EP3206954A1 - Method and device for packaging elastomer parts - Google Patents

Method and device for packaging elastomer parts

Info

Publication number
EP3206954A1
EP3206954A1 EP15808690.0A EP15808690A EP3206954A1 EP 3206954 A1 EP3206954 A1 EP 3206954A1 EP 15808690 A EP15808690 A EP 15808690A EP 3206954 A1 EP3206954 A1 EP 3206954A1
Authority
EP
European Patent Office
Prior art keywords
bag
nitrogen
primary
atmosphere
polyethylene
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Withdrawn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
EP15808690.0A
Other languages
German (de)
French (fr)
Inventor
Ghislain Fournier
François DESSUS
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.)
Aptar Stelmi SAS
Original Assignee
Aptar Stelmi SAS
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 Aptar Stelmi SAS filed Critical Aptar Stelmi SAS
Publication of EP3206954A1 publication Critical patent/EP3206954A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • 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
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
    • 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
    • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B65B31/02—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
    • B65B31/024—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas specially adapted for wrappers or bags
    • 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
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • 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
    • B65B55/12—Sterilising contents prior to, or during, packaging
    • B65B55/16—Sterilising contents prior to, or during, packaging by irradiation
    • 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
    • B65D65/00—Wrappers or flexible covers; Packaging materials of special type or form
    • B65D65/38—Packaging materials of special type or form
    • 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
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/38—Articles or materials enclosed in two or more wrappers disposed one inside the other
    • 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
    • B65D81/18—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 providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/20—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 providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
    • B65D81/2007—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 providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas under vacuum
    • B65D81/2023—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 providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas under vacuum in a flexible container
    • 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
    • B65D81/18—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 providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/20—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 providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
    • B65D81/2069—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 providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas in a special atmosphere
    • B65D81/2084—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 providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas in a special atmosphere in a flexible container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/23—Containers, e.g. vials, bottles, syringes, mail
    • 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
    • B65B2220/00—Specific aspects of the packaging operation
    • B65B2220/16—Packaging contents into primary and secondary packaging
    • B65B2220/20—Packaging contents into primary and secondary packaging the primary packaging being bags, the secondary packaging being further bags, the primary bags being either finished or formed concurrently with the secondary bags
    • 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
    • B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/08—Sterilising wrappers or receptacles prior to, or during, packaging by irradiation

Definitions

  • the present invention relates to a method and a device for packaging elastomeric parts, such as caps for pharmaceutical containers.
  • Pharmaceutical containers for containing pharmaceuticals are generally closed, after filling, tightly and sterile by appropriate plugs, typically made of elastomeric materials, such as rubber. These caps are generally delivered to the user responsible for filling separately containers, being packaged in appropriate packaging devices.
  • These ready-to-use plugs are generally packaged at ambient atmosphere in a primary bag having a good impermeability to air, typically a polyethylene (PE) or aluminum bag. The welding of the primary bag is done without evacuation.
  • This primary bag can itself be inserted into a secondary bag, generally of the polyethylene (PE) type, or particularly of the polyethylene / polyamide / polyethylene (PE / PA / PE) tri-layer type, which is intended to be evacuated .
  • the elastomeric caps tend to stick to each other, and this phenomenon is amplified over time (during storage) and even more after sterilization.
  • elastomer parts such as for example syringe pistons or syringe needle guards.
  • JP2003291917, DE3717916, WO201 1090942 and EP0201880 disclose devices of the state of the art.
  • the present invention aims to provide a method and a device for packaging elastomeric parts that do not reproduce the aforementioned drawbacks.
  • the present invention aims to ensure a very low rate, advantageously zero, of bonding between the parts contained in the primary bag of the packaging device, even after sterilization.
  • the subject of the present invention is therefore a process for packaging elastomer parts, such as stoppers for pharmaceutical containers, comprising the following steps: packaging the parts in a primary bag made of substantially airtight material, and application in said bag primary of a nitrogen-based atmosphere, with at least 80% nitrogen, said primary bag being conditioned in a secondary bag, with application of a vacuum between said primary bag and said secondary bag.
  • the subject of the present invention is also a device for packaging elastomer parts, such as stoppers for pharmaceutical containers, comprising a primary bag made of substantially air-tight material receiving said parts, said primary bag containing an atmosphere based on nitrogen, with at least 80% nitrogen, said primary bag being packaged in a secondary bag, with application of a vacuum between said primary bag and said secondary bag.
  • the atmosphere applied in said primary bag contains at least 90% nitrogen.
  • the atmosphere applied in said primary bag contains 100% nitrogen.
  • the atmosphere applied in said primary bag consists substantially of nitrogen and oxygen.
  • said substantially impervious primary bag comprises polyethylene or aluminum.
  • said secondary bag comprises several layers, in particular a tri-layer structure polyethylene / polyamide / polyethylene (PE / PA / PE).
  • the present invention also relates to a method for packaging elastomer parts, such as pharmaceutical container stoppers, comprising the following steps: conditioning the pieces in a primary bag made of breathable material, conditioning said primary bag in a secondary bag made of substantially air-impermeable material, and applying to said secondary bag a nitrogen-based atmosphere, with minus 80% nitrogen, said secondary bag being conditioned in a tertiary bag, with application of a vacuum between said secondary bag and said tertiary bag.
  • Another subject of the present invention is a device for packaging elastomer parts, such as stoppers for pharmaceutical containers, comprising a primary bag of air-permeable material receiving said parts, said primary bag being conditioned in a secondary bag of material substantially impervious to air, said primary bag and said secondary bag containing a nitrogen-based atmosphere, with at least 80% nitrogen, said secondary bag being conditioned in a tertiary bag, with application of a vacuum between said secondary bag and said tertiary bag.
  • the atmosphere applied in said secondary bag contains at least 90% nitrogen.
  • the atmosphere applied in said secondary bag contains 100% nitrogen.
  • the atmosphere applied in said secondary bag consists substantially of nitrogen and oxygen.
  • said air-permeable primary bag comprises polyethylene, in particular Tyvek®.
  • said secondary bag comprises several layers, in particular a four-layer structure with an inner polyethylene terephthalate layer, an aluminum layer, a polyamide layer and an outer polyethylene layer.
  • said tertiary bag comprises polyethylene.
  • FIG. 1 is a schematic view of a device for packaging elastomer parts containing plugs, according to a first embodiment
  • FIG. 2 is a schematic view of a device for packaging elastomer parts containing plugs, according to a second embodiment
  • FIG. 3 is a schematic view of a device for packaging elastomer parts containing plugs, according to a third embodiment
  • FIG. 4 is a graph illustrating the performance of a conditioning device of the prior art.
  • Figure 5 is a graph illustrating the performance of a packaging device according to the invention.
  • Figures 1 to 3 are diagrammatic, and it is understood that neither the shape of the pieces nor that of the different bags is representative of actual shapes or scales.
  • the parts may be in any number and of any shape, and the shapes and dimensions of the bags may also be arbitrary.
  • elastomer parts 1 such as caps for pharmaceutical containers, are packaged in a packaging device comprising a primary bag 10 directly receiving said parts.
  • the packaging device further comprises a secondary bag 20 receiving said primary bag 10, as illustrated in Figures 1 and 2.
  • a tertiary bag 30 receiving said secondary bag 20.
  • An air gap can be achieved, either between the primary bag 10 and the secondary bag 20 in the case of a two-bag configuration, ie, the case optionally, between the secondary bag 20 and the tertiary bag 30 in the case of a configuration with three bags.
  • This vacuum of air makes it possible to detect a possible problem of integrity, which would be manifested by a loss of vacuum causing the separation of said bags.
  • Figures 1 and 2 illustrate a two-bag configuration.
  • the primary bag 10 is sealed, while in the example of Figure 2, it comprises a door 40 adapted to cooperate with a suitable bag receiving device, to transfer the contents of the bag primary 10 directly in a chamber with controlled atmosphere.
  • the primary bag 10 is made of a material having good impermeability to air, such as for example polyethylene or aluminum. Other equivalent materials are also conceivable.
  • the secondary bag 20 can then advantageously be a polyethylene / polyamide / polyethylene (PE / PA / PE) trilayer bag.
  • the primary bag 10 is made of a material permeable to air, such as for example polyethylene including Tyvek®. Other equivalent materials are also conceivable.
  • the secondary bag 20 may in this case also comprise several layers, in particular a four-layer structure with an inner layer of polyethylene terephthalate, an aluminum layer, a polyamide layer and a polyethylene outer layer.
  • the tertiary bag 30 can also be multilayer, for example with an inner layer of polyethylene, a central layer of polyamide and an outer layer of polyethylene.
  • the atmosphere inside said primary bag 10 is predominantly nitrogen-based, with at least 80% nitrogen, advantageously at least 90% nitrogen.
  • this atmosphere consists substantially of nitrogen and oxygen.
  • said atmosphere may contain only nitrogen, that is to say 100% nitrogen.
  • the method for introducing nitrogen may in particular comprise the following steps, for a two-bag configuration according to FIG. 1 or 2:
  • the controls of the evacuation and the introduction of nitrogen can be carried out using manometers.
  • the nitrogen introduction process may notably comprise the following steps:
  • the following table illustrates the improved performance achieved with the present invention.
  • the configuration tested was a two-bag configuration, according to the embodiments of Figures 1 or 2.
  • Batches A, B and C tested contained 1,150 coins each, the results being reduced proportionally to 200 coins.
  • Each batch was tested one by one with a standard atmosphere (ambient air) and on the other hand with a nitrogen-based atmosphere, in this case about 100% nitrogen in these tests at the time of conditioning, respectively before and after gamma sterilization.
  • the sterilization was carried out with a radiation dose received by the 35 kGy pieces, knowing that the usual doses are generally between 18 and 32 kGy.
  • the tests, consisting of counting the pieces stuck in each batch were made at different time intervals, namely at T0 (after conditioning) before and after sterilization, then at T6 (after 6 months of storage) and at T24 (after 24 months of storage).
  • the invention has been described more particularly with reference to plugs of pharmaceutical containers, but it can also be applied to other types of elastomer parts, such as for example syringe pistons or syringe needle shields.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Toxicology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Vacuum Packaging (AREA)
  • Bag Frames (AREA)

Abstract

The invention relates to a method of packaging elastomer parts (1), such as pharmaceutical container stoppers, the method involving the following steps: - packaging the parts (1) in a first bag (10) made of a material which is substantially impervious to gases; and applying to the first bag (10) a nitrogen-based atmosphere, with at least 80% nitrogen, the first bag (10) being packaged in a second bag (20), with a vacuum being applied between the first bag (10) and the second bag (20).

Description

Procédé et dispositif de conditionnement de pièces en élastomère  Method and device for packaging elastomer parts
La présente invention concerne un procédé et un dispositif de conditionnement de pièces en élastomères, tels que des bouchons de récipients pharmaceutiques. The present invention relates to a method and a device for packaging elastomeric parts, such as caps for pharmaceutical containers.
Les récipients pharmaceutiques destinés à contenir des produits pharmaceutiques sont généralement fermés, après remplissage, de manière étanche et stérile par des bouchons appropriés, typiquement réalisés en matériaux élastomères, tel que du caoutchouc. Ces bouchons sont généralement livrés à l'utilisateur responsable du remplissage séparément des récipients, en étant conditionnés dans des dispositifs de conditionnement appropriés. Ces bouchons prêts à l'emploi sont généralement emballés à atmosphère ambiante dans un sac primaire ayant une bonne imperméabilité à l'air, typiquement un sac en polyéthylène (PE) ou en aluminium. La soudure du sac primaire se fait sans mise sous vide. Ce sac primaire peut lui-même être inséré dans un sac secondaire, généralement de type polyéthylène (PE), ou particulièrement de type tri-couches polyéthylène/polyamide/polyéthylène (PE/PA/PE), qui est destiné à être mis sous vide.  Pharmaceutical containers for containing pharmaceuticals are generally closed, after filling, tightly and sterile by appropriate plugs, typically made of elastomeric materials, such as rubber. These caps are generally delivered to the user responsible for filling separately containers, being packaged in appropriate packaging devices. These ready-to-use plugs are generally packaged at ambient atmosphere in a primary bag having a good impermeability to air, typically a polyethylene (PE) or aluminum bag. The welding of the primary bag is done without evacuation. This primary bag can itself be inserted into a secondary bag, generally of the polyethylene (PE) type, or particularly of the polyethylene / polyamide / polyethylene (PE / PA / PE) tri-layer type, which is intended to be evacuated .
Ces systèmes d'emballage présentent des inconvénients.  These packaging systems have disadvantages.
Ainsi, les bouchons en élastomères ont tendance à se coller les uns aux autres, et ce phénomène est amplifié avec le temps (lors du stockage) et plus encore après stérilisation.  Thus, the elastomeric caps tend to stick to each other, and this phenomenon is amplified over time (during storage) and even more after sterilization.
Le même problème peut se poser pour d'autres types de pièces en élastomère, tels que par exemple des pistons de seringues ou des protège- aiguille de seringues.  The same problem may arise for other types of elastomer parts, such as for example syringe pistons or syringe needle guards.
Les documents JP2003291917, DE3717916, WO201 1090942 et EP0201880 décrivent des dispositifs de l'état de la technique.  JP2003291917, DE3717916, WO201 1090942 and EP0201880 disclose devices of the state of the art.
La présente invention a pour objectif de fournir un procédé et un dispositif de conditionnement de pièces en élastomère qui ne reproduisent pas les inconvénients susmentionnés. En particulier, la présente invention a pour but de garantir un taux très faible, avantageusement nul, de collage entre les pièces contenues dans le sac primaire du dispositif de conditionnement, même après stérilisation. The present invention aims to provide a method and a device for packaging elastomeric parts that do not reproduce the aforementioned drawbacks. In particular, the present invention aims to ensure a very low rate, advantageously zero, of bonding between the parts contained in the primary bag of the packaging device, even after sterilization.
La présente invention a donc pour objet un procédé de conditionnement de pièces en élastomère, tels que des bouchons de récipients pharmaceutiques, comportant les étapes suivantes : conditionnement des pièces dans un sac primaire en matériau sensiblement imperméable à l'air, et application dans ledit sac primaire d'une atmosphère à base d'azote, avec au moins 80% d'azote, ledit sac primaire étant conditionné dans un sac secondaire, avec application d'un vide entre ledit sac primaire et ledit sac secondaire.  The subject of the present invention is therefore a process for packaging elastomer parts, such as stoppers for pharmaceutical containers, comprising the following steps: packaging the parts in a primary bag made of substantially airtight material, and application in said bag primary of a nitrogen-based atmosphere, with at least 80% nitrogen, said primary bag being conditioned in a secondary bag, with application of a vacuum between said primary bag and said secondary bag.
La présente invention a aussi pour objet un dispositif de conditionnement de pièces en élastomère, tels que des bouchons de récipients pharmaceutiques, comportant un sac primaire en matériau sensiblement imperméable à l'air recevant lesdites pièces, ledit sac primaire contenant une atmosphère à base d'azote, avec au moins 80% d'azote, ledit sac primaire étant conditionné dans un sac secondaire, avec application d'un vide entre ledit sac primaire et ledit sac secondaire.  The subject of the present invention is also a device for packaging elastomer parts, such as stoppers for pharmaceutical containers, comprising a primary bag made of substantially air-tight material receiving said parts, said primary bag containing an atmosphere based on nitrogen, with at least 80% nitrogen, said primary bag being packaged in a secondary bag, with application of a vacuum between said primary bag and said secondary bag.
Avantageusement, l'atmosphère appliquée dans ledit sac primaire contient au moins 90% d'azote.  Advantageously, the atmosphere applied in said primary bag contains at least 90% nitrogen.
Avantageusement, l'atmosphère appliquée dans ledit sac primaire contient 100% d'azote.  Advantageously, the atmosphere applied in said primary bag contains 100% nitrogen.
Avantageusement, l'atmosphère appliquée dans ledit sac primaire est constituée sensiblement d'azote et d'oxygène.  Advantageously, the atmosphere applied in said primary bag consists substantially of nitrogen and oxygen.
Avantageusement, ledit sac primaire sensiblement imperméable à l'air comprend du polyéthylène ou de l'aluminium.  Advantageously, said substantially impervious primary bag comprises polyethylene or aluminum.
Avantageusement, ledit sac secondaire comporte plusieurs couches, notamment une structure tri-couches polyéthylène/polyamide/polyéthylène (PE/PA/PE).  Advantageously, said secondary bag comprises several layers, in particular a tri-layer structure polyethylene / polyamide / polyethylene (PE / PA / PE).
La présente invention a aussi pour objet un procédé de conditionnement de pièces en élastomère, tels que des bouchons de récipients pharmaceutiques, comportant les étapes suivantes : conditionnement des pièces dans un sac primaire en matériau perméable à l'air, conditionnement dudit sac primaire dans un sac secondaire en matériau sensiblement imperméable à l'air, et application dans ledit sac secondaire d'une atmosphère à base d'azote, avec au moins 80% d'azote, ledit sac secondaire étant conditionné dans un sac tertiaire, avec application d'un vide entre ledit sac secondaire et ledit sac tertiaire. The present invention also relates to a method for packaging elastomer parts, such as pharmaceutical container stoppers, comprising the following steps: conditioning the pieces in a primary bag made of breathable material, conditioning said primary bag in a secondary bag made of substantially air-impermeable material, and applying to said secondary bag a nitrogen-based atmosphere, with minus 80% nitrogen, said secondary bag being conditioned in a tertiary bag, with application of a vacuum between said secondary bag and said tertiary bag.
La présente invention a aussi pour objet un dispositif de conditionnement de pièces en élastomère, tels que des bouchons de récipients pharmaceutiques, comportant un sac primaire en matériau perméable à l'air recevant lesdites pièces, ledit sac primaire étant conditionné dans un sac secondaire en matériau sensiblement imperméable à l'air, ledit sac primaire et ledit sac secondaire contenant une atmosphère à base d'azote, avec au moins 80% d'azote, ledit sac secondaire étant conditionné dans un sac tertiaire, avec application d'un vide entre ledit sac secondaire et ledit sac tertiaire.  Another subject of the present invention is a device for packaging elastomer parts, such as stoppers for pharmaceutical containers, comprising a primary bag of air-permeable material receiving said parts, said primary bag being conditioned in a secondary bag of material substantially impervious to air, said primary bag and said secondary bag containing a nitrogen-based atmosphere, with at least 80% nitrogen, said secondary bag being conditioned in a tertiary bag, with application of a vacuum between said secondary bag and said tertiary bag.
Avantageusement, l'atmosphère appliquée dans ledit sac secondaire contient au moins 90% d'azote.  Advantageously, the atmosphere applied in said secondary bag contains at least 90% nitrogen.
Avantageusement, l'atmosphère appliquée dans ledit sac secondaire contient 100% d'azote.  Advantageously, the atmosphere applied in said secondary bag contains 100% nitrogen.
Avantageusement, l'atmosphère appliquée dans ledit sac secondaire est constituée sensiblement d'azote et d'oxygène.  Advantageously, the atmosphere applied in said secondary bag consists substantially of nitrogen and oxygen.
Avantageusement, ledit sac primaire perméable à l'air comprend du polyéthylène, notamment du Tyvek®.  Advantageously, said air-permeable primary bag comprises polyethylene, in particular Tyvek®.
Avantageusement, ledit sac secondaire comporte plusieurs couches, notamment une structure quadri-couches avec une couche interne en polyéthylène téréphtalate, une couche en aluminium, une couche en polyamide et une couche externe en polyéthylène.  Advantageously, said secondary bag comprises several layers, in particular a four-layer structure with an inner polyethylene terephthalate layer, an aluminum layer, a polyamide layer and an outer polyethylene layer.
Avantageusement, ledit sac tertiaire comprend du polyéthylène.  Advantageously, said tertiary bag comprises polyethylene.
Avantageusement, après l'application de l'atmosphère à base d'azote dans le sac primaire ou dans le sac secondaire, lesdites pièces sont soumises à une stérilisation gamma. Ces caractéristiques et avantages et d'autres de la présente invention apparaîtront plus clairement au cours de la description détaillée suivante, faite en référence aux dessins joints, donnés à titre d'exemples non-limitatifs, et sur lesquels : Advantageously, after the application of the nitrogen-based atmosphere in the primary bag or in the secondary bag, said parts are subject to gamma sterilization. These and other features and advantages of the present invention will appear more clearly in the following detailed description, with reference to the accompanying drawings, given by way of non-limiting examples, and in which:
la figure 1 est une vue schématique d'un dispositif de conditionnement de pièces en élastomères contenant des bouchons, selon un premier mode de réalisation,  FIG. 1 is a schematic view of a device for packaging elastomer parts containing plugs, according to a first embodiment,
la figure 2 est une vue schématique d'un dispositif de conditionnement de pièces en élastomères contenant des bouchons, selon un second mode de réalisation,  FIG. 2 is a schematic view of a device for packaging elastomer parts containing plugs, according to a second embodiment,
la figure 3 est une vue schématique d'un dispositif de conditionnement de pièces en élastomères contenant des bouchons, selon un troisième mode de réalisation,  FIG. 3 is a schematic view of a device for packaging elastomer parts containing plugs, according to a third embodiment,
la figure 4 est un graphique illustrant les performances d'un dispositif de conditionnement de l'art antérieur, et  FIG. 4 is a graph illustrating the performance of a conditioning device of the prior art, and
la figure 5 est un graphique illustrant les performances d'un dispositif de conditionnement selon l'invention.  Figure 5 is a graph illustrating the performance of a packaging device according to the invention.
Les figures 1 à 3 sont schématiques, et il est entendu que ni la forme des pièces, ni celle des différents sacs n'est représentative des formes réelles ou des échelles. En particulier, les pièces peuvent être en nombre quelconque et de formes quelconques, et les formes et dimensions des sacs peuvent également être quelconques.  Figures 1 to 3 are diagrammatic, and it is understood that neither the shape of the pieces nor that of the different bags is representative of actual shapes or scales. In particular, the parts may be in any number and of any shape, and the shapes and dimensions of the bags may also be arbitrary.
De manière conventionnelle, des pièces en élastomère 1 , tels que des bouchons de récipients pharmaceutiques, sont conditionnés dans un dispositif de conditionnement comportant un sac primaire 10 recevant directement lesdites pièces.  Conventionally, elastomer parts 1, such as caps for pharmaceutical containers, are packaged in a packaging device comprising a primary bag 10 directly receiving said parts.
Avantageusement, le dispositif de conditionnement comporte en outre un sac secondaire 20 recevant ledit sac primaire 10, comme illustré sur les figures 1 et 2. Eventuellement, comme représenté sur la figure 3, on peut prévoir un sac tertiaire 30 recevant ledit sac secondaire 20.  Advantageously, the packaging device further comprises a secondary bag 20 receiving said primary bag 10, as illustrated in Figures 1 and 2. Optionally, as shown in Figure 3, there can be provided a tertiary bag 30 receiving said secondary bag 20.
Un vide d'air peut être réalisé, soit entre le sac primaire 10 et le sac secondaire 20 dans le cas d'une configuration à deux sacs, soit, le cas échéant, entre le sac secondaire 20 et le sac tertiaire 30 dans le cas d'une configuration à trois sacs. Ce vide d'air permet de détecter un éventuel problème d'intégrité, qui se manifesterait par une perte de vide provoquant la désolidarisation desdits sacs. An air gap can be achieved, either between the primary bag 10 and the secondary bag 20 in the case of a two-bag configuration, ie, the case optionally, between the secondary bag 20 and the tertiary bag 30 in the case of a configuration with three bags. This vacuum of air makes it possible to detect a possible problem of integrity, which would be manifested by a loss of vacuum causing the separation of said bags.
Les figures 1 et 2 illustrent une configuration à deux sacs.  Figures 1 and 2 illustrate a two-bag configuration.
Dans l'exemple de la figure 1 , le sac primaire 10 est scellé, alors que dans l'exemple de la figure 2, il comporte une porte 40 adaptée à coopérer avec un dispositif de réception de sac approprié, pour transférer le contenu du sac primaire 10 directement dans une enceinte à atmosphère contrôlée.  In the example of Figure 1, the primary bag 10 is sealed, while in the example of Figure 2, it comprises a door 40 adapted to cooperate with a suitable bag receiving device, to transfer the contents of the bag primary 10 directly in a chamber with controlled atmosphere.
Dans ces configurations à deux sacs, le sac primaire 10 est réalisé en un matériau ayant une bonne imperméabilité à l'air, tel que par exemple du polyéthylène ou de l'aluminium. D'autres matériaux équivalents sont aussi envisageables.  In these configurations with two bags, the primary bag 10 is made of a material having good impermeability to air, such as for example polyethylene or aluminum. Other equivalent materials are also conceivable.
Le sac secondaire 20 peut alors avantageusement être un sac tri- couches polyéthylène / polyamide / polyéthylène (PE/PA/PE).  The secondary bag 20 can then advantageously be a polyethylene / polyamide / polyethylene (PE / PA / PE) trilayer bag.
D'autres matériaux sont envisageables, à condition qu'ils permettent l'établissement et le maintien d'un vide entre le sac primaire 10 et le sac secondaire 20.  Other materials are possible, provided that they allow the establishment and maintenance of a vacuum between the primary bag 10 and the secondary bag 20.
Dans le mode de réalisation de la figure 3, lorsqu'il y a un sac tertiaire 30, le sac primaire 10 est réalisé en un matériau perméable à l'air, tel que par exemple du polyéthylène notamment du Tyvek®. D'autres matériaux équivalents sont aussi envisageables.  In the embodiment of Figure 3, when there is a tertiary bag 30, the primary bag 10 is made of a material permeable to air, such as for example polyethylene including Tyvek®. Other equivalent materials are also conceivable.
Le sac secondaire 20 peut dans ce cas aussi comporter plusieurs couches, notamment une structure quadri-couches avec une couche interne en polyéthylène téréphtalate, une couche en aluminium, une couche en polyamide et une couche externe en polyéthylène.  The secondary bag 20 may in this case also comprise several layers, in particular a four-layer structure with an inner layer of polyethylene terephthalate, an aluminum layer, a polyamide layer and a polyethylene outer layer.
Le sac tertiaire 30 peut aussi être multicouche, par exemple avec une couche interne en polyéthylène, une couche centrale en polyamide et une couche externe en polyéthylène.  The tertiary bag 30 can also be multilayer, for example with an inner layer of polyethylene, a central layer of polyamide and an outer layer of polyethylene.
D'autres matériaux sont envisageables pour ces sacs secondaire 20 et tertiaire 30, à condition qu'ils permettent l'établissement et le maintien d'un vide entre le sac secondaire 20 et le sac tertiaire 30. Selon l'invention, l'atmosphère à l'intérieur dudit sac primaire 10 est majoritairement à base d'azote, avec au moins 80% d'azote, avantageusement au moins 90% d'azote. Other materials are conceivable for these secondary and tertiary bags 30, provided that they allow the establishment and maintenance of a vacuum between the secondary bag 20 and the tertiary bag 30. According to the invention, the atmosphere inside said primary bag 10 is predominantly nitrogen-based, with at least 80% nitrogen, advantageously at least 90% nitrogen.
Avantageusement, cette atmosphère est constituée sensiblement d'azote et d'oxygène.  Advantageously, this atmosphere consists substantially of nitrogen and oxygen.
Eventuellement, ladite atmosphère peut contenir uniquement de l'azote, c'est-à-dire 100% d'azote.  Optionally, said atmosphere may contain only nitrogen, that is to say 100% nitrogen.
Le procédé d'introduction d'azote peut notamment comprendre les étapes suivantes, pour une configuration à deux sacs selon les figures 1 ou2:  The method for introducing nitrogen may in particular comprise the following steps, for a two-bag configuration according to FIG. 1 or 2:
- remplissage du sac primaire 10 avec les pièces 1 sous atmosphère ambiante,  filling the primary bag 10 with the pieces 1 under ambient atmosphere,
- mise en place du sac primaire 10 rempli dans une enceinte de mise sous vide pour évacuer tout l'oxygène contenu à l'intérieur dudit sac primaire 10,  placing the filled primary bag in a vacuum chamber to evacuate all the oxygen contained inside said primary bag,
- introduction d'azote dans ledit sac primaire 10, puis scellage dudit sac primaire 10.  introducing nitrogen into said primary bag 10, then sealing said primary bag 10.
Les contrôles de la mise sous vide puis de l'introduction d'azote peuvent être effectués à l'aide de manomètres.  The controls of the evacuation and the introduction of nitrogen can be carried out using manometers.
Dans le cas d'une configuration à trois sacs selon la figure 3, le procédé d'introduction d'azote peut notamment comprendre les étapes suivantes:  In the case of a configuration with three bags according to FIG. 3, the nitrogen introduction process may notably comprise the following steps:
- remplissage du sac primaire 10 perméable à l'air avec les pièces 1 sous atmosphère ambiante,  filling of the air-permeable primary bag with the pieces 1 under ambient atmosphere,
- fermeture dudit sac primaire 10 perméable à l'air rempli,  closing said filled permeable primary bag 10,
- introduction du sac primaire 10 fermé dans ledit sac secondaire 20, introducing the closed primary bag into said secondary bag 20,
- mise en place dudit sac secondaire 20 dans une enceinte de mise sous vide pour évacuer tout l'oxygène contenu à l'intérieur des sacs primaire 10 et secondaire 20, placing said secondary bag in a vacuum chamber to evacuate all the oxygen contained inside the primary and secondary bags 20,
- introduction d'azote dans ledit sac secondaire 20, puis scellage dudit sac secondaire 20.  introducing nitrogen into said secondary bag 20, then sealing said secondary bag 20.
Les contrôles de la mise sous vide puis de l'introduction d'azote peuvent être effectués à l'aide de manomètres. Test de collage : The controls of the evacuation and the introduction of nitrogen can be carried out using manometers. Collage test:
Le tableau ci-après illustre les performances améliorées obtenues avec la présente invention. La configuration testée était une configuration à deux sacs, selon les modes de réalisation des figures 1 ou 2.  The following table illustrates the improved performance achieved with the present invention. The configuration tested was a two-bag configuration, according to the embodiments of Figures 1 or 2.
Les lots A, B et C testés contenaient 1 150 pièces chacun, les résultats étant ramenés proportionnellement à 200 pièces. Chaque lot a été testé d'une par avec une atmosphère standard (air ambiant) et d'autre part avec une atmosphère à base d'azote, en l'occurrence environ 100% d'azote dans ces tests au moment du conditionnement, respectivement avant et après stérilisation gamma. La stérilisation a dans ces tests été réalisée avec une dose d'irradiation reçue par les pièces de 35 kGy, sachant que les doses habituelles se situent généralement entre 18 et 32 kGy. Les tests, consistant à compter les pièces collées dans chaque lot, ont été réalisés à différents intervalles de temps, à savoir à T0 (après conditionnement) avant et après stérilisation, puis à T6 (après 6 mois de stockage) et à T24 (après 24 mois de stockage). Batches A, B and C tested contained 1,150 coins each, the results being reduced proportionally to 200 coins. Each batch was tested one by one with a standard atmosphere (ambient air) and on the other hand with a nitrogen-based atmosphere, in this case about 100% nitrogen in these tests at the time of conditioning, respectively before and after gamma sterilization. In these tests, the sterilization was carried out with a radiation dose received by the 35 kGy pieces, knowing that the usual doses are generally between 18 and 32 kGy. The tests, consisting of counting the pieces stuck in each batch, were made at different time intervals, namely at T0 (after conditioning) before and after sterilization, then at T6 (after 6 months of storage) and at T24 (after 24 months of storage).
On constate que dans un dispositif de conditionnement selon l'art antérieur, dans lequel l'atmosphère contenue dans le sac primaire 10 est une atmosphère standard formée de l'air ambiant, les résultats après stérilisation sont systématiquement au-dessus de la limite acceptable de 2/200 pièces collées, aussi bien à T6 qu'à T24.  It can be seen that in a prior art packaging device, in which the atmosphere contained in the primary bag 10 is a standard atmosphere formed of the ambient air, the results after sterilization are systematically above the acceptable limit of 2/200 glued pieces, both T6 and T24.
Au contraire, avec la présente invention, il n'y a aucune pièce collée, ni avant stérilisation, ni après.  On the contrary, with the present invention, there is no bonded part, neither before sterilization, nor after.
Les figures 4 et 5 illustrent ces résultats sur des graphiques.  Figures 4 and 5 illustrate these results on graphs.
L'invention a été décrite plus particulièrement en référence à des bouchons de récipients pharmaceutiques, mais elle peut aussi s'appliquer à d'autres types de pièces en élastomère, tels que par exemple des pistons de seringue ou des protège-aiguilles de seringues.  The invention has been described more particularly with reference to plugs of pharmaceutical containers, but it can also be applied to other types of elastomer parts, such as for example syringe pistons or syringe needle shields.
La présente invention a été décrite en référence à plusieurs modes de réalisation particuliers, mais il est entendu qu'elle n'est pas limitée par ceux- ci mais qu'au contraire l'homme du métier peut y apporter toutes modifications utiles sans sortir du cadre de la présente invention tel que défini par les revendications annexées.  The present invention has been described with reference to several particular embodiments, but it is understood that it is not limited by them but that, on the contrary, the person skilled in the art can make any useful modifications without departing from the scope of the present invention as defined by the appended claims.

Claims

Revendications claims
1 . - Procédé de conditionnement de pièces en élastomère (1 ), tels que des bouchons de récipients pharmaceutiques, comportant les étapes suivantes : 1. - Process for packaging elastomer parts (1), such as caps for pharmaceutical containers, comprising the following steps:
- conditionnement des pièces (1 ) dans un sac primaire (10) en matériau sensiblement imperméable à l'air, et  - conditioning the pieces (1) in a primary bag (10) made of substantially air-impermeable material, and
- application dans ledit sac primaire (10) d'une atmosphère à base d'azote, avec au moins 80% d'azote,  - application in said primary bag (10) of a nitrogen-based atmosphere, with at least 80% of nitrogen,
caractérisé en ce que ledit sac primaire (10) est conditionné dans un sac secondaire (20), avec application d'un vide entre ledit sac primaire (10) et ledit sac secondaire (20).  characterized in that said primary bag (10) is packaged in a secondary bag (20), with application of a vacuum between said primary bag (10) and said secondary bag (20).
2. - Procédé selon la revendication 1 , dans lequel l'atmosphère appliquée dans ledit sac primaire (10) contient au moins 90% d'azote. 2. - The method of claim 1, wherein the atmosphere applied in said primary bag (10) contains at least 90% nitrogen.
3. - Procédé selon la revendication 2, dans lequel l'atmosphère appliquée dans ledit sac primaire (10) contient 100% d'azote. 3. - The method of claim 2, wherein the atmosphere applied in said primary bag (10) contains 100% nitrogen.
4. - Procédé selon la revendication 1 ou la revendication 2, dans lequel l'atmosphère appliquée dans ledit sac primaire (10) est constituée sensiblement d'azote et d'oxygène. 4. - The method of claim 1 or claim 2, wherein the atmosphere applied in said primary bag (10) consists substantially of nitrogen and oxygen.
5. - Procédé selon l'une quelconque des revendications précédentes, dans lequel ledit sac primaire (10) sensiblement imperméable à l'air comprend du polyéthylène ou de l'aluminium. The method of any one of the preceding claims, wherein said substantially impervious primary bag (10) comprises polyethylene or aluminum.
6. - Procédé selon l'une quelconque des revendications précédentes, dans lequel ledit sac secondaire (20) comporte plusieurs couches, notamment une structure tri-couches polyéthylène/polyamide/polyéthylène (PE/PA/PE). 6. - Method according to any one of the preceding claims, wherein said secondary bag (20) comprises several layers, including a tri-layer structure polyethylene / polyamide / polyethylene (PE / PA / PE).
7. - Procédé de conditionnement de pièces en élastomère (1 ), tels que des bouchons de récipients pharmaceutiques, comportant les étapes suivantes : 7. - Process for packaging elastomer parts (1), such as pharmaceutical container stoppers, comprising the following steps:
- conditionnement des pièces (1 ) dans un sac primaire (10) en matériau perméable à l'air,  - conditioning parts (1) in a primary bag (10) of breathable material,
- conditionnement dudit sac primaire (10) dans un sac secondaire (20) en matériau sensiblement imperméable à l'air, et  conditioning said primary bag (10) in a secondary bag (20) made of a substantially impervious material, and
- application dans ledit sac secondaire (20) d'une atmosphère à base d'azote, avec au moins 80% d'azote,  applying to said secondary bag (20) a nitrogen-based atmosphere with at least 80% nitrogen,
caractérisé en ce que ledit sac secondaire (20) est conditionné dans un sac tertiaire (30), avec application d'un vide entre ledit sac secondaire (20) et ledit sac tertiaire (30).  characterized in that said secondary bag (20) is packaged in a tertiary bag (30), with application of a vacuum between said secondary bag (20) and said tertiary bag (30).
8. - Procédé selon la revendication 7, dans lequel l'atmosphère appliquée dans ledit sac secondaire (20) contient au moins 90% d'azote. 8. - The method of claim 7, wherein the atmosphere applied in said secondary bag (20) contains at least 90% nitrogen.
9. - Procédé selon la revendication 8, dans lequel l'atmosphère appliquée dans ledit sac secondaire (20) contient 100% d'azote. 9. - The method of claim 8, wherein the atmosphere applied in said secondary bag (20) contains 100% nitrogen.
10. - Procédé selon la revendication 7 ou la revendication 8, dans lequel l'atmosphère appliquée dans ledit sac secondaire (20) est constituée sensiblement d'azote et d'oxygène. The method of claim 7 or claim 8, wherein the atmosphere applied in said secondary bag (20) is substantially nitrogen and oxygen.
1 1 . - Procédé selon l'une quelconque des revendications 7 à 10, dans lequel ledit sac primaire (10) perméable à l'air comprend du polyéthylène, notamment du Tyvek®. 1 1. The method of any one of claims 7 to 10, wherein said air permeable primary bag (10) comprises polyethylene, including Tyvek®.
12. - Procédé selon l'une quelconque des revendications 7 à 1 1 , dans lequel ledit sac secondaire (20) comporte plusieurs couches, notamment une structure quadri-couches avec une couche interne en polyéthylène téréphtalate, une couche en aluminium, une couche en polyamide et une couche externe en polyéthylène. 12. - Method according to any one of claims 7 to 11, wherein said secondary bag (20) comprises several layers, including a four-layer structure with an inner layer in polyethylene terephthalate, an aluminum layer, a polyamide layer and a polyethylene outer layer.
13. - Procédé selon l'une quelconque des revendications 7 à 12, dans lequel ledit sac tertiaire (30) comprend du polyéthylène. The method of any one of claims 7 to 12, wherein said tertiary bag (30) comprises polyethylene.
14. - Procédé selon l'une quelconque des revendications précédentes, dans lequel, après l'application de l'atmosphère à base d'azote dans le sac primaire (10) ou dans le sac secondaire (20), lesdites pièces (1 ) sont soumises à une stérilisation gamma. 14. - Process according to any one of the preceding claims, wherein, after the application of the nitrogen-based atmosphere in the primary bag (10) or in the secondary bag (20), said pieces (1) are subject to gamma sterilization.
15. - Dispositif de conditionnement de pièces en élastomère (1 ), tels que des bouchons de récipients pharmaceutiques, comportant un sac primaire (10) en matériau sensiblement imperméable à l'air recevant lesdites pièces (1 ), ledit sac primaire (10) contenant une atmosphère à base d'azote, avec au moins 80% d'azote, caractérisé en ce que ledit sac primaire (10) est conditionné dans un sac secondaire (20), avec application d'un vide entre ledit sac primaire (10) et ledit sac secondaire (20). 15. - Device for packaging elastomer parts (1), such as caps for pharmaceutical containers, comprising a primary bag (10) of substantially air-tight material receiving said parts (1), said primary bag (10) containing a nitrogen-based atmosphere, with at least 80% nitrogen, characterized in that said primary bag (10) is packaged in a secondary bag (20), with application of a vacuum between said primary bag (10) ) and said secondary bag (20).
16. - Dispositif selon la revendication 15, dans lequel l'atmosphère dans ledit sac primaire (10) contient au moins 90% d'azote. 16. - Device according to claim 15, wherein the atmosphere in said primary bag (10) contains at least 90% nitrogen.
17. - Dispositif selon la revendication 16, dans lequel l'atmosphère dans ledit sac primaire (10) contient 100% d'azote. 17. - Device according to claim 16, wherein the atmosphere in said primary bag (10) contains 100% nitrogen.
18. - Dispositif selon la revendication 15 ou la revendication 16, dans lequel l'atmosphère dans ledit sac primaire (10) est constituée sensiblement d'azote et d'oxygène. 18. - Device according to claim 15 or claim 16, wherein the atmosphere in said primary bag (10) consists substantially of nitrogen and oxygen.
19. - Dispositif selon l'une quelconque des revendications 15 à 18, dans lequel ledit sac primaire (10) comprend du polyéthylène ou de l'aluminium. 19. - Device according to any one of claims 15 to 18, wherein said primary bag (10) comprises polyethylene or aluminum.
20. - Dispositif selon l'une quelconque des revendications 15 à 19, dans lequel ledit sac secondaire (20) comporte plusieurs couches, notamment une structure tri-couches polyéthylène/polyamide/polyéthylène (PE/PA/PE). 20. - Device according to any one of claims 15 to 19, wherein said secondary bag (20) comprises several layers, including a tri-layer structure polyethylene / polyamide / polyethylene (PE / PA / PE).
21 . - Dispositif de conditionnement de pièces en élastomère (1 ), tels que des bouchons de récipients pharmaceutiques, comportant un sac primaire (10) en matériau perméable à l'air recevant lesdites pièces (1 ), ledit sac primaire (10) étant conditionné dans un sac secondaire (20) en matériau sensiblement imperméable à l'air, ledit sac primaire (10) et ledit sac secondaire (20) contenant une atmosphère à base d'azote, avec au moins 80% d'azote, caractérisé en ce que ledit sac secondaire (20) est conditionné dans un sac tertiaire (30), avec application d'un vide entre ledit sac secondaire (20) et ledit sac tertiaire (30). 21. - Device for packaging elastomer parts (1), such as caps for pharmaceutical containers, comprising a primary bag (10) of breathable material receiving said parts (1), said primary bag (10) being conditioned in a secondary bag (20) of substantially air-impermeable material, said primary bag (10) and said secondary bag (20) containing a nitrogen-based atmosphere with at least 80% nitrogen, characterized in that said secondary bag (20) is packaged in a tertiary bag (30), with application of a vacuum between said secondary bag (20) and said tertiary bag (30).
22. - Dispositif selon la revendication 21 , dans lequel l'atmosphère dans lesdits sacs primaire (10) et secondaire (20) contient au moins 90% d'azote. 22. - Device according to claim 21, wherein the atmosphere in said primary bags (10) and secondary (20) contains at least 90% nitrogen.
23. - Dispositif selon la revendication 22, dans lequel l'atmosphère dans lesdits sacs primaire (10) et secondaire (20) contient 100% d'azote. 23. - Device according to claim 22, wherein the atmosphere in said primary bags (10) and secondary (20) contains 100% nitrogen.
24.- Dispositif selon la revendication 21 ou la revendication 22, dans lequel l'atmosphère dans lesdits sacs primaire (10) et secondaire (20) est constituée sensiblement d'azote et d'oxygène. The device of claim 21 or claim 22, wherein the atmosphere in said primary (10) and secondary (20) bags is substantially nitrogen and oxygen.
25.- Dispositif selon l'une quelconque des revendications 21 à 24, dans lequel ledit sac primaire (10) perméable à l'air comprend du polyéthylène, notamment du Tyvek®. Apparatus according to any one of claims 21 to 24, wherein said air permeable primary bag (10) comprises polyethylene, especially Tyvek®.
26.- Dispositif selon l'une quelconque des revendications 21 à 25, dans lequel ledit sac secondaire (20) comporte plusieurs couches, notamment une structure quadri-couches avec une couche interne en polyéthylène téréphtalate, une couche en aluminium, une couche en polyamide et une couche externe en polyéthylène. 26.- Device according to any one of claims 21 to 25, wherein said secondary bag (20) comprises several layers, including a four-layer structure with an inner layer of polyethylene terephthalate, an aluminum layer, a polyamide layer and an outer layer of polyethylene.
27.- Dispositif selon l'une quelconque des revendications 21 à 26, dans lequel ledit sac tertiaire (30) comprend du polyéthylène. The device of any one of claims 21 to 26, wherein said tertiary bag (30) comprises polyethylene.
EP15808690.0A 2014-10-17 2015-10-12 Method and device for packaging elastomer parts Withdrawn EP3206954A1 (en)

Applications Claiming Priority (2)

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FR1460016A FR3027288B1 (en) 2014-10-17 2014-10-17 METHOD AND DEVICE FOR CONDITIONING ELASTOMER PARTS.
PCT/FR2015/052745 WO2016059337A1 (en) 2014-10-17 2015-10-12 Method and device for packaging elastomer parts

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IL (1) IL251561A0 (en)
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TWI592345B (en) 2017-07-21
KR20170070192A (en) 2017-06-21
WO2016059337A1 (en) 2016-04-21
FR3027288A1 (en) 2016-04-22
FR3027288B1 (en) 2022-11-04
US20170233124A1 (en) 2017-08-17
TW201615160A (en) 2016-05-01
IL251561A0 (en) 2017-05-29
JP2017531604A (en) 2017-10-26
CN107074428A (en) 2017-08-18

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