Method and system for sterilizing an analyte sensor
First Claim
Patent Images
1. A method of sterilizing a glucose sensor assembly, the method comprising:
- assembling a glucose sensor with a sensor mounting unit and a sensor delivery unit, where the glucose sensor comprises at least one electrode, an enzyme area, and a glucose diffusion limiting area, the sensor delivery unit comprises a housing and a metal sharp, and the sensor mounting unit comprises an adhesive;
irradiating the assembly with a predetermined dose level and/or for a predetermined time period to sterilize the assembly;
packaging the assembly in a first container;
packaging the first container in a second container that includes a predetermined number of packaged assemblies; and
irradiating the second container including packaged assemblies at a predetermined dose using one or more electron beam accelerators.
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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.
581 Citations
28 Claims
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1. A method of sterilizing a glucose sensor assembly, the method comprising:
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assembling a glucose sensor with a sensor mounting unit and a sensor delivery unit, where the glucose sensor comprises at least one electrode, an enzyme area, and a glucose diffusion limiting area, the sensor delivery unit comprises a housing and a metal sharp, and the sensor mounting unit comprises an adhesive; irradiating the assembly with a predetermined dose level and/or for a predetermined time period to sterilize the assembly; packaging the assembly in a first container; packaging the first container in a second container that includes a predetermined number of packaged assemblies; and irradiating the second container including packaged assemblies at a predetermined dose using one or more electron beam accelerators. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method of sensor delivery assembly sterilization, comprising:
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assembling an analyte sensor with an analyte sensor insertion device; packaging the assembled analyte sensor and sensor insertion device in a first container; packaging the first container in a second container that includes a predetermined number of packaged assembled analyte sensors and sensor insertion devices; and irradiating the second container including packaged assembled analyte sensor and sensor insertion device at a predetermined dose using one or more electron beam accelerators. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A method, comprising:
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packaging an assembled analyte sensor and sensor insertion device in a first container; exposing the first container including the analyte sensor and the sensor insertion device to electron beam irradiation to result in approximately 10−
6 sterility assurance level;packaging the first container in a second container that includes a predetermined number of packaged assembled analyte sensors and sensor insertion devices; and irradiating the second container including the predetermined number of packaged assembled analyte sensors and sensor insertion devices at a predetermined dose using one or more electron beam accelerators.
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Specification