Self-contained biological indicator for non traditional sterilization methods

• US 5,801,010 A
• Filed: 03/17/1997
• Issued: 09/01/1998
• Est. Priority Date: 03/17/1997
• Status: Expired due to Term

• Current Assignee: Surigot, Inc.
• Original Assignee: Surigot, Inc.
• Inventors: Lyons, Pamela M., Risner, Steven J., Shamsunder, Giridhar, Falkowski, Jerry
• Primary Examiner(s): REDDING, DAVID A
• Application Number:
  US08/818,944
• Time in Patent Office: 533 Days
• Field of Search: 435/287.4, 435/287.6, 435/808, 435/31, 435/34
• US Class Current: 435/31
• CPC Class Codes: C12Q 1/22 Testing for sterility conditions
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus

Abstract

A self-contained biological indicator for evaluating the efficacy of sterilization processes utilizing hydrogen peroxide and hydrogen peroxide/peracetic acid plasma and vapor as the sterilant is disclosed. The self-contained biological indicator includes a translucent, vapor-permeable, container including a source of dormant microorganisms, a sealed ampule containing a culture medium that is capable of promoting the growth of surviving microorganisms, a neutralizing tablet that is capable of decomposing hydrogen peroxide sterilant, and an actuating mechanism that permits mixture of the source of microorganisms, culture medium and the hydrogen peroxide neutralizing tablet to be brought into contact from the exterior of the indicator. In one embodiment the self-contained biological indicator is comprised of a plurality of generally cylindrical, telescoping vials being operable from an unsealed, sterilization test configuration to a sealed and activated configuration for incubation. In the sterilization test configuration the integrity of the enclosure is interrupted by a plurality of openings which permit the flow of sterilant vapor into the indicator during a sterilization cycle. After exposure to the sterilization cycle is complete the indicator is operable to a sealed configuration in which the gas permeable openings are blocked by the telescoping movement of the container vials. After the indicator has been exposed to a sterilization cycle and placed in the sealed condition the deformable container may be actuated by finger pressure to bring the microorganism source, culture medium, and the hydrogen peroxide decomposing tablet into contact.

Claims

1. A self-contained biological indicator for evaluating the effectiveness of a sterilizer utilizing hydrogen peroxide sterilant, said indicator comprising:

a deformable container means including a plurality of telescoping vial means adapted for sliding engagement one inside another from an unsealed sterilization test configuration to a sealed post-exposure configuration;

a source of viable microorganisms disposed within said container means;

a hydrogen peroxide neutralizing means capable of decomposing said sterilant and disposed within said container means; and

a frangible ampule containing a culture medium capable of promoting growth of said microorganisms and including a detector means capable of reacting with the metabolites of said microorganisms to produce a visual indication of an incomplete sterilization cycle, said ampule being openable by pressure applied to an external surface of said container means to permit said medium, said microorganisms, and said neutralizing means to come into contact after exposure to a sterilization cycle such that said neutralizing means will decompose any residual hydrogen peroxide sterilant within said container means enabling any of said microorganisms surviving said sterilization cycle to grow in said medium to provide an indication of the effectiveness of said sterilizer.

2. The biological indicator of claim 1 wherein said source of microorganisms includes a paper strip inoculated with a predetermined concentration of said microorganisms.

3. The biological indicator of claim 2 wherein said paper strip is attached to an external surface of said ampule.

4. The biological indicator of claim 1 wherein said neutralizing means includes catalase in tablet form.

5. The biological indicator of claim 4 wherein said catalase tablet comprises a lyophilized powder mixed with a hygroscopic substance such as cellulose capable of disintegrating on contact with said medium.

6. The biological indicator of claim 1 wherein said vial means includes in inner vial and an outer vial being generally cylindrical in construction and adapted for sliding engagement one inside another, each of said vials further including a plurality of gas permeable openings therein to permit said sterilant to permeate said indicator during said sterilization cycle in said test configuration, said openings being sealable by said sliding engagement of said inner vial and said outer vial to said sealed post-exposure configuration.

7. The self contained biological indicator of claim 6 wherein said vial means further includes a gas/liquid impermeable cap means being adapted to receive said inner vial and said outer vial in said sealed post-exposure configuration, said cap means being configured and dimensioned to interlock with said inner vial and said outer vial to prevent unsealing thereof.

8. The biological indicator of claim 7 wherein said cap means is generally cylindrical in construction including at least one internal peripheral groove formed therein, said groove being adapted to interlock with a mating locking flange formed about the outer periphery of said outer vial to secure said cap means thereon.

9. The biological indicator of claim 8 wherein said cap means is integrally formed with said inner vial at one end thereof and adapted to interlock with said locking flange on said outer vial to secure said cap means to said outer vial.

10. The biological indicator of claim 1 wherein said vial means are fabricated from a translucent plastic material.

11. A method of evaluating the effectiveness of a hydrogen peroxide sterilizer by subjecting a self-contained biological indicator to a sterilization cycle, said indicator being of the type having a deformable container means including a plurality of telescoping vial means adapted for sliding engagement one inside another from an unsealed sterilization test configuration to a sealed post-test configuration, said indicator further including source of viable microorganisms, a hydrogen peroxide neutralizing means, and frangible ampule containing a culture medium for promoting growth of said microorganisms, said method comprising steps of:

providing said self-contained biological indicator;

setting said indicator in said unsealed sterilization configuration;

positioning said indicator in said sterilizer;

subjecting said indicator to a sterilization cycle;

engaging said vial means in said sealed post-test configuration;

activating said indicator by applying pressure to said deformable container means to permit said medium, said microorganisms, and said neutralizing means to come into contact; and

incubating said indicator for a predetermined time to permit any of said microorganisms surviving said sterilization cycle to grow in said medium thereby providing an indication of the effectiveness of said sterilizer.

12. The method of claim 11 wherein the step of setting further includes the step of adjusting said vial means one inside another to expose a plurality of gas permeable openings formed therein to the atmosphere in said sterilizer allowing said sterilant to permeate said indicator.

13. The method of claim 12 wherein the step of positioning further includes inserting said indicator into a test pack comprising a gas permeable pouch means to simulate the mass and penetration characteristics of the items being sterilized.