Color changing steam sterilization indicator

• US 20030211618A1
• Filed: 11/04/2002
• Published: 11/13/2003
• Est. Priority Date: 05/07/2001
• Status: Abandoned Application

• Current Assignee: JP Laboratories Inc.
• Original Assignee: JP Laboratories Inc.
• Inventors: Patel, Gordhandhai Nathalal
• Application Number:
  US10/275,228
• Publication Number:
  US 20030211618A1
• Time in Patent Office: Days
• US Class Current: 436/38
• CPC Class Codes: A61L 2/07 Steam
• 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 31/226 for investigating the degree of sterilisation

Abstract

There is provided a device (10) for monitoring sterilization of a material with steam comprising at least one layer (20), having incorporated therein an isomeric indicator (22), capable of undergoing at least one color change and optionally a controller (23) for said indicator capable of influencing the time and temperature required for said color change when contact with steam. Composed of polymeric binder (21).

Claims

1. A device for monitoring integral value of time, temperature and water vapor comprising at least one layer of polymer comprising an isomeric indicator capable of undergoing at least one color change, a controller for said indicator capable of influencing the time and temperature required for said color change when contacted with water vapor, wherein said indicator undergoes an isomerization reaction which causes said indicator to undergo said color change.

2. The device of claim 1 where isomerization is due to phase change, polymorphism, tautomerism, dissolution, oxidation or reduction.

3. The device of claim 2 wherein said indicator has at least two isomeric forms each having different colors.

4. The device of claim 2 where said color change is due to dissolution of said indicator.

5. The device of claim 2 where said color change is due to oxidation of said indicator.

6. The device of claim 2 where said color change is due to reduction of said indicator.

7. The device of claim 1 wherein said indicator comprises at least one member of the group consisting of pigments, dyes, and precursors of dyes and pigments.

8. The device of claim 7 wherein said indicator comprises at least one member chosen from the group consisting of acid alizarin violet N, acid blue 113, acid blue 93, acid red 88, auramine-O, azures, benzo purpurin 4B, bismarck brown Y, brilliant crocein MOO, bromocresol purple, bromophenol blue, bromopyrogallol red, chrysoidin, chrysophenine, Congo red, darrow red, dimethylmethylene blue, direct blue 71, direct red 75, disperse blue 14, eriochrome blue black B, Guinea green B, indoline blue, Janus green B, leuco crystal violet, meta-cresol purple, methylene blue, methythymol blue, naphthochrome green, Nile blue chloride, oil blue N, pararosaniline acetate, pyrogallol red, quinoline yellow, rhodamine, solvent blue 59, solvent green 3, and thionin.

9. The device of claim 1 where said layer comprises said indicator and at least one neutral coloring material which does not change color with humidity.

10. The device of claim 1 wherein said color change is selected from a group consisting of red-to-blue, purple-to-blue, yellow-to-blue, colorless-to-green, colorless-to-blue, colorless-to-red, blue-to-red, red-to-yellow, and green-to-colorless.

11. The device of claim 1 wherein said polymer is soluble in an organic solvent.

12. The device of claim 1 wherein said polymer is soluble in water or is water dispersible.

13. The device of claim 12 wherein said polymer is a water soluble or water dispersable homopolymer, copolymer or a mixture thereof.

14. The device of claim 1 wherein said polymer comprises polymerized monomers of styrene, acrylate, acrylic acid, acrylamide, vinyl acetate, vinyl alcohol, vinyl chloride, polyurethanes, cellulose nitrate and carboxymethyl cellulose.

15. The device of claim 1 wherein said polymer is a homopolymer, copolymer or a mixture thereof.

16. The device of claim 1 wherein said polymer is an acrylate polymer.

17. The device of claim 1 wherein said polymer is cellulose nitrate or carboxymethylcellulose.

18. The device of claim 1 wherein said polymer is formed by high energy radiation.

19. The device of claim 1 said polymer is formed by UV light and electron beam.

20. The device of claim 1 wherein said controller is present in an amount of 0.1 to 50%, by weight.

21. The device of claim 20 where said controller is capable of introducing isomerization.

22. The device of claim 1 where said controller comprises a salt, amine, metal chelate, chelating agent, oxidizing agent, reducing agent or solid solvent.

23. The device of claim 22 where said salt is chosen from a group consisting of sodium chloride, sodium thiocyanate and zinc oxide.

24. The device of claim 22 where said amine is chosen from a group consisting of tetramethylhexane diamine, diethylamine, ethylene diamine, diethanolamine, and cyclohexylamine.

25. The device of claim 22 where said oxidizing agent comprises a compound chosen from a group consisting of nitrates, peroxides, persulfates, perchlorates, per-iodates, peroxyacids, amine-oxides, alkyl nitrates, complexes of halides such as bromine, and oxidized metal salts.

26. The device of claim 22 where said oxidizing agent comprises a compound chosen from a group consisting of ammonium nitrate, hydrogen peroxide and sodium persulfate.

27. The device of claim 22 where said reducing agent is chosen from a group consisting of borohydride, sulfite, sulfide, nitrite, salt of a reduced metal, hydride, hydrosulfite, hydazine, oxime, and unsaturated organic compound.

28. The device of claim 22 wherein said reducing agent is chosen from a group consisting of ascorbic acid, sodium sulfite, sodium hydrosulfite, sodium borohydride, sodium nitrite, hydrazine or its derivatives, ammonium sulfite, ammonium thiocyanate, calcium ferrocyanide, Fe(II) salts, isoascorbic acid, sodium bisulfite, sodium cyanate, sodium dithionite, sodium hydrosulfide, sodium sulfite, sodium thiocyanate, sodium thiosulfate, benzoquinone dioxime, cupferron, cyclopenatanone oxime, diphenylglyoxime, salicyladoxime, ascorbic acid and a derivative of ascorbid acid.

29. The device of claim 22 where said chelating agent comprises a compound chosen from a group consisting of benzylacetylacetonate, iron acetylacetonate, and aluminum acetylacetonate.

30. The device of claim 22 where said solid solvent melts below 150°

C. or is dissolved with water vapor.

31. The device of claim 22 where said solid solvent comprises a compound chosen from a group consisting of phenol, polyalcohols, acids, amines, esters, amides, lactones, parafins and halogenated parafins.

32. The device of claim 22 where said solid solvent comprises a compound chosen from a group consisting of benzoic acid, diphenyl butyro lactone, glucose pentaacetate, glyconolactone, inositol, chlorinated paraffins, trichlorobenzylacetate, trichloroacetamide, vitamin-c palmitate, tribenzylamine, salicylanamide, and hexachloro norborene dicarboxylic acid.

33. The device of claim 1 wherein the said controller is capable of influencing said time and said temperature required for said color change.

34. The device of claim 1 further comprising a second indicator layer.

35. The device of claim 1 further comprising a polymeric top layer.

36. The device of claim 1 further comprising a wedge shaped polymeric top layer.

37. The device of claim 1 further comprising plurality of devices wherein said plural devices comprise plural indicators and undergo color changes independently.

38. A process of making the device of any of claims 1-37 comprising:

a) dissolving or dispersing said indicator in a solvent to form a solution;

b) applying said solution to a substrate;

c) permitting said solvent to evaporate.

39. The process of claim 38 wherein said substrate is a container for an item to be sterilized.

40. The process of claim 38 wherein said substrate is chosen from plastic film, paper and metal.

41. The process of claim 38 wherein said substrate comprises polyester film, paper or spun bonded polyolefins.

42. The process of claim 38 wherein said solution is an ink formulation.

43. The process of claim 42 wherein said solution is an aqueous ink formulation.

44. The process of claim 42 wherein said ink formulation comprises an acrylate polymer.

45. The process of claim 38 wherein said solution is applied to said substrate by a spraying.

46. The process of claim 45 wherein said spraying is a jet spray.

47. A process of using a device of any of claims 1-37 for monitoring sterilization of materials comprising the steps of:

a) affixing said device to said materials or containers containing said materials;

b) carrying out a process of sterilization;

c) introducing steam during said process of sterilization; and

d) observing a color change indicating said sterilization has proceeded.

48. The process of claim 47 wherein said material is a medical supply, a food, a pharmaceutical, or a biological waste.

49. A process of using the device of claim 1 for monitoring steam comprising the steps of:

a) exposing said device to steam,

b) observing a color change in said device.

50. A formulation for making the device of claim 1 comprising a polymeric binder, indicator, controller and solvent.

51. The formulation of claim 50 further comprising a polymer of any of claims 11-19.

52. The device of claim 1 comprising 50-100%, by weight, of said isomeric indicator.