# US 10,246,731 B2 · Method for rapidly determining effective sterilization , deimmunization, and/or disinfection > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,246,731 B2 - Document ID: US10246731B2 - Status: Granted - Kind: B2 - Application number: 15/472,499 - Filed: 2017-03-29 - Published: 2017-10-05 - Granted: 2019-04-02 - Earliest claimed: 2016-03-29 - Assignees: ONEighty°C Technologies Corporation - Applicants: ONEighty°C Technologies Corporation - Inventors: Theresa L. O'Keefe - Web page: https://patentgrep.com/patent/US10246731B2 ## CPC - C12Q 1/22: Testing for sterility conditions - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES ## Abstract A method for rapidly determining effective sterilization, deimmunization, and/or disinfection of equipment and/or supplies by a device. The method includes providing a defined surrogate protein having a predetermined sequence representative of an infectious agent potentially contaminating the equipment and/or the supplies to be sterilized, deimmunized, and/or disinfected by the device. The defined surrogate protein having the predetermined sequence is subjected to sterilization, deimmunization, or disinfection. The effectiveness of the sterilization deimmunization, or disinfection is rapidly determined by determining if the defined surrogate protein has been destroyed. ## Claims ### Claim 1 A method for determining effective sterilization, deimmunization, and/or disinfection of equipment and/or supplies by a device, the method comprising: providing a defined surrogate protein having a predetermined sequence defined by a sequence which is at least about 95% homologous to the sequence (SEQ ID NO: 1) 10 20 30 40 50 MYNYTSAKYE VPIAIQDRSF NEDGSLNFPS EGDNPTIHPY WQPEFFGDTI MVNGRVWPNM NVDMTRYRFR LLNGSNARFY NLKFSNGMQF WQIGTDGGYL NKPVPLTSLL ISPGERADIL VDFTEIPAGT RIILNNDANA PYPTGDAPDK DTTGQIMQFT VQHNDHHHHH H representative of an infectious agent potentially contaminating the equipment and/or the supplies to be sterilized, deimmunized, and/or disinfected by the device; subjecting the defined surrogate protein having the predetermined sequence to sterilization, deimmunization, or disinfection; and determining the effectiveness of the sterilization, deimmunization, and/or disinfection by determining if the defined surrogate protein having the predetermined sequence has been destroyed; and wherein the sterilization, deimmunization, and/or disinfection occurs when the defined surrogate protein has been fragmented to yield a negative result in a protein analysis procedure. ### Claim 2 (depends on 1) The method of claim 1 in which the defined surrogate protein is a protein critical for stability, growth and/or infectious capacity of infectious agents. ### Claim 3 (depends on 1) The method of claim 1 in which the defined surrogate protein is a protein critical for stability, growth and/or infectious capacity of surrogate organisms of infectious agents. ### Claim 4 (depends on 2) The method of claim 2 in which the infectious agent includes one or more of: an infectious protein, an infectious spore forming bacteria, an infectious vegetative bacteria, an infections fungus, and an infectious virus. ### Claim 5 (depends on 1) The method of claim 1 in which the defined surrogate protein is a pathogenic protein, a protein critical for the growth of infectious agents, and an immunogenic protein. ### Claim 6 (depends on 1) The method of claim 1 in which the protein analysis procedure includes one or more of: a Western Blot analysis, a protein assay analysis, a magnetic separation analysis, a peptide analysis, a mass spectrometry analysis, and a gas chromatography analysis. ### Claim 7 (depends on 1) The method of claim 1 in which the protein analysis procedure includes fluorescence analysis of proteins covalently crosslinked on a solid surface. ### Claim 8 (depends on 1) The method of claim 1 in which the protein analysis procedure includes fluorescence analysis of proteins covalently crosslinked on magnetic beads. ### Claim 9 (depends on 1) The method of claim 1 in which the defined surrogate protein having the predetermined sequence is disposed on a surface. ### Claim 10 (depends on 1) The method of claim 1 in which the defined surrogate protein having the predetermined sequence is disposed on a test strip. ### Claim 11 (depends on 1) The method of claim 1 in which the defined surrogate protein having the predetermined sequence is disposed in or on a vessel. ### Claim 12 (depends on 1) The method of claim 1 in which the surrogate protein having the predetermined sequence is disposed on a tube. ### Claim 13 (depends on 1) The method of claim 1 in which the surrogate protein having the predetermined sequence is disposed on a holder. ### Claim 14 (depends on 13) The method of claim 13 in which the holder is disposed to receive a flow of a sterilization agent, a deimmunization agent or a disinfection agent. ### Claim 15 A method for determining effective sterilization, deimmunization, and/or disinfection of equipment and/or supplies by a device, the method comprising: providing a defined surrogate protein having a predetermined sequence defined by the sequence: (SEQ ID NO: 1) 10 20 30 40 50 MYNYTSAKYE VPIAIQDRSF NEDGSLNFPS EGDNPTIHPY WQPEFFGDTI MVNGRVWPNM NVDMTRYRFR LLNGSNARFY NLKFSNGMQF WQIGTDGGYL NKPVPLTSLL ISPGERADIL VDFTEIPAGT RIILNNDANA PYPTGDAPDK DTTGQIMQFT VQHNDHHHHH H representative of an infectious agent potentially contaminating the equipment and/or the supplies to be sterilized, deimmunized, and/or disinfected by the device; subjecting the defined surrogate protein having the predetermined sequence to sterilization, deimmunization, or disinfection; and determining the effectiveness of the sterilization, deimmunization, and/or disinfection by determining if the defined surrogate protein having the predetermined sequence has been destroyed; and wherein the sterilization, deimmunization, and/or disinfection occurs when the defined surrogate protein has been fragmented to yield a negative result in a protein analysis procedure.