초록 ▼

Devices and methods are disclosed for determining the amount of energy absorbed during irradiation. Such devices comprise a material that absorbs radiation in a quantifiable manner and a cooling agent to maintain the temperature of that material within a predetermined range, and may be used to deter

Devices and methods are disclosed for determining the amount of energy absorbed during irradiation. Such devices comprise a material that absorbs radiation in a quantifiable manner and a cooling agent to maintain the temperature of that material within a predetermined range, and may be used to determine the amount of energy absorbed during irradiation, for example during sterilization of a biological material.

대표청구항 ▼

1. A device for measuring the amount of energy absorbed by a product undergoing sterilization with radiation, comprising:(i) an effective amount of at least one material that absorbs radiation in a quantifiable manner; and(ii) an effective amount of at least one cooling agent for maintaining said at

1. A device for measuring the amount of energy absorbed by a product undergoing sterilization with radiation, comprising:(i) an effective amount of at least one material that absorbs radiation in a quantifiable manner; and(ii) an effective amount of at least one cooling agent for maintaining said at least one material within a predetermined temperature range between ?120° C. and ambient temperature during irradiation.2. The device according to claim 1, wherein said at least one material that absorbs radiation is selected from the group consisting of alanine, cellulose acetate, ethanol-chlorobenzene and radiochromic films.3. The device according to claim 1, wherein said at least one cooling agent comprises dry ice.4. The device according to claim 1, wherein said at least one cooling agent is of sufficient volume to contain at least a portion of said at least one material that absorbs radiation.5. The device according to claim 1, wherein said at least one cooling agent is in the form of particles.6. The device according to claim 5, wherein said particles have an average volume of not more than 17 cm3.7. The device according to claim 1, wherein said particles have an average volume of not more than 1 cm3.8. The device according to claim 1, wherein said at least one cooling agent is in the form of a solid or semi-solid.9. The device according to claim 1, further comprising a container of sufficient volume to contain at least a portion of said cooling agent and at least a portion of said material.10. The device according to claim 9, wherein said container is a vacuum Dewar.11. The device according to claim 1, wherein each endpoint of said temperature range is less than the freezing point of said product.12. The device according to claim 1, wherein each endpoint of said temperature range is less than ?20° C.13. The device according to claim 1, wherein each endpoint of said temperature range is less than ?40° C.14. The device according to claim 1, wherein each endpoint of said temperature range is less than ?60° C.15. The device according to claim 1, wherein each endpoint of said temperature range is less than ?70° C.16. A method for determining the amount of energy absorbed by a product undergoing irradiation, comprising:(a) placing within a suitable container at least one product to be sterilized and at least one device comprising:(i) at least one material that absorbs radiation in a quantifiable manner; and(ii) an effective amount of at least one cooling agent for maintaining said material within a predetermined temperature range between 120° C. and ambient temperature during irradiation;(b) irradiating with gamma radiation said container containing said at least one product and said at least one device; and(c) analyzing said at least one material to determine the amount of energy absorbed during said irradiation.17. A method for maintaining the temperature of a product undergoing irradiation within a predetermined temperature range between ?120° C. and ambient temperature, comprising:(a) placing at least one product to be irradiated comprising at least one material that absorbs radiation in a quantifiable manner in a suitable container having at least one side and a bottom, wherein the volume defined by said container is greater than the volume of said at least one product;(b) placing an effective amount of at least one cooling agent in said container between said at least one product and said at least one side; and(c) irradiating with gamma radiation said container containing said at least one product and said at least one cooling agent.18. The method according to claim 16 or 17, wherein said at least one product further comprises a biological material.19. The method according to claim 18, wherein said biological material is selected from the group consisting of dextrose, antithrombin III, plasma, plasminogen, urokinase, thrombin, trypsin, purified protein fraction, blood, blood cells, alpha-1 proteinase inhibitor, digestive enzymes, blood proteins and tissue.20. The method according to claim 19, wherein said tissue is selected from the group consisting of heart valves, ligaments and dimineralized bone matrix.21. The method according to claim 19, wherein said digestive enzymes are selected from the group consisting of galactosidases and sulfatases.22. The method according to claim 19, wherein said blood proteins are selected from the group consisting of albumin, Factor VIII, Factor VII, Factor IV, fibrinogen, monoclonal immunoglobulins and polyclonal immunoglobulins.23. The method according to claim 19, wherein said tissue is selected from the group consisting of tendons, nerves, bone, teeth, bone marrow, skin grafts, cartilage, corneas, arteries, veins and organs for transplantation.24. The method according to claim 18, further comprising at least one stabilizer in an amount effective to protect said biological material from said irradiation.25. The method according to claim 24, wherein said at least one stabilizer is selected from the group consisting of DMSO, mannitol, ascorbic acid and salts and esters thereof, trehalose and propylene glycol.26. The method according to claim 16 or 17, wherein said at least one cooling agent comprises dry ice.27. The method according to claim 16 or 17, wherein said at least one cooling agent is in the form of particles.28. The method according to claim 27, wherein said particles have an average volume of not more than 17 cm3.29. The method according to claim 28, wherein said particles have an average volume of not more than 1 cm3.30. The method according to claim 16 or 17, wherein said at least one cooling agent is in the form of a solid or semi-solid.31. The method according to claim 16 or 17, wherein said container is a vacuum Dewar.32. The method according to claim 16 or 17, wherein said container has a front side and a back side and a first side and a second side.33. The method according to claim 32, wherein said container is a foam box.34. The method according to claim 32, wherein said at least one cooling agent is placed between said at least one product and said first side, between said at least one product and said second side, or a combination thereof.35. The method according to claim 16 or 17, wherein said at least one material is selected from the group consisting of alanine, cellulose acetate, ethanol-chlorobenzene and radiochromic films.36. The method according to claim 16 or 17, wherein said at least one product is frozen.37. The method according to claim 16 or 17, wherein each endpoint of said temperature range is less than ambient temperature.38. The method according to claim 16 or 17, wherein each endpoint of said temperature range is less than the freezing point of said at least one product.39. The method according to claim 16 or 17, wherein each endpoint of said temperature range is less than ?70° C.40. The method according to claim 16 or 17, wherein each endpoint of said temperature range is less than the glass transition point of said at least one product.41. The method according to claim 16 or 17, wherein said temperature range is less than 10° C.42. The method according to claim 16 or 17, wherein said temperature range is less than 2° C.43. The method according to claim 16 or 17, wherein said temperature range is less than 0.1° C.44. The method according to claim 16 or 17, wherein said temperature range is less than 0.1° C. per kGy of radiation.45. The method according to claim 16 or 17, wherein said temperature range is less than 0.02° C. per kGy of radiation.