Method and system for sterilizing an analyte sensor
First Claim
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1. A method of sterilizing a glucose monitoring assembly, the method comprising:
- assembling a glucose sensor and a sensor introducer to form a glucose sensor assembly, wherein the glucose sensor comprises at least one electrode, an enzyme layer, and a glucose diffusion limiting layer;
assembling a medical device assembly including sensor electronics;
packaging the glucose sensor assembly in a first container;
packaging the first container in a second container that includes at least one glucose sensor assembly;
irradiating the second container including the at least one glucose sensor assembly at a predetermined dose level using electron beam irradiation; and
exposing the medical device unit assembly to a chemical solution for a second predetermined time period to sterilize the medical device assembly.
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Abstract
In one aspect, there is provided assembling an analyte sensor with an analyte sensor insertion device, packaging the assembled analyte sensor and sensor insertion device in a substantially airtight seal, and irradiating the packaged assembled analyte sensor and sensor insertion device at a predetermined dose using one or more electron beam accelerators.
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Citations
39 Claims
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1. A method of sterilizing a glucose monitoring assembly, the method comprising:
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assembling a glucose sensor and a sensor introducer to form a glucose sensor assembly, wherein the glucose sensor comprises at least one electrode, an enzyme layer, and a glucose diffusion limiting layer; assembling a medical device assembly including sensor electronics; packaging the glucose sensor assembly in a first container; packaging the first container in a second container that includes at least one glucose sensor assembly; irradiating the second container including the at least one glucose sensor assembly at a predetermined dose level using electron beam irradiation; and exposing the medical device unit assembly to a chemical solution for a second predetermined time period to sterilize the medical device assembly. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A method of sterilizing a glucose monitoring assembly, the method comprising:
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assembling a glucose sensor and a sensor introducer to form a glucose sensor assembly, wherein the glucose sensor comprises at least one electrode, an enzyme layer, and a glucose diffusion limiting layer; packaging the glucose sensor assembly in a first container; packaging the first container in a second container that includes at least one glucose sensor assembly; and irradiating the second container including the at least one glucose sensor assembly at a predetermined dose level using electron beam irradiation. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39)
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Specification