Microbial indicator device for use with process monitoring systems

Patent metadata

Field	Value
Publication number	US-11260140-B2
Application number	US-201716341209-A
Country	US
Kind code	B2
Filing date	Oct 12, 2017
Priority date	Oct 13, 2016
Publication date	Mar 1, 2022
Grant date	Mar 1, 2022

Abstract

A microbial indicator device for liquid disinfection comprises a first cavity, a source of biological activity fluidically coupled to the first cavity via a portion of a first fluidic path, a filter membrane positioned in a second fluidic path for a disinfectant, and a first coupling portion fluidically coupled to the source of biologically activity via the second fluidic path. The filter membrane has a first side and a second side, wherein the first side is in fluid communication with the first fluidic path. The filter membrane has a pore size sufficient to retain at least a portion of the source of biological activity on the first side. The device further comprises a frangible container contained in the first cavity, wherein a liquid in the container is in fluid communication with the first cavity when the container is fractured.

First claim

What is claimed is:

1. A microbial indicator device for liquid disinfection, comprising:
a first housing comprising:
a first cavity;
a source of biological activity, wherein the source of biological activity is fluidically coupled to the first cavity via a portion of a first fluidic path;
a first coupling portion having a first channel extending longitudinally therethrough that defines a portion of a second fluidic path, wherein the first coupling portion is fluidically coupled to the source of biologically activity via the second fluidic path;

a filter membrane positioned in the second fluidic path, wherein the filter membrane has a first side and a second side, wherein the second fluidic path is established between the first coupling portion and the second side, and
a vent, wherein the vent is fluidically coupled to a portion of the first fluidic path; and
wherein the filter membrane has effective porosity sufficient to retain at least a portion of the source of biological activity on the first side.

2. The microbial indicator device of claim 1 , wherein the filter membrane has a filter membrane surface area and the first coupling portion has an inlet area partially defined by a cross-section of the first channel, wherein a ratio of the filter membrane surface area to the inlet area is at least 100:1.

3. The microbial indicator device of claim 1 , further comprising:
a chemical indicator that indicates a presence of a disinfectant.

4. The microbial indicator device of claim 3 , further comprising:
a third cavity positioned in the second fluidic path, wherein the third cavity is positioned in the first housing and configured to house the chemical indicator, wherein the third cavity is fluidically coupled to the first coupling portion via the second fluidic path.

5. The microbial indicator device of claim 1 , further comprising a second housing.

6. The microbial indicator device of claim 5 , wherein the second side of the filter membrane is fluidically coupled to a second coupling portion with a channel extending longitudinally therethrough and positioned within the second housing.

7. The microbial indicator device of claim 5 , wherein the second housing comprises one or more side portions and the first housing comprises one or more side portions, wherein the one or more side portions of the first housing are configured to mate with the one or more side portions of the second housing.

8. The microbial indicator device of claim 5 , wherein the filter membrane is sandwiched between the first housing and the second housing.

9. The microbial indicator device of claim 1 , further comprising a second cavity positioned in the first housing and configured to house the source of biological activity, wherein the second cavity is fluidically coupled to the first cavity via the first fluidic path.

10. The microbial indicator device of claim 9 , further comprising a container containing a liquid and being dimensioned to be positioned in the first cavity, at least a portion of the container being frangible, the container having a first state in which the container is intact and the liquid is not in fluid communication with an interior of the first cavity and a second state in which the container is fractured and the liquid is in fluid communication with the first cavity.

11. The microbial indicator device of claim 10 , further comprising a funneling cavity positioned adjacent to the first cavity and positioned within a portion of the first fluidic path, wherein the funneling cavity is configured to direct the liquid when the container is in the second state towards the second cavity.

12. The microbial indicator device of claim 9 , wherein the first housing further comprises a first major surface, a second major surface, and a first drain passage formed from the first housing extending between the first major surface and the second major surface, wherein the first drain passage is fluidically coupled with the second cavity and the first cavity.

13. The microbial indicator device of claim 1 , wherein the filter membrane has an average pore size of no greater than 0.2 microns.

14. The microbial indicator device of claim 1 , wherein a resistance to flow of the filter membrane is no greater than 55 mm −3 at 25 degrees C.

15. A method of operating a microbial indicator device, comprising:
connecting a first coupling portion of the microbial indicator device comprising:
a first housing comprising:
a first cavity;
a source of biological activity, wherein the source of biological activity is fluidically coupled to the first cavity via a portion of a first fluidic path;
the first coupling portion having a first channel extending longitudinally therethrough that defines a portion of a second fluidic path, wherein the first coupling portion is fluidically coupled to the source of biologically activity via the second fluidic path;

a filter membrane positioned in the second fluidic path, wherein the filter membrane has a first side and a second side, wherein the second fluidic path is established between the first coupling portion and the second side, and
a vent, wherein the vent is fluidically coupled to a portion of the first fluidic path; and
wherein the filter membrane has effective porosity sufficient to retain at least a portion of the source of biological activity on the first side;

allowing a disinfectant to flow through the second fluidic path of the microbial indicator device;
wherein at least a portion of the source of biological activity is retained within a first filter cavity.

16. The method of claim 15 , wherein the microbial indicator device comprises a second housing, wherein the second side of the filter membrane is fluidically coupled to a second coupling portion with a channel extending longitudinally therethrough and positioned within the second housing,
wherein, when the disinfectant contacts the first coupling portion, the disinfectant has a first pressure and, at the second coupling portion, the disinfectant has a second pressure, wherein the second pressure is at least 90 percent of the first pressure.

17. The method of claim 15 , wherein the microbial indicator device comprises a container containing a liquid and being dimensioned to be positioned in the first cavity, at least a portion of the container being frangible, the container having a first state in which the container is intact and the liquid is not in fluid communication with an interior of the first cavity and a second state in which the container is fractured and the liquid is in fluid communication with the first cavity;
the method further comprising:
fracturing the container, wherein the container is changed from the first state to the second state;
allowing the liquid to flow into a second cavity;
determining whether the source of biological activity is biologically active.

18. A microbial indicator device for liquid disinfection, comprising:
a first housing comprising:
a first cavity;
a source of biological activity, wherein the source of biological activity is fluidically coupled to the first cavity via a portion of a first fluidic path;
a first coupling portion having a first channel extending longitudinally therethrough that defines a portion of a second fluidic path, wherein the first coupling portion is fluidically coupled to the source of biologically activity via the second fluidic path;

a filter membrane positioned in the second fluidic path, wherein the filter membrane has a first side and a second side, wherein the second fluidic path is establ

Assignees

• 3M Innovative Properties Co

Inventors

• Bommarito G Marco
• Nies Timothy J
• Robole Barry W
• Bennaars-Eiden Assumpta A G
• Connell Jodi L
• Bonilla Tonya D
• Kohman Timothy A
• Duda Ruthann R

Classifications

• A61L2103/15

  Laboratory, medical or dentistry appliances, e.g. catheters or sharps · CPC title

• A61L2/28 Primary

  Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour · CPC title

• C12Q1/22

  Testing for sterility conditions · CPC title

• A61L2202/24

  Human Necessities · mapped topic