Container monitoring system

• US 6,815,206 B2
• Filed: 12/21/2000
• Issued: 11/09/2004
• Est. Priority Date: 09/19/1997
• Status: Expired due to Fees

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Lin, Szu-Min, Wu, Su-Syin
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): CROSS, LATOYA I
• Application Number:
  US09/742,315
• Publication Number:
  US 20020022246A1
• Time in Patent Office: 1,419 Days
• Field of Search: 422/28, 422/34, 422/36, 422/37, 422/300, 436/1, 436/126, 436/128
• US Class Current: 436/1
• CPC Class Codes: A61L 2/208 Hydrogen peroxide
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61L 2202/122 Chambers for sterilisation
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• CPC Class Codes: Y10T 436/196666 Carbon containing compound [e.g., vinylchloride, etc.]

Abstract

A sterilization system uses a sterilization process monitoring device which is capable of indicating the efficacy of the sterilization process. To enhance accuracy of the monitoring function, the monitoring device is located in such a fashion that an antimicrobial agent used in the process can only reach the monitor through an area containing the article to be sterilized.

Claims

1. A system for monitoring a sterilization or disinfection process comprising:

a container defining a first space and a second space, the first space and second spac being in fluid communication with each other;

the first space being adapted to contain one or more articles to be sterilized or disinfected;

the second space having therein at least one indicator for indicating at least one parameter relevant to the sterilization or disinfection process;

an antimicrobial source for providing an antimicrobial agent to the first space, wherein the antimicrobial source comprises an aperture into the first space from outside of the container whereby antimicrobial fluids in space around the container may diffuse into the first space through the aperture,

a flow restriction between the first space and the second space; and

wherein the second space is in fluid communication with the antimicrobial source only through the first space.

2. A system according to claim 1 wherein the container is impermeable to microorganisms.

3. A system according to claim 1 wherein the second space is detachable from the first space.

4. A system according to claim 1 wherein the container comprises a pouch.

5. A system according to claim 1 wherein the indicator comprises a biological indicator.

6. A system according to claim 1 wherein the indicator comprises a chemical indicator.

7. A system according to claim 6 wherein the container comprises a pouch and wherein the chemical indicator is printed on the pouch inside the second space.

8. A system according to claim 1 and further comprising a flow restriction between the first space and the second space.

9. A system according to claim 1 wherein the first space is divided into two or more subspaces connected in series between the source of antimicrobial fluid and the second space.

10. A system according to claim 1 wherein the antimicrobial fluid comprises hydrogen peroxide.

11. A system according to claim 1 and further comprising a fan adapted to assist flow through the container from the source of antimicrobial fluid to the second space.

12. A system for monitoring a sterilization or disinfection process comprising:

a container defining a first space and a second space, the first space and second space being in fluid communication with each other;

the first space being adapted to contain one or more articles to be sterilized or disinfected;

the second space having therein at least one indicator for indicating at least one parameter relevant to the sterilization or disinfection process;

a flow restriction between the first space and the second space;

an antimicrobial source for providing an antimicrobial agent to the first space; and

wherein the second space is in fluid communication with the antimicrobial source only through the first space.

13. A system for monitoring a sterilization or disinfection process comprising:

a container defining a first space and a second space, the first space and second space being in fluid communication with each other;

the first space being adapted to contain one or more articles to be sterilized or disinfected;

the second space having therein at least one indicator for indicating at least one parameter relevant to the sterilization or disinfection process;

the first space being divided into two or more subspaces connected in series between the source of antimicrobial fluid and the second space;

an antimicrobial source for providing an antimicrobial agent to the first space; and

wherein the second space is in fluid communication with the antimicrobial source only through the first space.

14. A system according to claim 13 wherein at least a portion of the subspaces are detachable from the container.

15. A system for monitoring a sterilization or disinfection process comprising:

a container defining a first space and a second space, the first space and second space being in fluid communication with each other;

the first space being adapted to contain one or more articles to be sterilized or disinfected;

the second space having therein at least one indicator for indicating at least one parameter relevant to the sterilization or disinfection process;

an antimicrobial source for providing an antimicrobial agent to the first space wherein the antimicrobial fluid comprises hydrogen peroxide; and

wherein the second space is in fluid communication with the antimicrobial source only through the first space.

16. A system for monitoring a sterilization or disinfection process comprising:

a container defining a first space and a second space, the first space and second space being in fluid communication with each other;

the first space being adapted to contain one or more articles to be sterilized or disinfected;

the second space having therein at least one indicator for indicating at least one parameter relevant to the sterilization or disinfection process;

an antimicrobial source for providing an antimicrobial agent to the first space;

wherein the second space is in fluid communication with the antimicrobial source only through the first space; and

further comprising a fan adapted to assist flow through the container from the source of antimicrobial fluid to the second space.

17. A method for monitoring a disinfection or sterilization procedure comprising the steps of:

providing a container having a first space and a second space in fluid communication with each other;

placing an article to be disinfected or sterilized into the first space;

placing at least one indicator into the second space;

providing an antimicrobial agent to the first space;

flowing said antimicrobial agent to the second space only from the first space and reading a relevant function of the disinfection or sterilization procedure with the indicator; and

wherein the antimicrobial agent comprises hydrogen peroxide.

19. A method for monitoring a disinfection or sterilization procedure comprising the steps of:

providing a container having a first space and a second space in fluid communication with each other;

placing an article to be disinfected or sterilized into the first space;

placing at least one indicator into the second space;

providing an antimicrobial agent to the first space;

flowing said antimicrobial agent to the second space only from the first space and reading a relevant function of the disinfection or sterilization procedure with the indicator; and

further comprising the step of assisting the flow of the antimicrobial agent through the first space and to the second space with a fan.

18. A method according to claim 19 wherein the antimicrobial agent comprises hydrogen peroxide vapor.

20. A method for monitoring a disinfection or sterilization procedure comprising the steps of:

providing a container having a first space and a second space in fluid communication with each other;

placing an article to be disinfected or sterilized into the first space;

placing at least one indicator into the second space;

providing an antimicrobial agent to the first space;

flowing said antimicrobial agent to the second space only from the first space and reading a relevant function of the disinfection or sterilization procedure with the indicator; and

further comprising the step of recirculating the antimicrobial agent back to the first space from the second space.

21. A method for monitoring a disinfection or sterilization procedure comprising the steps of:

providing a container having a first space and a second space in fluid communication with each other;

placing an article to be disinfected or sterilized into the first space;

placing at least one indicator into the second space;

providing an antimicrobial agent to the first space;

flowing said antimicrobial agent to the second space only from the first space and reading a relevant function of the disinfection or sterilization procedure with the indicator; and

wherein the container is a pouch and further comprising the step of sealing the first space from the second space after flowing the antimicrobial agent into the second space and then removing the indicator from the second space.

22. A method according to claim 21 wherein the step of sealing the first space from the second space comprises heat sealing a portion of the pouch between the first space and the second space.