PL4363602T3 - Wskaźnik biologiczny do określania skuteczności procesu sterylizacji oksydacyjnej i sposoby jego stosowania - Google Patents

Wskaźnik biologiczny do określania skuteczności procesu sterylizacji oksydacyjnej i sposoby jego stosowania

Info

Publication number
PL4363602T3
PL4363602T3 PL22743906.4T PL22743906T PL4363602T3 PL 4363602 T3 PL4363602 T3 PL 4363602T3 PL 22743906 T PL22743906 T PL 22743906T PL 4363602 T3 PL4363602 T3 PL 4363602T3
Authority
PL
Poland
Prior art keywords
effectiveness
determining
methods
sterilization process
biological indicator
Prior art date
Application number
PL22743906.4T
Other languages
English (en)
Inventor
Esteban LOMBARDÍA
Adrián Jesús Rovetto
Pablo Ravasi
Carlos Ernesto RODRIGUEZ
Original Assignee
Terragene Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Terragene Llc filed Critical Terragene Llc
Publication of PL4363602T3 publication Critical patent/PL4363602T3/pl

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/22Testing for sterility conditions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/26Accessories
    • A61L2/28Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00Microorganisms; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/20Bacteria; Culture media therefor
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64Fluorescence; Phosphorescence
    • G01N21/6486Measuring fluorescence of biological material, e.g. DNA, RNA, cells
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12RINDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS
    • C12R2001/00Microorganisms ; Processes using microorganisms
    • C12R2001/01Bacteria or Actinomycetales ; using bacteria or Actinomycetales
    • C12R2001/07Bacillus
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12RINDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS
    • C12R2001/00Microorganisms ; Processes using microorganisms
    • C12R2001/01Bacteria or Actinomycetales ; using bacteria or Actinomycetales
    • C12R2001/07Bacillus
    • C12R2001/125Bacillus subtilis ; Hay bacillus; Grass bacillus
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N2021/7769Measurement method of reaction-produced change in sensor
    • G01N2021/7786Fluorescence
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/195Assays involving biological materials from specific organisms or of a specific nature from bacteria
    • G01N2333/32Assays involving biological materials from specific organisms or of a specific nature from bacteria from Bacillus (G)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biotechnology (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Plasma & Fusion (AREA)
  • Medicinal Chemistry (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Virology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Peptides Or Proteins (AREA)
  • Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
PL22743906.4T 2021-07-02 2022-06-30 Wskaźnik biologiczny do określania skuteczności procesu sterylizacji oksydacyjnej i sposoby jego stosowania PL4363602T3 (pl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17/367,224 US12448642B2 (en) 2021-07-02 2021-07-02 Biological indicator for determining the efficacy of an oxidative sterilization process and methods of use
PCT/IB2022/056130 WO2023275830A1 (en) 2021-07-02 2022-06-30 Biological indicator for determining the efficacy of an oxidative sterilization process and methods of use

Publications (1)

Publication Number Publication Date
PL4363602T3 true PL4363602T3 (pl) 2026-03-30

Family

ID=82608726

Family Applications (1)

Application Number Title Priority Date Filing Date
PL22743906.4T PL4363602T3 (pl) 2021-07-02 2022-06-30 Wskaźnik biologiczny do określania skuteczności procesu sterylizacji oksydacyjnej i sposoby jego stosowania

Country Status (13)

Country Link
US (1) US12448642B2 (pl)
EP (1) EP4363602B1 (pl)
JP (1) JP2024522837A (pl)
KR (1) KR20240038733A (pl)
CN (1) CN117693594A (pl)
AR (1) AR126286A1 (pl)
BR (1) BR112023027063A2 (pl)
CA (1) CA3223840A1 (pl)
CO (1) CO2023018647A2 (pl)
ES (1) ES3059531T3 (pl)
MX (1) MX2024000115A (pl)
PL (1) PL4363602T3 (pl)
WO (1) WO2023275830A1 (pl)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11884960B2 (en) * 2019-08-16 2024-01-30 Terragene Llc Biological indicator for determining the efficacy of a steam or heat sterilization process and its method of use

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0600522A (pt) * 2006-02-13 2007-10-23 Univ Sao Paulo kit ou dispositivo empregado na validação de processos de esterilização e processo de validação de processos de esterilização
US11085065B2 (en) 2006-02-21 2021-08-10 M. Boris Rotman Phenotypic engineering of spores
US8895239B2 (en) 2006-09-20 2014-11-25 American Sterilizer Company Genetically engineered biological indicator
EP2347007A2 (en) 2008-10-17 2011-07-27 3M Innovative Properties Company Biological sterilization indicator, system, and methods of using same
US20110195442A1 (en) 2008-10-17 2011-08-11 Sailaja Chandrapati Sterility indicating biological compositions, articles and methods
WO2011011189A1 (en) 2009-07-20 2011-01-27 3M Innovative Properties Company Biological sterilization indicator and method of using same
CN103189523B (zh) 2010-11-01 2016-03-02 3M创新有限公司 生物灭菌指示器
CN103282772B (zh) * 2010-12-22 2016-08-17 3M创新有限公司 包括中和剂的灭菌指示器以及方法
JP2014060947A (ja) 2012-09-20 2014-04-10 Olympus Corp 熱安定性を有する蛍光タンパク質およびそれを利用する方法
EP3436085A4 (en) 2016-03-29 2020-07-29 Oneighty°C Technologies Corporation PROCESS FOR RAPID DETERMINATION OF EFFECTIVE STERILIZATION, DISIMMUNIZATION AND / OR DISINFECTION
CN105907632B (zh) 2016-04-27 2018-01-12 南京巨鲨显示科技有限公司 基因工程生物指示剂
WO2018071732A1 (en) * 2016-10-12 2018-04-19 Verrix, Llc Systems and methods for sterility assurance
US11001799B2 (en) * 2018-10-18 2021-05-11 Terragene Llc Biological disinfection or sterilization indicator
US11884960B2 (en) * 2019-08-16 2024-01-30 Terragene Llc Biological indicator for determining the efficacy of a steam or heat sterilization process and its method of use

Also Published As

Publication number Publication date
ES3059531T3 (en) 2026-03-20
US12448642B2 (en) 2025-10-21
KR20240038733A (ko) 2024-03-25
EP4363602B1 (en) 2025-11-26
EP4363602C0 (en) 2025-11-26
MX2024000115A (es) 2024-01-19
BR112023027063A2 (pt) 2024-03-12
US20230002802A1 (en) 2023-01-05
AR126286A1 (es) 2023-10-04
EP4363602A1 (en) 2024-05-08
CO2023018647A2 (es) 2024-01-15
JP2024522837A (ja) 2024-06-21
WO2023275830A1 (en) 2023-01-05
CN117693594A (zh) 2024-03-12
CA3223840A1 (en) 2023-01-05

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