Ethylene oxide sterilization and aeration indicator

Claim 2

Means for monitoring and determining the effective end point of sterilization conditions in which an alkylene oxide is employed to sterilize in a sterilization chamber medical goods and articles including packs containing surgical instruments, and for monitoring and determining the effective end point of a process of aeration of so-sterilized goods and articles to desorb the same of the alkylene oxide, said means consisting essentiallv of a strong acid cation exhange resin in a discrete form suitable for inclusion with the goods during sterilization and aeration and a color changing pH indicator means associated with the said discrete form of cation exchange resins; said cation resin and said pH indicator means undergoing a two step reaction to monitor and determine the effective end point of sterilization wherein said cation exchange resin reacts with the alkylene oxide to effect a change in the pH of said cation exchange resin and said of pH indicator means registers such change by displaying a distinct color response visible to the naked eye; and said cation exchange resin and said pH indicator means being suitable for subsequently monitoring the effectiveness of the aeration process wherein said cation exchange resin undergoes an additional change which effects a reversion of the pH indicator means to its original precolored state.

Claim 3

The means of claim 1 in which the alkylene oxide is ethylene oxide and the cation exchange resin is in the discrete form of a gas permeable package of small, predetermined sized particles of a strong acid synthetic cation exchange resin which has been dyed with a selected pH indicator that changes color to reflect that reduction in hydrogen ion concentration on the surface of the said resin which is effected by the ethylene oxide adsorbed on and reacted with the said surface during ethylene oxide sterilization and that subsequently reverts to its original color to reflect the alteration of the surface of the said resin effected by air employed in desorbing the goods being sterilized of residual ethylene oxide.

Claim 4

Means for monitoring and determining the effective end point of sterilization conditions in which ethylene oxide is employed to sterilize in a sterilization chamber medical goods and articles including packs containing surgical instruments, and for monitoring and determining the effective end point of a process of aeration of so-sterilized goods and articles to desorb the same of the ethylene oxide, said means consisting essentially of a powdered strong acid cation exchange resin of small predetermined sized particles in a gas permeable, at least oartially transparent envelope suitable for inclusion with the goods during sterilization and aeration and a color changing pH indicator means deposited on the surface of the said cation exchange resin, said envelope permitting (1) penetration of ethylene oxide and of air when placed respectively in a sterilization zone and a subsequently an aeration zone and (2) visual inspection upon termination of said sterilization and said aeration; said cation exchange resin and said pH indicator means undergoing a two step reaction to monitor and determine the effective end point of sterilization wherein said cation exchange resin reacts with the ethylene oxide to effect a reduction in hydrogen ion concentration on the surface of said cation exchange resin to change the pH of said cation exchange resin and said pH indicator means registers such change by displaying a distinct color response visible to the naked eye; and said cation exchange resin and said pH indicator means being suitable for subsequently monitoring the effectiveness of the aeration process wherein said cation exchange resin undergoes an additional change which effects a reversion of the pH indicator means to its original precolored state.

Claim 5

Means for monitoring and determining the effective end point of sterilization conditions in which ethylene oxide is employed to sterilize in a sterilization chamber medical goods and articles including packs containing surgical instruments, and for monitoring and determining the effective end point of a process of aeration of so-sterilized goods and articles to desorb the same of the ethylene oxide, said means consisting essentially of a powdered strong acid cation exchange resin of small predetermined sized particles in a gas permeable, at least oartially transparent envelope suitable for inclusion with the goods during sterilization and aeration and a color changing pH indicator means deposited on the surface of the said cation exchange resin, said envelope permitting (1) penetration of ethylene oxide and of air when placed respectively in a sterilization zone and a subsequently an aeration zone and (2) visual inspection upon termination of said sterilization and said aeration; said cation exchange resin and said pH indicator means undergoing a two step reaction to monitor and determine the effective end point of sterilization wherein said cation exchange resin reacts with the ethylene oxide to effect a reduction in hydrogen ion concentration on the surface of said cation exchange resin to change the pH of said cation exchange resin and said pH indicator means registers such change by displaying a distinct color response visible to the naked eye; and said cation exchange resin and said pH indicator means being suitable for subsequently monitoring the effectiveness of the aeration process wherein said cation exchange resin undergoes an additional change which effects a reversion of the pH indicator means to its original precolored state.

Claim 6

Means for monitoring and determining the effective end point of sterilization conditions in which an alkylene oxide is employed to sterilize in a sterilization chamber medical goods and articles including packs containing surgical instruments, and for monitoring and determining the effective end point of a process of aeration of so-sterilized goods and articles to desorb the same of the alkylene oxide, said means consisting essentially of a powdered strong acid cation exchange resin suoported upon a substrate consisting of a plastic or cellulosic film suitable for inclusion with the goods during sterilization and aeration and a color changing pH indicator means associated with the said cation exchange resin; said cation exchange resin and said pH indicator means undergoing a two step reaction to monitor and determine the effective end point of sterilization wherein said cation exchange resin reacts with the alkylene oxide to effect a change in the pH of said cation exchange resin and said nH indicator means registers such change by displaying a distinct color response visible to the naked eye; and said cation exchange resin and said pH indicator means being suitable for subsequently monitoring the effectiveness of the aeration process wherein said cation exchange resin undergoes an additional change which effects a reversion of the pH indicator means to its original precolored state.

Claim 7

Means for monitoring and determining the effective end point of sterilization conditions in which an alkylene oxide is employed to sterilize in a sterilization chamber medical goods and articles including packs containing surgical instruments, and for monitoring and determining the effective end point of a process of aeration of so-sterilized goods and articles to desorb the same of the alkylene oxide, said means consisting essentially of a powdered strong acid cation exchange resin suoported upon a substrate consisting of a plastic or cellulosic film suitable for inclusion with the goods during sterilization and aeration and a color changing pH indicator means associated with the said cation exchange resin; said cation exchange resin and said pH indicator means undergoing a two step reaction to monitor and determine the effective end point of sterilization wherein said cation exchange resin reacts with the alkylene oxide to effect a change in the pH of said cation exchange resin and said nH indicator means registers such change by displaying a distinct color response visible to the naked eye; and said cation exchange resin and said pH indicator means being suitable for subsequently monitoring the effectiveness of the aeration process wherein said cation exchange resin undergoes an additional change which effects a reversion of the pH indicator means to its original precolored state.

Claim 8

Means for monitoring and determining the effective end point of sterilization conditions in which an alkylene oxide is employed to sterilize in a sterilization chamber medical goods and articles including packs containing surgical instruments, and for monitoring and determining the effective end point of a process of aeration of so-sterilized goods and articles to desorb the same of the alkylene oxide, said means consisting essentially of a strong acid cation exchange resin in a comminuted from and incorporated in a thermoplastic resin composition so as to form a flexible transparent plastic disk suitable for inclusion with the goods during sterilization and aeration and a color changing pH indicator means associated with the said cation exchange resin; said cation exchange resin and said pH indicator means undergoing a two step reaction to monitor and determine the effective end point of sterilization wherein said cation exchange resin reacts with the alkylene oxide to effect a change in the pH of said cation exchange resin and said pH indicator means registers such change by displaying a distinct color response visible to the naked eye; and said cation exchange resin and said pH indicator means being suitable for subsequently monitoring the effectiveness of the aeration process wherein said cation exchange resin undergoes an additional change which effects a reversion of the pH indicator means to its original precolored state.

Claim 9

Means for monitoring and determining the effective end point of sterilization conditions in which an alkylene oxide is employed to sterilize in a sterilization chamber medical goods and articles including packs containing surgical instruments, and for monitoring and determining the effective end point of a process of aeration of so-sterilized goods and articles to desorb the same of the alkylene oxide, said means consisting essentially of a strong acid cation exchange resin in a comminuted from and incorporated in a thermoplastic resin composition so as to form a flexible transparent plastic disk suitable for inclusion with the goods during sterilization and aeration and a color changing pH indicator means associated with the said cation exchange resin; said cation exchange resin and said pH indicator means undergoing a two step reaction to monitor and determine the effective end point of sterilization wherein said cation exchange resin reacts with the alkylene oxide to effect a change in the pH of said cation exchange resin and said pH indicator means registers such change by displaying a distinct color response visible to the naked eye; and said cation exchange resin and said pH indicator means being suitable for subsequently monitoring the effectiveness of the aeration process wherein said cation exchange resin undergoes an additional change which effects a reversion of the pH indicator means to its original precolored state.

Claim 10

The means of claim 5 in which the flexible transparent plastic disk consists of a composition cured at high temperature comprising a modified chlorethylene polymer.

Claim 11

Means for monitoring and determining the effective end point of sterilization conditions in which an alkylene oxide is employed to sterilize in a sterilization chamber medical goods and articles including packs containing surgical instruments, and for monitoring and determining the effective end point of a process of aeration of so-sterilized goods and articles to desorb the same of the alkylene oxide, said means consisting essentially of a strong acid cation exchange resin in a pellet from of compressed comminuted exchange resin suitable for inclusion with the goods during sterilization and aeration and a color changing pH indicator means associated with the said pellet form of cation exchange resin; said cation exchange resin and said pH indicator means undergoing a two step reaction to monitor and determine the effective end point of sterilization wherein said cation exchange resin reacts with the alkylene oxide to effect a change in the pH of said cation exchange resin and said pH indicator means registers such change by displaying a distinct color response visible to the naked eye; and said cation exchange resin and said pH indicator means being suitable for subsequently monitoring the effectiveness of the aeration process wherein said cation exchange resin undergoes an additional change which effects a reversion of the pH indicator means to its original precolored state.

Claim 12

Means for monitoring and determining the effective end point of sterilization conditions in which an alkylene oxide is employed to sterilize in a sterilization chamber medical goods and articles including packs containing surgical instruments, and for monitoring and determining the effective end point of a process of aeration of so-sterilized goods and articles to desorb the same of the alkylene oxide, said means consisting essentially of a strong acid cation exchange resin in a pellet from of compressed comminuted exchange resin suitable for inclusion with the goods during sterilization and aeration and a color changing pH indicator means associated with the said pellet form of cation exchange resin; said cation exchange resin and said pH indicator means undergoing a two step reaction to monitor and determine the effective end point of sterilization wherein said cation exchange resin reacts with the alkylene oxide to effect a change in the pH of said cation exchange resin and said pH indicator means registers such change by displaying a distinct color response visible to the naked eye; and said cation exchange resin and said pH indicator means being suitable for subsequently monitoring the effectiveness of the aeration process wherein said cation exchange resin undergoes an additional change which effects a reversion of the pH indicator means to its original precolored state.

Claim 13

The means of claim 7 in which the cation exchange resin is in admixture with an absorbent.

Claim 14

The means of claim 8 in which the absorbent is silica gel.

Claim 15

The means of claim 3, 4, or 5 in which the pH indicator is Quinidine red.

Claim 16

The means of claim 3, 4, or 5 in which the pH indicator is 4 phenylazodiphenylamine.

Claim 17

The means of claim 3, 4, or 5 in which the pH indicator is Metanil yellow.

Claim 18

The means of claim 3, 4, or 5 in which the pH indicator is Erythrosin B.