Activator system for biological indicator

Patent metadata

Field	Value
Publication number	US-12329874-B2
Application number	US-201917309502-A
Country	US
Kind code	B2
Filing date	Dec 19, 2019
Priority date	Dec 21, 2018
Publication date	Jun 17, 2025
Grant date	Jun 17, 2025

Abstract

A system for assessing efficacy of a sterilization process is disclosed. The system includes a biological indicator, a receptacle configured to receive the biological indicator, an actuator mechanism, and a sensing system operatively coupled to the actuator mechanism. A method of using the system for assessing efficacy of a sterilization process is also disclosed.

First claim

We claim:

1. A device for assessing efficacy of a sterilization process, comprising:
a biological indicator;
a receptacle configured to receive the biological indicator;
an actuator mechanism disposed within the system and adjacent to the receptacle; and
a sensing system configured to sense conditions of the sterilization process, wherein the sensing system senses a parameter selected from the group consisting of pressure, temperature, time, and a combination thereof of the sterilization process during exposure of the device to the sterilization process.

2. The device of claim 1 , wherein the biological indicator comprises a source of biological activity disposed therein.

3. The device of claim 1 , wherein the biological indicator comprises a sealed reservoir.

4. The device of claim 1 , wherein the actuator mechanism comprises a part that is configured to move from a first position to a second position.

5. The device ystem of claim 1 ;
wherein the receptacle comprises a compartment configured to hold the biological indicator;
wherein the compartment defines a volume;
wherein the second position is located within the volume.

6. The device of claim 1 , wherein the sensing system comprises a temperature-responsive chemical.

7. The device of claim 6 , wherein the temperature-responsive chemical has a first density when in a solid state and a second density when in a liquid state, wherein the first density is higher than the second density.

8. The device of claim 1 , wherein the sensing system is electrically or electronically connected to a sterilizer.

9. The device of claim 1 , wherein the actuator mechanism comprises at least one actuator chosen from a mechanical actuator, an electrical actuator, a chemical actuator, or a combination thereof.

10. The device of claim 1 , wherein the actuator mechanism comprises a mechanical actuator, wherein at least a portion of the mechanical actuator changes from a first physical state to a second physical state in response to a temperature between 100° C. and 134° C.

11. The device of claim 10 , wherein the portion has a higher density in the first physical state than in the second physical state.

12. The device of claim 10 , wherein the mechanical actuator comprises a wax.

13. The device of claim 1 , wherein the sensing system comprises a receiver that receives data from a sterilizer.

14. A device, comprising:
a receptacle configured to receive a biological indicator;
an actuator mechanism disposed within the device and adjacent to the receptacle; and
a sensing system configured to sense conditions of a sterilization process, wherein the sensing system is operatively coupled to the actuator mechanism, wherein the sensing system senses a parameter selected from the group consisting of pressure, temperature, time, and a combination thereof of the sterilization process during exposure of the device to the sterilization process.

15. A device for assessing efficacy of a sterilization process, comprising:
a biological indicator;
a receptacle configured to receive the biological indicator;
an actuator mechanism disposed within the system and adjacent to the receptacle; and
a sensing system configured to sense conditions of the sterilization process during exposure of the device to the sterilization process, wherein the sensing system is operatively coupled to the actuator mechanism, and the sensing system comprises a temperature-responsive chemical.

16. A device for assessing efficacy of a sterilization process, comprising:
a biological indicator;
a receptacle configured to receive the biological indicator;
an actuator mechanism disposed within the system and adjacent to the receptacle, wherein the actuator mechanism comprises a mechanical actuator, and at least a portion of the mechanical actuator changes from a first physical state to a second physical state in response to a temperature between 100° C. and 134° C.; and
a sensing system configured to sense conditions of the sterilization process during exposure of the device to the sterilization process, wherein the sensing system is operatively coupled to the actuator mechanism.

Assignees

• Solventum Intellectual Properties Company

Inventors

• Landgrebe Kevin D
• Bommarito G Marco
• Xia Wensheng
• Kohman Timothy A
• Nies Timothy J
• Powley Nicholas R

Classifications

• G01N21/77

  by observing the effect on a chemical indicator · CPC title

• G01N21/78

  producing a change of colour · CPC title

• A61L2202/14

  Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs · CPC title

• A61L2202/122

  Chambers for sterilisation · CPC title

• A61L2/28 Primary

  Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour · CPC title