JPH03270928A - Manufacture of rubber stopper for vial - Google Patents
Manufacture of rubber stopper for vialInfo
- Publication number
- JPH03270928A JPH03270928A JP2071399A JP7139990A JPH03270928A JP H03270928 A JPH03270928 A JP H03270928A JP 2071399 A JP2071399 A JP 2071399A JP 7139990 A JP7139990 A JP 7139990A JP H03270928 A JPH03270928 A JP H03270928A
- Authority
- JP
- Japan
- Prior art keywords
- rubber
- mold
- vulcanized
- rubber stopper
- lower mold
- 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.)
- Granted
Links
- 229920001971 elastomer Polymers 0.000 title claims abstract description 70
- 239000005060 rubber Substances 0.000 title claims abstract description 70
- 238000004519 manufacturing process Methods 0.000 title claims description 12
- 238000000034 method Methods 0.000 claims abstract description 17
- 229920003002 synthetic resin Polymers 0.000 claims abstract description 15
- 239000000057 synthetic resin Substances 0.000 claims abstract description 15
- 239000004636 vulcanized rubber Substances 0.000 claims abstract description 9
- 238000004073 vulcanization Methods 0.000 claims description 22
- 238000010438 heat treatment Methods 0.000 claims description 11
- 239000000126 substance Substances 0.000 claims description 6
- 238000005520 cutting process Methods 0.000 claims description 4
- 238000004080 punching Methods 0.000 claims description 3
- 238000010030 laminating Methods 0.000 claims 2
- 239000000047 product Substances 0.000 abstract description 22
- 230000002950 deficient Effects 0.000 abstract description 7
- 238000003825 pressing Methods 0.000 abstract description 4
- 239000012467 final product Substances 0.000 abstract description 3
- 238000000465 moulding Methods 0.000 description 7
- 239000003795 chemical substances by application Substances 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- -1 polyethylene Polymers 0.000 description 3
- 238000011282 treatment Methods 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 2
- 238000000071 blow moulding Methods 0.000 description 2
- 229920005549 butyl rubber Polymers 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 238000013329 compounding Methods 0.000 description 2
- 238000011109 contamination Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 229920003051 synthetic elastomer Polymers 0.000 description 2
- 239000005061 synthetic rubber Substances 0.000 description 2
- 229920000181 Ethylene propylene rubber Polymers 0.000 description 1
- 244000043261 Hevea brasiliensis Species 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 239000005062 Polybutadiene Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 239000006087 Silane Coupling Agent Substances 0.000 description 1
- UCKMPCXJQFINFW-UHFFFAOYSA-N Sulphide Chemical compound [S-2] UCKMPCXJQFINFW-UHFFFAOYSA-N 0.000 description 1
- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical class [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 125000000484 butyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 239000004927 clay Substances 0.000 description 1
- 239000007799 cork Substances 0.000 description 1
- 238000003851 corona treatment Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 229920005555 halobutyl Polymers 0.000 description 1
- 229920003049 isoprene rubber Polymers 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 239000000395 magnesium oxide Substances 0.000 description 1
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 229920003052 natural elastomer Polymers 0.000 description 1
- 229920001194 natural rubber Polymers 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 229920002857 polybutadiene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 230000036316 preload Effects 0.000 description 1
- 238000010058 rubber compounding Methods 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000004945 silicone rubber Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 238000000992 sputter etching Methods 0.000 description 1
- KUAZQDVKQLNFPE-UHFFFAOYSA-N thiram Chemical compound CN(C)C(=S)SSC(=S)N(C)C KUAZQDVKQLNFPE-UHFFFAOYSA-N 0.000 description 1
- 229960002447 thiram Drugs 0.000 description 1
- 238000011179 visual inspection Methods 0.000 description 1
Abstract
Description
本発明はバイアル用ゴム栓、特に医薬品容器のための合
成樹脂フィルムでラミネートされたゴム栓の製造方法に
関する。The present invention relates to a method for manufacturing rubber stoppers for vials, particularly rubber stoppers laminated with a synthetic resin film for pharmaceutical containers.
従来バイアル用ゴム栓は、特公昭５４−９１１９号公報
・特開昭５７−４７６３７号公報などに開示されている
ように、ゴム栓の中の加硫促進剤やその他の配合剤など
が薬液中に浸出したり、薬液成分がゴムに吸着されたり
することによる医薬品への影響を防止するために、薬液
と接触するゴム栓面を耐薬品性を有する合成樹脂フィル
ムでラミネートされたゴム栓が知られている。
かかるう短ネートされたゴム栓の製造方法については２
種々の製造方法が提案されている。
例えば特公昭５７−５３１８４号公報にみられるように
。
合成樹脂フィルムと未加硫ゴムシートを重ね合わせ、金
型中でラミネートした脚部形状のみの素栓を成形、カッ
トした後、これを別の金型中に装填し、天面部を成形、
接着する方法などがある。Conventional rubber stoppers for vials have been disclosed in Japanese Patent Publication No. 54-9119 and Japanese Patent Application Laid-Open No. 57-47637, etc., in which the vulcanization accelerator and other compounding agents in the rubber stopper are mixed into the chemical solution. In order to prevent the effects on medicines due to leaching or adsorption of drug components to the rubber, rubber stoppers are known in which the surface of the rubber stopper that comes into contact with the drug solution is laminated with a chemical-resistant synthetic resin film. It is being Regarding the manufacturing method of such a shortened rubber stopper, see 2.
Various manufacturing methods have been proposed. For example, as seen in Japanese Patent Publication No. 57-53184. Synthetic resin film and unvulcanized rubber sheet are overlapped and laminated in a mold to form and cut a base plug with only the leg shape, then this is loaded into another mold and the top part is molded.
There are methods of adhesion.
しかし、これらの方法では工業的に多数個取りの金型を
使用し量的生産を実施する場合に、ゴムとフィルムとの
間に空隙ができ、接着不良を起こしたり、成形物中に気
泡ができたり、フィルム表面に皺を発生したりし、不良
品の発生率が多いという問題があった。However, when using these methods for mass production using industrial multi-cavity molds, voids may form between the rubber and the film, resulting in poor adhesion and the formation of air bubbles in the molded product. There were problems in that the film surface was wrinkled, and there was a high incidence of defective products.
【課題を解決するための手段及び作用】本発明は多数個
取りの金型を使用し、不良品の発生率の極めて少ないう
くネートされたゴム栓を製造する技術を提案するもので
ある。
本発明の方法は、多数個取りの金型を使い、棒状の未加
硫ゴムリボンを使用し加圧加熱し、半加硫状態のゴム栓
脚部形状の成型品を成形した後。
金型を開き下金型表面に合成樹脂フィルムを挿入した後
、加圧加熱を継続した後、ハリ部をカットし ゴム栓脚
部形状の素栓を形勢し、別に成形したゴム栓天面部形状
の半加硫ゴムシートと前記素栓を組合せ、金型中で加圧
加熱し接着成形した後。
ハリ部をカットし、ラミネートされたゴム栓を製造する
方法である。
すなわち２本発明は、多数個取りの金型を使用し２合成
樹脂フィルムをゴム栓脚部全面又は一部にラミネートす
るか、又はゴム栓脚部全面及び天面部下面の一部にラミ
ネートするに際し、（１）棒状の未加硫ゴムリボンを、
外形がゴム栓脚部形状に適合した下金型と天面部に相当
する位置に若干の窪みを有するか又は平板状の上金型と
の間で。
所要加硫時間の１／１０乃至１／２の時間加圧加熱した
後、該半加硫ゴム・シートを上金型に付けた状態で上下
金型を開き、下金型表面に医薬用薬品に耐える性質を有
する合成樹脂フィルムを置き、上下金型を閉じ、所要加
硫時間の９７１０乃至１／２の時間加圧加熱し、一次成
形品を得る工程、（ｉｉ）該一次成形品を打ち抜き、素
栓を製造する工程、（ｉｉｉ）棒状の未加硫ゴムリボン
を外形がゴム栓天面部形状に適合した上金型と脚部に相
当する位置に若干の凹部を有するか、又は平板状の下金
型との間で所要加硫時間の１／２０乃至１／２の時間加
圧加熱した後、該加硫ゴムシートを上金型に付けた状態
で金型を開き、下金型を番孔に素栓を装填した金型と入
れ替えた後、所要加硫時間の１９／２０乃至１／２の時
間加圧加熱して、二次成形品を得る工程、 （ｉｖ ）
該二次成形品のパリ部を切断除去する工程よりなること
を特徴とするバイアル用ゴム栓の製造方法を要旨とする
。
本発明に使用する合成樹脂フィルムは、フッ素樹脂、ナ
イロン、ポリエチレン、ポリプロピレンなどの樹脂フィ
ルムであり、封入する薬品により適宜選択される。これ
らのフィルムは、ゴムと加硫接着性を有することが必要
であり、必要に応しゴムとの接着性を改善するために２
表面を化学処理、コロナ処理、スパッタ・エツチング処
理などの処理を行ってもよい。
本発明のゴム栓の材料としては、ブチルゴム。
ハロゲン化ブチルゴム、ブタヂエンゴム、イソプレンゴ
ム、エチレンプロピレンゴム、シリコンゴムなどの合成
ゴム又は天然ゴムが使用され、かつ適宜ゴム配合剤、充
填剤を含有している。
本発明において、一次成形品を得る工程で棒状未加硫ゴ
ムリボンを用い成形するのは、成形品中に気泡の含有を
防止するためであり、また、半加硫状態で金型を開き合
成樹脂フィルムと重ね合わせ継続加圧加熱を行うのは、
ゴムとフィルムとの接着を十分に行わせるためである。
半加硫の程度についてはゴム配合組成により異なるが、
所要加硫時間の１／１０乃至１／２が良い。この時間が
短いと未加硫ゴムの金型中への流れ込みが十分でなく成
形不良の原因となり、長すぎるとゴムの加硫が進みすぎ
、フィルムとの接着が不十分となる。本発明の一次成形
品のパリ部をカットし素栓を得る工程では、フィルムで
ラミネートしたい部分のみに打ち抜きを行う。
本発明の二次成形品を得る工程で、棒状ゴムリボンを用
いるのは一次成形品の場合と同様に成形品中への気泡の
含有防止のためであり、半加硫状態の天面形状ゴムシー
トを用いるのは、素栓との接着を十分に行わせるためで
あると同時に、フィルムラ暑ネート部分へのゴムの流れ
込みによるフィルム面への汚染を防止するためである。
半加硫の程度についてはゴム配合組成により異なるが。
所要加硫時間の１／２０乃至１／２が良い。
以下５本発明を図面により具体的に説明する。
第１図、第２図及び第３図は本発明の詳細な説明する工
程図であり、第４図及び第５図は本発明によって得られ
るバイアル用ゴム栓例の一部縦断面図である。
第１図及び第２図（ａ）に示すように一次成形のための
金型Ｂは、最終製品脚部形状をもつ金型であり、金型Ａ
は平板状の金型である。両金型間に第１図（ａ）又は同
図（ｂ）及び第２図（ａ）に示すように棒状の未加硫ゴ
ムリボン１を置き、第２図（ｂ）に示すように加圧加熱
して所要加硫時間の１／１０乃至１／２の時間加硫を行
った後、第２図（Ｃ）に示すように、半加硫ゴムシート
を上金型Ａに付いた状態で金型を開き、下金型表面に合
成樹脂フィルム２を置き。
両金型を再び閉して、残りの時間加硫を行う、この操作
により第２図（ｄ）に示すようなパリ部の付いたラミネ
ートが施された一次成形品が得られる。
この工程での加圧加熱条件は使用される樹脂フィルム、
ゴムの種類、配合剤、厚さ、金型サイズにより変わるが
、１３０〜１８０℃、 ５０〜３００ ｋｇ／ｃｊで５
〜２０分が適当である。得られた一次成形シートを第２
図（ｅ）に示すように最終製品脚部に相当する素栓に打
ち抜きを行う。
一方第３図（ａ）に示すようにゴム栓天面部形状をもつ
上金型Ｃと平板状の下金型りの間に棒状の未加硫ゴムリ
ボン１を置き、第３図（ロ）に示すように加圧加熱して
所要加硫時間の１７２０乃至１／２の時間加硫を行った
後、第３図（Ｃ）に示すように下金型を一次成形品より
作った上記ゴム栓脚部相当の素栓を装填した下金型Ｅと
交換し、引き続き残りの加硫時間加圧加熱を行い、第３
図（ｄ）に示すようなパリ部の付いた二次成形品を得る
。二次成形に用いる未加硫ゴムは一次成形に用いたもの
と同一組成の配合ゴムでも異なった組成の配合ゴムでも
よい。
また、加硫条件は配合ゴムの種類により適宜選択するこ
とができる。
最後ムこ二次成形品を金型より取りだし打ち抜き操作に
より周辺部のパリを除去して第３図（ｅ）に示すような
製品を得る。
本発明では金型の形状を適宜変更することにより、第４
図や第５図に示すような形状のバイアル用ゴム栓を製造
することができる。Means for Solving the Problems and Effects The present invention proposes a technique for manufacturing a sealed rubber stopper using a multi-cavity mold, with an extremely low incidence of defective products. The method of the present invention uses a multi-cavity mold and pressurizes and heats a rod-shaped unvulcanized rubber ribbon to form a semi-vulcanized rubber stopper leg-shaped molded product. After opening the mold and inserting a synthetic resin film onto the surface of the lower mold, continuing to pressurize and heat, cut the elastic part to form a bare stopper in the shape of the rubber stopper legs, and separately molded the rubber stopper top shape. After combining the semi-vulcanized rubber sheet and the above-mentioned plug, and pressurizing and heating in a mold to bond and mold. This is a method of manufacturing a laminated rubber stopper by cutting the elastic part. In other words, the present invention uses a multi-cavity mold to laminate a synthetic resin film to the entire surface or part of the rubber stopper leg, or to laminate the entire rubber stopper leg and a part of the lower surface of the top surface. (1) A rod-shaped unvulcanized rubber ribbon,
Between the lower mold whose outer shape matches the shape of the rubber stopper leg and the upper mold which has a slight depression or is flat at a position corresponding to the top surface. After pressurizing and heating for 1/10 to 1/2 of the required vulcanization time, the upper and lower molds are opened with the semi-vulcanized rubber sheet attached to the upper mold, and pharmaceutical chemicals are applied to the surface of the lower mold. A step of placing a synthetic resin film having properties that can withstand the , the step of manufacturing a blank stopper, (iii) a rod-shaped unvulcanized rubber ribbon with an upper mold whose outer shape matches the shape of the top surface of the rubber stopper and a slight recess at a position corresponding to the leg part, or a flat plate-like After applying pressure and heat to the lower mold for 1/20 to 1/2 of the required vulcanization time, open the mold with the vulcanized rubber sheet attached to the upper mold, and open the lower mold. After replacing the mold with a mold in which a raw stopper is loaded into the hole, heating under pressure for 19/20 to 1/2 of the required vulcanization time to obtain a secondary molded product, (iv)
The gist of the present invention is a method for manufacturing a rubber stopper for a vial, which comprises a step of cutting and removing the edge of the secondary molded product. The synthetic resin film used in the present invention is a resin film made of fluororesin, nylon, polyethylene, polypropylene, etc., and is appropriately selected depending on the chemical to be encapsulated. These films need to have vulcanization adhesion to rubber, and if necessary, two layers are added to improve the adhesion to rubber.
The surface may be subjected to treatments such as chemical treatment, corona treatment, sputter etching treatment, etc. The material for the rubber stopper of the present invention is butyl rubber. Synthetic rubber or natural rubber such as halogenated butyl rubber, butadiene rubber, isoprene rubber, ethylene propylene rubber, silicone rubber, etc. is used, and rubber compounding agents and fillers are appropriately contained. In the present invention, the reason why a rod-shaped unvulcanized rubber ribbon is used in the process of obtaining the primary molded product is to prevent the inclusion of air bubbles in the molded product, and also to open the mold in a semi-vulcanized state and use the synthetic resin. The process of continuously applying pressure and heating to the film is as follows:
This is to ensure sufficient adhesion between the rubber and the film. The degree of semi-vulcanization varies depending on the rubber composition, but
1/10 to 1/2 of the required vulcanization time is preferable. If this time is too short, the unvulcanized rubber will not flow into the mold sufficiently, causing molding defects; if it is too long, the rubber will be vulcanized too much, resulting in insufficient adhesion to the film. In the step of cutting the end portion of the primary molded product of the present invention to obtain a blank stopper, punching is performed only in the portion to be laminated with a film. In the process of obtaining the secondary molded product of the present invention, the rod-shaped rubber ribbon is used to prevent the inclusion of air bubbles in the molded product, as in the case of the primary molded product, and the semi-vulcanized top-shaped rubber sheet The purpose of using this is to ensure sufficient adhesion to the base stopper, and at the same time to prevent contamination of the film surface due to rubber flowing into the film laminate portion. The degree of semi-vulcanization varies depending on the rubber composition. 1/20 to 1/2 of the required vulcanization time is preferable. Hereinafter, five aspects of the present invention will be explained in detail with reference to the drawings. Figures 1, 2 and 3 are process diagrams explaining the present invention in detail, and Figures 4 and 5 are partial vertical cross-sectional views of examples of rubber stoppers for vials obtained by the present invention. . As shown in Fig. 1 and Fig. 2 (a), mold B for primary forming is a mold having a final product leg shape, and mold A
is a flat mold. A rod-shaped unvulcanized rubber ribbon 1 is placed between the two molds as shown in FIG. 1(a) or FIG. 2(b) and FIG. 2(a), and pressurized as shown in FIG. After heating and vulcanizing for 1/10 to 1/2 of the required vulcanization time, the semi-vulcanized rubber sheet is attached to the upper mold A as shown in Figure 2 (C). Open the mold and place the synthetic resin film 2 on the surface of the lower mold. Both molds are closed again and vulcanization is carried out for the remaining time. By this operation, a primary molded product having a laminate with a pad as shown in FIG. 2(d) is obtained. The pressure and heating conditions in this process are the resin film used,
5 at 130-180℃, 50-300 kg/cj, although it varies depending on the type of rubber, compounding agent, thickness, and mold size.
~20 minutes is appropriate. The obtained primary formed sheet is
As shown in Figure (e), a blank cork corresponding to the leg of the final product is punched out. On the other hand, as shown in Fig. 3(a), a rod-shaped unvulcanized rubber ribbon 1 is placed between the upper mold C having the shape of the top surface of the rubber stopper and the flat lower mold. After applying pressure and heating to vulcanize for 1,720 to 1/2 of the required vulcanization time as shown, the rubber stopper with the lower mold made from the primary molded product as shown in FIG. 3(C) Replace the lower mold E with a blank plug equivalent to the legs, continue to pressurize and heat for the remaining vulcanization time, and then press and heat the third mold.
A secondary molded product with a rib as shown in Figure (d) is obtained. The unvulcanized rubber used for secondary molding may have the same composition as that used for primary molding, or may have a different composition. Further, the vulcanization conditions can be appropriately selected depending on the type of compounded rubber. Finally, the mullioned secondary molded product is taken out from the mold and the peripheral parts are removed by a punching operation to obtain a product as shown in FIG. 3(e). In the present invention, by appropriately changing the shape of the mold, the fourth
Rubber stoppers for vials having shapes as shown in the figures and FIG. 5 can be manufactured.
以下５本発明を実施例と比較例により具体的に説明する
。
合成樹脂フィルムとして平均分子量４５０万、厚さ５０
μのポリエチレンフィルムを使用し、また。
配合ゴムとしてブチルゴム（日本合成ゴム■製ブチル３
６５） １００重量部、シランカップリング剤表面処理
済み焼成りレー６０重量部、活性亜鉛華３重量部、ジベ
ンタメチレンチュウラムテラサルファイド２重量部及び
酸化マグネシウム５重量部よりなる配合ゴムを使用した
。
加ｇ成形時の金型としては、−吹成形、二次成形とも１
４４個取りの金型を使用し、−吹成形は温度１６０°Ｃ
１圧力２００ｋｇ／ｃｉｉｌ、時間１０分（前加ｔＬ２
分、後加硫８分）の条件、二次成形は温度１６０°Ｃ１
圧力２００ｋｇ／ｃｄ、時間１２分（前加ｇ１分、後加
硫１１分）の条件を使用した。
本発明の方法により脚部長さ４．５閣、バイアル容器口
にかん合する箇所の外径１２．７ｍｍ、上蓋部の外径１
９．０ｎｍの第３図（ｅ）に示すような構造をしたゴム
栓を製造した。
得られたゴム栓について目視により、フィルムとゴムと
の接着性、フィルム表面の汚染状況、ゴム栓外面の気泡
等を観察した。その結果、不良品の発生率は０．５％で
あった。
比較例として、実施例と同一のフィルム、配合ゴム、加
硫条件を使用し、特公昭５７−５３１８４号公報に記載
の方法で実施例と同じゴム栓を製造した。
得られたゴム栓の目視による不良品の発生率は８．０％
であった。
これらから明らかなように本発明の製造方法によれば不
良品の発生の少ないことが分かる。The present invention will be specifically explained below using five examples and comparative examples. As a synthetic resin film, the average molecular weight is 4.5 million and the thickness is 50.
Also use μ polyethylene film. Butyl rubber (butyl 3 manufactured by Japan Synthetic Rubber) is used as compounded rubber.
65) A compounded rubber was used consisting of 100 parts by weight, 60 parts by weight of baked clay surface-treated with a silane coupling agent, 3 parts by weight of activated zinc white, 2 parts by weight of diventamethylene thiuram terra sulfide, and 5 parts by weight of magnesium oxide. . As for the mold for additive molding, - 1 for both blow molding and secondary molding.
A 44-cavity mold is used, and the blow molding temperature is 160°C.
1 pressure 200kg/ciil, time 10 minutes (pre-load tL2
post-vulcanization for 8 minutes), and the temperature for secondary molding is 160°C1.
The conditions used were a pressure of 200 kg/cd and a time of 12 minutes (pre-vulcanization 1 minute, post-vulcanization 11 minutes). By the method of the present invention, the length of the leg part is 4.5 mm, the outer diameter of the part that fits into the vial container mouth is 12.7 mm, and the outer diameter of the upper lid part is 1 mm.
A 9.0 nm rubber stopper having the structure shown in FIG. 3(e) was manufactured. The resulting rubber stopper was visually observed for adhesion between the film and the rubber, contamination on the film surface, air bubbles on the outer surface of the rubber stopper, and the like. As a result, the incidence of defective products was 0.5%. As a comparative example, a rubber plug similar to that in the example was manufactured using the same film, compounded rubber, and vulcanization conditions as in the example, and by the method described in Japanese Patent Publication No. 57-53184. The incidence of defective products by visual inspection of the obtained rubber stoppers was 8.0%.
Met. As is clear from these results, it can be seen that the production method of the present invention reduces the number of defective products.
本発明の方法によれば合成樹脂フィルムが栓体脚部にう
亙ネートされたバイアル用ゴム栓を、多数個取りの金型
を使用し不良品を発生することなく、経済的且つ効率的
に製造することができる。According to the method of the present invention, rubber stoppers for vials with synthetic resin film applied to the stopper legs can be manufactured economically and efficiently without producing defective products by using a multi-cavity mold. can be manufactured.
第１図、第２図及び第３図は１本発明の詳細な説明する
工程図であり、第４図及び第５図は本発明によって得ら
れるバイアル用ゴム栓例の一部縦断面図である。
１・−棒状未加硫ゴムリボン、２・−合成樹脂フィルム
、３−脚部形状素栓、Ａ及びＢ−−−一次成形用金型、
Ｃ，Ｄ及びＥ−二次成形用金型。1, 2 and 3 are process diagrams for explaining the present invention in detail, and FIGS. 4 and 5 are partial vertical cross-sectional views of examples of rubber stoppers for vials obtained by the present invention. be. 1--rod-shaped unvulcanized rubber ribbon, 2--synthetic resin film, 3--leg-shaped plug, A and B----primary molding mold,
C, D and E - molds for secondary forming.
Claims (1)
ゴム栓脚部全面又は一部にラミネートするか、又はゴム
栓脚部全面及び天面部下面の一部にラミネートするに際
し、（ｉ）棒状の未加硫ゴムリボンを、外形がゴム栓脚
部形状に適合した下金型と天面部に相当する位置に若干
の窪みを有するか、又は平板状の上金型との間で、所要
加硫時間の１／１０乃至１／２の時間加圧加熱した後、
該半加硫ゴム・シートを上金型に付けた状態で上下金型
を開き、下金型表面に医薬用薬品に耐える性質を有する
合成樹脂フィルムを置き、上下金型を閉じ、所要加硫時
間の９／１０乃至１／２の時間加圧加熱し、一次成形品
を得る工程、（ｉｉ）該一次成形品を打ち抜き、素栓を
製造する工程、（ｉｉｉ）棒状の未加硫ゴムリボンを外
形がゴム栓天面部形状に適合した上金型と脚部に相当す
る位置に若干の凹部を有するか、又は平板状の下金型と
の間で所要加硫時間の１／２０乃至１／２の時間加圧加
熱した後、該加硫ゴムシートを上金型に付けた状態で金
型を開き、下金型を各孔に素栓を装填した金型と入れ替
えた後、所要加硫時間の１９／２０乃至１／２の時間加
圧加熱して、二次成形品を得る工程、（ｉｖ）該二次成
形品のバリ部を切断除去する工程よりなることを特徴と
するバイアル用ゴム栓の製造方法。(1) When laminating a synthetic resin film on the entire surface or part of the rubber stopper leg using a multi-cavity mold, or when laminating the entire surface of the rubber stopper leg and a part of the lower surface of the top surface, (i) ) A rod-shaped unvulcanized rubber ribbon is placed between a lower mold whose external shape conforms to the shape of the rubber stopper leg and an upper mold which has a slight depression at the position corresponding to the top surface, or which is a flat plate. After heating under pressure for 1/10 to 1/2 of the vulcanization time,
With the semi-vulcanized rubber sheet attached to the upper mold, open the upper and lower molds, place a synthetic resin film that can withstand pharmaceutical chemicals on the surface of the lower mold, close the upper and lower molds, and perform the required vulcanization. A step of pressurizing and heating for 9/10 to 1/2 of the time to obtain a primary molded product, (ii) a step of punching out the primary molded product to produce a plug, (iii) a step of manufacturing a rod-shaped unvulcanized rubber ribbon. The upper mold, whose outer shape matches the shape of the top surface of the rubber stopper, has a slight recess at the position corresponding to the leg, or the lower mold has a flat plate shape, and the required vulcanization time is 1/20 to 1/20. After pressurizing and heating for 2 hours, open the mold with the vulcanized rubber sheet attached to the upper mold, replace the lower mold with a mold in which each hole is filled with a plug, and then perform the required vulcanization. for a vial, comprising the steps of: obtaining a secondary molded product by heating under pressure for 19/20 to 1/2 of the time; and (iv) cutting and removing the burr portion of the secondary molded product. Method for manufacturing rubber stoppers.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2071399A JP2528535B2 (en) | 1990-03-20 | 1990-03-20 | Method for manufacturing vial rubber stopper |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2071399A JP2528535B2 (en) | 1990-03-20 | 1990-03-20 | Method for manufacturing vial rubber stopper |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH03270928A true JPH03270928A (en) | 1991-12-03 |
| JP2528535B2 JP2528535B2 (en) | 1996-08-28 |
Family
ID=13459399
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2071399A Expired - Fee Related JP2528535B2 (en) | 1990-03-20 | 1990-03-20 | Method for manufacturing vial rubber stopper |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2528535B2 (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001340425A (en) * | 2000-06-06 | 2001-12-11 | Ohtsu Tire & Rubber Co Ltd :The | Medical rubber stopper |
| EP1228973A1 (en) | 2001-01-19 | 2002-08-07 | Daikyo Seiko, Ltd. | A laminated rubber stopper for a medicament vial |
| WO2004060764A1 (en) * | 2003-01-07 | 2004-07-22 | Procork Pty Ltd | Container stopper |
| JP2004216753A (en) * | 2003-01-16 | 2004-08-05 | Sumitomo Rubber Ind Ltd | Method for producing rubber stopper for pharmaceuticals |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5747637A (en) * | 1980-09-06 | 1982-03-18 | Daikyo Gomme Seikou:Kk | Manufacture of laminate rubber stopper |
| JPS595046A (en) * | 1982-06-30 | 1984-01-11 | Touritsu Kogyo:Kk | Production of medical rubber article |
| US4554125A (en) * | 1983-03-17 | 1985-11-19 | Schering Corporation | Method of making a stopper for a sterile fluid container |
| JPS63296756A (en) * | 1987-05-29 | 1988-12-02 | Daikyo Rubber Seiko:Kk | Double-side laminated rubber plug |
-
1990
- 1990-03-20 JP JP2071399A patent/JP2528535B2/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5747637A (en) * | 1980-09-06 | 1982-03-18 | Daikyo Gomme Seikou:Kk | Manufacture of laminate rubber stopper |
| JPS595046A (en) * | 1982-06-30 | 1984-01-11 | Touritsu Kogyo:Kk | Production of medical rubber article |
| US4554125A (en) * | 1983-03-17 | 1985-11-19 | Schering Corporation | Method of making a stopper for a sterile fluid container |
| JPS63296756A (en) * | 1987-05-29 | 1988-12-02 | Daikyo Rubber Seiko:Kk | Double-side laminated rubber plug |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001340425A (en) * | 2000-06-06 | 2001-12-11 | Ohtsu Tire & Rubber Co Ltd :The | Medical rubber stopper |
| EP1228973A1 (en) | 2001-01-19 | 2002-08-07 | Daikyo Seiko, Ltd. | A laminated rubber stopper for a medicament vial |
| WO2004060764A1 (en) * | 2003-01-07 | 2004-07-22 | Procork Pty Ltd | Container stopper |
| JP2004216753A (en) * | 2003-01-16 | 2004-08-05 | Sumitomo Rubber Ind Ltd | Method for producing rubber stopper for pharmaceuticals |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2528535B2 (en) | 1996-08-28 |
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