Process for detecting the completion of the sterilizing treatment using a color changing indicator composition
AssigneeSakata Shokai, Ltd.
InventorsKozo Miyamoto, Kunitaka Fujiwara
Life of this patent
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Abstract
Process for detecting the completion of a gaseous alkylene oxide sterilization treatment of medical or surgical equipment by the color change of particular azo dye indicators. The indicator composition contains an azo dye such as ##STR1##
Claims20
A process for detecting the completion of a sterilizing treatment of a medical or a surgical instrument in which a gaseous alkylene oxide is the sterilizing agent, which comprises exposing to said alkylene oxide the material to be sterilized and a color changing indicator composition, which indicator composition visibly exhibits a color change when exposed to said alkylene oxide, and maintaining said alkylene oxide in contact with said material and said indicator composition at least until said color change occurs in said indicator composition, said color changing indicator composition comprising from 1 to 5% by weight of an azo dye represented by the following formula ##STR28## wherein A represents an ethylene residual group, an o-phenylene residual group, or ##STR29## with proviso that --N is linked with X, while --C with N in the formula (1), respectively, which is further enabled to have an undissociative group as a substituent;
- X represents ##STR30## B represents an aniline-derivative residual group which can be coupled to the para-position or an enamine residual group having the formula, ##STR31## and the both groups are further enabled to have an undissociative group as a substituent, said R represents a hydrogen atom or a lower alkyl group having from 1 to 3 carbon atoms, said R.sup.1 represents a hydrogen atom, a lower alkyl group having from 1 to 3 carbon atoms or a phenyl group, said undissociative group represents a lower alkyl group having from 1 to 3 carbon atoms, an alkoxy group having from 1 to 3 carbon atoms, --R.sup.2 --OH, chlorine, a phenyl group or a nitro group, wherein R.sup.2 represents an alkylene group having from 1 to 3 carbon atoms, from 10 to 50% by weight of a hydrophobic polymer and from 30 to 85% by weight of a solvent or mixed solvent.
In a process for detecting the completion of a sterilizing treatment of a medical or a surgical instrument in the hermetically sealed sterilized condition with gaseous alkylene oxide by color change of a color changing indicator composition printed or coated on a herrmetically sealing material, the improvement wherein the color changing indicator composition comprises from 1 to 5% by weight of an azo dye represented by the following formula ##STR33## wherein A represents an ethylene residual group, an o-phenylene residual group, or ##STR34## with proviso that --N is linked with X, while --C with N in the formula (1), respectively, which is further enabled enabled to have an undissociative group as a substituent;
- X represents --S-- or ##STR35## B represents an aniline-derivative residual group which can be coupled to the para-position or an enamine residual group having the formula, ##STR36## and the both groups are further enabled to have an undissociative group as a substituent, said R represents a hydrogen atom or a lower alkyl group having from 1 to 3 carbon atoms, said R.sup.1 represents a hydrogen atom, a lower alkyl group having from 1 to 3 carbon atoms or a phenyl group, said undissociative group represents a lower alkyl group having from 1 to 3 carbon atoms, an alkoxyl group having from 1 to 3 carbon atoms, --R.sup.2 --OH, chlorine, a phenyl group or a nitro group, wherein R.sup.2 represents an alkylene group having from 1 to 3 carbon atoms, from 10 to 50% by weight of a hydrophobic polymer and from 30 to 85% by weight of a solvent or mixed solvent.
Dependencies are inferred from the claim text.