Method and apparatus for validation of sterilization process
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United States of America Patent
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Jan 5, 2010
Grant Date -
Jun 23, 2005
app pub date -
Dec 23, 2003
filing date -
Dec 23, 2003
priority date (Note) -
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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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