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Mold for gasket for prefilled syringe

a technology for gaskets and syringes, which is applied in the field of molds for prefilled syringe gaskets and prefilled syringe gaskets, can solve the problems of poor air tightness and liquid tightness of gaskets laminated with fluororesin films, and cannot be used for biopharmaceuticals, and achieve excellent air tightness and small surface roughness.

Inactive Publication Date: 2013-02-28
SUMITOMO RUBBER IND LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a gasket for a pre-filled syringe that has excellent air-tightness and liquid-tightness. The invention achieves this by using a mold that has a mirror finished surface, which results in a smooth sealing surface with a low roughness. This mold helps to produce a molded product with the inactive film laminated thereon and adjusted to have a small surface roughness.

Problems solved by technology

However, they cannot be used for those intended for biopharmaceuticals and the like because they cause inactivation of these drugs.
However, when used with a glass or resin syringe, gaskets laminated with a fluororesin film problematically exhibit poorer air-tightness and liquid-tightness than conventional, non-laminated rubber ones.
Even in the case that such a gasket is designed to have an annular protrusion that provides a wider sealing width to improve its sealing performance, the air-tightness and the liquid-tightness are not improved.
Moreover, in the approach to increase the annular rib diameter to increase compressibility, some problems may arise such as difficulty in setting the gasket in a syringe and creases on the stacked film around an annular sealing portion of the gasket.
Still another problem is high resistance against sliding of a piston.
Thus, such approach cannot provide an effective solution.Patent Document 1: JP 2005-185747 A

Method used

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Examples

Experimental program
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Effect test

examples

[0054]The following is set forth to specifically illustrate the present invention by way of examples but the present invention is not limited to only these examples.

[0055]The fluororesin films used in examples are listed below.

[0056]Homo-PTFE (polytetrafluoroethylene) skived film: VALFLON from Nippon Valqua Industries, Ltd.

[0057]Modified PTFE (tetrafluoroethylene-perfluoroalkoxide monomer copolymer) skived film: New VALFLON from Nippon Valqua Industries, Ltd.

[0058]Homo PTFE (polytetrafluoroethylene) cast film: cast film from GSI Creos Corp.

[0059]ETFE (ethylene-tetrafluoroethylene copolymer) extruded film: AFLEX from Asahi Glass Co., Ltd.

[0060]Modified ETFE (ETFE-another monomer copolymer)

[0061]extruded film: AFLEX from Asahi Glass Co., Ltd.

(Surface Roughness Measurement)

[0062]The surface roughness was measured for the films as mentioned below.

[0063]Measuring method: based on JIS B0601-2001

[0064]Measuring instrument: laser microscope VK-9710 from KEYENCE Corp., lens magnification ×50...

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Abstract

The present invention aims to provide a gasket for a pre-filled syringe which has excellent air-tightness and liquid-tightness and a mold for forming the gasket. The present invention relate to a mold for a gasket laminated with an inactive film for a pre-filled syringe, wherein at least a surface of the mold which forms a seal sliding surface of an annular protrusion of the gasket is mirror finished to have an arithmetic mean roughness Ra of less than 0.03 μm.

Description

TECHNICAL FIELD[0001]The present invention relates to a mold for a gasket for a pre-filled syringe and a gasket for a pre-filled syringe produced using the mold.BACKGROUND ART[0002]Recently, the use of pre-filled syringes, which are syringes already filled with a drug, has become popular due to their good user-friendliness and in view of preventing medical accidents such as mix-up of drugs (Patent Document 1). The front end portion of a pre-filled syringe to which a needle is to be attached is sealed with a nozzle cap. Prior to injection, the nozzle cap is removed from the front end portion and a needle is attached thereto. A gasket is then slid by pushing a plunger rod toward the front end portion so that the drug is expelled.[0003]For such pre-filled syringes, silicone lubricants are widely used. However, they cannot be used for those intended for biopharmaceuticals and the like because they cause inactivation of these drugs. Therefore, recently, in order to secure the stability o...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): B29C43/18A61M5/31
CPCB29C33/42B29L2031/7544B29C43/184A61M2207/10B29C33/3842B29C70/68A61M5/31511A61M5/31513A61M5/24B29C33/00
Inventor MAEDA, KATSUSHITASHIRO, JUNJINAKANO, HIROAKIYAO, EIJI
Owner SUMITOMO RUBBER IND LTD
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