# US 12,178,935 B2 · Sterilization test device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,935 B2 - Document ID: US12178935B2 - Status: Granted - Kind: B2 - Application number: 18/329,838 - Filed: 2023-06-06 - Published: 2023-10-12 - Granted: 2024-12-31 - Earliest claimed: 2020-05-18 - Assignees: American Sterilizer Company - Applicants: American Sterilizer Company - Inventors: Anthony J. Fiorello; Christopher J. Lannan - Web page: https://patentgrep.com/patent/US12178935B2 ## CPC - A61L 2/28: Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour - A61L 2/07: Steam - A61L 2/20: Gaseous substances, e.g. vapours - A61L 2/206: Ethylene oxide - A61L 2/208: Hydrogen peroxide - A61L 2103/50: Textiles, e.g. bedwear or towels - A61L 2202/121: Sealings, e.g. doors, covers, valves, sluices - A61L 2202/122: Chambers for sterilisation - 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) ## Abstract A sterilization process test device for verifying the efficacy of a sterilization process includes a tubular body defining a chamber for containing at least one sterilization indicator and a cap to sealingly close the tubular body. The tubular body includes at least one hole, which is covered by a gas and steam permeable cover. The only flow path into the chamber is provided through the steam and gas permeable cover and the at least one hole, which when combined are configured to control and restrict a flow of steam or a gaseous sterilization medium from an external environment. ## Claims ### Claim 1 A sterilization process test device, comprising: a body including a chamber configured to contain at least one sterilization indicator, an inlet opening configured to receive the at least one sterilization indicator, and at least one hole separate from the inlet opening, wherein each of the at least one hole is defined by an opening extending through a thickness of the body; a cap configured to engage the body to sealingly close the inlet opening; and a steam and gas permeable cover arranged over the at least one hole and attached to an outer surface of the body surrounding the at least one hole; wherein the only fluid communication between the chamber and an external environment is provided through the steam and gas permeable cover and the at least one hole, and wherein the cap is spaced from the at least one hole when the cap sealingly closes the inlet opening. ### Claim 2 (depends on 1) The sterilization process test device of claim 1, wherein the steam and gas permeable cover has a porosity of about 15 Gurley Seconds to about 25 Gurley Seconds when tested according to Tappi T-460, and a thickness of about 4.5 mil to about 7 mil. ### Claim 3 (depends on 1) The sterilization process test device of claim 1, wherein each of the at least one hole is defined by a generally circular shaped opening having a diameter of less than 0.1 inches. ### Claim 4 (depends on 3) The sterilization process test device of claim 3, wherein each of the at least one hole is defined by a generally circular shaped opening having a diameter of about 1/16 inches to about 3/32 inches. ### Claim 5 (depends on 1) The sterilization process test device of claim 1, wherein the at least one hole includes a single hole defined by a generally circular shaped opening having a diameter of about 1/16 inches. ### Claim 6 (depends on 1) The sterilization process test device of claim 1, wherein the at least one hole includes two holes, each defined by a generally circular shaped opening having a diameter of about 1/16 inches. ### Claim 7 (depends on 1) The sterilization process test device of claim 1, wherein the at least one hole includes one hole defined by a generally circular shaped opening having a diameter of about 3/32 inches. ### Claim 8 (depends on 1) The sterilization process test device of claim 1, wherein the cap is formed from silicone. ### Claim 9 (depends on 1) The sterilization process test device of claim 1, wherein the body is a tubular body formed from polycarbonate. ### Claim 10 (depends on 1) The sterilization process test device of claim 1, further including one or both of a biological indicator and a chemical indicator. ### Claim 11 (depends on 10) The sterilization process test device of claim 10, wherein the sterilization process test device is configured to exhibit fail conditions after a sterilization process cycle at 132° F. for 4 minutes and exhibit pass conditions after a sterilization process cycle at 132° F. for 10 minutes cycle, wherein when the sterilization process test device includes a biological indicator, the fail conditions include a positive biological indicator result indicating at least some microorganisms in the biological indicator survived the sterilization process cycle at 132° F. for 4 minutes, and wherein the pass conditions include a negative biological indicator result indicating all microorganisms in the biological indicator were killed during the sterilization process cycle at 132° F. for 10 minutes, and wherein when the sterilization process test device includes a chemical indicator, the fail conditions includes that the chemical indicator did not reach an endpoint color after the sterilization process cycle at 132° F. for 4 minutes, and wherein a pass chemical indicator result indicates that the chemical indicator reached an endpoint color after the sterilization process cycle at 132° F. for 10 minutes. ### Claim 12 (depends on 11) The sterilization process test device of claim 11 further including a biological indicator and a chemical indicator. ### Claim 13 (depends on 1) The sterilization process test device of claim 1, further including one or both of a biological indicator and a chemical indicator, wherein the sterilization process test device is configured to exhibit fail conditions after a sterilization process cycle at 132° F. for 4 minutes and exhibit pass conditions after a sterilization process cycle at 132° F. for 10 minutes cycle, wherein when the sterilization process test device includes a biological indicator, the fail conditions include a positive biological indicator result indicating at least some microorganisms in the biological indicator survived the sterilization process cycle at 132° F. for 4 minutes, and wherein the pass conditions include a negative biological indicator result indicating all microorganisms in the biological indicator were killed during the sterilization process cycle at 132° F. for 10 minutes, and wherein when the sterilization process test device includes a chemical indicator, the fail conditions includes that the chemical indicator did not reach an endpoint color after the sterilization process cycle at 132° F. for 4 minutes, and wherein a pass chemical indicator result indicates that the chemical indicator reached an endpoint color after the sterilization process cycle at 132° F. for 10 minutes. ### Claim 14 (depends on 13) The sterilization process test device of claim 13 further including a biological indicator and a chemical indicator.