Integrated chemical indicator device

• US 9,726,652 B2
• Filed: 10/10/2014
• Issued: 08/08/2017
• Est. Priority Date: 07/19/2007
• Status: Active Grant

• Current Assignee: Steris Inc (Steris Corporation)
• Original Assignee: Steris Inc (Steris Corporation)
• Inventors: Lacy, Stephen Michael, Tyers, Neil David
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US14/511,593
• Publication Number:
  US 20150024501A1
• Time in Patent Office: 1,033 Days
• 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 31/005 investigating the presence of an element by oxidation G01N31/12 takes precedence
• CPC Class Codes: G01N 31/226 for investigating the degree of sterilisation
• CPC Class Codes: G01N 31/228 for peroxides

Abstract

A chemical indicator device for use in detecting exposure to an oxidizing agent, such as hydrogen peroxide, comprising a substrate or support upon which is disposed a chemical indicator composition (ink) for detecting an oxidizing agent, such as hydrogen peroxide. The chemical indicator composition further comprises an indicator dye that achieves a distinct range of different color changes with clear transitions between colors, upon exposure to different doses of the oxidizing agent, thus allowing for both a qualitative and semi-quantitative assessment of exposure to the agent.

Claims

1. An indicator device that semi-quantitatively assesses the dose of a sterilant to which an object is exposed during a single cycle of a low temperature sterilization process utilizing ethylene oxide or hydrogen peroxide as sterilants, consisting of:

a. a support;

b. a chemical indicator ink composition dispersed in a uniform concentration on the support, consisting of

(i) a single dye, which, when reacted directly with the sterilant, achieves at least three different, distinct color changes corresponding to different doses of sterilant to which the device was exposed during the single sterilization cycle;

(ii) a binder consisting of nitrocellulose, hydroxypropyl methyl cellulose, ethyl cellulose, a polyamide, polypropylene, polyethylene, polystyrene, polyethylene terephthalate, polyvinyl alcohol, polyvinyl acetate or a mixture of two or more thereof present in amounts ranging from about 5 wt. % to about 90 wt. %;

(iii) a UV-protectant consisting of 2-(2′

-hydroxyphenyl) benzotriazole or derivatives of benzophenone, or mixtures thereof present in amounts ranging from about 0.5 wt. % to about 5 wt. %;

(iv) a silicone-based anti-foaming agent present in amounts ranging from about 0.1 wt. % to about 2 wt. %; and

(v) a plasticizer present in amounts ranging from about 0.5 wt. % to about 5 wt. %, and

c. a pre-calibrated visual color chart for assessing, semi-quantitatively, the dose of sterilant to which the device was exposed based upon the color change achieved,

wherein the single dye consists of pararosaniline base present in amounts ranging from about 0.05 wt. % to about 10 wt. %; and

wherein the weight percentages are based upon the total weight of the chemical indicator ink composition.

2. The indicator device according to claim 1, wherein the chemical indicator ink composition is encapsulated in a transparent polymer that is permeable or semipermeable to the sterilant to afford abrasion protection, to waterproof the ink and to enhance user safety, wherein the transparent polymer comprises polymethacrylate, polyethylene, polyethylene terephthalate, cellophane, polypropylene, or mixtures of two or more thereof.

3. The indicator device according to claim 1, wherein the chemical indicator ink composition is incorporated into a wax or solid resin prior to being disposed uniformly on the support.

4. The indicator device according to claim 1, wherein the chemical indicator ink composition is dispersed in a solvent consisting of water, 2-methoxyethanol, 2-ethoxyethanol, methanol, ethanol, 1-propanol, 2-propanol, butanol, acetone, methyl ethyl ketone, butyl acetate, or mixtures of two or more thereof, prior to being disposed uniformly on the support.

5. A method of monitoring the effectiveness of a low temperature chemical sterilization process that utilizes ethylene oxide or hydrogen peroxide as a sterilant and of determining, semi-quantitatively, the dose of sterilant to which an object is exposed in a single sterilization cycle, comprising the steps of:

a. providing an indicator device consisting of a chemical indicator ink composition disposed in a uniform concentration on a support, wherein the chemical indicator ink composition consists of;

(i) a single dye, pararosaniline base, present in amounts ranging from about 0.05 wt. % to about 10 wt. %, that achieves at least three different, distinct color changes over time in response to the dose of sterilant to which the device was exposed during the single sterilization cycle;

(ii) a UV protectant consisting of 2-(2′

-hydroxyphenyl) benzotriazole or derivatives of benzophenone, or mixtures thereof, present in amounts ranging from about 0.5 wt. % to about 5 wt. %;

(iii) a polysiloxane antifoam compound present in amounts ranging from about 0.1 wt. % to about 2 wt. %;

(iv) a binder consisting of nitrocellulose, hydroxypropyl methyl cellulose, ethyl cellulose, a polyamide, polypropylene, polyethylene, polystyrene, polyethylene terephthalate, polyvinyl alcohol, polyvinyl acetate or mixtures of two or more thereof, present in amounts ranging from about 5 wt. % to about 90 wt. %;

(v) a plasticizer, and

(vi) a solvent to balance up to 100 wt. %,

b. placing the device into a low-temperature sterilizing environment wherein the ink composition will be directly exposed to the ethylene oxide or hydrogen peroxide sterilants; and

c. comparing the color achieved by the chemical indicator ink composition at any point in time during the sterilization cycle to a pre-calibrated, visual color chart to assess the dose of sterilant to which the chemical indicator ink composition was exposed based on the color achieved.

6. The method according to claim 5, wherein the plasticizer is dioctyl phthalate.

7. The chemical indicator ink composition according to claim 5, wherein the solvent consists of water, 2-methoxyethanol, 2-ethoxyethanol;

methanol, ethanol, 1-propanol, 2-propanol, butanol;

acetone, methyl ethyl ketone, butyl acetate, or mixtures of two or more thereof.

8. A chemical indicator ink composition, for use in monitoring the effectiveness of a low temperature chemical sterilization process that utilizes hydrogen peroxide as a sterilant and for determining, semi-quantitatively, the dose of hydrogen peroxide to which the composition is exposed during a single sterilization cycle, consisting of:

a. pararosaniline base, present in an amount ranging from 0.05 wt. % to about 10 wt. %, based on the total weight of the chemical indicator ink composition, that achieves at least three different, distinct color changes over time corresponding to the dose of hydrogen peroxide to which the chemical indicator ink composition is exposed during a single sterilization cycle;

b. ethyl cellulose, present in an amount ranging from about 5 wt. % to about 90 wt. %, based on the total weight of the chemical indicator composition;

c. a benzotriazole-based UV protectant, present in amounts ranging from about 0.5 wt. % to about 5 wt. %, based on the total weight of the chemical indicator composition;

d. dioctyl phthalate present in amounts ranging from about 0.5 wt. % to about 5 wt. %, based on the total weight of the chemical indicator composition;

e. a polysiloxane antifoaming agent present in amounts ranging from about 0.1 wt. % to about 2 wt. %, based on the total weight of the chemical indicator composition;

f. glycerol present in amounts ranging from about 0.5 wt. % to about 30 wt. %, and

g 2-methoxyethanol to balance up to 100 wt.

9. The chemical indicator ink composition of claim 8, wherein the polysiloxane antifoaming agent is polydimethylsiloxane.