Multilayer test pack for sterilization monitoring
AssigneeSolventum Intellectual Properties Company
InventorsG. Marco Bommarito, Timothy J. Nies, Paul N. Holt
Life of this patent
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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.
Claims20
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.
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.
Dependencies are inferred from the claim text.