초록 ▼

A packaging system in accordance with the principles of the present invention includes a sterilization pouch. The pouch includes a posterior portion attached to an anterior portion along three edges. The two portions define the pouch. The top part of the pouch is inverted so that the inside part of

A packaging system in accordance with the principles of the present invention includes a sterilization pouch. The pouch includes a posterior portion attached to an anterior portion along three edges. The two portions define the pouch. The top part of the pouch is inverted so that the inside part of the pouch is facing outward and forms a cuff around the pouch. An integral internal sterilization indicator is further provided. The integral indicator comprises a sterilizing agent sensitive substance. The sterilizing agent sensitive substance can be an indicator ink printed as an ink line on the interior of the sterilization pouch below the cuff. Thus, the indicator becomes visible during aseptic delivery of the packaged article to provide a clear indication as to whether or not adequate conditions for sterilization have been achieved. In a further embodiment, the indicator ink line repeats as a pattern throughout the interior of the sterilization pouch. Alternatively, the indicator could be printed as an ink line on the exterior of the sterilization pouch below the cuff. In a further embodiment, both interior and exterior printing could be used.

대표청구항 ▼

What is claimed is: 1. A packaging system for a sterilizable article comprising: a sterilization pouch comprising a uniform material; and an integral sterilization indicator that repeats as a pattern throughout the interior surface of the sterilization pouch, wherein when the sterilization pouch is

What is claimed is: 1. A packaging system for a sterilizable article comprising: a sterilization pouch comprising a uniform material; and an integral sterilization indicator that repeats as a pattern throughout the interior surface of the sterilization pouch, wherein when the sterilization pouch is in a first position, the pattern on the interior surface of the sterilization pouch is not visible, and when the sterilization pouch is in a second position, the pattern on the interior surface of the sterilization pouch is visible, and wherein the integral sterilization indicator comprises a plurality of chemical indicators that are responsive to different sterilization environments. 2. The packaging system of claim 1 further wherein the sterilization pouch includes a posterior portion attached to an anterior portion along three edges, wherein the posterior and anterior portions define the sterilization pouch. 3. The packaging system of claim 1 further wherein the sterilization pouch comprising a sterilizable, flexible, elongate-tubular member having an outside, a closed end and an open end. 4. The packaging system of claim 1 further wherein a top part of the sterilization pouch is inverted so that the inside part of the sterilization pouch is facing outward and forms a cuff around the sterilization pouch. 5. The packaging system of claim 4 further wherein the integral sterilization indicator is located on the interior of the sterilization pouch below the cuff. 6. The packaging system of claim 5 further wherein the integral sterilization indicator is located on the interior of the sterilization pouch immediately below the cuff. 7. The packaging system of claim 4 further wherein the integral sterilization indicator is located on the cuff. 8. The packaging system of claim 1 further wherein the integral sterilization indicator is located on the exterior of the sterilization pouch. 9. The packaging system of claim 1 further wherein the integral sterilization indicator comprises a sterilizing agent sensitive substance. 10. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance comprises a first indicating state prior to exposure to a sterilization procedure and a second indicating state after exposure to the sterilization procedure. 11. The packaging system of claim 10 further wherein the first indicating state comprises a first color and the second indicating state comprises a color that is visually distinguishable from the first color. 12. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance comprises a first color prior to exposure to a sterilization procedure and comprises a second color that is visually distinguishable from the first color after exposure to the sterilization procedure. 13. The packaging system of claim 12 further wherein the first color comprises a substantially clear or transparent or translucent state, and the second color comprises a substantially opaque or colored state. 14. The packaging system of claim 1 further wherein the integral sterilization indicator comprises an indicator ink printed on the interior of the pouch. 15. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance is responsive to hydrogen peroxide sterilization. 16. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance is responsive to steam sterilization. 17. The packaging system of claim 16 further wherein the sterilizing agent sensitive substance includes sulfur-containing radicals that decompose under steam sterilization conditions to become a visually distinct. 18. The packaging system of claim 16 further wherein the sterilizing agent sensitive substance includes sulfur-containing radicals that decompose under steam sterilization conditions with a pronounced color change. 19. The packaging system of claim 17 further wherein the sterilizing agent sensitive substance includes sulfur-containing radicals that decompose to metal sulfide under steam sterilization conditions. 20. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance is responsive to ethylene oxide sterilization. 21. The packaging system of claim 20 further wherein the sterilizing agent sensitive substance comprises 4(4-nitrobenzyl)pyridine. 22. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance is responsive to peracetic acid sterilization. 23. The packaging system of claim 22 further wherein the sterilizing agent sensitive substance comprises a colorant susceptible to halogenation. 24. The packaging system of claim 23 further wherein the colorant comprises an indicating ink. 25. The packaging system of claim 24 further wherein the indicating ink may comprises fluorescein or phenol red or both. 26. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance comprises a dye selected from the group of dyes suitable for use in a sterilizing agent sensitive substance and combinations thereof. 27. The packaging system of claim 26 further wherein the dyes are selected from the group comprising phenol red, fluorescein, ethyl red, thymol blue, Acid Fuchsin, m-cresol purple, bromophenol blue, bromocresol green, cresol red, and combinations thereof. 28. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance is formulated to be of the classes of chemical indicators found in Sterilization of Health Care Products-Chemical Indicators-Part 1: General Requirements, ANSI/AAMI ST 60-(1996). 29. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance satisfies the 121° Celsius test defined in Section 6.1 of the Sterilization of Health Care Products-Chemical Indicators-Part 1: General requirements, ANSI/AAMI ST 60-(1996). 30. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance satisfies the 134° Celsius test defined in Section 6.1 of the Sterilization of Health Care Products-Chemical Indicators-Part 1: General Requirements, ANSI/AAMI ST 60-(1996). 31. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance satisfies both the 121° Celsius test and the 134° Celsius test defined in Section 61 of the Sterilization of Health Care Products-Chemical Indicators-Part 1: General Requirements, ANSI/AAMI ST 60-(1996). 32. The packaging system of claim 9 further wherein the sterilizing agent sensitive substance satisfies the tests for ethylene oxide sterilization processes defined in Sterilization of Health Care Products-Chemical Indicators-Part 1: General Requirements, ANSI/AAMI ST 60-(1996). 33. The packaging system of claim 1 further wherein the sterilizing agent sensitive substance is formulated so that it reacts to critical parameters over a specific range of a sterilization process. 34. The packaging system of claim 33 further wherein the sterilizing agent sensitive substance reacts to the parameters of a steam sterilization process. 35. The packaging system of claim 34 further wherein the sterilizing agent sensitive substance reacts to the parameters of time, temperature and saturated steam. 36. A packaging system for a sterilizable article comprising: a sterilization pouch comprising a uniform material; a top part of the sterilization pouch inverted so that the inside part of the sterilization pouch is facing outward and forms a cuff around the sterilization pouch; and an integral sterilization indicator that repeats as a pattern throughout the interior surface of the sterilization pouch below the cuff, wherein when the sterilization pouch is in a closed position, the pattern on the interior surface of the sterilization pouch is not visible, and when the sterilization pouch is in an open position, the pattern on the interior surface of the sterilization pouch is visible, wherein the integral sterilization indicator comprises a plurality of chemical indicators that are responsive to different sterilization environments. 37. The packaging system of claim 36 further wherein the integral sterilization indicator is located on the interior of the sterilization pouch below the cuff. 38. The packaging system of claim 37 further wherein the integral sterilization indicator is located on the interior of the sterilization pouch immediately below the cuff. 39. The packaging system of claim 36 further wherein the integral sterilization indicator is located on the cuff. 40. The packaging system of claim 36 further wherein the integral sterilization indicator comprises a sterilizing agent sensitive substance. 41. The packaging system of claim 40 further wherein the sterilizing agent sensitive substance comprises a first indicating state prior to exposure to a sterilization procedure and a second indicating state after exposure the sterilization procedure. 42. The packaging system of claim 40 further wherein the sterilizing agent sensitive substance comprises a dye selected from the group of dyes suitable for use in a sterilizing agent sensitive substance and combinations thereof. 43. A packaging system for a sterilizable article comprising: a sterilization pouch comprising a uniform material, and adapted to aseptically deliver a sterilized article by inverting the pouch; and an integral internal sterilization indicator that repeats as a pattern throughout the interior surface of the sterilization pouch, wherein when the sterilization pouch is in a closed position, the pattern on the interior surface of the sterilization pouch is not visible, and when the sterilization pouch is inverted during aseptic delivery of the sterilized article, the pattern on the interior surface of the sterilization pouch becomes visible, wherein the integral sterilization indicator comprises a plurality of chemical indicators that are responsive to different sterilization environments. 44. The packaging system of claim 43 further wherein a top part of the sterilization pouch is inverted so that the inside part of the sterilization pouch is facing outward and forms a cuff around the sterilization pouch. 45. The packaging system of claim 44 further wherein the integral internal sterilization indicator is located on the interior of the sterilization pouch below the cuff. 46. The packaging system of claim 45 further wherein the integral internal sterilization indicator is located on the cuff. 47. The packaging system of claim 43 further wherein the integral internal sterilization indicator comprises a sterilizing agent sensitive substance. 48. The packaging system of claim 47 further wherein the sterilizing agent sensitive substance comprises a first indicating state prior to exposure to a sterilization procedure and a second indicating state after exposure to the sterilization procedure. 49. The packaging system of claim 47 further wherein the integral internal sterilization indicator comprises an indicator ink printed on the interior of the pouch. 50. The packaging system of claim 47 further wherein the integral internal sterilization indicator comprises an indicator ink printed on the exterior of the pouch. 51. The packaging system of claim 40 further wherein the sterilizing agent sensitive substance is responsive to hydrogen peroxide sterilization. 52. The packaging system of claim 40 further wherein the sterilizing agent sensitive substance is responsive to steam sterilization. 53. The packaging system of claim 40 further wherein the sterilizing agent sensitive substance is responsive to ethylene oxide sterilization. 54. The packaging system of claim 40 further wherein the sterilizing agent sensitive substance is responsive to peracetic acid sterilization. 55. The packaging system of claim 47 further wherein the sterilizing agent sensitive substance comprises a dye selected from the group of dyes suitable for use in a sterilizing agent sensitive substance and combinations thereof.