MX393428B - Indicador de esterilización biológico. - Google Patents

Indicador de esterilización biológico.

Info

Publication number
MX393428B
MX393428B MX2021006311A MX2021006311A MX393428B MX 393428 B MX393428 B MX 393428B MX 2021006311 A MX2021006311 A MX 2021006311A MX 2021006311 A MX2021006311 A MX 2021006311A MX 393428 B MX393428 B MX 393428B
Authority
MX
Mexico
Prior art keywords
culture medium
cap
container
sterilization indicator
breakable barrier
Prior art date
Application number
MX2021006311A
Other languages
English (en)
Other versions
MX2021006311A (es
Inventor
Anthony Fiorello
Harry Bala
Richard Koszyk
Original Assignee
American Sterilizer Co
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 American Sterilizer Co filed Critical American Sterilizer Co
Publication of MX2021006311A publication Critical patent/MX2021006311A/es
Publication of MX393428B publication Critical patent/MX393428B/es

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
    • C12MAPPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M37/00Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination
    • C12M37/06Means for testing the completeness of the sterilization
    • 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
    • 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
    • A61L2/02Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/04Heat
    • A61L2/06Hot gas
    • A61L2/07Steam
    • 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
    • A61L2/16Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/208Hydrogen peroxide
    • 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/14Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Immunology (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Sustainable Development (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

La presente invención se refiere a un indicador de esterilización biológico para evaluar la eficacia de un proceso de esterilización, el indicador de esterilización caracterizado porque comprende: un recipiente configurado para contener una concentración de microorganismos y/o una enzima; una tapa que comprende una cámara configurada para contener un medio de cultivo y/o un sustrato reactivo con la enzima; y una barra rompible unida a la tapa que encierra el medio de cultivo y/o un sustrato reactivo con la enzima dentro de la cámara, en donde la barrera rompible se forma por una estructura de múltiples capas que comprende una configuración capa externa/capa de aluminio/capa de unión/ capa de sellado o una configuración capa externa/capa de aluminio/capa de adhesivo/capa de sellado que tiene un grosor de 0.5 mm a 3.0 mm, en donde la capa externa está formada por recubrimiento de laca a base de nitrocelulosa en peso de 1.0 g/m2, la capa de aluminio es una lámina de aluminio con un grosor de 0.5mm a 0.8 mm, la capa de unión está formada por un recubrimiento de laca a base de polipropileno en peso de 3.5 g/m2, y la capa de sellado está formada por una película de polipropileno homopolimero que se sella térmicamente que tiene un grosor de 1.0 mm a 2.0 mm, en donde la capa de aluminio y la capa de sellado están laminadas con una capa de adhesivo entre ellas; y en donde la tapa está formada por polipropileno, y en donde la capa de sellado de la barra rompible se sella térmicamente a la tapa.
MX2021006311A 2018-11-28 2019-11-25 Indicador de esterilización biológico. MX393428B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US16/203,180 US11248251B2 (en) 2018-11-28 2018-11-28 Biological sterilization indicator
PCT/US2019/063039 WO2020112651A1 (en) 2018-11-28 2019-11-25 Biological sterilization indicator

Publications (2)

Publication Number Publication Date
MX2021006311A MX2021006311A (es) 2022-06-27
MX393428B true MX393428B (es) 2025-03-24

Family

ID=68982435

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021006311A MX393428B (es) 2018-11-28 2019-11-25 Indicador de esterilización biológico.

Country Status (5)

Country Link
US (1) US11248251B2 (es)
EP (1) EP3887534B1 (es)
AU (1) AU2019386967B2 (es)
MX (1) MX393428B (es)
WO (1) WO2020112651A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10907126B2 (en) 2016-03-01 2021-02-02 Asp Global Manufacturing Gmbh Self-contained biological indicator
AU2020350213A1 (en) 2019-09-20 2022-03-31 Asp Global Manufacturing Gmbh Biological indicator for use with a liquid sterilant
CA3186656A1 (en) 2020-07-23 2022-01-27 Harry Bala Sterilization process challenge device
MX2023005304A (es) * 2020-11-10 2023-06-23 Advanced Sterilization Products Inc Rompeampollas para un indicador biologico.
US11603551B2 (en) 2020-12-02 2023-03-14 Steritec Products Mfg. Co., Inc. Biological indicators, and systems and methods for determining efficacy of sterilization
CN112871803B (zh) * 2021-01-12 2022-07-15 南京庚鼠科技有限公司 一种培养基熟化灭菌设备
FR3121074B1 (fr) * 2021-03-24 2023-02-10 Psa Automobiles Sa Procédé de contamination d’un filtre à air

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2798856A (en) * 1954-03-19 1957-07-09 Baxter Don Inc Steam sterilization indicator
DE3217002A1 (de) 1982-05-06 1983-11-10 Merck Patent Gmbh, 6100 Darmstadt Bioindikator
US5516648A (en) 1994-08-18 1996-05-14 Steris Corporation Encapsulated biological indicator
US5736355A (en) 1996-05-13 1998-04-07 Steris Corporation Self contained biological indicator
US7569359B2 (en) 2004-10-14 2009-08-04 American Sterilizer Company Indicator device having an active agent encapsulated in an electrospun nanofiber
US8173388B2 (en) * 2008-09-30 2012-05-08 American Sterilizer Company Self-contained biological indicator
US20130230910A1 (en) 2012-03-02 2013-09-05 Process Challenge Devices, LLC. Apparatus and Method for Process Challenge Devices
JP6246997B2 (ja) 2012-03-29 2017-12-13 大日本印刷株式会社 レトルト殺菌包装容器用の蓋材
US9289528B2 (en) * 2013-06-26 2016-03-22 Eastman Kodak Company Methods for using indicator compositions

Also Published As

Publication number Publication date
US11248251B2 (en) 2022-02-15
AU2019386967A1 (en) 2021-06-17
US20200165658A1 (en) 2020-05-28
AU2019386967B2 (en) 2025-08-14
WO2020112651A1 (en) 2020-06-04
EP3887534B1 (en) 2026-02-25
MX2021006311A (es) 2022-06-27
CA3121154A1 (en) 2020-06-04
EP3887534A1 (en) 2021-10-06

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