EP3206954A1 - Verfahren und vorrichtung zur verpackung von elastomerteilen - Google Patents

Verfahren und vorrichtung zur verpackung von elastomerteilen

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Withdrawn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
English (en)
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/de
Withdrawn legal-status Critical Current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

  • Mechanical Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Toxicology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Bag Frames (AREA)
  • Vacuum Packaging (AREA)
EP15808690.0A 2014-10-17 2015-10-12 Verfahren und vorrichtung zur verpackung von elastomerteilen Withdrawn EP3206954A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1460016A FR3027288B1 (fr) 2014-10-17 2014-10-17 Procede et dispositif de conditionnement de pieces en elastomere.
PCT/FR2015/052745 WO2016059337A1 (fr) 2014-10-17 2015-10-12 Procédé et dispositif de conditionnement de pièces en élastomère

Publications (1)

Publication Number Publication Date
EP3206954A1 true EP3206954A1 (de) 2017-08-23

Family

ID=52345306

Family Applications (1)

Application Number Title Priority Date Filing Date
EP15808690.0A Withdrawn EP3206954A1 (de) 2014-10-17 2015-10-12 Verfahren und vorrichtung zur verpackung von elastomerteilen

Country Status (9)

Country Link
US (1) US20170233124A1 (de)
EP (1) EP3206954A1 (de)
JP (1) JP2017531604A (de)
KR (1) KR20170070192A (de)
CN (1) CN107074428A (de)
FR (1) FR3027288B1 (de)
IL (1) IL251561A0 (de)
TW (1) TWI592345B (de)
WO (1) WO2016059337A1 (de)

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JP2024061493A (ja) 2022-10-21 2024-05-07 住友ゴム工業株式会社 医療用ゴム部品の滅菌方法

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US20110226762A1 (en) * 2008-06-09 2011-09-22 Beton Dickinson France S.A.S. Sterile packing and sterilization method using this packing

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WO2015092236A1 (fr) 2013-12-16 2015-06-25 Aptar Stelmi Sas Procede et dispositif de conditionnement de pieces en elastomere

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

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