METHOD AND APPARATUS FOR VALIDATION OF STERILIZATION
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Accused Products
Abstract
An apparatus, system and method for verifying the achievement of a desired sterility assurance level (SAL) for components manipulated within a low-energy electron beam sterilization chamber. The components are preferably pre-sterilized and connected together in an assembly fashion which creates and maintains the sterility of the connection by subjecting the components to low-energy (less than 300 KeV) electron beam radiation. The verification is completed by measuring the sterilization dose delivered to a sensor, also known as a dosimeter, positioned within the sterilization process to simulate the components.
99 Citations
45 Claims
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1-9. -9. (canceled)
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10. A radiation sterilization verification device comprising:
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a dosimeter; a first dosimeter block including an interior surface with a cavity defined therein wherein the dosimeter is positioned within the cavity; a second dosimeter block configured to operate with the first dosimeter block, at least one of the first and second dosimeter blocks having a radiation resistant material and a sufficient density and thickness to shield the dosimeter from indirect exposure to radiation. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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29-32. -32. (canceled)
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33. A radiation sterilization verification device comprising:
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a plurality of dosimeters; a first dosimeter block including an interior surface with a plurality of cavities defined therein wherein a dosimeter is positioned within each cavity; and a second dosimeter block configured to operate with the first dosimeter block, the first and second dosimeter blocks having a radiation resistant material and a sufficient density and thickness to shield the dosimeter from radiation. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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45-62. -62. (canceled)
Specification