Vapor phase decontamination process biological indicator evaluator resistomer (BIER) vessel
AssigneeSTERIS Inc.
InventorsGerald E. McDonnell, Iain F. McVey, Michael Geanous
Life of this patent
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Abstract
A BIER vessel evaluates biological indicators for sterilization processes. By flowing gaseous sterilant, such as vaporized hydrogen peroxide, through a chamber (12) before, during, and after introducing the indicators, the indicators are instantaneously exposed to preselected steady state conditions, allowing accurate and reproducible evaluation of the indicator response. A door (32) to an opening (30) in the chamber opens for introducing the indicators to the chamber without appreciably disturbing the steady state conditions therein. After a preselected time, the biological indicators are removed and evaluated for remaining biological activity.
Claims28
A system for evaluating biological indicators comprising:
- a) a chamber;
- b) an access port for selectively introducing biological indicators into the chamber and for subsequently removing the biological indicators from the chamber;
- c) a generator for generating a multi-component sterilant vapor;
- d) a circulating system for supplying the multi-component sterilant vapor to the chamber;
- e) a source of a first component of the multi-component sterilant vapor fluidly connected with the vaporizer;
- and
- f) a source of a second component of the multi-component sterilant vapor, separate from the first source, fluidly connected with the vaporizer.
A system for evaluating biological indicators comprising:
- a) a chamber;
- b) an access port for selectively introducing biological indicators into the chamber and for subsequently removing the biological indicators from the chamber, the access port including:
- a tube having a cross section shaped to receive a sample holder therethrough and an opening in fluid communication with the chamber at one end thereof, and
- a valve which selectively closes the opening;
- c) a generator for generating a multi-component sterilant vapor;
- d) a circulating system for supplying the multi-component sterilant vapor to the chamber.
A method of evaluating a biological indicator comprising:
- generating a multi-component vapor from a first component and a second component;
- passing the multi-component vapor through a test chamber until steady state conditions are achieved;
- introducing the biological indicator to be evaluated into the chamber;
- maintaining the steady state conditions for a selected period, including adjusting a ratio of the first component to the second component in the multi-component vapor and introducing the adjusted multi-component vapor to the test chamber;
- removing the biological indicator from the test chamber after a preselected time period;
- assessing the effects upon the indicator.
An evaluation system:
- a vessel which defines an interior chamber;
- a source of an antimicrobial fluid which supplies the antimicrobial fluid to the chamber;
- a tube, fluidly connected with the chamber, which extends from the vessel for receiving a sample holder therein, the sample holder carrying a sample to be evaluated and being movable within the tube between a first position, in which the sample is positioned outside the chamber and a second position, in which the sample is positioned inside the chamber to be exposed to the antimicrobial fluid;
- means for applying suction to the chamber;
- means associated with at least one of the tube and the sample holder, for resisting movement of the sample holder into the chamber under the influence of a reduced pressure applied by the suction means.
A method of evaluating an effect of an antimicrobial process upon an indicator for the process, the method including:
- a) supplying an antimicrobial fluid to the chamber;
- b) positioning the indicator on a sample holder;
- c) inserting the sample holder into a first end of a tube which is fluidly connected with a chamber at a second end;
- d) opening a valve which seals the chamber from the second end of the tube;
- e) pushing the sample holder through the tube until the indicator is positioned within the chamber;
- f) exposing the indicator to the antimicrobial fluid in the chamber;
- g) withdrawing the sample holder from the chamber;
- and
- h) evaluating the indicator to determine the effect of the antimicrobial process upon the indicator.
Dependencies are inferred from the claim text.