Method for sterilizing membrane comprising an oxidoreductase enzyme and associated biosensor

• US 9,968,696 B2
• Filed: 05/29/2013
• Issued: 05/15/2018
• 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: Chen, Rui, Xu, Yida, Chen, Lin
• Primary Examiner(s): Johnson, Kara
• Application Number:
  US14/402,473
• Publication Number:
  US 20150151013A1
• Time in Patent Office: 1,812 Days
• CPC Class Codes: A61L 2/0035 Gamma radiation
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 2333/904 acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)

Abstract

A method for sterilizing a membrane comprising an oxidoreductase enzyme in an environment having a relative humidity, comprises: irradiating the membrane comprising an oxidoreductase enzyme with gamma radiation under vacuum at a relative humidity lower than the relative humidity of the environment. Associated biosensors are also described.

Claims

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

a) providing a receptacle containing a desiccant and the MCOE;

b) applying vacuum to the receptacle containing the desiccant and the MCOE such that the interior pressure of the receptacle is lower than atmospheric pressure;

c) sealing the vacuumed receptacle containing the desiccant and the MCOE; and

d) irradiating the vacuumed receptacle containing the desiccant and the MCOE with gamma radiation.

2. The method of claim 1, wherein the receptacle is a flexible bag.

3. The method of claim 1, wherein the interior pressure of the receptacle is 50 kPa lower than atmospheric pressure.

4. The method of claim 1, wherein the desiccant comprises silica gel, activated charcoal, calcium sulfate, calcium chloride, montmorillonite clay, and/or a molecular sieve.

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

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

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

8. The method of claim 1, wherein the oxidoreductase enzyme is glucose oxidase.

9. The method of claim 1, wherein the membrane comprising an oxidoreductase enzyme is in a biosensor.

10. A method for sterilizing a membrane comprising an oxidoreductase enzyme (MCOE) contained in a receptacle, wherein the receptacle has an environment having a relative humidity, the method comprising:

a) lowering the relative humidity inside the receptacle by adding a desiccant to the receptacle containing the MCOE;

b) applying a vacuum to the receptacle containing the desiccant and the MCOE of step a);

c) maintaining the receptacle containing the desiccant and the MCOE under vacuum;

d) sealing the receptacle containing the desiccant and the MCOE; and

e) irradiating the vacuumed receptacle containing the desiccant and the MCOE with gamma radiation.

11. The method of claim 10, wherein the membrane comprising an oxidoreductase enzyme is held under vacuum with the relative humidity of about half of the relative humidity of the environment.

12. The method of claim 10, further comprising a step of sealing the receptacle between a) and b).

13. The method of claim 10, wherein the desiccant comprises silica gel, activated charcoal, calcium sulfate, calcium chloride, montmorillonite clay, and/or a molecular sieve.