WO2014076717A1 - Utilisation de pvc en vue de la fabrication de récipients stérilisables - Google Patents

Utilisation de pvc en vue de la fabrication de récipients stérilisables Download PDF

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Publication number
WO2014076717A1
WO2014076717A1 PCT/IT2012/000345 IT2012000345W WO2014076717A1 WO 2014076717 A1 WO2014076717 A1 WO 2014076717A1 IT 2012000345 W IT2012000345 W IT 2012000345W WO 2014076717 A1 WO2014076717 A1 WO 2014076717A1
Authority
WO
WIPO (PCT)
Prior art keywords
derivatives
formulated product
pvc
esters
mercapturic
Prior art date
Application number
PCT/IT2012/000345
Other languages
English (en)
Inventor
Marco TOSCANO
Andrea ZANICHELLI
Original Assignee
RESILIA S.r.l.
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 RESILIA S.r.l. filed Critical RESILIA S.r.l.
Priority to PCT/IT2012/000345 priority Critical patent/WO2014076717A1/fr
Priority to EP12818939.6A priority patent/EP2920242A1/fr
Publication of WO2014076717A1 publication Critical patent/WO2014076717A1/fr

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L27/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers
    • C08L27/02—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L27/04—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment containing chlorine atoms
    • C08L27/06—Homopolymers or copolymers of vinyl chloride
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K5/00—Use of organic ingredients
    • C08K5/36—Sulfur-, selenium-, or tellurium-containing compounds
    • C08K5/38—Thiocarbonic acids; Derivatives thereof, e.g. xanthates ; i.e. compounds containing -X-C(=X)- groups, X being oxygen or sulfur, at least one X being sulfur
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K5/00—Use of organic ingredients
    • C08K5/56—Organo-metallic compounds, i.e. organic compounds containing a metal-to-carbon bond
    • C08K5/57—Organo-tin compounds
    • C08K5/58—Organo-tin compounds containing sulfur
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L33/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and only one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
    • C08L33/04—Homopolymers or copolymers of esters
    • C08L33/06—Homopolymers or copolymers of esters of esters containing only carbon, hydrogen and oxygen, which oxygen atoms are present only as part of the carboxyl radical
    • 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
    • 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
    • A61J1/1468—Containers characterised by specific material properties

Definitions

  • the present invention refers to the use of rigid and/or semi-rigid PVC for manufacturing containers which are apt to be terminally sterilised through ionising radiations, as well as to a PVC formulated product suited for such a use and to a film and/or to a container which may be obtained from such formulated product.
  • non-fragile objects to be transported arranged in an orderly manner, may be transported wrapped in a sheet of paper or little more, while fragile objects and/or objects to be transported together with many other objects are generally put into boxes of sturdy material (for example cardboard, plastic or wood), containing inside layers of soft and flexible material, such as fabric or plastic material partly blown with air or another gas which surround them, so as to dampen the impacts between the different parts contained in the wrapping or with the walls of the wrapping, making such impacts harmless for the objects to be transported.
  • sturdy material for example cardboard, plastic or wood
  • Sterilisation may occur thermally, chemically or through ionising radiations.
  • the technique with ionising radiations is preferred, as it allows to sterilise materials which would soften at temperatures above 100°C, it is less expensive and does not require long waiting times to remove from the container the toxic agents by which the sterilisation has been performed.
  • ⁇ rays naturally available and effective, are normally used.
  • Other types of radiations such as ⁇ rays
  • a number of materials, in the presence of ionising radiations tend to deteriorate, losing a good deal of the mechanical properties and of the value thereof, even aesthetic ones. For this reason, the materials used until today in this field are very few.
  • PVC polyvinyl chloride
  • the problem at the basis of the invention is to propose a packaging structure which overcomes the mentioned drawbacks and which allows a safe, non-toxic packaging with the full opportunity to terminally sterilise with ionising radiations, at lower costs than those which are faced today and through a simplified productive process.
  • This object is achieved through the use of rigid and/or semi-rigid PVC for the manufacture of containers which may be terminally sterilised with ionising radiations.
  • the present invention relates also to a PVC formula, characterised in that it contains polyvinyl chloride, mercapturic tin and/or derivatives thereof, tioglycolic acid and/or derivatives thereof, acrylic and metacrylic copolymers, as well as to a film and to a terminally sterilisable container with ionising radiations, manufactured starting from such formulated product.
  • the present invention consists in the use of PVC for manufacturing containers which are apt to be terminally sterilised with ionising radiations.
  • PVC polyvinyl styrene
  • any kind of rigid and/or semi-rigid PVC formulated product which is used for manufacturing containers apt to be terminally sterilised with ionising radiations falls within the scope of the present invention.
  • a formulated product comprising: polyvinyl chloride, mercapturic tin and/or derivatives thereof, tioglycolic acid and/or derivatives thereof, acrylic and metacrylic copolymers.
  • a formulated product containing: polyvinyl chloride, organic phosphitic esters, epoxy soy oil, mercapturic tin and/or derivatives thereof, tioglycolic acid and/or derivatives thereof, acrylic and metacrylic copolymers, fatty acid esters of mono and polyhydric alcohols, polyetylenic waxes, sterammides and/or derivatives thereof.
  • concentrations, expressed as percentages by weight, of the individual components are as follows: polyvinyl chloride 75-90%, organic phosphitic esters 0.1-1%, epoxy soy oil 1-5%, mercapturic tin and/or derivatives thereof 1-5%, tioglycolic acid and/or derivatives thereof 0.5- 5%, acrylic and metacrylic copolymers 5-20%, esters of mono and polyhydric alcohols 0.2-2.0%, polyetylenic waxes 0.01-0.2% and sterammides and/or derivatives thereof 0.1-0.5%.
  • the formulated product can be made semirigid by optionally adding up to 7% of one or more plasticisers, known per se.
  • a PVC is preferred with a monomer content below 1 ppm and having Kw ranging between 56 and 62, produced in slurry or in mass.
  • epoxy soy oil is deodorised before employing it for the preparation of the formula.
  • mercapturic tin those chosen among methyl, ethyl, butyl, hexyl, octyl (mono-, di-, o tri-substituted) are preferred.
  • tioglycolic acid single or double derivatives are preferred, preferably with linear and branched hydrocarbon chains, from C to C 8 .
  • Acrylic and metacrylic copolymers will be apt to contain or not sty- rene, butadiene and/or butylacrilate.
  • fatty acid esters with mono and polyhydric alcohols can be partial or total and the ones with high molecular weight among them are preferred, with glycerols and calcium soaps.
  • polyetylenic waxes will preferably have a high molecular weight and can be oxidised or non oxidised.
  • plasticisers any additive is meant which imparts flexibility, elasticity and manageability to the plastic material.
  • composition according to the present invention can be obtained in pellets or in powder (for example as so-called dry-blend), according to the standard procedures of organic chemistry.
  • the formulated product according to the present invention is generally manufactured through a dry blending. That is, the components of the formulated product are blended through heating.
  • the temperature may vary between 80 and 150°C, preferably between 100 and 130°C.
  • a particularly preferred temperature for blending is 110°C.
  • the obtained powder may possibly be pelletised. In this case it is first proceeded to gelification of the dry blend obtained; such gelification is preferably obtained thermally in an extruder, but can be obtained through any prior art procedure. Compacting of the molten material then occurs, followed by the cutting thereof into pellets, at the exit of a drawing machine.
  • the pellets are used, in a way known per se, for manufacturing a rigid film, possibly apt to be combined to form multiple layers.
  • the film can be prepared, starting from the pellets, according to some processes, known per se in the art.
  • a suitable process is calendering: the plastic material, in the paste state, is caused to pass through a series of pairs of rotary cylinders which obtain sheets or plates thereof of the desired thickness, which depends on the distance between the cylinders.
  • Another suitable process is planar-head extrusion : the material is plastically deformed, using an outlet, said linear head and suitable cooling cylinders as well as dimensional abutment cylinders, so as to obtain a constant-thickness film or plate.
  • bubble extrusion can be resorted to: here too a head is used, which allows to produce a constant-thickness film through a forced flow of cooling and stretching air, resorting also to a dimensional abutment frame.
  • the film then undergoes thermoforming, still in a known manner, in order to obtain containers.
  • a particularly preferred use is for manufacturing containers for equipment and devices for medical and/or pharmaceutical use.
  • rigid or semi-rigid PVC used according to the present invention, can undergo terminal sterilisation, both chemically and by irradiation with ionising radiations and is fully stable in both cases.
  • the features of the final container can be widely modulated, depending on the packaging requirements and on the process for the manufacture thereof. There is no depolymerisation risk during film manufacture, which process, as seen previously, can occur preferably by extrusion or by calendering, with no need to first dry the formulated product.
  • thermoforming the same procedures employed for PETG may be used, preferably using lower work temperatures.
  • the film preferably undergoes a softening process; that is generally obtained by heating the film and deforming it inside moulds or predesigned cavities.
  • any technique which obtains the desired container can be used in the scope of the present invention.
  • the container manufactured according to the present invention may be advantageously sealed with paper or with high-density polyethylene fibers, laminated with a suitable adhesive.
  • the rigid or semirigid PVC used according to the present invention, has, in addition to a lower cost of raw materials, the following advantages: A) it is more resistant to possible depoly- merisation during the transformation step; B) it is more easily processable, since the PVC formulated product does not require a drying step before forming the film and/or thermoforming the same; C) it requires lower processing temperatures, so as to be able to be manufactured with a discrete energy saving; and D) being used as formulated product, it is more easily adaptable to the end consumer's requirements.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention concerne l'utilisation d'un produit formulé à base de PVC, ne contenant éventuellement pas plus de 7 % en poids, sur la base du poids d'ensemble du produit formulé, de plastifiant, en vue de la fabrication de récipients pouvant être stérilisés après conditionnement grâce à un rayonnement ionisant. Ledit produit formulé contient, de préférence, du chlorure de polyvinyle, de l'étain mercapturique et/ou des dérivés de celui-ci, de l'acide thioglycolique et/ou des dérivés de celui-ci, et des copolymères d'acide acrylique et méthacrylique. L'invention concerne également le produit formulé et un récipient fabriqué selon l'invention.
PCT/IT2012/000345 2012-11-13 2012-11-13 Utilisation de pvc en vue de la fabrication de récipients stérilisables WO2014076717A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/IT2012/000345 WO2014076717A1 (fr) 2012-11-13 2012-11-13 Utilisation de pvc en vue de la fabrication de récipients stérilisables
EP12818939.6A EP2920242A1 (fr) 2012-11-13 2012-11-13 Utilisation de pvc en vue de la fabrication de récipients stérilisables

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2012/000345 WO2014076717A1 (fr) 2012-11-13 2012-11-13 Utilisation de pvc en vue de la fabrication de récipients stérilisables

Publications (1)

Publication Number Publication Date
WO2014076717A1 true WO2014076717A1 (fr) 2014-05-22

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IT2012/000345 WO2014076717A1 (fr) 2012-11-13 2012-11-13 Utilisation de pvc en vue de la fabrication de récipients stérilisables

Country Status (2)

Country Link
EP (1) EP2920242A1 (fr)
WO (1) WO2014076717A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9993389B2 (en) 2011-09-19 2018-06-12 Fenwal, Inc. Red blood cell products and the storage of red blood cells in containers free of phthalate plasticizer
US10398625B2 (en) 2013-03-13 2019-09-03 Fenwal, Inc. Medical containers with terephthalate plasticizer for storing red blood cell products
US11160728B2 (en) 2014-02-20 2021-11-02 Fresenius Kabi Deutschland Gmbh Medical containers and system components with non-DEHP plasticizers for storing red blood cell products, plasma and platelets

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5661448A (en) * 1979-10-25 1981-05-26 Mitsubishi Plastics Ind Ltd Vinyl resin composition having good gamma radiation resistance
EP0050071A2 (fr) * 1980-10-13 1982-04-21 ATO CHIMIE, Société Anonyme dite: Procédé pour rendre des polymères résistants aux radiations ionisantes, et compositions obtenues
US4726928A (en) * 1983-11-15 1988-02-23 American Hoechst Corporation Radiation-resistant vinyl halide resin compositions and a process for their production
EP0345662A1 (fr) * 1988-06-06 1989-12-13 The B.F. Goodrich Company Articles rigides en polymère vinylique résistant à la décoloration par des radiations gamma
US20100010131A1 (en) * 2006-09-11 2010-01-14 Kaneka Corporation Resin composition for medical use, resin pellets and part for medical use

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3640953A (en) * 1969-01-23 1972-02-08 Argus Chem Stabilization of polyvinyl chloride resins
CS213022B1 (cs) * 1980-08-28 1982-03-26 Marie Voeroesova Směsi ne bázi homopolymerů anebo kopolymerů vinylchloridu se zvýšenou tepelnou stabilitou, odolností proti účinku světla, kyslíku s povětrnostního stárnutí
JPS60155237A (ja) * 1984-01-24 1985-08-15 Mitsubishi Plastics Ind Ltd 熱収縮性ラベル用フイルム

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5661448A (en) * 1979-10-25 1981-05-26 Mitsubishi Plastics Ind Ltd Vinyl resin composition having good gamma radiation resistance
EP0050071A2 (fr) * 1980-10-13 1982-04-21 ATO CHIMIE, Société Anonyme dite: Procédé pour rendre des polymères résistants aux radiations ionisantes, et compositions obtenues
US4726928A (en) * 1983-11-15 1988-02-23 American Hoechst Corporation Radiation-resistant vinyl halide resin compositions and a process for their production
EP0345662A1 (fr) * 1988-06-06 1989-12-13 The B.F. Goodrich Company Articles rigides en polymère vinylique résistant à la décoloration par des radiations gamma
US20100010131A1 (en) * 2006-09-11 2010-01-14 Kaneka Corporation Resin composition for medical use, resin pellets and part for medical use

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Week 198128, Derwent World Patents Index; AN 1981-50824D, XP002703998 *
See also references of EP2920242A1 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9993389B2 (en) 2011-09-19 2018-06-12 Fenwal, Inc. Red blood cell products and the storage of red blood cells in containers free of phthalate plasticizer
US11000551B2 (en) 2011-09-19 2021-05-11 Fenwal, Inc. Red blood cell products and the storage of red blood cells in containers free of phthalate plasticizer
US11833175B2 (en) 2011-09-19 2023-12-05 Fenwal, Inc. Red blood cell products and the storage of red blood cells in containers free of phthalate plasticizer
US10398625B2 (en) 2013-03-13 2019-09-03 Fenwal, Inc. Medical containers with terephthalate plasticizer for storing red blood cell products
US11957639B2 (en) 2013-03-13 2024-04-16 Fenwal, Inc. Medical containers with terephthalate plasticizer for storing red blood cell products
US11160728B2 (en) 2014-02-20 2021-11-02 Fresenius Kabi Deutschland Gmbh Medical containers and system components with non-DEHP plasticizers for storing red blood cell products, plasma and platelets

Also Published As

Publication number Publication date
EP2920242A1 (fr) 2015-09-23

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