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Vial rubber-stopper

a technology of rubber stoppers and vials, applied in the field of rubber stoppers, can solve the problems of difficulty in sealing properties of vials, frequent defective molding, and troublesome lines, and achieve the effects of low reactivity, high sealing properties, and gas barrier properties

Inactive Publication Date: 2010-08-19
DAIKYO SEIKO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0027]This invention has been completed to solve conventional problems as described above and accordingly it is an object of the invention is to provide a vial rubber stopper of high sealing properties, gas barrier properties, chemical resistance and needling resistance as well as low reactivity, having improved productivity in the pharmaceutical manufacturing process and mechanical conveying properties, which is prepared without silicone coating.

Problems solved by technology

Conventional vial rubber stoppers tend to stick each other on a conveying line during the production process to cause troubles of the line due to sticky nature of their surface.
However, the above mentioned rubber stopper in which all surface of the cylindrical leg portion and the bottom surface of the flange are laminated arouses difficulties in sealing properties of the vial because both of these surfaces in contact with the vial opened portion are all laminated with a laminate film.
In the case of the rubber stopper in which lamination is applied on the surface other than that of the peripheral root portion of the cylindrical leg (ring portion under the flange), the peripheral root portion is left as a naked rubber stock, thereby improving sealing properties of the vial, while the rubber stopper sometimes comes up to the surface after it is driven into the vial opened portion due to strong friction and repulsion of the naked rubber stock, thereby causing such problems that the stopper might be driven repeatedly plural times or is hardly to drive completely.
Further, in the case of the rubber stopper in which only the cylindrical leg portion is thoroughly laminated, friction resistance of the rubber stock is decreased but leakage of the naked rubber stock is occurred around the peripheral root portion (ring portion under the flange) to be connected to the bottom surface of the disc-like top portion when the leg is joined monolithically to the disc, thereby causing defective molding frequently.
However, various harmful effects caused by silicone oil used for silicone coating have been pointed out and are tried to avoid such disadvantages which include, for example, a decrease in strength observed when the silicone oil comes in contact with a medical liquid kept in the vial to absorb the active ingredient or an infection to human body caused by injection of the medical liquid contaminated with a pealed material of silicone oil itself as fine particles.

Method used

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Examples

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example

[0081]A plate stock of uncured rubber composition shown in Table 1 was used as a rubber stock for molding the cylindrical leg portion 3 and the disc-like top portion 2. There was used “Dai D3” (0.05 mm in thickness), available from Nitto Denka Corporation, as an inactive synthetic resin (PTFE) for laminating the cylindrical leg portion 3 and the disc-like top portion 2.

TABLE 1Composition of Rubber StockParts by Weightbutyl rubber100wet water-containing silica (1)30zinc oxide (2)1.51,1-bis(t-butylperoxide)-3,3,5-trimethylhexane (3)2(1) Nipushiiru ER; available from Nippon Sirika Kogyo(2) Active Chinese White AZO; available from Seido Kagaku Kogyo(3) Perhexane 3M-40; available from NOF Corporation

[0082]As shown in FIG. 3, using a bottom force (not shown), press molding and lamination of the cylindrical leg portion 3 was conducted at the same time under a condition of molding pressure: 100 kg / cm2 and molding temperature: 165° C., followed by opening and releasing of the force and washi...

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Abstract

There is provided a rubber stopper used to seal an opened portion of vials and syringes for keeping medical liquid and, in particular, to a rubber stopper in which stoppering properties can be improved without damaging sealing properties in the absence of silicone coating.A vial rubber stopper 1 comprises a disc-like top portion 3 and a cylindrical leg portion 2 of smaller diameter compared with that of the disc-like top portion, which is protruded from a bottom surface of the disc-like top portion 3 to shape into a flange 2A upward. An under-flange ring portion 3A connected to a flange bottom surface 2B is divided on an outer peripheral surface of the cylindrical leg portion 2, and the first ring-like raised portion 3B and the second ring-like raised portion 3C are formed downward of the under-flange ring portion 3A in the circumferential direction. An upper surface of the disc-like top portion 3 including a flange-upper surface, a maximum diametral portion of a flange-peripheral surface, a bottom surface of the disc-like top portion 3 located inside of the cylindrical leg portion 2 and a surface of the cylindrical leg portion 2 other than the under-flange ring portion 3A are laminated with a synthetic resin to leave the flange bottom surface and the surface of the under-flange ring portion 3A as a naked rubber stock.

Description

TECHNICAL FIELD[0001]This invention relates to a rubber stopper used to seal an opened portion of vials and syringes as medical vessels which will be hereinafter simply referred to as vial and, in particular, to a rubber stopper in which stoppering properties can be improved without damaging sealing properties in the absence of silicone coating.BACKGROUND OF THE INVENTION[0002]It is required for a stopper body used to seal an opened portion of chemical or medical liquid-containing vial to meet various quality requirements such as sealing properties, gas barrier properties, chemical resistance, needling resistance, low reactivity and the like and, in general, a rubber stopper body of high elastic deformation is frequently employed as a product sufficient to satisfy these requirements, which will be hereinafter referred to as rubber stopper.[0003]A syringe needle is often stuck through the rubber stopper from an upper surface thereof to suck up a chemical or medical liquid in a vial. ...

Claims

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Application Information

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IPC IPC(8): B65D39/00
CPCA61J2001/1468B65D2539/008B65D2539/003B65D39/0023A61J1/1468
Inventor KOSHIDAKA, TSUYOSHISUDO, MASAMICHI
Owner DAIKYO SEIKO LTD