428/24967—Absolute thicknesses specified
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/24—Structurally defined web or sheet [e.g., overall dimension, etc.]
    • Y10T428/24942—Structurally defined web or sheet [e.g., overall dimension, etc.] including components having same physical characteristic in differing degree
    • Y10T428/2495—Thickness [relative or absolute]
    • Y10T428/24967—Absolute thicknesses specified
    • Y10T428/24975—No layer or component greater than 5 mils thick
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/28—Web or sheet containing structurally defined element or component and having an adhesive outermost layer
    • Y10T428/2813—Heat or solvent activated or sealable
    • Y10T428/2817—Heat sealable
    • Y10T428/2826—Synthetic resin or polymer
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31855—Of addition polymer from unsaturated monomers
    • Y10T428/31909—Next to second addition polymer from unsaturated monomers
    • Y10T428/31913—Monoolefin polymer
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31855—Of addition polymer from unsaturated monomers
    • Y10T428/31909—Next to second addition polymer from unsaturated monomers
    • Y10T428/31928—Ester, halide or nitrile of addition polymer
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31855—Of addition polymer from unsaturated monomers
    • Y10T428/31935—Ester, halide or nitrile of addition polymer

Definitions

  • the present invention relates to medical multilayer sealant films, and more particularly to a medical multilayer sealant film which is useful as a material for forming the innermost layer of films for medical containers, medical container packaging films and medical container covering films and methods for preparing the same.
  • plastic film materials for example, for making medical containers, packaging medical containers or covering medical containers.
  • film materials include as a component a base film.
  • resin material for the base film is, for example, nylon, polyethylene terephthalate, polyvinyl alcohol or the like.
  • sealant film to the base film of the film material with a silicone, epoxy, urethane, urethane-epoxy, acryl or like adhesive.
  • sealant film is a film of resin having a low melting point and low density, such as low-density polyethylene.
  • resin film affords a high heat-sealing strength, permits sealing at a low temperature, gives a specified heat-sealing strength despite adhesion of dust or the like, and is therefore excellent in quality and properties as a sealant film.
  • the base film and the adhesive often contain contaminants.
  • Various additives added to the material to be formed into the base film for giving improved properties to the film are phthalic acid esters [(such as dioctyl phthalate (DOP), di-n-butyl phthalate (DNBP), diethyl phthalate (DEP), diethylhexyl phthalate (DEHP)], chlorinated paraffin, adipic acid esters, fatty acid amide, phosphorus derivatives antioxidants, phenol derivatives antioxidants, etc.
  • DOP dioctyl phthalate
  • DNBP di-n-butyl phthalate
  • DEP diethyl phthalate
  • DEHP diethylhexyl phthalate
  • the sealant film providing the innermost layer of the film material conventionally available has no barrier properties to these contaminants, so that if the base film and/or the adhesive contains the contaminant, the contaminant migrates to the inside of the innermost layer through the adhesive layer and the sealant film.
  • the products prepared from the film material are unable to protect the contents, such as medicinals, from contamination with contaminants.
  • An object of the present invention is to provide a formability-improved medical multilayer sealant film having excellent heat-sealing properties and barrier properties to the foregoing contaminants.
  • Another object of the invention is to provide contamination preventing film for medical containers, medical container packaging film and medical container covering film which include the sealant film as the innermost layer.
  • Still another object of the invention is to provide contamination preventing products, such as a medical container, a medical container packaging bag (hereinafter referred to as a “packaging bag”) and a medical container cover (hereinafter referred to as a “cover”), which include the sealant film as the innermost layer.
  • a medical container such as a medical container, a medical container packaging bag (hereinafter referred to as a “packaging bag”) and a medical container cover (hereinafter referred to as a “cover”), which include the sealant film as the innermost layer.
  • Still another object of the invention is to provide a highly productive method of producing the above multilayer sealant film of high quality.
  • the present invention provides a medical multilayer sealant film which is a multilayer sealant film having as the innermost layer a first layer comprising at least one resin selected from the group consisting of linear low-density polyethylene, low-density polyethylene, polypropylene and polybutene-1, the sealant film being characterized in that a third layer comprising an ethylene-vinyl alcohol copolymer is laminated to the outer side of the first layer with a second layer serving as an adhesive layer and comprising a resin containing, as a main component, at least one of an amorphous polyolefin, adherent polyolefin and ethylene-vinyl acetate copolymer, and in that the difference in density between the resin constituting the first layer and the resin constituting the second layer is 0.02 g/cm 3 or less.
  • the present invention provides a method of producing a medical multilayer, wherein a co-extrusion inflation process is used to produce the above constructed multilayer sealant film, and wherein the lay flat width of the film is set to be 420 mm-1100 mm and the film take-off speed is set to be 7.0-15.0 m/min when forming the film.
  • the sealant film of the present invention may comprise, in addition to the three-layer structure of the first to third layers, a fourth layer and a fifth layer successively formed over the outer side of the third layer constituting the outermost layer of the structure.
  • the resin mentioned for the second layer is used for forming the fourth layer
  • the resin mentioned for the first layer is used for forming the fifth layer
  • the difference in density between both resins needs to be 0.02 g/cm 3 or less.
  • the sealant film of the present invention is usable for forming the innermost layer of films for medical containers, medical container packaging films and medical container covering films.
  • films for medical containers refers to films for use in forming medical containers.
  • packaging films refers to films for forming packaging bags which wraps and seals off a medical container entirely (hereinafter referred to as “packaging films”).
  • the term “medical container covering films” refers to films for forming a cover which wraps in at least one compartment of a medical container locally adheres to the container (hereinafter referred to as “covering films”).
  • FIG. 1 is a sectional view showing a medical multilayer sealant film of the three-layer type according to the invention.
  • FIG. 2 is a sectional view showing a medical multilayer sealant film of the five-layer type according to the invention.
  • FIG. 3 is a view in vertical section showing an example of medical container formed from a film including a sealant film of the invention.
  • FIG. 4 is a view in vertical section showing an example of packaging bag prepared from a like film.
  • FIG. 5 is a view in vertical section showing another example prepared from the same film.
  • FIG. 6 is a view in vertical section showing an example of cover prepared from a like film.
  • FIG. 7 is a view in vertical section showing the sealant film of the invention as locally adhered to the base film of a packaging film or covering film.
  • FIG. 1 shows an example of medical multilayer sealant film having a three-layer structure and embodying the present invention.
  • a first layer 1 providing the innermost layer has desirable heat-sealing properties and is made from at least one resin selected from the group consisting of linear low-density polyethylene, low-density polyethylene, polypropylene and polybutene-1. Among these, linear low-density polyethylene or low-density polyethylene is preferable.
  • the first layer 1 may comprise a mixture of at least two resins which are different in miscibility.
  • the preferred density of the resin to be used for forming the first layer 1 is 0.895-0.945 g/cm 3 , for example.
  • the thickness of the first layer 1 is at least 10 ⁇ m, and is suitably determined preferably from the range of about 10 to about 40 ⁇ m.
  • a third layer 3 having barrier properties to contaminants is formed over the outer side of the first layer 1 with a second layer 2 interposed therebetween.
  • the third layer 3 is made from an ethylene-vinyl alcohol copolymer (also termed saponified ethylene-vinyl acetate copolymer) having barrier properties to contaminants. It is suitable that the thickness of this layer be at least 10 ⁇ m, preferably about 10 to about 25 ⁇ m.
  • the ethylene copolymerization mole ratio of the resin can be selected from a wide range, and is preferably 29 to 44% in view of flexibility, barrier properties to contaminants, etc.
  • the ethylene-vinyl alcohol copolymer for forming the third layer 3 can be made into a two-layer film along with the first layer 1 by co-extrusion, this method is not desirable since the resulting film is much inferior to usual co-extruded films in interlaminar strength. According to the invention, therefore, the second layer 2 which is highly adherent to the third layer 3 and the first layer 1 (innermost layer) is provided between the two layers.
  • the second layer 2 comprises a resin containing, as a main component, at least one of an amorphous polyolefin, adherent polyolefin, and ethylene-vinyl acetate copolymer which is improved in adhesion when required, and is preferably 5 to 25 ⁇ m, more preferably 5 to 15 ⁇ m, in thickness.
  • the amorphous polyolefin to be used for forming the second layer 2 is, for example, an ethylene- ⁇ -olefin copolymer (hereinafter referred to as an “amorphous polyethylene”) having a density of 0.880 to 0.890 g/cm 3 , propylene- ⁇ -olefin copolymer (hereinafter referred to as an “amorphous polypropylene”) having a density of 0.880 3 to 0.890 g/cm 3 , or the like.
  • amorphous polyethylene is desirable.
  • ⁇ -olefins examples include propylene, 1-butene, 1-pentene, 1-hexene, 4-methyl-1-pentene, 1-heptene, 1-octene, 1-nonene, 1-decene, 1-undecene, 1-dodecene and the like which have 3 to 12 carbon atoms.
  • 1-butene is desirable for forming the copolymer.
  • propylene is excluded in the case of propylene- ⁇ -olefin copolymer.
  • the adherent polyolefin is prepared by graft-polymerizing maleic acid with polyethylene, polypropylene or like polyolefin and improved in adhesion.
  • polyethylene polypropylene or like polyolefin
  • adherent polyethylene adherent polyethylene, adherent polypropylene, etc., among which adherent polyethylene is preferred.
  • the ethylene-vinyl acetate copolymer exhibits good adhesion or poor adhesion depending on the ethylene copolymerization mole ratio of the resin.
  • the copolymer is used as it is in the former case, whereas in the latter case, maleic acid is graft-polymerized with the copolymer to impart improved adhesion.
  • the densities of the adherent polyolefin and the adhesion-improved ethylene-vinyl acetate copolymer are approximately 0.890-0.945 g/cm 3 . If there is too great a difference in density between the resin used for forming the first layer and the resin used for forming the second layer, the formability decreases. Accordingly, the density difference therebetween needs to be 0.02 g/cm 3 or less.
  • the resin used for forming the first layer or high density polyethylene may be added to the resin used for forming the second layer.
  • the first layer 1 and the second layer 2 are formed inwardly of the third layer 3 having barrier properties to contaminants and are therefore undesirable if containing contaminants. Accordingly, the foregoing resins for forming the first layer 1 and the second layer 2 are used without adding thereto additives which will become contaminants.
  • the third layer 3 is formed also without using any additive, so that no additive migrates from the third layer 3 inward.
  • the medical multilayer sealant film of the present invention at least have a three-layer structure comprising the first layer 1 (innermost layer), second layer 2 and third layer 3 as shown in FIG. 1. Another layer can be laminated to the outer side of the third layer 3 when so required.
  • a suitable known plastic resin layer can be selected for use as the other layer in this case. Presence of a contaminant in this layer poses no particular problem.
  • a fifth layer 5 which comprises at least one resin selected from the group consisting of linear low-density polyethylene, low-density polyethylene, polypropylene and polybutene-1 using a fourth layer 4 serving as an adhesive layer and comprising an amorphous polyolefin, adherent polyolefin, or ethylene-vinyl acetate copolymer which is improved in adhesion when required, as seen in FIG. 2.
  • the difference in density between the resins for the forth and fifth layers is set to be 0.02 g/cm 3 or less from the view point of formability.
  • the thickness of the fourth layer 4 is suitably selected from the range preferably of 5 to 25 ⁇ m, more preferably of 5 to 15 ⁇ m.
  • the thickness of the fifth layer 5 is suitably selected from the range preferably of 10 to 40 ⁇ m, more preferably of 10 to 20 ⁇ m.
  • the overall thickness of the medical multilayer sealant film of the type shown in FIG. 1, as well as of the type shown in FIG. 2, is suitably selected from the range of 50 to 80 ⁇ m.
  • the multilayer sealant film of the present invention is formed by using a water-cooled or air-cooled co-extrusion inflation process.
  • the present invention since the difference in density between the resins for forming the first and second layers is small, i.e., 0.02 g/cm 3 or less, whereby the formability of the multilayer film is improved. Accordingly, it is possible to increase the lay flat width of the film, during formation, up to 420-1100 mm, and also it is possible to maintain the film take-off speed at a relatively high, i.e., 7.0-15.0 rm/min during formation of the film, thereby producing the above-mentioned multilayer sealant film with high productivity. Further, because of the improved formability, the resultant product has no wrinkle and therefore has high quality.
  • a film for medical containers, packaging film or covering film is obtained by laminating a base film to the outer layer of the present sealant film.
  • the sealant film of the invention can be laminated to the base film by dry lamination or wet lamination. Further in the case where the outermost layer of the present sealant film has heat-sealing properties, and the innermost layer of the base film has heat-sealing properties, heat-sealing means may be used for adhering the films.
  • FIG. 3 shows a medical container film prepared by laminating a sealant film A of the invention to a base film B, and a medical container a formed from the film.
  • Various known films for use in making medical containers are usable as the base film B.
  • FIGS. 4 and 5 show a packaging film with the invention sealant film A laminated to the base film B 1 and packaging bags b formed from the film. Medical containers a 1 , a 2 are enclosed in the respective bags b.
  • FIG. 5 shows a double-chamber container a 2 as enclosed in a folded state.
  • the base film B 1 to be used for forming the packaging bags b needs to be film having gas barrier properties and moisture impermeability to preclude the degradation of the medicinals in the containers a 1 and a 2 .
  • the base film B 1 having high gas barrier properties and moisture impermeability is a composite film comprising a polyolefin film and aluminum foil laminated thereto and impervious to oxygen and water vapor, a single or multi-layered resin film material comprising polyethylene terephthalate (PET), polyvinylidene chloride, polyvinyl alcohol, polyamide, ethylene-vinyl acetate copolymer as saponified or the like, or a laminated film material of the resin film and the above composite film.
  • PET polyethylene terephthalate
  • PET polyvinylidene chloride
  • polyvinyl alcohol polyamide
  • ethylene-vinyl acetate copolymer as saponified or the like
  • Other materials favorably usable include a composite film which comprises a polyvinyl alcohol film, polyethylene terephthalate film or saponified ethylene-vinyl acetate copolymer film, and a silicon oxide layer formed on the film by vacuum deposition.
  • a multilayer film comprising a composite film prepared by forming a silicon oxide layer on a polyvinyl alcohol film by vacuum deposition, and a PET film (outermost layer) formed on the silicon oxide layer of the composite film by dry lamination.
  • a multilayer film which comprises a composite film prepared by forming a silicon oxide layer on a polyvinyl alcohol film by vacuum deposition, and the multilayer film (I) and which is prepared by dry lamination with the polyvinyl alcohol film of the film (I) superposed on the silicon oxide layer of the composite film.
  • the packaging bag b is used also for protecting the medical container a 1 or a 2 from an external impact.
  • Used as the base film B 1 in this case is a single-layer or multilayer film material which includes as a component a film of PET, nylon, polyethylene, polypropylene or the like having a high impact strength.
  • FIG. 6 shows a covering film which comprises the sealant film A of the invention and a base film B 2 laminated thereto, and a cover c formed from the covering film and enclosing one chamber of the double-chamber container a 2 therewith.
  • the cover c is used for the same purpose as the. packaging bag b, so that like the base films B 1 , B 2 to be used is a film material having high gas barrier properties and moisture impermeability.
  • the sealant film A is adhered to the base film B 1 or B 2 over the entire surface thereof as seen in FIGS. 4 to 6, or locally thereto so as to provide a space between the base film B 1 or B 2 and the film A as shown in FIG. 7.
  • the present invention provides products made from a film material comprising the sealant film of the invention and a base film laminated to the outer layer thereof, i.e., medical containers, packaging bags and covers, such as those shown in FIGS. 3 to 6 .
  • the sealant film has barrier properties to contaminants and therefore eliminates the likelihood that the contaminants present in the base film and/or those from outside will penetrate into the medical container to prevent the contaminants from contaminating the medicinal.
  • the medical containers shown in FIGS. 3 to 6 are used for containing common medicinals, which may be powder preparations, liquid preparations or solid preparations.
  • Examples of powder preparations include antibiotics, anticancer agents, proteins, peptides, steroids, fibrinolytic agents and vitamins.
  • antibiotics are cephazolin, ⁇ -lactam type such as ampicillin, carbapenem type such as imipenem, aminoglycoside type such as kanamycin, polypeptide type such as vancomycin and macrolide type such as erythromycin.
  • liquid preparations are physiological saline, glucose solution, distilled water for injection, electrolytic solutions, amino acid solutions, fat emulsions, etc.
  • the powder preparations such as antibiotics among the above-mentioned medicinals are necessary to be dissolved in the physiological saline or the glucose solution for injection into a patient when being used. Therefore, there has been recently developed a multi-compartment container having two compartments as shown in FIGS. 6 in order to render their operations simple.
  • FIGS. 6 shows multi-compartment container.
  • the upper compartment thereof accommodates an antibiotic easy to be adversely affected by even a little amount of contaminants, and the lower compartment accommodates a solvent such as physiological saline or glucose solution. Only the upper compartment is double-covered with the cover.
  • FIG. 1 type Using a water-cooled co-extrusion inflation machine, a sealant film was prepared which had a three-layer structure comprising an outermost layer, i.e., a 15- ⁇ m-thick third layer of ethylene-vinyl alcohol copolymer (manufactured by Nihon Goseikagaku Co., Ltd., brand name: SOANOL, 44% in ethylene copolymerization mole ratio, hereinafter referred to as “EVOH (1)”), an intermediate layer, i.e., a 10- ⁇ m-thick second layer of adherent polyethylene (manufactured by Mitsui Petrochemical Industries, Ltd., brand name: ADMER, 0.940 g/cm 3 in density, hereinafter referred to as “PE ( 1 )”), and an innermost layer, i.e., a 40- ⁇ m-thick first layer of linear low-density polyethylene (manufacture
  • Third layer (outermost layer): EVOH (1), 15 ⁇ m in thickness
  • Second layer (intermediate layer): PE(1), 0.940 g/cm 3 in density and 10 ⁇ m in thickness
  • First layer (innermost layer): linear low-density polyethylene (manufactured by Mitsui Petrochemical Industries, Ltd., brand name: ultzex), 0.930 g/cm 3 in density and 40 ⁇ m in thickness
  • Third layer (outermost layer): EVOH (1), 15 ⁇ m in thickness
  • Second layer (intermediate layer): PE(1), 0.940 g/cm 3 and 10 ⁇ m in thickness
  • First layer (innermost layer): linear low-density polyethylene (manufactured by Mitsui Petrochemical Industries, Ltd., brand name: ultzex), 0.920 g/cm 3 in density and 40 ⁇ m in thickness
  • Third layer (outermost layer): EVOH (1), 15 ⁇ m in thickness
  • Second layer adherent polypropylene (manufactured by Mitsui Petrochemical Industries, Ltd., brand name: ADMER), 0.910 g/cm and 10 ⁇ m in thickness
  • First layer (innermost layer): polypropylene (manufactured by Mitsui Petrochemical Industries, Ltd. and sold by Grand Polymer, Ltd., brand name: HIPOL), 0.910 g/cm 3 in density and 40 ⁇ m in thickness
  • Third layer (outermost layer): EVOH (manufactured by Nihon Goseikagaku Co., Ltd., brand name: SOANOL, 38% in ethylene copolymerization mole ratio, hereinafter referred to as “EVOH (2)”), 15 ⁇ m in thickness
  • Second layer adherent polyethylene (manufactured by Mitsui Petrochemical Industries, Ltd., brand name: ADMER, 0.930 g/cm 3 in density)+amorphous polyethylene (manufactured by Mitsui Petrochemical Industries, Ltd., brand name: TAFMER A, 0.880 g/cm 3 in density), 0.9125 g/cm 3 in density and 10 ⁇ m in thickness
  • First layer (innermost layer): linear low-density polyethylene (manufactured by Mitsui Petrochemical Industries, Ltd., brand name: ultzex, 0.940 g/cm 3 in density)+polypropylene (manufactured by Mitsui Petrochemical Industries, Ltd. and sold by Grand Polymer, Ltd., brand name: HIPOL, 0.910 g/cm 3 in density), 0.925 g/cm 3 in density and 40 ⁇ m in thickness
  • Third layer (outermost layer): EVOH (manufactured by Kuraray Co., Ltd., brand name: EVAL type-F, 32% in ethylene copolymerization mole ratio, hereinafter referred to as “EVOH (3)”), 15 ⁇ m in thickness
  • Second layer adherent ethylene-vinyl acetate copolymer (manufactured by Mitsui Petrochemical Industries, Ltd., brand name: ADMER), 0.908 g/cm 3 in density and 10 ⁇ m in thickness
  • First layer (innermost layer): low-density polyethylene (manufactured by Mitsui Petrochemical Industries, Ltd., brand name: MIRASON), 0.908 g/cm 3 in density and 40 ⁇ m in thickness
  • Third layer (outermost layer): EVOH (3), 10 ⁇ m in thickness
  • Second layer adherent polypropylene (manufactured by Mitsui Petrochemical Industries, Ltd., brand name: ADMER, 0.910 g/cm in density)+amorphous polyolefin (manufactured by Mitsui Petrochemical Industries, Ltd., brand name: TAFMER, 0.890 g/cm 3 in density), 0.909 g/cm 3 in density and 10 ⁇ m in thickness
  • First layer innermost layer: polypropylene (manufactured by Mitsui Petrochemical Industries, Ltd. and sold by Grand Polymer, Ltd., brand name: HIPOL), 0.910 g/cm 3 in density and 40 ⁇ m in thickness
  • Third layer (outermost layer): EVOH (manufactured by Kuraray Co., Ltd., brand name: EVAL, 44% in ethylene copolymerization mole ratio, hereinafter referred to as “EVOH (4)”), 10 ⁇ m in thickness
  • Second layer intermediate layer: the same as in Embodiment 7, 0.909 g/cm3 in density and 20 ⁇ m in thickness
  • First layer (innermost layer): the same as in Embodiment 7, 0.910 g/cm 3 in density and 40 ⁇ m in thickness
  • Embodiments 1 to 8 were prepared by water-cooled co-extrusion inflation with a flat width of 420 mm (Ex. 1), 450 mm (Ex. 2), 500 mm (Ex. 3), 540 mm (Ex. 4), 680 mm (Ex. 5), 800 mm (Ex. 6), 1080 mm (Ex. 7) and 1100 mm (Ex. 8) and Comparative Example 1 were prepared by water-cooled co-extrusion inflation with a flat width of 540 mm.
  • the film take-off speed for Embodiments 1, 2 and 7, and Comparative Example 1 was 7 to 10 m/min, and the film take-off speed for Embodiments 3 to 6 and 8 was 9 to 15 m/min.
  • the base film Y given below was united to the sealant films of Embodiment 1 and Comparative Example 1 over the outer layer thereof to obtain films as Embodiment 1Y and Comparative Example 1Y. (The dry lamination process was used for Embodiment 1, and heat-sealing means for Comparative Example 1.)
  • the oriented nylon (ONy) film, polyethylene terephthalate (PET) film and low-density polyethylene (LDPE) film for constituting the base films, and the urethane-epoxy resin (adhesive) for use in dry lamination were all those generally available commercially.
  • Embodiments 1X-8X, Embodiment 1Y, Comparative Example 1Y and Comparative Example 1Z were used for making medical containers wherein the sealant film served as the innermost layer, and the containers were tested by the following contamination experiments.
  • Contamination Experiment 1 DOP, di-n-butyl phthalate (DNBP) and diethyl phthalate (DEP) used as contaminants were applied by coating or spraying to the outer surface of the medical container (externally measuring 10 cm ⁇ 10 cm) which was filled with 1 g (potency) of cephazolin sodium (CEZ), and thereafter preserved at 40° C. and 75% RH (relative humidity) for 3 months.
  • CEZ cephazolin sodium
  • the CEZ filled in was checked for the migration of the contaminants by GLC (Gas Liquid Chromatography) and the GC-MS (Gas Liquid chromatography-Mass Spectrography) method.
  • Contamination Experiment 2 After a die rust inhibitor (KG type, manufactured by Kobe Gosei Co., Ltd.) was sprayed onto the outer surface of the medical container as filled with 1 g (potency) of CEZ, it was preserved under the condition of 40° C. in temperature and 75% in RH for two weeks. Then, it was checked whether contaminants were migrated into the filled CEZ by GLC and the GC-MS method.
  • a die rust inhibitor KG type, manufactured by Kobe Gosei Co., Ltd.
  • the sealant film used for comparative examples i.e., the single-layer film of L-LDPE (1), was checked for contamination by cutting out a piece approximately 1 cm square from the film, subjecting 2 g of the piece to extraction with 150 ml of n-hexane as purified by distillation, concentrating the extract to dryness and dissolving again the dry solid in the n-hexane purified by distillation and analyzing it by GLC and the GC-MS method, whereby the film was found totally free from any contaminants.
  • Carrier gas He 4.0 kg/cm
  • CAP Caprolactam
  • EPO epoxy compound
  • Rust inhibitor components The peak obtained by analyzing the inhibitor alone is compared with the retention time of fragment data. Meanings of the symbols in Tables 1 and 2:
  • the present invention provides medical multilayer sealant films retaining satisfactory heat-sealing properties.
  • Use of films including the sealant film affords medical containers, packaging bags and covers which effectively prevent contamination.
  • the sealant film obtained according to the above forming method has an increased lay flat width of 420 mm, 450 mm, 500 mm, 540 mm, 680 mm, 800 mm, 1080 mm and 1100 mm and the film take-off speed is set to be relatively high, i.e., 7-15 m/min, there occurs no wrinkle in the obtained film at all, thereby obtaining improved film formability.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Laminated Bodies (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Wrappers (AREA)
  • Sealing Material Composition (AREA)
  • Packages (AREA)
  • Materials For Medical Uses (AREA)
  • Beans For Foods Or Fodder (AREA)
  • Control And Other Processes For Unpacking Of Materials (AREA)
  • Perforating, Stamping-Out Or Severing By Means Other Than Cutting (AREA)
US08/796,755 1994-03-15 1997-02-06 Medical multilayer sealant films and methods for producing the same Abandoned US20010008686A1 (en)

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CN104608450A (zh) * 2015-01-15 2015-05-13 上海迈高新材料科技有限公司 内带,制造内带的方法及使用内带的包装容器
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US7037968B2 (en) 2001-01-29 2006-05-02 Glucd Ltd Adhesive
WO2003055943A2 (en) * 2001-12-27 2003-07-10 Showa Denko Plastic Products Co., Ltd. Resin composition, and container packaging film, container packaging bag and container package using the resin composition
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US20090299324A1 (en) * 2005-11-29 2009-12-03 Fujio Inoue Multichamber Bag and Gas Barrier Film
CN104608450A (zh) * 2015-01-15 2015-05-13 上海迈高新材料科技有限公司 内带,制造内带的方法及使用内带的包装容器
US20210275470A1 (en) * 2020-03-06 2021-09-09 Baxter International Inc. Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation
US20230181495A1 (en) * 2020-03-06 2023-06-15 Baxter International, Inc. Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation
WO2023183511A1 (en) * 2022-03-25 2023-09-28 Tidi Products, Llc Single use, elongated tubular sleeve for medical or dental instrument

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EG20610A (en) 1999-09-30
EP0698487A4 (de) 1997-08-27
DK0698487T3 (da) 2005-06-06
CN1128005A (zh) 1996-07-31
DE69534195D1 (de) 2005-06-16
DE69534195T2 (de) 2006-02-16
EP0698487A1 (de) 1996-02-28
CA2162123A1 (en) 1995-09-21
WO1995025010A1 (fr) 1995-09-21
KR100318654B1 (ko) 2002-06-27
ATE295260T1 (de) 2005-05-15
ES2239318T3 (es) 2005-09-16
US20030124329A1 (en) 2003-07-03
CN1636712A (zh) 2005-07-13
TW296355B (de) 1997-01-21
CN1636712B (zh) 2010-07-28
CA2162123C (en) 2003-12-02
JP3263738B2 (ja) 2002-03-11
US6773775B2 (en) 2004-08-10
AU691261B2 (en) 1998-05-14
AU1862695A (en) 1995-10-03

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