Biological indicator for use with vaporous microbial deactivating agents and method for making same

Abstract

A biological indicator and method of making same. The biological indicator includes a carrier having a recess formed therein in order to restrict movement of an inoculum deposited onto the carrier. The inoculum includes microorganisms (e.g., bacterial spores) suspended in a suspension medium. The microorganisms are prepared by removing extraneous material and subjecting the microorganisms to sonication to break up agglomerations. The suspension medium includes a wetting agent to reduce surface tension, thereby facilitating flow of the suspension medium to prevent stacking of microorganisms on the surface of the carrier, and to allow the inoculum to more evenly “plate out” on carrier surfaces. The carrier, with inoculum deposited thereon, is enclosed in an envelope made of a material permeable to a vaporous deactivating agent (e.g., vaporized hydrogen peroxide, ozone, chlorine dioxide, ethylene oxide, etc.), thereby facilitating exposure to the vaporous deactivating agent.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a biological indicator for determining the efficacy of a microbial deactivation process.BACKGROUND OF THE INVENTION[0002]Many articles (e.g., medical instruments and devices) and enclosed regions of a wide range of facilities (e.g., medical treatment and research facilities, pharmaceutical manufacturing facilities, animal research facilities, laboratories, patient rooms, hotel rooms, offices, cruise ships, recreational facilities and vehicles) are treated with a vaporous deactivating agent (e.g., vaporized hydrogen peroxide) in a microbial deactivation process to deactivate microbial contamination on the articles or contaminated surfaces within the enclosed region. In order to determine whether the treated articles or enclosed regions have been successfully deactivated, and thereby safe for use, it is necessary to determine whether all of the parameters necessary for deactivation were met during the deactivation process or...

AI Technical Summary

Benefits of technology

[0011]An advantage of the present invention is the provision of a biological indicator having an inoculum with minimal extraneous material therein.

[0012]Another advantage of the present invention is the provision of a biological indicator having a suspension medium that minimizes stacking of microorganisms.

[0013]Still another advantage of the present invention is the provision of a biological indicator having a carrier dimensioned to inhibit migration of inoculum.

[0014]Still another advantage of the present invention is the provision of a biological indicator having a carrier formed of a material compatible with an oxidative vaporous microbial deactivating agent.

[0015]Still another advantage of the present invention is the provision of a biological indicator having a protective packaging with improved permeability for vaporous microbial deactivating agents.

Problems solved by technology

One problem with known biological indicators is that microorganisms become “stacked” on the surface of the carrier, thereby shielding some of the microorganisms from exposure to the vaporous deactivating agent. FIG. 1 illustrates a prior art biological indicator 70 comprised of a carrier 72 having microorganisms 78 suspended within a suspension medium 76.

Still another problem encountered with known biological indicators is that microorganisms disposed on the flat upper surface of the carrier come into contact with the package enclosing the carrier.

Yet another problem with known biological indicators is that the carrier may shift positions within the protective package, thereby causing the side of the carrier having microorganisms deposited thereon to face the impermeable side of the protective package.

The problems described above result in a biological indicator that does not accurately indicate the efficacy of a microbial deactivation process.

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