Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
1998-11-23
2001-05-08
Thornton, Krisanne (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
C206S364000, C422S001000, C422S028000, C422S032000, C422S033000, C604S199000
Reexamination Certificate
active
06228324
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a sterilizing method for medical sterilization packaging and an injection pack. More particularly, the present invention relates to a method of sterilizing a medical product, e.g., a medicine-filled injector enclosed in a packaging container, by a hydrogen peroxide gas while keeping the packaged condition, which method is capable of efficiently conducting the sterilizing treatment and of surely preventing the hydrogen peroxide gas from remaining in the packaging container, and to an injection pack comprising a packaging container and a medicine-filled injector enclosed in the packaging container, which is sealed by a sterile paper and capable of mainly allowing only the sterilizing gas to penetrate therethrough, and enables the medicine-filled injector enclosed in the packaging container to be readily sterilized.
Medicine-filled injectors, have been suitably subjected to medical sterilization packaging and then distributed or marketed, as well as other disposable medical products or appliances. The medical sterilization packaging is a packaging method which comprises using a packaging container composed of a container body composed of a synthetic resin having a gas-barrier property, and a sterile paper as a lid which can allow a sterilizing gas to penetrate therethrough and can be welded to the container body, and after enclosing the medical product in the packaging container, exposing the medical product to a sterilizing gas while keeping the packaged condition, whereby an inside of the packaging container is sterilized by the sterilizing gas which is caused to penetrate thereinto through the sterile paper.
In the above-mentioned medical sterilization packaging, in order to solve the problem caused by toxicity of the sterilizing gas, it has been studied for sterilization of various medical products to use a hydrogen peroxide gas instead of ethylene oxide. However, even though any of ethylene oxide and the hydrogen peroxide gas is used, it has been inevitably required that the packaged medical products are subjected to post-treatment for removing the sterilizing gas from the inside of the packaging container, thereby eliminating an adverse influence on human bodies due to the residual harmful gas upon distribution thereof. Incidentally, the techniques concerning disinfection or sterilization using hydrogen peroxide has been described in Japanese Patent Publication (KOKOKU) No. 61-4543 (1986) (GB-A 2127692), Japanese Patent Application Laid-open (KOKAI) No. 1-121057 (1989) (EP-A 0302420) or the like. In addition, the techniques concerning medicine-filled injectors has been described in Japanese Patent Application Laid-open (KOKAI) No. 4-150868 (1992) (EP-A 0505579) or the like.
Meanwhile, in the medical sterilization packaging, in order to completely remove the sterilizing gas from the packaging container after the sterilizing treatment, it is necessary to allow the packaged medical products to stand for a considerably long period of time. The gas-removing operation has resulted in low productivity of the packaged medical products. Especially, in the case of the injection packs, since the injection packs are stacked up in multiple stages when sterilized, there arises a problem that the efficiency of penetrating the sterilizing gas through the sterile paper is deteriorated, because the surface of the sterile paper is disadvantageously covered by the container body of the upper or lower packaging container stacked. Further, in the injection packs, in view of a shape of the packaging container thereof, there has also been caused a problem that a degassing efficiency of removing the penetrated gas from an inside of the packaging container is deteriorated.
Furthermore, in the above-mentioned medical sterilization packaging, when a container composed of a polyester-based resin is used as the packaging container, the container has a high adsorptivity for the sterilizing gas, so that it becomes more difficult to remove the sterilizing gas therefrom. For this reason, there have been used many containers composed of vinyl chloride-based resins as a main component. As a result, the visibility of an inside of the container is deteriorated, and there has been further caused a problem that a chlorine gas or hydrogen chloride gas is generated upon disposal of the vinyl chloride-based resins.
SUMMARY OF THE INVENTION
The present invention has been attained in order to solve the above-mentioned problems.
It is an object of the present invention to provide a method of sterilizing a medical product, e.g., a medicine-filled injectors with a hydrogen peroxide gas while keeping the packaged condition for medical sterilization packaging, which method is capable of efficiently conducting the sterilizing treatment, can surely prevent the hydrogen peroxide gas from remaining in the packaging container, and is applicable to such a case where a packaging material composed of a polyester-based resin is used.
It is another object of the present invention to provide an injection pack comprising a suitably molded packaging container and a medicine-filled injector enclosed in the packaging container which is sealed by a sterile paper and capable of readily sterilizing the medicine-filled injector enclosed therein.
To accomplish the aims, in a first aspect of the present invention, there is provided a method of sterilizing a medical product enclosed in a packaging container by a hydrogen peroxide gas, comprising:
using as said packaging container, a container comprising a container body composed of a synthetic resin having a gas-barrier property, and a sterile paper capable of allowing said hydrogen peroxide gas to penetrate therethrough and weldable to said container body; and
after the sterilization by said hydrogen peroxide gas, subjecting said packaging container enclosing said medical product to degassing treatment while heating, thereby removing said hydrogen peroxide gas from an inside of said packaging container.
In a second aspect of the present invention, there is provided an injection pack comprising a packaging container and a medicine-filled injector enclosed in said packaging container,
said packaging container comprising a container body which is composed of a transparent resin, integrally molded into an approximate elongated vessel shape and opened at bottom thereof, and
a sterile paper composed of a sheet material capable of allowing a sterilizing gas to penetrate therethrough and closing the open bottom of said container body,
said container body comprising a first swelled portion for receiving a needle-fitting portion of an injector cylinder of said medicine-filled injector,
a second swelled portion for receiving an approximately central portion of said medicine-filled injector,
a third swelled portion for receiving a flange of said injector cylinder and a pusher of a piston rod, and
two constricted portions connecting said swelled portions to each other, said third swelled portion being formed into a saddle shape recessed at a central portion thereof when viewed from the longitudinal side of said container body.
REFERENCES:
patent: 4230663 (1980-10-01), Forstrom et al.
patent: 4878903 (1989-11-01), Mueller
patent: 5407070 (1995-04-01), Bascos et al.
patent: 5615772 (1997-04-01), Naganuma
patent: 5792422 (1998-08-01), Lin et al.
patent: 5817065 (1998-10-01), Dufresne et al.
patent: 44 28 291 (1996-02-01), None
patent: 0302 420 (1988-07-01), None
patent: 0 505 579 1 (1991-10-01), None
patent: 0 624 518 (1994-11-01), None
patent: 2 127 692 (1982-09-01), None
TYVEK® Catalog, No date available.
TYVEK® Sterile Package News, vol. 1, 1994.
TYVEK® Sterile Package News, vol. 4, 1995.
TYVEK® for Sterile Packaging, 1996.
TYVEK® English translation of Hydrogen peroxide gas sterilization and TYVEK® No date available.
Hasegawa Mitsuru
Kanaguchi Takeshi
Maeda Shuichi
Mitomi Tokushi
Conlin David G.
Dike Bronstein, Roberts & Cushman LLP
Seikagaku Corporation
Thornton Krisanne
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