# US 10,119,946 B2 · Sterilization test strip > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,119,946 B2 - Document ID: US10119946B2 - Status: Granted - Kind: B2 - Application number: 15/136,006 - Filed: 2016-04-22 - Published: 2017-10-26 - Granted: 2018-11-06 - Earliest claimed: 2016-04-22 - Assignees: American Sterilizer Company - Applicants: American Sterilizer Company - Inventors: Harry Bala; Mark Bala - Web page: https://patentgrep.com/patent/US10119946B2 ## CPC - G01N 31/226: {for investigating the degree of sterilisation} - A61L 2/07: Steam - A61L 2/28: Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour - G01K 11/06: using melting, freezing, or softening - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - G01K: MEASURING TEMPERATURE; MEASURING QUANTITY OF HEAT; THERMALLY-SENSITIVE ELEMENTS NOT OTHERWISE PROVIDED FOR (radiation pyrometry G01J5/00) ## Abstract A compact sterilization indicator includes a wicking element having at least two different wicking rates across the length of the wicking element. ## Claims ### Claim 1 A sterilization indicator, comprising: a base element formed from a thermally conductive material having a length and a width, the base element having a recess formed therein extending along about a longitudinal centerline thereof, the recess formed within the base material less than the length and the width of the base material; a first adhesive layer disposed on the base element; an indicator chemical composition deposited in the recess; a wicking element positioned at least in part in contact with the indicator chemical composition and positioned at least in part within the recess, the wicking element extending less than the length and width of the base element, wherein the wicking element includes a first zone, a second zone, and a third zone, wherein the first zone has a generally constant width W38 and the third zone has a generally constant width W40, wherein W38 is less than W40, wherein the second zone is arranged between the first zone and the third zone and has a width that increases from W38 to W40, wherein a wicking rate across the first zone is greater than a wicking rate across the third zone, wherein the wicking element is arranged such that an end portion of the first zone is in contact with the indicator chemical composition; a film layer positioned over the base element, the wicking element and the indicator chemical composition; a paper layer disposed over the film layer; a second adhesive layer disposed between the paper layer and the film layer, wherein the paper layer and the second adhesive layer include a window therein; and an acceptance marker; wherein, the indicator is configured to indicate that an acceptable level of sterilization has occurred when the indicator chemical composition wicks along the wicking element to a location beyond the acceptance marker after a sterilization process. ### Claim 2 (depends on 1) The sterilization indicator of claim 1, wherein the indicator chemical composition contains a temperature and steam sensitive material. ### Claim 3 (depends on 1) The sterilization indicator of claim 1, wherein the indicator chemical composition contains a dye. ### Claim 4 (depends on 1) The sterilization indicator of claim 1, wherein the film layer is formed from a cast polypropylene having a thickness of 2.0 to 2.2 mils. ### Claim 5 (depends on 1) The sterilization indicator of claim 1, wherein the film layer is formed from a cast polypropylene having a thickness of 3.0 to 3.2 mils. ### Claim 6 (depends on 1) The sterilization indicator of claim 1, wherein the base element formed from an aluminum foil. ### Claim 7 (depends on 1) The sterilization indicator of claim 1, wherein the base element is formed from an aluminum foil having a thickness of 3 mils. ### Claim 8 (depends on 1) The sterilization indicator of claim 1, wherein the first adhesive layer is formed from an acrylic adhesive. ### Claim 9 (depends on 1) The sterilization indicator of claim 1, wherein the second adhesive layer is formed from an acrylic adhesive. ### Claim 10 (depends on 1) The sterilization indicator of claim 1, wherein the wicking element is formed from a wicking paper having a basis weight of 66 g/m2 to 186 g/m2. ### Claim 11 (depends on 1) The sterilization indicator of claim 1, wherein the wicking element is formed from a wicking paper having a thickness of 7.3 mil to 13.3 mil. ### Claim 12 A sterilization indicator, comprising: a base element formed from a thermally conductive material having a length and a width, the base element having a recess formed therein extending along about a longitudinal centerline thereof, the recess formed within the base material less than the length and the width of the base material; a first adhesive layer disposed on the base element; an indicator chemical composition deposited in the recess; a wicking element positioned at least in part in contact with the indicator chemical composition and positioned at least in part within the recess, the wicking element extending less than the length and width of the base element, wherein the wicking element includes at least two zones comprising a first zone and a second zone, wherein the first zone has a thickness greater than a thickness of the second zone; a film layer positioned over the base element, the wicking element and the indicator chemical composition; a paper layer disposed over the film layer; a second adhesive layer disposed between the paper layer and the film layer, wherein the paper layer and the second adhesive layer include a window therein; and an acceptance marker; wherein, the indicator is configured to indicate that an acceptable level of sterilization has occurred when the indicator chemical composition wicks along the wicking element to a location beyond the acceptance marker after a sterilization process. ### Claim 13 (depends on 12) The sterilization indicator of claim 12, wherein the wicking element is formed from a layer of a wicking paper, wherein the first zone includes a second layer of a wicking paper. ### Claim 14 A sterilization indicator, comprising: a base element formed from a thermally conductive material having a length and a width, the base element having a recess formed therein extending along about a longitudinal centerline thereof, the recess formed within the base material less than the length and the width of the base material; a first adhesive layer disposed on the base element; an indicator chemical composition deposited in the recess; a wicking element positioned at least in part in contact with the indicator chemical composition and positioned at least in part within the recess, the wicking element extending less than the length and width of the base element, wherein the wicking element includes at least two zones comprising a first zone and a second zone, wherein the first zone is formed from a first wicking paper and the second zone is formed from a second wicking paper, wherein a wicking rate of the first wicking paper is greater than a wicking rate of the second wicking paper; a film layer positioned over the base element, the wicking element and the indicator chemical composition; a paper layer disposed over the film layer; a second adhesive layer disposed between the paper layer and the film layer, wherein the paper layer and the second adhesive layer include a window therein; and an acceptance marker; wherein, the indicator is configured to indicate that an acceptable level of sterilization has occurred when the indicator chemical composition wicks along the wicking element to a location beyond the acceptance marker after a sterilization process. ### Claim 15 A sterilization indicator, comprising: a base element formed from a thermally conductive material having a length and a width, the base element having a recess formed therein extending along about a longitudinal centerline thereof, the recess formed within the base material less than the length and the width of the base material; a first adhesive layer disposed on the base element; an indicator chemical composition deposited in the recess; a wicking element positioned at least in part in contact with the indicator chemical composition and positioned at least in part within the recess, the wicking element extending less than the length and width of the base element, wherein the wicking element includes a first zone, a second zone, and a third zone, wherein a width of the first zone is less than a width of the third zone, wherein the second zone is arranged between the first zone and the third zone and has a width that increases from the width of the first zone to the width of the third zone, wherein the wicking element is position such that an end portion of the first zone is in contact with the indicator chemical composition, wherein the base element has a length of 1.75 inches to 4 inches, and the wicking element has a length of 1.125 inches to 1.625 inches, wherein the first zone has a width of 0.125 inches to 0.375 inches and the third zone has a width of 0.175 inches to 0.425 inches, wherein the width of the first zone is 0.03 inches to 0.07 inches less than the width of the third zone, wherein a criteria for the sterilization process is selected from 12 minutes at 121° C., 15 minutes at 121° C., 20 minutes at 121° C., 30 minutes at 121° C., 4 minutes at 132° C., 3.5 minutes at 134° C., 4 minutes at 134° C., 5 minutes at 134° C., 7 minutes at 134° C., and 3 minutes at 135° C.; a film layer positioned over the base element, the wicking element and the indicator chemical composition; a paper layer disposed over the film layer; a second adhesive layer disposed between the paper layer and the film layer, wherein the paper layer and the second adhesive layer include a window therein; and an acceptance marker; wherein, the indicator is configured to indicate that an acceptable level of sterilization has occurred when the indicator chemical composition wicks along the wicking element to a location beyond the acceptance marker after a sterilization process. ### Claim 16 (depends on 15) The sterilization indicator of claim 15, wherein the indicator chemical composition contains a temperature and steam sensitive material, wherein the film layer is formed from a cast polypropylene having a thickness of 2.0 to 2.2 mils or a thickness of 3.0 to 3.2 mils, and wherein the wicking element is formed from a cotton wicking material having a basis weight of 186 g/m2 and a thickness of 13.3 mil.