Ultraviolet Sanitization In Pharmacy Environments

• US 20080199353A1
• Filed: 02/22/2008
• Published: 08/21/2008
• Est. Priority Date: 12/22/2005
• Status: Active Grant

• Current Assignee: ArXium, Inc. (Van Humbeck Family)
• Original Assignee: Intelligent Hospital Systems, Inc. (Van Humbeck Family)
• Inventors: Eliuk, Walter W., Rob, Ronald H., Mlodzinski, Lance R., Reinhardt, Alex H., Davidson, Robert Keith
• Granted Patent: US 7,931,859 B2
• Time in Patent Office: Days
• US Class Current: 422/24
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 2200/74 for weight
• CPC Class Codes: A61J 2205/10 Bar codes
• CPC Class Codes: A61J 2205/30 Printed labels
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: B01F 33/85 Mixing plants with mixing receptacles or mixing tools that can be indexed into different working positions
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 55/08 by irradiation
• CPC Class Codes: G07F 11/165 using xyz-picker or multi-dimensional article picking arrangements
• CPC Class Codes: G07F 11/1657 the picking arrangements using suction
• CPC Class Codes: G07F 11/44 in which magazines the articles are stored in bulk
• CPC Class Codes: G07F 11/48 the storage containers or supports, e.g. magazine, being pivotally mounted
• CPC Class Codes: G07F 11/54 about vertical axes
• CPC Class Codes: G07F 11/62 in which the articles are stored in compartments in fixed receptacles
• CPC Class Codes: G07F 17/0092 for assembling and dispensing of pharmaceutical articles medical dispensers for private use, A61J7/00
• CPC Class Codes: G07F 9/10 Casings or parts thereof, e.g. with means for heating or cooling
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: Y10S 604/905 : Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

Systems and methods to reduce bioburden on at least a portion of a fluid transfer port include supplying a dose of radiation to the portion in optical communication with at least one source of radiation. In an illustrative example, a medical container, such as a vial or IV bag, receives a dose of ultraviolet (UV) energy substantially at a predetermined region of a fluid transfer site. In some examples, such a sanitization process may precede a fluid transfer operation in which a fluid is transferred into or out of the medical container by passing through the sanitized region. Such fluid transfers may be used in automated or semi-automated pharmaceutical processes, such as drug reconstitution. Various embodiments may further include one or more seal assemblies, each seal assembly having an aperture through which the radiation dose is supplied from the source to a controlled region on the fluid transfer port.

Claims

1. A system to automate pharmaceutical compounding, the system comprising:

a chamber;

an automated system to transport medical containers within the chamber;

a compounding system disposed in the chamber to transfer medicaments between medical containers; and

a sanitization system to substantially reduce bioactivity on at least a portion of a fluid transfer port of a medical container, the sanitization system comprising;

at least one radiation source to supply a dose of radiation;

a plurality of radiation seal assemblies, each radiation seal assembly having an aperture and configured to engage a fluid transfer port of a medical container having a particular shape;

a controller to determine which radiation seal assembly corresponds to the fluid transfer port to be sanitized; and

an actuator to bring the portion of the fluid transfer port to be sanitized into optical communication with the radiation source through the aperture of the determined radiation seal assembly.

2. The system of claim 1 further comprising a control system to regulate a pressure in the chamber.

3. The system of claim 1, wherein the radiation source comprises an ultraviolet (UV) source.

4. The system of claim 3, wherein the UV source is configured to supply a dose of UV radiation comprising a substantially pulsed wave form.

5. The system of claim 3, wherein the UV source is configured to supply a dose of UV radiation comprising a substantially constant wave form.

6. The system of claim 3, wherein the UV source is configured to maintain a predetermined profile of UV output by calibration.

7. The system of claim 3, wherein the UV source is configured to maintain a predetermined profile of UV output by closed-loop control.

8. The system of claim 1, wherein the sanitization system further comprising at least one optical conduit configured to transmit radiation from the radiation source to the portion of the fluid transfer port to be sanitized.

9. The system of claim 1, wherein each radiation seal assembly is configured to not touch the portion of the fluid transfer port to be sanitized.

10. The system of claim 1, wherein at least one radiation seal assembly comprises a gasket formed around the aperture.

11. The system of claim 10, wherein the radiation seal assembly further comprises chamfered guides to promote engagement between the fluid port to be sanitized and the gasket.

12. The system of claim 10, wherein the gasket comprises a flexible UV blocking material.

13. The system of claim 10, the sanitization system further comprising a pressure chamber configured to substantially form a light seal between the fluid transfer port to be sanitized and the gasket.

14. The system of claim 1, wherein the sanitization system further comprising an interlock to determine whether the radiation source can be activated to supply the dose of radiation.

15. The system of claim 1 further comprising a fluid transfer system that can transfer fluid through the sanitized portion of the fluid transfer port.

16. The system of claim 1, wherein the medical container to be sanitized comprises a drug vial.

17. The system of claim 1, wherein the medical container to be sanitized comprises an IV bag.

18. The system of claim 1, wherein the medical container to be sanitized comprises a syringe.

19. The system of claim 1, wherein an interior of the chamber is substantially aseptic.

20. The system of claim 19, wherein the interior of the chamber meets ISO Class 5 clean room standards.

21. The system of claim 1, wherein the sanitization system substantially disinfects the portion of the fluid transfer port to be sanitized.

22. The system of claim 21, wherein the sanitization system substantially sterilizes the portion of the fluid transfer port to be sanitized.

23. A sanitization system to substantially reduce bioactivity on at least a portion of a fluid transfer port of a medical container, the system comprises:

at least one radiation source to supply a dose of radiation;

a plurality of radiation seal assemblies, each radiation seal assembly having an aperture and configured to engage a fluid transfer port of a medical container having a particular shape; and

an actuator to bring the portion of the fluid transfer port to be sanitized into optical communication with the radiation source through the aperture of the radiation seal assembly determined to correspond to the fluid transport to be sanitized.

24. The sanitization system of claim 23 further comprising a controller to determine which radiation seal assembly corresponds to the fluid transfer port to be sanitized.

25. The sanitization system of claim 23, wherein the radiation source comprises an ultraviolet (UV) source.

26. The sanitization system of claim 25, wherein the UV source is configured to supply a dose of UV radiation comprising a substantially pulsed wave form.

27. The sanitization system of claim 25, wherein the UV source is configured to supply a dose of UV radiation comprising a substantially constant wave form.

28. The sanitization system of claim 25, wherein the UV source is configured to maintain a predetermined profile of UV output by calibration.

29. The sanitization system of claim 25, wherein the UV source is configured to maintain a predetermined profile of UV output by closed-loop control.

30. The sanitization system of claim 23, wherein the sanitization system further comprising at least one optical conduit configured to transmit radiation from the radiation source to the portion of the fluid transfer port to be sanitized.

31. The sanitization system of claim 23, wherein each radiation seal assembly is configured to not touch the portion of the fluid transfer port to be sanitized.

32. The sanitization system of claim 23, wherein at least one radiation seal assembly comprises a gasket formed around the aperture.

33. The sanitization system of claim 32, wherein the radiation seal assembly further comprises chamfered guides to promote engagement between the fluid port to be sanitized and the gasket.

34. The sanitization system of claim 32, wherein the gasket comprises a flexible UV blocking material.

35. The sanitization system of claim 32 further comprising a pressure chamber configured to substantially form a light seal between the fluid transfer port to be sanitized and the gasket.

36. The sanitization system of claim 23 further comprising an interlock to determine whether the radiation source can be activated to supply the dose of radiation.

37. The sanitization system of claim 23, wherein the medical container to be sanitized comprises a drug vial.

38. The sanitization system of claim 23, wherein the medical container to be sanitized comprises an IV bag.

39. The sanitization system of claim 23, wherein the medical container to be sanitized comprises a syringe.

40. The sanitization system of claim 23 further comprising a pressure controlled chamber that substantially contains the radiation source, the plurality of radiation seal assemblies, and the actuator.

41. The sanitization system of claim 40, wherein an interior of the pressure controlled chamber is substantially aseptic.

42. The sanitization system of claim 40, wherein the interior of the pressure controller chamber meets ISO Class 5 clean room standards.

43. The sanitization system of claim 23, wherein the controller is coupled to receive identifying information about the medical container from a pharmaceutical prescription database.

44. The sanitization system of claim 23, said sanitization system substantially disinfects the portion of the fluid transfer port to be sanitized.

45. The system of claim 44, said sanitization system substantially sterilizes the portion of the fluid transfer port to be sanitized.

46. A method of substantially sanitizing at least a portion of a fluid transfer port of a medical container, the method comprising the steps of:

providing a sanitization system having at least one radiation source and a plurality of radiation seal assemblies, each radiation seal assembly having an aperture and configured to engage a fluid transfer port of a medical container having a particular shape;

retrieving the medical container to be sanitized;

determining which radiation seal assembly corresponds to the medical container;

engaging the medical container with the determined radiation seal assembly; and

supplying a predetermined dose of radiation from the radiation source to the portion of the fluid transfer port to be sanitized to substantially reduce bioactivity thereon.

47. The method of claim 46, wherein the radiation source comprises an ultraviolet (UV) source.

48. The method of claim 46, wherein retrieving the medical container comprises actuating an automated transfer mechanism to bring the fluid transfer port to be sanitized into substantial register with the determined radiation seal assembly.

49. The method of claim 46, wherein supplying a predetermined dose comprises transmitting the dose through an optical conduit.

50. The method of claim 46, wherein engaging the medical container with the determined radiation seal assembly comprises substantially forming a light seal between the medical container to be sanitized and the determined radiation seal assembly using a pressure chamber.

51. The method of claim 46, wherein the retrieved medical container comprises a drug vial.

52. The method of claim 46, wherein the retrieved medical container comprises an IV bag.

53. The method of claim 46, wherein the retrieved medical container comprises a syringe.

54. The method of claim 46 further comprising transferring fluid through the sanitized portion of the fluid transfer port.

55. The method of claim 46, wherein each radiation seal assembly is configured to not touch the portion of the fluid transfer port to be sanitized.

56. The method of claim 46, wherein sanitizing the portion of the fluid transfer port comprises substantially disinfecting the portion of the fluid transfer port to be sanitized.

57. The method of claim 46, wherein sanitizing the portion of the fluid transfer port comprises substantially sterilizing the portion of the fluid transfer port to be sanitized.