Packaging systems for peracid sterilization processes

• US 5,620,656 A
• Filed: 12/04/1995
• Issued: 04/15/1997
• Est. Priority Date: 08/25/1993
• Status: Expired due to Term

• Current Assignee: DePuy Orthopaedics Incorporated (Johnson & Johnson)
• Original Assignee: Abtox, Inc.
• Inventors: Wensky, Afaf, Caputo, Ross A., Martens, Phillip A.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Dawson, E. Leigh
• Application Number:
  US08/566,477
• Time in Patent Office: 498 Days
• Field of Search: 422/27, 422/28, 422/55, 422/56, 422/57, 422/61, 422/86, 422/87, 422/292, 422/294, 435/31, 436/1, 206/459.1, 206/439, 116/206
• US Class Current: 422/28
• 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: C12Q 1/22 Testing for sterility conditions
• CPC Class Codes: G01N 31/226 for investigating the degree of sterilisation

Abstract

Devices useful to monitor whether or not an article has been exposed to sterilizing conditions are provided and comprise a package and an indicator associated with the package. The package is sufficiently permeable to admit sterilizing gas or vapor into the package. The indicator associated with the package changes color from a first color (indicating ambient conditions) to a second color (indicating exposure to acidic gas or vapor). Both the first and second colors of the indicator are stable and preferably substantially maintain their colors under ambient conditions. Particularly, preferred embodiments are adapted for use with peracetic acid sterilization processes.

Claims

1. A device useful to indicate sterilization cycle exposure of an article when the sterilization cycle includes an acidic gas or vapor, comprising:

a package capable of sealingly enclosing an article, the package having at least a portion with sufficient permeability to admit a sterilizing gas or vapor into contact with the article when sealingly enclosed within the package, the package being substantially bacteria impermeable when sealed; and

,

an indicator associated with the package and adapted to be visually observed therewith, the indicator including a pH sensitive dye and a pH adjusting agent, the indicator having a first color under ambient conditions and adapted to change color from the first color to a second color in response to acidic gas or vapor exposure, the pH adjusting agent effective to place the pH of the indicator to an acidic point about where color change from the first color to the second color begins to occur, wherein said indicator is adapted to substantially maintain the first color under ambient conditions in the absence of exposure to a sterilization cycle and to substantially maintain the second color after acidic gas or vapor exposure is terminated.

2. The device as in claim 1 wherein the permeable package portion admits peracid and/or acetic acid vapor at reduced pressure.

3. The device as in claim 2 wherein the package permits visual observation into the package and the indicator is adapted to be sealingly enclosed within the package.

4. The device as in claim 3 wherein the permeable package portion begins to admit vapor in less than about five minutes after package exposure thereto.

5. The device as in claim 2 wherein the pH adjusting agent of the indicator is acidic.

6. The device as in claim 2 wherein the indicator includes a substrate and a dye composition, the dye composition being absorbed on the substrate and having a pH adjusted by the pH adjusting agent to between about 4.6 to about 6.5.

7. The device as in claim 6 wherein the dye composition includes Bromophenol Blue.

8. The device as in claim 1 wherein the package is adapted sealingly to enclose an article and the indicator by heat sealing or adhesive bonding.

9. A package for articles to be sterilized by a sterilization cycle including exposure to an acidic fluid, comprising:

a package portion having sufficient permeability to admit a sterilizing amount of gas or vapor into the package when an article to be sterilized is enclosed therein, the package being sealable and substantially bacteria impermeable after sealing; and

,

a dye composition adapted to be stably carried by the package and visually observable from a position exterior to the package when sealed, the dye composition being substantially stable and capable of visually indicating whether exposure to an acidic fluid of a sterilization cycle has occurred, the dye composition including a pH sensitive dye and a pH adjusting agent, the pH sensitive dye giving a substantially stable color change in response to acetic fluid exposure, the pH adjusting agent adjusting the pH of the dye composition to between about 4.6 to about 6.5.

10. The package as in claim 9 wherein the acidic fluid includes peracid and/or acetic acid vapor.

11. The package as in claim 10 wherein the pH sensitive dye changes color at a pH of about 4.6.

12. The package as in claim 9 further comprising:

a biological indicator.

13. The package as in claim 12 wherein the biological indicator includes a selected number of viable organism spores and a carrier being inoculated with the spores.

14. The package as in claim 13 wherein the organism includes Bacillus circulans.

15. The package as in claim 9 or 12 wherein the dye composition includes Bromophenol Blue or Bromocresol Green.

16. The package as in claim 9 or 12 wherein the dye composition is affixed to a package surface.

17. A packaging system for monitoring exposure to a sterilizing process, comprising:

a selected number of viable organism spores, the organism being Bacillus circulans;

a carrier being inoculated with the spores;

a package for the inoculated carrier, the package including at least a portion having sufficient permeability to admit a sterilizing amount of gas or vapor into contact with the spores, the package being substantially bacteria impermeable; and

,

an indicator associated with the package and adapted to be visually observed therewith, the indicator changing color from a first color to a different color in response to a fluid component of a sterilizing process, wherein the indicator substantially maintains the first color in the absence of acidic gas or vapor exposure and the different color after acidic gas or vapor exposure is terminated.

18. The packaging system as in claim 17 wherein the sterilizing process component is an acidic gas or vapor.

19. A tape adapted to be affixed to biocontamination barriers for articles to be sterilized by a sterilization cycle including exposure to an acidic fluid, comprising:

an elongated, flexible member having an adhesive layer on one side and a dye composition on the other side, the dye composition being substantially stable and capable of visually indicating whether exposure to an acidic fluid of a sterilization cycle has occurred, the dye composition including a pH sensitive dye and a pH adjusting agent, the pH sensitive dye giving a substantially stable color change in response to acetic fluid exposure, the pH adjusting agent adjusting the pH of the dye composition to between about 4.6 to about 6.5.

20. The tape as in claim 19 wherein the dye composition includes Bromophenol Blue or Bromocresol Green.

21. The tape as in claim 20 wherein the dye composition changes color in response to acetic acid exposure and substantially maintains the changed color after exposure to acetic acid is terminated.