EP2582402A1 - Conditionnement comprenant un contenu stérilisé - Google Patents

Conditionnement comprenant un contenu stérilisé

Info

Publication number
EP2582402A1
EP2582402A1 EP11724661.1A EP11724661A EP2582402A1 EP 2582402 A1 EP2582402 A1 EP 2582402A1 EP 11724661 A EP11724661 A EP 11724661A EP 2582402 A1 EP2582402 A1 EP 2582402A1
Authority
EP
European Patent Office
Prior art keywords
package
mvtr
layer
day
wall
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP11724661.1A
Other languages
German (de)
English (en)
Inventor
Pascal Maria Hubert Pierre Tijssen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
DSM IP Assets BV
Original Assignee
DSM IP Assets BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by DSM IP Assets BV filed Critical DSM IP Assets BV
Priority to EP11724661.1A priority Critical patent/EP2582402A1/fr
Publication of EP2582402A1 publication Critical patent/EP2582402A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06114—Packages or dispensers for needles or sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B2050/314—Flexible bags or pouches
    • 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
    • A61J1/16—Holders for containers

Definitions

  • the invention relates to a package comprising a sterilized content, the package having at least one layer of a polymer composition.
  • Such a package is known from EP-398316, wherein a package for the storage of a medical container holding a medical fluid is described.
  • containers include blood bags containing a solution of an anticoagulant or transfusion bags, containing a transfusion solution, the solution for example comprising nutrition components or a medicament.
  • the package contains a suture, a combination of a suture and a needle or even one or more medical instruments.
  • EP-398316 A problem with the package of EP-398316 is that during the sterilization water penetrates through the package wall into the package. After cooling down the water is present as water drops. It is however highly unwanted that the content, for example a blood bag or an instrument is wet when taken out of the package. This is because it gives the impression to personnel handling the bag and the content, that the bag was not properly sealed and that the content is not sterile.
  • a package consisting of a multi-layer polymer film structure, wherein one of the layers has barrier properties for water.
  • the package is complicated, because of the multi-layer structure. Further it is still possible that water is present in the package, for example water of the solution of the anticoagulant, that penetrates trough the wall of a blood bag that is stored in the package.
  • JP-5084281 a package for sterilization of blood bags is proposed consisting of two compartments having a membrane between the two compartments.
  • a blood bag is placed in one of the compartments and that compartment is closed.
  • the blood bag and the package are sterilized in a steam atmosphere and steam penetrates in the open compartment of the package and through the membrane into the closed compartment comprising the blood bag.
  • the package is kept for a period of several hours at an elevated temperature to remove the water again from the package through the membrane and the opening of the second compartment. Finally the second compartment is closed as well.
  • packages having a non-woven porous fleece as package wall are used. These walls have a high permeability for water, so that after the sterilization the content of the package may be dried easily. However there is insufficient guarantee that the package provides a full barrier small bacteria and viruses.
  • Object of the invention is to provide a package for sterilization and storage of a content that is simple and allows a straightforward sterilization process.
  • MVTR moisture vapor transmission rate
  • the package contains only one compartment and no extra barrier layer is needed in the package. Furthermore the sterilization process is very simple and straightforward.
  • the content for example a blood bag, is placed in the package and the package is closed.
  • the package may be placed in an autoclave and is sterilized with steam. Because of the limited permeability and the relative short time wherein the sterilization takes place only a very limited amount of water penetrates into the package. After sterilization, because of the permeability for water vapor, a drying step under mild conditions fulfills to release the water from the package. It might even be possible that, if stored in a relatively dry room, the water is released from the package, without special treatment.
  • the MVTR is at least 125 g/m 2 .day, more preferably at least 150 g/m 2 .day, even more preferably at least 175 g/m 2 .day.
  • the MVTR is at most 1250 g/m 2 .day, more preferably at most 1000 g/m 2 .day, even more preferably at most 750 g/m 2 .day, most preferably at most 500 g/m 2 .day.
  • a part of the container wall has an MVTR different from the value defined above.
  • part of the wall has a MVTR that is lower than the MVTR defined above.
  • the entire wall of the package has the same structure and composition, so that the MVTR has the same or about the same value for the whole of the container.
  • the package might be a container, for example as disclosed in EP- 398316.
  • the package is a bag. This is because a bag fulfills in general the demands posed on the package during sterilization, transport and storage and a bag is easy to produce from all kind of polymer compositions.
  • Polymers that are suitable for use in the package wall according to the invention include polyamides, for example PA-6, PA-66, PA-666.
  • the polymer is a polar thermoplastic elastomer.
  • thermoplastic elastomer is a rubbery material with the processing characteristics of a conventional thermoplastic and below its melting or softening temperature the performance properties of a conventional thermoset rubber.
  • Thermoplastic elastomers are described in Handbook of Thermoplastic Elastomers, second edition, Van Nostrand Reinhold, New York (ISBN 0-442-29184-1 ).
  • the polar thermoplastic elastomer preferably contains oxygen (O) and/or nitrogen (N) atoms.
  • O oxygen
  • N nitrogen
  • the polar thermoplastic elastomer contains at least one N or one O atom at every 8 C atoms, preferably at every 6 C-atoms, more preferably at every 4 C atoms.
  • Good examples of polar groups contained in the polar thermoplastic elastomer are -NH-, -O- , -COO-, and -CO-NH- groups.
  • polar thermoplastic elastomers are polyester based thermoplastic elastomers, polyamide based thermoplastic elastomers and polyurethanes.
  • polyester based thermoplastic elastomers include polyetherester elastomers, polyurethane ester elastomers, polycarbonate ester elastomers.
  • thermoplastic copolyetherester elastomers are used.
  • the thermoplastic copolyetherester elastomer suitably contains hard segments that are built up from repeating units derived from at least one alkylene diol and at least one aromatic dicarboxylic acid or an ester thereof. As alternative to segment, also the term block is being used.
  • the alkylene diol may be a linear or a cycloaliphatic alkylene diol.
  • the linear or cycloaliphatic alkylene diol contains generally 2-6 C-atoms, preferably 2-4 C-atoms. Examples thereof include ethylene glycol, propylene diol and butylene diol.
  • propylene diol or butylene diol are used, more preferably 1 ,4-butylene diol.
  • Suitable aromatic dicarboxylic acids include terephthalic acid, 2,6-naphthalenedicarboxylic acid, 4,4'-biphenyldicarboxylic acid or combinations of these.
  • the advantage thereof is that the resulting polyester is generally semi-crystalline with a melting point of above 150, preferably above 175, and more preferably of above 190°C.
  • the hard segments may optionally further contain a minor amount of units derived from other dicarboxylic acids, for example isophthalic acid, which generally lowers the melting point of the polyester.
  • the amount of other dicarboxylic acids is preferably limited to not more than 10 mol%, more preferably not more than 5 mol%, so as to ensure that, among other things, the crystallization behaviour of the copolyetherester is not adversely affected.
  • the hard segment is preferably built up from ethylene terephthalate, propylene terephthalate, and in particular from butylene terephthalate as repeating units. Advantages of these readily available units include favourable crystallisation behaviour and a high melting point, resulting in copolyetheresters with good processing properties, excellent thermal and chemical resistance and good puncture resistance.
  • Suitable aliphatic polyether soft segments in the thermoplastic copolyetherester elastomer are flexible polyethers that are substantially amorphous and have a glass-transition temperature (T g ) of below 0°C.
  • T g glass-transition temperature
  • the T g is below - 20 °C, more preferably below -40, and most preferably below -50 °C.
  • the molar mass of the segments may vary within a wide range, but preferably the molar mass is chosen between 400 and 6000, more preferably between 500 and 4000, and most preferably between 750 and 3000 g/mol.
  • Suitable aliphatic polyethers include a poly(alkylene oxide)diol derived from an alkylene oxide of 2-6 C-atoms, preferably 2-4 C-atoms, or combinations thereof. Examples include poly(ethylene oxide)diol, poly(tetramethylene oxide)diol or poly(tetrahydrofuran)diol, poly(neopentylene oxide-co-tetramethylene oxide)diol and polypropylene oxide)diol. In one preferred embodiment the
  • thermoplastic polyetherester elastomer contains as polyether segments ethylene oxide- terminated poly(propylene oxide)diol segments.
  • thermoplastic copolyetherester elastomer contains chain branching agents.
  • Suitable chain branching agents include e.g. trimellitic acid, trimellitic acid anhydride and trimethylol propane.
  • the amount and type of chain extension or branching agent is chosen such that a block copolyester of desirable melt viscosity is obtained. In general, the amount of a chain branching agent will not be higher than 6.0 equivalents per 100 moles of dicarboxylic acids presenting the copolyetherester.
  • the copolyetherester can further contain the usual catalysts and stabilisers.
  • copolyetheresters are for example described in Handbook of Thermoplastics, ed. O.OIabishi, Chapter 17, Marcel Dekker Inc., New York 1997, ISBN 0-8247-9797-3, in Thermoplastic Elastomers, 2nd Ed, Chapter 8, Carl Hanser Verlag (1996), ISBN 1 -56990-205-4, in Encyclopedia of Polymer Science and Engineering, Vol. 12, Wiley & Sons, New York (1988), ISBN 0-471 -80944, p.75-1 17, and the references cited therein.
  • copolyetherester with hard segments built up from butylene terephthalate units and soft segments derived from ethylene oxide- terminated polypropylene oxide)diol.
  • the copolyetherester elastomer has been subjected to a post condensation process.
  • Post condensation of the elastomer is a suitable and economic way of obtaining a high molecular weight, resulting in an elastomer having the desired viscosity, necessary for obtaining the good processability of the
  • composition to obtain the tubular film according to the invention.
  • Most suitable is solid state post condensation.
  • the solid copolyetherester elastomer is heated to about 10 - 20 Q C below its melting point in a tumble dryer. A vacuum is applied to remove condensation products from the elastomer.
  • the package wall might be of a multilayer structure.
  • the package wall is of a two layer structure, a first layer that is a base layer containing one or more of the polymers described above and a second layer of a polymer composition being capable of sealing the bag.
  • a polymer being capable of sealing the bag include PA-6,6.6, polyvinyl acetate (PVAc), copolymers of ethylene with PA-6,6.6, polyvinyl acetate (PVAc), copolymers of ethylene with
  • (meth)acrylates or vinyl alcohol. These polymers also provide a layer with a suitable MVTR, so that the MVTR of the entire package wall is in the desired area.
  • the second layer preferably is thinner than the first layer and the composition of the second layer preferably has a melting point of 20 Q C, more preferably of 30 Q below the melting point of the composition of the base layer. Sealing is normally carried out by applying heat and pressure to the package.
  • the package wall is a one layer structure, so that the package wall consists of the base layer.
  • the package for example has to be closed by welding or by a applying a sealing agent.
  • the package wall next to the base layer an outer layer of a polymer composition capable of acting as anti-blocking layer to prevent packages to stick together during storage of the package.
  • a good example of an antiblocking layer is a layer of PBT or PA-6.
  • PA-6 is used in the anti-blocking layer.
  • the MVTR of the package wall increases with decreasing thickness of the layers. However in choosing the thickness of the layer is also important to consider the other functions of the layer. If the base layer becomes to thin, the package wall might loose its strength.
  • a suitable thickness for the base layer therefore is between 20 and 80 microns, preferably between 30 and 60 microns.
  • the thickness of the layer capable of sealing the package may be between 10 and 30 microns, the antiblocking layer may be between 5 and 15 microns.
  • the base layer of the packaging according to the invention consists preferably of a blend of PA-6 and a thermoplastic copolyetherester preferably in a ratio PA-6: thermoplastic copolyetherester of between 90 : 10 and 50 : 50.
  • the blend may contain non-polymeric additives.
  • a base layer of such a blend is very strong, has the desired MVTR and has good-anti-blocking properties, so that a special anti-blocking layer is not necessary any more.
  • the bags may for example be produced by blowing a film and cutting and welding the blown film into bags.
  • Another possibility is the produce a film with a slit die, to weld the films into a tubular film and to produce in the same manner the bags by cutting and welding.
  • Sterilization process may comprise the step of placing the content to be sterilized into the package, sterilizing the package and its content in a steam autoclave, drying of the package and its content by a heat treatment.
  • a drying time of less than 5 hours is regarded to be an acceptable drying time. Longer drying times are giving logistical and economic drawbacks.
  • strerilization is carried out by using a gas, for example ethylene oxide gas.
  • composition 2 Arnitel® VT3108 (co-polyether-ester)
  • composition 3 blend of 90% Akulon® S240C (polyamide 6,6) + 10%
  • composition 4 blend of 70% Akulon® F136 (polyamide 6) + 30% Arnitel® VT3108
  • composition 5 Akulon® F136
  • composition A Arnite® A02 306 (poly-ethylene- terephthalate)
  • composition B BOPP (Bi-axial-Oriented-PolyPropylene)
  • Polymer compositions 1 - 6 are available from DSM Engineering Plastics and composition 7 was a standard BOPP film.

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Food Science & Technology (AREA)
  • Packages (AREA)
  • Laminated Bodies (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

L'invention concerne un conditionnement comprenant un contenu stérilisé et qui est caractérisé en ce qu'au moins une partie de la paroi du conditionnement présente une valeur d'étanchéité à la vapeur d'eau (MVTR) comprise entre 100 et 1500 g/m2.jour, mesurée selon la procédure B d'ASTM E96/E96M-05, à 38°C et à une humidité relative de 50%.
EP11724661.1A 2010-06-16 2011-06-14 Conditionnement comprenant un contenu stérilisé Withdrawn EP2582402A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP11724661.1A EP2582402A1 (fr) 2010-06-16 2011-06-14 Conditionnement comprenant un contenu stérilisé

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP10166109 2010-06-16
PCT/EP2011/059836 WO2011157705A1 (fr) 2010-06-16 2011-06-14 Conditionnement comprenant un contenu stérilisé
EP11724661.1A EP2582402A1 (fr) 2010-06-16 2011-06-14 Conditionnement comprenant un contenu stérilisé

Publications (1)

Publication Number Publication Date
EP2582402A1 true EP2582402A1 (fr) 2013-04-24

Family

ID=42617408

Family Applications (1)

Application Number Title Priority Date Filing Date
EP11724661.1A Withdrawn EP2582402A1 (fr) 2010-06-16 2011-06-14 Conditionnement comprenant un contenu stérilisé

Country Status (5)

Country Link
US (1) US20130206634A1 (fr)
EP (1) EP2582402A1 (fr)
JP (1) JP2013534885A (fr)
CN (1) CN102946909A (fr)
WO (1) WO2011157705A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017502884A (ja) * 2013-12-18 2017-01-26 ディーエスエム アイピー アセッツ ビー．ブイ． フィルムに包まれた生鮮食品製品
CN106457795A (zh) * 2014-06-27 2017-02-22 帝斯曼知识产权资产管理有限公司 包含新鲜食物产品的包装件
US10350047B2 (en) 2015-09-02 2019-07-16 Edwards Lifesciences Corporation Method and system for packaging and preparing a prosthetic heart valve and associated delivery system
US10357351B2 (en) 2015-12-04 2019-07-23 Edwards Lifesciences Corporation Storage assembly for prosthetic valve
JP6930255B2 (ja) * 2017-07-06 2021-09-01 大日本印刷株式会社 バリア性積層体および輸液バッグ用外装袋
JP7818886B2 (ja) * 2019-10-10 2026-02-24 信越ポリマー株式会社 結露水付着用の包装用フィルム

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JPS58192551A (ja) 1982-05-06 1983-11-10 テルモ株式会社 医療用容器の保存用包装容器
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JPH0584281A (ja) 1991-09-25 1993-04-06 Kawasumi Lab Inc 医療容器の高圧蒸気滅菌方法
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Also Published As

Publication number Publication date
CN102946909A (zh) 2013-02-27
JP2013534885A (ja) 2013-09-09
US20130206634A1 (en) 2013-08-15
WO2011157705A1 (fr) 2011-12-22

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