Method and apparatus for validation of sterilization
First Claim
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1. A radiation sterilization verification device comprising:
- 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, the second dosimeter block including an interior surface forming a protrusion configured to abut an interior surface of the cavity of 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.
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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.
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Citations
30 Claims
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1. 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, the second dosimeter block including an interior surface forming a protrusion configured to abut an interior surface of the cavity of 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 (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. 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 one of the plurality of dosimeters is positioned within each cavity; and a second dosimeter block configured to operate with the first dosimeter block, the second dosimeter block including an interior surface with a plurality of protrusions each configured to abut an interior surface of one of the plurality of cavities of 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 (20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A radiation sterilization verification device comprising:
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a dosimeter; a first dosimeter block including an interior surface with a plurality of cavities defined therein, wherein the dosimeter is positioned within one of the plurality of cavities; a second dosimeter block configured to operate with the first dosimeter block, the second dosimeter block including a plurality of protrusions, each protrusion configured to abut an interior surface of one of the plurality of cavities, 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.
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Specification