Biological indicators for determining efficacy of steam or heat sterilization process and methods of using same

A biological indicator, steam technology, applied in the direction of microorganism-based methods, biochemical equipment and methods, microorganisms, etc., can solve problems such as the success of wrong sterilization, and achieve time-effective and cost-effective effects

Pending Publication Date: 2021-04-02
TERRAGENE LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This possibility of changes presents a serious potential drawback to biological indicators that rely on enzymatic reactions, as these changes may falsely indicate the success of sterilization

Method used

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  • Biological indicators for determining efficacy of steam or heat sterilization process and methods of using same
  • Biological indicators for determining efficacy of steam or heat sterilization process and methods of using same
  • Biological indicators for determining efficacy of steam or heat sterilization process and methods of using same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] This example uses F.&M. GmbH & Co. Resistometer (resistometer), which allows sublethal time exposure to assess the biological indicator prediction.

[0109] During this example, BIONOVA BT224 biological indicator, which is the fastest indicator currently available on the market, was used in the test together with the biological indicator of the present invention to obtain comparative data.

[0110] Use the IC10 / 20FRLCD incubator for quick readings. Long-term readings (7 days) were performed at 60°C in a humidity chamber at 80% relative humidity.

[0111] The medium contained in the ampoule of the biological indicator of the present invention consists of 1 g / L bacto-peptone, 1 g / L yeast extract and 0.5 g / L-valine.

[0112] According to the method of the present invention, a fluorescence reading is performed with the biological indicator of the present invention within 0-20 seconds.

[0113] For each specific exposure time, 20 tests of the biological indicator of the ...

Embodiment 2

[0119] The conditions of Example 1 were repeated except as noted here.

[0120] The content of the ampoule of the biological indicator of the present invention is as follows: bromothymol blue is used as a colorimetric component of the culture medium, and 0.1 mg / mL of 8-anilinonaphthalene-1-sulfonic acid is used as a fluorophore. Albumin at 0.5 g / mL was used as exogenous sensor protein.

[0121] Together with the ampoule, will contain 2.5 x 10 6 The carrier of CFU of Bacillus stearothermophilus ATCC 7953 spores was placed in the tube. The exposure time was performed at 132°C.

[0122]

Embodiment 3

[0124] The conditions of Example 1 were repeated except as noted here.

[0125] The content of the ampoule of the biological indicator of the present invention is as follows: 5-bromo-4-chloro-3-indolyl β-D-galactopyranoside is used as a colorimetric component of the medium, and 0.1 mg / mL 8-Anilinonaphthalene-1-sulfonic acid was used as the fluorophore. Casein at 0.5 g / mL was used as exogenous sensor protein.

[0126] Together with the ampoule, will contain 2.5 x 10 6 The carrier of CFU of Bacillus stearothermophilus ATCC 7953 spores was placed in the tube. The exposure time was performed at 132°C.

[0127]

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PUM

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Abstract

A biological indicator for determining the efficacy of a steam or heat sterilization process. The biological indicator comprises a group of microbial spores, microbial spore exogenous sensor proteins,fluorophores and a culture medium. Methods of determining the efficacy of a steam or heat sterilization process using the biological indicator are disclosed.

Description

technical field [0001] The present invention relates to biological indicators suitable for determining the results of steam sterilization or heat sterilization processes. Background technique [0002] Sterilization is a process intended to render surfaces or objects (such as laboratory or medical equipment, instruments or utensils) free of viable life forms. Such processes are widely used in settings such as the medical industry or numerous scientific research activities. [0003] An important aspect of such processes is the ability to determine the success of the sterilization process to ensure the desired conditions for the materials and / or surfaces being used to be sterilized. For this, several methods with different quality levels are used. [0004] Biological indicators known in the art generally involve subjecting a known amount of microbial spores, such as bacterial spores, to a sterilization process along with a target material and / or surface. Immediately after th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/04C12R1/07C12R1/125C12R1/01
CPCC12Q1/04C12Q1/045G01N2333/32G01N2333/195C12Q1/22A61L2/28A61L2/07A61L2202/24A61L2/04C12N1/20G01N21/6486
Inventor E·伦巴第A·J·罗卫托P·拉瓦西
Owner TERRAGENE LLC
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