Method and system for sterilizing an analyte sensor
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.
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.
2. The method of claim 1 , wherein the chemical solution is a gaseous solution.
3. The method of claim 2 , wherein the gaseous solution includes one of ethylene oxide, vaporized hydrogen peroxide, and nitrogen oxide.
4. The method of claim 1 , further comprising sealing the first container with a cover, wherein the first container includes thermoformed plastic.
5. The method of claim 4 , wherein the cover includes aluminum.
6. The method of claim 4 , wherein the cover and the first container form the seal with an adhesive material disposed therebetween.
7. The method of claim 1 , wherein the packaged glucose sensor assembly is irradiated at a surface dosage of between 25 kGy and 60 kGy.
8. The method of claim 1 , wherein the irradiation of the packaged glucose sensor assembly and the exposure of the medical device assembly to the chemical solution results in a 10 −6 sterility assurance level for both of the assemblies.
9. The method of claim 1 , wherein both the packaged glucose sensor assembly and the medical device assembly are sterilized to maintain a predetermined sterility level for at least six months.
10. The method of claim 1 , wherein both the packaged glucose sensor assembly and the medical device assembly are sterilized to maintain a predetermined sterility level for at least 18 months.
11. The method of claim 1 , wherein the enzyme layer comprises a mediator.
12. The method of claim 11 , wherein the enzyme layer comprises a redox polymer.
13. The method of claim 11 , wherein the redox polymer comprises an osmium-containing polymer.
14. The method of claim 1 , wherein the glucose diffusion limiting layer comprises a polymer.
15. The method of claim 1 , wherein the glucose sensor comprises a planar substrate on which the at least one electrode is positioned.
16. The method of claim 1 , wherein the packaged glucose sensor assembly is irradiated using at least one electron beam accelerator.
17. The method of claim 1 , wherein the medical device assembly is exposed to the chemical solution in an environment with a predetermined temperature.
18. The method of claim 17 , wherein the environment has a predetermined humidity.
19. The method of claim 18 , wherein the second predetermined time period is determined based on at least one of the predetermined temperature and the predetermined humidity of the environment, and wherein the chemical solution has a predetermined concentration.
20. The method of claim 1 , further comprising packaging the medical device assembly and the glucose sensor assembly in a kit.
21. The method of claim 1 , wherein the medical device assembly includes a sensor delivery unit.
22. The method of claim 1 , wherein the medical device assembly includes an adhesive for adhering the sensor electronics assembly to a skin surface.
23. The method of claim 1 , wherein the glucose sensor assembly includes a desiccant.
24. 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;
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.
25. The method of claim 24 , wherein packaging the glucose sensor assembly in the first container includes sealing the first container including thermoformed plastic with a cover.
26. The method of claim 25 , wherein the cover includes foil.
27. The method of claim 25 , wherein the cover and the first container form a seal with an adhesive material disposed therebetween.
28. The method of claim 24 , wherein irradiating the second container includes irradiating at a surface dosage of between 25 kGy and 60 kGy.
29. The method of claim 24 , wherein irradiating the second container including a predetermined number of glucose sensor assemblies results in a 10 −6 sterility assurance level.
30. The method of claim 24 , wherein the packaged glucose sensor assembly is sterilized to maintain a predetermined sterility level for at least six months.
31. The method of claim 24 , wherein the packaged glucose sensor assembly is sterilized to maintain a predetermined sterility level for at least 18 months.
32. The method of claim 24 , wherein the enzyme layer comprises a mediator.
33. The method of claim 32 , wherein the enzyme layer comprises a redox polymer.
34. The method of claim 33 , wherein the redox polymer comprises an osmium-containing polymer.
35. The method of claim 24 , wherein the glucose diffusion limiting layer comprises a polymer.
36. The method of claim 24 , wherein the packaged glucose sensor assembly is irradiated using an electron beam accelerator.
37. The method of claim 24 , wherein the glucose sensor assembly includes a desiccant.
38. The method of claim 24 , further comprising:
assembling a medical device assembly including sensor electronics; and
packaging the sterilized glucose sensor assembly with the medical device assembly.
39. The method of claim 38 , wherein the medical device assembly includes a sensor delivery unit.