Moving-front sterilization monitoring devices

Patent metadata

Field	Value
Publication number	US-2023302179-A1
Application number	US-202118040882-A
Country	US
Kind code	A1
Filing date	Aug 10, 2021
Priority date	Aug 12, 2020
Publication date	Sep 28, 2023
Grant date	—

Abstract

The present disclosure relates to sterilization monitoring devices, as well as and methods and kits for evaluating sterilization processes using sterilization monitoring devices.

First claim

1 . A sterilization monitoring device comprising:
a challenge network comprising:
a flow channel comprising an entry port for receiving a sterilant, and
a plurality of indicator compartments,
each indicator compartment comprising one or more indicator, and
each indicator compartment being in fluid communication with the flow channel; and

a shell encasing the challenge network such that access to the plurality of indicator compartments is only through the flow channel.

2 . A sterilization monitoring device comprising:
a plurality of challenge networks, each challenge network comprising:
a flow channel comprising an entry port for receiving a sterilant, and
one or more indicator compartment comprising one or more indicator,
wherein at least one indicator is a biological indicator;

at least one medium compartment comprising a nutrient medium,
wherein the medium compartment is in fluid communication with one or more indicator compartment; and
a shell encasing the challenge network such that access to the one or more indicator compartment is only through the flow channels.

3 . (canceled)

4 . (canceled)

5 . (canceled)

6 . (canceled)

7 . (canceled)

8 . The sterilization indicator device of claim 1 , the flow channel characterized by one or more:
a length of about 10 mm to about 800 mm, a maximum cross-sectional width of about 0.125 mm to about 20 mm, wherein the width is uniform or non-uniform along a length of the flow channel, and a maximum cross-sectional height of about 0.05 mm to about 25 mm, wherein the height is uniform or non-uniform along a length of the flow channel.

9 . (canceled)

10 . The sterilization indicator device of claim 1 , the flow channel having a hydraulic radius of about 0.025 mm to about 12.5 mm, wherein the hydraulic radius is uniform or non-uniform along a length of the flow channel.

11 . (canceled)

12 . (canceled)

13 . The sterilization monitoring device of claim 1 , wherein the flow channel is comprised of a polyethylene terephthalate film and a silane-terminated polyurethane adhesive.

14 . The sterilization monitoring device of claim 1 , further comprising one or more sub-flow channel extending from the flow channel.

15 . (canceled)

16 . (canceled)

17 . The sterilization monitoring device of claim 14 , each sub-flow channel independently characterized by one or more:
a length of about 2 mm to about 200 mm, a maximum width at any point of about 0.125 mm to about 20 mm, wherein the width is uniform or non-uniform along the length of the sub-flow channel, and a height at any point of about 0.05 mm to about 25 mm, wherein the height is uniform or non-uniform along the length of the sub-flow channel.

18 . (canceled)

19 . The sterilization monitoring device of claim 1 , each indicator compartment independently having a volume between about 0.25 cm 3 and about 10 cm 3 .

20 . The sterilization monitoring device of claim 1 , one or more indicator compartments independently comprising an indicator selected from a steam indicator, an ethylene oxide indicator, and a hydrogen peroxide indicator, the indicator being a biological indicator, a chemical indicator, or a combination thereof.

21 . (canceled)

22 . The sterilization monitoring device of any one of claim 1 , wherein one or more indicator compartment comprises a biological indicator selected from Geobacillus stearothermophilus spores, Bacillus atrophaeus spores, Aspergillus niger, Bacillus subtilis, Clostridium spp., Bacillus subtilis var. niger, and a combination thereof.

23 . (canceled)

24 . The sterilization monitoring device of claim 1 , wherein one or more indicator compartment independently comprises a chemical indicator selected from a coloring-changing dye, a color-changing pigment, a metal sulfide precursor(s), a metal complex or salt, a fluorescent molecular switch, and a combination thereof.

25 . The sterilization monitoring device of claim 1 , further comprising at least one medium compartment comprising a medium selected from a nutrient medium, a fluorogenic medium, a pH indicator medium, and a combination thereof, wherein the medium compartment is in fluid communication with one or more indicator compartment.

26 . The sterilization monitoring device of claim 1 , further comprising:
a medium port for receiving a medium selected from a nutrient medium, a fluorogenic medium, a pH indicator medium, and a combination thereof, and a medium path, wherein one or more indicator compartment is in fluid communication with the medium port via the medium path.

27 . (canceled)

28 . The sterilization monitoring device of claim 25 , further comprising at least one removeable barrier separating the at least one medium compartment from the one or more indicator compartment.

29 . (canceled)

30 . (canceled)

31 . (canceled)

32 . The sterilization monitoring device of claim 1 , further comprising a package that is at least partly permeable to the sterilant, wherein the package at least partly surrounds the shell.

33 . A method for evaluating a sterilization process, the method comprising:
providing a sterilization monitoring device of claim 1 ; exposing the sterilization monitoring device to conditions set forth in a sterilization protocol; allowing a sterilant to contact the sterilization monitoring device at a temperature for a period; inspecting one or more indicators for a change in one or more of color, pH, and fluorescence; comparing the change in one or more of color, pH, and fluorescence with a sterilization threshold value; and determining whether or not the change in one or more of color, pH, and fluorescence indicates a satisfactory sterilization in view of the sterilization threshold value.

34 . The method of claim 33 , further comprising contacting one or more indicators with a nutrient medium, a fluorogenic medium, a pH indicator medium, or a combination thereof prior to the inspecting.

35 . (canceled)

36 . (canceled)

37 . (canceled)

38 . (canceled)

39 . (canceled)

40 . (canceled)

41 . A kit comprising:
a sterilization monitoring device of claim 1 ; and instructions directing a user to: expose the sterilization monitoring device to conditions set forth in a sterilization protocol; allow a sterilant to contact the sterilization monitoring device at a temperature for a period; inspect one or more indicators for a change in one or more of color, pH, and fluorescence; compare the change in one or more of color, pH, and fluorescence with a sterilization threshold value; and determine whether or not the change in one or more of color, pH, and fluorescence indicates a satisfactory sterilization in view of the sterilization threshold value.

42 . The kit of claim 41 , further comprising a container comprising nutrient medium, a fluorogenic medium, or a pH indicator medium.

43 . (canceled)

44 . (canceled)

45 . The kit of claim 41 , further comprising a medium packet comprising a medium selected from a nutrient medium, a fluorogenic

Assignees

• 3M Innovative Properties Company

Inventors

• Erickson Joshua D
• Bommarito Giuseppe M
• Woldt Ryan T
• Nies Timothy J
• Flynn Jeffrey M

Classifications

• A61L2/208 Primary

  Hydrogen peroxide · CPC title

• A61L2/24

  Apparatus using programmed or automatic operation · CPC title

• A61L2/206

  Ethylene oxide · CPC title

• A61L2101/34

  Hydroxy compounds · CPC title

• A61L2/20 Primary

  Gaseous substances, e.g. vapours · CPC title