Biological sterilization indicator

Patent metadata

Field	Value
Publication number	US-10047334-B2
Application number	US-201615064918-A
Country	US
Kind code	B2
Filing date	Mar 9, 2016
Priority date	Nov 1, 2010
Publication date	Aug 14, 2018
Grant date	Aug 14, 2018

Abstract

A biological sterilization indicator (BI). The BI can include a housing, and a container positioned in the housing. The container can contain a liquid and at least a portion of the container can be frangible. The BI can further include a first chamber and a second chamber. The second chamber can include at least one source of biological activity. The BI can further include a substrate positioned in the housing between the first chamber and the second chamber. The substrate can be positioned in fluid communication with the first chamber and the second chamber, and the substrate can be further positioned such that the substrate is not in direct contact with the source of biological activity.

First claim

What is claimed is:

1. A biological sterilization indicator comprising:
a housing;
a container containing a liquid and being dimensioned to be positioned in the housing, 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 housing and a second state in which the container is fractured and the liquid is in fluid communication with the interior of the housing;
a first chamber in the housing in which the container is positioned when the container is in the first state;
a second chamber in the housing in which the container and the liquid are not positioned when the container is in the first state, the second chamber comprising a source of biological activity that is not in fluid communication with the liquid when the container is in the first state and that is in fluid communication with the liquid when the container is in the second state;
a flange, formed from the housing, comprising an opening that separates the first chamber and the second chamber; and
a substrate positioned in the first chamber adjacent the flange and dimensioned to rest atop of the wall, the substrate positioned in fluid communication with the first chamber and the second chamber, the substrate is adapted to collect broken portions of the container when the container is in the second state, the substrate further positioned between the container and the source of biological activity such that the substrate is not in direct contact with the source of biological activity, wherein the substrate includes an aperture formed therein that is approximately centered in the substrate, and wherein the aperture can be dimensioned to control fluid flow between the first chamber and the second chamber.

2. The biological sterilization indicator of claim 1 , wherein the second chamber includes a volume to be interrogated to determine the lethality of a sterilization process, and wherein the substrate is positioned outside of the volume to be interrogated.

3. The biological sterilization indicator of claim 1 , wherein the substrate is positioned in the liquid when the container is in the second state.

4. The biological sterilization indicator of claim 1 , wherein the substrate at least partially defines the first chamber and the second chamber.

5. The biological sterilization indicator of claim 1 , wherein the source of biological activity is housed in a source carrier, and wherein the substrate is not in direct contact with the source carrier.

6. The biological sterilization indicator of claim 1 , wherein the flange and the substrate are oriented at a non-zero and non-right angle with respect to a longitudinal direction of the biological sterilization indicator.

7. The biological sterilization indicator of claim 1 , wherein the substrate is adapted to concentrate an indicator reagent when the container is in the second state and the substrate is in fluid communication with a liquid comprising the indicator reagent.

8. The biological sterilization indicator of claim 1 , wherein the substrate is adapted to selectively concentrate an inhibitor when the container is in the second state and the substrate is in fluid communication with a liquid comprising the inhibitor.

9. The biological sterilization indicator of claim 1 , wherein the substrate is adapted to selectively concentrate a first indicator reagent when the container is in the second state and the substrate is in fluid communication with a liquid comprising the first indicator reagent and a second indicator reagent.

10. The biological sterilization indicator of claim 1 , wherein the substrate comprises nylon.

11. The biological sterilization indicator of claim 1 , wherein the substrate comprises charged nylon.

12. The biological sterilization indicator of claim 1 , wherein the substrate is positioned to limit diffusion of a detectable product from the second chamber to the first chamber when the container is in the second state.

13. The biological sterilization indicator of claim 1 , wherein the substrate is formed of a different material than the housing.

14. The biological sterilization indicator of claim 1 , wherein the substrate does not form a portion of an internal or external wall positioned to define at least a portion of the first chamber or the second chamber.

15. The biological sterilization indicator of claim 1 , further comprising: an insert comprising an opening formed in the insert and an open space around the insert such that the opening defines a fluid path that allows the liquid to reach the source of biological activity, the insert is adapted to hold the container such that the container is held intact in a location separate from the source of biological activity during sterilization.

16. The biological sterilization indicator, wherein the substrate is positioned between the insert and the wall.

Assignees

• 3M Innovative Properties Co

Inventors

• Chandrapati Sailaja
• Webb Heather M
• Pederson Jeffrey C
• Smith Jeffrey D
• Duda Ruthann R
• Engel Brian J

Classifications

• G01N21/6486

  Measuring fluorescence of biological material, e.g. DNA, RNA, cells (G01N21/6428 takes precedence) · CPC title

• C12Q1/22 Primary

  Testing for sterility conditions · CPC title

• C12Q1/04

  Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor {(C12Q1/6897 takes precedence)} · CPC title

• C12M37/06 Primary

  Means for testing the completeness of the sterilization (testing for sterility conditions C12Q1/22) · CPC title

• C12M25/06

  Plates; Walls; Drawers; Multilayer plates · CPC title