WO2012090328A1 - バイアル用ゴム栓 - Google Patents
バイアル用ゴム栓 Download PDFInfo
- Publication number
- WO2012090328A1 WO2012090328A1 PCT/JP2010/073807 JP2010073807W WO2012090328A1 WO 2012090328 A1 WO2012090328 A1 WO 2012090328A1 JP 2010073807 W JP2010073807 W JP 2010073807W WO 2012090328 A1 WO2012090328 A1 WO 2012090328A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- rubber
- vial
- stopper
- hardness
- cap
- Prior art date
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Classifications
-
- 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
- B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
- B65D39/0052—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in more than one piece
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1406—Septums, pierceable membranes
-
- 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
- B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
- B65D39/0052—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers made in more than one piece
- B65D39/007—Plastic cap-shaped hollow plugs
-
- 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
- B65D51/00—Closures not otherwise provided for
- B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
Definitions
- the present invention relates to a rubber stopper for a vial. More specifically, it is a rubber stopper for vials suitable for production and use of lyophilized preparations.
- vials and ampoules as containers for storing small amounts of chemicals.
- the vial is mainly sealed in a small amount container such as glass or plastic by a rubber stopper being plugged into the opening of the container. Even if the container is not opened (or destroyed), it can be communicated with an instrument such as a syringe by inserting a hollow needle into the rubber stopper, so that the work can be performed in a sanitary manner without opening the container carelessly. Therefore, it is used as a container for various drugs regardless of liquid powder.
- vials are manufactured by the following procedure.
- a predetermined amount of drug is sealed in a cylindrical bottle container having an upper opening, and a rubber plug leg is lightly inserted into the opening (half-plugging).
- Plugging is performed by a plurality of plugging machines prepared as described above. (In the case of a freeze-dried preparation vial, the vial is placed in a freeze-drier in a half-plugged state, the drug is lyophilized, and plugged with a stopper). The plugging is performed by knocking down the pressing plate from above and pushing in the rubber plug.
- the presser plate and the rubber plug are pressure-contacted in the plugging process.
- the vial will be lifted together with the rubber stopper when the holding plate is raised, the lifted vial falls and breaks, and all lots cannot be used End up. Therefore, it is desired to increase the hardness of the top surface of the rubber plug from the viewpoint of avoiding sticking between the pressing plate and the rubber plug.
- Japanese Patent Application Laid-Open No. 2004-231216 is an example of a rubber plug formed using a plurality of rubber materials in order to have a plurality of functions. This is made of chlorinated polyethylene rubber or chlorosulfonated polyethylene rubber, etc., from the viewpoint of long-term stability of the drug in the vial and prevention of alteration of the rubber stopper by the drug.
- the needle stick part uses natural rubber, isoprene rubber or butadiene rubber.
- the configuration of the rubber plug of Patent Document 1 is insufficient.
- the rubber plug of Patent Document 1 prevents sticking to the pressing plate by providing a projection on the top surface of the cap, but currently, the sticking of the pressing plate is prevented only by providing the projection on the top surface. Can fail and vial breakage may occur.
- the needle stick part should be formed of natural rubber, isoprene rubber or butadiene rubber in consideration of resealability, but these rubbers have high gas permeability, so If the rubber is formed through these rubbers, the storage state of the drug in the vial is affected.
- An object of the present invention is to provide a rubber stopper for a vial which uses a plurality of rubbers and does not cause sticking to a pressing plate and coring.
- a rubber stopper for a vial provided with a leg portion that is located outward from the puncture region and that protrudes downward from the bottom surface of the cap portion, the puncture region having a rubber hardness of 20
- the top of the cap portion other than the concave portion is made of rubber having a rubber hardness of 58 to 90, and is a rubber stopper for vials.
- the vial stopper for the vial is formed of a rubber having a high rubber hardness at the top of the cap portion that is in pressure contact with the pressing plate, and the portion into which the hollow needle is punctured is formed of a rubber having a low rubber hardness. Prevents sticking to the holding plate and does not cause coring. For this reason, the inventors have found that there is no breakage of the vial at the time of manufacture and no mixing of the rubber fine pieces into the drug at the time of use.
- the rubber stopper for vials of the present invention can be suitably used for medical treatment because it does not stick to the holding plate and does not cause coring.
- FIG. 1 is a longitudinal sectional view of an embodiment of a rubber stopper for vials according to the present invention.
- FIG. 2 is a longitudinal sectional view of an embodiment having a plurality of puncture regions of the rubber stopper for vials of the present invention.
- FIG. 3 is a longitudinal sectional view of another embodiment of the rubber stopper for vials of the present invention.
- FIG. 4 is a longitudinal sectional view of another embodiment of the rubber stopper for vials of the present invention.
- FIG. 5 is a longitudinal sectional view of another embodiment of the rubber stopper for vials of the present invention.
- the shade portion 1 having a flange has a concave portion 2 at the center of the top surface, and a plurality of protrusions are formed at equal intervals radially away from the concave portion in a certain direction.
- a puncture region is provided so as to run vertically from the concave portion to the bottom surface.
- two circular columnar leg portions projecting downward are formed so as to surround the puncture region.
- An upper portion of the container body 1 is formed to have an inclined portion 11 inclined toward the spout.
- the puncture area is formed of chlorinated butyl rubber (rubber having a low rubber hardness) that does not include clay, and the puncture area is formed of a rubber having a high rubber hardness including 60 clay with respect to the chlorinated butyl rubber 100. ing. By selecting rubber in this way, coring does not occur even when the hollow needle is pierced, and sticking to the pressing plate does not occur.
- chlorinated butyl rubber is used as both a rubber having a high rubber hardness and a rubber having a low rubber hardness.
- Chlorinated butyl rubber is excellent in gas impermeability, has no deterioration due to chemicals, and does not elute into chemicals, and therefore can be suitably used.
- the rubber hardness of the rubber plug is adjusted by adding clay to chlorinated butyl rubber.
- chlorinated butyl rubber was mentioned, but it is not limited to chlorinated butyl rubber, and it is highly airtight so that it can be used as a rubber stopper for vials. Any material may be used as long as it does not cause adverse effects such as elution of components.
- the top of the cap portion of the rubber plug is made of rubber that does not stick to the pressure plate
- the puncture area is made of a material that does not cause coring by hollow needle puncture. If used, the rubber is not particularly limited.
- the top of the cap and the puncture area are both formed of chlorinated butyl rubber, but the top of the cap and the puncture area may not be the same rubber.
- one recess is formed at the center of the top of the cap, and is formed so as to be longitudinally cut from the recess to the bottom of the cap.
- the concave portion may not be provided at the center of the top of the cap portion, or may be a plurality of recesses.
- Two concave portions may be formed, and a puncture region may be provided so as to run vertically from the respective concave portions to the bottom surface of the cap portion.
- the puncture region is set to be present inside the region surrounded by the legs of the cap. If the puncture region is provided so as to have a recess with respect to the top surface of the cap portion, contact with the pressing plate can be avoided, and the puncturing region does not stick to the pressing plate.
- the shape of the leg portion is not particularly limited as long as it is airtight / liquid-tightly inserted into the opening of the vial.
- a simple cylindrical shape may be used.
- a cylindrical columnar body provided with a defective portion as used for a rubber stopper of a freeze-dried vial is a type, a C-shaped columnar body, or a cylinder that is found in the above embodiments. What provided the hole in the cap part side etc. is good.
- the top portion of the cap portion and the flange excluding the concave portion may be formed of rubber having high rubber hardness, and the other portions may be formed of rubber having low rubber hardness.
- the top and side portions of the cap portion excluding the concave portions may be formed of rubber with high rubber hardness, and other portions may be formed of rubber with low rubber hardness.
- the top portion of the cap portion other than the concave portion and the portion of the flange that does not come into contact with the bottle may be formed of rubber having high rubber hardness, and the other portion may be formed of rubber having low rubber hardness.
- the rubber having a low rubber hardness comes into contact with the bottle, so that it becomes easier to seal.
- a rubber material having a high rubber hardness is put into a first mold having a cap portion in the shape of an annular donut, and the mold is clamped and semi-vulcanized to form a primary molded product. Thereafter, the primary molded product is transferred to a second mold, a rubber material having low rubber hardness is charged, the mold is clamped, and the entire vulcanization is obtained.
- the compounding example of a filler is shown in Table 1 below.
- the rubber stopper formed by the composition of Table 1 is plugged into a vial, and a metal rod with a diameter of 6 mm is pushed into the puncture area from the top surface of the rubber stopper with a force of 60 N so that the puncture area part is the other part.
- Ten samples of the interfacial peel test were conducted to confirm whether or not they were separated, but none were separated.
- the manufacturing method is not limited to the above, and it can be manufactured by various methods. For example, once the rubber with high rubber hardness is formed by semi-vulcanization, the puncture area is hollowed out, the hollowed portion is filled with a rubber material with low rubber hardness, and the mold is clamped and fully vulcanized. can get.
- a hollow needle (18G11 / 2′RB metal needle manufactured by Nipro) is punctured 50 times at 3000 mm / min in the puncture area of each rubber plug to check for the presence of rubber pieces and missing rubber.
- the rubber hardness of the rubber plugs shown in Table 1 was measured using a micro rubber hardness meter MD-1capa (manufactured by Kobunshi Keiki Co., Ltd.).
- the rubber hardness of the puncture area was 30, and the rubber hardness of the part other than the puncture area was 65.
- vial rubber stoppers were made from various rubbers.
- Table 2 shows a blending example of the filler.
- a rubber stopper for a vial was prepared using the rubber listed in Table 2 as a rubber having a high rubber hardness and a rubber having a low rubber hardness, respectively.
- the top plate sticking test and the coring test were similarly performed on the rubber stopper for vials.
- Table 3 lists the rubber hardnesses of Formulations A to G and the test results.
- the rubber hardness that exhibits the effect of preventing sticking to the pressing plate is 58 to 90, and the rubber hardness that does not cause coring is 20 to 35.
- the rubber hardness 20 to 90 is a value capable of exhibiting the function as a rubber.
- the rubber stopper for vials of the present invention can be suitably used for medical treatment because it does not stick to the pressing plate and does not cause coring as described above.
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Closures For Containers (AREA)
Abstract
Description
25個のバイアル瓶に各々ゴム栓をSUS#400プレートで半打栓し、5.0Kgf/cm2の押し込み圧で15分間保持した後、SUSプレートを上昇させる。この時にくっついてバイアルが持ち上げられ、落下するまでの時間及び倒瓶本数を数える。
10個のゴム栓について各々ゴム栓の穿刺領域に、中空針(18G11/2’RB金属針 ニプロ製)を3000mm/minで50回穿刺し、ゴム片及びゴム欠の有無について確認する。
2 穿刺領域
3 笠部
4 脚部
Claims (4)
- フランジを有する笠部と、該笠部の天面に凹部を有するように形成され、前記凹部から底面まで前記笠部を軸方向に縦断するように形成された穿刺領域と、前記笠部の軸心に対して前記穿刺領域より外方位置であって、且つ、前記笠部の底面に下方に突出するように形成された脚部とを備えるバイアル用ゴム栓であって、
前記穿刺領域はゴム硬さ20~35のゴムで形成され、
かつ、前記笠部の前記凹部以外の天面はゴム硬さ58~90のゴムで形成されてなる
バイアル用ゴム栓。 - 前記笠部の前記凹部以外の天面を除いてゴム硬さ20~35のゴムで形成されてなる、請求項1に記載のバイアル用ゴム栓。
- 前記笠部の前記凹部以外の天面及び側部を除いてゴム硬さ20~35のゴムで形成されてなる、請求項1に記載のバイアル用ゴム栓。
- 前記笠部の前記凹部以外の天面及び前記フランジを除いてゴム硬さ20~35のゴムで形成されてなる、請求項1に記載のバイアル用ゴム栓。
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/997,513 US10131472B2 (en) | 2010-12-28 | 2010-12-28 | Vial rubber stopper |
CN201080070973.2A CN103269955B (zh) | 2010-12-28 | 2010-12-28 | 小瓶橡胶塞 |
JP2012550647A JP5768820B2 (ja) | 2010-12-28 | 2010-12-28 | バイアル用ゴム栓 |
EP10861474.4A EP2660163B1 (en) | 2010-12-28 | 2010-12-28 | Rubber stopper for vial |
PCT/JP2010/073807 WO2012090328A1 (ja) | 2010-12-28 | 2010-12-28 | バイアル用ゴム栓 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/JP2010/073807 WO2012090328A1 (ja) | 2010-12-28 | 2010-12-28 | バイアル用ゴム栓 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2012090328A1 true WO2012090328A1 (ja) | 2012-07-05 |
Family
ID=46382476
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2010/073807 WO2012090328A1 (ja) | 2010-12-28 | 2010-12-28 | バイアル用ゴム栓 |
Country Status (5)
Country | Link |
---|---|
US (1) | US10131472B2 (ja) |
EP (1) | EP2660163B1 (ja) |
JP (1) | JP5768820B2 (ja) |
CN (1) | CN103269955B (ja) |
WO (1) | WO2012090328A1 (ja) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2016502066A (ja) * | 2012-10-23 | 2016-01-21 | コパン イタリア エス.ピー.エー | 生物流体用の容器の閉鎖要素 |
WO2022137609A1 (ja) | 2020-12-23 | 2022-06-30 | 株式会社大協精工 | ゴム栓 |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
IT201700047199A1 (it) * | 2017-05-02 | 2018-11-02 | Goglio Spa | Tappo a pressione e contenitore ermetico dotato di tale tappo a pressione |
IL271173B2 (en) * | 2017-07-21 | 2024-04-01 | Amgen Inc | Gas permeable sealing element for drug container and methods of assembly |
CN113474083A (zh) * | 2019-01-04 | 2021-10-01 | 仪器实验室公司 | 用于高刺穿计数应用的容器塞子 |
RU203187U1 (ru) * | 2020-06-03 | 2021-03-25 | Производственное унитарное предприятие "АЛКОПАК" | Пробка медицинская |
EP4190378A1 (en) * | 2021-12-06 | 2023-06-07 | Becton, Dickinson and Company | Stopper for a syringe having anti-sticking features |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
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JPS55101758U (ja) * | 1979-01-11 | 1980-07-15 | ||
JP2001219949A (ja) * | 2000-02-10 | 2001-08-14 | Sekisui Chem Co Ltd | 真空検体採取容器用栓体 |
JP2002065810A (ja) * | 2000-08-29 | 2002-03-05 | Ohtsu Tire & Rubber Co Ltd :The | 医療用ゴム栓 |
JP2002306569A (ja) * | 2001-04-12 | 2002-10-22 | Ohtsu Tire & Rubber Co Ltd :The | 医療用ゴム栓 |
JP2004215860A (ja) * | 2003-01-14 | 2004-08-05 | Sytecs Corp | 薬液容器用接合栓 |
JP2004231216A (ja) | 2003-01-29 | 2004-08-19 | Sumitomo Rubber Ind Ltd | 高密封容器用ゴム栓 |
WO2004103453A1 (ja) * | 2003-05-22 | 2004-12-02 | Otsuka Pharmaceutical Factory, Inc. | 封止体とそれを備えるキャップおよび医療用容器 |
US20060175280A1 (en) * | 2003-07-18 | 2006-08-10 | Hideo Anraku | Hermetically sealed container and vacuum test substance-collecting container |
Family Cites Families (7)
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US4465200A (en) * | 1983-06-06 | 1984-08-14 | Becton, Dickinson And Company | Low contamination closure for blood collection tubes |
JPH0397450A (ja) | 1989-09-11 | 1991-04-23 | Yukitaka Furukawa | 真空採血管 |
CA2015571A1 (en) * | 1990-04-26 | 1991-10-26 | Samco Scientific, Inc. | Reinsertable closure for sample tubes |
EP1066881A3 (en) | 1999-07-09 | 2002-07-03 | Becton Dickinson and Company | Specimen collection assembly with cap |
JP4579484B2 (ja) | 2002-06-24 | 2010-11-10 | ニプロ株式会社 | 液漏れの改良された医療用ゴム栓 |
JP2004123121A (ja) | 2002-09-30 | 2004-04-22 | Sumitomo Rubber Ind Ltd | 凍結乾燥用ゴム栓 |
DE602005008839D1 (de) * | 2004-09-14 | 2008-09-25 | Daikyo Seiko Ltd | Behälter für Medikamente und Gummiverschluss |
-
2010
- 2010-12-28 CN CN201080070973.2A patent/CN103269955B/zh active Active
- 2010-12-28 WO PCT/JP2010/073807 patent/WO2012090328A1/ja active Application Filing
- 2010-12-28 US US13/997,513 patent/US10131472B2/en active Active
- 2010-12-28 EP EP10861474.4A patent/EP2660163B1/en active Active
- 2010-12-28 JP JP2012550647A patent/JP5768820B2/ja active Active
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
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JPS55101758U (ja) * | 1979-01-11 | 1980-07-15 | ||
JP2001219949A (ja) * | 2000-02-10 | 2001-08-14 | Sekisui Chem Co Ltd | 真空検体採取容器用栓体 |
JP2002065810A (ja) * | 2000-08-29 | 2002-03-05 | Ohtsu Tire & Rubber Co Ltd :The | 医療用ゴム栓 |
JP2002306569A (ja) * | 2001-04-12 | 2002-10-22 | Ohtsu Tire & Rubber Co Ltd :The | 医療用ゴム栓 |
JP2004215860A (ja) * | 2003-01-14 | 2004-08-05 | Sytecs Corp | 薬液容器用接合栓 |
JP2004231216A (ja) | 2003-01-29 | 2004-08-19 | Sumitomo Rubber Ind Ltd | 高密封容器用ゴム栓 |
WO2004103453A1 (ja) * | 2003-05-22 | 2004-12-02 | Otsuka Pharmaceutical Factory, Inc. | 封止体とそれを備えるキャップおよび医療用容器 |
US20060175280A1 (en) * | 2003-07-18 | 2006-08-10 | Hideo Anraku | Hermetically sealed container and vacuum test substance-collecting container |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2016502066A (ja) * | 2012-10-23 | 2016-01-21 | コパン イタリア エス.ピー.エー | 生物流体用の容器の閉鎖要素 |
WO2022137609A1 (ja) | 2020-12-23 | 2022-06-30 | 株式会社大協精工 | ゴム栓 |
KR20230101873A (ko) | 2020-12-23 | 2023-07-06 | 가부시끼가이샤 다이쿄 세이코 | 고무마개 |
Also Published As
Publication number | Publication date |
---|---|
JP5768820B2 (ja) | 2015-08-26 |
CN103269955B (zh) | 2016-03-30 |
EP2660163A4 (en) | 2014-06-11 |
US20130270271A1 (en) | 2013-10-17 |
US10131472B2 (en) | 2018-11-20 |
CN103269955A (zh) | 2013-08-28 |
EP2660163A1 (en) | 2013-11-06 |
EP2660163B1 (en) | 2018-11-28 |
JPWO2012090328A1 (ja) | 2014-06-05 |
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