Biological sterilization indicator, system, and methods of using same

• US 9,717,812 B2
• Filed: 02/18/2015
• Issued: 08/01/2017
• Est. Priority Date: 10/17/2008
• Status: Active Grant

• Current Assignee: Solventum Intellectual Properties Company (Solventum Corp.)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Ludowise, Peter D., Chandrapati, Sailaja, Pederson, Jeffrey C., Webb, Heather M., Smith, Jeffrey D., Halverson, Kurt J., Behun, Bryan S.
• Primary Examiner(s): Joyner, Kevin
• Application Number:
  US14/625,176
• Publication Number:
  US 20150165082A1
• Time in Patent Office: 895 Days
• Field of Search: 4352874
• 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: C12Q 1/22 Testing for sterility conditions

Abstract

A biological sterilization indicator, system, and methods of determining the effectiveness of a sterilization process. The biological sterilization indicator can include a locus of spores, a reservoir containing a liquid, and a sterilant path positioned to provide fluid communication between ambience and the locus of spores. The reservoir can have a closed state in which the reservoir is not in fluid communication with the locus of spores and an open state in which the reservoir is in fluid communication with the locus of spores. The biological sterilization indicator system can include the biological sterilization indicator and a detection device adapted to be coupled to the biological sterilization indicator. In some embodiments, the method can include assaying the spores for a detectable change in a characteristic, and detecting substantially all of the detectable change.

Claims

1. A biological sterilization indicator comprising:

a housing;

a spore reservoir located in the housing, the spore reservoir comprising a locus of spores, the spore reservoir having a volume, wherein the locus of spores is positioned on a carrier;

a first reservoir positioned in fluid communication with the locus of spores;

a channel positioned to fluidly couple the first reservoir to the spore reservoir;

a second reservoir containing a liquid, the second reservoir having a closed state in which the second reservoir is not in fluid communication with the spore reservoir and an open state in which the second reservoir is in fluid communication with the spore reservoir, wherein the second reservoir is defined by a frangible container, and wherein the frangible container is positioned within the first reservoir; and

a wicking material positioned adjacent the channel to facilitate flow of the liquid from an interior of the housing into the spore reservoir when the second reservoir is in the open state, wherein the wicking material is separate from the carrier.

2. The biological sterilization indicator of claim 1, further comprising a detection window in the housing, wherein the detection window is located adjacent the locus of spores, and wherein the detection window has at least one dimension that is sized substantially the same as at least one dimension of at least one of the spore reservoir and the locus of spores.

3. The biological sterilization indicator of claim 1, further comprising a seal positioned to move between a first position relative to a sterilant path in which the locus of spores is in fluid communication with ambience and a second position relative to the sterilant path in which the locus of spores is not in fluid communication with ambience, the seal adapted to be in the second position when the reservoir is in the open state.

4. The biological sterilization indicator of claim 3, wherein the seal includes

a film positioned to cover at least a portion of the sterilant path, the film being movable between the first position and the second position, and

an adhesive positioned to adhere the film when the film is in the second position.

5. The biological sterilization indicator of claim 1, further comprising means for facilitating contact between the liquid and the locus of spores.

6. The biological sterilization indicator of claim 1, further comprising a cover positioned over the locus of spores.

7. The biological sterilization indicator of claim 1, wherein the locus of spores is positioned adjacent at least one reflective surface.

8. The biological sterilization indicator of claim 1, wherein the locus of spores is positioned adjacent a white surface.

9. The biological sterilization indicator of claim 1, wherein the locus of spores is positioned adjacent a black surface.

10. The biological sterilization indicator of claim 1, wherein:

the volume of the spore reservoir is a first volume,

the second reservoir includes a second volume of liquid, and

the first volume is less than the second volume.

11. The biological sterilization indicator of claim 1, wherein the liquid includes water, and further comprising a dry nutrient medium positioned on the carrier to be combined with the water when the second reservoir is in the open state.

12. The biological sterilization indicator of claim 1, wherein the spore reservoir is in fluid communication with the first reservoir via a channel, wherein the channel has a cross-sectional area, and wherein the ratio of the volume of the spore reservoir to a portion of the channel located toward the spore reservoir is at least 25.

13. The biological sterilization indicator system of claim 1, wherein the wicking material is positioned at least partially in the channel.

14. The biological sterilization indicator system of claim 1, wherein the wicking material is positioned externally with respect to the channel.

15. The biological sterilization indicator system of claim 1, wherein the wicking material is at least one of a microstructured carrier, a microporous paper, polymer cloth, or combinations thereof.

16. The biological sterilization indicator of claim 1, further comprising a sterilant path positioned to provide fluid communication between ambience and the spore reservoir when the second reservoir is in the closed state and further positioned to provide a vent when the second reservoir is in the open state, the sterilant path having a portion located toward the spore reservoir, the portion of the sterilant path having a cross-sectional area.

17. The biological sterilization indicator of claim 16, wherein the ratio of the volume of the spore reservoir to the cross-sectional area of the portion of the sterilant path located toward the spore reservoir is at least 25.