| 摘要 |
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. |
| 主权项 |
1. A chemical indicator device for monitoring a sterilization process that uses an oxidizing agent as a sterilant and for semi-quantitatively assessing the dose of the oxidizing agent to which an object is exposed during a single sterilization cycle, consisting of:
a. a support; b. a chemical indicator ink composition dispersed in a uniform concentration on the support, consisting of
(i) pararosaniline base, present in amounts ranging from about 0.05 wt. % to about 10 wt. %;(ii) a binder present in amounts ranging from about 5 wt. % to about 90 wt. %;(iii) a UV-protectant 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 to about 5 wt. %, wherein the wt. % are based upon the total weight of the composition, wherein a uniform concentration of pararosaniline base, when reacted directly with the oxidizing agent, achieves a range of different, distinct color changes over time in response to exposure to different doses of the oxidizing agent during a single sterilization cycle, and wherein the colors achieved by the pararosaniline base are compared to a pre-calibrated, visual color chart so that a semi-quantitative assessment of the dose of the oxidizing agent to which an object was exposed can be made. |
