Multilayer test pack for sterilization monitoring

Patent metadata

Field	Value
Publication number	US-12544472-B2
Application number	US-201917309613-A
Country	US
Kind code	B2
Filing date	Dec 26, 2019
Priority date	Dec 27, 2018
Publication date	Feb 10, 2026
Grant date	Feb 10, 2026

Abstract

The disclosed multilayer test pack comprises a channel lamina to form a recessed channel, and then a seal layer covers the recessed channel to form an embedded channel. By providing the recessed channel in a thin-film channel lamina, the recessed channel tolerances are better controlled. Further, using thin films for the channel lamina, which can be formed into a roll, allows for a continuous unrolling and continuous bonding to a seal layer.

First claim

What is claimed is:

1 . A multilayer test pack for sterilization monitoring, the multilayer test pack comprising:
a channel lamina configured to provide resistance for exposing a sterilant to a sterilization indicator contained within the multilayer test pack, the channel lamina comprising:
a channel layer, comprising:
a top surface;
a bonding surface; and
a recessed channel having a depth defined by an entire thickness of the channel layer and extending through the entire thickness of the channel layer, wherein the thickness of the channel layer extends from the bonding surface to the top surface; and

a surface layer fixed to the top surface of the channel layer;
a seal layer comprising a seal surface and an outer surface opposite from the seal surface, wherein the seal surface is bonded to the bonding surface; and a sealed cavity formed in a layer of the multilayer test pack other than the channel lamina, wherein the sealed cavity holds the sterilization indicator, wherein the recessed channel extends from an inlet port exposed to an external environment to an outlet port exposed to the sealed cavity.

2 . The multilayer test pack of claim 1 , wherein the channel lamina comprises a first continuous layer comprising the channel layer and a second continuous layer comprising the surface layer.

3 . The multilayer test pack of claim 2 , wherein the recessed channel extends entirely through the first continuous layer.

4 . The multilayer test pack of claim 1 , wherein the surface layer and the bonding surface are planar.

5 . The multilayer test pack of claim 1 , wherein the channel lamina further comprises an edge surrounding the channel layer and the surface layer.

6 . The multilayer test pack of claim 1 , wherein the seal layer further comprises an edge surrounding the seal surface and the outer surface.

7 . The multilayer test pack of claim 1 , wherein the seal layer further comprises the sealed cavity.

8 . The multilayer test pack of claim 1 , wherein the inlet port is located at an edge of the channel lamina, is located at the surface layer, or is at the seal layer.

9 . The multilayer test pack of claim 1 , wherein the outlet port is located at the channel layer or at the seal layer.

10 . The multilayer test pack of claim 1 , wherein the sealed cavity holds at least one of a biological indicator or a chemical indicator.

11 . The multilayer test pack of claim 1 , wherein the seal surface is bonded to the bonding surface by thermal bonding or adhesive bonding.

12 . The multilayer test pack of claim 1 , further comprising a biological indicator disposed in the sealed cavity.

13 . The multilayer test pack of claim 1 , wherein the sterilant comprises steam, ethylene oxide, or hydrogen peroxide.

14 . The multilayer test pack of claim 1 , wherein the recessed channel is configured to provide sufficient challenge to the sterilant reaching an indicator within the sealed cavity.

15 . A method of making a multilayer test pack for sterilization monitoring, the method comprising:
providing a channel lamina configured to provide resistance for exposing a sterilant to a sterilization indicator contained within the multilayer test pack and comprising a channel layer and a surface layer fixed to the channel layer, wherein the channel layer comprises:
a top surface;
a bonding surface; and
a recessed channel having a depth defined by an entire thickness of the channel layer and extending through the entire thickness of the channel layer, wherein the thickness of the channel layer extends from the bonding surface to the top surface;
providing a seal layer comprising a seal surface and an outer surface opposite from the seal surface; and forming a sealed cavity in a layer of the multilayer test pack other than the channel lamina; and disposing the sterilization indicator in the sealed cavity.

16 . The method of claim 15 , wherein the recessed channel extends from an inlet port exposed to an external environment to an outlet port exposed to the sealed cavity.

17 . The method of claim 15 , wherein bonding the seal surface to the bonding surface comprises thermal bonding or adhesive bonding.

18 . The method of claim 15 , wherein the channel lamina comprises a single, unitary structure, and wherein the method further comprises microreplicating the recessed channel into the channel layer.

19 . The method of claim 15 , wherein the channel lamina comprises a first continuous layer comprising the channel layer and a second continuous layer comprising the surface layer, and wherein the method further comprises bonding the first continuous layer to the second continuous layer.

20 . The method of claim 15 , wherein the channel lamina is provided on a first roll and the seal layer is provided on a second roll, the method further comprising:
unrolling the channel lamina; unrolling the seal layer; and continuously bonding the seal surface to the bonding surface.

Assignees

• Solventum Intellectual Properties Company

Inventors

• Bommarito G Marco
• Nies Timothy J
• Holt Paul N

Classifications

• B32B2250/03

  3 layers · CPC title

• B32B2250/02

  2 layers · CPC title

• B32B38/18

  Handling of layers or the laminate · CPC title

• B32B37/153

  at least one layer is extruded and immediately laminated while in semi-molten state · CPC title

• B32B37/10

  characterised by the pressing technique, e.g. using action of vacuum or fluid pressure · CPC title