Monitoring sterilant concentration in a sterilization process

• US 20030063997A1
• Filed: 08/29/2002
• Published: 04/03/2003
• Est. Priority Date: 12/21/1999
• Status: Abandoned Application

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Engstrom, Keith, Lin, Szu-Min, Timm, Debra, Fryer, Ben, Hui, Henry K.
• Application Number:
  US10/230,527
• Publication Number:
  US 20030063997A1
• Time in Patent Office: Days
• US Class Current: 422/3
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: G01N 25/28 the rise in temperature of the gases resulting from combustion being measured directly
• CPC Class Codes: G01N 25/32 using thermoelectric elements
• CPC Class Codes: G01N 31/223 for investigating presence of specific gases or aerosols G01N31/221, G01N31/222 take precedence; actuation of fire alarm by presence of smoke or gases G08B17/10
• CPC Class Codes: G01N 31/226 for investigating the degree of sterilisation

Abstract

A method monitors the concentration of an oxidative gas or vapor during a sterilization process in a sterilization chamber. A sensor formed of a chemical reactive with the oxidative gas or vapor coupled to a temperature probe is positioned inside of an enclosure containing an item to be sterilized. The enclosure is defined by a barrier impermeable to contaminating microorganisms and having at least a portion thereof which is permeable to the oxidative gas or vapor. The sensor is electrically connected through the barrier to contacts located exterior of the enclosure and connected to a control system thereby.

Claims

1. A method of monitoring the concentration of an oxidative gas or vapor during a sterilization process in a sterilization chamber, the method comprising:

providing a sensor which comprises a chemical which undergoes a reaction with the oxidative gas or vapor, thereby producing a heat change, said chemical being coupled to a first temperature probe which detects the heat change produced by the reaction between the chemical and the oxidative gas or vapor to be monitored;

positioning the sensor inside of an enclosure containing an item to be sterilized, the enclosure being defined by a barrier, said barrier being impermeable to contaminating microorganisms and having at least a portion thereof which is permeable to the oxidative gas or vapor, the sensor being electrically connected through the barrier to contacts located exterior of the enclosure;

connecting the sensor to a control system exterior of the enclosure via the contacts;

exposing the sensor to the oxidative gas or vapor at the location; and

determining the concentration of the oxidative gas or vapor interior of the enclosure based upon the heat change produced by the reaction between the chemical and the oxidative gas or vapor.

2. The method of claim 1 wherein the oxidative gas or vapor comprises hydrogen peroxide.

3. The method of claim 1 which further comprises the step of releasably attaching the sensor to interior contacts inside of the enclosure.

4. The method of claim 1 and further comprising providing the sensor with a second temperature probe not coupled to the chemical and determining the concentration of the oxidative gas or vapor interior of the enclosure based upon a differential measured between the first temperature probe and the second temperature probe.

5. The method of claim 1 and further comprising via the control system modifying a parameter of the sterilization process based upon one or more determinations of the concentration of the oxidative gas or vapor interior of the enclosure.

6. The method of claim 5 wherein the parameter is chosen from the group consisting of:

time of exposure to the oxidative gas or vapor, amount of the oxidative gas or vapor to which the enclosure is exposed, temperature inside of the chamber, and pressure inside of the chamber.

7. The method of claim 1 wherein the barrier is flexible.

8. The method of claim 1 and further comprising the step of disconnecting the sensor from the control system via the contacts.

9. The method of claim 8 and further comprising removing the enclosure from the chamber.

10. The method of claim 9 and thereafter comprising the step of having the sterilized device in the enclosure.

11. An enclosure adapted to hold an item for sterilization in an oxidative gas or vapor, the enclosure comprising:

a barrier defining the enclosure, the barrier being impermeable to contaminating microorganisms and having at least a portion thereof which is permeable to the oxidative gas or vapor;

a sensor disposed within the enclosure which comprises a first temperature probe coupled to a chemical which is reactive with the oxidative gas or vapor to produce a heat change; and

wherein the sensor is electrically connected through the barrier to contacts located exterior of the enclosure.

12. An enclosure according to claim 11 wherein the chemical is reactive to hydrogen peroxide.

13. An enclosure according to claim 11 wherein the sensor is releasably attached to interior contacts interior of the enclosure whereby the sensor may be replaced.

14. An enclosure according to claim 11 wherein the sensor further comprises a second temperature probe not coupled to the chemical whereby to determine the concentration of the oxidative gas or vapor interior of the enclosure based upon a differential measured between the first temperature probe and the second temperature probe.

15. An enclosure according to claim 11 wherein the barrier is flexible so that the enclosure is flexible.

16. An enclosure according to claim 11 wherein the barrier is substantially rigid whereby to form a rigid container.