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1. WO1996006184 - ENCAPSULATED BIOLOGICAL INDICATOR

Publication Number WO/1996/006184
Publication Date 29.02.1996
International Application No. PCT/US1995/010443
International Filing Date 16.08.1995
Chapter 2 Demand Filed 01.02.1996
IPC
A61L 2/28 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS 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
2Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
26Accessories
28Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
C12Q 1/22 2006.01
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
QMEASURING 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
1Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
02involving viable microorganisms
22Testing for sterility conditions
CPC
A61L 2/28
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS 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
2Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
26Accessories ; or devices or components used for biocidal treatment
28Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
C12Q 1/22
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS
1Measuring or testing processes involving enzymes, nucleic acids or microorganisms
02involving viable microorganisms
22Testing for sterility conditions
Y10S 435/832
YSECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
10TECHNICAL SUBJECTS COVERED BY FORMER USPC
STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
435Chemistry: molecular biology and microbiology
8215Microorganisms
822using bacteria or actinomycetales
832Bacillus
Applicants
  • STERIS CORPORATION [US/US]; 5960 Heisley Road Mentor, OH 44060, US
Inventors
  • MALCHESKY, Paul, S.; US
  • RICHARDSON, Donna, M.; US
Agents
  • KOCOVSKY, Thomas, E., Jr.; Fay, Sharpe, Beall, Fagan, Minnich & McKee Suite 700 1100 Superior Avenue Cleveland, OH 44114-2518, US
  • KOCOVSKY, Jr., Thomas E.; Fay, Shape, Beall, Fagan, Minnich & McKee 1100 Superior Avenue, Suite 700 Cleveland, OH 44114-2518, US
Priority Data
08/292,73718.08.1994US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) ENCAPSULATED BIOLOGICAL INDICATOR
(FR) INDICATEUR BIOLOGIQUE ENCAPSULE
Abstract
(EN)
Reference microorganisms are sealed into an interior cavity of a microporous membrane (14, 20). In one embodiment, the reference microbes are inoculated on element (12) which is sealed in a microporous envelope (14) (figure 1). In another embodiment, the reference microbes (22) are loaded into an interior bore or cavity of a microporous plastic tube or envelope (20) (figure 3). The microporous membrane and the reference microbes, such as spores, are immersed concurrently with items to be microbially decontaminated separately into an anti-microbial fluid. The microporous membrane is constructed of a material which is sufficiently resistant to temperature, water, strong oxidants, and other anti-microbial agents or processes used for microbial decontamination or sterilization that retains its integrity during the immersion in any common steam, gas, or liquid microbial decontamination or sterilization fluid or system. The micropores are sufficiently small that the reference microbes are entrapped, yet sufficiently open that anti-microbial steam, gas, or liquid are passed into the interior for direct contact with the reference microbes. After the microbial decontamination process, the microporous membrane and the contained reference microbes are immersed in a culture medium (40) and monitored to determine whether any of the reference microbes remain alive and commence growing.
(FR)
Des micro-organismes de référence sont enfermés hermétiquement dans une cavité interne d'une membrane microporeuse (14, 20). Selon un mode de réalisation, les microbes de référence sont inoculés sur un élément (12) qui est enfermé hermétiquement dans une enveloppe microporeuse (14). Selon un autre mode de réalisation, les microbes (22) sont chargés dans un trou ou cavité interne d'un tube ou une enveloppe en plastique microporeux (20). La membrane microporeuse et les microbes, tels que des spores, sont immergés simultanément avec des produits à décontaminer, mais séparément de ceux-ci, dans un fluide antimicrobien. La membrane microporeuse est fabriquée dans un matériau suffisamment résistant aux températures, à l'eau, aux oxydants puissants et autres agents antimicrobiens ou à des procédés utilisés dans la décontamination microbienne ou la stérilisation, ce qui lui permet de conserver son intégrité lors de son immersion dans tout fluide ou système commun de stérilisation ou décontamination microbienne se présentant sous forme de vapeur, gaz ou liquide. Les micropores sont suffisamment petits pour que les microbes de référence soient piégés, mais suffisamment ouverts pour que la vapeur, le gaz ou le liquide antimicrobiens pénètrent par les micropores pour venir directement en contact avec les microbes. Après ce processus de décontamination microbienne, la membrane microporeuse et les microbes qu'elle renferme sont immergés dans un milieu de culture (40) et contrôlés afin de déterminer si des microbes sont encore vivants et commencent à se développer.
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