Invention Grant
- Patent Title: Biological indicator for determining the efficacy of a steam or heat sterilization process and its method of use
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Application No.: US16543279Application Date: 2019-08-16
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Publication No.: US11884960B2Publication Date: 2024-01-30
- Inventor: Adrian Jesus Rovetto , Esteban Lombardia , Pablo Ravasi
- Applicant: TERRAGENE S.A. , TERRAGENE LLC
- Applicant Address: AR TX Provincia de Santa Fe
- Assignee: Terragene LLC,Terragene SA
- Current Assignee: Terragene LLC,Terragene SA
- Current Assignee Address: US TX Spring; AR Santa Fe
- Agency: Fish & Richardson P.C.
- Main IPC: C12Q1/22
- IPC: C12Q1/22 ; C12N1/20 ; G01N21/64

Abstract:
The invention relates to a biological indicator for determining the efficacy of a steam or heat sterilization process, and its method. The biological indicator comprises microbial spores (a), at least one sensor protein exogenous to the microbial spores (b), one fluorophore (c), and a culture medium (d). The invention also refers to the method of use of this biological indicator. This method consists of (a) placing the biological indicator along with a target material to be steam or heat sterilized within a steam or heat sterilizer, (b) carrying out a steam or heat sterilization process, (c) placing the biological indicator in a an incubator, (d) screening the biological indicator for immediate detectable changes in fluorescence intensity, while incubating the biological indicator in the incubator, (e) determining the efficacy of the steam or heat sterilization process based on the screening carried out during step d), (f) extending the incubation of the biological indicator obtained in step d), (g) screening the incubated biological indicators obtained in step e) for an optically detectable color change, and (h) determining the efficacy of the steam or heat sterilization process, according to optically detectable changes obtained in step g).
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