Sterilization indicators and methods

• US 5,780,098 A
• Filed: 12/20/1996
• Issued: 07/14/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: 3M Company
• Original Assignee: 3M Company
• Inventors: Battles, Donald R.
• Primary Examiner(s): DUDASH, DIANA L
• Application Number:
  US08/771,779
• Time in Patent Office: 571 Days
• Field of Search: 427/208.4, 427/2.1, 427/2.31, 427/208.6, 427/8, 427/209, 422/1, 422/26, 422/28, 422/119, 422/40
• US Class Current: 427/2.1
• 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: G01N 31/226 for investigating the degree of sterilisation
• CPC Class Codes: Y10T 428/1462 Polymer derived from material having at least one acrylic or alkacrylic group or the nitrile or amide derivative thereof [e.g., acrylamide, acrylate ester, etc.]
• CPC Class Codes: Y10T 428/149 Sectional layer removable
• CPC Class Codes: Y10T 428/169 Sections connected flexibly with external fastener
• CPC Class Codes: Y10T 428/17 Three or more coplanar interfitted sections with securing means
• CPC Class Codes: Y10T 428/18 Longitudinally sectional layer of three or more sections
• CPC Class Codes: Y10T 428/192 Sheets or webs coplanar
• CPC Class Codes: Y10T 428/24273 including aperture
• CPC Class Codes: Y10T 428/24281 Struck out portion type
• CPC Class Codes: Y10T 428/24331 including nonapertured component
• CPC Class Codes: Y10T 428/2835 including moisture or waterproof component
• CPC Class Codes: Y10T 428/2852 Adhesive compositions

Abstract

Sterilization indicators utilizing moisture-resistant, water-dispersible, pressure sensitive adhesives are provided. The sterilization indicators comprise at least one backing strip, preferably water-dispersible, which is coated on at least one side with the moisture-resistant, water-dispersible, pressure sensitive adhesive. A sterilization indicator strip is affixed to the backing strip and is easily removable from the sterilization indicator. The indicator tapes are useful to maintain a sterilization wrapper containing articles to be sterilized in a closed position during sterilization, and normal pre- and post-sterilization handling, while also providing a means to indicate if the wrapped articles have passed through a sterilization cycle. After use, the sterilization indicator strip is easily removed, and the adhesives coating the sterilization indicators, and preferably also the backing strips, disperse an aqueous alkali solution, such as are found in commercial laundries. Methods of making and using the sterilization indicators are also provided.

Claims

1. A method of making a sterilization indicator, comprising:

providing at least one backing strip having ends and opposing sides;

providing a sterilization indicator strip comprising an indicator ink in combination with a binder printed onto a backing;

coating a moisture resistant, water-dispersible, pressure sensitive adhesive on one of the opposing sides of the at least one backing strip; and

affixing the sterilization indicator strip to an end of the at least one backing strip, wherein the sterilization indicator strip is easily removable from the at least one backing strip prior to laundering and wherein the indicator ink is capable of undergoing a color change when exposed to sterilization conditions.

2. The method of claim 1, further comprising the step of perforating the at least one backing strip near the end to which the sterilization indicator strip is affixed.

3. The method of claim 1, wherein the method comprises providing two backing strips and wherein the affixing step comprises affixing the sterilization indicator backing to an end of each of the two backing strips.

8. The method of claim 1, wherein the backing strip is water-dispersible.

9. The method of claim 2, wherein the backing strip is non-water-dispersible.

10. The method of claim 1, wherein the backing strip is selected from the group consisting of woven backings, non-woven backings, cloth backings, film backings, paper backings, and foil backings.

11. The method of claim 1, wherein the indicator ink is selected from the group consisting of steam sterilization indicator inks, ethylene oxide sterilization indicator inks, or a combination of a steam sterilization indicator ink and an ethylene oxide sterilization indicator ink.

12. The method of claim 11, wherein the steam sterilization indictor ink comprises a lead carbonate-sulfur indicator ink.

13. The method of claim 1, wherein the binder comprises an acrylate binder.

14. The method of claim 1, wherein the moisture resistant, water-dispersible, pressure sensitive adhesive comprises a composition which is dispersible at an alkaline pH but not at an acidic or neutral pH, comprising:

a polymer formed from A, B, and C monomers wherein

A is a hydrophobic monomer selected from the group consisting of an acrylic or a methacrylic ester of a non-tertiary alcohol having from 2 to 14 carbon atoms, wherein A comprises from 50 to 80% by weight of the polymer,

B is a monomer selected from the group consisting of β

carboxyethylacrylate, the salt of β

-carboxyethylacrylate, vinyl carboxylic acid, the salt of vinyl carboxylic acid, and mixtures thereof, wherein B comprises from 10 to 30% by weight of the polymer, wherein the carboxylic acid groups of the polymer have been neutralized with from about 0.5 to about 2 equivalents of an alkali metal hydroxide per carboxylic acid group, and wherein when the mixture of β

-carboxyethylacrylate and vinyl carboxylic acid is used, the β

-carboxyethylacrylate comprises at least 10% by weight of the polymer, and

C is a water-dispersible macromolecular monomer which has the formula X-Y-Z, wherein X is a moiety copolymerizable with A and B, Y is a divalent linking group which joins X to Z, and Z is a water-dispersible group which contains at least two units which are essentially unreactive under the free radical initiated copolymerization conditions used to form the polymer, and wherein C comprises from 10 to 30% by weight of the polymer; and

less than about 0.1 parts plasticizer per part of the polymer.

15. The method of claim 1, wherein the indicator is capable of maintaining a wrapped bundle of articles in a closed position during sterilization and normal pre-and post-sterilization handling.

16. The method of claim 1, wherein the pressure sensitive adhesive exhibits sufficient adhesion to maintain the wrapped bundle of articles in the closed position during sterilization and normal pre- and post-sterilization handling.

17. The method of claim 1, wherein the backing strips exhibit sufficient strength that they will not tear during sterilization and normal pre- and post-sterilization handling.

4. A method of using a sterilization indicator as a wrapper closure, comprising:

providing an indicator comprising at least one backing strip having ends, opposing sides, and a moisture resistant, water-dispersible, pressure sensitive adhesive coated on one of the opposing sides, the at least one backing strip having a sterilization indicator strip affixed to an end thereof comprising an indicator ink in combination with a binder printed onto a backing, wherein the indicator ink is capable of undergoing a color change when exposed to sterilization conditions; and

applying the indicator to a sterilization wrapper containing a bundle of articles such that the bundle will remain substantially closed during sterilization and normal pre- and post-sterilization handling.

5. The method of claim 4, further comprising removing the sterilization indicator strip from the sterilization wrapper prior to laundering the sterilization wrapper.

6. The method of claim 4, wherein the at least one backing strip of the indicator is perforated near the end to which the sterilization indicator strip is affixed.

7. A method of making a sterilization indicator, comprising:

providing a backing strip having opposing sides and at least one aperture;

providing a sterilization indicator strip, said sterilization indicator strip comprising an indicator ink in combination with a binder printed onto a backing;

coating a moisture resistant, water-dispersible, pressure sensitive adhesive on one of said opposing sides of said backing; and

affixing said sterilization indicator strip to said backing strip such that said sterilization indicator strip is viewable through said at least one aperture.

18. A method of making a sterilization indicator, comprising:

providing a backing strip having ends and opposing sides, a first portion of the backing strip having one or more apertures;

providing a sterilization indicator strip comprising an indicator ink in combination with a binder printed onto a backing;

coating a moisture resistant, water-dispersible, pressure sensitive adhesive on one of the opposing sides of the backing strip; and

affixing the sterilization indicator strip to the first portion of the backing strip such that the sterilization indicator strip is viewable through the one or more apertures, wherein the sterilization indicator strip is easily removable from the backing strip prior to laundering and wherein the indicator ink is capable of undergoing a color change when exposed to sterilization conditions.

19. The method of claim 18, further comprising the step of perforating the backing strip near the portion to which the sterilization indicator strip is affixed.

20. The method of claim 18, wherein the backing strips are selected from the group consisting of woven backings, non-woven backings, cloth backings, film backings, paper backings, and foil backings, wherein the indicator ink is selected from the group consisting of steam sterilization indicator inks, ethylene oxide sterilization indicator inks, or a combination of a steam sterilization indicator ink and an ethylene oxide sterilization indicator ink, and wherein the binder comprises an acrylate binder.

21. The method of claim 18, wherein the moisture resistant, water-dispersible, pressure sensitive adhesive comprises a composition which is dispersible at an alkaline pH but not at an acidic or neutral pH, comprising:

a polymer formed from A, B, and C monomers wherein

A is a hydrophobic monomer selected from the group consisting of an acrylic or a methacrylic ester of a non-tertiary alcohol having from 2 to 14 carbon atoms, wherein A comprises from 50 to 80% by weight of the polymer,

B is a monomer selected from the group consisting of β

-carboxyethylacrylate, the salt of β

-carboxyethylacrylate, vinyl carboxylic acid, the salt of vinyl carboxylic acid, and mixtures thereof, wherein B comprises from 10 to 30% by weight of the polymer, wherein the carboxylic acid groups of the polymer have been neutralized with from about 0.5 to about 2 equivalents of an alkali metal hydroxide per carboxylic acid group, and wherein when the mixture of β

-carboxyethylacrylate and vinyl carboxylic acid is used, the β

-carboxyethylacrylate comprises at least 10% by weight of the polymer, and

C is a water-dispersible macromolecular monomer which has the formula X-Y-Z, wherein X is a moiety copolymerizable with A and B, Y is a divalent linking group which joins X to Z, and Z is a water-dispersible group which contains at least two units which are essentially unreactive under the free radical initiated copolymerization conditions used to form the polymer, and wherein C comprises from 10 to 30% by weight of the polymer; and

less than about 0.1 parts plasticizer per part of the polymer.