Methods of sterilizing elastomeric sealing articles
First Claim
1. A method of sterilizing a rubber article, comprising the steps of:
- a) irradiating a rubber article, wherein the rubber article is prepared from a composition comprising butyl rubber and about 5% to about 50% by weight of an elastomeric copolymer on a basis of total weight of the composition; and
b) exposing the irradiated rubber article to a sterilizing gas for a time period sufficient to sterilize the rubber article.
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Abstract
The present invention provides a method sterilizing butyl rubber/styrene butadiene rubber (SBR) articles used in syringes or medical containers, comprising irradiating the butyl rubber/SBR elastomeric copolymer rubber article with gamma irradiation, wherein the SBR elastomeric copolymer comprises about 5% to about 50% of the rubber composition on a basis of total weight of the composition; and then exposing the irradiated rubber composition to a sterilizing gas for a time period sufficient to sterilize the rubber composition. The irradiated, sterilized rubber composition of the present invention is capable of maintaining superior performance standards with respect to sealability, recoverability from stress and elasticity.
33 Citations
22 Claims
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1. A method of sterilizing a rubber article, comprising the steps of:
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a) irradiating a rubber article, wherein the rubber article is prepared from a composition comprising butyl rubber and about 5% to about 50% by weight of an elastomeric copolymer on a basis of total weight of the composition; and
b) exposing the irradiated rubber article to a sterilizing gas for a time period sufficient to sterilize the rubber article. - View Dependent Claims (4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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2. A method of sterilizing a container comprising the steps of:
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a) irradiating a container comprising a container body and a rubber closure that are assembled or unassembled, wherein the rubber closure is prepared from a composition comprising butyl rubber and about 5% to about 50% by weight of an elastomeric copolymer on a basis of total weight of the composition; and
b) exposing the irradiated container and rubber closure to a sterilizing gas for a time period sufficient to sterilize the container and rubber closure.
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3. A method of sterilizing a prefilled container, comprising the steps of:
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a) irradiating a prefilled container comprising a container body, a rubber closure, and a fluid medium contained therein, wherein the rubber closure is prepared from a composition comprising butyl rubber and about 5% to about 50% by weight of an elastomeric copolymer on a basis of total weight of the composition; and
b) exposing the irradiated prefilled container to a sterilizing gas for a time period sufficient to sterilize the prefilled container.
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Specification