Process for detecting the completion of the sterilizing treatment using a color changing indicator composition

• US 4,015,937 A
• Filed: 11/14/1975
• Issued: 04/05/1977
• Est. Priority Date: 11/14/1975
• Status: Expired due to Term

• Current Assignee: Sakata Shokai Limited
• Original Assignee: Sakata Shokai Limited
• Inventors: Fujiwara, Kunitaka, Miyamoto, Kozo
• Primary Examiner(s): Marantz, Sidney
• Application Number:
  US05/631,904
• Time in Patent Office: 508 Days
• Field of Search: 23/230 R, 23/232 R, 23/253 TP, 252/408, 21/DIG. 4, 116/114 AM
• US Class Current: 436/1
• 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: C09B 29/08 Amino benzenes
• CPC Class Codes: C09B 29/081 unsubstituted alkylamino, alkenylamino, alkynylamino, cycloalkylamino, aralkylamino or arylamino
• CPC Class Codes: C09B 29/3613 from an indole
• CPC Class Codes: C09B 35/34 the tetrazo component being heterocyclic
• CPC Class Codes: G01N 31/226 for investigating the degree of sterilisation
• CPC Class Codes: Y10S 436/903 Diazo reactions
• CPC Class Codes: Y10T 436/142222 Hetero-O [e.g., ascorbic acid, etc.]

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##

Claims

1. 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 R¹ 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, --R² --OH, chlorine, a phenyl group or a nitro group, wherein R² 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.

2. The process of claim 1 wherein the azo dye is a member selected from the group consisting of ##STR32##

3. The process of claim 1 wherein the hydrophobic polymer is at least one member selected from the group consisting of nitrocellulose, ethyl cellulose, polyvinyl butyral, polyamide, rosin modified maleic resin, shellac, cellulose propionate and an acrylate resin.

4. The process of claim 1 wherein the solvent is at least one member selected from the group consisting of a lower alcohol having from 1 to 6 carbon atoms and Cellosolve.

5. The process of claim 1 wherein the mixed solvent is a mixture of at least one member selected from the group consisting of an aromatic hydrocarbons, a lower alkyl ester having from 1 to 4 carbon atoms of acetic acid and a ketone, with at least one member selected from the group consisting of a lower alcohol having from 1 to 6 carbon atoms and Cellosolve.

6. The process of claim 1 wherein the alkylene oxide is ethylene oxide.

7. The process of claim 1 wherein the color changing indicator composition comprises from 1 to 5% by weight of an azo dye, from 10 to 50% by weight of a hydrophobic polymer, from 30 to 85% by weight of a solvent or mixed solvent and from 1 to 5% by weight of a catalyst.

8. The process of claim 1 wherein the color changing indicator composition comprises from 1 to 5% by weight of an azo dye, from 10 to 50% by weight of a hydrophobic polymer, from 30 to 85% by weight of a solvent or mixed solvent and from 1 to 10% by weight of a filler.

9. The process of claim 1 wherein the color changing indicator composition comprises from 1 to 5% by weight of an azo dye, from 10 to 50% by weight of a hydrophobic polymer, from 30 to 85% by weight of a solvent or a mixed solvent, from 1 to 5% by weight of a catalyst and from 1 to 10% by weight of a filler.

10. 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 R¹ 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, --R² --OH, chlorine, a phenyl group or a nitro group, wherein R² 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.

11. The process of claim 10 wherein the azo dye is a member selected from the group consisting of ##STR37##

12. The process of claim 10 wherein the color changing indicator composition contains another dye or pigment which does not change in color when contacted with said alkylene oxide.

13. The process of claim 10 wherein the hydrophobic polymer is at least one member selected from the group consisting of nitrocellulose, ethyl cellulose, polyvinyl butyral, polyamide, rosin modified maleic resin, shellac, cellulose propionate and an acrylate resin.

14. The process of claim 10 wherein the solvent is at least one member selected from the group consisting of a lower alcohol having from 1 to 6 carbon atoms and Cellosolve.

15. The process of claim 10 wherein the mixed solvent is a mixture of at least one member selected from the group consisting of an aromatic hydrocarbon, a lower alkyl ester having from 1 to 4 carbon atoms of acetic acid and a ketone, with at least one member selected from the group consisting of a lower alcohol having from 1 to 6 carbon atoms and Cellosolve.

16. The process of claim 10 wherein the alkylene oxide is ethylene oxide.

17. The process of claim 10 wherein the color changing indicator composition comprises from 1 to 5% by weight of an azo dye, from 10 to 50% by weight of a hydrophobic polymer, from 30 to 85% by weight of a solvent or mixed solvent and from 1 to 5% by weight of a catalyst.

18. The process of claim 10 wherein the color changing indicator composition comprises from 1 to 5% by weight of an azo dye, from 10 to 50% by weight of a hydrophobic polymer, from 30 to 85% by weight of a solvent or mixed solvent and from 1 to 10% by weight of a filler.

19. The process of claim 10 wherein the color changing indicator composition comprises from 1 to 5% by weight of an azo dye, from 10 to 50% by weight of a hydrophobic polymer, from 30 to 85% by weight of a solvent or a mixed solvent, from 1 to 5% by weight of a catalyst and from 1 to 10% by weight of a filler.

20. The process of claim 10 wherein the color changing indicator composition comprises from 1 to 5% by weight of the azo dye having the formula ##STR38## from 10 to 50% by weight of butyral resin, from 30 to 85% by weight of a mixed solvent comprising toluene, methanol and Methyl Cellosolve, and from 1 to 5% by weight of malonic acid.