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Sterilization indicator including a simplified genetically engineered biological indicator

A biological indicator, sterilization indicator technology, applied in the field of sterilization indicators including simplified genetically engineered biological indicators, can solve problems such as increasing the overall process complexity, achieve elimination of quantity and complexity, increase sensitivity and Signal strength, effect of increasing sensitivity

Inactive Publication Date: 2015-12-09
AMERICAN STERILIZER CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Additionally, it will be recognized that having to include repressor genes in vectors used to induce uptake of reporter genes by test organisms only adds to the complexity of the overall process for producing genetically engineered biological indicator systems

Method used

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  • Sterilization indicator including a simplified genetically engineered biological indicator
  • Sterilization indicator including a simplified genetically engineered biological indicator
  • Sterilization indicator including a simplified genetically engineered biological indicator

Examples

Experimental program
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Embodiment

[0113] Figure 4 and Figure 5 Showing the effect of the presence of xylose, the effect of omitting xylose, and the resulting benefits of the invention, Figure 4 and Figure 5 is the absorbance at wavelengths from 325 nm to 900 nm before autoclaving, after 1 autoclaving cycle, and after 2 autoclaving cycles. As can be appreciated, conventionally at least the second compartment containing the inducer will undergo two cycles of autoclaving before the absorbance is read during the determination of sterilization efficacy. The first autoclave cycle occurs when the sterilization indicator is fabricated and it is necessary to ensure the sterility of the growth medium and enzyme substrate; the second autoclave cycle occurs when the sterilization indicator undergoes sterilization processing occurs, in which it is an indicator.

[0114] Figure 4 Absorbance of growth medium without xylose (ie, containing 0% xylose) is shown before autoclaving, after one cycle of autoclaving, and a...

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PUM

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Abstract

A sterilization indicator, including a first compartment containing a genetically engineered biological indicator, and a second compartment containing an enzyme substrate, the second compartment adapted to maintain the enzyme substrate separate from the biological indicator during sterilization, and to permit the enzyme substrate to contact the biological indicator after the biological indicator has been exposed to the sterilization medium; in which the genetically engineered biological indicator comprises at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and the test organism is free of any active or activatable repressor gene that would inhibit expression of the reporter gene if present in the test organism or sterilization indicator, and the indicator enzyme and the enzyme substrate are selected such that enzymatic action of the indicator enzyme upon the enzyme substrate yields a detectable signal.

Description

Background technique [0001] The inventors of the present application have previously disclosed a genetically engineered biological indicator comprising at least one test organism for producing indicator enzymes and at least one reporter gene which is taken up by the test organism (takenup), the test organism comprises a bacterial spore; at least one repressor gene, which suppresses expression of a reporter gene until the reporter gene is exposed to at least one inducer; wherein the genetically engineered biological indicator is a self-contained biological indicator A component of a self-contained biological indicator such as a combination of a two-compartment system such as a vial and a cap that also contains a growth medium for the genetically engineered biological indicator. See, eg, U.S. Patent No. 8,372,624. [0002] In the genetically engineered biological indicator system and method disclosed in US8372624, a repressor gene suppresses the expression of a reporter gene un...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12N15/75C12Q1/22G01N33/52
CPCC12Q1/22C12N15/74C12N15/75
Inventor 菲利普·P·弗兰契什科维奇特里西娅·A·克雷格W·A·依拉瓦
Owner AMERICAN STERILIZER CO
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