WO2006072310A1 - Procede de reticulation permettant de produire des tubes de port multicouches qui peuvent etre sterilises a la vapeur - Google Patents

Procede de reticulation permettant de produire des tubes de port multicouches qui peuvent etre sterilises a la vapeur Download PDF

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Publication number
WO2006072310A1
WO2006072310A1 PCT/EP2005/013075 EP2005013075W WO2006072310A1 WO 2006072310 A1 WO2006072310 A1 WO 2006072310A1 EP 2005013075 W EP2005013075 W EP 2005013075W WO 2006072310 A1 WO2006072310 A1 WO 2006072310A1
Authority
WO
WIPO (PCT)
Prior art keywords
crosslinking
port
cross
layer
cooling
Prior art date
Application number
PCT/EP2005/013075
Other languages
German (de)
English (en)
Inventor
Stefan Eibl
Jörg Müller
Original Assignee
Rehau Ag + Co
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 Rehau Ag + Co filed Critical Rehau Ag + Co
Publication of WO2006072310A1 publication Critical patent/WO2006072310A1/fr

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
    • B29C35/02—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
    • B29C35/08—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation
    • B29C35/10—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation for articles of indefinite length
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • B29C48/10—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels flexible, e.g. blown foils
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/90—Thermal treatment of the stream of extruded material, e.g. cooling with calibration or sizing, i.e. combined with fixing or setting of the final dimensions of the extruded article
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
    • B29C35/02—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
    • B29C35/08—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation
    • B29C35/0805—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation using electromagnetic radiation
    • B29C2035/0827—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation using electromagnetic radiation using UV radiation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
    • B29C35/16—Cooling
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/16—Articles comprising two or more components, e.g. co-extruded layers
    • B29C48/18—Articles comprising two or more components, e.g. co-extruded layers the components being layers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/90—Thermal treatment of the stream of extruded material, e.g. cooling with calibration or sizing, i.e. combined with fixing or setting of the final dimensions of the extruded article
    • B29C48/901—Thermal treatment of the stream of extruded material, e.g. cooling with calibration or sizing, i.e. combined with fixing or setting of the final dimensions of the extruded article of hollow bodies
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/911—Cooling
    • B29C48/9115—Cooling of hollow articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0018—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds having particular optical properties, e.g. fluorescent or phosphorescent
    • B29K2995/0026—Transparent
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2009/00—Layered products
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2023/00—Tubular articles
    • B29L2023/005—Hoses, i.e. flexible
    • B29L2023/007—Medical tubes other than catheters

Definitions

  • the present invention relates to a crosslinking process for the production of steam-sterilizable multilayered port hoses.
  • Port hoses are extruded as multilayer tubing.
  • the outer layer has the necessary compatibility with the container material. This ensures a good weldability between the port hose and the container, which prevents bursting of the bond between the port hose and the container during steam sterilization in the autoclave.
  • the outer layer ensures good compatibility with the container material
  • the underlying layers are characterized not only by high transparency but also by high flexibility. This flexibility is required to substantially prevent kinking of connectors and / or infusion tubes that are inserted into the port tubes.
  • ionizing radiation is gamma radiation and / or electron radiation.
  • the crosslinking with ionizing radiation takes place after the extrusion in a separate manufacturing step.
  • Port hoses are packaged in polyethylene bags to protect them from microbial germs after extrusion as bundle goods. These bags are transported on pallets through an irradiation facility. Due to the bundling into lots, different degrees of crosslinking are observed as a function of the position relative to the radiation source and / or penetration depth of the radiation. Distal parts have a lower degree of cross-linking, in contrast to parts that are passed relatively close to the radiation source.
  • the high-energy ⁇ -irradiation leads to a high degree to a cleavage of acetic acid from the vinyl acetate portion of the EVA copolymer.
  • This released acetic acid has particularly negative effects on infusion solutions by reducing the pH. Especially in unbuffered solutions, the pH can thereby drift outside the specification limits.
  • the object of the invention is therefore to provide a crosslinking process by which the disadvantages of the prior art in the production of steam-sterilizable multilayer port tubes are remedied by ionizing radiation.
  • the solution of the problem is achieved in that at least one layer of the multilayered inner tube arranged inside is crosslinked by UV radiation.
  • the crosslinking in the extrusion section is carried out continuously in one step, ie in a process referred to here as "inline", in one step.
  • the extrusion line consists of individual production facilities, which are arranged in series one behind the other.
  • These production facilities comprise at least two extruders with a coextrusion tool, at least one calibrating and cooling device, at least one UV radiation source, as well as a withdrawal unit and optionally further devices for cutting, collecting, marking, counting and packaging, etc. of the port tubes thus produced.
  • the coextrusion tool is designed so that a multi-layered hose can be produced.
  • two extruders are used, and accordingly three extruders are used for the production of three-layered port hoses.
  • the associated devices for forming a hose are designed as coextrusion tools correspondingly so that two-layered or three-layered hoses can be produced.
  • the at least one UV radiation source is arranged in the extrusion direction downstream of the coextrusion tool and downstream of the at least one calibration and cooling unit.
  • the multi-layered port tube is exposed to UV radiation.
  • the UV radiation sources emit UV light in the wavelength range 10 nm ⁇ ⁇ 400 nm. According to the invention, UV radiation sources are used which emit monochromatic UV light and / or polychromatic UV light.
  • the in-line UV cross-linking process which can be carried out in one step, in combination with coextrusion offers the advantage that it is possible to selectively crosslink individual layers of the port tube.
  • UV absorbers UV absorbers
  • crosslinking enhancers are added to the polymer material of the layer of the port tube to be crosslinked, whereby crosslinking of the polymer material takes place under the influence of UV radiation.
  • a selective crosslinking of at least one internally arranged layer of the port tube can be achieved with the present method.
  • the UV radiation selectively cross-links in the inner layer of the port tube, which may be the inner layer that defines the lumen in the tube, or an intermediate layer that lies between the outer tube layer and the lumen limiting layer.
  • the latter can be advantageous, for example, in the case of three-layered port hoses, if an intermediate layer which is to lie between the outer layer of the port hose and the inner layer, which delimits the inner lumen, and should be networked.
  • the interlayer and the inner layer to be crosslinked in the case of a three-layered tube.
  • the networking of an internally arranged layer of a port tube is homogeneous, uniform, reproducible and fast, the entire wall thickness of the layer to be crosslinked is detected.
  • a port hose with properties tailored to the respective requirements can advantageously be produced cost-effectively in an in-line method, the aforementioned disadvantages of the prior art being avoided.
  • the degree of crosslinking and / or crosslinking distribution can be controlled by the addition of UV active substances to the polymer material of the layer to be crosslinked and by conducting the crosslinking process.
  • the material of the inner and / or intermediate layer softens for a short time.
  • the UV crosslinking process according to the invention during vapor sterilization prevents dripping of the flexible and transparent inner and / or intermediate layer.
  • the sequence of cooling device / calibration device, followed by the UV radiation source advantageously ensures that the temperature of the port tube can be kept below 120 ° C. when the UV radiation acts for crosslinking. This is preferably achieved in that the extrusion tool is assigned directly to a cooling / calibrating device, which lowers the temperature of the port hose by cooling.
  • the crosslinking is carried out so that the port tube has a temperature of less than 80 0 C, preferably from 50 to 70 0 C, when the UV radiation is applied.
  • the degree of crosslinking of the layer to be crosslinked can advantageously be increased without the tube being subjected to a high thermal load.
  • a high dimensional accuracy of the port tube can advantageously be achieved by the multiple calibration.
  • the extrusion speed can be selected between 5 and 80 m / min.
  • the port tube then passes through the cooling and calibration device (s) and UV radiation source (e ⁇ ).
  • the degree of crosslinking can be controlled according to the invention by the number, type and sequence of cooling and calibration devices and UV radiation sources in the range from 50 to 80%.
  • the following examples show a section of the possibilities according to the invention of UV crosslinking of steam-sterilizable port hoses. These embodiments are not restrictive.
  • Example 1 two-layer hose
  • Outer layer Mixture of polypropylene and ethylene-propylene copolymer
  • Inner layer 100% by weight of ethylene vinyl acetate (EVA) (crosslinking) 1.5% by weight of photoinitiator (benzophenone derivative) 1.5% by weight of crosslinking enhancer triallyl cyanurate (TAC)
  • EVA ethylene vinyl acetate
  • photoinitiator benzophenone derivative
  • TAC crosslinking enhancer triallyl cyanurate
  • Example 2 Three-layer hose
  • Outer layer Mixture of polypropylene and ethylene-propylene copolymer and thermoplastic elastomer
  • Interlayer 100 weight percent polyolefin elastomer (POE) (to be crosslinked) 2 weight percent photoinitiator (benzophenone derivative) 1.5 weight percent cross-linking enhancer triallyl cyanurate
  • Inner layer Mixture of polypropylene and ethylene-propylene copolymer and thermoplastic elastomer
  • Outer layer Mixture of polypropylene and ethylene-propylene copolymer
  • Interlayer 100 weight percent ethylene-methyl acrylate copolymer (to be crosslinked) (EMA)

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  • Physics & Mathematics (AREA)
  • Thermal Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Toxicology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Extrusion Moulding Of Plastics Or The Like (AREA)

Abstract

La présente invention concerne un procédé de réticulation permettant de produire des tubes de port extrudés multicouches qui peuvent être stérilisés à la vapeur. Ces tubes sont constitués d'au moins une couche extérieure transparente et soudable et d'une couche transparente et souple, placée à l'intérieur. Selon cette invention, au moins une couche placée à l'intérieur est réticulée au moyen d'un rayonnement UV. La réticulation par UV est réalisée en ligne dans la voie d'extrusion après formage du tube de port. La vitesse d'extrusion est choisie entre 5 et 80 m/min. La température du tube de port formé à réticuler est maintenue inférieure à 120 °C lors de la réticulation et le degré de réticulation est commandé par le nombre, le type et la séquence de dispositifs de refroidissement et de calibrage et de sources de rayonnement UV, dans une plage située entre 50 et 80 %.
PCT/EP2005/013075 2004-12-23 2005-12-07 Procede de reticulation permettant de produire des tubes de port multicouches qui peuvent etre sterilises a la vapeur WO2006072310A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102004061986A DE102004061986A1 (de) 2004-12-23 2004-12-23 Vernetzungsverfahren zur Herstellung von dampfsterilisierbaren mehrschichtigen Portschläuchen
DE102004061986.7 2004-12-23

Publications (1)

Publication Number Publication Date
WO2006072310A1 true WO2006072310A1 (fr) 2006-07-13

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2005/013075 WO2006072310A1 (fr) 2004-12-23 2005-12-07 Procede de reticulation permettant de produire des tubes de port multicouches qui peuvent etre sterilises a la vapeur

Country Status (3)

Country Link
DE (1) DE102004061986A1 (fr)
TW (1) TW200635736A (fr)
WO (1) WO2006072310A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7744803B2 (en) 2006-08-02 2010-06-29 Shawcor Ltd. Photo-crosslinkable polyolefin compositions

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102006032751A1 (de) * 2006-07-14 2008-01-31 Veritas Ag Flexibler Schlauch
LT2992044T (lt) 2013-05-03 2022-03-25 Uponor Innovation Ab Poliolefino vamzdis
GB2525453A (en) 2014-04-23 2015-10-28 Uponor Innovation Ab Polyolefin pipe

Citations (6)

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Publication number Priority date Publication date Assignee Title
EP0380270A2 (fr) * 1989-01-23 1990-08-01 W.R. Grace & Co.-Conn. Tube flexible pour solution médicale
US5538512A (en) * 1993-02-25 1996-07-23 Zenzon; Wendy J. Lubricious flow directed catheter
US6291543B1 (en) * 2000-05-24 2001-09-18 Polyzen, Inc. Surfacially cross-linked elastoplastic articles, and method of making the same
EP1184154A1 (fr) * 2000-08-31 2002-03-06 Tokai Rubber Industries, Ltd. Procédé pour la fabrication d'un tuyau de carburant et composition réticulable par UV à base d' EPDM
US20030125710A1 (en) * 2001-12-27 2003-07-03 Scimed Life Systems, Inc. Catheter incorporating a curable polymer layer to control flexibility and method of manufacture
US6663646B1 (en) * 2000-10-24 2003-12-16 Tilak M. Shah Isotropically expansible balloon articles useful in in vivo lumenal procedures, and method of making such balloon articles

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Publication number Priority date Publication date Assignee Title
US4401536A (en) * 1979-08-10 1983-08-30 Delmed, Inc. Biocompatible, steam-sterilizable irradiated articles comprised of ethylene copolymer and polypropylene blends
DE3131812C2 (de) * 1981-08-12 1983-06-16 Hewing GmbH & Co, 4434 Ochtrup Verfahren zur Herstellung von Formlingen aus durch Bestrahlen mit Elektronenstrahlen vernetzten Polyolefin-Formmassen
US4643926A (en) * 1985-04-29 1987-02-17 W. R. Grace & Co., Cryovac Div. Flexible medical solution pouches
EP0921921B2 (fr) * 1995-09-20 2007-04-04 Uponor Wirsbo AB Procede de chauffage et/ou de reticulation de polymeres et dispositif associe
DE19719593C2 (de) * 1997-05-09 2003-10-30 Rehau Ag & Co Polymermischungen
DE10004633A1 (de) * 2000-02-03 2001-08-09 Gerodur Mpm Kunststoffverarbei Verfahren zur Herstellung von Halbzeugen aus vernetzbaren Kunststoffen
DE10314547A1 (de) * 2002-04-19 2003-11-20 Murata Machinery Ltd Parallelmanipulator und Vorrichtung zu seiner Steuerung

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0380270A2 (fr) * 1989-01-23 1990-08-01 W.R. Grace & Co.-Conn. Tube flexible pour solution médicale
US5538512A (en) * 1993-02-25 1996-07-23 Zenzon; Wendy J. Lubricious flow directed catheter
US6291543B1 (en) * 2000-05-24 2001-09-18 Polyzen, Inc. Surfacially cross-linked elastoplastic articles, and method of making the same
EP1184154A1 (fr) * 2000-08-31 2002-03-06 Tokai Rubber Industries, Ltd. Procédé pour la fabrication d'un tuyau de carburant et composition réticulable par UV à base d' EPDM
US6663646B1 (en) * 2000-10-24 2003-12-16 Tilak M. Shah Isotropically expansible balloon articles useful in in vivo lumenal procedures, and method of making such balloon articles
US20030125710A1 (en) * 2001-12-27 2003-07-03 Scimed Life Systems, Inc. Catheter incorporating a curable polymer layer to control flexibility and method of manufacture

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7744803B2 (en) 2006-08-02 2010-06-29 Shawcor Ltd. Photo-crosslinkable polyolefin compositions
US7923121B2 (en) 2006-08-02 2011-04-12 Shawcor Ltd. Photo-crosslinkable polyolefin compositions

Also Published As

Publication number Publication date
TW200635736A (en) 2006-10-16
DE102004061986A1 (de) 2006-07-06

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