IPC분류정보
국가/구분 |
United States(US) Patent
등록
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국제특허분류(IPC7판) |
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출원번호 |
US-0091260
(2002-03-04)
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발명자
/ 주소 |
- Felkner, Ira C.
- Laico, Joseph P.
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출원인 / 주소 |
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대리인 / 주소 |
Akin Gump Strauss Hauer &
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인용정보 |
피인용 횟수 :
12 인용 특허 :
46 |
초록
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A novel biological indicator system to detect the effectiveness of a sterilization treatment and methods for assessing the viability of and/or changes in bacterial spores exposed to a sterilization or disinfection method by multiangle light scattering thereby detecting a change in the spores as indi
A novel biological indicator system to detect the effectiveness of a sterilization treatment and methods for assessing the viability of and/or changes in bacterial spores exposed to a sterilization or disinfection method by multiangle light scattering thereby detecting a change in the spores as indicators of spore viability and the efficacy of the sterilization or disinfection method.
대표청구항
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1. A method of assessing viability of a spore after a sterilization treatment, comprising:(a) exposing a spore to a sterilization treatment; (b) examining the spore of step (a) after treatment using multiangle light scattering; and (c) evaluating a difference between the multiangle light scattering
1. A method of assessing viability of a spore after a sterilization treatment, comprising:(a) exposing a spore to a sterilization treatment; (b) examining the spore of step (a) after treatment using multiangle light scattering; and (c) evaluating a difference between the multiangle light scattering of the spore treated in step (a) and a multiangle light scattering of a like spore not exposed to a sterilization treatment to evaluate a change in spore morphology and determine whether the spore treated in step (a) viable. 2. The method of claim 1, wherein the spore and the like spore are selected from the group consisting of a B. subtilis spore, and a B. stearothermophilus spore.3. The spore of claim 2, wherein the spore and the like spore are B. subtilis. 4. The spore of claim 2, wherein the spore and the like spore are B. stearothermophilus. 5. The method of claim 1, wherein the sterilization treatment is selected from the group consisting of a chemical sterilization treatment, and a physical sterilization treatment.6. The method of claim 5, wherein the chemical sterilization treatment is selected from the group consisting of an ethylene oxide sterilization treatment, a hydrogen peroxide sterilization treatment, a tetrasilver tetraoxide sterilization treatment, and an ozone sterilization treatment.7. The method of claim 5, wherein the physical sterilization treatment is selected from the group consisting of a radiation sterilization treatment, a gas plasma sterilization treatment, a steam sterilization treatment, and a dry heat sterilization treatment.8. The method of claim 1, further comprising examining the like spore using multiangle light scattering prior to the sterilization treatment of the spore in step (a) to provide a standard multiangle light scattering data set for use as the multiangle light scattering of the like spore in step (c).9. The method of claim 8, further comprising storing the standard multiangle light scattering data set to assess viability of a second like spore after sterilizing the second like spore using the sterilization treatment of step (a).10. The method of claim 1, further comprising incubating the spore treated in step (a) with a growth medium prior to step (b).11. The method of claim 10, wherein the growth medium is selected from the group consisting of trypticase soy broth, nutrient broth, and brain heart infusion broth.12. The method of claim 10, further comprising incubating the spore up to about 24 hours prior to step (b).13. The method of claim 10, further comprising heat-shocking the spore treated in step (a) prior to incubating the treated spore with the growth medium.14. The method of claim 1, wherein the sterilization treatment is selected from the group consisting of a steam sterilization treatment, and an ozone sterilization treatment, and the method further comprises examining the spore directly after the sterilization treatment.15. A method of assessing efficacy of a sterilization treatment, comprising(a) exposing a biological indicator to a sterilization treatment; (b) examining a like biological indicator which has not been exposed to a sterilization treatment using multiangle light scattering to create a standard profile; (c) examining the biological indicator treated in step (a) using multiangle light scattering to create a post-sterilization profile; and (d) comparing the post-sterilization profile of the biological indicator treated in step (a) to the standard profile wherein a difference between the post-sterilization profile of the biological indicator treated in step (a) and the standard profile indicates efficacy of the sterilization treatment. 16. The method of claim 15 wherein the biological indicator and the like biological indicator are B. subtilis spores.17. The method of claim 15, wherein the sterilization treatment is selected from the group consisting of a physical sterilization treatment, and a chemical sterilization treatment.18. The method of claim 17, wherein the chemical sterilization treatment is selected from the group consisting of a tetrasilver tetraoxide sterilization treatment, an ethylene oxide sterilization treatment, a hydrogen peroxide sterilization treatment, and an ozone sterilization treatment.19. The method of claim 17, wherein the physical sterilization treatment is selected from the group consisting of a radiation sterilization treatment, a gas plasma sterilization treatment, a dry heat sterilization treatment, and a steam sterilization treatment.20. The method of claim 15, wherein the sterilization treatment is selected from the group consisting of a steam sterilization treatment, and an ozone sterilization treatment, and the method further comprises examining the spore directly after the sterilization treatment.21. A method of detecting a change in a biological indicator exposed to a sterilization treatment, comprising exposing a biological indicator to a sterilization treatment, and comparing a multiangle light scattering of the biological indicator after exposing the biological indicator to the sterilization treatment to a multiangle light scattering of a like biological indicator not exposed to a sterilization treatment, wherein a difference between the multiangle light scattering of the biological indicator after exposing the biological indicator to the sterilization treatment and the multiangle light scattering of the like biological indicator indicates a change in the biological indicator after exposing the biological indicator to the sterilization treatment.22. The method of claim 21, further comprising incubating the biological indicator after exposing the biological indicator to the sterilization treatment with a growth medium for up to about 24 hours before examining the multiangle light scattering of the biological indicator.23. The method of claim 22, further comprising heat-shocking the biological indicator prior to incubating the biological indicator with the growth medium.24. The method of claim 21, further comprising using an instrument selected from the group consisting of a nephelometer, and a photometer to examine the multiangle light scattering of the biological indicator.25. The method of claim 21, wherein the sterilization treatment is selected from the group consisting of a steam sterilized on treatment, and an ozone sterilization treatment, and the method further comprises examining the spore directly after the sterilization treatment.
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