Method for sterilizing membrane comprising glucose oxidase and associated bio-sensor

• US 10,369,238 B2
• Filed: 01/30/2018
• Issued: 08/06/2019
• Est. Priority Date: 05/31/2012
• Status: Active Grant

• Current Assignee: Global Life Sciences Solutions USA LLC (Danaher Corporation)
• Original Assignee: General Electric Company
• Inventors: Xu, Yida, Chen, Rui, Chen, Lin
• Primary Examiner(s): Spamer, Donald R
• Application Number:
  US15/884,310
• Publication Number:
  US 20180154026A1
• Time in Patent Office: 553 Days
• CPC Class Codes: A61L 2/0035 Gamma radiation
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: C12M 41/32 of substances in solution
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/26 involving oxidoreductase

Abstract

A method for sterilizing a membrane comprising an oxidoreductase enzyme, comprises: irradiating with gamma radiation the membrane comprising an oxidoreductase enzyme soaked in an aqueous buffer solution. Associated biosensors and bioreactors are also described.

Claims

1. A method for sterilizing a membrane comprising an oxidoreductase enzyme, the method comprising:

irradiating with gamma radiation the membrane comprising the oxidoreductase enzyme soaked in a phosphate buffer saline (PBS) buffer solution,

wherein the PBS buffer consists essentially of sodium phosphate dibasic, sodium acid phosphate, sodium chloride, glycine, N, N′

-ethanediybis (N-carboxymethyl) dipotassium, sodium benzoate, and gentamicin sulphate in water.

2. The method of claim 1, wherein the oxidoreductase enzyme is selected from the group consisting of glucose oxidase, lactate oxidase and glutamate oxidase.

3. The method of claim 2, wherein the oxidoreductase enzyme is glucose oxidase.

4. The method of claim 1, wherein the wherein the gamma radiation is conducted at a rate of more than 3 kGy/hour and a dose of at least 25 kGy.

5. The method of claim 1, wherein the aqueous buffer solution is substantially free from organic components.

7. The method of claim 1, wherein a dose of the gamma radiation is in a range of from about 25 kGy to about 40 kGy.

8. The method of claim 1, wherein a rate of the gamma radiation is about 20 kGy/hour.

9. The method of claim 1, wherein the membrane is in a plastic container.

10. The method of claim 1, wherein the membrane is in a biosensor.

11. The method of claim 10, wherein the biosensor comprises a Pt electrode and an Ag/AgCl electrode.

13. A biosensor comprising the membrane sterilized using the method of claim 1.

14. The biosensor of claim 13, wherein the membrane comprises glucose oxidase and the sensitivity of the biosensor to glucose is about 80% of the sensitivity of a biosensor comprising a membrane comprising glucose oxidase without sterilization to glucose.

15. The biosensor of claim 13, comprising a Pt electrode and an Ag/AgCl electrode.

16. A bioreactor comprising the biosensor of claim 13.

6. A method for sterilizing a membrane comprising glucose oxidase, the method comprising:

making a phosphate buffer saline (PBS) solution by dissolving a PBS buffer powder in water,

wherein the PBS buffer powder consists essentially of 50-55% wt sodium phosphate dibasic, 10-15% wt sodium acid phosphate, 16-22% wt sodium chloride, less than 10% wt glycine and N, N′

-ethanediylbis (N-carboxymethyl) dipotassium, less than 10% wt sodium benzoate, and less than 1% wt gentamicin sulphate, and

irradiating with gamma radiation the membrane comprising glucose oxidase soaked in a phosphate buffer saline (PBS) solution,

wherein the gamma radiation is carried out in a range of from about 25 kGy to about 40 kGy at rate of about 20 kGy/hour.

12. The method of claim 6, wherein the biosensor comprises a Pt electrode and an Ag/AgCl electrode.

17. A biosensor comprising a sterilized membrane that comprises glucose oxidase, wherein the membrane is sterilized by:

irradiating with gamma radiation while the membrane comprising glucose oxidase is soaked in a phosphate buffer saline (PBS) solution,

wherein the PBS buffer is made by dissolving a PBS powder in water, wherein the PBS buffer powder consists essentially of 50-55% wt sodium phosphate dibasic, 10-15% wt sodium acid phosphate, 16-22% wt sodium chloride, less than 10% wt glycine and N, N′

-ethanediylbis (N-carboxymethyl) dipotassium, less than 10% wt sodium benzoate, and less than 1% wt gentamicin sulphate, and

wherein the gamma radiation is carried out in a range of from about 25 kGy to about 40 kGy at rate of about 20 kGy/hour.

18. The biosensor of claim 17, wherein the biosensor comprises a Pt electrode and an Ag/AgCl electrode.

19. The biosensor of claim 17, wherein the sensitivity of the sterilized biosensor to glucose is about 80% of the sensitivity of a biosensor prior to sterilization.

20. A bioreactor comprising the biosensor of claim 17.