# US 8,541,196 B2 · Method for activating a self-contained biological indicator

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- Number: US 8,541,196 B2
- Document ID: US8541196B2
- Status: Granted
- Kind: B2
- Application number: 13/438,951
- Filed: 2012-04-04
- Published: 2012-08-02
- Granted: 2013-09-24
- Earliest claimed: 2008-06-12
- Assignees: American Sterilizer Company
- Applicants: Joseph T. Sestak; Peter J. Buczynski
- Inventors: Joseph T. Sestak; Peter J. Buczynski
- Web page: https://patentgrep.com/patent/US8541196B2

## CPC

- C12M 37/06: {Means for testing the completeness of the sterilization (testing for sterility conditions C12Q1/22)}
- C12M 23/32: {Frangible parts}
- C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS}

## Abstract

The present invention provides a device for activating a self-contained biological indicator. The biological indicator includes a casing, an ampule having a growth-promoting medium disposed therein and microorganisms. The ampule and microorganisms are disposed within the casing. The device is comprised of a first lever arm having a cavity formed therein. The cavity is dimensioned to receive a biological indicator. A second lever arm has a protrusion extending from a surface thereof and is moveable relative to the first lever arm to deform a casing of the biological indicator thereby fracturing an ampule in the casing and exposing microorganisms in the casing to a growth-promoting medium in the ampule of the biological indicator.

## Claims

### Claim 1

A method of activating a self-contained biological indicator using a device having a first lever arm and a second lever arm wherein a cavity is formed in said first lever arm and said first lever arm is movable relative to said second lever arm, said biological indicator including a casing and a cap disposed on said casing, said cap movable between an open position and a sealed position relative to said casing and said casing defining an interior cavity dimensioned to receive microorganisms and an ampule having a growth-promoting medium disposed therein, said method comprising the steps of:
a) moving said device to an open position wherein said cavity of said first lever arm is accessible;
b) locating a biological indicator in said cavity of said first lever arm while said device is in said open position; and
c) moving said device to a closed position to activate said biological indicator, wherein said second lever arm of said device is moved relative to said first lever arm, said step of moving said device to said closed position includes:
1) applying a compressive force to said cap of said biological indicator located in said cavity of said first lever arm to move said cap to said sealed position; and
2) after said cap is in said sealed position, deforming said casing of said biological indicator thereby fracturing said ampule within said casing to expose said microorganisms within said interior cavity of said casing to said growth promoting medium in said ampule.

### Claim 2 (depends on 1)

A method as defined in claim 1, further comprising the steps of:
d) moving said second lever arm relative to said first lever arm such that said device is in said open position and said cavity of said first lever arm is accessible; and
e) removing said biological indicator from said cavity of said first lever arm.

### Claim 3 (depends on 1)

A method as defined in claim 1, wherein said first lever arm and said second lever arm are movable relative to each other using one hand.

### Claim 4 (depends on 1)

A method as defined in claim 1, wherein an end of said first lever arm is hinged to an end of said second lever arm for moving said second lever arm relative to said first lever arm.

### Claim 5 (depends on 1)

A method as defined in claim 1, wherein during said step c) of moving said device to said closed position an engaging edge of said second lever arm applies said compressive force to said cap of said biological indicator to move said cap to said sealed position.

### Claim 6 (depends on 5)

A method as defined in claim 5, wherein during said step c) of moving said device to said closed position said engaging edge of said second lever arm moves toward an end wall of said cavity of said first lever arm.

### Claim 7 (depends on 1)

A method as defined in claim 1, wherein during said step c) of moving said device to said closed position a protrusion formed on said second lever arm contacts said casing of said biological indicator to deform said casing.

### Claim 8 (depends on 7)

A method as defined in claim 7, wherein during said step c) of moving said device to said closed position said protrusion moves in a direction substantially perpendicular to a bottom wall of said cavity of said first lever arm.