Apparatus for testing sterilization methods and materials
First Claim
1. An apparatus for testing one or more sterilization indicators by contacting them under controlled sterilization conditions with a flowing antimicrobial gas comprising hydrogen peroxide vapor, the apparatus comprising:
- (a) antimicrobial gas generating means for providing the flowing antimicrobial gas comprising hydrogen peroxide vapor, the antimicrobial gas generating means comprising;
(1) a vaporization plenum having an inner surface;
(2) means for breaking a vaporizable liquid comprising hydrogen peroxide into fine particles and for flowing the fine particles in the vaporization plenum, the bulk flow of the fine particles flowing in the vaporization plenum being in a first direction;
(3) means for flowing a gas or vapor comprising a first substance in the vaporization plenum and for flowing at least some of the first substance between the inner surface of the vaporization plenum and substantially all of the fine particles to create a curtain of first substance between the inner surface of the vaporization plenum and substantially all of the fine particles, the bulk flow of the first substance in the vaporization plenum flowing in substantially the same direction as the first direction; and
(4) means for causing substantially all of the fine particles to vaporize in the flow of the first substance to produce a substantially continuous flow of a gas-phase mixture of the first substance and vaporized hydrogen peroxide of substantially constant hydrogen peroxide concentration as a function of time, the antimicrobial gas comprising the gas-phase mixture;
(b) a chamber in which the one or more sterilization indicators can be contacted with the flowing antimicrobial gas;
(c) means for rapidly placing the one or more sterilization indicators in the chamber while the flow of the antimicrobial gas in the chamber is substantially continuous and the concentration of hydrogen peroxide in the antimicrobial gas is substantially constant as a function of time;
(d) means for continuing to flow the antimicrobial gas in the chamber to contact the one or more sterilization indicators from substantially the moment they are placed in the chamber, the contact being under substantially uniform conditions for the desired contact time, the flow of the antimicrobial gas during the contact being substantially continuous and the concentration of hydrogen peroxide in the antimicrobial gas during the contact being substantially constant as a function of time; and
(e) means for rapidly removing the one or more sterilization indicators from the chamber after the desired contact time of the one or more sterilization indicators with the antimicrobial gas has elapsed.
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Accused Products
Abstract
Apparatus and method for testing one or more sterilization indicators (e.g., biological indicators or chemical indicators) or other articles by contacting them under controlled sterilization conditions with a flowing antimicrobial gas containing hydrogen peroxide vapor are disclosed. This invention also provides apparatus and method for testing sterilization processes that use a flowing antimicrobial gas containing hydrogen peroxide vapor under controlled sterilization conditions, or for testing materials for such processes under controlled sterilization conditions, or for testing both such processes and such materials under controlled sterilization conditions. There can be an essentially square-wave contact of the sterilization indicators or other articles with the antimicrobial gas (i.e., short rise time to reach full concentration of the antimicrobial gas in contact with the sterilization indicators or other articles and short fall time to remove all of the antimicrobial gas from contact with the sterilization indicators or other articles). A preferred way of generating a substantially constant flow of antimicrobial gas of substantially constant hydrogen peroxide concentration may be used to generate the antimicrobial gas. A preferred way of determining the hydrogen peroxide concentration in the antimicrobial gas may be used.
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Citations
53 Claims
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1. An apparatus for testing one or more sterilization indicators by contacting them under controlled sterilization conditions with a flowing antimicrobial gas comprising hydrogen peroxide vapor, the apparatus comprising:
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(a) antimicrobial gas generating means for providing the flowing antimicrobial gas comprising hydrogen peroxide vapor, the antimicrobial gas generating means comprising; (1) a vaporization plenum having an inner surface; (2) means for breaking a vaporizable liquid comprising hydrogen peroxide into fine particles and for flowing the fine particles in the vaporization plenum, the bulk flow of the fine particles flowing in the vaporization plenum being in a first direction; (3) means for flowing a gas or vapor comprising a first substance in the vaporization plenum and for flowing at least some of the first substance between the inner surface of the vaporization plenum and substantially all of the fine particles to create a curtain of first substance between the inner surface of the vaporization plenum and substantially all of the fine particles, the bulk flow of the first substance in the vaporization plenum flowing in substantially the same direction as the first direction; and (4) means for causing substantially all of the fine particles to vaporize in the flow of the first substance to produce a substantially continuous flow of a gas-phase mixture of the first substance and vaporized hydrogen peroxide of substantially constant hydrogen peroxide concentration as a function of time, the antimicrobial gas comprising the gas-phase mixture; (b) a chamber in which the one or more sterilization indicators can be contacted with the flowing antimicrobial gas; (c) means for rapidly placing the one or more sterilization indicators in the chamber while the flow of the antimicrobial gas in the chamber is substantially continuous and the concentration of hydrogen peroxide in the antimicrobial gas is substantially constant as a function of time; (d) means for continuing to flow the antimicrobial gas in the chamber to contact the one or more sterilization indicators from substantially the moment they are placed in the chamber, the contact being under substantially uniform conditions for the desired contact time, the flow of the antimicrobial gas during the contact being substantially continuous and the concentration of hydrogen peroxide in the antimicrobial gas during the contact being substantially constant as a function of time; and (e) means for rapidly removing the one or more sterilization indicators from the chamber after the desired contact time of the one or more sterilization indicators with the antimicrobial gas has elapsed. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. An apparatus for testing one or more sterilization indicators by contacting them under controlled sterilization conditions with a flowing antimicrobial gas comprising hydrogen peroxide vapor, the apparatus comprising:
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(a) antimicrobial aas generating means for providing the flowing antimicrobial gas comprising hydrogen peroxide vapor, the antimicrobial gas generating means comprising; (1) a vaporization plenum having an inner surface; (2) means for breaking a vaporizable liquid comprising hydrogen peroxide into fine particles and for flowing the fine particles in the vaporization plenum, the bulk flow of the fine particles flowing in the vaporization plenum being in a first direction; (3) means for flowing a gas or vapor comprising a first substance in the vaporization plenum and for flowing at least some of the first substance between the inner surface of the vaporization plenum and substantially all of the fine particles to create a curtain of first substance between the inner surface of the vaporization plenum and substantially all of the fine particles, the bulk flow of the first substance in the vaporization plenum flowing in substantially the same direction as the first direction; and (4) means for causing substantially all of the fine particles to vaporize in the flow of the first substance to produce a substantially continuous flow of a gas-phase mixture of the first substance and vaporized hydrogen peroxide of substantially constant hydrogen peroxide concentration as a function of time, the antimicrobial aas comprising the gas-phase mixture; (b) a chamber in which the one or more sterilization indicators can be contacted with the flowing antimicrobial gas; (c) means for suddenly commencing the contact of the flowing antimicrobial gas with the one or more sterilization indicators in the chamber and means for continuing the contact of the flowing antimicrobial gas with the one or more sterilization indicators in the chamber under substantially uniform conditions for the desired contact time, the flow of the antimicrobial gas in the chamber during the contact being substantially continuous and the concentration of the hydrogen peroxide in the antimicrobial gas during the contact being substantially constant as a function of time; and (d) means for suddenly halting the contact of the antimicrobial gas with the sterilization indicators after the desired contact time has elapsed. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 50, 51, 52, 53)
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34. An apparatus for testing sterilization processes that use a flowing antimicrobial gas comprising hydrogen peroxide vapor under controlled sterilization conditions, or for testing materials for such processes under controlled sterilization conditions, or for testing both such processes and such materials under controlled sterilization conditions, the materials comprising one or more articles, the apparatus comprising:
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(a) antimicrobial gas generating means for providing the flowing antimicrobial gas comprising hydrogen peroxide vapor, the antimicrobial gas generating means comprising; (1) a vaporization plenum having an inner surface; (2) means for breaking a vaporizable liquid comprising hydrogen peroxide into fine particles and for flowing the fine particles in the vaporization plenum, the bulk flow of the fine particles flowing in the vaporization plenum being in a first direction; (3) means for flowing a gas or vapor comprising a first substance in the vaporization plenum and for flowing at least some of the first substance between the inner surface of the vaporization plenum and substantially all of the fine particles to create a curtain of first substance between the inner surface of the vaporization plenum and substantially all of the fine particles, the bulk flow of the first substance in the vaporization plenum flowing in substantially the same direction as the first direction; and (4) means for causing substantially all of the fine particles to vaporize in the flow of the first substance to produce a substantially continuous flow of a gas-phase mixture of the first substance and vaporized hvdroaen peroxide of substantially constant hvdroaen peroxide concentration as a function of time, the antimicrobial gas comprising the gas-phase mixture; (b) a chamber in which the antimicrobial gas is flowed to provide contact of any one or more of the articles with the antimicrobial gas when articles are in the chamber; (c) means for flowing the antimicrobial gas in the chamber to contact any such one or more articles under substantially uniform conditions for the desired time, the flow of the antimicrobial gas in the chamber during the desired time being substantially continuous and the concentration of the hydrogen peroxide in the antimicrobial gas during the desired time being substantially constant as a function of time; and (d) means for halting the flow of the flowing antimicrobial gas after the desired time has elapsed. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49)
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Specification