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Chemical indicator for determining the adequacy of a liquid sterilization process

a liquid sterilization process and indicator technology, applied in the direction of chemical indicators, instruments, and investigating the degree of sterilization, can solve the problems of difficult to see and read, difficult to achieve the objective, and small indicator ink associated with the produ

Inactive Publication Date: 2003-06-26
3M INNOVATIVE PROPERTIES CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Practically, this is a very difficult objective to achieve, especially with a liquid sterilant.
The indicator ink associated with the product, however, is very small and difficult to see and read.

Method used

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  • Chemical indicator for determining the adequacy of a liquid sterilization process
  • Chemical indicator for determining the adequacy of a liquid sterilization process

Examples

Experimental program
Comparison scheme
Effect test

example 1

A Chemical Indicator for Peracetic Acid as a Comparative Example

[0037] To demonstrate the improvement in uniformity achieved by the invention, an example without a raised portion (e.g., 14) was prepared. This Example includes an indicator ink prepared in accordance with copending and coassigned U.S. patent application Ser. No. 09 / 019,341, which is hereby incorporated herein by reference.

[0038] A base layer 12 was prepared by laminating a layer of filter paper to a polymeric film. The filter paper used in this lamination is commercially available as SS-410 from Schleicher & Schuell of New Hampshire. The polymeric film used in this lamination is a ethylene / methacrylic acid ionomer resin commercially available under the "Surlyn" trade name from E. I. Dupont de Nemours of Wilmington, Del. The thickness of the finished lamination was 0.040" (1.5 mm).

[0039] An indicating compound suitable for detecting the presence of peracetic acid vapor was prepared by mixing 10 grams of potassium bromi...

example 2

An Alternate Comparative Example

[0044] A second comparative example was prepared. The procedure of Example 1 was followed, except that after the laminate was dipped and dried, but before the VHB adhesive was applied, the pieces of laminate were inserted into a 4000TN LaserJet printer equipped with a model C4127X black ink cartridge, both commercially available from Hewlett-Packard of Palo Alto, Calif. Under computer control, an annular ring of black ink was applied to the surface of the laminate bearing the indicating compound. The annulus of ink had an outside diameter of 19 mm and an inside diameter of 13 mm. The disks that were then cut from the laminate corresponded to the outside diameter of the inked region.

example 3

An Experimental Example

[0045] The procedure of Example 1 was followed, except that after the laminate was dipped and dried, an additional layer of the paper / film laminate was adhered using the VHB adhesive over the top of the layer that had been dipped. This top layer had holes of 13 mm punched in it prior to being applied, so that windows of indicating compound showed through the holes. Disks of 19 mm in outside diameter were cut from this double laminate so that the 13 mm window was concentric with the outside of the disk. This additional layer therefore forms a torus (e.g., doughnut) shaped raised lamina surrounding the indicating region. This assembly was then adhered with an acrylic transfer adhesive to the vapor permeable backing and the receptacle formed in the manner described above in Example 1.

[0046] The raised portion in this Example is a lamination. It could be a single layer of added material, or indeed the disk could be all of one material with a raised lip extending a...

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Abstract

A sterilization indicator that presents a visually distinct and uniform color transition after having been passed through sterilizing conditions. This sterilization indicator has a base layer with an indicator compound applied to at least an indicating region thereon. It also has a raised lamina attached to the base layer so as to substantially surround the indicating region.

Description

[0001] The invention relates generally to chemical indicators used to monitor the adequacy of a liquid sterilization process, and more specifically to chemical indicators that exhibit a uniform, easy to read color change when exposed to sterilizing conditions. An objective test for measuring color uniformity in chemical sterilization indicators is also described.BACKGROUND OF THE INVENTION.[0002] A reliable supply of sterile instruments and supplies is vitally important to modern medical practice. Various types of apparatus are known for sterilizing reusable goods within a hospital setting. Perhaps the best known is the steam autoclave, which uses high temperature and high pressure steam to render medical goods sterile. Steam as a sterilizing gas is fast and effective, but requires high temperatures. Goods that cannot withstand autoclaving temperatures can be sterilized with sterilizers using biocidal gases such as ethylene oxide or hydrogen peroxide.[0003] Alternatively, some types...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61L2/18A61L2/26A61L2/28G01N31/22
CPCG01N31/226A61L2/28
Inventor HEHENBERGER, RODNEY K.
Owner 3M INNOVATIVE PROPERTIES CO