Ultraviolet sanitization in pharmacy environments

• US 7,931,859 B2
• Filed: 02/22/2008
• Issued: 04/26/2011
• 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: Davidson, Robert Keith, Eliuk, Walter W., Rob, Ronald H., Mlodzinski, Lance R., Reinhardt, Alex H.
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Chorbaji; Monzer R
• Application Number:
  US12/035,850
• Publication Number:
  US 20080199353A1
• Time in Patent Office: 1,159 Days
• Field of Search: 422/1, 422/22, 422/24, 422/121, 422/186, 422/186.3, 422/305, 250/455.11, 250/492.1, 250/435, 606/15, 606/7, 221/123, 221/130, 604/29, 604/411, 604/905
• 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 first fluid transfer port of a first form of medical container and a second fluid transfer port of a second form of medical container, the sanitization system comprising;

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

a first radiation seal assembly having a first aperture and being configured to engage the first fluid transfer port of the first form of medical container;

at least a second radiation seal assembly substantially different from the first radiation seal assembly, wherein the second radiation seal assembly has a second aperture and is configured to engage the second fluid transfer port of the second form of medical container, the second form medical container being substantially different from the first form of medical container;

a controller to determine which radiation seal assembly corresponds to a third fluid transfer port to be sanitized, wherein the third fluid transfer port is part of a third medical container, the third medical container being one of the first form and the second form; and

an actuator to bring the portion of the third 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 to reduce at least 99% of biocontaminants.

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

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

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

8. The system of claim 7, wherein the first radiation seal assembly or the second radiation seal assembly further comprises chamfered guides to promote engagement between the third fluid port and the gasket.

9. The system of claim 7, wherein the gasket comprises a flexible UV blocking material.

10. The system of claim 7, wherein the sanitization system further comprises a pressure chamber configured to substantially form a light seal between the third fluid transfer port and the gasket.

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

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

13. The system of claim 1, wherein at least one of the first form of medical container and the second form of medical container comprises a drug vial, an IV bag, or a syringe.

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

15. The system of claim 14, wherein the interior of the chamber meets ISO Class 5 clean room standards.

16. The system of claim 1, wherein the third medical container is disposed on a moveable platen.

17. The system of claim 1, wherein the first radiation seal assembly and the second radiation seal assembly are coupled to a rotating carousel.

18. The system of claim 17, wherein the rotating carousel is configured to receive removable or interchangeable radiation seal assemblies.

19. The system of claim 1, wherein the sanitization system further comprises at least one optical sensor to detect the presence of the radiation.

20. The system of claim 1, further comprising a pharmacy computer system, wherein the controller can obtain information indicating the form of the third medical container from the pharmacy computer system.

21. The system of claim 1, wherein the sanitization system further comprises a cooling and venting system including at least one HEPA fan filter unit.

22. A sanitization system to substantially reduce bioactivity on at least a portion of a first fluid transfer port of a first form of medical container and a second fluid transfer port of a second form of medical container, the system comprising:

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

a first radiation seal assembly having a first aperture and being configured to engage the first fluid transfer port of the first form of medical container;

at least a second radiation seal assembly substantially different from the first radiation seal assembly, wherein the second radiation seal assembly has a second aperture and is configured to engage the second fluid transfer port of the second form of medical container, wherein the second form of medical container has particular shape substantially different from the first form of medical container;

a controller to determine which radiation seal assembly corresponds to a third fluid transfer port to be sanitized, wherein the third fluid transfer port is part of a third medical container, the third medical container being one of the first form and the second form; and

an actuator to bring the portion of the third 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 third fluid transfer port.

23. The sanitization system of claim 22, wherein the radiation source comprises an ultraviolet (UV) source.

24. The system of claim 23, wherein the UV source is configured to supply a dose of UV radiation to reduce at least 99% of biocontaminants.

25. The sanitization system of claim 22, wherein the sanitization system further comprises at least one optical conduit configured to transmit radiation from the radiation source to the portion of the third fluid transfer port to be sanitized.

26. The sanitization system of claim 22, wherein each radiation seal assembly is configured to not touch the portion of the third fluid transfer port to be sanitized.

27. The sanitization system of claim 22, wherein at least one of the first radiation seal assembly and the second radiation seal assembly comprises a gasket formed around the aperture.

28. The sanitization system of claim 27, wherein the at least one of the first radiation seal assembly and the second radiation seal assembly further comprises chamfered guides to promote engagement between the third fluid port to be sanitized and the gasket.

29. The sanitization system of claim 27, wherein the gasket comprises a flexible UV blocking material.

30. The sanitization system of claim 27 further comprising a pressure chamber configured to substantially form a light seal between the third fluid transfer port to be sanitized and the gasket.

31. The sanitization system of claim 22 further comprising an interlock to determine whether the radiation source can be activated to supply the dose of radiation.

32. The sanitization system of claim 22, wherein at least one of the first form of medical container and the second form of medical container comprises a drug vial, an IV bag, or a syringe.

33. The sanitization system of claim 22 further comprising a pressure controlled chamber that substantially contains the radiation source, the first radiation seal assembly, the second radiation seal assembly, and the actuator.

34. The sanitization system of claim 33, wherein an interior of the pressure controlled chamber is substantially aseptic.

35. The sanitization system of claim 33, wherein the interior of the pressure controlled chamber meets ISO Class 5 clean room standards.

36. The sanitization system of claim 33, further comprising a cooling and venting system configured to manage an environment of the pressure controlled chamber, wherein the cooling and venting system includes at least one HEPA fan filter unit.

37. The sanitization system of claim 22, wherein the controller is coupled to receive indentifying information about the third medical container from a pharmaceutical prescription database.

38. The system of claim 22, further comprising a pharmacy computer system, wherein the controller can obtain information indicating the form of the third medical container from the pharmacy computer system.

39. The system of claim 22, wherein the controller generates a sanitizing profile tailored to sanitize the third medical container based on one or more of a size, type, and shape of the third medical container.

40. The sanitization system of claim 22, wherein the third medical container is disposed on a moveable platen.

41. The sanitization system of claim 22, wherein the first radiation seal assembly and the second radiation seal assembly are coupled to a rotating carousel.

42. The sanitization system of claim 22, further comprising at least one optical sensor to detect the presence of the radiation.

43. A method of substantially sanitizing at least a portion of a first fluid transfer port of a first form of medical container and at least a portion of a second fluid transfer port of a second form of medical container, the method comprising the steps of:

providing a sanitization system having at least one radiation source, a first radiation seal assembly having a first aperture and being configured to engage the first fluid transfer port of the first form of medical container, and a second radiation seal assembly substantially different from the first radiation seal assembly, wherein the second radiation seal assembly has a second aperture and is configured to engage the second fluid transfer port of the second form of medical container, wherein the second form of medical container has a particular shape substantially different from the first form of medical container;

retrieving a third medical container to be sanitized, wherein the third medical container has one of the first form and the second form;

determining, using a controller, which radiation seal assembly corresponds to the third medical container;

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

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

44. The method of claim 43, wherein the radiation source comprises an ultraviolet (UV) source.

45. The method of claim 44, wherein the UV source is configured to supply a dose of UV radiation to reduce at least 99% of biocontaminants.

46. The method of claim 45, further comprising, upon determining the corresponding radiation seal assembly, rotating the rotating carousel to align the corresponding radiation seal assembly for engagement with the third medical container.

47. The method of claim 43, wherein retrieving the third medical container comprises actuating an automated transfer mechanism to bring the third fluid transfer port to be sanitized into substantial register with the determined radiation seal assembly.

48. The method of claim 43, wherein supplying the predetermined dose comprises transmitting the dose through an optical conduit.

49. The method of claim 43, wherein engaging the third medical container with the determined radiation seal assembly comprises substantially forming a light seal between the third medical container to be sanitized and the determined radiation seal assembly using a pressure chamber.

50. The method of claim 43, wherein the third medical container comprises a drug vial, an IV bag, or a syringe.

51. The method of claim 43 further comprising transferring fluid through the sanitized portion of the third fluid transfer port.

52. The method of claim 43, wherein each radiation seal assembly is configured to not touch the portion of the third fluid transfer port to be sanitized.

53. The method of claim 43, further comprising disposing the third medical container on a movable platen, wherein engaging the third medical container comprises moving the movable platen to put the third medical container in an engaged position in relation to the determined radiation seal assembly.

54. The method of claim 43, wherein the first radiation seal assembly and the second radiation seal assembly are coupled to a rotating carousel.

55. The method of claim 43, wherein the sanitization system further comprises at least one optical sensor to detect the presence of the radiation.

56. The method of claim 43, further comprising obtaining information indicating the form of the third medical container from a pharmacy computer system.