WO2015092236A1 - Procede et dispositif de conditionnement de pieces en elastomere - Google Patents
Procede et dispositif de conditionnement de pieces en elastomere Download PDFInfo
- Publication number
- WO2015092236A1 WO2015092236A1 PCT/FR2014/053320 FR2014053320W WO2015092236A1 WO 2015092236 A1 WO2015092236 A1 WO 2015092236A1 FR 2014053320 W FR2014053320 W FR 2014053320W WO 2015092236 A1 WO2015092236 A1 WO 2015092236A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- bag
- parts
- tertiary
- primary
- layer
- Prior art date
Links
Classifications
-
- 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
- A61L2/04—Heat
- A61L2/06—Hot gas
- A61L2/07—Steam
-
- 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
- B65B63/00—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged
-
- 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
- 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
- B65B5/00—Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
- B65B5/06—Packaging groups of articles, the groups being treated as single articles
- B65B5/061—Filled 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
- B65B55/10—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
- 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
-
- 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
-
- 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 pharmaceutical products are generally closed, after filling, in a sealed and sterile manner by appropriate plugs, typically made of elastomeric materials. 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 usually packaged in two bags, namely a polyethylene (PE) primary bag, including Tyvek®, containing the plugs directly, and a polyethylene / polyamide / polyethylene triple-layer secondary bag (PE / PA / PE) disposed around said primary bag.
- PE polyethylene
- PA polyethylene
- This packaging system has disadvantages. Thus, it does not allow in particular to ensure optimum moisture content of the caps at the opening of the bags by the customer. In fact, insufficient impermeability of the constituent materials said bags does not ensure this optimal rate, which can cause difficulties when using said plugs after opening of said bags, such as the release of moisture plugs to the conditioned substance.
- the same problem may arise for other types of elastomer parts, such as for example syringe pistons or syringe needle guards.
- 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 an optimal moisture content in the primary bag of the packaging device.
- the present invention therefore relates to a method of packaging elastomeric parts, such as caps for pharmaceutical containers, comprising the following steps:
- said primary bag containing said washed parts is subjected to steam sterilization, in particular in an autoclave.
- said parts are subject to gamma sterilization.
- said primary bag comprises polyethylene, in particular Tyvek®.
- said secondary bag comprises an aluminum layer.
- 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.
- the present invention also relates to a device for packaging elastomer parts, such as caps for pharmaceutical containers, characterized in that it comprises a primary bag directly receiving said washed parts, a secondary waterproof and impervious bag receiving said primary bag , and a tertiary bag receiving said bag secondary, the space between said secondary and tertiary bags being subjected to a vacuum.
- said primary bag comprises polyethylene, in particular Tyvek®.
- said secondary bag comprises an aluminum layer.
- 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 primary bag containing plugs
- FIG. 2 is a schematic view of a secondary bag disposed around the primary bag of FIG. 1,
- FIG. 3 is a schematic view of a tertiary bag disposed around the secondary bag of FIG. 2, and
- Figure 4 is a graph illustrating the permeability test applicable to the secondary bag.
- 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, a sealed and waterproof secondary bag 20 receiving said primary bag 10, and a tertiary bag 30 receiving said secondary bag 20.
- An air gap is formed between the secondary 20 and tertiary bag 30. This vacuum of air can detect a possible integrity problem, which would manifest itself by a loss of vacuum causing the separation of said secondary and tertiary bags 30.
- the primary bag 10 advantageously comprises polyethylene, in particular Tyvek®. This material has a very vapor permeable face.
- Tertiary bag 30 also advantageously comprises polyethylene.
- This tertiary bag 30 may be multilayer, for example with an inner layer of polyethylene, a central layer of polyamide and an outer layer of polyethylene.
- Other materials are also conceivable, provided that they allow the establishment and maintenance of a vacuum between the secondary bag 20 and the tertiary bag 30.
- the secondary bag 20 advantageously comprises aluminum, which has excellent impermeability properties.
- This secondary bag may for example comprise several layers, including a four-layer structure with an inner layer of polyethylene terephthalate, an aluminum layer, a polyamide layer and a polyethylene outer layer.
- This secondary bag 20 is considered waterproof and impermeable within the meaning of the present invention if it presents satisfactory results in the following permeability test.
- This test consists of measuring the weight gain of a hygroscopic powder (CaCl 2 ) packaged in the material to be tested and exposed in an environment whose humidity and temperature are controlled.
- the CaCl 2 powder is pre-dried in an oven for 72 hours at 150 ° C.
- the bag is considered waterproof and impermeable within the meaning of the present invention if the weight gain recorded after 60 days does not exceed 0.1 g.
- PE polyethylene
- PA polyamide / polyethylene
- a four-layer bag according to an advantageous embodiment of the present invention is perfectly waterproof and impervious to it, and thus satisfies the permeability test.
- the thicker the secondary bag the more waterproof and impervious it will be.
- the parts are first washed and then packaged in the primary bag.
- Said primary bag is then subjected to steam sterilization, for example in an autoclave.
- a drying step to reach the desired moisture content.
- the primary bag after steam sterilization and drying, is then packaged in the secondary bag which itself is conditioned in the tertiary bag, with application of a vacuum between the secondary and tertiary bags.
- the parts are first washed and then packaged in the primary bag. After packaging in the primary bag, the pieces are dried to reach a desired moisture content.
- the primary bag, after drying is then packaged in the secondary bag which itself is packaged in the tertiary bag, with application of a vacuum between the secondary and tertiary bags. Then, the whole is sterilized by gamma irradiation, which can be done after cardboard and palletizing.
- the invention makes it possible to guarantee the moisture content of the sterile pieces until the bags are opened, whatever the conditions and duration 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.
Abstract
Description
Claims
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US15/100,078 US20160368646A1 (en) | 2013-12-16 | 2014-12-12 | Method and device for packaging elastomer parts |
JP2016539920A JP2017508672A (ja) | 2013-12-16 | 2014-12-12 | エラストマー部品のパッケージ方法及びパッケージ装置 |
CN201480067927.5A CN105813943B (zh) | 2013-12-16 | 2014-12-12 | 用于封装弹性体部件的方法和装置 |
KR1020167019067A KR20160097368A (ko) | 2013-12-16 | 2014-12-12 | 탄성체 부품을 패키징하는 방법 및 디바이스 |
EP14833506.0A EP3083409A1 (fr) | 2013-12-16 | 2014-12-12 | Procédé et dispositif de conditionnement de pièces en élastomère |
IL245732A IL245732A0 (en) | 2013-12-16 | 2016-05-19 | Method and device for packing elastomer parts |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR1362719 | 2013-12-16 | ||
FR1362719A FR3014851B1 (fr) | 2013-12-16 | 2013-12-16 | Procede et dispositif de conditionnement de pieces en elastomere. |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2015092236A1 true WO2015092236A1 (fr) | 2015-06-25 |
Family
ID=50482989
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/FR2014/053320 WO2015092236A1 (fr) | 2013-12-16 | 2014-12-12 | Procede et dispositif de conditionnement de pieces en elastomere |
Country Status (8)
Country | Link |
---|---|
US (1) | US20160368646A1 (fr) |
EP (1) | EP3083409A1 (fr) |
JP (1) | JP2017508672A (fr) |
KR (1) | KR20160097368A (fr) |
CN (1) | CN105813943B (fr) |
FR (1) | FR3014851B1 (fr) |
IL (1) | IL245732A0 (fr) |
WO (1) | WO2015092236A1 (fr) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TWI628123B (zh) * | 2016-04-01 | 2018-07-01 | 阿普塔斯黛美簡易股份公司 | 用於包裝由彈性體製成的部件的包裝方法和裝置 |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR3027288B1 (fr) | 2014-10-17 | 2022-11-04 | Aptar Stelmi Sas | Procede et dispositif de conditionnement de pieces en elastomere. |
Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4449632A (en) * | 1982-12-15 | 1984-05-22 | Marusiak Jr Frank | Tamper-proof package and method |
EP0201880A2 (fr) | 1985-05-13 | 1986-11-20 | ANTIBIOTICI CRISTALLIZZATI STERILI ACS S.p.A. | Récipient composite pour produits solides stériles |
FR2589447A3 (fr) * | 1985-11-04 | 1987-05-07 | Philips Nv | Sac d'isolation thermique pour l'emballage sous vide de micropoudres |
DE3717916A1 (de) * | 1987-05-27 | 1988-12-08 | Muenchner Medizin Mechanik | Verfahren zum verpacken von sterilisiergut und sterilisierverpackung |
DE9407863U1 (de) * | 1993-05-19 | 1994-07-14 | Helvoet Pharma | Beutel zur Aufnahme und Sterilisation von medizinischen Geräten |
FR2756259A1 (fr) | 1996-11-25 | 1998-05-29 | Pml Microbiologicals Inc | Procede pour fabriquer un emballage sterile et produit ainsi forme |
DE102007056261A1 (de) * | 2007-05-23 | 2008-11-27 | Helvoet Pharma Belgium N.V. | Vielzahl von in einem Transportbehältnis zusammengefassten Sterilisationsobjekten, Transportbehältnis, sowie Verfahren zur Sterilisierung von derartigen Objekten |
JP3166576U (ja) | 2010-12-27 | 2011-03-10 | 日本メディカルマテリアル株式会社 | 生体埋植用医療機器の包装体 |
EP3206954A1 (fr) | 2014-10-17 | 2017-08-23 | Aptar Stelmi SAS | Procédé et dispositif de conditionnement de pièces en élastomère |
Family Cites Families (10)
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DE4438360C2 (de) * | 1994-10-27 | 1999-05-20 | Schott Glas | Vorfüllbare partikelarme, sterile Einmalspritze für die Injektion von Präparaten und Verfahren zu ihrer Herstellung |
US6161695A (en) * | 1998-08-21 | 2000-12-19 | Depuy Orthopaedics, Inc. | Protective packaging unit |
US6818178B2 (en) * | 2001-08-16 | 2004-11-16 | Environmental Tectonics Corporation | Method for high vacuum sterilization of closures |
US7220053B2 (en) * | 2003-12-16 | 2007-05-22 | Sunbeam Products, Inc. | Flexible composite bag for vacuum sealing |
CN1328130C (zh) * | 2004-01-16 | 2007-07-25 | 力特光电科技股份有限公司 | 光学薄板的包装组合及其方法 |
EP2293821B1 (fr) * | 2008-06-09 | 2013-08-28 | Becton Dickinson France | Emballage stérile et procédé de stérilisation utilisant ledit emballage |
CN201351006Y (zh) * | 2009-01-01 | 2009-11-25 | 方敏 | 伤口贴铝箔复合型包装袋 |
JP2010220681A (ja) * | 2009-03-19 | 2010-10-07 | Terumo Corp | 血液回路セット |
JP5919658B2 (ja) * | 2011-06-21 | 2016-05-18 | 三浦工業株式会社 | 薬剤包装体 |
JP3194151U (ja) * | 2014-08-28 | 2014-11-06 | 栄研化学株式会社 | 培地包装体 |
-
2013
- 2013-12-16 FR FR1362719A patent/FR3014851B1/fr active Active
-
2014
- 2014-12-12 KR KR1020167019067A patent/KR20160097368A/ko not_active Application Discontinuation
- 2014-12-12 EP EP14833506.0A patent/EP3083409A1/fr not_active Withdrawn
- 2014-12-12 US US15/100,078 patent/US20160368646A1/en not_active Abandoned
- 2014-12-12 CN CN201480067927.5A patent/CN105813943B/zh active Active
- 2014-12-12 JP JP2016539920A patent/JP2017508672A/ja active Pending
- 2014-12-12 WO PCT/FR2014/053320 patent/WO2015092236A1/fr active Application Filing
-
2016
- 2016-05-19 IL IL245732A patent/IL245732A0/en unknown
Patent Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4449632A (en) * | 1982-12-15 | 1984-05-22 | Marusiak Jr Frank | Tamper-proof package and method |
EP0201880A2 (fr) | 1985-05-13 | 1986-11-20 | ANTIBIOTICI CRISTALLIZZATI STERILI ACS S.p.A. | Récipient composite pour produits solides stériles |
FR2589447A3 (fr) * | 1985-11-04 | 1987-05-07 | Philips Nv | Sac d'isolation thermique pour l'emballage sous vide de micropoudres |
DE3717916A1 (de) * | 1987-05-27 | 1988-12-08 | Muenchner Medizin Mechanik | Verfahren zum verpacken von sterilisiergut und sterilisierverpackung |
DE9407863U1 (de) * | 1993-05-19 | 1994-07-14 | Helvoet Pharma | Beutel zur Aufnahme und Sterilisation von medizinischen Geräten |
FR2756259A1 (fr) | 1996-11-25 | 1998-05-29 | Pml Microbiologicals Inc | Procede pour fabriquer un emballage sterile et produit ainsi forme |
DE102007056261A1 (de) * | 2007-05-23 | 2008-11-27 | Helvoet Pharma Belgium N.V. | Vielzahl von in einem Transportbehältnis zusammengefassten Sterilisationsobjekten, Transportbehältnis, sowie Verfahren zur Sterilisierung von derartigen Objekten |
JP3166576U (ja) | 2010-12-27 | 2011-03-10 | 日本メディカルマテリアル株式会社 | 生体埋植用医療機器の包装体 |
EP3206954A1 (fr) | 2014-10-17 | 2017-08-23 | Aptar Stelmi SAS | Procédé et dispositif de conditionnement de pièces en élastomère |
Non-Patent Citations (1)
Title |
---|
See also references of EP3083409A1 |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TWI628123B (zh) * | 2016-04-01 | 2018-07-01 | 阿普塔斯黛美簡易股份公司 | 用於包裝由彈性體製成的部件的包裝方法和裝置 |
CN108778950A (zh) * | 2016-04-01 | 2018-11-09 | 阿普塔斯黛美简易股份公司 | 包装由弹性体制成的部件的包装方法和包装装置 |
CN108778950B (zh) * | 2016-04-01 | 2020-09-04 | 阿普塔斯黛美简易股份公司 | 包装由弹性体制成的部件的包装方法和包装装置 |
Also Published As
Publication number | Publication date |
---|---|
KR20160097368A (ko) | 2016-08-17 |
FR3014851A1 (fr) | 2015-06-19 |
FR3014851B1 (fr) | 2016-01-22 |
EP3083409A1 (fr) | 2016-10-26 |
JP2017508672A (ja) | 2017-03-30 |
US20160368646A1 (en) | 2016-12-22 |
CN105813943A (zh) | 2016-07-27 |
IL245732A0 (en) | 2016-07-31 |
CN105813943B (zh) | 2019-05-14 |
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